[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[From the U.S. Government Publishing Office]


          21



          Food and Drugs



[[Page 1]]

PARTS 170 TO 199

          Revised as of April 1, 1996
          CONTAINING
          A CODIFICATION OF DOCUMENTS
          OF GENERAL APPLICABILITY
          AND FUTURE EFFECT

          AS OF APRIL 1, 1996
          With Ancillaries
          Published by
          the Office of the Federal Register
          National Archives and Records
          Administration

          as a Special Edition of
          the Federal Register



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                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 1996



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



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                            Table of Contents


                                                                    Page
  Explanation.................................................       v

  Title 21:
    Chapter I--Food and Drug Administration, Department of 
        Health and Human Services (Continued).................       3
  Finding Aids:
    Material Approved for Incorporation by Reference..........     557
    Table of CFR Titles and Chapters..........................     571
    Alphabetical List of Agencies Appearing in the CFR........     578
    Redesignation Table.......................................     597
    List of CFR Sections Affected.............................     599

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----------------------------------------------------------                    
    Cite this Code:  CFR
                                                                                                                
    To cite the regulations in this volume use title, part
      and section number. Thus, 21 CFR 170.3 refers to
      title 21, part 170, section 3.

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                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 1996), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request. Many agencies have begun publishing numerous OMB 
control numbers as

[[Page vi]]

amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I), and Acts Requiring Publication 
in the Federal Register (Table II). A list of CFR titles, chapters, and 
parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.


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REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408.
SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
M-F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours 
a day. For payment by check, write to the Superintendent of Documents, 
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Customer Service call 202-512-1803.

                              Richard L. Claypoole,
                                    Director,
                          Office of the Federal Register.

April 1, 1996.



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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 1996.

    The Table of Exempt Prescription Products to part 1308 appears in 
the volume containing part 1300-end.

    Redesignation tables for Chapter I--Food and Drug Administration 
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.

    For this volume, Ruth Reedy Green was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

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[GRAPHIC] [TIFF OMITTED] TFRORDR.FRM

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                                                                     HN




                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 170 to 199)

  --------------------------------------------------------------------
                                                                    Part
chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         170

  Cross References: Food Safety and Inspection Service, Department of 
Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  United States Customs Service, Department of the Treasury: See Customs 
Duties, 19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I.

  Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: 
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.

[[Page 3]]





CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)




                           (Parts 170 to 199)

  --------------------------------------------------------------------

  Editorial Note: The Food and Drug Administration published a document 
at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform 
effective date for compliance for regulations affecting the labeling of 
food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 
1, 1989 as a new uniform effective date for compliance. The new uniform 
effective date will apply only to final FDA food labeling regulations 
published after July 1, 1986, and before January 1, 1988. At 55 FR 276, 
Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective 
date for compliance. The new uniform effective date will apply only to 
final FDA food labeling regulations published after January 1, 1990 and 
before January 1, 1992.

            SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CON'T.)
Part                                                                Page
170             Food additives..............................           5
171             Food additive petitions.....................          21
172             Food additives permitted for direct addition 
                    to food for human consumption...........          26
173             Secondary direct food additives permitted in 
                    food for human consumption..............         110
174             Indirect food additives: General............         135
175             Indirect food additives: Adhesives and 
                    components of coatings..................         136
176             Indirect food additives: Paper and 
                    paperboard components...................         177
177             Indirect food additives: Polymers...........         214
178             Indirect food additives: Adjuvants, 
                    production aids, and sanitizers.........         325
179             Irradiation in the production, processing 
                    and handling of food....................         402
180             Food additives permitted in food or in 
                    contact with food on an interim basis 
                    pending additional study................         407
181             Prior-sanctioned food ingredients...........         412
182             Substances generally recognized as safe.....         416

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184             Direct food substances affirmed as generally 
                    recognized as safe......................         434
186             Indirect food substances affirmed as 
                    generally recognized as safe............         526
189             Substances prohibited from use in human food         532
197             Seafood inspection program..................         537
198-199   [Reserved]

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                SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION


PART 170--FOOD ADDITIVES--Table of Contents




                      Subpart A--General Provisions

Sec.
170.3  Definitions.
170.6  Opinion letters on food additive status.
170.10  Food additives in standardized foods.
170.15  Adoption of regulation on initiative of Commissioner.
170.17  Exemption for investigational use and procedure for obtaining 
          authorization to market edible products from experimental 
          animals.
170.18  Tolerances for related food additives.
170.19  Pesticide chemicals in processed foods.

                     Subpart B--Food Additive Safety

170.20  General principles for evaluating the safety of food additives.
170.22  Safety factors to be considered.
170.30  Eligibility for classification as generally recognized as safe 
          (GRAS).
170.35  Affirmation of generally recognized as safe (GRAS) status.
170.38  Determination of food additive status.
170.39  Threshold of regulation for substances used in food-contact 
          articles.

        Subpart C--Specific Administrative Rulings and Decisions

170.45  Fluorine-containing compounds.
170.50  Glycine (aminoacetic acid) in food for human consumption.
170.60  Nitrites and/or nitrates in curing premixes.

    Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348, 371).

    Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 170.3   Definitions.

    For the purposes of this subchapter, the following definitions 
apply:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) As used in this part, the term act means the Federal Food, Drug, 
and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as 
amended (21 U.S.C. 301-392).
    (e)(1) Food additives includes all substances not exempted by 
section 201(s) of the act, the intended use of which results or may 
reasonably be expected to result, directly or indirectly, either in 
their becoming a component of food or otherwise affecting the 
characteristics of food. A material used in the production of containers 
and packages is subject to the definition if it may reasonably be 
expected to become a component, or to affect the characteristics, 
directly or indirectly, of food packed in the container. ``Affecting the 
characteristics of food'' does not include such physical effects, as 
protecting contents of packages, preserving shape, and preventing 
moisture loss. If there is no migration of a packaging component from 
the package to the food, it does not become a component of the food and 
thus is not a food additive. A substance that does not become a 
component of food, but that is used, for example, in preparing an 
ingredient of the food to give a different flavor, texture, or other 
characteristic in the food, may be a food additive.
    (2) Uses of food additives not requiring a listing regulation. 
Substances used in food-contact articles (e.g., food-packaging and food-
processing equipment) that migrate, or may be expected to migrate, into 
food at such negligible levels that they have been exempted from 
regulation as food additives under Sec. 170.39.
    (f) Common use in food means a substantial history of consumption of 
a substance for food use by a significant number of consumers.
    (g) The word substance in the definition of the term ``food 
additive'' includes a food or food component consisting of one or more 
ingredients.
    (h) Scientific procedures include those human, animal, analytical, 
and other scientific studies, whether published or unpublished, 
appropriate to establish the safety of a substance.
    (i) Safe or safety means that there is a reasonable certainty in the 
minds of competent scientists that the

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substance is not harmful under the intended conditions of use. It is 
impossible in the present state of scientific knowledge to establish 
with complete certainty the absolute harmlessness of the use of any 
substance. Safety may be determined by scientific procedures or by 
general recognition of safety. In determining safety, the following 
factors shall be considered:
    (1) The probable consumption of the substance and of any substance 
formed in or on food because of its use.
    (2) The cumulative effect of the substance in the diet, taking into 
account any chemically or pharmacologically related substance or 
substances in such diet.
    (3) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety of food and 
food ingredients, are generally recognized as appropriate.
    (j) The term nonperishable processed food means any processed food 
not subject to rapid decay or deterioration that would render it unfit 
for consumption. Examples are flour, sugar, cereals, packaged cookies, 
and crackers. Not included are hermetically sealed foods or manufactured 
dairy products and other processed foods requiring refrigeration.
    (k) General recognition of safety shall be determined in accordance 
with Sec. 170.30.
    (l) Prior sanction means an explicit approval granted with respect 
to use of a substance in food prior to September 6, 1958, by the Food 
and Drug Administration or the United States Department of Agriculture 
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry 
Products Inspection Act, or the Meat Inspection Act.
    (m) Food includes human food, substances migrating to food from 
food-contact articles, pet food, and animal feed.
    (n) The following general food categories are established to group 
specific related foods together for the purpose of establishing 
tolerances or limitations for the use of direct human food ingredients. 
Individual food products will be included within these categories 
according to the detailed classifications lists contained in Exhibit 33B 
of the report of the National Academy of Sciences/National Research 
Council report, ``A Comprehensive Survey of Industry on the Use of Food 
Chemicals Generally Recognized as Safe'' (September 1972), which is 
incorporated by reference. Copies are available from the National 
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, 
VA 22161, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408:
    (1) Baked goods and baking mixes, including all ready-to-eat and 
ready-to-bake products, flours, and mixes requiring preparation before 
serving.
    (2) Beverages, alcoholic, including malt beverages, wines, distilled 
liquors, and cocktail mix.
    (3) Beverages and beverage bases, nonalcoholic, including only 
special or spiced teas, soft drinks, coffee substitutes, and fruit and 
vegetable flavored gelatin drinks.
    (4) Breakfast cereals, including ready-to-eat and instant and 
regular hot cereals.
    (5) Cheeses, including curd and whey cheeses, cream, natural, 
grating, processed, spread, dip, and miscellaneous cheeses.
    (6) Chewing gum, including all forms.
    (7) Coffee and tea, including regular, decaffeinated, and instant 
types.
    (8) Condiments and relishes, including plain seasoning sauces and 
spreads, olives, pickles, and relishes, but not spices or herbs.
    (9) Confections and frostings, including candy and flavored 
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, 
powdered, and raw sugars.
    (10) Dairy product analogs, including nondairy milk, frozen or 
liquid creamers, coffee whiteners, toppings, and other nondairy 
products.
    (11) Egg products, including liquid, frozen, or dried eggs, and egg 
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and 
frozen multicourse egg meals, but not fresh eggs.
    (12) Fats and oils, including margarine, dressings for salads, 
butter, salad oils, shortenings and cooking oils.
    (13) Fish products, including all prepared main dishes, salads, 
appetizers, frozen multicourse meals, and spreads

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containing fish, shellfish, and other aquatic animals, but not fresh 
fish.
    (14) Fresh eggs, including cooked eggs and egg dishes made only from 
fresh shell eggs.
    (15) Fresh fish, including only fresh and frozen fish, shellfish, 
and other aquatic animals.
    (16) Fresh fruits and fruit juices, including only raw fruits, 
citrus, melons, and berries, and home-prepared ``ades'' and punches made 
therefrom.
    (17) Fresh meats, including only fresh or home-frozen beef or veal, 
pork, lamb or mutton and home-prepared fresh meat-containing dishes, 
salads, appetizers, or sandwich spreads made therefrom.
    (18) Fresh poultry, including only fresh or home-frozen poultry and 
game birds and home-prepared fresh poultry-containing dishes, salads, 
appetizers, or sandwich spreads made therefrom.
    (19) Fresh vegetables, tomatoes, and potatoes, including only fresh 
and home-prepared vegetables.
    (20) Frozen dairy desserts and mixes, including ice cream, ice 
milks, sherbets, and other frozen dairy desserts and specialties.
    (21) Fruit and water ices, including all frozen fruit and water 
ices.
    (22) Gelatins, puddings, and fillings, including flavored gelatin 
desserts, puddings, custards, parfaits, pie fillings, and gelatin base 
salads.
    (23) Grain products and pastas, including macaroni and noodle 
products, rice dishes, and frozen multicourse meals, without meat or 
vegetables.
    (24) Gravies and sauces, including all meat sauces and gravies, and 
tomato, milk, buttery, and specialty sauces.
    (25) Hard candy and cough drops, including all hard type candies.
    (26) Herbs, seeds, spices, seasonings, blends, extracts, and 
flavorings, including all natural and artificial spices, blends, and 
flavors.
    (27) Jams and jellies, home-prepared, including only home-prepared 
jams, jellies, fruit butters, preserves, and sweet spreads.
    (28) Jams and jellies, commercial, including only commercially 
processed jams, jellies, fruit butters, preserves, and sweet spreads.
    (29) Meat products, including all meats and meat containing dishes, 
salads, appetizers, frozen multicourse meat meals, and sandwich 
ingredients prepared by commercial processing or using commercially 
processed meats with home preparation.
    (30) Milk, whole and skim, including only whole, lowfat, and skim 
fluid milks.
    (31) Milk products, including flavored milks and milk drinks, dry 
milks, toppings, snack dips, spreads, weight control milk beverages, and 
other milk origin products.
    (32) Nuts and nut products, including whole or shelled tree nuts, 
peanuts, coconut, and nut and peanut spreads.
    (33) Plant protein products, including the National Academy of 
Sciences/National Research Council ``reconstituted vegetable protein'' 
category, and meat, poultry, and fish substitutes, analogs, and extender 
products made from plant proteins.
    (34) Poultry products, including all poultry and poultry-containing 
dishes, salads, appetizers, frozen multicourse poultry meals, and 
sandwich ingredients prepared by commercial processing or using 
commercially processed poultry with home preparation.
    (35) Processed fruits and fruit juices, including all commercially 
processed fruits, citrus, berries, and mixtures; salads, juices and 
juice punches, concentrates, dilutions, ``ades'', and drink substitutes 
made therefrom.
    (36) Processed vegetables and vegetable juices, including all 
commercially processed vegetables, vegetable dishes, frozen multicourse 
vegetable meals, and vegetable juices and blends.
    (37) Snack foods, including chips, pretzels, and other novelty 
snacks.
    (38) Soft candy, including candy bars, chocolates, fudge, mints, and 
other chewy or nougat candies.
    (39) Soups, home-prepared, including meat, fish, poultry, vegetable, 
and combination home-prepared soups.
    (40) Soups and soup mixes, including commercially prepared meat, 
fish, poultry, vegetable, and combination soups and soup mixes.
    (41) Sugar, white, granulated, including only white granulated 
sugar.
    (42) Sugar substitutes, including granulated, liquid, and tablet 
sugar substitutes.

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    (43) Sweet sauces, toppings, and syrups, including chocolate, berry, 
fruit, corn syrup, and maple sweet sauces and toppings.
    (o) The following terms describe the physical or technical 
functional effects for which direct human food ingredients may be added 
to foods. They are adopted from the National Academy of Sciences/
National Research Council national survey of food industries, reported 
to the Food and Drug Administration under the contract title ``A 
Comprehensive Survey of Industry on the Use of Food Chemicals Generally 
Recognized as Safe'' (September 1972), which is incorporated by 
reference. Copies are available from the National Technical Information 
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408:
    (1) ``Anticaking agents and free-flow agents'': Substances added to 
finely powdered or crystalline food products to prevent caking, lumping, 
or agglomeration.
    (2) ``Antimicrobial agents'': Substances used to preserve food by 
preventing growth of microorganisms and subsequent spoilage, including 
fungistats, mold and rope inhibitors, and the effects listed by the 
National Academy of Sciences/National Research Council under 
``preservatives.''
    (3) ``Antioxidants'': Substances used to preserve food by retarding 
deterioration, rancidity, or discoloration due to oxidation.
    (4) ``Colors and coloring adjuncts'': Substances used to impart, 
preserve, or enhance the color or shading of a food, including color 
stabilizers, color fixatives, color-retention agents, etc.
    (5) ``Curing and pickling agents'': Substances imparting a unique 
flavor and/or color to a food, usually producing an increase in shelf 
life stability.
    (6) ``Dough strengtheners'': Substances used to modify starch and 
gluten, thereby producing a more stable dough, including the applicable 
effects listed by the National Academy of Sciences/National Research 
Council under ``dough conditioner.''
    (7) ``Drying agents'': Substances with moisture-absorbing ability, 
used to maintain an environment of low moisture.
    (8) ``Emulsifiers and emulsifier salts'': Substances which modify 
surface tension in the component phase of an emulsion to establish a 
uniform dispersion or emulsion.
    (9) ``Enzymes'': Enzymes used to improve food processing and the 
quality of the finished food.
    (10) ``Firming agents'': Substances added to precipitate residual 
pectin, thus strengthening the supporting tissue and preventing its 
collapse during processing.
    (11) ``Flavor enhancers'': Substances added to supplement, enhance, 
or modify the original taste and/or aroma of a food, without imparting a 
characteristic taste or aroma of its own.
    (12) ``Flavoring agents and adjuvants'': Substances added to impart 
or help impart a taste or aroma in food.
    (13) ``Flour treating agents'': Substances added to milled flour, at 
the mill, to improve its color and/or baking qualities, including 
bleaching and maturing agents.
    (14) ``Formulation aids'': Substances used to promote or produce a 
desired physical state or texture in food, including carriers, binders, 
fillers, plasticizers, film-formers, and tableting aids, etc.
    (15) ``Fumigants'': Volatile substances used for controlling insects 
or pests.
    (16) ``Humectants'': Hygroscopic substances incorporated in food to 
promote retention of moisture, including moisture-retention agents and 
antidusting agents.
    (17) ``Leavening agents'': Substances used to produce or stimulate 
production of carbon dioxide in baked goods to impart a light texture, 
including yeast, yeast foods, and calcium salts listed by the National 
Academy of Sciences/National Research Council under ``dough 
conditioners.''
    (18) ``Lubricants and release agents'': Substances added to food 
contact surfaces to prevent ingredients and finished products from 
sticking to them.
    (19) ``Non-nutritive sweeteners'': Substances having less than 2 
percent of the caloric value of sucrose per equivalent unit of 
sweetening capacity.

[[Page 9]]

    (20) ``Nutrient supplements'': Substances which are necessary for 
the body's nutritional and metabolic processes.
    (21) ``Nutritive sweeteners'': Substances having greater than 2 
percent of the caloric value of sucrose per equivalent unit of 
sweetening capacity.
    (22) ``Oxidizing and reducing agents'': Substances which chemically 
oxidize or reduce another food ingredient, thereby producing a more 
stable product, including the applicable effect listed by the National 
Academy of Sciences/National Research Council under ``dough 
conditioners.''
    (23) ``pH control agents'': Substances added to change or maintain 
active acidity or basicity, including buffers, acids, alkalies, and 
neutralizing agents.
    (24) ``Processing aids'': Substances used as manufacturing aids to 
enhance the appeal or utility of a food or food component, including 
clarifying agents, clouding agents, catalysts, flocculents, filter aids, 
and crystallization inhibitors, etc.
    (25) ``Propellants, aerating agents, and gases'': Gases used to 
supply force to expel a product or used to reduce the amount of oxygen 
in contact with the food in packaging.
    (26) ``Sequestrants'': Substances which combine with polyvalent 
metal ions to form a soluble metal complex, to improve the quality and 
stability of products.
    (27) ``Solvents and vehicles'': Substances used to extract or 
dissolve another substance.
    (28) ``Stabilizers and thickeners'': Substances used to produce 
viscous solutions or dispersions, to impart body, improve consistency, 
or stabilize emulsions, including suspending and bodying agents, setting 
agents, jellying agents, and bulking agents, etc.
    (29) ``Surface-active agents'': Substances used to modify surface 
properties of liquid food components for a variety of effects, other 
than emulsifiers, but including solubilizing agents, dispersants, 
detergents, wetting agents, rehydration enhancers, whipping agents, 
foaming agents, and defoaming agents, etc.
    (30) ``Surface-finishing agents'': Substances used to increase 
palatability, preserve gloss, and inhibit discoloration of foods, 
including glazes, polishes, waxes, and protective coatings.
    (31) ``Synergists'': Substances used to act or react with another 
food ingredient to produce a total effect different or greater than the 
sum of the effects produced by the individual ingredients.
    (32) ``Texturizers'': Substances which affect the appearance or feel 
of the food.

[42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 
53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July 
17, 1995]



Sec. 170.6   Opinion letters on food additive status.

    (a) Over the years the Food and Drug Administration has given 
informal written opinions to inquiries as to the safety of articles 
intended for use as components of, or in contact with, food. Prior to 
the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929; 
Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1) 
of the Federal Food, Drug, and Cosmetic Act, which reads in part: ``A 
food shall be deemed to be adulterated if it bears or contains any 
poisonous or deleterious substance which may render it injurious to 
health''.
    (b) Since enactment of the Food Additives Amendment, the Food and 
Drug Administration has advised such inquirers that an article:
    (1) Is a food additive within the meaning of section 201(s) of the 
act; or
    (2) Is generally recognized as safe (GRAS); or
    (3) Has prior sanction or approval under that amendment; or
    (4) Is not a food additive under the conditions of intended use.
    (c) In the interest of the public health, such articles which have 
been considered in the past by the Food and Drug Administration to be 
safe under the provisions of section 402(a)(1), or to be generally 
recognized as safe for their intended use, or to have prior sanction or 
approval, or not to be food additives under the conditions of intended 
use, must be reexamined in

[[Page 10]]

the light of current scientific information and current principles for 
evaluating the safety of food additives if their use is to be continued.
    (d) Because of the time span involved, copies of many of the letters 
in which the Food and Drug Administration has expressed an informal 
opinion concerning the status of such articles may no longer be in the 
file of the Food and Drug Administration. In the absence of information 
concerning the names and uses made of all the articles referred to in 
such letters, their safety of use cannot be reexamined. For this reason 
all food additive status opinions of the kind described in paragraph (c) 
of this section given by the Food and Drug Administration are hereby 
revoked.
    (e) The prior opinions of the kind described in paragraph (c) of 
this section will be replaced by qualified and current opinions if the 
recipient of each such letter forwards a copy of each to the Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, 200 C Street SW., Washington, DC 
20204, along with a copy of his letter of inquiry, on or before July 23, 
1970.
    (f) This section does not apply to food additive status opinion 
letters pertaining to articles that were considered by the Food and Drug 
Administration to be food additives nor to articles included in 
regulations in parts 170 through 189 of this chapter if the articles are 
used in accordance with the requirements of such regulations.

[42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989]



Sec. 170.10   Food additives in standardized foods.

    (a) The inclusion of food ingredients in parts 170 through 189 of 
this chapter does not imply that these ingredients may be used in 
standardized foods unless they are recognized as optional ingredients in 
applicable food standards. Where a petition is received for the issuance 
or amendment of a regulation establishing a definition and standard of 
identity for a food under section 401 of the Act, which proposes the 
inclusion of a food additive in such definition and standard of 
identity, the provisions of the regulations in this part shall apply 
with respect to the information that must be submitted with respect to 
the food additive. Since section 409(b)(5) of the Act requires that the 
Secretary publish notice of a petition for the establishment of a food-
additive regulation within 30 days after filing, notice of a petition 
relating to a definition and standard of identity shall also be 
published within that time limitation if it includes a request, so 
designated, for the establishment of a regulation pertaining to a food 
additive.
    (b) If a petition for a definition and standard of identity contains 
a proposal for a food-additive regulation, and the petitioner fails to 
designate it as such, the Commissioner, upon determining that the 
petition includes a proposal for a food-additive regulation, shall so 
notify the petitioner and shall thereafter proceed in accordance with 
the regulations in this part.
    (c) A regulation will not be issued allowing the use of a food 
additive in a food for which a definition and standard of identity is 
established, unless its issuance is in conformity with section 401 of 
the Act or with the terms of a temporary permit issued under Sec. 130.17 
of this chapter. When the contemplated use of such additive complies 
with the terms of a temporary permit, the food additive regulation will 
be conditioned on such compliance and will expire with the expiration of 
the temporary permit.



Sec. 170.15   Adoption of regulation on initiative of Commissioner.

    (a) The Commissioner upon his own initiative may propose the 
issuance of a regulation prescribing, with respect to any particular use 
of a food additive, the conditions under which such additive may be 
safely used. Notice of such proposal shall be published in the Federal 
Register and shall state the reasons for the proposal.
    (b) Action upon a proposal made by the Commissioner shall proceed as 
provided in part 10 of this chapter.

[42 FR 14486, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]

[[Page 11]]



Sec. 170.17   Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.

    A food additive or food containing a food additive intended for 
investigational use by qualified experts shall be exempt from the 
requirements of section 409 of the Act under the following conditions:
    (a) If intended for investigational use in vitro or in laboratory 
research animals, it bears a label which states prominently, in addition 
to the other information required by the act, the warning:

    Caution. Contains a new food additive for investigational use only 
in laboratory research animals or for tests in vitro. Not for use in 
humans.

    (b) If intended for use in animals other than laboratory research 
animals and if the edible products of the animals are to be marketed as 
food, permission for the marketing of the edible products as food has 
been requested by the sponsor, and authorization has been granted by the 
Food and Drug Administration in accordance with Sec. 511.1 of this 
chapter or by the Department of Agriculture in accordance with 9 CFR 
309.17, and it bears a label which states prominently, in addition to 
the other information required by the Act, the warning:

    Caution. Contains a new food additive for use only in 
investigational animals. Not for use in humans.
    Edible products of investigational animals are not to be used for 
food unless authorization has been granted by the U.S. Food and Drug 
Administration or by the U.S. Department of Agriculture.

    (c) If intended for nonclinical laboratory studies in food-producing 
animals, the study is conducted in compliance with the regulations set 
forth in part 58 of this chapter.

[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]



Sec. 170.18   Tolerances for related food additives.

    (a) Food additives that cause similar or related pharmacological 
effects will be regarded as a class, and in the absence of evidence to 
the contrary, as having additive toxic effects and will be considered as 
related food additives.
    (b) Tolerances established for such related food additives may limit 
the amount of a common component that may be present, or may limit the 
amount of biological activity (such as cholinesterase inhibition) that 
may be present or may limit the total amount of related food additives 
that may be present.
    (c) Where food additives from two or more chemicals in the same 
class are present in or on a food, the tolerance for the total of such 
additives shall be the same as that for the additive having the lowest 
numerical tolerance in this class, unless there are available methods 
that permit quantitative determination of the amount of each food 
additive present or unless it is shown that a higher tolerance is 
reasonably required for the combined additives to accomplish the 
physical or technical effect for which such combined additives are 
intended and that the higher tolerance will be safe.
    (d) Where residues from two or more additives in the same class are 
present in or on a food and there are available methods that permit 
quantitative determination of each residue, the quantity of combined 
residues that are within the tolerance may be determined as follows:
    (1) Determine the quantity of each residue present.
    (2) Divide the quantity of each residue by the tolerance that would 
apply if it occurred alone, and multiply by 100 to determine the 
percentage of the permitted amount of residue present.
    (3) Add the percentages so obtained for all residues present.
    (4) The sum of the percentage shall not exceed 100 percent.



Sec. 170.19   Pesticide chemicals in processed foods.

    When pesticide chemical residues occur in processed foods due to the 
use of raw agricultural commodities that bore or contained a pesticide 
chemical in conformity with an exemption granted or a tolerance 
prescribed under section 408 of the Act, the processed food will not be 
regarded as adulterated so long as good manufacturing practice has been 
followed in removing

[[Page 12]]

any residue from the raw agricultural commodity in the processing (such 
as by peeling or washing) and so long as the concentration of the 
residue in the processed food when ready to eat is not greater than the 
tolerance prescribed for the raw agricultural commodity. But when the 
concentration of residue in the processed food when ready to eat is 
higher than the tolerance prescribed for the raw agricultural commodity, 
the processed food is adulterated unless the higher concentration is 
permitted by a tolerance obtained under section 409 of the Act. For 
example, if fruit bearing a residue of 7 parts per million of DDT 
permitted on the raw agricultural commodity is dried and a residue in 
excess of 7 parts per million of DDT results on the dried fruit, the 
dehydrated fruit is adulterated unless the higher tolerance for DDT is 
authorized by the regulations in this part. Food that is itself ready to 
eat, and which contains a higher residue than allowed for the raw 
agricultural commodity, may not be legalized by blending or mixing with 
other foods to reduce the residue in the mixed food below the tolerance 
prescribed for the raw agricultural commodity.



                     Subpart B--Food Additive Safety



Sec. 170.20   General principles for evaluating the safety of food additives.

    (a) In reaching a decision on any petition filed under section 409 
of the Act, the Commissioner will give full consideration to the 
specific biological properties of the compound and the adequacy of the 
methods employed to demonstrate safety for the proposed use, and the 
Commissioner will be guided by the principles and procedures for 
establishing the safety of food additives stated in current publications 
of the National Academy of Sciences-National Research Council. A 
petition will not be denied, however, by reason of the petitioner's 
having followed procedures other than those outlined in the publications 
of the National Academy of Sciences-National Research Council if, from 
available evidence, the Commissioner finds that the procedures used give 
results as reliable as, or more reliable than, those reasonably to be 
expected from the use of the outlined procedures. In reaching a 
decision, the Commissioner will give due weight to the anticipated 
levels and patterns of consumption of the additive specified or 
reasonably inferrable. For the purposes of this section, the principles 
for evaluating safety of additives set forth in the abovementioned 
publications will apply to any substance that may properly be classified 
as a food additive as defined in section 201(s) of the Act.
    (b) Upon written request describing the proposed use of an additive 
and the proposed experiments to determine its safety, the Commissioner 
will advise a person who wishes to establish the safety of a food 
additive whether he believes the experiments planned will yield data 
adequate for an evaluation of the safety of the additive.



Sec. 170.22   Safety factors to be considered.

    In accordance with section 409(c)(5)(C) of the Act, the following 
safety factors will be applied in determining whether the proposed use 
of a food additive will be safe: Except where evidence is submitted 
which justifies use of a different safety factor, a safety factor in 
applying animal experimentation data to man of 100 to 1, will be used; 
that is, a food additive for use by man will not be granted a tolerance 
that will exceed \1/100\th of the maximum amount demonstrated to be 
without harm to experimental animals.



Sec. 170.30   Eligibility for classification as generally recognized as safe (GRAS).

    (a) General recognition of safety may be based only on the views of 
experts qualified by scientific training and experience to evaluate the 
safety of substances directly or indirectly added to food. The basis of 
such views may be either (1) scientific procedures or (2) in the case of 
a substance used in food prior to January 1, 1958, through experience 
based on common use in food. General recognition of safety requires 
common knowledge about the substance throughout the scientific community 
knowledgeable about the safety of substances directly or indirectly 
added to food.

[[Page 13]]

    (b) General recognition of safety based upon scientific procedures 
shall require the same quantity and quality of scientific evidence as is 
required to obtain approval of a food additive regulation for the 
ingredient. General recognition of safety through scientific procedures 
shall ordinarily be based upon published studies which may be 
corroborated by unpublished studies and other data and information.
    (c)(1) General recognition of safety through experience based on 
common use in food prior to January 1, 1958, may be determined without 
the quantity or quality of scientific procedures required for approval 
of a food additive regulation. General recognition of safety through 
experience based on common use in food prior to January 1, 1958, shall 
be based solely on food use of the substance prior to January 1, 1958, 
and shall ordinarily be based upon generally available data and 
information. An ingredient not in common use in food prior to January 1, 
1958, may achieve general recognition of safety only through scientific 
procedures.
    (2) A substance used in food prior to January 1, 1958, may be 
generally recognized as safe through experience based on its common use 
in food when that use occurred exclusively or primarily outside of the 
United States if the information about the experience establishes that 
the use of the substance is safe within the meaning of the act (see 
Sec. 170.3(i)). Common use in food prior to January 1, 1958, that 
occurred outside of the United States shall be documented by published 
or other information and shall be corroborated by information from a 
second, independent source that confirms the history and circumstances 
of use of the substance. The information used to document and to 
corroborate the history and circumstances of use of the substance must 
be generally available; that is, it must be widely available in the 
country in which the history of use has occurred and readily available 
to interested qualified experts in this country. Persons claiming GRAS 
status for a substance based on its common use in food outside of the 
United States should obtain FDA concurrence that the use of the 
substance is GRAS.
    (d) The food ingredients listed as GRAS in part 182 of this chapter 
or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter do not 
include all substances that are generally recognized as safe for their 
intended use in food. Because of the large number of substances the 
intended use of which results or may reasonably be expected to result, 
directly or indirectly, in their becoming a component or otherwise 
affecting the characteristics of food, it is impracticable to list all 
such substances that are GRAS. A food ingredient of natural biological 
origin that has been widely consumed for its nutrient properties in the 
United States prior to January 1, 1958, without known detrimental 
effects, which is subject only to conventional processing as practiced 
prior to January 1, 1958, and for which no known safety hazard exists, 
will ordinarily be regarded as GRAS without specific inclusion in part 
182, part 184 or Sec. 186.1 of this chapter.
    (e) Food ingredients were listed as GRAS in part 182 of this chapter 
during 1958-1962 without a detailed scientific review of all available 
data and information relating to their safety. Beginning in 1969, the 
Food and Drug Administration has undertaken a systematic review of the 
status of all ingredients used in food on the determination that they 
are GRAS or subject to a prior sanction. All determinations of GRAS 
status or food additive status or prior sanction status pursuant to this 
review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of 
this chapter. Affirmation of GRAS status shall be announced in part 184 
or Sec. 186.1 of this chapter.
    (f) The status of the following food ingredients will be reviewed 
and affirmed as GRAS or determined to be a food additive or subject to a 
prior sanction pursuant to Sec. 170.35, Sec. 170.38, or Sec. 180.1 of 
this chapter:
    (1) Any substance of natural biological origin that has been widely 
consumed for its nutrient properties in the United States prior to 
January 1, 1958, without known detrimental effect, for which no health 
hazard is known, and which has been modified by processes first 
introduced into commercial use after January 1, 1958, which may

[[Page 14]]

reasonably be expected significantly to alter the composition of the 
substance.
    (2) Any substance of natural biological origin that has been widely 
consumed for its nutrient properties in the United States prior to 
January 1, 1958, without known detrimental effect, for which no health 
hazard is known, that has had significant alteration of composition by 
breeding or selection after January 1, 1958, where the change may be 
reasonably expected to alter the nutritive value or the concentration of 
toxic constituents.
    (3) Distillates, isolates, extracts, and concentration of extracts 
of GRAS substances.
    (4) Reaction products of GRAS substances.
    (5) Substances not of a natural biological origin, including those 
for which evidence is offered that they are identical to a GRAS 
counterpart of natural biological origin.
    (6) Substances of natural biological origin intended for consumption 
for other than their nutrient properties.
    (g) A food ingredient that is not GRAS or subject to a prior 
sanction requires a food additive regulation promulgated under section 
409 of the act before it may be directly or indirectly added to food.
    (h) A food ingredient that is listed as GRAS in part 182 of this 
chapter or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter 
shall be regarded as GRAS only if, in addition to all the requirements 
in the applicable regulation, it also meets all of the following 
requirements:
    (1) It complies with any applicable food grade specifications of the 
Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in 
the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed. 
(1981), which are incorporated by reference, except that any substance 
used as a component of articles that contact food and affirmed as GRAS 
in Sec. 186.1 of this chapter shall comply with the specifications 
therein, or in the absence of such specifications, shall be of a purity 
suitable for its intended use. Copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) It performs an appropriate function in the food or food-contact 
article in which it is used.
    (3) It is used at a level no higher than necessary to achieve its 
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its 
intended purpose in that article.
    (i) If a substance is affirmed as GRAS in part 184 or Sec. 186.1 of 
this chapter with no limitation other than good manufacturing practice, 
it shall be regarded as GRAS if its conditions of use are not 
significantly different from those reported in the regulation as the 
basis on which the GRAS status of the substance was affirmed. If the 
conditions of use are significantly different, such use of the substance 
may not be GRAS. In such a case a manufacturer may not rely on the 
regulation as authorizing the use but must independently establish that 
the use is GRAS or must use the substance in accordance with a food 
additive regulation.
    (j) If an ingredient is affirmed as GRAS in part 184 or Sec. 186.1 
of this chapter with specific limitation(s), it may be used in food only 
within such limitation(s) (including the category of food(s), the 
functional use(s) of the ingredient, and the level(s) of use). Any use 
of such an ingredient not in full compliance with each such established 
limitation shall require a food additive regulation.
    (k) Pursuant to Sec. 170.35, a food ingredient may be affirmed as 
GRAS in part 184 or Sec. 186.1 of this chapter for a specific use(s) 
without a general evaluation of use of the ingredient. In addition to 
the use(s) specified in the regulation, other uses of such an ingredient 
may also be GRAS. Any affirmation of GRAS status for a specific use(s), 
without a general evaluation of use of the ingredient, is subject to 
reconsideration upon such evaluation.
    (l) New information may at any time require reconsideration of the 
GRAS status of a food ingredient. Any change in part 182, part 184, or 
Sec. 186.1 of this

[[Page 15]]

chapter shall be accomplished pursuant to Sec. 170.38.

[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53 
FR 16546, May 10, 1988]



Sec. 170.35   Affirmation of generally recognized as safe (GRAS) status.

    (a) The Commissioner, either on his initiative or on the petition of 
an interested person, may affirm the GRAS status of substances that 
directly or indirectly become components of food.
    (b)(1) If the Commissioner proposes on his own initiative that a 
substance is entitled to affirmation as GRAS, he will place all of the 
data and information on which he relies on public file in the office of 
the Dockets Management Branch and will publish in the Federal Register a 
notice giving the name of the substance, its proposed uses, and any 
limitations proposed for purposes other than safety.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Dockets Management Branch. Copies of all 
comments received shall be made available for examination in the Dockets 
Management Branch's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is convincing evidence that the substance is GRAS 
as described in Sec. 170.30, he will publish a notice in the Federal 
Register listing the substance as GRAS in part 182, part 184, or part 
186 of this chapter, as appropriate.
    (4) If, after evaluation of the comments, the Commissioner concludes 
that there is a lack of convincing evidence that the substance is GRAS 
and that it should be considered a food additive subject to section 409 
of the Act, he shall publish a notice thereof in the Federal Register in 
accordance with Sec. 170.38.
    (c)(1) Persons seeking the affirmation of GRAS status of substances 
as provided in Sec. 170.30(e), except those subject to the NAS/NRC GRAS 
list survey (36 FR 20546; October 23, 1971), shall submit a petition for 
GRAS affirmation pursuant to part 10 of this chapter. Such petition 
shall contain information to establish that the GRAS criteria as set 
forth in Sec. 170.30 (b) or (c) have been met, in the following form:
    (i) Description of the substance, including:
    (a) Common or usual name.
    (b) Chemical name.
    (c) Chemical Abstract Service (CAS) registry number.
    (d) Empirical formula.
    (e) Structural formula.
    (f) Specifications for food grade material, including arsenic and 
heavy metals. (Recommendation for any change in the Food Chemicals Codex 
monograph should be included where applicable.)
    (g) Quantitative compositions.
    (h) Manufacturing process (excluding any trade secrets).
    (ii) Use of the substance, including:
    (a) Date when use began.
    (b) Information and reports or other data on past uses in food.
    (c) Foods in which used, and levels of use in such foods, and for 
what purposes.
    (iii) Methods for detecting the substance in food, including:
    (a) References to qualitative and quantitative methods for 
determining the substance(s) in food, including the type of analytical 
procedures used.
    (b) Sensitivity and reproducibility of such method(s).
    (iv) Information to establish the safety and functionality of the 
substance in food. Published scientific literature, evidence that the 
substance is identical to a GRAS counterpart of natural biological 
origin, and other data may be submitted to support safety. Any adverse 
information or consumer complaints shall be included. Complete 
bibliographic references shall be provided where a copy of the article 
is not provided.
    (v) A statement signed by the person responsible for the petition 
that to the best of his knowledge it is a representative and balanced 
submission that includes unfavorable information, as well as favorable 
information, known to him pertinent to the evaluation of the safety and 
functionality of the substance.
    (vi) If nonclinical laboratory studies are involved, additional 
information and data submitted in support of filed petitions shall 
include, with respect to

[[Page 16]]

each nonclinical study, either a statement that the study was conducted 
in compliance with the requirements set forth in part 58 of this 
chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.
    (vii) [Reserved]
    (viii) A claim for categorical exclusion under Sec. 25.24 of this 
chapter or an environmental assessment under Sec. 25.31 of this chapter.
    (2) Within 30 days after the date of filing the petition, the 
Commissioner will place the petition on public file in the office of the 
Dockets Management Branch and will publish a notice of filing in the 
Federal Register giving the name of the petitioner and a brief 
description of the petition including the name of the substance, its 
proposed use, and any limitations proposed for reasons other than 
safety. A copy of the notice will be mailed to the petitioner at the 
time the original is sent to the Federal Register.
    (3) The notice of filing in the Federal Register will allow a period 
of 60 days during which any interested person may review the petition 
and/or file comments with the Dockets Management Branch. Copies of all 
comments received shall be made available for examination in the Dockets 
Management Branch's office.
    (4) The Commissioner will evaluate the petition and all available 
information including all comments received. If the petition and such 
information provide convincing evidence that the substance is GRAS as 
described in Sec. 170.30 he will publish an order in the Federal 
Register listing the substance as GRAS in part 182, part 184, or part 
186 of this chapter, as appropriate.
    (5) If, after evaluation of the petition and all available 
information, the Commissioner concludes that there is a lack of 
convincing evidence that the substance is GRAS and that it should be 
considered a food additive subject to section 409 of the Act, he shall 
publish a notice thereof in the Federal Register in accordance with 
Sec. 170.38.
    (6) The notice of filing in the Federal Register will request 
submission of proof of any applicable prior sanction for use of the 
ingredient under conditions different from those proposed to be 
determined to be GRAS. The failure of any person to come forward with 
proof of such an applicable prior sanction in response to the notice of 
filing will constitute a waiver of the right to assert or rely on such 
sanction at any later time. The notice of filing will also constitute a 
proposal to establish a regulation under part 181 of this chapter, 
incorporating the same provisions, in the event that such a regulation 
is determined to be appropriate as a result of submission of proof of 
such an applicable prior sanction in response to the notice of filing.

(Information collection requirements were approved by the Office of 
Management and Budget under control number 0910-0132)

[42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 
FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988]



Sec. 170.38   Determination of food additive status.

    (a) The Commissioner may, in accordance with Sec. 170.35(b)(4) or 
(c)(5), publish a notice in the Federal Register determining that a 
substance is not GRAS and is a food additive subject to section 409 of 
the Act.
    (b)(1) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may issue a 
notice in the Federal Register proposing to determine that a substance 
is not GRAS and is a food additive subject to section 409 of the Act. 
Any petition shall include all relevant data and information of the type 
described in Sec. 171.130(b). The Commissioner will place all of the 
data and information on which he relies on public file in the office of 
the Dockets Management Branch and will include in the Federal Register 
notice the name of the substance, its known uses, and a summary of the 
basis for the determination.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Dockets Management Branch. Copies of all 
comments shall be made available for examination in the Dockets 
Management Branch's office.

[[Page 17]]

    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is a lack of convincing evidence that the substance 
is GRAS or is otherwise exempt from the definition of a food additive in 
section 201(s) of the Act, he will publish a notice thereof in the 
Federal Register. If he concludes that there is convincing evidence that 
the substance is GRAS, he will publish an order in the Federal Register 
listing the substance as GRAS in part 182, part 184, or part 186 of this 
chapter, as appropriate.
    (c) A Federal Register notice determining that a substance is a food 
additive shall provide for the use of the additive in food or food 
contact surfaces as follows:
    (1) It may promulgate a food additive regulation governing use of 
the additive.
    (2) It may promulgate an interim food additive regulation governing 
use of the additive.
    (3) It may require discontinuation of the use of the additive.
    (4) It may adopt any combination of the above three approaches for 
different uses or levels of use of the additive.
    (d) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of the substance, he will concurrently propose a 
separate regulation covering such use of the ingredient under part 181 
of this chapter. If the Commissioner is unaware of any such applicable 
prior sanction, the proposed regulation will so state and will require 
any person who intends to assert or rely on such sanction to submit 
proof of its existence. Any regulation promulgated pursuant to this 
section constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof of such an applicable prior sanction in response 
to the proposal.

[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
54 FR 24896, June 12, 1989]



Sec. 170.39  Threshold of regulation for substances used in food-contact articles.

    (a) A substance used in a food-contact article (e.g., food-packaging 
or food-processing equipment) that migrates, or that may be expected to 
migrate, into food will be exempted from regulation as a food additive 
because it becomes a component of food at levels that are below the 
threshold of regulation if:
    (1) The substance has not been shown to be a carcinogen in humans or 
animals, and there is no reason, based on the chemical structure of the 
substance, to suspect that the substance is a carcinogen. The substance 
must also not contain a carcinogenic impurity or, if it does, must not 
contain a carcinogenic impurity with a TD50 value based on chronic 
feeding studies reported in the scientific literature or otherwise 
available to the Food and Drug Administration of less than 6.25 
milligrams per kilogram bodyweight per day (The TD50, for the 
purposes of this section, is the feeding dose that causes cancer in 50 
percent of the test animals when corrected for tumors found in control 
animals. If more than one TD50 value has been reported in the 
scientific literature for a substance, the Food and Drug Administration 
will use the lowest appropriate TD50 value in its review.);
    (2) The substance presents no other health or safety concerns 
because:
    (i) The use in question has been shown to result in or may be 
expected to result in dietary concentrations at or below 0.5 parts per 
billion, corresponding to dietary exposure levels at or below 1.5 
micrograms/person/day (based on a diet of 1,500 grams of solid food and 
1,500 grams of liquid food per person per day); or
    (ii) The substance is currently regulated for direct addition into 
food, and the dietary exposure to the substance resulting from the 
proposed use is at or below 1 percent of the acceptable daily intake as 
determined by safety data in

[[Page 18]]

the Food and Drug Administration's files or from other appropriate 
sources;
    (3) The substance has no technical effect in or on the food to which 
it migrates; and
    (4) The substance use has no significant adverse impact on the 
environment.
    (b) Notwithstanding paragraph (a) of this section, the Food and Drug 
Administration reserves the right to decline to grant an exemption in 
those cases in which available information establishes that the proposed 
use may pose a public health risk. The reasons for the agency's decision 
to decline to grant an exemption will be explained in the Food and Drug 
Administration's response to the requestor.
    (c) A request for the Food and Drug Administration to exempt a use 
of a substance from regulation as a food additive shall include three 
copies of the following information (If part of the submitted material 
is in a foreign language, it must be accompanied by an English 
translation verified to be complete and accurate in accordance with 
Sec. 10.20(c)(2) of this chapter):
    (1) The chemical composition of the substance for which the request 
is made, including, whenever possible, the name of the chemical in 
accordance with current Chemical Abstract Service (CAS) nomenclature 
guidelines and a CAS registry number, if available;
    (2) Detailed information on the conditions of use of the substance 
(e.g., temperature, type of food with which the substance will come into 
contact, the duration of the contact, and whether the food-contact 
article will be for repeated or single use applications);
    (3) A clear statement as to whether the request for exemption from 
regulation as a food additive is based on the fact that the use of the 
substance in the food-contact article results in a dietary concentration 
at or below 0.5 parts per billion, or on the fact that it involves the 
use of a regulated direct food additive for which the dietary exposure 
is at or below 1 percent of the acceptable dietary intake (ADI);
    (4) Data that will enable the Food and Drug Administration to 
estimate the daily dietary concentration resulting from the proposed use 
of the substance. These data should be in the form of:
    (i) Validated migration data obtained under worst-case (time/
temperature) intended use conditions utilizing appropriate food 
simulating solvents;
    (ii) Information on the amount of the substance used in the 
manufacture of the food-contact article; or
    (iii) Information on the residual level of the substance in the 
food-contact article. For repeat-use articles, an estimate of the amount 
of food that contacts a specific unit of surface area over the lifetime 
of the article should also be provided. (In cases where data are 
provided only in the form of manufacturing use levels or residual levels 
of the substance present in the food-contact article, the Food and Drug 
Administration will calculate a worst-case dietary concentration level 
assuming 100 percent migration.) A detailed description of the 
analytical method used to quantify the substance should also be 
submitted along with data used to validate the detection limit.
    (iv) In cases where there is no detectable migration into food or 
food simulants, or when no residual level of a substance is detected in 
the food-contact article by a suitable analytical method, the Food and 
Drug Administration will, for the purposes of estimating the dietary 
concentration, consider the validated detection limit of the method used 
to analyze for the substance.
    (5) The results of an analysis of existing toxicological information 
on the substance and its impurities. This information on the substance 
is needed to show whether an animal carcinogen bioassay has been carried 
out, or whether there is some other basis for suspecting that the 
substance is a carcinogen or potent toxin. This type of information on 
the impurities is needed to show whether any of them are carcinogenic, 
and, if carcinogenic, whether their TD50 values are greater than 6.25 
milligrams per kilogram bodyweight per day in accordance with paragraph 
(a)(1) of this section.
    (6) Information on the environmental impact that would result from 
the proposed use of the substance. Depending on the type of use, this 
information

[[Page 19]]

should be in the form of an abbreviated environmental assessment as 
specified in Sec. 25.31a(b)(1) or (b)(2) of this chapter.
    (d) Data to be reviewed under this section shall be submitted to the 
Food and Drug Administration's Office of Premarket Approval (HFS-200), 
200 C St. SW., Washington, DC 20204.
    (e) The Food and Drug Administration will inform the requestor by 
letter whether the specific food-contact application is exempt from 
regulation as a food additive or not. Although a substance that migrates 
to food at a level that results in a dietary concentration at or below 
the threshold of regulation will not be the subject of a regulation 
published in the Federal Register and will not appear in the Code of 
Federal Regulations, the Food and Drug Administration will maintain a 
list of substances exempted from regulation as food additives under this 
section on display at the Dockets Management Branch. This list will 
include the name of the company that made the request, the chemical name 
of the substance, the specific use for which it has received an 
exemption from regulation as a food additive, and any appropriate 
limitations on its use. The list will not include any trade names. This 
list will enable interested persons to see the types of uses of food-
contact materials being exempted under the regulation. Interested 
persons may also obtain a copy of the list of exempted substances by 
contacting the Food and Drug Administration's Office of Premarket 
Approval (HFS-200), 200 C St. SW., Washington, DC 20204. The agency's 
finding of no significant impact and the evidence supporting that 
finding, contained in an environmental assessment, also will be 
available for public inspection at the Dockets Management Branch in 
accordance with Sec. 25.41(b)(2) of this chapter. Requests for copies of 
releasable information contained in submissions requesting exemptions 
from the food additive regulations will be handled in accordance with 
the Food and Drug Administration's Freedom of Information Act 
procedures, as described in part 20 of this chapter. In particular, data 
and information that fall within the definitions of a trade secret or 
confidential commercial or financial information are not available for 
public disclosure in accordance with Sec. 20.61(c) of this chapter.
    (f) If the request for an exemption from regulation as a food 
additive is not granted, the requestor may submit a petition to the Food 
and Drug Administration for reconsideration of the decision in 
accordance with the provisions of Sec. 10.33 of this chapter.
    (g) If the Food and Drug Administration receives significant new 
information that raises questions about the dietary concentration or the 
safety of a substance that the agency has exempted from regulation, the 
Food and Drug Administration may reevaluate the substance. If the Food 
and Drug Administration tentatively concludes that the information that 
is available about the substance no longer supports an exemption for the 
use of the food-contact material from the food additive regulations, the 
agency will notify any persons that requested an exemption for the 
substance of its tentative decision. The requestors will be given an 
opportunity to show why the use of the substance should not be regulated 
under the food additive provisions of the act. If the requestors fail to 
adequately respond to the new evidence, the agency will notify them that 
further use of the substance in question for the particular use will 
require a food additive regulation. This notification will be placed on 
public display at the Dockets Management Branch as part of the file of 
uses of substances exempted from regulation as food additives. The Food 
and Drug Administration recognizes that manufacturers other than those 
that actually made a request for exemption may also be using exempted 
substances in food-contact articles under conditions of use (e.g., use 
levels, temperature, type of food contacted, etc.) that are similar to 
those for which the exemption was issued. Because only requestors will 
be notified as part of the revocation process described in this section, 
the Food and Drug Administration plans to notify other manufacturers by 
means of a notice published in the Federal Register of its decision to 
revoke an exemption issued for a specific use of a substance in a food 
contact article.
    (h) Guidelines to assist requestors in the preparation of 
submissions seeking

[[Page 20]]

exemptions from the food additive regulations are available from the 
Food and Drug Administration's Office of Premarket Approval (HFS-200), 
200 C St. SW., Washington, DC 20204. Interested persons are encouraged 
to obtain specific guidance from the Food and Drug Administration on the 
appropriate protocols to be used for obtaining migration data, on the 
validation of the analytical methods used to quantify migration levels, 
on the procedures used to relate migration data to dietary exposures, 
and on any other issue not specifically covered in the Food and Drug 
Administration's guidelines.

[60 FR 36595, July 17, 1995]



        Subpart C--Specific Administrative Rulings and Decisions



Sec. 170.45   Fluorine-containing compounds.

    The Commissioner of Food and Drugs has concluded that it is in the 
interest of the public health to limit the addition of fluorine 
compounds to foods (a) to that resulting from the fluoridation of public 
water supplies as stated in Sec. 250.203 of this chapter, (b) to that 
resulting from the fluoridation of bottled water within the limitation 
established in Sec. 103.35(d) of this chapter, and (c) to that 
authorized by regulations (40 CFR part 180) under section 408 of the 
Act.



Sec. 170.50   Glycine (aminoacetic acid) in food for human consumption.

    (a) Heretofore, the Food and Drug Administration has expressed the 
opinion in trade correspondence that glycine is generally recognized as 
safe for certain technical effects in human food when used in accordance 
with good manufacturing practice; however:
    (1) Reports in scientific literature indicate that adverse effects 
were found in cases where high levels of glycine were administered in 
diets of experimental animals.
    (2) Current usage information indicates that the daily dietary 
intake of glycine by humans may be substantially increasing due to 
changing use patterns in food technology.

Therefore, the Food and Drug Administration no longer regards glycine 
and its salts as generally recognized as safe for use in human food and 
all outstanding letters expressing sanction for such use are rescinded.
    (b) The Commissioner of Food and Drugs concludes that by May 8, 
1971, manufacturers:
    (1) Shall reformulate food products for human use to eliminate added 
glycine and its salts; or
    (2) Shall bring such products into compliance with an authorizing 
food additive regulation. A food additive petition supported by toxicity 
data is required to show that any proposed level of glycine or its salts 
added to foods for human consumption will be safe.
    (c) The status of glycine as generally recognized as safe for use in 
animal feed, as prescribed in Sec. 582.5049 of this chapter, remains 
unchanged because the additive is considered an essential nutrient in 
certain animal feeds and is safe for such use under conditions of good 
feeding practice.



Sec. 170.60   Nitrites and/or nitrates in curing premixes.

    (a) Nitrites and/or nitrates are food additives when combined in 
curing premixes with spices and/or other flavoring or seasoning 
ingredients that contain or constitute a source of secondary or tertiary 
amines, including but not limited to essential oils, disodium inosinate, 
disodium guanylate, hydrolysates of animal or plant origin (such as 
hydrolyzed vegetable protein), oleoresins of spices, soy products, and 
spice extractives. Such food additives may be used only after the 
establishment of an authorizing food additive regulation. A food 
additive petition submitted pursuant to Secs. 171.1 and 171.100 of this 
chapter, supported by data demonstrating that nitrosamines are not 
formed in curing premixes containing such food additives, is required to 
establish safety.
    (b) Nitrites and/or nitrates, when packaged separately from 
flavoring and seasoning in curing premixes, may continue to be used 
under prior sanctions in the commercial curing of meat and meat products 
and poultry products and in accordance with the provisions of 
Secs. 172.170 and 172.175 of this chapter that apply to meat curing 
preparations for the home curing of

[[Page 21]]

meat and meat products, including poultry and wild game. To assure safe 
use of such ingredients the labeling of the premixes shall bear 
instructions to the user that such separately packaged ingredients are 
not to be combined until just prior to use. Encapsulating or coating 
some or all of the ingredients does not constitute separate packaging.



PART 171--FOOD ADDITIVE PETITIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
171.1  Petitions.
171.6  Amendment of petition.
171.7  Withdrawal of petition without prejudice.
171.8  Threshold of regulation for substances used in fook-contact 
          articles.

            Subpart B--Administrative Actions on Applications

171.100  Regulation based on petition.
171.102  Effective date of regulation.
171.110  Procedure for objections and hearings.
171.130  Procedure for amending and repealing tolerances or exemptions 
          from tolerances.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14489, Mar. 15, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 171.1  Petitions.

    (a) Petitions to be filed with the Commissioner under the provisions 
of section 409(b) of the Act shall be submitted in triplicate. If any 
part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
petition shall state petitioner's post office address to which published 
notices or orders issued or objections filed pursuant to section 409 of 
the Act may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of the Food and 
Drug Administration. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized in a written statement 
signed by the person who submitted it. Any reference to published 
information offered in support of a food additive petition should be 
accompanied by reprints or photostatic copies of such references.
    (c) Petitions shall include the following data and be submitted in 
the following form:
________________________________________________________________________
                                                              (Date)    
Name of petitioner______________________________________________________
Post-office address_____________________________________________________
Date____________________________________________________________________
Name of food additive and proposed use----______________________________
........................................................................
........................................................................
Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.

Dear Sirs:
    The undersigned, __________ submits this petition pursuant to 
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with 
respect to __________
........................................................................
(Name of the food additive and proposed use)

    Attached hereto, in triplicate, and constituting a part of this 
petition, are the following:
    A. The name and all pertinent information concerning the food 
additive, including chemical identity and composition of the food 
additive, its physical, chemical, and biological properties, and 
specifications prescribing the minimum content of the desired 
component(s) and identifying and limiting the reaction byproducts and 
other impurities. Where such information is not available, a statement 
as to the reasons why it is not should be submitted.
    When the chemical identity and composition of the food additive is 
not known, the petition shall contain information in sufficient detail 
to permit evaluation regarding the method of manufacture and the 
analytical controls used during the various stages of manufacturing, 
processing, or packing of the food additive which are relied upon to 
establish that it is a substance of reproducible composition. 
Alternative methods and controls and variations in methods and controls 
within reasonable limits that do not affect the characteristics of the 
substance or the reliability of the controls may be specified.
    If the food additive is a mixture of chemicals, the petition shall 
supply a list of all substances used in the synthesis, extraction, or 
other method of preparation, regardless of

[[Page 22]]

whether they undergo chemical change in the process. Each substance 
should be identified by its common English name and complete chemical 
name, using structural formulas when necessary for specific 
identification. If any proprietary preparation is used as a component, 
the proprietary name should be followed by a complete quantitative 
statement of composition. Reasonable alternatives for any listed 
substance may be specified.
    If the petitioner does not himself perform all the manufacturing, 
processing, and packing operations for a food additive, the petition 
shall identify each person who will perform a part of such operations 
and designate the part.
    The petition shall include stability data, and, if the data indicate 
that it is needed to insure the identity, strength, quality, or purity 
of the additive, the expiration date that will be employed.
    B. The amount of the food additive proposed for use and the purposes 
for which it is proposed, together with all directions, recommendations, 
and suggestions regarding the proposed use, as well as specimens of the 
labeling proposed for the food additive and any labeling that will be 
required by applicable provisions of the Federal Food, Drug, and 
Cosmetic Act on the finished food by reason of the use of the food 
additive. If the additive results or may reasonably be expected to 
result from the use of packaging material, the petitioner shall show how 
this may occur and what residues may reasonably be anticipated.
    (Typewritten or other draft-labeling copy will be accepted for 
consideration of the petition, provided a statement is made that final 
printed labeling identical in content to the draft copy will be 
submitted as soon as available and prior to the marketing of the food 
additive.)
    (If the food additive is one for which a tolerance limitation is 
required to assure its safety, the level of use proposed should be no 
higher than the amount reasonably required to accomplish the intended 
physical or other technical effect, even though the safety data may 
support a higher tolerance.)
    C. Data establishing that the food additive will have the intended 
physical or other technical effect or that it may reasonably be expected 
to become a component, or to affect the characteristics, directly or 
indirectly, of food and the amount necessary to accomplish this. These 
data should include information in sufficient detail to permit 
evaluation with control data.
    D. A description of practicable methods to determine the amount of 
the food additive in the raw, processed, and/or finished food and of any 
substance formed in or on such food because of its use. The test 
proposed shall be one that can be used for food-control purposes and 
that can be applied with consistent results by any properly equipped and 
trained laboratory personnel.
    E. Full reports of investigations made with respect to the safety of 
the food additive.
    (A petition may be regarded as incomplete unless it includes full 
reports of adequate tests reasonably applicable to show whether or not 
the food additive will be safe for its intended use. The reports 
ordinarily should include detailed data derived from appropriate animal 
and other biological experiments in which the methods used and the 
results obtained are clearly set forth. The petition shall not omit 
without explanation any reports of investigations that would bias an 
evaluation of the safety of the food additive.)
    F. Proposed tolerances for the food additive, if tolerances are 
required in order to insure its safety. A petitioner may include a 
proposed regulation.
    G. If submitting petition to modify an existing regulation issued 
pursuant to section 409(c)(1)(A) of the Act, full information on each 
proposed change that is to be made in the original regulation must be 
submitted. The petition may omit statements made in the original 
petition concerning which no change is proposed. A supplemental petition 
must be submitted for any change beyond the variations provided for in 
the original petition and the regulation issued on the basis of the 
original petition.
    H. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.24 of this chapter or an 
environmental assessment under Sec. 25.31 of this chapter.

Yours very truly,
      Petitioner________________________________________________________
        By______________________________________________________________
                                                    (Indicate authority)

    (d) The petitioner will be notified of the date on which his 
petition is filed; and an incomplete petition, or one that has not been 
submitted in triplicate, will usually be retained but not filed as a 
petition under section 409 of the Act. The petitioner will be notified 
in what respects his petition is incomplete.
    (e) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (f) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application, the 
present petition may incorporate it by specific reference to the 
earlier. If part of the data have been submitted by the manufacturer of 
the food additive as a master file, the petitioner may refer to the

[[Page 23]]

master file if and to the extent he obtains the manufacturer's written 
permission to do so. The manufacturer may authorize specific reference 
to the data without disclosure to the petitioner. Nothing herein shall 
prevent reference to published data.
    (g) A petition shall be retained but shall not be filed if any of 
the data prescribed by section 409(b) of the Act are lacking or are not 
set forth so as to be readily understood.
    (h)(1) The following data and information in a food additive 
petition are available for public disclosure, unless extraordinary 
circumstances are shown, after the notice of filing of the petition is 
published in the Federal Register or, if the petition is not promptly 
filed because of deficiencies in it, after the petitioner is informed 
that it will not be filed because of the deficiencies involved:
    (i) All safety and functionality data and information submitted with 
or incorporated by reference in the petition.
    (ii) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (iii) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (iv) A list of all ingredients contained in a food additive, whether 
or not it is in descending order of predominance. A particular 
ingredient or group of ingredients shall be deleted from any such list 
prior to public disclosure if it is shown to fall within the exemption 
established in Sec. 20.61 of this chapter, and a notation shall be made 
that any such ingredient list is incomplete.
    (v) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (2) The following data and information in a food additive petition 
are not available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or they 
relate to a product or ingredient that has been abandoned and they no 
longer represent a trade secret or confidential commercial or financial 
information as defined in Sec. 20.61 of this chapter:
    (i) Manufacturing methods or processes, including quality control 
procedures.
    (ii) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (iii) Quantitative or semiquantitative formulas.
    (3) All correspondence and written summaries of oral discussions 
relating to a food additive petition are available for public disclosure 
in accordance with the provisions of part 20 of this chapter when the 
food additive regulation is published in the Federal Register.
    (4) For purposes of this regulation, safety and functionality data 
include all studies and tests of a food additive on animals and humans 
and all studies and tests on a food additive for identity, stability, 
purity, potency, performance, and usefulness.
    (i)(1) Within 15 days after receipt, the Commissioner will notify 
the petitioner of acceptance or nonacceptance of a petition, and if not 
accepted the reasons therefor. If accepted, the date of the notification 
letter sent to petitioner becomes the date of filing for the purposes of 
section 409(b)(5) of the Act. If the petitioner desires, he may 
supplement a deficient petition after being notified regarding 
deficiencies. If the supplementary material or explanation of the 
petition is deemed acceptable, petitioner shall be notified. The date of 
such notification becomes the date of filing. If the petitioner does not 
wish to supplement or explain the petition and requests in writing that 
it be filed as submitted, the petition shall be filed and the petitioner 
so notified.

[[Page 24]]

The date of such notification becomes the date of filing.
    (2) The Commissioner will publish in the Federal Register within 30 
days from the date of filing of such petition, a notice of the filing, 
the name of the petitioner, and a brief description of the proposal in 
general terms. In the case of a food additive which becomes a component 
of food by migration from packaging material, the notice shall include 
the name of the migratory substance, and where it is different from that 
of one of the original components, the name of the parent component, the 
maximum quantity of the migratory substance that is proposed for use in 
food, and the physical or other technical effect which the migratory 
substance or its parent component is intended to have in the packaging 
material. A copy of the notice will be mailed to the petitioner when the 
original is forwarded to the Federal Register for publication.
    (j) The Commissioner may request a full description of the methods 
used in, and the facilities and controls used for, the production of the 
food additive, or a sample of the food additive, articles used as 
components thereof, or of the food in which the additive is proposed to 
be used, at any time while a petition is under consideration. The 
Commissioner shall specify in the request for a sample of the food 
additive, or articles used as components thereof, or of the food in or 
on which the additive is proposed to be used, a quantity deemed adequate 
to permit tests of analytical methods to determine quantities of the 
food additive present in foods for which it is intended to be used or 
adequate for any study or investigation reasonably required with respect 
to the safety of the food additive or the physical or technical effect 
it produces. The date used for computing the 90-day limit for the 
purposes of section 409(c)(2) of the Act shall be moved forward 1 day 
for each day after the mailing date of the request taken by the 
petitioner to submit the sample. If the information or sample is 
requested a reasonable time in advance of the 180 days, but is not 
submitted within such 180 days after filing of the petition, the 
petition will be considered withdrawn without prejudice.
    (k) If nonclinical laboratory studies are involved, petitions filed 
with the Commissioner under section 409(b) of the act shall include, 
with respect to each nonclinical study contained in the petition, either 
a statement that the study has been, or will be, conducted in compliance 
with the good laboratory practice regulations as set forth in part 58 of 
this chapter, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (l) [Reserved]
    (m) If clinical investigations involving human subjects are 
involved, petitions filed with the Commissioner under section 409(b) of 
the Act shall include statements regarding each such clinical 
investigation relied upon in the petition that it either was conducted 
in compliance with the requirements for institutional review set forth 
in part 56 of this chapter, or was not subject to such requirements in 
accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.

[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 
46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, 
1985]



Sec. 171.6  Amendment of petition.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof. In such cases, if the 
Commissioner determines that the additional information or data amount 
to a substantive amendment, the petition as amended will be given a new 
filing date, and the time limitation will begin to run anew. If 
nonclinical laboratory studies are involved, additional information and 
data submitted in support of filed petitions shall include, with respect 
to each nonclinical study, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.

[50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985]

[[Page 25]]



Sec. 171.7   Withdrawal of petition without prejudice.

    (a) In some cases the Commissioner will notify the petitioner that 
the petition, while technically complete, is inadequate to justify the 
establishment of a regulation or the regulation requested by petitioner. 
This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal will be without prejudice to a future filing. Upon refiling, 
the time limitation will begin to run anew from the date of refiling.
    (b) At any time before the order provided for in Sec. 171.100(a) has 
been forwarded to the Federal Register for publication, the petitioner 
may withdraw the petition without prejudice to a future filing. Upon 
refiling the time limitation will begin to run anew.



Sec. 171.8  Threshold of regulation for substances used in food-contact articles.

    Substances used in food-contact articles (e.g., food-packaging or 
food-processing equipment) that migrate or that may be expected to 
migrate into food at negligible levels may be reviewed under Sec. 170.39 
of this chapter. The Food and Drug Administration will exempt substances 
whose uses it determines meet the criteria in Sec. 170.39 of this 
chapter from regulation as food additives and, therefore, a food 
additive petition will not be required for the exempted use.

[60 FR 36596, July 17, 1995]



            Subpart B--Administrative Actions on Applications



Sec. 171.100   Regulation based on petition.

    (a) The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 409(c)(2) of the 
Act), a regulation prescribing the conditions under which the food 
additive may be safely used (including, but not limited to, 
specifications as to the particular food or classes of food in or on 
which such additive may be used, the maximum quantity that may be used 
or permitted to remain in or on such food, the manner in which such 
additive may be added to or used in or on such food, and any directions 
or other labeling or packaging requirements for such additive deemed 
necessary by him to assure the safety of such use), and prior to the 
forwarding of the order to the Federal Register for publication shall 
notify the petitioner of such order and the reasons for such action; or 
by order deny the petition, and shall notify the petitioner of such 
order and of the reasons for such action.
    (b) If the Commissioner determines that additional time is needed to 
study and investigate the petition, he shall by written notice to the 
petitioner extend the 90-day period for not more than 180 days after the 
filing of the petition.



Sec. 171.102   Effective date of regulation.

    A regulation published in accordance with Sec. 171.100(a) shall 
become effective upon publication in the Federal Register.



Sec. 171.110   Procedure for objections and hearings.

    Objections and hearings relating to food additive regulations under 
section 409(c), (d), or (h) of the Act shall be governed by part 12 of 
this chapter.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]



Sec. 171.130   Procedure for amending and repealing tolerances or exemptions from tolerances.

    (a) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may propose 
the issuance of a regulation amending or repealing a regulation 
pertaining to a food additive or granting or repealing an exception for 
such additive.
    (b) Any such petition shall include an assertion of facts, supported 
by data, showing that new information exists with respect to the food 
additive or that new uses have been developed or old uses abandoned, 
that new data are

[[Page 26]]

available as to toxicity of the chemical, or that experience with the 
existing regulation or exemption may justify its amendment or repeal. 
New data shall be furnished in the form specified in Secs. 171.1 and 
171.100 for submitting petitions.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]



PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION--Table of Contents




                      Subpart A--General Provisions

Sec.
172.5  General provisions for direct food additives.

                      Subpart B--Food Preservatives

172.105  Anoxomer.
172.110  BHA.
172.115  BHT.
172.120  Calcium disodium EDTA.
172.130  Dehydroacetic acid.
172.133  Dimethyl dicarbonate.
172.135  Disodium EDTA.
172.140  Ethoxyquin.
172.145  Heptylparaben.
172.150  4-Hydroxymethyl-2,6-di-tert-butyl-phenol.
172.155  Natamycin (pimaricin).
172.160  Potassium nitrate.
172.165  Quaternary ammonium chloride combination.
172.170  Sodium nitrate.
172.175  Sodium nitrite.
172.177  Sodium nitrite used in processing smoked chub.
172.180  Stannous chloride.
172.185  TBHQ.
172.190  THBP.

            Subpart C--Coatings, Films and Related Substances

172.210  Coatings on fresh citrus fruit.
172.215  Coumarone-indene resin.
172.225  Methyl and ethyl esters of fatty acids produced from edible 
          fats and oils.
172.230  Microcapsules for flavoring substances.
172.235  Morpholine.
172.250  Petroleum naphtha.
172.255  Polyacrylamide.
172.260  Oxidized polyethylene.
172.270  Sulfated butyl oleate.
172.275  Synthetic paraffin and succinic derivatives.
172.280  Terpene resin.

          Subpart D--Special Dietary and Nutritional Additives

172.310  Aluminum nicotinate.
172.315  Nicotinamide-ascorbic acid complex.
172.320  Amino acids.
172.325  Bakers yeast protein.
172.330  Calcium pantothenate, calcium chloride double salt.
172.335  D-Pantothenamide.
172.340  Fish protein isolate.
172.345  Folic acid (folacin).
172.350  Fumaric acid and salts of fumaric acids.
172.365  Kelp.
172.370  Iron-choline citrate complex.
172.372  N-Acetyl-L-methionine.
172.375  Potassium iodide.
172.385  Whole fish protein concentrate.
172.395  Xylitol.
172.399  Zinc methionine sulfate.

                      Subpart E--Anticaking Agents

172.410  Calcium silicate.
172.430  Iron ammonium citrate.
172.480  Silicon dioxide.
172.490  Yellow prussiate of soda.

           Subpart F--Flavoring Agents and Related Substances

172.510  Natural flavoring substances and natural substances used in 
          conjunction with flavors.
172.515  Synthetic flavoring substances and adjuvants.
172.520  Cocoa with dioctyl sodium sulfoccinate for manufacturing.
172.530  Disodium guanylate.
172.535  Disodium inosinate.
172.540  DL-Alanine.
172.560  Modified hop extract.
172.575  Quinine.
172.580  Safrole-free extract of sassafras.
172.585  Sugar beet extract flavor base.
172.590  Yeast-malt sprout extract.

        Subpart G--Gums, Chewing Gum Bases and Related Substances

172.610  Arabinogalactan.
172.615  Chewing gum base.
172.620  Carrageenan.
172.623  Carrageenan with polysorbate 80.
172.626  Salts of carrageenan.
172.655  Furcelleran.
172.660  Salts of furcelleran.
172.665  Gellan gum.
172.695  Xanthan gum.

                Subpart H--Other Specific Usage Additives

172.710  Adjuvants for pesticide use dilutions.
172.715  Calcium lignosulfonate.
172.720  Calcium lactobionate.
172.723  Epoxidized soybean oil.

[[Page 27]]

172.725  Gibberellic acid and its potassium salt.
172.730  Potassium bromate.
172.735  Glycerol ester of wood rosin.
172.755  Stearyl monoglyceridyl citrate.
172.765  Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770  Ethylene oxide polymer.
172.775  Methacrylic acid-divinylbenzene copolymer.

                    Subpart I--Multipurpose Additives

172.800  Acesulfame potassium.
172.802  Acetone peroxides.
172.804  Aspartame.
172.806  Azodicarbonamide.
172.808  Copolymer condensates of ethylene oxide and propylene oxide.
172.810  Dioctyl sodium sulfosuccinate.
172.811  Glyceryl tristearate.
172.812  Glycine.
172.814  Hydroxylated lecithin.
172.816  Methyl glucoside-coconut oil ester.
172.818  Oxystearin.
172.820  Polyethylene gylcol (mean molecular weight 200-9,500).
172.822  Sodium lauryl sulfate.
172.824  Sodium mono- and dimethyl naphthalene sulfonates.
172.826  Sodium stearyl fumarate.
172.828  Acetylated monoglycerides.
172.830  Succinylated monoglycerides.
172.832  Monoglyceride citrate.
172.834  Ethoxylated mono- and diglycerides.
172.836  Polysorbate 60.
172.838  Polysorbate 65.
172.840  Polysorbate 80.
172.841  Polydextrose.
172.842  Sorbitan monostearate.
172.844  Calcium stearoyl-2-lactylate.
172.846  Sodium stearoyl-2-lactylate.
172.848  Lactylic esters of fatty acids.
172.850  Lactylated fatty acid esters of glycerol and propylene glycol.
172.852  Glyceryl-lacto esters of fatty acids.
172.854  Polyglycerol esters of fatty acids.
172.856  Propylene glycol mono- and diesters of fats and fatty acids.
172.858  Propylene glycol alginate.
172.859  Sucrose fatty acid esters.
172.860  Fatty acids.
172.861  Cocoa butter substitute from coconut oil, palm kernel oil, or 
          both oils.
172.862  Oleic acid derived from tall oil fatty acids.
172.863  Salts of fatty acids.
172.864  Synthetic fatty alcohols.
172.866  Synthetic glycerin produced by the hydrogenolysis of 
          carbohydrates.
172.867  Olestra.
172.868  Ethyl cellulose.
172.870  Hydroxypropyl cellulose.
172.872  Methyl ethyl cellulose.
172.874  Hydroxypropyl methylcellulose.
172.876  Castor oil.
172.878  White mineral oil.
172.880  Petrolatum.
172.882  Synthetic isoparaffinic petroleum hydrocarbons.
172.884  Odorless light petroleum hydrocarbons.
172.886  Petroleum wax.
172.888  Synthetic petroleum wax.
172.890  Rice bran wax.
172.892  Food starch-modified.
172.894  Modified cottonseed products intended for human consumption.
172.896  Dried yeasts.
172.898  Bakers yeast glycan.

    Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 379e).

    Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.

    Editoral Note: Nomenclature changes to part 172 appear at 61 FR 
14482, Apr. 2, 1996.



                      Subpart A--General Provisions



Sec. 172.5   General provisions for direct food additives.

    (a) Regulations prescribing conditions under which food additive 
substances may be safely used predicate usage under conditions of good 
manufacturing practice. For the purposes of this part, good 
manufacturing practice shall be defined to include the following 
restrictions.
    (1) The quantity of the substance added to food does not exceed the 
amount reasonably required to accomplish its intended physical, 
nutritive, or other technical effect in food.
    (2) Any substance intended for use in or on food is of appropriate 
food grade and is prepared and handled as a food ingredient.
    (b) The existence of a regulation prescribing safe conditions of use 
for a food additive shall not be construed to relieve the use of the 
substance from compliance with any other provision of the Act.
    (c) The existence of any regulation prescribing safe conditions of 
use for a nutrient substance does not constitute a finding that the 
substance is useful or required as a supplement to the diet of humans.

[[Page 28]]



                      Subpart B--Food Preservatives



Sec. 172.105  Anoxomer.

    Anoxomer as identified in this section may be safely used in 
accordance with the following conditions:
    (a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with 
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-
(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-
57-2) prepared by condensation polymerization of divinylbenzene (m- and 
p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-
cresol and 4,4'-isopropylidenediphenol.
    (b) The polymeric antioxidant meets the following specifications:
    (1) Polymer, not less than 98.0 percent as determined by an 
ultraviolet method entitled ``Ultraviolet Assay, ``1982, which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Molecular weight: Total monomers, dimers and trimers below 500 
not more than 1 percent as determined by a method entitled ``Low 
Molecular Weight Anoxomer Analysis,'' 1982, which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (3) Phenol content: Not less than 3.2 milliequivalent/gram and not 
more than 3.8 milliequivalent/gram as determined by a method entitled 
``Total Phenols,'' 1982, which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (4) Heavy metals as lead (as Pb), not more than 10 parts per 
million. Arsenic (as As), not more than 3 parts per million. Mercury (as 
Hg), not more than 1 part per million.
    (c) Anoxomer may be safely used as an antioxidant in food at a level 
of not more than 5,000 parts per million based on fat and oil content of 
the food.

[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]



Sec. 172.110  BHA.

    The food additive BHA (butylated hydroxyanisole) alone or in 
combination with other antioxidants permitted in food for human 
consumption in this Subpart B may be safely used in or on specified 
foods, as follows:
    (a) The BHA meets the following specification:

Assay (total BHA), 98.5 percent minimum. Melting point 48 deg. C 
minimum.

    (b) The BHA is used alone or in combination with BHT, as an 
antioxidant in foods, as follows:

------------------------------------------------------------------------
                                                             Limitations
                                                              (total BHA
                            Food                               and BHT) 
                                                              parts per 
                                                               million  
------------------------------------------------------------------------
Dehydrated potato shreds...................................           50
Active dry yeast...........................................     \1\1,000
Beverages and desserts prepared from dry mixes.............         \1\2
Dry breakfast cereals......................................           50
Dry diced glazed fruit.....................................        \1\32
Dry mixes for beverages and desserts.......................        \1\90
Emulsion stabilizers for shortenings.......................          200
Potato flakes..............................................           50
Potato granules............................................           10
Sweetpotato flakes.........................................           50
------------------------------------------------------------------------
\1\BHA only.                                                            

    (c) To assure safe use of the additive:
    (1) The label of any market package of the additive shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) When the additive is marketed in a suitable carrier, in addition 
to meeting the requirement of paragraph (c)(1) of this section, the 
label shall declare the percentage of the additive in the mixture.
    (3) The label or labeling of dry mixes for beverages and desserts 
shall bear adequate directions for use to provide that beverages and 
desserts prepared from the dry mixes contain no more than 2 parts per 
million BHA.

[[Page 29]]



Sec. 172.115   BHT.

    The food additive BHT (butylated hydroxytoluene), alone or in 
combination with other antioxidants permitted in this Subpart B may be 
safely used in or on specified foods, as follows:
    (a) The BHT meets the following specification: Assay (total BHT) 99 
percent minimum.
    (b) The BHT is used alone or in combination with BHA, as an 
antioxidant in foods, as follows:

------------------------------------------------------------------------
                                                             Limitations
                                                              (total BHA
                            Food                               and BHT) 
                                                              parts per 
                                                               million  
------------------------------------------------------------------------
Dehydrated potato shreds...................................           50
Dry breakfast cereals......................................           50
Emulsion stabilizers for shortenings.......................          200
Potato flakes..............................................           50
Potato granules............................................           10
Sweetpotato flakes.........................................           50
------------------------------------------------------------------------

    (c) To assure safe use of the additive:
    (1) The label of any market package of the additive shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) When the additive is marketed in a suitable carrier, in addition 
to meeting the requirement of paragraph (c)(1) of this section, the 
label shall declare the percentage of the additive in the mixture.



Sec. 172.120   Calcium disodium EDTA.

    The food additive calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate) may be safely used in designated foods for the 
purposes and in accordance with the conditions prescribed, as follows:
    (a) The additive contains a minimum of 99 percent by weight of 
either the dihydrate 
C10H12O8N2CaNa22H2O or the 
trihydrate C10H12O8N2CaNa23H2O, 
or any mixture of the two.
    (b) It is used or intended for use as follows:
    (1) Alone, in the following foods at not to exceed the levels 
prescribed, calculated as the anhydrous compound:

------------------------------------------------------------------------
                                      Limitation                        
                Food                  (parts per            Use         
                                       million)                         
------------------------------------------------------------------------
Cabbage, pickled....................        220   Promote color, flavor,
                                                   and texture          
                                                   retention.           
Canned carbonated soft drinks.......         33   Promote flavor        
                                                   retention.           
Canned white potatoes...............        110   Promote color         
                                                   retention.           
Clams (cooked canned)...............        340   Promote color         
                                                   retention.           
Crabmeat (cooked canned)............        275   Retard struvite       
                                                   formation; promote   
                                                   color retention.     
Cucumbers pickled...................        220   Promote color, flavor,
                                                   and texture          
                                                   retention.           
Distilled alcoholic beverages.......         25   Promote stability of  
                                                   color, flavor, and/or
                                                   product clarity.     
Dressings, nonstandardized..........         75   Preservative.         
Dried lima beans (cooked canned)....        310   Promote color         
                                                   retention.           
Egg product that is hard-cooked and      \1\200   Preservative.         
 consists, in a cylindrical shape,                                      
 of egg white with an inner core of                                     
 egg yolk.                                                              
Fava beans (cooked canned)..........        365   Promote color         
                                                   retention.           
Fermented malt beverages............         25   Antigushing agent.    
French dressing.....................         75   Preservative.         
Mayonnaise..........................         75       Do.               
Mushrooms (cooked canned)...........        200   Promote color         
                                                   retention.           
Oleomargarine.......................         75   Preservative.         
Pecan pie filling...................        100   Promote color         
                                                   retention.           
 Pink beans (cooked canned).........        165   Promote color         
                                                   retention.           
Potato salad........................        100   Preservative.         
Processed dry pinto beans...........        800   Promote color         
                                                   retention.           
Red beans (cooked canned)...........        165   Promote color         
                                                   retention.           
Salad dressing......................         75   Preservative.         
Sandwich spread.....................        100       Do.               
Sauces..............................         75       Do.               
Shrimp (cooked canned)..............        250   Retard struvite       
                                                   formation; promote   
                                                   color retention.     
Spice extractives in soluble                 60   Promote color and     
 carriers.                                         flavor retention.    
Spreads, artificially colored and           100   Promote color         
 lemon-flavored or orange-flavored.                retention.           
------------------------------------------------------------------------
\1\By weight of egg yolk portion.                                       

    (2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the 
following foods at not to exceed, in combination, the levels prescribed, 
calculated as anhydrous C10H12O8N2CaNa2:

------------------------------------------------------------------------
                                      Limitation                        
                Food                  (parts per            Use         
                                       million)                         
------------------------------------------------------------------------
Dressings, nonstandardized..........         75   Preservative.         
French dressing.....................         75       Do.               
Mayonnaise..........................         75       Do.               
Salad dressing......................         75       Do.               
Sandwich spread.....................        100       Do.               

[[Page 30]]

                                                                        
Sauces..............................         75       Do.               
------------------------------------------------------------------------

    (c) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to provide a final food product that complies 
with the limitations provided in paragraph (b) of this section.
    (d) In the standardized foods listed in paragraph (b) of this 
section, the additives are used only in compliance with the applicable 
standards of identity for such foods.

[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983; 
58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995]



Sec. 172.130   Dehydroacetic acid.

    The food additive dehydroacetic acid and/or its sodium salt may be 
safely used in accordance with the following prescribed conditions:
    (a) The food additive meets the following specifications:

Dehydroacetic acid: Melting point, 109 deg. C-111 deg. C; assay, minimum 
98 percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry 
basis).

    (b) It is used or intended for use as a preservative for cut or 
peeled squash, and is so used that no more than 65 parts per million 
expressed as dehydroacetic acid remains in or on the prepared squash.
    (c) The label or labeling of any package of the additive intended 
for use in food shall bear adequate directions for use to insure 
compliance with this section.



Sec. 172.133  Dimethyl dicarbonate.

    Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive meets the following specifications:
    (1) The additive has a purity of not less than 99.8 percent as 
determined by the following titration method:

                          Principles of Method

    Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine 
with which it reacts quantitatively. The excess amine is backtitrated 
with acid.

                                Apparatus

250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, eg., Metrohm burette)
Stirrer
Device for potentiometric titration
Reference electrode
Glass electrode

                                Reagents

Acetone, analytical-grade
Solution of 1 N diisobutylamine in chlorobenzene, distilled
1 N Acetic Acid

                                Procedure

    Accurately weigh in about 2 grams of the sample (W) and dissolve in 
100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution 
by pipette and allow to stand for 5 minutes. Subsequently, titrate the 
reaction mixture potentiometrically with 1 N hydrochloric acid 
(consumption=a mL) while stirring. For determining the blank 
consumption, carry out the analysis without a sample (consumption=b mL).

                               Calculation
[GRAPHIC] [TIFF OMITTED] TR01JA93.386

    Note: For adding the diisobutylamine solution, always use the same 
pipette and wait for a further three drops to fall when the flow has 
stopped.

    (2) The additive contains not more than 2,000 ppm (0.2 percent) 
dimethyl carbonate as determined by a method entitled ``Gas 
Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl 
Dicarbonate,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a). Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), 200 C Street SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol

[[Page 31]]

Street, NW., suite 700, Washington, DC 20408.
    (b) The additive is used or intended for use as follows:
    (1) Inhibitor of yeast in wine, dealcoholized wine, and low alcohol 
wine, under normal circumstances of bottling where the viable yeast 
count has been reduced to 500 per milliliter or less by current good 
manufacturing practices such as flash pasteurization or filtration. The 
additive may be added to wine, dealcoholized wine, or low alcohol wine 
in an amount not to exceed 200 parts per million (ppm).
    (2) Inhibitor of yeast in ready-to-drink teas, under normal 
circumstances of bottling or canning where the viable yeast count has 
been reduced to 500 per milliliter or less by current good manufacturing 
practices such as heat treatment, sterile filtration, or both. The 
additive may be added to teas in an amount not to exceed 250 ppm.
    (c) To ensure the safe use of the food additive, the label of the 
package containing the additive shall bear, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The name of the additive ``dimethyl dicarbonate.''
    (2) Directions to provide that not more than 200 ppm of dimethyl 
dicarbonate will be added to the wine, dealcoholized wine, or low 
alcohol wine and not more than 250 ppm of dimethyl dicarbonate will be 
added to the ready-to-drink tea.

[53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59 
FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996]



Sec. 172.135   Disodium EDTA.

    The food additive disodium EDTA (disodium ethylenediaminetetraace-
tate) may be safely used in designated foods for the purposes and in 
accordance with the following prescribed conditions:
    (a) The additive contains a minimum of 99 percent disodium 
ethylenedia-minetetraacetate dihydrate 
(C10H14O8N2Na22H2O).
    (b) It is used or intended for use as follows:
    (1) Alone, in the following foods at not to exceed the levels 
prescribed, calculated as anhydrous calcium disodium EDTA:

------------------------------------------------------------------------
                                      Limitation                        
                Food                  (parts per            Use         
                                       million)                         
------------------------------------------------------------------------
Aqueous multivitamin preparations...        150   With iron salts as a  
                                                   stabilizer for       
                                                   vitamin B\12\ in     
                                                   liquid multivitamin  
                                                   preparations.        
Canned black-eyed peas..............        145   Promote color         
                                                   retention.           
Canned cooked chickpeas.............        165       Do.               
Canned kidney beans.................        165   Preservative.         
Canned strawberry pie filling.......        500   Promote color         
                                                   retention.           
Cooked sausage......................         36   As a cure accelerator 
                                                   with sodium ascorbate
                                                   or ascorbic acid.    
Dressings, nonstandardized..........         75   Preservative.         
French dressing.....................         75       Do.               
Frozen white potatoes including cut         100   Promote color         
 potatoes.                                         retention.           
Gefilte fish balls or patties in          \1\50   Inhibit discoloration.
 packing medium.                                                        
Mayonnaise..........................         75   Preservative.         
Ready-to-eat cereal products             \2\315   Promote color         
 containing dried bananas.                         retention.           
Salad dressing......................         75   Preservative.         
Sandwich spread.....................        100       Do.               
Sauces..............................         75       Do.               
------------------------------------------------------------------------
\1\Based on total weight of finished product including packing medium.  
\2\In dried banana component of cereal product.                         

    (2) With calcium disodium EDTA (calcium disodium 
ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo) 
tetraacetate), in the following foods at not to exceed, in combination, 
the levels prescribed, calculated as anhydrous 
C10H12O8N2CaNa2:

------------------------------------------------------------------------
                                      Limitation                        
                Food                  (parts per            Use         
                                       million)                         
------------------------------------------------------------------------
Dressings, nonstandardized..........         75   Preservative.         
French dressing.....................         75       Do.               
Mayonnaise..........................         75       Do.               
Salad dressing......................         75       Do.               
Sandwich spread.....................        100       Do.               
Sauces..............................         75       Do.               
------------------------------------------------------------------------

    (3) Alone, as a sequestrant in the nonnutritive sweeteners that are 
listed in Sec. 180.37 of this chapter and that, in addition, are 
designed for aqueous solution: Provided, That the amount of the 
additive, calculated as anhydrous

[[Page 32]]

calcium disodium EDTA, does not exceed 0.1 percent by weight of the dry 
nonnutritive sweetener.
    (c) To assure the safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to provide a final food product that complies 
with the limitations provided in paragraph (b) of this section.
    (d) In the standardized foods listed in paragraphs (b)(1) and (2) of 
this section the additives are used only in compliance with the 
applicable standards of identity for such foods.



Sec. 172.140   Ethoxyquin.

    (a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may 
be safely used as an antioxidant for preservation of color in the 
production of chili powder, paprika, and ground chili at levels not in 
excess of 100 parts per million.
    (b) In order to provide for the safe use of the additive in feed 
prepared in accordance with Secs. 573.380 and 573.400 of this chapter, 
tolerances are established for residues of ethoxyquin in or on edible 
products of animals as follows:

5 parts per million in or on the uncooked fat of meat from animals 
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.



Sec. 172.145   Heptylparaben.

    (a) The food additive heptylparaben is the chemical n-heptyl p-
hydroxybenzoate.
    (b) It may be safely used to inhibit microbiological spoilage in 
accordance with the following prescribed conditions:
    (1) In fermented malt beverages in amounts not to exceed 12 parts 
per million.
    (2) In noncarbonated soft drinks and fruit-based beverages in 
amounts not to exceed 20 parts per million, when standards of identity 
established under section 401 of the Act (21 U.S.C. 341) do not preclude 
such use.



Sec. 172.150   4-Hydroxymethyl-2,6-di-tert-butylphenol.

    The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The additive has a solidification point of 140 deg. C-141 deg. 
C.
    (b) The additive is used as an antioxidant alone or in combination 
with other permitted antioxidants.
    (c) The total amount of all antioxidants added to such food shall 
not exceed 0.02 percent of the oil or fat content of the food, including 
the essential (volatile) oil content of the food.



Sec. 172.155  Natamycin (pimaricin).

    (a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is 
a polyene macrolide antimycotic substance possessing an empirical 
formula of C33H47NO13 and a molecular weight of 665.7.
    (b) The additive shall conform to the following specifications:

Purity: 97 percent plus-minus 2 percent on an anhydrous basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.

    (c) The additive may be applied to the surface of cuts and slices of 
cheese to inhibit mold spoilage with the following limitations:
    (1) The additive may be applied by dipping or by spraying, using an 
aqueous solution containing 200 to 300 parts per million of the 
additive.
    (2) The additive may be applied to the surface of those cuts and 
slices of cheese(s) listed in part 133 of this chapter only if the 
cheese standards provide for the use of ``safe and suitable'' mold-
inhibiting ingredients.

[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985]



Sec. 172.160   Potassium nitrate.

    The food additive potassium nitrate may be safely used as a curing 
agent in the processing of cod roe, in an amount not to exceed 200 parts 
per million of the finished roe.

[[Page 33]]



Sec. 172.165  Quaternary ammonium chloride combination.

    The food additive, quaternary ammonium chloride combination, may be 
safely used in food in accordance with the following conditions:
    (a) The additive contains the following compounds: n-dodecyl 
dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl 
dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n-
hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n-
octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n-
tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n-
tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-
29-4).
    (b) The additive meets the following specifications: pH (5 percent 
active solution) 7.0-8.0; total amines, maximum 1 percent as combined 
free amines and amine hydrochlorides.
    (c) The additive is used as an antimicrobial agent, as defined in 
Sec. 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added 
prior to clarification when further processing of the sugar cane juice 
must be delayed.
    (d) The additive is applied to the sugar juice in the following 
quantities, based on the weight of the raw cane:

------------------------------------------------------------------------
                                                              Parts per 
                         Component                             million  
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride................     0.25-1.0
n-Dodecyl dimethyl ethylbenzyl ammonium chloride...........     3.4-13.5
n-Hexadecyl dimethyl benzyl ammonium chloride..............      1.5-6.0
n-Octadecyl dimethyl benzyl ammonium chloride..............     0.25-1.0
n-Tetradecyl dimethyl benzyl ammonium chloride.............     3.0-12.0
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride........      1.6-6.5
------------------------------------------------------------------------


[50 FR 3890, Jan. 29, 1985]



Sec. 172.170   Sodium nitrate.

    The food additive sodium nitrate may be safely used in or on 
specified foods in accordance with the following prescribed conditions:
    (a) It is used or intended for use as follows:
    (1) As a preservative and color fixative, with or without sodium 
nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked, 
cured shad, so that the level of sodium nitrate does not exceed 500 
parts per million and the level of sodium nitrite does not exceed 200 
parts per million in the finished product.
    (2) As a preservative and color fixative, with or without sodium 
nitrite, in meat-curing preparations for the home curing of meat and 
meat products (including poultry and wild game), with directions for use 
which limit the amount of sodium nitrate to not more than 500 parts per 
million in the finished meat product and the amount of sodium nitrite to 
not more than 200 parts per million in the finished meat product.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive or of a mixture containing the 
additive shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive in any 
mixture.
    (2) If in a retail package intended for household use, the label and 
labeling of the additive, or of a mixture containing the additive, shall 
bear adequate directions for use to provide a final food product that 
complies with the limitations prescribed in paragraph (a) of this 
section.
    (3) If in a retail package intended for household use, the label of 
the additive or of a mixture containing the additive, shall bear the 
statement ``Keep out of the reach of children''.



Sec. 172.175   Sodium nitrite.

    The food additive sodium nitrite may be safely used in or on 
specified foods in accordance with the following prescribed conditions:
    (a) It is used or intended for use as follows:
    (1) As a color fixative in smoked cured tunafish products so that 
the level of sodium nitrite does not exceed 10 parts per million (0.001 
percent) in the finished product.
    (2) As a preservative and color fixative, with or without sodium 
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked, 
cured shad so that the level of sodium nitrite does not exceed 200 parts 
per million and the

[[Page 34]]

level of sodium nitrate does not exceed 500 parts per million in the 
finished product.
    (3) As a preservative and color fixative, with sodium nitrate, in 
meat-curing preparations for the home curing of meat and meat products 
(including poultry and wild game), with directions for use which limit 
the amount of sodium nitrite to not more than 200 parts per million in 
the finished meat product, and the amount of sodium nitrate to not more 
than 500 parts per million in the finished meat product.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive or of a mixture containing the 
additive shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive in any 
mixture.
    (2) If in a retail package intended for household use, the label and 
labeling of the additive, or of a mixture containing the additive, shall 
bear adequate directions for use to provide a final food product which 
complies with the limitations prescribed in paragraph (a) of this 
section.
    (3) If in a retail package intended for household use, the label of 
the additive, or of a mixture containing the additive, shall bear the 
statement ``Keep out of the reach of children''.



Sec. 172.177   Sodium nitrite used in processing smoked chub.

    The food additive sodium nitrite may be safely used in combination 
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation 
from Clostridium botulinum type E in the commercial processing of smoked 
chub in accordance with the following prescribed conditions:
    (a) All fish in smoking establishments shall be clean and wholesome 
and shall be expeditiously processed, packed, and stored under adequate 
sanitary conditions in accordance with good manufacturing practice.
    (b) The brining procedure is controlled in such a manner that the 
water phase portion of the edible portion of the finished smoked product 
has a salt (NaCl) content of not less than 3.5 percent, as measured in 
the loin muscle, and the sodium nitrite content of the edible portion of 
the finished smoked product is not less than 100 parts per million and 
not greater than 200 parts per million, as measured in the loin muscle.
    (c) Smoked chub shall be heated by a controlled heat process which 
provides a monitoring system positioned in as many strategic locations 
in the smokehouse as necessary to assure a continuous temperature 
throughout each fish of at least 160 deg.F for a minimum of 30 minutes.
    (d) The finished product shall be cooled to a temperature of 50 deg. 
F or below within 3 hours after smoking and further cooled to a 
temperature of 38 deg. F or below within 12 hours after smoking. A 
temperature of 38 deg. F or below shall be maintained during all 
subsequent storage and distribution. All shipping containers, retail 
packages, and shipping records shall indicate with appropriate notice 
the perishable nature of the product and specify that the product shall 
be held under refrigeration (38 deg. F or below) until consumed.
    (e) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate directions to assure use in compliance with the provisions of 
this section.



Sec. 172.180   Stannous chloride.

    The food additive stannous chloride may be safely used for color 
retention in asparagus packed in glass, with lids lined with an inert 
material, in an amount not to exceed 20 parts per million calculated as 
tin (Sn).



Sec. 172.185   TBHQ.

    The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-
1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), 
also known as tertiary butylhydroquinone, may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive has a melting point of 126.5 deg.C-
128.5 deg.C.

[[Page 35]]

    (b) It is used as an antioxidant alone or in combination with BHA 
and/or BHT.
    (c) The total antioxidant content of a food containing the additive 
will not exceed 0.02 percent of the oil or fat content of the food, 
including the essential (volatile) oil content of the food.



Sec. 172.190   THBP.

    The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely 
used in food in accordance with the following prescribed conditions:
    (a) The food additive has a melting point of 149 deg.C-153 deg.C.
    (b) It is used as an antioxidant alone or in combination with other 
permitted antioxidants.
    (c) The total antioxidant content of a food containing the additive 
will not exceed 0.02 percent of the oil or fat content of the food, 
including the essential (volatile) oil content of the food.



            Subpart C--Coatings, Films and Related Substances



Sec. 172.210   Coatings on fresh citrus fruit.

    Coatings may be applied to fresh citrus fruit for protection of the 
fruit in accordance with the following conditions:
    (a) The coating is applied in the minimum amount required to 
accomplish the intended effect.
    (b) The coating may be formulated from the following components, 
each used in the minimum quantity required to accomplish the intended 
effect:
    (1) Substances generally recognized as safe for the purpose or 
previously sanctioned for the purpose.
    (2) One or more of the following:

------------------------------------------------------------------------
           Component                           Limitations              
------------------------------------------------------------------------
Fatty acids....................  Complying with Sec.  172.860.          
Oleic acid derived from tall     Complying with Sec.  172.862.          
 oil fatty acids.                                                       
Partially hydrogenated rosin...  Catalytically hydrogenated to a maximum
                                  refractive index of 1.5012 at 100 deg.
                                  C. Color of WG or paler.              
Pentaerythritol ester of maleic  Acid number of 134-145; drop-softening 
 anhydride-modified wood rosin.   point of 127 deg. C-173 deg. C;       
                                  saponification number of less than    
                                  280; and a color of M or paler.       
    Do.........................  Acid number of 176-186; drop-softening 
                                  point of 110 deg. C-118 deg. C;       
                                  saponification number of less than    
                                  280; and a color of M or paler.       
Polyethylene glycol............  Complying with Sec.  172.820. As a     
                                  defoamer and dispersing adjuvant.     
Polyhydric alcohol diesters of   Complying with Sec.  178.3770 of this  
 oxidatively refined              chapter and having a dropping point of
 (Gersthofen process) montan      77 to 83 deg. C (170.6 to 181.4 deg.  
 wax acids.                       F), as determined by ASTM Method D566-
                                  76 (Reapproved 1982), ``Standard Test 
                                  Method for Dropping Point of          
                                  Lubricating Grease,'' which is        
                                  incorporated by reference (copies are 
                                  available from the American Society   
                                  for Testing and Materials, 1916 Race  
                                  St., Philadelphia, PA 19103, or       
                                  available for inspection at the Office
                                  of the Federal Register, 800 North    
                                  Capitol Street, NW., suite 700,       
                                  Washington, DC 20408) using as a      
                                  solvent xylene-ethyl alcohol in a 2:1 
                                  ratio instead of toluene-ethyl alcohol
                                  in a 2:1 ratio.                       
Sodium lauryl sulfate..........  Complying with Sec.  172.822. As a film
                                  former.                               
Wood rosin.....................  Color of K or paler.                   
------------------------------------------------------------------------


------------------------------------------------------------------------
           Component                           Limitations              
------------------------------------------------------------------------
Vinyl chloride-vinylidene        As an aqueous dispersion containing a  
 chloride copolymer.              minimum of 75 percent water when      
                                  applied.                              
Polyethylene glycol............  Complying with Sec.  172.820. As a     
                                  defoamer and dispersing adjuvant.     
Polyvinylpyrrolidone...........  As an adjuvant.                        
Potassium persulfate...........      Do.                                
Propylene glycol alginate......      Do.                                
Sodium decylbenzenesulfonate...      Do.                                
------------------------------------------------------------------------


[[Page 36]]



------------------------------------------------------------------------
           Component                           Limitations              
------------------------------------------------------------------------
Calcium salt of partially        Having a maximum drop-softening point  
 dimerized rosin.                 of 197 deg. C and a color of H or     
                                  paler. It is prepared by reaction with
                                  not more than 7 parts hydrated lime   
                                  per 100 parts of partially dimerized  
                                  rosin. The partially dimerized rosin  
                                  is rosin that has been dimerized by   
                                  sulfuric acid catalyst to a drop-     
                                  softening point of 95 deg. C to 105   
                                  deg. C and a color of WG or paler.    
Petroleum naphtha..............  As adjuvant. Complying with Sec.       
                                  172.250.                              
Sperm oil......................  As adjuvant.                           
------------------------------------------------------------------------

[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 
FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 
1996]



Sec. 172.215   Coumarone-indene resin.

    The food additive coumarone-indene resin may be safely used on 
grapefruit, lemons, limes, oranges, tangelos, and tangerines in 
accordance with the following prescribed conditions:
    (a) The food additive is manufactured by the polymerization of a 
crude, heavy coal-tar solvent naphtha meeting the following 
specifications:
    (1) It is a mixture of indene, indan (hydrindene), substituted 
benzenes, and related compounds.
    (2) It contains no more than 0.25 percent tar bases.
    (3) 95 percent distills in the range 167 deg. C-184 deg. C.
    (b) The food additive meets the following specifications:
    (1) Softening point, ring and ball: 126 deg. C minimum as determined 
by ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for 
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Refractive index (n25/D) 1.63-1.64.
    (c) It is used or intended for use as a protective coating for 
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the 
maximum amount of the resin remaining on the fruit does not exceed 200 
parts per million on a fresh-weight basis.
    (d) To assure safe use of the additive:
    (1) The label of the market package or any intermediate premix of 
the additive shall bear, in addition to the other information required 
by the act:
    (i) The name of the additive, coumarone-indene resin.
    (ii) A statement of the concentration of the additive therein.
    (2) The label or accompanying labeling shall bear adequate 
directions that, if followed, will result in a finished food not in 
conflict with the requirements of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]



Sec. 172.225  Methyl and ethyl esters of fatty acids produced from edible fats and oils.

    Methyl esters and ethyl esters of fatty acids produced from edible 
fats and oils may be safely used in food, subject to the following 
prescribed conditions:
    (a) The additive consists of a mixture of either methyl or ethyl 
esters of fatty acids produced from edible fats and oils and meets the 
following specifications:
    (1) Not less than 90 percent methyl or ethyl esters of fatty acids.
    (2) Not more than 1.5 percent unsaponifiable matter.
    (b) The additive is used or intended for use at the level not to 
exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes 
to produce raisins, whereby the residue of the additive on the raisins 
does not exceed 200 parts per million.

[57 FR 12711, Apr. 13, 1992]



Sec. 172.230  Microcapsules for flavoring substances.

    Microcapsules may be safely used for encapsulating discrete 
particles of flavoring substances that are generally recognized as safe 
for their intended use or are regulated under this part, in accordance 
with the following conditions:
    (a) The microcapsules may be formulated from the following 
components,

[[Page 37]]

each used in the minimum quantity required to accomplish the intended 
effect:
    (1) Substances generally recognized as safe for the purpose.
    (2) One or more of the following components:

                        Component and Limitations

Succinylated gelatin--Not to exceed 15 percent by combined weight of the 
microcapsule and flavoring oil. Succinic acid content of the gelatin is 
4.5 to 5.5 percent.
Arabinogalactan--Complying with Sec. 172.610; as adjuvant.
Silicon dioxide--Complying with Sec. 172.480; as adjuvant.

    (3) In lieu of the components listed in paragraph (a)(2) of this 
section, the following components:

                        Component and Limitations

Glutaraldehyde--As cross-linking agent for insolubilizing a coacervate 
of gum arabic and gelatin.
n-Octyl alcohol--As a defoamer.

    (4) In lieu of the components listed in paragraphs (a)(2) and (3) of 
this section, the following component:

                        Component and Limitations

Petroleum wax--Complying with Sec. 172.886. Not to exceed 50 percent by 
combined weight of the microcapsule and spice-flavoring substance.

    (b) The microcapsules produced from the components listed in 
paragraphs (a) (1), (2), and (3) of this section may be used for 
encapsulating authorized flavoring oils for use, in accordance with good 
manufacturing practice, in foods for which standards of identity 
established under section 401 of the Act do not preclude such use, 
except that microcapsules formulated from components listed in paragraph 
(a)(2) of this section may be used only for encapsulating lemon oil, 
distilled lime oil, orange oil, peppermint oil, and spearmint oil for 
use in dry mixes for puddings and gelatin desserts.
    (c) The microcapsules produced from the components listed in 
paragraphs (a) (1) and (4) of this section may be used only for 
encapsulating authorized spice-flavoring substances for use, in 
accordance with good manufacturing practice, in frozen pizzas which are 
to be further processed by heat. Such pizzas shall bear labels or 
labeling including adequate directions for use to ensure heating to 
temperatures which will melt the wax to release the spice-flavoring 
substances.

[45 FR 48123, July 18, 1980]



Sec. 172.235   Morpholine.

    Morpholine may be safely used as a component of food, subject to the 
following restrictions.
    (a) It is used as the salt(s) of one or more of the fatty acids 
meeting the requirements of Sec. 172.860, as a component of protective 
coatings applied to fresh fruits and vegetables.
    (b) It is used at a level not in excess of that reasonably required 
to produce its intended effect.



Sec. 172.250   Petroleum naphtha.

    Petroleum naphtha may be safely used in food in accordance with the 
following conditions:
    (a) The additive is a mixture of liquid hydrocarbons, essentially 
paraffinic and naphthenic in nature obtained from petroleum,
    (b) The additive is refined to meet the following specifications 
when subjected to the procedures described in this paragraph.
    (1) Boiling-point range: 175 deg. F-300 deg. F.
    (2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.
    (3) Ultraviolet absorbance limits, as follows:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                 Wavelength (milli-microns)                   centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280-289.....................................................        0.15
290-299.....................................................         .13
300-359.....................................................         .08
360-400.....................................................         .02
------------------------------------------------------------------------

             Analytical Specification for Petroleum Naphtha

                          general instructions

    All glassware should be scrupulously cleaned to remove all organic 
matter such as oil, grease, detergent residues, etc. Examine all 
glassware, including stoppers and stopcocks, under ultraviolet light to 
detect any residual fluorescent contamination. As a precautionary 
measure, it is recommended practice to rinse all glassware with purified 
isooctane immediately before use. No grease

[[Page 38]]

is to be used on stopcocks or joints. Great care to avoid contamination 
of petroleum naphtha samples in handling and to assure absence of any 
extraneous material arising from inadequate packaging is essential. 
Because some of the polynuclear hydrocarbons sought in this test are 
very susceptible to photo-oxidation, the entire procedure is to be 
carried out under subdued light.

                                apparatus

    Separatory funnels. 250-milliliter, and 2,000-milliliter capacity, 
equipped with tetrafluoroethylene polymer stopcocks.
    Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.
    Evaporation flask. 250-milliliter capacity all-glass flask equipped 
with 24/40 standard taper stopper having inlet and outlet tubes to 
permit passage of nitrogen across the surface of the container liquid to 
be evaporated.
    Condenser. 24/40 joints, fitted with drying tube, length optional.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5,000 centimeters plus-minus0.005 centimeter; also for 
checking spectrophotometer performance only, optical path length in the 
range 1,000 centimeter plus-minus0.005 centimeter. With distilled 
water in the cells, determine any absorbance difference.
    Spectrophotometer. Spectral range 250-400 m with spectral 
slit width of 2 m or less; under instrument operating 
conditions for these absorbance measurements, the spectrophotometer 
shall also meet the following performance requirements:

Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
Absorbance accuracy,1 plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    1 As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). 
The accuracy is to be determined by comparison with the standard values 
at 290, 345, and 400 millimicrons. The procedure is incorporated by 
reference. Copies of the material incorporated by reference are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

Wavelength repeatability, plus-minus0.2 millimicron.
Wavelength accuracy, plus-minus1.0 millimicron.

    Ultraviolet lamp. Long wavelength (3400-3800A deg.).

                                reagents

    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-
milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane, 
insert the head assembly, allow nitrogen gas to flow into the inlet tube 
and connect the outlet tube to a solvent trap and vacuum line in such a 
way as to prevent any back flow of condensate into the flask. The 
contents of the flask are evaporated on a steam bath until 1 milliliter 
of residue remains. Dissolve the 1 milliliter of hexadecane residue in 
isooctane and make up to 25 milliliters. Determine the absorbance in a 
5-centimeter path length cell compared to isooctane as reference. The 
absorbance should not exceed 0.01 per centimeter path length between 
280-400 m. If necessary, isooctane may be purified by passage 
through a column of activated silica gel (Grade 12, Davidson Chemical 
Co., Baltimore, Md., or equivalent) or by distillation.
    Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed 
as with isooctane. The absorbance per centimeter of path length should 
be 0.00 between 280-400 m. Methyl alcohol may be purified by 
simple distillation or by refluxing in the presence of potassium 
hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3 
hours followed by distillation.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference between 280-
400 m. The absorbance per centimeter path length shall not 
exceed 0.00 in this range. Purify, if necessary, by percolation through 
activated silica gel or by distillation.
    Sodium borohydride. 98 percent.
    Water. All distilled water must be extracted with isooctane before 
use. A series of three successive extracts of 1.5 liters of distilled 
water with 100-milliliter portions of isooctane is satisfactory.

                                procedure

    Determination of ultraviolet absorbance. Add a 25-milliliter aliquot 
of the hydrocarbon solvent together with 1 milliliter of hexadecane to 
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen, 
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through 
a 8plus-minus1-milliliter outer-diameter tube, drawn out into a 
2plus-minus1-centimeter long and 1plus-minus0.5-millimeter 
inner-diameter capillary tip. This is positioned so that the capillary 
tip extends 4 centimeters into the flask. The nitrogen flow rate is such 
that the surface of the liquid is barely disturbed. After the volume is 
reduced to that of the 1 milliliter of hexadecane, the flask is left on 
the steam bath for 10 more minutes before removing. Add 10 milliliters 
of purified isooctane to the flask and reevaporate the solution to a 1-
milliliter volume in the same manner as described above, except do not 
heat for an added 10 minutes. Repeat this operation twice more. Let the 
flask cool.

[[Page 39]]

    Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium 
borohydride. (Minimize exposure of the borohydride to the atmosphere; a 
measuring dipper may be used.) Immediately fit a water-cooled condenser 
equipped with a 24/40 joint and with a drying tube into the flask, mix 
until the sodium borohydride is dissolved, and allow to stand for 30 
minutes at room temperature, with intermittent swirling. At the end of 
this time, disconnect the flask and evaporate the methyl alcohol on the 
steam bath under nitrogen until sodium borohydride begins to drop out of 
solution. Remove the flask and let it cool.
    Add 6 milliliters of isooctane to the flask and swirl to wash the 
crystalline slurry. Carefully transfer the isooctane extract to a 250-
milliliter separatory funnel. Dissolve the crystals in the flask with 
about 25 milliliters of distilled water and pour this also into the 
separatory funnel. Adjust the water volume in the separatory funnel to 
about 100 milliliters and shake for 1 minute. After separation of the 
layers, draw off the aqueous layer into a second 250-milliliter 
separatory funnel. Transfer the hydrocarbon layer in the first funnel to 
a 25-milliliter volumetric flask.
    Carefully wash the Erlenmeyer flask with an additional 6 milliliters 
of isooctane, swirl, and transfer to the second separatory funnel. Shake 
the funnel for 1 minute. After separation of the layers, draw off the 
aqueous layer into the first separatory funnel. Transfer the isooctane 
in the second funnel to the volumetric flask. Again wash the Erlenmeyer 
flask with an additional 6 milliliters of isooctane, swirl, and transfer 
to the first separatory funnel. Shake the funnel for 1 minute. After 
separation of the layers, draw off the aqueous layer and discard. 
Transfer the isooctane layer to the volumetric flask and adjust the 
volume to 25 milliliters of isooctane. Mix the contents well, then 
transfer to the first separatory funnel and wash twice with 50-
milliliter portions of distilled water. Discard the aqueous layers after 
each wash.
    Determine the ultraviolet absorbance of the isooctane extract in 5-
centimeter path length cells compared to isooctane as reference between 
280-400 m. Determine a reagent blank concurrently with the 
sample, using 25 milliliters of purified isooctane instead of a solvent 
sample and measuring the ultraviolet absorbance of the blank between 
280-400m.
    The reagent blank absorbance should not exceed 0.04 per centimeter 
path length between 280-289 m; 0.020 between 290-359 
m; and 0.010 between 360-400 m.
    Determination of boiling-point range. Use ASTM method D86-82, 
``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    Determination of nonvolatile residue. For hydrocarbons boiling below 
121 deg. C, determine the nonvolatile residue by ASTM method D1353-78, 
``Standard Test Method for Nonvolatile Matter in Volatile Solvents for 
Use in Paint, Varnish, Lacquer, and Related Products;'' for those 
boiling above 121 deg. C, use ASTM method D381-80, ``Standard Test 
Method for Existent Gum in Fuels by Jet Evaporation,'' which methods are 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

    (c) Petroleum naphtha containing antioxidants shall meet the 
specified ultraviolet absorbance limits after correction for any 
absorbance due to the antioxidants. Petroleum naphtha may contain 
antioxidants authorized for use in food in an amount not to exceed that 
reasonably required to accomplish the intended effect or to exceed any 
prescribed limitations.
    (d) Petroleum naphtha is used or intended for use as a solvent in 
protective coatings on fresh citrus fruit in compliance with 
Sec. 172.210.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 
49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989]



Sec. 172.255   Polyacrylamide.

    Polyacrylamide containing not more than 0.2 percent of acrylamide 
monomer may be safely used as a film former in the imprinting of soft-
shell gelatin capsules when the amount used is not in excess of the 
minimum required to produce the intended effect.



Sec. 172.260   Oxidized polyethylene.

    Oxidized polyethylene may be safely used as a component of food, 
subject to the following restrictions:
    (a) Oxidized polyethylene is the basic resin produced by the mild 
air oxidation of polyethylene. The polyethylene used in the oxidation 
process conforms to the density, maximum n-hexane extractable fraction, 
and maximum xylene soluble fraction specifications prescribed in item 
2.3 of the table in Sec. 177.1520(c) of this chapter. The

[[Page 40]]

oxidized polyethylene has a minimum number average molecular weight of 
1,200, as determined by high temperature vapor pressure osmometry; 
contains a maximum of 5 percent by weight of total oxygen; and has an 
acid value of 9 to 19.
    (b) The additive is used or intended for use as a protective coating 
or component of protective coatings for fresh avocados, bananas, beets, 
coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, 
muskmelons, onions, oranges, papaya, peas (in pods), pineapple, 
plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, 
turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, 
pecans, and walnuts (all nuts in shells).
    (c) The additive is used in accordance with good manufacturing 
practice and in an amount not to exceed that required to produce the 
intended effect.



Sec. 172.270  Sulfated butyl oleate.

    Sulfate butyl oleate may be safely used in food, subject to the 
following prescribed conditions:
    (a) The additive is prepared by sulfation, using concentrated 
sulfuric acid, of a mixture of butyl esters produced by 
transesterification of an edible vegetable oil using 1-butanol. 
Following sulfation, the reaction mixture is washed with water and 
neutralized with aqueous sodium or potassium hydroxide. Prior to 
sulfation, the butyl oleate reaction mixture meets the following 
specifications:
    (1) Not less than 90 percent butyl oleate.
    (2) Not more than 1.5 percent unsaponifiable matter.
    (b) The additive is used or intended for use at a level not to 
exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes 
to produce raisins, whereby the residue of the additive on the raisins 
does not exceed 100 parts per million.

[57 FR 12711, Apr. 13, 1992]



Sec. 172.275   Synthetic paraffin and succinic derivatives.

    Synthetic paraffin and succinic derivatives identified in this 
section may be safely used as a component of food, subject to the 
following restrictions:
    (a) The additive is prepared with 50 percent Fischer-Tropsch process 
synthetic paraffin, meeting the definition and specifications of 
Sec. 172.615, and 50 percent of such synthetic paraffin to which is 
bonded succinic anhydride and succinic acid derivatives of isopropyl 
alcohol, polyethylene glycol, and polypropylene glycol. It consists of a 
mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic 
anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl 
succinic anhydride polyethylene glycol half ester, and dialkyl succinic 
anhydride polypropylene glycol half ester, where the alkane (alkyl) has 
a chain length of 30-70 carbon atoms and the polyethylene and 
polypropylene glycols have molecular weights of 600 and 260, 
respectively.
    (b) The additive meets the following specifications: Molecular 
weight, 880-930; melting point, 215 deg.-217 deg. F; acid number, 43-47; 
and saponification number, 75-78.
    (c) It is used or intended for use as a protective coating or 
component of protective coatings for fresh grapefruit, lemons, limes, 
muskmelons, oranges, sweetpotatoes, and tangerines.
    (d) It is used in an amount not to exceed that required to produce 
the intended effect.



Sec. 172.280   Terpene resin.

    The food additive terpene resin may be safely used in accordance 
with the following prescribed conditions:
    (a) The food additive is the betapinene polymer obtained by 
polymerizing terpene hydrocarbons derived from wood. It has a softening 
point of 112 deg. C-118 deg. C, as determined by ASTM method E28-67 
(Reapproved 1982), ``Standard Test Method for Softening Point By Ring-
and-Ball Apparatus,'' which is incorporated by reference. Copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (b) It is used or intended for use as follows:
    (1) As a moisture barrier on soft gelatin capsules in an amount not 
to

[[Page 41]]

exceed 0.07 percent of the weight of the capsule.
    (2) As a moisture barrier on powders of ascorbic acid or its salts 
in an amount not to exceed 7 percent of the weight of the powder.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984]



          Subpart D--Special Dietary and Nutritional Additives



Sec. 172.310   Aluminum nicotinate.

    Aluminum nicotinate may be safely used as a source of niacin in 
foods for special dietary use. A statement of the concentration of the 
additive, expressed as niacin, shall appear on the label of the food 
additive container or on that of any intermediate premix prepared 
therefrom.



Sec. 172.315   Nicotinamide-ascorbic acid complex.

    Nicotinamide-ascorbic acid complex may be safely used in accordance 
with the following prescribed conditions:
    (a) The additive is the product of the controlled reaction between 
ascorbic acid and nicotinamide, melting in the range 141 deg.C to 
145 deg.C.
    (b) It is used as a source of ascorbic acid and nicotinamide in 
multivitamin preparations.



Sec. 172.320   Amino acids.

    The food additive amino acids may be safely used as nutrients added 
to foods in accordance with the following conditions:
    (a) The food additive consists of one or more of the following 
individual amino acids in the free, hydrated or anhydrous form or as the 
hydrochloride, sodium or potassium salts:

L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine

    (b) The food additive meets the following specifications:
    (1) As found in ``Food Chemicals Codex,'' National Academy of 
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), which is 
incorporated by reference (copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) for the following:

L-Alanine
L-Arginine
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
DL-Methionine
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine

    (2) As found in ``Specifications and Criteria for Biochemical 
Compounds,'' NAS/NRC Publication, 3rd Ed. (1972), which is incorporated 
by reference (copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408) for the following:

L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine

    (c) The additive(s) is used or intended for use to significantly 
improve the biological quality of the total protein in

[[Page 42]]

a food containing naturally occurring primarily-intact protein that is 
considered a significant dietary protein source, provided that:
    (1) A reasonable daily adult intake of the finished food furnishes 
at least 6.5 grams of naturally occurring primarily intact protein 
(based upon 10 percent of the daily allowance for the ``reference'' 
adult male recommended by the National Academy of Sciences in 
``Recommended Dietary Allowances,'' NAS Publication No. 1694, 7th Ed. 
(1968), which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) The additive(s) results in a protein efficiency ratio (PER) of 
protein in the finished ready-to-eat food equivalent to casein as 
determined by the method specified in paragraph (d) of this section.
    (3) Each amino acid (or combination of the minimum number necessary 
to achieve a statistically significant increase) added results in a 
statistically significant increase in the PER as determined by the 
method described in paragraph (d) of this section. The minimum amount of 
the amino acid(s) to achieve the desired effect must be used and the 
increase in PER over the primarily-intact naturally occurring protein in 
the food must be substantiated as a statistically significant difference 
with at least a probability (P) value of less than 0.05.
    (4) The amount of the additive added for nutritive purposes plus the 
amount naturally present in free and combined (as protein) form does not 
exceed the following levels of amino acids expressed as percent by 
weight of the total protein of the finished food:

------------------------------------------------------------------------
                                                              Percent by
                                                               weight of
                                                                 total  
                                                                protein 
                                                              (expressed
                                                                as free 
                                                                 amino  
                                                                 acid)  
------------------------------------------------------------------------
L-Alanine...................................................         6.1
L-Arginine..................................................         6.6
L-Aspartic acid (including L-asparagine)....................         7.0
L-Cystine (including L-cysteine)............................         2.3
L-Glutamic acid (including L-glutamine).....................        12.4
Aminoacetic acid (glycine)..................................         3.5
L-Histidine.................................................         2.4
L-Isoleucine................................................         6.6
L-Leucine...................................................         8.8
L-Lysine....................................................         6.4
L- and DL-Methionine........................................         3.1
L-Phenylalanine.............................................         5.8
L-Proline...................................................         4.2
L-Serine....................................................         8.4
L-Threonine.................................................         5.0
L-Tryptophan................................................         1.6
L-Tyrosine..................................................         4.3
L-Valine....................................................         7.4
------------------------------------------------------------------------

    (d) Compliance with the limitations concerning PER under paragraph 
(c) of this section shall be determined by the method described in 
sections 43.212-43.216, ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408. Each manufacturer or person employing the 
additive(s) under the provisions of this section shall keep and maintain 
throughout the period of his use of the additive(s) and for a minimum of 
3 years thereafter, records of the tests required by this paragraph and 
other records required to assure effectiveness and compliance with this 
regulation and shall make such records available upon request at all 
reasonable hours by any officer or employee of the Food and Drug 
Administration, or any other officer or employee acting on behalf of the 
Secretary of Health and Human Services and shall permit such officer or 
employee to conduct such inventories of raw and finished materials on 
hand as he deems necessary and otherwise to check the correctness of 
such records.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:

[[Page 43]]

    (1) The name of the amino acid(s) contained therein including the 
specific optical and chemical form.
    (2) The amounts of each amino acid contained in any mixture.
    (3) Adequate directions for use to provide a finished food meeting 
the limitations prescribed by paragraph (c) of this section.
    (f) The food additive amino acids added as nutrients to special 
dietary foods that are intended for use solely under medical supervision 
to meet nutritional requirements in specific medical conditions and 
comply with the requirements of part 105 of this chapter are exempt from 
the limitations in paragraphs (c) and (d) of this section and may be 
used in such foods at levels not to exceed good manufacturing practices.

[42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
47 FR 11836, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, 
June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR 14480, Apr. 2, 1996]



Sec. 172.325   Bakers yeast protein.

    Bakers yeast protein may be safely used in food in accordance with 
the following conditions:
    (a) Bakers yeast protein is the insoluble proteinaceous material 
remaining after the mechanical rupture of yeast cells of Saccharomyces 
cerevisiae and removal of whole cell walls by centrifugation and 
separation of soluble cellular materials.
    (b) The additive meets the following specifications on a dry weight 
basis:
    (1) Zinc salts less than 500 parts per million (ppm) as zinc.
    (2) Nucleic acid less than 2 percent.
    (3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 
ppm mercury, and 0.3 ppm selenium.
    (c) The viable microbial content of the finished ingredient is:
    (1) Less than 10,000 organisms/gram by aerobic plate count.
    (2) Less than 10 yeasts and molds/gram.
    (3) Negative for Salmonella, E. coli, coagulase positive 
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any 
other recognized microbial pathogen or any harmful microbial toxin.
    (d) The ingredient is used in food as a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter.



Sec. 172.330   Calcium pantothenate, calcium chloride double salt.

    The food additive calcium chloride double salt of calcium 
pantothenate may be safely used in foods for special dietary uses in 
accordance with good manufacturing practice and under the following 
prescribed conditions:
    (a) The food additive is of the d (dextrorotatory) or the dl 
(racemic) form.
    (b) To assure safe use of the additive, the label and labeling of 
the food additive container, or that of any intermediate premixes 
prepared therefrom, shall bear, in addition to the other information 
required by the Act, the following:
    (1) The name of the additive ``calcium chloride double salt of d-
calcium pantothenate'' or ``calcium chloride double salt of dl-calcium 
pantothenate'', whichever is appropriate.
    (2) A statement of the appropriate concentration of the additive, 
expressed as pantothenic acid.



Sec. 172.335   D-Pantothenamide.

    The food additive D-pantothenamide as a source of pantothenic acid 
activity, may be safely used in foods for special dietary use in an 
amount not in excess of that reasonably required to produce its intended 
effect.



Sec. 172.340  Fish protein isolate.

    (a) The food additive fish protein isolate may be safely used as a 
food supplement in accordance with the following prescribed conditions:
    (1) The additive shall consist principally of dried fish protein 
prepared from the edible portions of fish after removal of the heads, 
fins, tails, bones, scales, viscera, and intestinal contents.
    (2) The additive shall be derived only from species of bony fish 
that are generally recognized by qualified scientists as safe for human 
consumption and that can be processed as prescribed to meet the required 
specifications.
    (3) Only wholesome fresh fish otherwise suitable for human 
consumption may be used. The fish shall be handled expeditiously under 
sanitary

[[Page 44]]

conditions. These conditions shall be in accordance with recognized good 
manufacturing practice for fish to be used as human food.
    (4) The additive shall be prepared by extraction with hexane and 
food-grade ethanol to remove fat and moisture. Solvent residues shall be 
reduced by drying.
    (b) The food additive meets the following specifications: (Where 
methods of determination are specified, they are Association of Official 
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by 
reference).1
---------------------------------------------------------------------------

    1 Copies are available from: Association of Official Analytical 
Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

    (1) Protein content, as N X 6.25, shall not be less than 90 percent 
by weight of the final product, as determined by the method described in 
section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)--
Official Final Action.
    (2) Moisture content shall not be more than 10 percent by weight of 
the final product, as determined by the method described in section 
24.003, Air Drying (1)--Official First Action.
     (3) Fat content shall not be more than 0.5 percent by weight of the 
final product, as determined by the method described in section 24.005, 
Crude Fat or Ether Extract--Official Final Action.
    (4) Solvent residues in the final product shall not be more than 5 
parts per million of hexane and 3.5 percent ethanol by weight.

[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 
54 FR 24897, June 12, 1989]



Sec. 172.345  Folic acid (folacin).

    Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, 
may be safely used in food as a nutrient in accordance with the 
following prescribed conditions:
    (a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
    (b) Folic acid meets the specifications of the ``Food Chemicals 
Codex,'' 3d ed. (1981), pp. 125 to 126, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321, 
Washington, DC or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (c) Folic acid may be added to foods subject to a standard of 
identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act (the act) when the standard of identity specifically 
provides for the addition of folic acid.
    (d) Folic acid may be added, at levels not to exceed 400 micrograms 
(g) per serving, to breakfast cereals, as defined under 
Sec. 170.3(n)(4) of this chapter.
    (e) Folic acid may be added to infant formula in accordance with 
section 412(i)(1) of the act or with regulations issued under section 
412(i)(2) of the act which are codified in Sec. 107.100 of this chapter.
    (f) Folic acid may be added to a medical food, as defined in section 
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to 
exceed the amount necessary to meet the distinctive nutritional 
requirements of the disease or condition for which the food is 
formulated.
    (g) Folic acid may be added to food for special dietary use at 
levels not to exceed the amount necessary to meet the special dietary 
needs for which the food is formulated.
    (h) Folic acid may be added to foods represented as meal-replacement 
products, in amounts not to exceed:
    (1) Four hundred g per serving if the food is a meal-
replacement that is represented for use once per day; or
    (2) Two hundred g per serving if the food is a meal-
replacement that is represented for use more than once per day.

[61 FR 8807, Mar. 5, 1996]

[[Page 45]]



Sec. 172.350   Fumaric acid and salts of fumaric acid.

    Fumaric acid and its calcium, ferrous, magnesium, potassium, and 
sodium salts may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additives meet the following specifications:
    (1) Fumaric acid contains a minimum of 99.5 percent by weight of 
fumaric acid, calculated on the anhydrous basis.
    (2) The calcium, magnesium, potassium, and sodium salts contain a 
minimum of 99 percent by weight of the respective salt, calculated on 
the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent 
total iron and not more than 2 percent ferric iron.
    (b) With the exception of ferrous fumarate, fumaric acid and the 
named salts are used singly or in combination in food at a level not in 
excess of the amount reasonably required to accomplish the intended 
effect.
    (c) Ferrous fumarate is used as a source of iron in foods for 
special dietary use, when the use is consistent with good nutrition 
practice.



Sec. 172.365   Kelp.

    Kelp may be safely added to a food as a source of the essential 
mineral iodine, provided the maximum intake of the food as may be 
consumed during a period of one day, or as directed for use in the case 
of a dietary supplement, will not result in daily ingestion of the 
additive so as to provide a total amount of iodine in excess of 225 
micrograms for foods labeled without reference to age or physiological 
state; and when age or the conditions of pregnancy or lactation are 
specified, in excess of 45 micrograms for infants, 105 micrograms for 
children under 4 years of age, 225 micrograms for adults and children 4 
or more years of age, and 300 micrograms for pregnant or lactating 
women. The food additive kelp is the dehydrated, ground product prepared 
from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and 
Laminaria cloustoni.



Sec. 172.370   Iron-choline citrate complex.

    Iron-choline citrate complex made by reacting approximately 
equimolecular quantities of ferric hydroxide, choline, and citric acid 
may be safely used as a source of iron in foods for special dietary use.



Sec. 172.372  N-Acetyl-L-methionine.

    The food additive N-acetyl-L-methionine may be safely added to food 
(except infant foods and foods containing added nitrites/nitrates) as a 
source of L-methionine for use as a nutrient in accordance with the 
following conditions:
    (a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No. 
65-82-7) is the derivative of the amino acid methionine formed by 
addition of an acetyl group to the alpha-amino group of methionine. It 
may be in the free, hydrated or anhydrous form, or as the sodium or 
potassium salts.
    (b) The additive meets the following specifications:
    (1) Purity assay, on a dry basis: Minimum 99 percent.
    (2) Residue on ignition: Maximum 0.1 percent.
    (3) Specific optical rotation [alpha]\20\D: Between -19 deg. 
and -23 deg..
    (4) The additive may contain residues of not more than 500 ppm ethyl 
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm 
acetone, when used as processing solvents.
    (c) The additive is used or intended for use as a source of L-
methionine to improve significantly the biological quality of the total 
protein in a food containing naturally occurring primarily intact 
vegetable protein that is considered a significant dietary protein 
source, provided that:
    (1) A reasonable daily adult intake of the finished food furnishes 
at least 6.5 grams of naturally occurring primarily intact vegetable 
protein.
    (2) The additive results in a protein efficiency ratio (PER) of 
protein in the finished ready-to-eat food equivalent to casein as 
determined by the method specified in paragraph (d) of this section.
    (3) The use of the additive results in a statistically significant 
increase in the PER as determined by the method described in paragraph 
(d) of this

[[Page 46]]

section. The minimum amount of the additive to achieve the desired 
effect must be used, and the increase in PER over the primarily intact 
naturally occurring vegetable protein in the food must be substantiated 
as a statistically significant difference with at least a probability 
(P) value of less than 0.05.
    (4) The amount of the additive added for nutritive purpose shall not 
exceed the level that will provide a total of 3.1 percent L- and DL-
methionine (expressed as the free amino acid) by weight of the total 
protein of the finished food, including the amount naturally present in 
free and combined (as protein) form.
    (5) The additive shall not be added to infant foods or to foods 
containing added nitrites/nitrates.
    (d) Compliance with the limitations concerning PER under paragraph 
(c) of the section shall be determined by the method described in 
sections 43.212-43.216, ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408. Each manufacturer or person employing the additive 
under the provisions of this section shall keep and maintain throughout 
the period of use of the additive and for a minimum of 3 years 
thereafter, records of the tests required by this paragraph and other 
records required to assure effectiveness and compliance with this 
regulation. Those records shall be made available upon request at all 
reasonable hours by any officer or employee acting on behalf of the 
Secretary of Health and Human Services. Those officers or employees 
shall be permitted to conduct inventories of raw and finished materials 
on hand as are deemed necessary to verify the records.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The name of the additive contained therein.
    (2) The amounts of additive and each amino acid contained in any 
mixture.
    (3) Adequate directions for use to provide a finished food meeting 
the limitations prescribed by paragraph (c) of this section.
    (f) When the food additive is added as a nutrient to special dietary 
foods that are intended for use solely under medical supervision to meet 
nutritional requirements in specific medical conditions and these foods 
comply with the requirements of part 105 of this chapter, the food 
additive is exempt from the limitations in paragraphs (c)(1) through (4) 
and (d) of this section and may be used in those foods at levels not to 
exceed good manufacturing practices.

[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49 
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.375   Potassium iodide.

    The food additive potassium iodide may be safely used in accordance 
with the following prescribed conditions:
    (a) Potassium iodide may be safely added to a food as a source of 
the essential mineral iodine, provided the maximum intake of the food as 
may be consumed during a period of one day, or as directed for use in 
the case of a dietary supplement, will not result in daily ingestion of 
the additive so as to provide a total amount of iodine in excess of 225 
micrograms for foods labeled without reference to age or physiological 
state; and when age or the conditions of pregnancy or lactation are 
specified, in excess of 45 micrograms for infants, 105 micrograms for 
children under 4 years of age, 225 micrograms for adults and children 4 
or more years of age, and 300 micrograms for pregnant or lactating 
women.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act, the label of the additive shall bear:
    (1) The name of the additive.
    (2) A statement of the concentration of the additive in any mixture.

[[Page 47]]



Sec. 172.385   Whole fish protein concentrate.

    The food additive whole fish protein concentrate may be safely used 
as a food supplement in accordance with the following prescribed 
conditions:
    (a) The additive is derived from whole, wholesome hake and hakelike 
fish, herring of the genera Clupea, menhaden, and anchovy of the species 
Engraulis mordax, handled expeditiously and under sanitary conditions in 
accordance with good manufacturing practices recognized as proper for 
fish that are used in other forms for human food.
    (b) The additive consists essentially of a dried fish protein 
processed from the whole fish without removal of heads, fins, tails, 
viscera, or intestinal contents. It is prepared by solvent extraction of 
fat and moisture with isopropyl alcohol or with ethylene dichloride 
followed by isopropyl alcohol, except that the additive derived from 
herring, menhaden and anchovy is prepared by solvent extraction with 
isopropyl alcohol alone. Solvent residues are reduced by conventional 
heat drying and/or microwave radiation and there is a partial removal of 
bone.
    (c) The food additive meets the following specifications:
    (1) Protein content (N  x  6.25) shall not be less than 75 percent 
by weight of the final product, as determined by the method described in 
section 2.057 in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists'' (AOAC), 13th Ed. (1980). Protein quality 
shall not be less than 100, as determined by the method described in 
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by 
reference, and copies may be obtained from the Association of Official 
Analytical Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (2) Moisture content shall not exceed 10 percent by weight of the 
final product, as determined by the method described in section 24.003 
of the AOAC. See paragraph (c)(1) of this section for availability of 
the material incorporated by reference.
    (3) Fat content shall not exceed 0.5 percent by weight of the final 
product, as determined by the method described in section 24.005 of the 
AOAC. See paragraph (c)(1) of the this section for availability of the 
material incorporated by reference.
    (4) The additive may contain residues of isopropyl alcohol and 
ethylene dichloride not in excess of 250 parts per million and 5 parts 
per million, respectively, when used as solvents in the extraction 
process.
    (5) Microwave radiation meeting the requirements of Sec. 179.30 of 
this chapter may be used to reduce residues of the solvents used in the 
extraction process.
    (6) The additive shall contain not in excess of 100 parts per 
million fluorides (expressed as F).
    (7) The additive shall be free of Escherichia coli and pathogenic 
organisms, including Salmonella, and shall have a total bacterial plate 
count of not more than 10,000 per gram.
    (8) The additive shall have no more than a faint characteristic fish 
odor and taste.
    (d) When the additive is used or intended for use in the household 
as a protein supplement in food for regular consumption by children up 
to 8 years of age, the amount of the additive from this source shall not 
exceed 20 grams per day (about one heaping tablespoon).
    (e) When the additive is used as a protein supplement in 
manufactured food, the total fluoride content (expressed as F) of the 
finished food shall not exceed 8 ppm based on the dry weight of the food 
product.
    (f) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of consumer-sized or bulk containers of the additive 
shall bear the name ``whole fish protein concentrate''.
    (2) The label or labeling of containers of the additive shall bear 
adequate directions for use to comply with the limitations prescribed by 
paragraphs (d) and (e) of this section.
    (3) Labels of manufactured foods containing the additive shall bear, 
in the ingredient statement, the name of the

[[Page 48]]

additive, ``whole fish protein concentrate'' in the proper order of 
decreasing predominance in the finished food.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 
54 FR 24897, June 12, 1989]



Sec. 172.395   Xylitol.

    Xylitol may be safely used in foods for special dietary uses, 
provided the amount used is not greater than that required to produce 
its intended effect.



Sec. 172.399  Zinc methionine sulfate.

    Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used 
in accordance with the following prescribed conditions:
    (a) The additive is the product of the reaction between equimolar 
amounts of zinc sulfate and DL-methionine in purified water.
    (b) The additive meets the following specifications:

    Zinc content--19 to 22 percent.
    C5H11NO2S ``DL-methionine''--46 to 50 percent.
    Cadmium--not more than 0.05 part per million.

    (c) The additive is used in tablet form as a source of dietary zinc.

[46 FR 58297, Dec. 1, 1981]



                      Subpart E--Anticaking Agents



Sec. 172.410   Calcium silicate.

    Calcium silicate, including synthetic calcium silicate, may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) It is used as an anticaking agent in food in an amount not in 
excess of that reasonably required to produce its intended effect.
    (b) It will not exceed 2 percent by weight of the food, except that 
it may be present up to 5 percent by weight of baking powder.



Sec. 172.430   Iron ammonium citrate.

    Iron ammonium citrate may be safely used in food in accordance with 
the following prescribed conditions:
    (a) The additive is the chemical green ferric ammonium citrate.
    (b) The additive is used, or intended for use as an anticaking agent 
in salt for human consumption so that the level of iron ammonium citrate 
does not exceed 25 parts per million (0.0025 percent) in the finished 
salt.
    (c) To assure safe use of the additive the label or labeling of the 
additive shall bear, in addition to the other information required by 
the Act:
    (1) The name of the additive.
    (2) Adequate directions to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.



Sec. 172.480   Silicon dioxide.

    The food additive silicon dioxide may be safely used in food in 
accordance with the following conditions:
    (a) The food additive is manufactured by vapor phase hydrolysis or 
by other means whereby the particle size is such as to accomplish the 
intended effect.
    (b) It is used as an anticaking agent, subject to the following 
conditions:
    (1) It is used in only those foods in which the additive has been 
demonstrated to have an anticaking effect.
    (2) It is used in an amount not in excess of that reasonably 
required to produce its intended effect.
    (3) [Reserved]
    (4) It is used in an amount not to exceed 2 percent by weight of the 
food.
    (c) It is used or intended for use as a stabilizer in the production 
of beer, and is removed from the beer by filtration prior to final 
processing.
    (d) It is used or intended for use as an adsorbent for dl-a-
tocopheryl acetate and pantothenyl alcohol in tableted foods for special 
dietary use, in an amount not greater than that required to accomplish 
the intended physical or technical effect.



Sec. 172.490   Yellow prussiate of soda.

    (a) The food additive yellow prussiate of soda (sodium ferrocyanide 
decahydrate; Na4Fe(CN)6110H2O contains a minimum 
of 99 percent by weight of sodium ferrocyanide decahydrate.
    (b) The additive is used or intended for use as an anticaking agent 
in salt and as an adjuvant in the production of dendritic crystals of 
salt in an amount needed to produce its intended effect but not in 
excess of 13 parts per million

[[Page 49]]

calculated as anhydrous sodium ferrocyanide.

[42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]



           Subpart F--Flavoring Agents and Related Substances



Sec. 172.510   Natural flavoring substances and natural substances used in conjunction with flavors.

    Natural flavoring substances and natural adjuvants may be safely 
used in food in accordance with the following conditions.
    (a) They are used in the minimum quantity required to produce their 
intended physical or technical effect and in accordance with all the 
principles of good manufacturing practice.
    (b) In the appropriate forms (plant parts, fluid and solid extracts, 
concretes, absolutes, oils, gums, balsams, resins, oleoresins, waxes, 
and distillates) they consist of one or more of the following, used 
alone or in combination with flavoring substances and adjuvants 
generally recognized as safe in food, previously sanctioned for such 
use, or regulated in any section of this part.

------------------------------------------------------------------------
          Common name              Scientific name        Limitations   
------------------------------------------------------------------------
Aloe..........................  Aloe perryi Baker, A.                   
                                 barbadensis Mill.,                     
                                 A. ferox Mill., and                    
                                 hybrids of this sp.                    
                                 with A. africana                       
                                 Mill. and A. spicata                   
                                 Baker.                                 
Althea root and flowers.......  Althea officinalis L.                   
Amyris (West Indian             Amyris balsamifera L.                   
 sandalwood).                                                           
Angola weed...................  Roccella fuciformis    In alcoholic     
                                 Ach.                   beverages only. 
Arnica flowers................  Arnica montana L., A.      Do.          
                                 fulgens Pursh, A.                      
                                 sororia Greene, or                     
                                 A. cordifolia Hooker.                  
Artemisia (wormwood)..........  Artemisia spp........  Finished food    
                                                        thujone free.\1\
Artichoke leaves..............  Cynara scolymus L....  In alcoholic     
                                                        beverages only. 
Benzoin resin.................  Styrax benzoin                          
                                 Dryander, S.                           
                                 paralleloneurus                        
                                 Perkins, S.                            
                                 tonkinensis (Pierre)                   
                                 Craib ex Hartwich,                     
                                 or other spp. of the                   
                                 Section Anthostyrax                    
                                 of the genus Styrax.                   
Blackberry bark...............  Rubus, Section                          
                                 Eubatus..                              
Boldus (boldo) leaves.........  Peumus boldus Mol....      Do.          
Boronia flowers...............  Boronia megastigma                      
                                 Nees..                                 
Bryonia root..................  Bryonia alba L., or        Do.          
                                 B. diocia Jacq.                        
Buchu leaves..................  Barosma betulina                        
                                 Bartl. et Wendl., B.                   
                                 crenulata (L.) Hook.                   
                                 or B. serratifolia                     
                                 Willd..                                
Buckbean leaves...............  Menyanthes trifoliata      Do.          
                                 L.                                     
Cajeput.......................  Melaleuca                               
                                 leucadendron L. and                    
                                 other Melaleuca spp.                   
Calumba root..................  Jateorhiza palmata         Do.          
                                 (Lam.) Miers.                          
Camphor tree..................  Cinnamomum camphora    Safrole free.    
                                 (L.) Nees et Eberm.                    
Cascara sagrada...............  Rhamnus purshiana DC.                   
Cassie flowers................  Acacia farnesiana                       
                                 (L.) Willd..                           
Castor oil....................  Ricinus communis L...                   
Catechu, black................  Acacia catechu Willd.                   
Cedar, white (aborvitae),       Thuja occidentalis L.  Finished food    
 leaves and twigs.                                      thujone free.\1\
Centuary......................  Centaurium umbellatum  In alcoholic     
                                 Gilib.                 beverages only. 
Cherry pits...................  Prunus avium L. or P.  Not to exceed 25 
                                 cerasus L.             p.p.m. prussic  
                                                        acid.           
Cherry-laurel leaves..........  Prunus laurocerasus L      Do.          
Chestnut leaves...............  Castanea dentata                        
                                 (Marsh.) Borkh.                        
Chirata.......................  Swertia chirata Buch.- In alcoholic     
                                 Ham.                   beverages only. 
Cinchona, red, bark...........  Cinchona succirubra    In beverages     
                                 Pav. or its hybrids.   only; not more  
                                                        than 83 p.p.m.  
                                                        total cinchona  
                                                        alkaloids in    
                                                        finished        
                                                        beverage.       
Cinchona, yellow, bark........  Cinchona ledgeriana        Do.          
                                 Moens, C. calisaya                     
                                 Wedd., or hybrids of                   
                                 these with other                       
                                 spp. of Cinchona..                     
Copaiba.......................  South American spp.                     
                                 of Copaifera L.                        
Cork, oak.....................  Quercus suber L., or   In alcoholic     
                                 Q. occidentalis F.     beverages only. 
                                 Gay.                                   
Costmary......................  Chrysanthemum              Do.          
                                 balsamita L.                           
Costus root...................  Saussurea lappa                         
                                 Clarke..                               
Cubeb.........................  Piper cubeba L. f....                   
Currant, black, buds and        Ribes nigrum L.......                   
 leaves.                                                                
Damiana leaves................  Turnera diffusa Willd                   
Davana........................  Artemisia pallens                       
                                 Wall..                                 
Dill, Indian..................  Anethum sowa Roxb.                      
                                 (Peucedanum                            
                                 graveolens Benth et                    
                                 Hook., Anethum                         
                                 graveolens L.).                        
Dittany (fraxinella) roots....  Dictamnus albus L....      Do.          

[[Page 50]]

                                                                        
Dittany of Crete..............  Origanum dictamnus L.                   
Dragon's blood (dracorubin)...  Daemonorops spp......                   
Elder tree leaves.............  Sambucus nigra L.....  In alcoholic     
                                                        beverages only; 
                                                        not to exceed 25
                                                        p.p.m. prussic  
                                                        acid in the     
                                                        flavor.         
Elecampane rhizome and roots..  Inula helenium L.....  In alcoholic     
                                                        beverages only. 
Elemi.........................  Canarium commune L.                     
                                 or C. luzonicum Miq..                  
Erigeron......................  Erigeron canadensis L                   
Eucalyptus globulus leaves....  Eucalyptus globulus                     
                                 Labill.                                
Fir (``pine'') needles and      Abies sibirica                          
 twigs.                          Ledeb., A. alba                        
                                 Mill., A.                              
                                 sachalinesis Masters                   
                                 or A. mayriana                         
                                 Miyabe et Kudo.                        
Fir, balsam, needles and twigs  Abies balsamea (L.)                     
                                 Mill..                                 
Galanga, greater..............  Alpinia galanga Willd      Do.          
Galbanum......................  Ferula galbaniflua                      
                                 Boiss. et Buhse and                    
                                 other Ferula spp.                      
Gambir (catechu, pale)........  Uncaria gambir Roxb..                   
Genet flowers.................  Spartium junceum L...                   
Gentian rhizome and roots.....  Gentiana lutea L.....                   
Gentian, stemless.............  Gentiana acaulis L...      Do.          
Germander, chamaedrys.........  Teucrium chamaedrys L      Do.          
Germander, golden.............  Teucrium polium L....      Do.          
Guaiac........................  Guaiacum officinale                     
                                 L., G. santum L.,                      
                                 Bulnesia sarmienti                     
                                 Lor.                                   
Guarana.......................  Paullinia cupana HBK.                   
Haw, black, bark..............  Viburnum prunifolium                    
                                 L..                                    
Hemlock needles and twigs.....  Tsuga canadensis (L.)                   
                                 Carr. or T.                            
                                 heterophylla (Raf.)                    
                                 Sarg.                                  
Hyacinth flowers..............  Hyacinthus orientalis                   
                                 L.                                     
Iceland moss..................  Cetraria islandica         Do.          
                                 Ach.                                   
Imperatoria...................  Peucedanum ostruthium                   
                                 (L.). Koch                             
                                 (Imperatoria                           
                                 ostruthium L.).                        
Iva...........................  Achillea moschata          Do.          
                                 Jacq.                                  
Labdanum......................  Cistus spp...........                   
Lemon-verbena.................  Lippia citriodora HBK      Do.          
Linaloe wood..................  Bursera delpechiana                     
                                 Poiss. and other                       
                                 Bursera spp..                          
Linden leaves.................  Tillia spp...........      Do.          
Lovage........................  Levisticum officinale                   
                                 Koch.                                  
Lungmoss (lungwort)...........  Sticta pulmonacea Ach                   
Maidenhair fern...............  Adiantum capillus-         Do.          
                                 veneris L.                             
Maple, mountain...............  Acer spicatum Lam....                   
Mimosa (black wattle) flowers.  Acacia decurrens                        
                                 Willd. var.                            
                                 dealbata..                             
Mullein flowers...............  Verbascum phlomoides       Do.          
                                 L. or V. thapsiforme                   
                                 Schrad.                                
Myrrh.........................  Commiphora molmol                       
                                 Engl., C. abyssinica                   
                                 (Berg) Engl., or                       
                                 other Commiphora spp.                  
Myrtle leaves.................  Myrtus communis L....      Do.          
Oak, English, wood............  Quercus robur L......      Do.          
Oak, white, chips.............  Quercus alba L.......                   
Oak moss......................  Evernia prunastri      Finished food    
                                 (L.) Ach., E.          thujone.        
                                 furfuracea (L.)                        
                                 Mann, and other                        
                                 lichens.                               
Olibanum......................  Boswellia carteri                       
                                 Birdw. and other                       
                                 Boswellia spp.                         
Opopanax (bisabolmyrrh).......  Opopanax chironium                      
                                 Koch (true opopanax)                   
                                 of Commiphora                          
                                 erythraea Engl. var.                   
                                 Llabrescens.                           
Orris root....................  Iris germanica L.                       
                                 (including its                         
                                 variety florentina                     
                                 Dykes) and I.                          
                                 pallida Lam.                           
Pansy.........................  Viola tricolor L.....  In alcoholic     
                                                        beverages only. 
Passion flower................  Passiflora incarnata                    
                                 L.                                     
Patchouly.....................  Pogostemon cablin                       
                                 Benth. and P.                          
                                 heyneanus Benth.                       
Peach leaves..................  Prunus persica (L.)    In alcoholic     
                                 Batsch.                beverages only; 
                                                        not to exceed 25
                                                        p.p.m. prussic  
                                                        acid in the     
                                                        flavor.         
Pennyroyal, American..........  Hedeoma pulegioides                     
                                 (L.) Pers.                             
Pennyroyal, European..........  Mentha pulegium L....                   
Pine, dwarf, needles and twigs  Pinus mugo Turra var.                   
                                 pumilio (Haenke)                       
                                 Zenari.                                
Pine, Scotch, needles and       Pinus sylvestris L...                   
 twigs.                                                                 
Pine, white, bark.............  Pinus strobus L......  In alcoholic     
                                                        beverages only. 
Pine, white oil...............  Pinus palustris                         
                                 Mill., and other                       
                                 Pinus spp..                            
Poplar buds...................  Populus balsamifera        Do.          
                                 L. (P. tacamahacca                     
                                 Mill.), P. candicans                   
                                 Ait., or P. nigra L.                   
Quassia.......................  Picrasma excelsa                        
                                 (Sw.) Planch, or                       
                                 Quassia amara L.                       

[[Page 51]]

                                                                        
Quebracho bark................  Aspidosperma           Schinopsis       
                                 quebracho-blanco       lorentzii       
                                 Schlecht, or           (Griseb.) Engl. 
                                 (Quebrachia                            
                                 lorentzii (Griseb)).                   
Quillaia (soapbark)...........  Quillaja saponaria                      
                                 Mol.                                   
Red saunders (red sandalwood).  Pterocarpus san        In alcoholic     
                                 alinus L.              beverages only. 
Rhatany root..................  Krameria triandra                       
                                 Ruiz et Pav. or K.                     
                                 argentea Mart.                         
Rhubarb, garden root..........  Rheum rhaponticum L..      Do.          
Rhubarb root..................  Rheum officinale                        
                                 Baill., R. palmatum                    
                                 L., or other spp.                      
                                 (excepting R.                          
                                 rhaponticum L.) or                     
                                 hybrids of Rheum                       
                                 grown in China.                        
Roselle.......................  Hibiscus sabdariffa L      Do.          
Rosin (colophony).............  Pinus palustris            Do.          
                                 Mill., and other                       
                                 Pinus spp.                             
St. Johnswort leaves, flowers,  Hypericum perforatum   Hypericin-free   
 and caulis.                     L.                     alcohol         
                                                        distillate form 
                                                        only; in        
                                                        alcoholic       
                                                        beverages only. 
Sandalwood, white (yellow, or   Santalum album L.....                   
 East Indian).                                                          
Sandarac......................  Tetraclinis            In alcoholic     
                                 articulata (Vahl.),    beverages only. 
                                 Mast.                                  
Sarsaparilla..................  Smilax                                  
                                 aristolochiaefolia                     
                                 Mill., (Mexican                        
                                 sarsaparilla), S.                      
                                 regelii Killip et                      
                                 Morton (Honduras                       
                                 sarsaparilla), S.                      
                                 febrifuga Kunth                        
                                 (Ecuadorean                            
                                 sarsaparilla), or                      
                                 undetermined Smilax                    
                                 spp. (Ecuadorean or                    
                                 Central American                       
                                 sarsaparilla).                         
Sassafras leaves..............  Sassafras albidum      Safrole free.    
                                 (Nutt.) Nees.                          
Senna, Alexandria.............  Cassia acutifolia                       
                                 Delile.                                
Serpentaria (Virginia           Aristolochia           In alcoholic     
 snakeroot).                     serpentaria L.         beverages only. 
Simaruba bark.................  Simaruba amara Aubl..      Do.          
Snakeroot, Canadian (wild       Asarum canadense L...                   
 ginger).                                                               
Spruce needles and twigs......  Picea glauca (Moench)                   
                                 Voss or P. mariana                     
                                 (Mill.) BSP.                           
Storax (styrax)...............  Liquidambar                             
                                 orientalis Mill. or                    
                                 L. styraciflua L..                     
Tagetes (marigold)............  Tagetes patula L., T.  As oil only.     
                                 erecta L., or T.                       
                                 minuta L. (T.                          
                                 glandulifera                           
                                 Schrank).                              
Tansy.........................  Tanacetum vulgare L..  In alcoholic     
                                                        beverages only; 
                                                        finished        
                                                        alcoholic       
                                                        beverage thujone
                                                        free.\1\        
Thistle, blessed (holy          Onicus benedictus L..  In alcoholic     
 thistle).                                              beverages only. 
Thymus capitatus (Spanish       Thymus capitatus                        
 ``origanum'').                  Hoffmg. et Link..                      
Tolu..........................  Myroxylon balsamum                      
                                 (L.) Harms.                            
Turpentine....................  Pinus palustris Mill.                   
                                 and other Pinus spp.                   
                                 which yield terpene                    
                                 oils exclusively.                      
Valerian rhizome and roots....  Valeriana officinalis                   
                                 L.                                     
Veronica......................  Veronica officinalis       Do.          
                                 L.                                     
Vervain, European.............  Verbena officinalis L      Do.          
Vetiver.......................  Vetiveria zizanioides      Do.          
                                 Stapf.                                 
Violet, Swiss.................  Viola calcarata L....                   
Walnut husks (hulls), leaves,   Juglans nigra L. or                     
 and green nuts.                 J. regia L.                            
Woodruff, sweet...............  Asperula odorata L...  In alcoholic     
                                                        beverages only. 
Yarrow........................  Achillea millefolium   In beverages     
                                 L.                     only; finished  
                                                        beverage thujone
                                                        free.\1\        
Yerba santa...................  Eriodictyon                             
                                 californicum (Hook,                    
                                 et Arn.) Torr..                        
Yucca, Joshua-tree............  Yucca brevifolia                        
                                 Engelm.                                
Yucca, Mohave.................  Yucca schidigera                        
                                 Roezl ex Ortgies (Y.                   
                                 mohavensis Sarg.).                     
------------------------------------------------------------------------
\1\As determined by using the method (or, in other than alcoholic       
  beverages, a suitable adaptation thereof) in section 9.129 of the     
  ``Official Methods of Analysis of the Association of Official         
  Analytical Chemists,'' 13th Ed. (1980), which is incorporated by      
  reference. Copies may be obtained from the Association of Official    
  Analytical Chemists International, 481 North Frederic Ave., suite 500,
  Gaithersburg, MD 20877-2504, or may be examined at the Office of the  
  Federal Register, 800 North Capitol Street, NW., suite 700,           
  Washington, DC 20408                                                  


[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.515   Synthetic flavoring substances and adjuvants.

    Synthetic flavoring substances and adjuvants may be safely used in 
food in accordance with the following conditions.
    (a) They are used in the minimum quantity required to produce their 
intended effect, and otherwise in accordance with all the principles of 
good manufacturing practice.
    (b) They consist of one or more of the following, used alone or in 
combination

[[Page 52]]

with flavoring substances and adjuvants generally recognized as safe in 
food, prior-sanctioned for such use, or regulated by an appropriate 
section in this part.

Acetal; acetaldehyde diethyl acetal.
Acetaldehyde phenethyl propyl acetal.
Acetanisole; 4'-methoxyacetophenone.
Acetophenone; methyl phenyl ketone.
Allyl anthranilate.
Allyl butyrate.
Allyl cinnamate.
Allyl cyclohexaneacetate.
Allyl cyclohexanebutyrate.
Allyl cyclohexanehexanoate.
Allyl cyclohexaneproprionate.
Allyl cyclohexanevalerate.
Allyl disulfide.
Allyl 2-ethylbutyrate.
Allyl hexanoate; allyl caproate.
Allyl -ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-
heptadiene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
-Amylcinnamaldehyde.
-Amylcinnamaldehyde dimethyl acetal.
-Amylcinnamyl acetate.
-Amylcinnamyl alcohol.
-Amylcinnamyl formate.
-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzophenone; diphenylketone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; -toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl -methoxyethyl 
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
-Bourbonene; 
1,2,3,3a,3b,4,5,6,6a,6b-deca-hydro-
l-isopropyl-3aa-methyl-6-methylene-cyclobuta [1,2:3,4] 
dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.

[[Page 53]]

Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-
oxatricylo [8.2.0.04,6] dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-citronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
-Decalactone; 4-hydroxy-decanoic acid, -lactone.
-Decalactone; 5-hydroxy-decanoic acid, -lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl--butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid, 
-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
,-Dimethylbenzyl isobutyrate; phenyldimethylcarbinyl 
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
,-Dimethylphenethyl acetate; benzylpropyl acetate; 
benzyldimethylcarbinyl acetate.
,-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
,-Dimethylphenethyl butyrate; benzyldimethylcarbinyl 
butyrate.
,-Dimethylphenethyl formate; benzyldimethylcarbinyl 
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
-Dodecalactone; 4-hydroxydodecanoic acid -lactone.
2-Dodecenal.
Estragole.
-Ethoxybenzaldehyde.
Ethyl acetoacetate.
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl -anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
-Ethylbenzyl butyrate; -phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol diester; 
cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.

[[Page 54]]

Ethyl heptanoate.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein.
Ethyl hexanoate.
Ethyl isobutyrate.
Ethyl isovalerate.
Ethyl lactate.
Ethyl laurate.
Ethyl levulinate.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4-one.
Ethyl 2-methylbutyrate.
Ethyl myristate.
Ethyl nitrite.
Ethyl nonanoate.
Ethyl 2-nonynoate; ethyl octyne carbonate.
Ethyl octanoate.
Ethyl oleate.
Ethyl phenylacetate.
Ethyl 4-phenylbutyrate.
Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Eugenyl methyl ether; 4-allylveratrole; methyl eugenol.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl 
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; -methoxyphenol.
Guaiacyl acetate; -methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-(-hydroxy-isopropyl)-
9,10-octahydroazulene acetate.
-Heptalactone; 4-hydroxyheptanoic acid, -lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, 
-lactone; ambrettolide.
-Hexalactone; 4-hydroxyhexanoic acid, -lactone; 
tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellal; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxybenzyl acetone.
Indole.
-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-
one; 6-methylionone.
Isoamyl acetate.

[[Page 55]]

Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; -isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; -isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.
Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
-Isobutylphenethyl alcohol; isobutyl benzyl carbinol; 4-methyl-
1-phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and 2-hexyl-2-
cyclopenten-1-one.
-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-
methyl-3-buten-2-one; methyl -ionone.
Isopropyl acetate.
-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
-Isopropylbenzyl alcohol; cuminic alcohol; -cymen-7-
ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
-Isopropylphenylacetaldehyde; -cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-(-Isopropylphenyl)-propionaldehyde; -
isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-
methylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.
Menthadienol; p-mentha-1,8(10)-dien-9-ol.
p- Mentha-1,8-dien-7-ol; perillyl alcohol.
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p- menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p- Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl 
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; -methylanisylidene acetone; 
ethone.

[[Page 56]]

1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
-Methylbenzyl acetate; styralyl acetate.
-Methylbenzyl alcohol; styralyl alcohol.
-Methylbenzyl butyrate; styralyl butyrate.
-Methylbenzyl isobutyrate; styralyl isobutyrate.
-Methylbenzyl formate; styralyl formate.
-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methylcyclopentane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in 
Sec. 172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl -ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-
3-one.
Methyl -ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-
3-one.
Methyl -ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-
penten-3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; -methyl-p-
isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl-3-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl -naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl 
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; -isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myrcene; 7-methyl-3-methylene-1,6-octadiene.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
-Nonalactone; 4-hydroxynonanoic acid, -lactone; 
aldehyde C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.

[[Page 57]]

Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo[4,4,0]-dec-1-en-3-one.
Ocimene; trans--ocimene; 3,7-dimethyl-1,3,6-octatriene.
-Octalactone; 4-hydroxyoctanoic acid, -lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.
Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
-Pentadecalactone; 15-hydroxypentadeca-noic acid, -
lactone; pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;p-mentha-
1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
-Phellandrene; -mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; -phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; -toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; -toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde dimethyl 
acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
-Pinene; 2-pinene.
-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
-Propylphenethyl alcohol.

[[Page 58]]

Propyl phenylacetate.
Propyl propionate.
Pulegone; p-menth-4(8)-en-3-one.
Pyridine.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol,  and .
Santalyl acetate.
Santalyl phenylacetate.
Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
-Terpinene.
-Terpinene.
-Terpineol; p-menth-1-en-8-ol.
-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-
2-cyclohexen-1-one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methylbenzylacetone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methylhydratropic aldehyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
-Undecalactone; 4-hydroxyundecanoic acid -lactone; 
peach aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.

    (c) -Decalactone and -dodecalactone when used 
separately or in combination in oleomargarine are used at levels not to 
exceed 10 parts per million and 20 parts per million, respectively, in 
accordance with Sec. 166.110 of this chapter.
    (d) BHA (butylated hydroxyanisole) may be used as an antioxidant in 
flavoring substances whereby the additive does not exceed 0.5 percent of 
the essential (volatile) oil content of the flavoring substance.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43 
FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25, 
1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR 
5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, 
1989; 61 FR 14245, Apr. 1, 1996]



Sec. 172.520   Cocoa with dioctyl sodium sulfosuccinate for manufacturing.

    The food additive ``cocoa with dioctyl sodium sulfosuccinate for 
manufacturing,'' conforming to Sec. 163.117 of this chapter and 
Sec. 172.810, is used or intended for use as a flavoring substance in 
dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate 
does not exceed 75 parts per million of the finished beverage. The 
labeling of the dry beverage mix shall bear adequate directions to 
assure use in compliance with this section.



Sec. 172.530   Disodium guanylate.

    Disodium guanylate may be safely used as a flavor enhancer in foods, 
at a level not in excess of that reasonably required to produce the 
intended effect.

[[Page 59]]



Sec. 172.535   Disodium inosinate.

    The food additive disodium inosinate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the disodium salt of inosinic acid, 
manufactured and purified so as to contain no more than 150 parts per 
million of soluble barium in the compound disodium inosinate with seven 
and one-half molecules of water of crystallization.
    (b) The food additive is used as a flavoring adjuvant in food.



Sec. 172.540  DL-Alanine.

    DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-
72-7) may be safely used as a flavor enhancer for sweeteners in pickling 
mixtures at a level not to exceed 1 percent of the pickling spice that 
is added to the pickling brine.

[56 FR 6968, Feb. 21, 1991]



Sec. 172.560   Modified hop extract.

    The food additive modified hop extract may be safely used in beer in 
accordance with the following prescribed conditions:
    (a) The food additive is used or intended for use as a flavoring 
agent in the brewing of beer.
    (b) The food additive is manufactured by one of the following 
processes:
    (1) The additive is manufactured from a hexane extract of hops by 
simultaneous isomerization and selective reduction in an alkaline 
aqueous medium with sodium borohydride, whereby the additive meets the 
following specifications:
    (i) A solution of the food additive solids is made up in 
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n 
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show 
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This 
absorbance is obtained by approximately 0.03 milligram solids 
permilliliter.) The ultraviolet absorption spectrum of this solution 
exhibits the following characteristics: An absorption peak at 253 
millimicrons; no absorption peak at 325 to 330 millimicrons; the 
absorbance at 268 millimicrons does not exceed the absorbance at 272 
millimicrons.
    (ii) The boron content of the food additive does not exceed 310 
parts per million (0.0310 percent), calculated as boron.
    (2) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using benzene, light petroleum spirits, 
and methyl alcohol as solvents, followed by isomerization by potassium 
carbonate treatment. Residues of solvents in the modified hop extract 
shall not exceed 1.0 part per million of benzene, 1.0 part per million 
of light petroleum spirits, and 250 parts per million of methyl alcohol. 
The light petroleum spirits and benzene solvents shall comply with the 
specifications in Sec. 172.250 except that the boiling point range for 
light petroleum spirits is 150 deg.F-300 deg.F.
    (3) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using methylene chloride, hexane, and 
methyl alcohol as solvents, followed by isomerization by sodium 
hydroxide treatment. Residues of the solvents in the modified hop 
extract shall not exceed 5 parts per million of methylene chloride, 25 
parts per million of hexane, and 100 parts per million of methyl 
alcohol.
    (4) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using benzene, light petroleum spirits, 
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed 
by isomerization by potassium carbonate treatment. Residues of solvents 
in the modified hop extract shall not exceed 1.0 part per million of 
benzene, 1.0 part per million of light petroleum spirits, 50 parts per 
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and 
1 part per million of ethyl acetate. The light petroleum spirits and 
benzene solvents shall comply with the specifications in Sec. 172.250 
except that the boiling point range for light petroleum spirits is 
150 deg. F to 300 deg. F.
    (5) The additive is manufactured from hops by an initial extraction 
and fractionation using one or more of the following solvents: Ethylene 
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene 
chloride, trichloroethylene, and water; followed

[[Page 60]]

by isomerization by calcium chloride or magnesium chloride treatment in 
ethylene dichloride, methylene chloride, or trichloroethylene and a 
further sequence of extractions and fractionations using one or more of 
the solvents set forth in this paragraph. Residues of the solvents in 
the modified hop extract shall not exceed 125 parts per million of 
hexane; 150 parts per million of ethylene dichloride, methylene 
chloride, or trichloroethylene; or 250 parts per million of isopropyl 
alcohol or methyl alcohol.
    (6) The additive is manufactured from hops by an initial extraction 
and fractionation using one or more of the solvents listed in paragraph 
(b)(5) of this section followed by: Hydrogenation using palladium as a 
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol 
acidified with hydrochloric or sulfuric acid; oxidation with peracetic 
acid; isomerization by calcium chloride or magnesium chloride treatment 
in ethylene dichloride, methylene chloride, or trichloroethylene 
(alternatively, the hydrogenation and isomerization steps may be 
performed in reverse order); and a further sequence of extractions and 
fractionations using one or more of the solvents listed in paragraph 
(b)(5) of this section. The additive shall meet the residue limitations 
as prescribed in paragraph (b)(5) of this section.
    (7) The additive is manufactured from hops as set forth in paragraph 
(b)(6) of this section followed by reduction with sodium borohydride in 
aqueous alkaline methyl alcohol, and a sequence of extractions and 
fractionations using one or more of the solvents listed in paragraph 
(b)(5) of this section. The additive shall meet the residue limitations 
as prescribed in paragraph (b)(5) of this section, and a boron content 
level not in excess of 300 parts per million (0.0300 percent), 
calculated as boron.
    (8) The additive is manufactured from hops as a nonisomerizable 
nonvolatile hop resin by an initial extraction and fractionation using 
one or more of the solvents listed in paragraph (b)(5) of this section 
followed by a sequence of aqueous extractions and removal of nonaqueous 
solvents to less than 0.5 percent. The additive is added to the wort 
before or during cooking in the manufacture of beer.



Sec. 172.575   Quinine.

    Quinine, as the hydrochloride salt or sulfate salt, may be safely 
used in food in accordance with the following conditions:

------------------------------------------------------------------------
                  Uses                              Limitations         
------------------------------------------------------------------------
In carbonated beverages as a flavor.....  Not to exceed 83 parts per    
                                           million, as quinine. Label   
                                           shall bear a prominent       
                                           declaration of the presence  
                                           of quinine either by the use 
                                           of the word ``quinine'' in   
                                           the name of the article or   
                                           through a separate           
                                           declaration.                 
------------------------------------------------------------------------



Sec. 172.580   Safrole-free extract of sassafras.

    The food additive safrole-free extract of sassafras may be safely 
used in accordance with the following prescribed conditions:
    (a) The additive is the aqueous extract obtained from the root bark 
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
    (b) It is obtained by extracting the bark with dilute alcohol, first 
concentrating the alcoholic solution by vacuum distillation, then 
diluting the concentrate with water and discarding the oily fraction.
    (c) The purified aqueous extract is safrole-free.
    (d) It is used as a flavoring in food.



Sec. 172.585   Sugar beet extract flavor base.

    Sugar beet extract flavor base may be safely used in food in 
accordance with the provisions of this section.
    (a) Sugar beet extract flavor base is the concentrated residue of 
soluble sugar beet extractives from which sugar and glutamic acid have 
been recovered, and which has been subjected to ion exchange to minimize 
the concentration of naturally occurring trace minerals.
    (b) It is used as a flavor in food.



Sec. 172.590   Yeast-malt sprout extract.

    Yeast-malt sprout extract, as described in this section, may be 
safely used in food in accordance with the following prescribed 
conditions:

[[Page 61]]

    (a) The additive is produced by partial hydrolysis of yeast extract 
(derived from Saccharomyces cereviseae, Saccharomyces fragilis, or 
Candida utilis) using the sprout portion of malt barley as the source of 
enzymes. The additive contains a maximum of 6 percent 5' nucleotides by 
weight.
    (b) The additive may be used as a flavor enhancer in food at a level 
not in excess of that reasonably required to produce the intended 
effect.



        Subpart G--Gums, Chewing Gum Bases and Related Substances



Sec. 172.610   Arabinogalactan.

    Arabinogalactan may be safely used in food in accordance with the 
following conditions:
    (a) Arabinogalactan is a polysaccharide extracted by water from 
Western larch wood, having galactose units and arabinose units in the 
approximate ratio of six to one.
    (b) It is used in the following foods in the minimum quantity 
required to produce its intended effect as an emulsifier, stabilizer, 
binder, or bodying agent: Essential oils, nonnutritive sweeteners, 
flavor bases, nonstandardized dressings, and pudding mixes.



Sec. 172.615   Chewing gum base.

    The food additive chewing gum base may be safely used in the 
manufacture of chewing gum in accordance with the following prescribed 
conditions:
    (a) The food additive consists of one or more of the following 
substances that meet the specifications and limitations prescribed in 
this paragraph, used in amounts not to exceed those required to produce 
the intended physical or other technical effect.

                         Masticatory Substances                         
    natural (coagulated or concentrated latices) of vegetable origin    
------------------------------------------------------------------------
             Family                         Genus and species           
------------------------------------------------------------------------
Sapotaceae:                                                             
  Chicle.......................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.                         
  Chiquibul....................  Manilkara zapotilla Gilly.             
  Crown gum....................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.                         
  Gutta hang kang..............  Palaquium leiocarpum Boerl. and        
                                  Palaquium oblongifolium Burck.        
  Massaranduba balata (and the   Manilkara huberi (Ducke) Chevalier.    
   solvent-free resin extract                                           
   of Massaranduba balata).                                             
  Massaranduba chocolate.......  Manilkara solimoesensis Gilly.         
  Nispero......................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.                         
  Rosidinha (rosadinha)........  Micropholis (also known as Sideroxylon)
                                  spp.                                  
  Venezuelan chicle............  Manilkara williamsii Standley and      
                                  related spp.                          
Apocynaceae:                                                            
  Jelutong.....................  Dyera costulata Hook, F. and Dyera     
                                  lowii Hook, F.                        
  Leche caspi (sorva)..........  Couma macrocarpa Barb. Rodr.           
  Pendare......................  Couma macrocarpa Barb. Rodr. and Couma 
                                  utilis (Mart.) Muell. Arg.            
  Perillo......................  Couma macrocarpa Barb. Rodr. and Couma 
                                  utilis (Mart.) Muell. Arg.            
Moraceae:                                                               
  Leche de vaca................  Brosimum utile (H.B.K.) Pittier and    
                                  Poulsenia spp.; also Lacmellea        
                                  standleyi (Woodson), Monachino        
                                  (Apocynaceae).                        
  Niger gutta..................  Ficus platyphylla Del.                 
  Tunu (tuno)..................  Castilla fallax Cook.                  
Euphorbiaceae:                                                          
  Chilte.......................  Cnidoscolus (also known as Jatropha)   
                                  elasticus Lundell and Cnidoscolus     
                                  tepiquensis (Cost. and Gall.) McVaugh.
  Natural rubber (smoked sheet   Hevea brasiliensis.                    
   and latex solids).                                                   
                                                                        
------------------------------------------------------------------------
 Synthetic                                                Specifications
                                                                        
------------------------------------------------------------------------
  Butadiene-styrene rubber.....  Basic polymer.                         
  Isobutylene-isoprene               Do.                                
   copolymer (butyl rubber).                                            

[[Page 62]]

                                                                        
Paraffin.......................  Synthesized by Fischer-Tropsch process 
                                  from carbon monoxide and hydrogen     
                                  which are catalytically converted to a
                                  mixture of paraffin hydrocarbon. Lower
                                  molecular weight fractions are removed
                                  by distillation. The residue is       
                                  hydrogenated and further treated by   
                                  percolation through activated         
                                  charcoal. The product has a congealing
                                  point of 93-99 C as determined by ASTM
                                  method D938-71 (Reapproved 1981),     
                                  ``Standard Test Method for Congealing 
                                  Point of Petroleum Waxes, Including   
                                  Petrolatum,'' a maximum oil content of
                                  0.5 percent as determined by ASTM     
                                  method D721-56T, ``Tentative Method of
                                  Test for Oil Content of Petroleum     
                                  Waxes,'' and an absorptivity of less  
                                  than 0.01 at 290 millimicrons in      
                                  decahydronaphthalene at 88 C as       
                                  determined by ASTM method D2008-80,   
                                  ``Standard Test Method for Ultraviolet
                                  Absorbance and Absorptivity of        
                                  Petroleum Products,'' which are       
                                  incorporated by reference. Copies may 
                                  be obtained from the American Society 
                                  for Testing Materials, 1916 Race St., 
                                  Philadelphia, PA 19103, or may be     
                                  examined at the Office of the Federal 
                                  Register, 800 North Capitol Street,   
                                  NW., suite 700, Washington, DC 20408. 
  Petroleum wax................  Complying with Sec.  172.886.          
  Petroleum wax synthetic......  Complying with Sec.  172.888.          
  Polyethylene.................  Molecular weight 2,000-21,000.         
  Polyisobutylene..............  Minimum molecular weight 37,000        
                                  (Flory).                              
  Polyvinyl acetate............  Molecular weight, minimum 2,000.       
                                                                        
------------------------------------------------------------------------
                   Plasticizing Materials (Softeners)                   
                                                                        
------------------------------------------------------------------------
Glycerol ester of partially      Having an acid number of 3-8, a drop-  
 dimerized rosin.                 softening point of 109 deg. C-119 deg.
                                  C, and a color of M or paler.         
Glycerol ester of partially      Having an acid number of 3-10, a drop- 
 hydrogenated gum or wood rosin.  softening point of 79 deg. C-88 deg.  
                                  C, and a color of N or paler.         
Glycerol ester of polymerized    Having an acid number of 3-12, a       
 rosin.                           melting-point range 80 deg. C-126 deg.
                                  C, and a color of M or paler.         
Glycerol ester of gum rosin....  Having an acid number of 5-9, a drop-  
                                  softening point of 88 deg. C-96 deg.  
                                  C, and a color of N or paler. The     
                                  ester is purified by steam stripping. 
Glycerol ester of tall oil       Having an acid number of 2-12, a       
 rosin.                           softening point (ring and ball) of 80 
                                  deg.-88 deg. C, and a color of N or   
                                  paler. The ester is purified by steam 
                                  stripping.                            
Glycerol ester of wood rosin...  Having an acid number of 3-9, a drop-  
                                  softening point of 88 deg. C-96 deg.  
                                  C, and a color of N or paler. The     
                                  ester is purified by steam stripping. 
Lanolin........................  .......................................
Methyl ester of rosin,           Having an acid number of 4-8, a        
 partially hydrogenated..         refractive index of 1.5170-1.5205 at  
                                  20 deg. C, and a viscosity of 23-66   
                                  poises at 25 deg. C. The ester is     
                                  purified by steam stripping.          
Pentaerythritol ester of         Having an acid number of 7-18, a drop- 
 partially hydrogenated gum or    softening point of 102 deg. C-110 deg.
 wood resin.                      C, and a color of K or paler.         
Pentaerythritol ester of gum or  Having an acid number of 6-16, a drop- 
 wood rosin.                      softening point of 109 deg. C-116 deg.
                                  C, and a color of M or paler.         
Rice bran wax..................  Complying with Sec.  172.890.          
Stearic acid...................  Complying with Sec.  172.860.          
Sodium and potassium stearates.  Complying with Sec.  172.863.          
                                                                        
------------------------------------------------------------------------
                             Terpene Resins                             
                                                                        
------------------------------------------------------------------------
Synthetic resin................  Consisting of polymers of -   
                                  pinene, -pinene, and/or      
                                  dipentene; acid value less than 5,    
                                  saponification number less than 5, and
                                  color less than 4 on the Gardner scale
                                  as measured in 50 percent mineral     
                                  spirit solution.                      
Natural resin..................  Consisting of polymers of -   
                                  pinene; softening point minimum 155 C,
                                  determined by U.S.P. closed-capillary 
                                  method, United States Pharmacopeia XX 
                                  (1980) (page 961).                    
                                                                        
------------------------------------------------------------------------
                              Antioxidants                              
                                                                        
------------------------------------------------------------------------
Butylated hydroxyanisole.......  Not to exceed antioxidant content of   
                                  0.1% when used alone or in any        
                                  combination.                          
Butylated hydroxytoluene.......      Do.                                
Propyl gallate.................      Do.                                
                                                                        
------------------------------------------------------------------------
                              Miscellaneous                             
                                                                        
------------------------------------------------------------------------
Sodium sulfate.................  .......................................

[[Page 63]]

                                                                        
Sodium sulfide.................  Reaction-control agent in synthetic    
                                  polymer production.                   
------------------------------------------------------------------------

    (b) In addition to the substances listed in paragraph (a) of this 
section, chewing gum base may also include substances generally 
recognized as safe in food.
    (c) To assure safe use of the additive, in addition to the other 
information required by the act, the label and labeling of the food 
additive shall bear the name of the additive, ``chewing gum base.'' As 
used in this paragraph, the term ``chewing gum base'' means the 
manufactured or partially manufactured nonnutritive masticatory 
substance comprised of one or more of the ingredients named and so 
defined in paragraph (a) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980; 
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984]



Sec. 172.620   Carrageenan.

    The food additive carrageenan may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the refined hydrocolloid prepared by 
aqueous extraction from the following members of the families 
Gigartinaceae and Solieriaceae of the class Rodophyceae (red seaweed):

    Chondrus crispus.
    Chondrus ocellatus.
    Eucheuma cottonii.
    Eucheuma spinosum.
    Gigartina acicularis.
    Gigartina pistillata.
    Gigartina radula.
    Gigartina stellata.

    (b) The food additive conforms to the following conditions:
    (1) It is a sulfated polysaccharide the dominant hexose units of 
which are galactose and anhydrogalactose.
    (2) Range of sulfate content: 20 percent to 40 percent on a dry-
weight basis.
    (c) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the additive, carrageenan.



Sec. 172.623   Carrageenan with polysorbate 80.

    Carrageenan otherwise meeting the definition and specifications of 
Sec. 172.620 (a) and (b) and salts of carrageenan otherwise meeting the 
definition of Sec. 172.626(a) may be safely produced with the use of 
polysorbate 80 meeting the specifications and requirements of 
Sec. 172.840 (a) and (b) in accordance with the following prescribed 
conditions:
    (a) The polysorbate 80 is used only to facilitate separation of 
sheeted carrageenan and salts of carrageenan from drying rolls.
    (b) The carrageenan and salts of carrageenan contain not more than 5 
percent by weight of polysorbate 80, and the final food containing the 
additives contains polysorbate 80 in an amount not to exceed 500 parts 
per million.
    (c) The carrageenan and salts of carrageenan so produced are used 
only in producing foods in gel form and only for the purposes defined in 
Secs. 172.620(c) and 172.626(b), respectively.
    (d) The carrageenan and salts of carrageenan so produced are not 
used in foods for which standards of identity exist unless the standards 
provide for the use of carrageenan, or salts of carrageenan, combined 
with polysorbate 80.
    (e) The carrageenan and salts of carrageenan produced in accordance 
with this section, and foods containing the same, in addition to the 
other requirements of the Act, are labeled to show the presence of 
polysorbate 80, and the label or labeling of the carrageenan and salts 
of carrageenan so produced bear adequate directions for use.

[[Page 64]]



Sec. 172.626   Salts of carrageenan.

    The food additive salts of carrageenan may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive consists of carrageenan, meeting the 
provisions of Sec. 172.620, modified by increasing the concentration of 
one of the naturally occurring salts (ammonium, calcium, potassium, or 
sodium) of carrageenan to the level that it is the dominant salt in the 
additive.
    (b) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the salt of carrageenan that 
dominates the mixture by reason of the modification, e.g., ``sodium 
carrageenan'', ``potassium carrageenan'', etc.



Sec. 172.655   Furcelleran.

    The food additive furcelleran may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the refined hydrocolloid prepared by 
aqueous extraction of furcellaria fastigiata of the class Rodophyceae 
(red seaweed).
    (b) The food additive conforms to the following:
    (1) It is a sulfated polysaccharide the dominant hexose units of 
which are galactose and anhydrogalactose.
    (2) Range of sulfate content: 8 percent to 19 percent, on a dry-
weight basis.
    (c) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the additive, furcelleran.



Sec. 172.660   Salts of furcelleran.

    The food additive salts of furcelleran may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive consists of furcelleran, meeting the 
provisions of Sec. 172.655, modified by increasing the concentration of 
one of the naturally occurring salts (ammonium, calcium, potassium, or 
sodium) of furcelleran to the level that it is the dominant salt in the 
additive.
    (b) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the salt of furcelleran that 
dominates the mixture by reason of the modification, e.g., ``sodium 
furcelleran'', ``potassium furcelleran'', etc.



Sec. 172.665  Gellan gum.

    The food additive gellan gum may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The additive is a high molecular weight polysaccharide gum 
produced from Pseudomonas elodea by a pure culture fermentation process 
and purified by recovery with isopropyl alcohol. It is composed of 
tetrasaccharide repeat units, each containing one molecule of rhamnose 
and glucuronic acid, and two molecules of glucose. The glucuronic acid 
is neutralized to a mixed potassium, sodium, calcium, and magnesium 
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups 
as the O-glycosidically linked esters.
    (b) The strain of P. elodea is nonpathogenic and nontoxic in man and 
animals.
    (c) The additive is produced by a process that renders it free of 
viable cells of P. elodea.
    (d) The additive meets the following specifications:
    (1) Positive for gellan gum when subjected to the following 
identification tests:
    (i) A 1-percent solution is made by hydrating 1 gram of gellan gum 
in 99 milliliters of distilled water. The mixture is stirred for about 2 
hours, using a motorized stirrer and a propeller-type stirring blade. A 
small amount of the above solution is drawn into a wide

[[Page 65]]

bore pipet and transferred into a solution of 10-percent calcium 
chloride. A tough worm-like gel will form instantly.
    (ii) To the 1-percent distilled water solution prepared for 
identification test (i), 0.50 gram of sodium chloride is added. The 
solution is heated to 80  deg.C with stirring, held at 80  deg.C for 1 
minute, and allowed to cool to room temperature without stirring. A firm 
gel will form.
    (2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as 
determined by the procedure described in the Xanthan Gum monograph, the 
``Food Chemicals Codex,'' 3d Ed. (1981), p. 347, which reads:

    IPA Standard Solution. Transfer 500.0 milligrams (mg) 
chromatographic quality isopropyl alcohol into a 50-milliliter (ml) 
volumetric flask, dilute to volume with water, and mix. Pipet 10 ml of 
this solution into a 100-ml volumetric flask, dilute to volume with 
water, and mix.
    Tert-Butyl Alcohol (TBA) Standard Solution. Transfer 500.0 mg of 
chromatographic quality tert-butyl alcohol into a 50-ml volumetric 
flask, dilute to volume with water, and mix. Pipet 10 ml of this 
solution into a 100-ml volumetric flask, dilute to volume with water, 
and mix.
    Mixed Standard Solution. Pipet 4 ml each of the IPA Standard 
Solution and of the TBA Standard Solution into a 125-ml graduated 
Erlenmeyer flask, dilute to about 100 ml with water, and mix. This 
solution contains approximately 40 micrograms (g) each of 
isopropyl alcohol and tert-butyl alcohol per ml.
    Sample Preparation. Disperse 1 ml of a suitable antifoam emulsion, 
such as Dow-Corning G-10 or equivalent, in 200 ml of water contained in 
a 1000-ml 24/40 round-bottom distilling flask. Add about 5 grams (g) of 
the sample, accurately weighed. and shake for 1 hour on a wrist-action 
mechanical shaker. Connect the flask to a fractionating column and 
distill about 100 ml, adjusting the heat so that foam does not enter the 
column. Add 4.0 ml of TBA Standard Solution to the distillate to obtain 
the Sample Preparation.
    Procedure. Inject about 5 microliters (l) of the Mixed 
Standard Solution into a suitable gas chromatograph equipped with a 
flame-ionization detector and a 1.8 meters (m) x 3.2 millimeters (mm) 
stainless steel column packed with 80/100-mesh Porapak QS or equivalent. 
The carrier is helium flowing at 80 ml per minute (min). The injection 
port temperature is 200  deg.C, the column temperature is 165  deg.C, 
and the detector temperature is 200  deg.C. The retention time of 
isopropyl alcohol is about 2 min, and that of tert-butyl alcohol about 3 
min.
    Determine the areas of IPA and TBA peaks, and calculate the response 
factor, f, by the formula AIPA/ATBA, in which AIPA is the 
area of the isopropyl alcohol peak, and ATBA is the area of the 
tert-butyl alcohol peak.
    Similarly, inject about 5 l of the Sample Preparation, and 
determine the peak areas, recording the area of the isopropyl alcohol 
peak as a aIPA, and that of the tert-butyl alcohol peak as 
aTBA. Calculate the isopropyl alcohol content, in parts per million 
(ppm), in the sample taken by the formula (aIPA x 4000)/
(f x aTBA x W), in which W is the weight of the sample taken in 
grams.

    (e) The additive is used or intended for use in accordance with 
current good manufacturing practice as a stabilizer and thickener as 
defined in Sec. 170.3(o)(28) of this chapter. The additive may be used 
in foods where standards of identity established under section 401 of 
the Federal Food, Drug, and Cosmetic Act do not preclude such use.
    (f) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
name of the additive and the designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.

[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992]



Sec. 172.695   Xanthan gum.

    The food additive xanthan gum may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The additive is a polysaccharide gum derived from Xanthomonas 
campestris by a pure-culture fermentation process and purified by 
recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and 
D-glucuronic acid as the dominant hexose units and is manufactured as 
the sodium, potassium, or calcium salt.
    (b) The strain of Xanthomonas campestris is nonpathogenic and 
nontoxic in man or other animals.
    (c) The additive is produced by a process that renders it free of 
viable cells of Xanthomonas campestris.
    (d) The additive meets the following specifications:
    (1) Residual isopropyl alcohol not to exceed 750 parts per million.

[[Page 66]]

    (2) An aqueous solution containing 1 percent of the additive and 1 
percent of potassium chloride stirred for 2 hours has a minimum 
viscosity of 600 centipoises at 75 deg. F, as determined by Brookfield 
Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60 
r.p.m., and the ratio of viscosities at 75 deg. F and 150 deg. F is in 
the range of 1.02 to 1.45.
    (3) Positive for xanthan gum when subjected to the following 
procedure:

                        Locust Bean Gum Gel Test

    Blend on a weighing paper or in a weighing pan 1.0 gram of powdered 
locust bean gum with 1.0 gram of the powdered polysaccharide to be 
tested. Add the blend slowly (approximately \1/2\ minute) at the point 
of maximum agitation to a stirred solution of 200 milliliters of 
distilled water previously heated to 80 deg. C in a 400-milliliter 
beaker. Continue mechanical stirring until the mixture is in solution, 
but stir for a minimum time of 30 minutes. Do not allow the water 
temperature to drop below 60 deg. C.
    Set the beaker and its contents aside to cool in the absence of 
agitation. Allow a minimum time of 2 hours for cooling. Examine the 
cooled beaker contents for a firm rubbery gel formation after the 
temperature drops below 40 deg. C.
    In the event that a gel is obtained, make up a 1 percent solution of 
the polysaccharide to be tested in 200 milliliters of distilled water 
previously heated to 80 deg. C (omit the locust bean gum). Allow the 
solution to cool without agitation as before. Formation of a gel on 
cooling indicates that the sample is a gelling polysaccharide and not 
xanthan gum.
    Record the sample as ``positive'' for xanthan gum if a firm, rubbery 
gel forms in the presence of locust bean gum but not in its absence. 
Record the sample as ``negative'' for xanthan gum if no gel forms or if 
a soft or brittle gel forms both with locust bean gum and in a 1 percent 
solution of the sample (containing no locust bean gum).

    (4) Positive for xanthan gum when subjected to the following 
procedure:

                            Pyruvic Acid Test

    Pipet 10 milliliters of an 0.6 percent solution of the 
polysaccharide in distilled water (60 milligrams of water-soluble gum) 
into a 50-milliliter flask equipped with a standard taper glass joint. 
Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux 
the mixture for 3 hours. Take precautions to avoid loss of vapor during 
the refluxing. Cool the solution to room temperature. Add distilled 
water to make up any weight loss from the flask contents.
    Pipet 1 milliliter of a 2,4-dinitrophenylhydrazine reagent (0.5 
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel 
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum) 
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to 
stand at room temperature for 5 minutes. Extract the mixture with 5 
milliliters of ethyl acetate. Discard the aqueous layer.
    Extract the hydrazone from the ethyl acetate with three 5 milliliter 
portions of 10 percent sodium carbonate solution. Dilute the combined 
sodium carbonate extracts to 100 milliliters with additional 10 percent 
sodium carbonate in a 10-milliliter volumetric flask. Measure the 
optical density of the sodium carbonate solution at 375 millimicrons.
    Compare the results with a curve of the optical density versus 
concentration of an authentic sample of pyruvic acid that has been run 
through the procedure starting with the preparation of the hydrazone.
    Record the percent by weight of pyruvic acid in the test 
polysaccharide. Note ``positive'' for xanthan gum if the sample contains 
more than 1.5 percent of pyruvic acid and ``negative'' for xanthan gum 
if the sample contains less than 1.5 percent of pyruvic acid by weight.

    (e) The additive is used or intended for use in accordance with good 
manufacturing practice as a stabilizer, emulsifier, thickener, 
suspending agent, bodying agent, or foam enhancer in foods for which 
standards of identity established under section 401 of the Act do not 
preclude such use.
    (f) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to other 
information required by the Act, the name of the additive and the 
designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



                Subpart H--Other Specific Usage Additives



Sec. 172.710   Adjuvants for pesticide use dilutions.

    The following surfactants and related adjuvants may be safely added 
to pesticide use dilutions by a grower or applicant prior to application 
to the growing crop:

    n-Alkyl (C8-C18) amine acetate, where the alkyl groups 
(C8-C18) are derived from coconut oil, as a surfactant in 
emulsifier blends at levels not in excess of 5 percent by weight

[[Page 67]]

of the emulsifier blends that are added to herbicides for application to 
corn and sorghum.
    Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the 
alkyl groups (C8-C18) are derived from coconut oil, as 
surfactants in emulsifier blends at levels not in excess of 5 percent by 
weight of emulsifier blends that are added to herbicides for application 
to corn or sorghum.
    Diethanolamide condensate based on a mixture of saturated and 
unsaturated soybean oil fatty acids (C16-C18) as a surfactant 
in emulsifier blends that are added to the herbicide atrazine for 
application to corn.
    Diethanolamide condensate based on stripped coconut fatty acids 
(C10C18) as a surfactant in emulsifier blends that are added 
to the herbicide atrazine for application to corn.
    -(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced 
by the condensation of 1 mole of dodecylphenol (dodecyl group is a 
proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of 
ethylene oxide; if a blend of products is used, the average number of 
moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70.
    Ethylene dichloride.
    Polyglyceryl phthalate ester of coconut oil fatty acids.
    -[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles 
of ethylene oxide; if a blend of products is used, the average number of 
moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70.
    -[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene oxide.
    Sodium acrylate and acrylamide copolymer with a minimum average 
molecular weight of 10,000,000 in which 30 percent of the polymer is 
comprised of acrylate units and 70 percent acrylamide units, for use as 
a drift control agent in herbicide formulations applied to crops at a 
level not to exceed 0.5 ounces of the additive per acre.



Sec. 172.715   Calcium lignosulfonate.

    Calcium lignosulfonate may be safely used in or on food, subject to 
the provisions of this section.
    (a) Calcium lignosulfonate consists of sulfonated lignin, primarily 
as calcium and sodium salts.
    (b) It is used in an amount not to exceed that reasonably required 
to accomplish the intended physical or technical effect when added as a 
dispersing agent and stabilizer in pesticides for preharvest or 
postharvest application to bananas.



Sec. 172.720   Calcium lactobionate.

    The food additive calcium lactobionate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the calcium salt of lactobionic acid (4-
(, D-galactosido)-D-gluconic acid) produced by the oxidation of 
lactose.
    (b) It is used or intended for use as a firming agent in dry pudding 
mixes at a level not greater than that required to accomplish the 
intended effect.



Sec. 172.723  Epoxidized soybean oil.

    Epoxidized soybean oil may be safely used in accordance with the 
following prescribed conditions:
    (a) The additive is prepared by reacting soybean oil in toluene with 
hydrogen peroxide and formic acid.
    (b) It meets the following specifications:
    (1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 
8.0 percent, as determined by the American Oil Chemists' Society 
(A.O.C.S.) method Cd 9-57, ``Oxirane Oxygen,'' reapproved 1989, which is 
incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR 
part 51. Copies are available from the American Oil Chemists' Society, 
P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the 
Division of Petition Control (HFS-215), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., 
suite 1200, Washington, DC, or at the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (2) The maximum iodine value is 3.0, as determined by A.O.C.S. 
method Cd 1-25, ``Iodine Value of Fats and Oils Wijs Method,'' revised 
1993, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in paragraph (b)(1) of this section.

[[Page 68]]

    (3) The heavy metals (as Pb) content can not be more than 10 parts 
per million, as determined by the ``Heavy Metals Test,'' Food Chemicals 
Codex, 3d ed. (1981), p. 512, Method II (with a 2-gram sample and 20 
microgram of lead ion in the control), which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Box 285, Washington, DC 20055, or may be examined 
at the Division of Petition Control (HFS-215), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. 
NW., suite 1200, Washington, DC, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) The additive is used as a halogen stabilizer in brominated 
soybean oil at a level not to exceed 1 percent.

[60 FR 32903, June 26, 1995]



Sec. 172.725   Gibberellic acid and its potassium salt.

    The food additives gibberellic acid and its potassium salt may be 
used in the malting of barley in accordance with the following 
prescribed conditions:
    (a) The additives meet the following specifications:
    (1) The gibberellic acid is produced by deep-culture fermentation of 
a suitable nutrient medium by a strain of Fusarium moniliforme or a 
selection of this culture.
    (2) The gibberellic acid produced is of 80 percent purity or better.
    (3) The empirical formula of gibberellic acid is represented by 
C19H22O6.
    (4) Potassium gibberellate is the potassium salt of the specified 
gibberellic acid.
    (5) The potassium gibberellate is of 80 percent purity or better.
    (6) The gibberellic acid or potassium gibberellate may be diluted 
with substances generally recognized as safe in foods or with salts of 
fatty acids conforming to Sec. 172.863.
    (b) They are used or intended for use in the malting of barley under 
conditions whereby the amount of either or both additives present in the 
malt is not in excess of 2 parts per million expressed as gibberellic 
acid, and the treated malt is to be used in the production of fermented 
malt beverages or distilled spirits only, whereby the finished distilled 
spirits contain none and the finished malt beverage contains not more 
than 0.5 part per million of gibberellic acid.
    (c) To insure the safe use of the food additives the label of the 
package shall bear, in addition to the other information required by the 
Act:
    (1) The name of the additive, ``gibberellic acid'' or ``potassium 
gibberellate'', whichever is appropriate.
    (2) An accurate statement of the concentration of the additive 
contained in the package.
    (3) Adequate use directions to provide not more than 2 parts per 
million of gibberellic acid in the finished malt.
    (4) Adequate labeling directions to provide that the final malt is 
properly labeled as described in paragraph (d) of this section.
    (d) To insure the safe use of the additive the label of the treated 
malt shall bear, in addition to the other information required by the 
Act, the statements:
    (1) ``Contains not more than 2 parts per million __________'', the 
blank being filled in with the words ``gibberellic acid'' or ``potassium 
gibberellate'', whichever is appropriate; and
    (2) ``Brewer's malt--To be used in the production of fermented malt 
beverages only'' or ``Distiller's malt--To be used in the production of 
distilled spirits only'', whichever is appropriate.



Sec. 172.730   Potassium bromate.

    The food additive potassium bromate may be safely used in the 
malting of barley under the following prescribed conditions:
    (a)(1) It is used or intended for use in the malting of barley under 
conditions whereby the amount of the additive present in the malt from 
the treatment does not exceed 75 parts per million of bromate 
(calculated as Br), and the treated malt is used only in the production 
of fermented malt beverages or distilled spirits.
    (2) The total residue of inorganic bromides in fermented malt 
beverages, resulting from the use of the treated malt plus additional 
residues of inorganic bromides that may be present

[[Page 69]]

from uses in accordance with other regulations in this chapter 
promulgated under sections 408 and/or 409 of the act, does not exceed 25 
parts per million of bromide (calculated as Br). No tolerance is 
established for bromide in distilled spirits because there is evidence 
that inorganic bromides do not pass over in the distillation process.
    (b) To assure safe use of the additive, the label or labeling of the 
food additive shall bear, in addition to the other information required 
by the Act, the following:
    (1) The name of the additive.
    (2) Adequate directions for use.
    (c) To assure safe use of the additive, the label or labeling of the 
treated malt shall bear, in addition to other information required by 
the Act, the statement, ``Brewer's Malt--To be used in the production of 
fermented malt beverages only'', or ``Distiller's Malt--To be used in 
the production of distilled spirits only'', whichever is the case.



Sec. 172.735   Glycerol ester of wood rosin.

    Glycerol ester of wood rosin may be safely used in food in 
accordance with the following prescribed conditions:
    (a) It has an acid number of 3 to 9, a drop-softening point of 
88 deg. C-96 deg. C; and a color of N or paler as determined in 
accordance with Official Naval Stores Standards of the United States. It 
is purified by countercurrent steam distillation.
    (b) It is used to adjust the density of citrus oils used in the 
preparation of beverages whereby the amount of the additive does not 
exceed 100 parts per million of the finished beverage.



Sec. 172.755   Stearyl monoglyceridyl citrate.

    The food additive stearyl monoglyceridyl citrate may be safely used 
in food in accordance with the following provisions:
    (a) The additive is prepared by controlled chemical reaction of the 
following:

------------------------------------------------------------------------
                 Reactant                           Limitations         
------------------------------------------------------------------------
Citric acid..............................  .............................
Monoglycerides of fatty acids............  Prepared by the glycerolysis 
                                            of edible fats and oils or  
                                            derived from fatty acids    
                                            conforming with Sec.        
                                            172.860.                    
Stearyl alcohol..........................  Derived from fatty acids     
                                            conforming with Sec.        
                                            172.860, or derived         
                                            synthetically in conformity 
                                            with Sec.  172.864.         
------------------------------------------------------------------------

    (b) The additive stearyl monoglyceridyl citrate, produced as 
described under paragraph (a) of this section, meets the following 
specifications:

Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Saponification number 215-255.

    (c) The additive is used or intended for use as an emulsion 
stabilizer in or with shortenings containing emulsifiers.



Sec. 172.765   Succistearin (stearoyl propylene glycol hydrogen succinate).

    The food additive succistearin (stearoyl propylene glycol hydrogen 
succinate) may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additive is the reaction product of succinic anhydride, 
fully hydrogenated vegetable oil (predominantly C16 or C18 
fatty acid chain length), and propylene glycol.
    (b) The additive meets the following specifications:

Acid number 50-150.
Hydroxyl number 15-50.
Succinated ester content 45-75 percent.

    (c) The additive is used or intended for use as an emulsifier in or 
with shortenings and edible oils intended for use in cakes, cake mixes, 
fillings, icings, pastries, and toppings, in accordance with good 
manufacturing practice.



Sec. 172.770   Ethylene oxide polymer.

    The polymer of ethylene oxide may be safely used as a foam 
stabilizer in fermented malt beverages in accordance with the following 
conditions.
    (a) It is the polymer of ethylene oxide having a minimum viscosity 
of 1,500 centipoises in a 1 percent aqueous solution at 25 deg. C.
    (b) It is used at a level not to exceed 300 parts per million by 
weight of the fermented malt beverage.

[[Page 70]]

    (c) The label of the additive bears directions for use to insure 
compliance with paragraph (b) of this section.



Sec. 172.775   Methacrylic acid-divinylbenzene copolymer.

    Methacrylic acid-divinylbenzene copolymer may be safely used in food 
in accordance with the following prescribed conditions:
    (a) The additive is produced by the polymerization of methacrylic 
acid and divinylbenzene. The divinylbenzene functions as a cross-linking 
agent and constitutes a minimum of 4 percent of the polymer.
    (b) Aqueous extractives from the additive do not exceed 2 percent 
(dry basis) after 24 hours at 25 deg. C.
    (c) The additive is used as a carrier of vitamin B12 in foods 
for special dietary use.



                    Subpart I--Multipurpose Additives



Sec. 172.800  Acesulfame potassium.

    Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as 
acesulfame K, may be safely used as a sweetening agent in food in 
accordance with the following prescribed conditions:
    (a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-
oxathiazine-4(3H)-one-2,2-dioxide.
    (b) The additive meets the following specifications:
    (1) Purity is not less than 99 percent on a dry basis. The purity 
shall be determined by a method titled ``Acesulfame Potassium Assay,'' 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Fluoride content is not more than 30 parts per million, as 
determined by method III of the Fluoride Limit Test of the Food 
Chemicals Codex, 3d Ed. (1981), p. 511, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) The additive may be used in the following foods when standards 
of identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act do not preclude such use:
    (1) Sugar substitute, including granulated, powdered, liquid, and 
tablet form.
    (2) [Reserved]
    (3) Chewing gum.
    (4) Dry bases for beverages, instant coffee, and instant tea.
    (5) Dry bases for gelatins, puddings, and pudding desserts.
    (6) Dry bases for dairy product analogs.
    (7) Confections, hard candy, and soft candy.
    (8) Baked goods and baking mixes, including frostings, icings, 
toppings, and fillings for baked goods.
    (9) Yogurt and yogurt-type products.
    (10) Frozen and refrigerated desserts.
    (11) Sweet sauces, toppings, and syrups.
    (12) Alcoholic beverages.
    (d) If the food containing the additive is represented to be for 
special dietary uses, it shall be labeled in compliance with part 105 of 
this chapter.
    (e) The additive shall be used in accordance with current good 
manufacturing practice in an amount not to exceed that reasonably 
required to accomplish the intended effect.

[53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59 
FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995]



Sec. 172.802   Acetone peroxides.

    The food additive acetone peroxides may be safely used in flour, and 
in bread and rolls where standards of identity do not preclude its use, 
in accordance with the following prescribed conditions:
    (a) The additive is a mixture of monomeric and linear dimeric 
acetone peroxide, with minor proportions of higher polymers, 
manufactured by reaction of hydrogen peroxide and acetone.
    (b) The additive may be mixed with an edible carrier to give a 
concentration of: (1) 3 grams to 10 grams of hydrogen peroxide 
equivalent per 100 grams of the additive, plus carrier, for

[[Page 71]]

use in flour maturing and bleaching; or (2) approximately 0.75 gram of 
hydrogen peroxide equivalent per 100 grams of the additive, plus 
carrier, for use in dough conditioning.
    (c) It is used or intended for use: (1) In maturing and bleaching of 
flour in a quantity not more than sufficient for such effect; and (2) as 
a dough-conditioning agent in bread and roll production at not to exceed 
the quantity of hydrogen peroxide equivalent necessary for the 
artificial maturing effect.
    (d) To insure safe use of the additive, the label of the food 
additive container and any intermediate premix thereof shall bear, in 
addition to the other information required by the act:
    (1) The name of the additive, ``acetone peroxides''.
    (2) The concentration of the additive expressed in hydrogen peroxide 
equivalents per 100 grams.
    (3) Adequate use directions to provide a final product that complies 
with the limitations prescribed in paragraph (c) of this section.



Sec. 172.804   Aspartame.

    The food additive aspartame may be safely used in food in accordance 
with good manufacturing practice as a sweetening agent or for an 
authorized technological purpose in foods for which standards of 
identity established under section 401 of the Act do not preclude such 
use under the following conditions:
    (a) Aspartame is the chemical

            1-methyl N-l--aspartyl-l-phenylalanine 
                    (C14H18N2O5).

    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981) pp. 28-29 and First Supplement p. 5, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are 
available from the National Academy Press, 2101 Constitution Avenue NW., 
Washington, DC 20418, or for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) The additive may be used as a sweetener in the following foods:
    (1) Dry, free-flowing sugar substitutes for table use (not to 
include use in cooking) in package units not exceeding the sweetening 
equivalent of 1 pound of sugar.
    (2) Sugar substitute tablets for sweetening hot beverages, including 
coffee and tea. L-leucine may be used as a lubricant in the manufacture 
of such tablets at a level not to exceed 3.5 percent of the weight of 
the tablet.
    (3) Breakfast cereals.
    (4) Chewing gum.
    (5) Dry bases for:
    (i) Beverages.
    (ii) Instant coffee and tea beverages.
    (iii) Gelatins, puddings, and fillings.
    (iv) Dairy product analog toppings.
    (6) Ready-to-serve nonalcoholic flavored beverages, tea beverages, 
fruit juice based beverages, and their concentrates or syrups.
    (7) Chewable multivitamin food supplements.
    (8) [Reserved]
    (i) Fruit juice based drinks (where food standards do not preclude 
such use).
    (ii) Fruit flavored drinks and ades.
    (iii) Imitation fruit flavored drinks and ades.
    (9) Frozen stick-type confections and novelties.
    (10) Breath mints, hard and soft candy.
    (11) [Reserved]
    (12) [Reserved]
    (13) Refrigerated ready-to-serve gelatins, puddings, and fillings.
    (14) Fruit (including grape) wine beverages with ethanol contents 
below 7 percent volume per volume.
    (15) Yogurt-type products where aspartame is added after 
pasteurization and culturing.
    (16) Refrigerated flavored milk beverages.
    (17) Frozen desserts.
    (18) Frostings, toppings, fillings, glazes, and icings for precooled 
baked goods.
    (19) Frozen, ready-to-thaw-and-eat cheesecakes, fruit, and fruit 
toppings.
    (20) Frozen dairy and nondairy frostings, toppings, and fillings.
    (21) Fruit spreads, fruit toppings, and fruit syrups.
    (22) Malt beverages of less than 7 percent ethanol by volume and 
containing fruit juice.

[[Page 72]]

    (23) Baked goods and baking mixes in an amount not to exceed 0.5 
percent by weight of ready-to-bake products or of finished formulations 
prior to baking. Generally recognized as safe (GRAS) ingredients or food 
additives approved for use in baked goods shall be used in combination 
with aspartame to ensure its functionality as a sweetener in the final 
baked product. The level of aspartame used in these products is 
determined by an analytical method entitled ``Analytical Method for the 
Determination of Aspartame and Diketopiperazine in Baked Goods and 
Baking Mixes,'' October 8, 1992, which was developed by the NutraSweet 
Co., and is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the Center for Food Safety 
and Applied Nutrition, (HFS-200), 200 C St. SW., Washington, DC 20204, 
or are available for inspection at the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (d) The additive may be used as a flavor enhancer in chewing gum, 
hard candy, and malt beverages containing less than 3 percent alcohol by 
volume.
    (e) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The principal display panel of any intermediate mix of the 
additive for manufacturing purposes shall bear a statement of the 
concentration of the additive contained therein;
    (2) The label of any food containing the additive shall bear, either 
on the principal display panel or on the information panel, the 
following statement:

PHENYLKETONURICS: CONTAINS PHENYLALANINE

The statement shall appear in the labeling prominently and conspicuously 
as compared to other words, statements, designs or devices and in bold 
type and on clear contrasting background in order to render it likely to 
be read and understood by the ordinary individual under customary 
conditions of purchase and use.
    (3) When the additive is used in a sugar substitute for table use, 
its label shall bear instructions not to use in cooking or baking.
    (4) Packages of the dry, free-flowing additive shall prominently 
display the sweetening equivalence in teaspoons of sugar.
    (f) If the food containing the additive purports to be or is 
represented for special dietary uses, it shall be labeled in compliance 
with part 105 of this chapter.

[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 31382, July 8, 1983; 49 
FR 22468, May 30, 1984; 51 FR 43000-43002, Nov. 28, 1986; 53 FR 20837--
20842, June 7, 1988; 53 FR 40879, Oct. 19, 1988; 53 FR 51273, Dec. 21, 
1988; 54 FR 23647, June 2, 1989; 54 FR 31333, July 28, 1989; 57 FR 3702, 
3703, 3704, Jan. 30, 1992; 58 FR 19771, Apr. 16, 1993; 58 FR 21097, 
21098, 21099, Apr. 19, 1993; 58 FR 48598, Sept. 17, 1993; 61 FR 14480, 
Apr. 2, 1996]



Sec. 172.806   Azodicarbonamide.

    The food additive azodicarbonamide may be safely used in food in 
accordance with the following prescribed conditions:
    (a) It is used or intended for use:
    (1) As an aging and bleaching ingredient in cereal flour in an 
amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent; 
45 parts per million).
    (2) As a dough conditioner in bread baking in a total amount not to 
exceed 0.0045 percent (45 parts per million) by weight of the flour 
used, including any quantity of azodicarbonamide added to flour in 
accordance with paragraph (a)(1) of this section.
    (b) To assure safe use of the additive:
    (1) The label and labeling of the additive and any intermediate 
premix prepared therefrom shall bear, in addition to the other 
information required by the Act, the following:
    (i) The name of the additive.
    (ii) A statement of the concentration or the strength of the 
additive in any intermediate premixes.
    (2) The label or labeling of the food additive shall also bear 
adequate directions for use.



Sec. 172.808   Copolymer condensates of ethylene oxide and propylene oxide.

    Copolymer condensates of ethylene oxide and propylene oxide may be 
safely used in food under the following prescribed conditions:
    (a) The additive consists of one of the following:

[[Page 73]]

    (1) -Hydro-omega-hydroxy-poly (oxyethylene) 
poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer, 
having a molecular weight range of 9,760-13,200 and a cloud point above 
100 deg. C in 1 percent aqueous solution.
    (2) -Hydro-omega-hydroxy-poly 
(oxyethylene)poly(oxypropylene)-(53-59 moles)poly(oxyethylene)(14-16 
moles) block copolymer, having a molecular weight range of 3,500-4,125 
and a cloud point of 9 deg. C-12 deg. C in 10 percent aqueous solution.
    (3) -Hydro-omega-hydroxy-poly(ox-yethylene)/
poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer, 
having a minimum average molecular weight of 1900 and a minimum cloud 
point of 9 deg. C-12 deg. C in 10 percent aqueous solution.
    (4) -Hydro-omega-hydroxy-poly(ox-yethylene) poly 
(oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having 
an average molecular weight of 14,000 and a cloud point above 100 deg. C 
in 1 percent aqueous solution.
    (b) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a)(1) of this section is 
used in practice as a solubilizing and stabilizing agent in flavor 
concentrates (containing authorized flavoring oils) for use in foods for 
which standards of identity established under section 401 of the Act do 
not preclude such use, provided that the weight of the additive does not 
exceed the weight of the flavoring oils in the flavor concentrate.
    (2) The additive identified in paragraph (a)(2) of this section is 
used as a processing aid and wetting agent in combination with dioctyl 
sodium sulfosuccinate for fumaric acid as prescribed in Sec. 172.810.
    (3) The additive identified in paragraph (a)(3) of this section is 
used:
    (i) As a surfactant and defoaming agent, at levels not to exceed 
0.05 percent by weight, in scald baths for poultry defeathering, 
followed by potable water rinse. The temperatures of the scald baths 
shall be not less than 125 deg. F.
    (ii) As a foam control and rinse adjuvant in hog dehairing machines 
at a use level of not more than 5 grams per hog.
    (4) The additive identified in paragraph (a)(4) of this section is 
used as a dough conditioner in yeast-leavened bakery products for which 
standards of identity established under section 401 of the Act do not 
preclude such use, provided that the amount of the additive dose not 
exceed 0.5 percent by weight of the flour used.

[42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24, 1981]



Sec. 172.810   Dioctyl sodium sulfosuccinate.

    The food additive dioctyl sodium sulfosuccinate, which meets the 
specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 102-104, 
which is incorporated by reference (copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408), may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) As a wetting agent in the following fumaric acid-acidulated 
foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks, 
when standards of identity do not preclude such use. The labeling of the 
dry gelatin dessert and dry beverage base shall bear adequate directions 
for use, and the additive shall be used in such an amount that the 
finished gelatin dessert will contain not in excess of 15 parts per 
million of the additive and the finished beverage or fruit juice drink 
will contain not in excess of 10 parts per million of the additive.
    (b) As a processing aid in sugar factories in the production of 
unrefined cane sugar, in an amount not in excess of 0.5 part per million 
of the additive per percentage point of sucrose in the juice, syrup, or 
massecuite being processed, and so used that the final molasses will 
contain no more than 25 parts per million of the additive.
    (c) As a solubilizing agent on gums and hydrophilic colloids to be 
used in food as stabilizing and thickening agents, when standards of 
identity do not preclude such use. The additive is used in an amount not 
to exceed 0.5

[[Page 74]]

percent by weight of the gums or hydrophilic colloids.
    (d) As an emulsifying agent for cocoa fat in noncarbonated beverages 
containing cocoa, whereby the amount of the additive does not exceed 25 
parts per million of the finished beverage.
    (e) As a dispersing agent in ``cocoa with dioctyl sodium 
sulfosuccinate for manufacturing'' that conforms to the provisions of 
Sec. 163.117 of this chapter and the use limitations prescribed in 
Sec. 172.520, in an amount not to exceed 0.4 percent by weight thereof.
    (f) As a processing aid and wetting agent in combination with 
-hydro-omega - hydroxy - poly(oxyethylene) - poly-
(oxypropylene) (53-59 moles) poly(oxyethylene) (14-16 moles) block 
copolymer, having a molecular weight range of 3,500-4,125 and a cloud 
point of 9 deg. C-12 deg. C in 10 percent aqueous solution, for fumaric 
acid used in fumaric acid-acidulated dry beverage base and in fumaric 
acid-acidulated fruit juice drinks, when standards of identity do not 
preclude such use. The labeling of the dry beverage base shall bear 
adequate directions for use, and the additives shall be used in such an 
amount that the finished beverage or fruit juice drink will contain not 
in excess of a total of 10 parts per million of the dioctyl sodium 
sulfosuccinate-block copolymer combination.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.811  Glyceryl tristearate.

    The food additive glyceryl tristearate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive (CAS Reg. No. 555-43-1) is prepared by 
reacting stearic acid with glycerol in the presence of a suitable 
catalyst.
     (b) The food additive meets the following specifications:

                                                                        
                                                                        
                                                                        
                                                                        
 Acid number..............................   Not to exceed 1.0.         
 Iodine number............................   Not to exceed 1.0.         
 Saponification number....................   186-192.                   
 Hydroxyl number..........................   Not to exceed 5.0.         
 Free glycerol content....................   Not to exceed 0.5 percent. 
 Unsaponifiable matter....................   Not to exceed 0.5 percent. 
 Melting point (Class II).................  69 C-73 C.                  
                                                                        

    (c) The additive is used or intended for use as follows when 
standards of identity established under section 401 of the Act do not 
preclude such use:

------------------------------------------------------------------------
                 Uses                             Limitations           
------------------------------------------------------------------------
1. As a crystallization accelerator    Not to exceed 1 percent of the   
 in cocoa products, in imitation        combined weight of the          
 chocolate, and in compound coatings.   formulation.                    
2. As a formulation aid as defined in  Not to exceed 0.5 percent.       
 Sec.  170.3(o)(14) of this chapter,                                    
 lubricant and release agent as                                         
 defined in Sec.  170.3(o)(18) of                                       
 this chapter, and surface-finishing                                    
 agent as defined in Sec.                                               
 170.3(o)(30) of this chapter in food.                                  
3. As a formulation aid as defined in  Not to exceed 3.0 percent of the 
 Sec.  170.3(o)(14) of this chapter     combined weight of the          
 in confections.                        formulation.                    
4. As a formulation aid as defined in  Not to exceed 1.0 percent of the 
 Sec.  170.3(o)(14) of this chapter     combined weight of the          
 in fats and oils as defined in Sec.    formulation.                    
 170.3 (n)(12) of this chapter.                                         
5. As a winterization and              Not to exceed 0.5 percent by     
 fractionation aid in fat and oil       weight of the processed fat or  
 processing.                            oil.                            
------------------------------------------------------------------------

    (d) To assure safe use of the additive:
    (1) In addition to the other information required by the act, the 
label or labeling of the additive shall bear the name of the additive.
    (2) The label of the additive shall bear adequate directions to 
provide a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994]



Sec. 172.812   Glycine.

    The food additive glycine may be safely used for technological 
purposes in food in accordance with the following prescribed conditions:
    (a) The additive complies with the specifications of the ``Food 
Chemicals Codex,'' 3d Ed. (1981), p. 140, which is incorporated by 
reference. Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (b) The additive is used or intended for use as follows:

[[Page 75]]



------------------------------------------------------------------------
                   Uses                              Limitations        
------------------------------------------------------------------------
As a masking agent for the bitter           Not to exceed 0.2 percent in
 aftertaste of saccharin used in             the finished beverage.     
 manufactured beverages and beverage bases.                             
As a stabilizer in mono- and diglycerides   Not to exceed 0.02 percent  
 prepared by the glycerolysis of edible      of the mono- and           
 fats or oils.                               diglycerides.              
------------------------------------------------------------------------

    (c) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The labeling of the additive shall bear adequate directions for 
use of the additive in compliance with the provisions of this section.
    (2) The labeling of beverage bases containing the additive shall 
bear adequate directions for use to provide that beverages prepared 
therefrom shall contain no more than 0.2 percent glycine.


[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.814   Hydroxylated lecithin.

    The food additive hydroxylated lecithin may be safely used as an 
emulsifier in foods in accordance with the following conditions:
    (a) The additive is obtained by the treatment of lecithin in one of 
the following ways, under controlled conditions whereby the separated 
fatty acid fraction of the resultant product has an acetyl value of 30 
to 38:
    (1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and 
sodium hydroxide.
    (2) With hydrogen peroxide, acetic acid, and sodium hydroxide.
    (b) It is used or intended for use, in accordance with good 
manufacturing practice, as an emulsifier in foods, except for those 
standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive, ``hydroxylated lecithin''.
    (2) Adequate directions for its use.



Sec. 172.816   Methyl glucoside-coconut oil ester.

    Methyl glucoside-coconut oil ester may be safely used in food in 
accordance with the following conditions:
    (a) It is the methyl glucoside-coconut oil ester having the 
following specifications:

Acid number...................................................     10-20
Hydroxyl number...............................................   200-300
pH (5% aqueous)...............................................   4.8-5.0
Saponification number.........................................   178-190
                                                                        

    (b) It is used or intended for use as follows:
    (1) As an aid in crystallization of sucrose and dextrose at a level 
not to exceed the minimum quantity required to produce its intended 
effect.
    (2) As a surfactant in molasses at a level not to exceed 320 parts 
per million in the molasses.



Sec. 172.818   Oxystearin.

    The food additive oxystearin may be safely used in foods, when such 
use is not precluded by standards of identity in accordance with the 
following conditions:
    (a) The additive is a mixture of the glycerides of partially 
oxidized stearic and other fatty acids obtained by heating hydrogenated 
cottonseed or soybean oil under controlled conditions, in the presence 
of air and a suitable catalyst which is not a food additive as so 
defined. The resultant product meets the following specifications:

Acid number...............................  Maximum 15.                 
Iodine number.............................  Maximum 15.                 
Saponification number.....................  225-240.                    
Hydroxyl number...........................  30-45.                      
Unsaponifiable material...................  Maximum 0.8 percent.        
Refractive index (butyro).................  60plus-minus1 at 48 deg. C. 
                                                                        

    (b) It is used or intended for use as a crystallization inhibitor in 
vegetable oils and as a release agent in vegetable oils and vegetable 
shortenings, whereby the additive does not exceed 0.125 percent of the 
combined weight of the oil or shortening.
    (c) To insure safe use of the additive, the label and labeling of 
the additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive.
    (2) Adequate directions to provide an oil or shortening that 
complies with

[[Page 76]]

the limitations prescribed in paragraph (b) of this section.



Sec. 172.820   Polyethylene glycol (mean molecular weight 200-9,500).

    Polyethylene glycol identified in this section may be safely used in 
food in accordance with the following prescribed conditions:
    (a) Identity. (1) The additive is an addition polymer of ethylene 
oxide and water with a mean molecular weight of 200 to 9,500.
    (2) It contains no more than 0.2 percent total by weight of ethylene 
and diethylene glycols when tested by the analytical methods prescribed 
in paragraph (b) of this section.
    (b) Analytical method. (1) The analytical method prescribed in the 
National Formulary XV (1980), page 1244, for polyethylene glycol 400 
shall be used to determine the total ethylene and diethylene glycol 
content of polyethylene glycols having mean molecular weights of 450 or 
higher.
    (2) The following analytical method shall be used to determine the 
total ethylene and diethylene glycol content of polyethylene glycols 
having mean molecular weights below 450.

                            Analytical Method

  ethylene glycol and diethylene glycol content of polyethylene glycols

    The analytical method for determining ethylene glycol and diethylene 
glycol is as follows:

                                apparatus

    Gas chromatograph with hydrogen flame ionization detector (Varian 
Aerograph 600 D or equivalent). The following conditions shall be 
employed with the Varian Aerograph 600 D gas chromatograph:
    Column temperature: 165 deg. C.
    Inlet temperature: 260 deg. C.
    Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
    Hydrogen and air flow to burner: Optimize to give maximum 
sensitivity.
    Sample size: 2 microliters.
    Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5 
minutes.
    Recorder: -0.5 to +1.05 millivolt, full span, 1 second full response 
time.
    Syringe: 10-microliter (Hamilton 710 N or equivalent).
    Chromatograph column: 5 feet  x  \1/8\ inch. I.D. stainless steel 
tube packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, 
or equivalent) 12 percent in H2O by weight on 60-80 mesh nonacid 
washed diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent).

                         reagents and materials

    Carrier gas, nitrogen: Commercial grade in cylinder equipped with 
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
    Ethylene glycol: Commercial grade. Purify if necessary, by 
distillation.
    Diethylene glycol: Commercial grade. Purify, if necessary, by 
distillation.
    Glycol standards: Prepare chromatographic standards by dissolving 
known amounts of ethylene glycol and diethylene glycol in water. 
Suitable concentrations for standardization range from 1 to 6 milligrams 
of each component per milliliter (for example 10 milligrams diluted to 
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram 
per milliliter).

                             standardization

    Inject a 2-microliter aliquot of the glycol standard into the gas 
chromatograph employing the conditions described above. Measure the net 
peak heights for the ethylene glycol and for the diethylene glycol. 
Record the values as follows:
    A=Peak height in millimeters of the ethylene glycol peak.
    B=milligrams of ethylene glycol per milliliter of standard solution.
    C=Peak height in millimeters of the diethylene glycol peak.
    D=Milligrams of diethylene glycol per milliliter of standard 
solution.

                                procedure

    Weigh approximately 4 grams of polyethylene glycol sample accurately 
into a 10-milliliter volumetric flask. Dilute to volume with water. Mix 
the solution thoroughly and inject a 2-microliter aliquot into the gas 
chromatograph. Measure the heights, in millimeters, of the ethylene 
glycol peak and of the diethylene glycol peak and record as E and F, 
respectively.

     Percent ethylene glycol=(E x B)/(A  x  sample weight in grams)

   Percent diethylene glycol=(F  x  D)/(C  x  sample weight in grams)

    (c) Uses. It may be used, except in milk or preparations intended 
for addition to milk, as follows:
    (1) As a coating, binder, plasticizing agent, and/or lubricant in 
tablets used for food.
    (2) As an adjuvant to improve flavor and as a bodying agent in 
nonnutritive

[[Page 77]]

sweeteners identified in Sec. 180.37 of this chapter.
    (3) As an adjuvant in dispersing vitamin and/or mineral 
preparations.
    (4) As a coating on sodium nitrite to inhibit hygroscopic 
properties.
    (d) Limitations. (1) It is used in an amount not greater than that 
required to produce the intended physical or technical effect.
    (2) A tolerance of zero is established for residues of polyethylene 
glycol in milk.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.822   Sodium lauryl sulfate.

    The food additive sodium lauryl sulfate may be safely used in food 
in accordance with the following conditions:
    (a) The additive meets the following specifications:
    (1) It is a mixture of sodium alkyl sulfates consisting chiefly of 
sodium lauryl sulfate [CH2(CH2)10CH2OSO2Na].
    (2) It has a minimum content of 90 percent sodium alkyl sulfates.
    (b) It is used or intended for use:
    (1) As an emulsifier in or with egg whites whereby the additive does 
not exceed the following limits:

Egg white solids, 1,000 parts per million.
Frozen egg whites, 125 parts per million.
Liquid egg whites, 125 parts per million.

    (2) As a whipping agent at a level not to exceed 0.5 percent by 
weight of gelatine used in the preparation of marshmallows.
    (3) As a surfactant in:
    (i) Fumaric acid-acidulated dry beverage base whereby the additive 
does not exceed 25 parts per million of the finished beverage and such 
beverage base is not for use in a food for which a standard of identity 
established under section 401 of the Act precludes such use.
    (ii) Fumaric acid-acidulated fruit juice drinks whereby the additive 
does not exceed 25 parts per million of the finished fruit juice drink 
and it is not used in a fruit juice drink for which a standard of 
identity established under section 401 of the Act precludes such use.
    (4) As a wetting agent at a level not to exceed 10 parts per million 
in the partition of high and low melting fractions of crude vegetable 
oils and animal fats, provided that the partition step is followed by a 
conventional refining process that includes alkali neutralization and 
deodorization of the fats and oils.
    (c) To insure the safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive, sodium lauryl sulfate.
    (2) Adequate use directions to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978]



Sec. 172.824   Sodium mono- and dimethyl naphthalene sulfonates.

    The food additive sodium mono- and dimethyl naphthalene sulfonates 
may be safely used in accordance with the following prescribed 
conditions:
    (a) The additive has a molecular weight range of 245-260.
    (b) The additive is used or intended for use:
    (1) In the crystallization of sodium carbonate in an amount not to 
exceed 250 parts per million of the sodium carbonate. Such sodium 
carbonate is used or intended for use in potable water systems to reduce 
hardness and aid in sedimentation and coagulation by raising the pH for 
the efficient utilization of other coagulation materials.
    (2) As an anticaking agent in sodium nitrite at a level not in 
excess of 0.1 percent by weight thereof for authorized uses in cured 
fish and meat.
    (3) In the washing or to assist in the lye peeling of fruits and 
vegetables as prescribed in Sec. 173.315 of this chapter.
    (c) In addition to the general labeling requirements of the Act:
    (1) Sodium carbonate produced in accordance with paragraph (b)(1) of 
this section shall be labeled to show the presence of the additive and 
its label or labeling shall bear adequate directions for use.
    (2) Sodium nitrite produced in accordance with paragraph (b)(2) of 
this section shall bear the labeling required by Sec. 172.175 and a 
statement declaring the presence of sodium mono- and dimethyl 
naphthalene sulfonates.

[[Page 78]]



Sec. 172.826   Sodium stearyl fumarate.

    Sodium stearyl fumarate may be safely used in food in accordance 
with the following conditions:
    (a) It contains not less than 99 percent sodium stearyl fumarate 
calculated on the anhydrous basis, and not more than 0.25 percent sodium 
stearyl maleate.
    (b) The additive is used or intended for use:
    (1) As a dough conditioner in yeast-leavened bakery products in an 
amount not to exceed 0.5 percent by weight of the flour used.
    (2) As a conditioning agent in dehydrated potatoes in an amount not 
to exceed 1 percent by weight thereof.
    (3) As a stabilizing agent in nonyeast-leavened bakery products in 
an amount not to exceed 1 percent by weight of the flour used.
    (4) As a conditioning agent in processed cereals for cooking in an 
amount not to exceed 1 percent by weight of the dry cereal, except for 
foods for which standards of identity preclude such use.
    (5) As a conditioning agent in starch-thickened or flour-thickened 
foods in an amount not to exceed 0.2 percent by weight of the food.



Sec. 172.828   Acetylated monoglycerides.

    The food additive acetylated monoglycerides may be safely used in or 
on food in accordance with the following prescribed conditions:
    (a) The additive is manufactured by:
    (1) The interesterification of edible fats with triacetin and in the 
presence of catalytic agents that are not food additives or are 
authorized by regulation, followed by a molecular distillation or by 
steam stripping; or
    (2) The direct acetylation of edible monoglycerides with acetic 
anhydride without the use of catalyst or molecular distillation, and 
with the removal by vacuum distillation, if necessary, of the acetic 
acid, acetic anhydride, and triacetin.
    (b) The food additive has a Reichert-Meissl value of 75-200 and an 
acid value of less than 6.
    (c) The food additive is used at a level not in excess of the amount 
reasonably required to produce its intended effect in food, or in food-
processing, food-packing, or food-storage equipment.

[42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985]



Sec. 172.830   Succinylated monoglycerides.

    The food additive succinylated monoglycerides may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is a mixture of semi-and neutral succinic acid 
esters of mono- and diglycerides produced by the succinylation of a 
product obtained by the glycerolysis of edible fats and oils, or by the 
direct esterification of glycerol with edible fat-forming fatty acids.
    (b) The additive meets the following specifications:

Succinic acid content...................................     14.8%-25.6%
Melting point...........................................    50 deg. C-60
                                                                 deg. C.
Acid number.............................................          70-120
                                                                        

    (c) The additive is used or intended for use in the following foods:
    (1) As an emulsifier in liquid and plastic shortenings at a level 
not to exceed 3 percent by weight of the shortening.
    (2) As a dough conditioner in bread baking, when such use is 
permitted by an appropriate food standard, at a level not to exceed 0.5 
percent by weight of the flour used.



Sec. 172.832   Monoglyceride citrate.

    A food additive that is a mixture of glyceryl monooleate and its 
citric acid monoester manufactured by the reaction of glyceryl 
monooleate with citric acid under controlled conditions may be safely 
used as a synergist and solubilizer for antioxidants in oils and fats, 
when used in accordance with the conditions prescribed in this section.
    (a) The food additive meets the following specifications:

    Acid number, 70-100.
    Total citric acid (free and combined), 14 percent-17 percent.

    (b) It is used, or intended for use, in antioxidant formulations for 
addition to oils and fats whereby the additive does not exceed 200 parts 
per million of the combined weight of the oil or fat and the additive.
    (c) To assure safe use of the additive:

[[Page 79]]

    (1) The container label shall bear, in addition to the other 
information required by the Act, the name of the additive.
    (2) The label or accompanying labeling shall bear adequate 
directions for the use of the additive which, if followed, will result 
in a food that complies with the requirements of this section.



Sec. 172.834   Ethoxylated mono- and diglycerides.

    The food additive ethoxylated mono-and diglycerides (polyoxyethylene 
(20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by:
    (1) Glycerolysis of edible fats primarily composed of stearic, 
palmitic, and myristic acids; or
    (2) Direct esterification of glycerol with a mixture of primarily 
stearic, palmitic, and myristic acids;

to yield a product with less than 0.3 acid number and less than 0.2 
percent water, which is then reacted with ethylene oxide.
    (b) The additive meets the following specifications:

    Saponification number, 65-75.
    Acid number, 0-2.
    Hydroxyl number, 65-80.
    Oxyethylene content, 60.5-65.0 percent.

    (c) The additive is used or intended for use in the following foods 
when standards of identity established under section 401 of the Act do 
not preclude such use:

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
1. As an emulsifier in pan-release agents   Not to exceed levels        
 for and as a dough conditioner in yeast-    required to produce the    
 leavened bakery products.                   intended effects, total not
                                             to exceed 0.5 percent by   
                                             weight of the flour used.  
2. As an emulsifier in cakes and cake       Not to exceed 0.5 percent by
 mixes.                                      weight of the dry          
                                             ingredients.               
3. As an emulsifier in whipped vegetable    Not to exceed 0.45 percent  
 oil toppings and topping mixes.             by weight of the finished  
                                             whipped vegetable oil      
                                             toppings.                  
4. As an emulsifier in icings and icing     Not to exceed 0.5 percent by
 mixes.                                      weight of the finished     
                                             icings.                    
5. As an emulsifier in frozen desserts....  Not to exceed 0.2 percent by
                                             weight of the finished     
                                             frozen desserts.           
6. As an emulsifier in edible vegetable     Not to exceed 0.4 percent by
 fat-water emulsions intended for use as     weight of the finished     
 substitutes for milk or cream in beverage   vegetable fat-water        
 coffee.                                     emulsions.                 
------------------------------------------------------------------------

    (d) When the name ``polyglycerate 60'' is used in labeling it shall 
be followed by either ``polyoxyethylene (20) mono-and diglycerides of 
fatty acids'' or ``ethoxylated mono- and diglycerides'' in parentheses.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26, 1977; 
50 FR 49536, Dec. 3, 1985]



Sec. 172.836  Polysorbate 60.

    The food additive polysorbate 60 (polyoxyethylene (20) sorbitan 
monostearate) which is a mixture of polyoxyethylene ethers of mixed 
partial stearic and palmitic acid esters of sorbitol anhydrides and 
related compounds, may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield a product with a maximum acid number of 10 and a 
maximum water content of 0.2 percent, which is then reacted with 
ethylene oxide.
    (b) The food additive meets the following specifications:

    Saponification number 45-55.
    Acid number 0-2.
    Hydroxyl number 81-96.
    Oxyethylene content 65 percent-69.5 percent.

    (c) It is used or intended for use as follows:
    (1) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 65;
    (iii) Polysorbate 80;

whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping; except that a combination of the additive with sorbitan 
monostearate may be used in excess of 0.4 percent, provided that the 
amount of the additive does

[[Page 80]]

not exceed 0.77 percent and the amount of sorbitan monostearate does not 
exceed 0.27 percent of the weight of the finished whipped edible oil 
topping.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.

When used alone, the maximum amount of polysorbate 60 shall not exceed 
0.46 percent of the cake or cake mix, on a dry-weight basis. When used 
with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 
0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
sorbitan monostearate exceed 0.61 percent, and no combination of these 
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all 
calculated on a dry-weight basis.
    (3) As an emulsifier, alone or in combination with sorbitan 
monostearate, in nonstandardized confectionery coatings and standardized 
cacao products specified in Secs. 163.123, 163.130, 163.135, 163.140, 
163.145, and 163.150 of this chapter, as follows:
    (i) It is used alone in an amount not to exceed 0.5 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (ii) It is used with sorbitan monostearate in any combination of up 
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan 
monostearate: Provided, That the total combination does not exceed 1 
percent of the weight of the finished nonstandardized confectionery 
coating or standardized cacao product.
    (4) [Reserved]
    (5) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.

When used alone, the maximum amount of polysorbate 60 shall not exceed 
0.46 percent of the weight of the cake icings and cake fillings. When 
used with polysorbate 65 and/or sorbitan monostearate, it shall not 
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or 
the sorbitan monostearate exceed 0.7 percent, and no combination of 
these emulsifiers shall exceed 1 percent of the weight of the cake icing 
or cake filling.
    (6) To impart greater opacity to sugar-type confection coatings 
whereby the maximum amount of the additive does not exceed 0.2 percent 
of the weight of the finished sugar coating.
    (7) As an emulsifier in nonstandardized dressings whereby the 
maximum amount of the additive does not exceed 0.3 percent of the weight 
of the finished dressings.
    (8) As an emulsifier, alone or in combination with polysorbate 80, 
in shortenings and edible oils intended for use in foods as follows, 
when standards of identity established under section 401 of the act do 
not preclude such use:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished shortening or oil.
    (ii) It is used with polysorbate 80 in any combination providing no 
more than 1 percent of polysorbate 60 and no more than 1 percent of 
polysorbate 80, provided that the total combination does not exceed 1 
percent of the finished shortening or oil.
    (iii) The 1-percent limitation specified in paragraph (c)(8) (i) and 
(ii) of this section may be exceeded in premix concentrates of 
shortening or edible oil if the labeling complies with the requirements 
of paragraph (d) of this section.
    (9) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.

The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (10) As a foaming agent in nonalcoholic mixes, to be added to 
alcoholic beverages in the preparation of mixed alcoholic drinks, at a 
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
    (11) As a dough conditioner in yeast-leavened bakery products in an 
amount not to exceed 0.5 percent by weight of the flour used.

[[Page 81]]

    (12) As an emulsifier, alone or in combination with sorbitan 
monostearate, in the minimum quantity required to accomplish the 
intended effect, in formulations of white mineral oil conforming with 
Sec. 172.878 and/or petroleum wax conforming with Sec. 172.886 for use 
as protective coatings on raw fruits and vegetables.
    (13) As a dispersing agent in artificially sweetened gelatin 
desserts and in artificially sweetened gelatin dessert mixes, whereby 
the amount of the additive does not exceed 0.5 percent on a dry-weight 
basis.
    (14) As an emulsifier in chocolate flavored syrups, whereby the 
maximum amount of the additive does not exceed 0.05 percent in the 
finished product.
    (15) As a surfactant and wetting agent for natural and artificial 
colors in food as follows:
    (i) In powdered soft drink mixes in an amount not to exceed 4.5 
percent by weight of the mix.
    (ii) In sugar-based gelatin dessert mixes in an amount not to exceed 
0.5 percent by weight of the mix.
    (iii) In artificially sweetened gelatin dessert mixes in an amount 
not to exceed 3.6 percent by weight of the mix.
    (iv) In sugar-based pudding mixes in an amount not to exceed 0.5 
percent by weight of the mix.
    (v) In artificially sweetened pudding mixes in an amount not to 
exceed 0.5 percent by weight of the mix.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45 
FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]



Sec. 172.838   Polysorbate 65.

    The food additive polysorbate 65 (polyoxyethylene (20) sorbitan 
tristearate), which is a mixture of polyoxyethylene ethers of mixed 
stearic acid esters of sorbitol anhydrides and related compounds, may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield a product with a maximum acid number of 15 and a 
maximum water content of 0.2 percent, which is then reacted with 
ethylene oxide.
    (b) The food additive meets the following specifications:

    Saponification number 88-98.
    Acid number 0-2.
    Hydroxyl number 44-60.
    Oxyethylene content 46 percent-50 percent.

    (c) The additive is used, or intended for use, as follows:
    (1) As an emulsifier in ice cream, frozen custard, ice milk, fruit 
sherbet and nonstandardized frozen desserts when used alone or in 
combination with polysorbate 80, whereby the maximum amount of the 
additives, alone or in combination, does not exceed 0.1 percent of the 
finished frozen dessert.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.

When used alone, the maximum amount of polysorbate 65 shall not exceed 
0.32 percent of the cake or cake mix, on a dry-weight basis. When used 
with sorbitan monostearate and/or polysorbate 60, it shall not exceed 
0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or 
the polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all 
calculated on a dry-weight basis.
    (3) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 60;
    (iii) Polysorbate 80;

whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping.

[[Page 82]]

    (4) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.

The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (5) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.

When used alone, the maximum amount of polysorbate 65 shall not exceed 
0.32 percent of the weight of the cake icing or cake filling. When used 
with sorbitan monostearate and/or polysorbate 60, it shall not exceed 
0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or 
the polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 1 percent of the weight of the cake icing or 
cake filling.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]



Sec. 172.840   Polysorbate 80.

    The food additive polysorbate 80 (polyoxyethylene (20) sorbitan 
monooleate), which is a mixture of polyoxyethylene ethers of mixed 
partial oleic acid esters of sorbitol anhydrides and related compounds, 
may be safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting oleic acid 
(usually containing associated fatty acids) with sorbitol to yield a 
product with a maximum acid number of 7.5 and a maximum water content of 
0.5 percent, which is then reacted with ethylene oxide.
    (b) The food additive meets the following specifications:

    Saponification number 45-55.
    Acid number 0-2.
    Hydroxyl number 65-80.
    Oxyethylene content 65 percent-69.5 percent.

    (c) The additive is used or intended for use as follows:
    (1) An emulsifier in ice cream, frozen custard, ice milk, fruit 
sherbet, and nonstandardized frozen desserts, when used alone or in 
combination with polysorbate 65 whereby the maximum amount of the 
additives, alone or in combination, does not exceed 0.1 percent of the 
finished frozen dessert.
    (2) In yeast-defoamer formulations whereby the maximum amount of the 
additive does not exceed 4 percent of the finished yeast defoamer and 
the maximum amount of the additive in the yeast from such use does not 
exceed 4 parts per million.
    (3) As a solubilizing and dispersing agent in pickles and pickle 
products, whereby the maximum amount of the additive does not exceed 500 
parts per million.
    (4) As a solubilizing and dispersing agent in:
    (i) Vitamin-mineral preparations containing calcium caseinate in the 
absence of fat-soluble vitamins, whereby the maximum intake of 
polysorbate 80 shall not exceed 175 milligrams from the recommended 
daily dose of the preparations.
    (ii) Fat-soluble vitamins in vitamin and vitamin-mineral 
preparations containing no calcium caseinate, whereby the maximum intake 
of polysorbate 80 shall not exceed 300 milligrams from the recommended 
daily dose of the preparations.
    (iii) In vitamin-mineral preparations containing both calcium 
caseinate and fat-soluble vitamins, whereby the maximum intake of 
polysorbate 80 shall not exceed 475 milligrams from the recommended 
daily dose of the preparations.
    (5) As a surfactant in the production of coarse crystal sodium 
chloride whereby the maximum amount of the

[[Page 83]]

additive in the finished sodium chloride does not exceed 10 parts per 
million.
    (6) In special dietary foods, as an emulsifier for edible fats and 
oils, with directions for use which provide for the ingestion of not 
more than 360 milligrams of polysorbate 80 per day.
    (7) As a solubilizing and dispersing agent for dill oil in canned 
spiced green beans, not to exceed 30 parts per million.
    (8) As an emulsifier, alone or in combination with polysorbate 60, 
in shortenings and edible oils intended for use in foods as follows, 
when standards of identity established under section 401 of the act do 
not preclude such use:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished shortening or oil.
    (ii) It is used with polysorbate 60 in any combination providing no 
more than 1 percent of polysorbate 80 and no more than 1 percent of 
polysorbate 60, provided that the total combination does not exceed 1 
percent of the finished shortening or oil.
    (iii) The 1-percent limitation specified in paragraph (c)(8) (i) and 
(ii) of this section may be exceeded in premix concentrates of 
shortening or edible oil if the labeling complies with the requirements 
of paragraph (d) of this section.
    (9) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 60;
    (iii) Polysorbate 65;

whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping.
    (10) It is used as a wetting agent in scald water for poultry 
defeathering, followed by potable water rinse. The concentration of the 
additive in the scald water does not exceed 0.0175 percent.
    (11) As a dispersing agent in gelatin desserts and in gelatin 
dessert mixes, whereby the amount of the additive does not exceed 0.082 
percent on a dry-weight basis.
    (12) As an adjuvant added to herbicide use and plant-growth 
regulator use dilutions by a grower or applicator prior to application 
of such dilutions to the growing crop. Residues resulting from such use 
are exempt from the requirement of a tolerance. When so used or intended 
for use, the additive shall be exempt from the requirements of paragraph 
(d)(1) of this section.
    (13) As a defoaming agent in the preparation of the creaming mixture 
for cottage cheese and lowfat cottage cheese, as identified in 
Secs. 133.128 and 133.131 of this chapter, respectively, whereby the 
amount of the additive does not exceed .008 percent by weight of the 
finished products.
    (14) As a surfactant and wetting agent for natural and artificial 
colors for use in barbecue sauce where the level of the additive does 
not exceed 0.005 percent by weight of the barbecue sauce.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45 
FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]



Sec. 172.841  Polydextrose.

    Polydextrose as identified in this section may be safely used in 
food in accordance with the following prescribed conditions:
    (a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially 
metabolizable water-soluble polymer prepared by the condensation of a 
melt which consists either of approximately 89 percent D-glucose, 10 
percent sorbitol, and 1 percent citric acid or of approximately 90 
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid, 
on a weight basis.
    (2) Polydextrose may be partially neutralized with potassium 
hydroxide.
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 3d ed. (1981), 2d supp. (1986), pp. 57-59, as

[[Page 84]]

amended by the 3d supp. (1992), p. 136, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
200 C St. SW., Washington DC, or at the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (c) Polydextrose is used in accordance with current good 
manufacturing practices as a bulking agent, formulation aid, humectant, 
and texturizer in the following foods when standards of identity 
established under section 401 of the act do not preclude such use: Baked 
goods and baking mixes (restricted to fruit, custard, and pudding-filled 
pies; cakes; cookies; and similar baked products); chewing gum; 
confections and frostings; dressings for salads; frozen dairy desserts 
and mixes; fruit spreads; gelatins, puddings and fillings; hard and soft 
candy; peanut spread; sweet sauces, toppings, and syrups.
    (d) If the food containing the additive purports to be or is 
represented for special dietary uses, it shall be labeled in compliance 
with part 105 of this chapter.
    (e) The label and labeling of food a single serving of which would 
be expected to exceed 15 grams of the additive shall bear the statement: 
``Sensitive individuals may experience a laxative effect from excessive 
consumption of this product''.

[46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60 
FR 54425, Oct. 24, 1995]



Sec. 172.842   Sorbitan monostearate.

    The food additive sorbitan monostearate, which is a mixture of 
partial stearic and palmitic acid esters of sorbitol anhydrides, may be 
safely used in or on food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield essentially a mixture of esters.
    (b) The food additive meets the following specifications:

Saponification number.........................................   147-157
Acid number...................................................      5-10
Hydroxyl number...............................................   235-260
                                                                        

    (c) It is used or intended for use, alone or in combination with 
polysorbate 60 as follows:
    (1) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Polysorbate 60;
    (ii) Polysorbate 65;
    (iii) Polysorbate 80;

whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping; except that a combination of the additive with polysorbate 60 
may be used in excess of 0.4 percent: Provided, That the amount of the 
additive does not exceed 0.27 percent and the amount of polysorbate 60 
does not exceed 0.77 percent of the weight of the finished whipped 
edible oil topping.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Polysorbate 65.
    (ii) Polysorbate 60.

When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.61 percent of the cake or cake mix, on a dry-weight basis. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.61 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of the 
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake 
mix, calculated on a dry-weight basis.
    (3) As an emulsifier, alone or in combination with polysorbate 60 in 
nonstandardized confectionery coatings and standardized cacao products 
specified in Secs. 163.123, 163.130, 163.135, 163.140, 163.145, and 
163.150 of this chapter, as follows:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (ii) It is used with polysorbate 60 in any combination of up to 1 
percent sorbitan monostearate and up to 0.5

[[Page 85]]

percent polysorbate 60 provided that the total combination does not 
exceed 1 percent of the weight of the finished nonstandardized 
confectionery coating or standardized cacao product.
    (4) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Polysorbate 60.

When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.7 percent of the weight of the cake icing or cake filling. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.7 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 1 percent of the weight of the cake icing or 
cake filling.
    (5) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Polysorbate 60.
    (ii) Polysorbate 65.

The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (6) It is used alone as a rehydration aid in the production of 
active dry yeast in an amount not to exceed 1 percent by weight of the 
dry yeast.
    (7) As an emulsifier, alone or in combination with polysorbate 60, 
in the minimum quantity required to accomplish the intended effect, in 
formulations of white mineral oil conforming with Sec. 172.878 and/or 
petroleum wax conforming with Sec. 172.886 for use as protective 
coatings on raw fruits and vegetables.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]



Sec. 172.844   Calcium stearoyl-2-lactylate.

    The food additive calcium stearoyl-2-lactylate may be safely used in 
or on food in accordance with the following prescribed conditions:
    (a) The additive, which is a mixture of calcium salts of stearoyl 
lactylic acids and minor proportions of other calcium salts of related 
acids, is manufactured by the reaction of stearic acid and lactic acid 
and conversion to the calcium salts.
    (b) The additive meets the following specifications:

    Acid number, 50-86.
    Calcium content, 4.2-5.2 percent.
    Lactic acid content, 32-38 percent.
    Ester number, 125-164.

    (c) It is used or intended for use as follows:
    (1) As a dough conditioner in yeast-leavened bakery products and 
prepared mixes for yeast-leavened bakery products in an amount not to 
exceed 0.5 part for each 100 parts by weight of flour used.
    (2) As a whipping agent in:
    (i) Liquid and frozen egg white at a level not to exceed 0.05 
percent.
    (ii) Dried egg white at a level not to exceed 0.5 percent.
    (iii) Whipped vegetable oil topping at a level not to exceed 0.3 
percent of the weight of the finished whipped vegetable oil topping.
    (3) As a conditioning agent in dehydrated potatoes in an amount not 
to exceed 0.5 percent by weight thereof.
    (d) To assure safe use of the additive:
    (1) The label and labeling of the food additive and any intermediate 
premix prepared therefrom shall bear, in addition to the other 
information required by the act, the following:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling of the food additive shall also bear 
adequate directions of use to provide a finished food

[[Page 86]]

that complies with the limitations prescribed in paragraph (c) of this 
section.



Sec. 172.846  Sodium stearoyl lactylate.

    The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-
997) may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additive, which is a mixture of sodium salts of stearoyl 
lactylic acids and minor proportions of sodium salts of related acids, 
is manufactured by the reaction of stearic acid and lactic acid and 
conversion to the sodium salts.
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 300-301, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) It is used or intended for use as follows when standards of 
identity established under section 401 of the Act do not preclude such 
use:
    (1) As a dough strengthener, emulsifier, or processing aid in baked 
products, pancakes, and waffles, in an amount not to exceed 0.5 part for 
each 100 parts by weight of flour used.
    (2) As a surface-active agent, emulsifier, or stabilizer in icings, 
fillings, puddings, and toppings, at a level not to exceed 0.2 percent 
by weight of the finished food.
    (3) As an emulsifier or stabilizer in liquid and solid edible fat-
water emulsions intended for use as substitutes for milk or cream in 
beverage coffee, at a level not to exceed 0.3 percent by weight of the 
finished edible fat-water emulsion.
    (4) As a formulation aid, processing aid, or surface-active agent in 
dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry 
weight of the food.
    (5) As an emulsifier, stabilizer, or texturizer in snack dips, at a 
level not to exceed 0.2 percent by weight of the finished product.
    (6) As an emulsifier, stabilizer, or texturizer in cheese 
substitutes and imitations and cheese product substitutes and 
imitations, at a level not to exceed 0.2 percent by weight of the 
finished food.
    (7) As an emulsifier, stabilizer, or texturizer in sauces or 
gravies, and the products containing the same, in an amount not to 
exceed 0.25 percent by weight of the finished food.
    (8) In prepared mixes for each of the foods listed in paragraphs (c) 
(1) through (7) of this section, provided the additive is used only as 
specified in each of those paragraphs.

[45 FR 51767, Aug. 5, 1980, as amended at 49 FR 10105, Mar. 19, 1984; 50 
FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. 27, 
1986]



Sec. 172.848   Lactylic esters of fatty acids.

    Lactylic esters of fatty acids may be safely used in food in 
accordance with the following prescribed conditions:
    (a) They are prepared from lactic acid and fatty acids meeting the 
requirements of Sec. 172.860(b) and/or oleic acid derived from tall oil 
fatty acids meeting the requirements of Sec. 172.862.
    (b) They are used as emulsifiers, plasticizers, or surface-active 
agents in the following foods, when standards of identity do not 
preclude their use:

------------------------------------------------------------------------
                   Foods                             Limitations        
------------------------------------------------------------------------
Bakery mixes..............................  ............................
Baked products............................  ............................
Cake icings, fillings, and toppings.......  ............................
Dehydrated fruits and vegetables..........  ............................
Dehydrated fruit and vegetable juices.....  ............................
Edible vegetable fat-water emulsions......  As substitutes for milk or  
                                             cream in beverage coffee.  
Frozen desserts...........................  ............................
Liquid shortening.........................  For household use.          
Pancake mixes.............................  ............................
Precooked instant rice....................  ............................
Pudding mixes.............................  ............................
------------------------------------------------------------------------

    (c) They are used in an amount not greater than required to produce 
the intended physical or technical effect, and they may be used with 
shortening and edible fats and oils when such are required in the foods 
identified in paragraph (b) of this section.



Sec. 172.850   Lactylated fatty acid esters of glycerol and propylene glycol.

    The food additive lactylated fatty acid esters of glycerol and 
propylene glycol may be safely used in food in

[[Page 87]]

accordance with the following prescribed conditions:
    (a) The additive is a mixture of esters produced by the lactylation 
of a product obtained by reacting edible fats or oils with propylene 
glycol.
    (b) The additive meets the following specifications: Water insoluble 
combined lactic acid, 14-18 percent; and acid number, 12 maximum.
    (c) It is used in amounts not in excess of that reasonably required 
to produce the intended physical effect as an emulsifier, plasticizer, 
or surface-active agent in food.



Sec. 172.852   Glyceryl-lacto esters of fatty acids.

    Glyceryl-lacto esters of fatty acids (the lactic acid esters of 
mono- and diglycerides) may be safely used in food in accordance with 
the following prescribed conditions:
    (a) They are manufactured from glycerin, lactic acid, and fatty 
acids conforming with Sec. 172.860 and/or oleic acid derived from tall 
oil fatty acids conforming with Sec. 172.862 and/or edible fats and 
oils.
    (b) They are used in amounts not in excess of those reasonably 
required to accomplish their intended physical or technical effect as 
emulsifiers and plasticizers in food.



Sec. 172.854   Polyglycerol esters of fatty acids.

    Polyglycerol esters of fatty acids, up to and including the 
decaglycerol esters, may be safely used in food in accordance with the 
following prescribed conditions:
    (a) They are prepared from corn oil, cottonseed oil, lard, palm oil 
from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and 
tallow and the fatty acids derived from these substances (hydrogenated 
and nonhydrogenated) meeting the requirements of Sec. 172.860(b) and/or 
oleic acid derived from tall oil fatty acids meeting the requirements of 
Sec. 172.862.
    (b) They are used as emulsifiers in food, in amounts not greater 
than that required to produce the intended physical or technical effect.
    (c) Polyglycerol esters of a mixture of stearic, oleic, and coconut 
fatty acids are used as a cloud inhibitor in vegetable and salad oils 
when use is not precluded by standards of identity. The fatty acids used 
in the production of the polyglycerol esters meet the requirements of 
Sec. 172.860(b), and the polyglycerol esters are used at a level not in 
excess of the amount required to perform its cloud-inhibiting effect. 
Oleic acid derived from tall oil fatty acids conforming with 
Sec. 172.862 may be used as a substitute for or together with the oleic 
acid permitted by this paragraph.
    (d) Polyglycerol esters of butter oil fatty acids are used as 
emulsifiers in combination with other approved emulsifiers in dry, 
whipped topping base. The fatty acids used in the production of the 
polyglycerol esters meet the requirements of Sec. 172.860(b), and the 
polyglycerol esters are used at a level not in excess of the amount 
required to perform their emulsifying effect.



Sec. 172.856   Propylene glycol mono- and diesters of fats and fatty acids.

    Propylene glycol mono- and diesters of fats and fatty acids may be 
safely used in food, subject to the following prescribed conditions:
    (a) They are produced from edible fats and/or fatty acids in 
compliance with Sec. 172.860 and/or oleic acid derived from tall oil 
fatty acids in compliance with Sec. 172.862.
    (b) They are used in food in amounts not in excess of that 
reasonably required to produce their intended effect.



Sec. 172.858  Propylene glycol alginate.

    The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2) 
may be used as an emulsifier, flavoring adjuvant, formulation aid, 
stabilizer, surfactant, or thickener in foods in accordance with the 
following prescribed conditions:
    (a) The additive meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408), and the additional specification that it shall 
have up to 85 percent of the carboxylic acid

[[Page 88]]

groups esterified with the remaining groups either free or neutralized.
    (b) The additive is used or intended for use in the following foods 
as defined in Sec. 170.3(n) of this chapter, when standards of identity 
established under section 401 of the act do not preclude such use:
    (1) As a stabilizer in frozen dairy desserts, in fruit and water 
ices, and in confections and frostings at a level not to exceed 0.5 
percent by weight of the finished product.
    (2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener 
in baked goods at a level not to exceed 0.5 percent by weight of the 
finished product.
    (3) As an emulsifier, stabilizer, or thickener in cheeses at a level 
not to exceed 0.9 percent by weight of the finished product.
    (4) As an emulsifier, stabilizer, or thickener in fats and oils at a 
level not to exceed 1.1 percent by weight of the finished product.
    (5) As an emulsifier, stabilizer, or thickener in gelatins and 
puddings at a level not to exceed 0.6 percent by weight of the finished 
product.
    (6) As a stabilizer or thickener in gravies and in sweet sauces at a 
level not to exceed 0.5 percent by weight of the finished product.
    (7) As a stabilizer in jams and jellies at a level not to exceed 0.4 
percent by weight of the finished product.
    (8) As an emulsifier, stabilizer, or thickener in condiments and 
relishes at a level not to exceed 0.6 percent by weight of the finished 
product.
    (9) As a flavoring adjunct or adjuvant in seasonings and flavors at 
a level not to exceed 1.7 percent by weight of the finished product.
    (10) As an emulsifier, flavoring adjuvant, formulation aid, 
stabilizer or thickener, or surface active agent in other foods, where 
applicable, at a level not to exceed 0.3 percent by weight of the 
finished product.
    (c) To ensure safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the act:
    (1) The name of the additive, ``propylene glycol alginate'' or 
``propylene glycol ester of alginic acid''.
    (2) Adequate directions for use.

[47 FR 29950, July 9, 1982]



Sec. 172.859  Sucrose fatty acid esters.

    Sucrose fatty acid esters identified in this section may be safely 
used in accordance with the following prescribed conditions:
    (a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of 
sucrose with fatty acids and are derived from sucrose and edible tallow 
or hydrogenated edible tallow or edible vegetable oils. The only 
solvents which may be used in the preparation of sucrose fatty acid 
esters are those generally recognized as safe in food or regulated for 
such use by an appropriate section in this part. Ethyl acetate or methyl 
ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-
propanol) may be used in the preparation of sucrose fatty acid esters.
    (b) Sucrose fatty acid esters meet the following specifications:
    (1) The total content of mono-, di-, and tri-esters is not less than 
80 percent as determined by a method title ``Sucrose Fatty Acid Esters, 
Method of Assay,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (2) The free sucrose content is not more than 5 percent as 
determined by Test S.2 in the method titled ``Sucrose Fatty Acid Esters, 
Method of Assay,'' which is incorporated by reference. The availability 
of this incorporation by reference is given in paragraph (b)(1) of this 
section.
    (3) The acid value is not more than 6.
    (4) The residue on ignition (sulfated ash) is not more than 2 
percent.
    (5) The total ethyl acetate content is not more than 350 parts per 
million as determined by a method titled ``Determination of Ethyl 
Acetate,'' which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[[Page 89]]

    (6) Arsenic is not more than 3 parts per million.
    (7) Total heavy metal content (as Pb) is not more than 50 parts per 
million.
    (8) Lead is not more than 10 parts per million.
    (9) The total content of methyl ethyl ketone or of methanol shall 
not be more than 10 parts per million as determined by a method titled 
``Methyl Ethyl Ketone Test; Methyl Alcohol Test,'' which is incorporated 
by reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (10) The total dimethyl sulfoxide content is not more than 2 parts 
per million as determined by a method entitled ``Determination of 
Dimethyl Sulfoxide,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (11) The total isobuytl alcohol (2-methyl-1-propanol) content is not 
more than 10 parts per million as determined by a method entitled 
``Determination of Isobutyl Alcohol,'' which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) Sucrose fatty acid esters may be used as follows when standards 
of identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act do not preclude such use:
    (1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter, 
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in 
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this 
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 
in coffee and tea beverages with added dairy ingredients and/or dairy 
product analogues, in confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter, in dairy product analogues as defined 
in Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes 
as defined in Sec. 170.3(n)(20) of this chapter, and in whipped milk 
products.
    (2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter 
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this 
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of 
this chapter, and in surimi-based fabricated seafood products.
    (3) As components of protective coatings applied to fresh apples, 
avocados, bananas, banana plantains, limes, melons (honeydew and 
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard 
ripening and spoiling.
    (d) Sucrose fatty acid esters are used in accordance with current 
good manufacturing practice and in an amount not to exceed that 
reasonably required to accomplish the intended effect.

[47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23, 1983; 
52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR 
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995]



Sec. 172.860   Fatty acids.

    The food additive fatty acids may be safely used in food and in the 
manufacture of food components in accordance with the following 
prescribed conditions:
    (a) The food additive consists of one or any mixture of the 
following straight-chain monobasic carboxylic acids and their associated 
fatty acids manufactured from fats and oils derived from edible sources: 
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid, 
palmitic acid, and stearic acid.
    (b) The food additive meets the following specifications:
    (1) Unsaponifiable matter does not exceed 2 percent.
    (2) It is free of chick-edema factor:
    (i) As evidenced during the bioassay method for determining the 
chick-edema factor as prescribed in paragraph (c)(2) of this section; or
    (ii) As evidenced by the absence of chromatographic peaks with a 
retention time relative to aldrin (RA)

[[Page 90]]

between 10 and 25, using the gas chromatographic-electron capture method 
prescribed in paragraph (c)(3) of this section. If chromatographic peaks 
are found with RA values between 10 and 25, the food additive shall meet 
the requirements of the bioassay method prescribed in paragraph (c)(2) 
of this section for determining chick-edema factor.
    (c) For the purposes of this section:
    (1) Unsaponifiable matter shall be determined by the method 
described in the 13th Ed. (1980) of the ``Official Methods of Analysis 
of the Association of Official Analytical Chemists,'' which is 
incorporated by reference. Copies are available from the Association of 
Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or available for inspection at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Chick-edema factor shall be determined by the bioassay method 
described in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), sections 28.127-28.130, 
which is incorporated by reference. Copies may be obtained from the 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (3) The gas chromatographic-electron capture method for testing 
fatty acids for chick-edema shall be the method described in the 
``Journal of the Association of Official Analytical Chemists,'' Volume 
50 (No. 1), pages 216-218 (1967), or the modified method using a 
sulfuric acid clean-up procedure, as described in the ``Journal of the 
Association of the Offical Analytical Chemists,'' Volume 51 (No. 2), 
pages 489-490 (1968), which are incorporated by reference. See paragraph 
(c)(2) of this section for availability of these references.
    (d) It is used or intended for use as follows:
    (1) In foods as a lubricant, binder, and as a defoaming agent in 
accordance with good manufacturing practice.
    (2) As a component in the manufacture of other food-grade additives.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the act, the following:
    (1) The common or usual name of the acid or acids contained therein.
    (2) The words ``food grade'', in juxtaposition with and equally as 
prominent as the name of the acid.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.861  Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.

    The food additive, cocoa butter substitute from coconut oil, palm 
kernel oil, or both oils, may be safely used in food in accordance with 
the following conditions:
    (a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS 
Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is 
manufactured by esterification of glycerol with food-grade fatty acids 
(complying with Sec. 172.860) derived from edible coconut oil, edible 
palm kernel oil, or both oils.
    (b) The ingredient meets the following specifications:

Acid number...............................  Not to exceed 0.5.          
Saponification number.....................  220 to 260.                 
Iodine number.............................  Not to exceed 3.            
Melting range.............................  30 to 44  deg.C.            
                                                                        

    (c) The ingredient is used or intended for use as follows:
    (1) As coating material for sugar, table salt, vitamins, citric 
acid, succinic acid, and spices; and
    (2) In compound coatings, cocoa creams, cocoa-based sweets, toffees, 
caramel masses, and chewing sweets as defined in Sec. 170.3 (n)(9) and 
(n)(38) of this chapter, except that the ingredient may not be used in a 
standardized food unless permitted by the standard of identity.
    (d) The ingredient is used in accordance with current good 
manufacturing practice and in an amount not to

[[Page 91]]

exceed that reasonably required to accomplish the intended effect.

[56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992]



Sec. 172.862   Oleic acid derived from tall oil fatty acids.

    The food additive oleic acid derived from tall oil fatty acids may 
be safely used in food and as a component in the manufacture of food-
grade additives in accordance with the following prescribed conditions:
    (a) The additive consists of purified oleic acid separated from 
refined tall oil fatty acids.
    (b) The additive meets the following specifications:
    (1) Specifications for oleic acid prescribed in the ``Food Chemicals 
Codex.'' 3d Ed. (1981), pp. 207-208, which is incorporated by reference, 
except that titer (solidification point) shall not exceed 13.5 deg. C 
and unsaponifiable matter shall not exceed 0.5 percent. Copies of the 
material incorporated by reference may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) The resin acid content does not exceed 0.01 as determined by 
ASTM method D1240-82, ``Standard Test Method for Rosin Acids in Fatty 
Acids,'' which is incorporated by reference. Copies may be obtained from 
the American Society for Testing Materials, 1916 Race St., Philadelphia, 
PA 19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (3) The requirements for absence of chick-edema factor as prescribed 
in Sec. 172.860.
    (c) It is used or intended for use as follows:
    (1) In foods as a lubricant, binder, and defoaming agent in 
accordance with good manufacturing practice.
    (2) As a component in the manufacture of other food-grade additives.
    (d) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The common or usual name of the acid.
    (2) The words ``food grade'' in juxtaposition with and equally as 
prominent as the name of the acid.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.863   Salts of fatty acids.

    The food additive salts of fatty acids may be safely used in food 
and in the manufacture of food components in accordance with the 
following prescribed conditions:
    (a) The additive consists of one or any mixture of two or more of 
the aluminum, calcium, magnesium, potassium, and sodium salts of the 
fatty acids conforming with Sec. 172.860 and/or oleic acid derived from 
tall oil fatty acids conforming with Sec. 172.862.
    (b) The food additive is used or intended for use as a binder, 
emulsifier, and anticaking agent in food in accordance with good 
manufacturing practice.
    (c) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The common or usual name of the fatty acid salt or salts 
contained therein.
    (2) The words ``food grade'', in juxtaposition with and equally as 
prominent as the name of the salt.



Sec. 172.864   Synthetic fatty alcohols.

    Synthetic fatty alcohols may be safely used in food and in the 
synthesis of food components in accordance with the following prescribed 
conditions:
    (a) The food additive consists of any one of the following fatty 
alcohols:
    (1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl; 
manufactured by fractional distillation of alcohols obtained by a 
sequence of oxidation and hydrolysis of organo-aluminums generated by 
the controlled reaction of low molecular weight trialkylaluminum with 
purified ethylene (minimum 99 percent by volume C2H4), and 
utilizing the hydrocarbon solvent as defined in paragraph (b) of this 
section, such that:

[[Page 92]]

    (i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not 
less than 99 percent of total alcohols and not less than 96 percent of 
straight chain alcohols. Any nonalcoholic impurities are primarily 
paraffins.
    (ii) Cetyl and stearyl alcohols contain not less than 98 percent of 
total alcohols and not less than 94 percent of straight chain alcohols. 
Any nonalcoholic impurities are primarily paraffins.
    (iii) The synthetic fatty alcohols contain no more than 0.1 weight 
percent of total diols as determined by a method available upon request 
from the Commissioner of Food and Drugs.
    (2) Hexyl, octyl, and decyl; manufactured by fractional distillation 
of alcohols obtained by a sequence of oxidation, hydrolysis, and 
catalytic hydrogenation (catalyst consists of copper, chromium, and 
nickel) of organo-aluminums generated by the controlled reaction of low 
molecular weight trialkylaluminum with purified ethylene (minimum 99 
percent by volume C2H4), and utilizing an external coolant 
such that these alcohols meet the specifications prescribed in paragraph 
(a)(1) (i) and (iii) of this section.
    (b) The hydrocarbon solvent used in the process described in 
paragraph (a)(1) of this section is a mixture of liquid hydrocarbons 
essentially paraffinic in nature, derived from petroleum and refined to 
meet the specifications described in paragraph (b)(1) of this section 
when subjected to the procedures described in paragraph (b) (2) and (3) 
of this section.
    (1) The hydrocarbon solvent meets the following specifications:
    (i) Boiling-point range: 175 deg. C-275 deg. C.
    (ii) Ultraviolet absorbance limits as follows:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                   Wavelength (millicrons)                    centimeter
                                                                optical 
                                                                 path   
                                                                length  
------------------------------------------------------------------------
280-289.....................................................        0.15
290-299.....................................................         .12
300-359.....................................................         .05
360-400.....................................................         .02
------------------------------------------------------------------------

    (2) Use ASTM method D86-82, ``Standard Method for Distillation of 
Petroleum Products,'' which is incorporated by reference, to determine 
boiling point range. Copies of the material incorporated by reference 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (3) The analytical method for determining ultraviolet absorbance 
limits is as follows:

                          General Instructions

    All glassware should be scrupulously cleaned to remove all organic 
matter such as oil, grease, detergent residues, etc. Examine all 
glassware, including stoppers and stopcocks, under ultraviolet light to 
detect any residual fluorescent contamination. As a precautionary 
measure, it is recommended practice to rinse all glassware with purified 
isooctane immediately before use. No grease is to be used on stopcocks 
or joints. Great care to avoid contamination of hydrocarbon solvent 
samples in handling and to assure absence of any extraneous material 
arising from inadequate packaging is essential. Because some of the 
polynuclear hydrocarbons sought in this test are very susceptible to 
photo-oxidation, the entire procedure is to be carried out under subdued 
light.

                                Apparatus

    Chromatographic tube. 450 millimeters in length (packing section), 
inside diameter 19 millimeters plus-minus 1 millimeter, equipped 
with a wad of clean Pyrex brand filtering wool (Corning Glass Works 
Catalog No. 3950 or equivalent). The tube shall contain a 250-milliliter 
reservoir and a 2-millimeter tetrafluoroethylene polymer stopcock at the 
opposite end. Overall length of the tube is 670 millimeters.
    Stainless steel rod. 2 feet in length, 2 to 4 millimeters in 
diameter.
    Vacuum oven. Similar to Labline No. 3610 but modified as follows: A 
copper tube one-fourth inch in diameter and 13 inches in length is bent 
to a right angle at the 4-inch point and plugged at the opposite end; 
eight copper tubes one-eighth inch in diameter and 5 inches in length 
are silver soldered in drilled holes (one-eighth inch in diameter) to 
the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and 
12.5-inch points; the one-eighth-inch copper tubes are bent to conform 
with the inner periphery of the oven.
    Beakers. 250-milliliter and 500-milliliter capacity.
    Graduated cylinders. 25-milliliter, 50-milliliter, and 150-
milliliter capacity.
    Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge 
needle.
    Volumetric flask. 5-milliliter capacity.

[[Page 93]]

    Spectrophotometric cells. Fused quartz ground glass stoppered cells, 
optical path length in the range of 1.000 centimeter 
plus-minus0.005 centimeter. With distilled water in the cells, 
determine any absorbance difference.
    Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons 
with spectral slit width of 2 millimicrons or less: under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Absorbance accuracy,\1\ plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    \1\ As determined by using potassium chromate for reference standard 
and described in National Bureau of Standards Circular 484, 
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is 
to be determined by comparison with the standard values at 290, 345, and 
400 millimicrons. Circular 484 is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    Wavelength repeatability, plus-minus0.2 millimicron.
    Wavelength accuracy, plus-minus1.0 millimicron.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         Reagents and Materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane, benzene, hexane, and 1,2-dichloroethane designated in the 
list following this paragraph shall pass the following test:
    To the specified quantity of solvent in a 250-milliliter beaker, add 
1 milliliter of purified n-hexadecane and evaporate in the vacuum oven 
under a stream of nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. (To the residue from benzene add a 5-
milliliter portion of purified isooctane, reevaporate, and repeat once 
to insure complete removal of benzene.)
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 5 milliliters volume. Determine the absorbance in the 1-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue shall not exceed 0.02 
per centimeter path length between 280 and 300 m and shall not 
exceed 0.01 per centimeter path length between 300 and 400 m.
    Isooctane (2,2,4-trimethylpentane). Use 10 milliliters for the test 
described in the preceding paragraph. If necessary, isooctane may be 
purified by passage through a column of activated silica gel (Grade 12, 
Davison Chemical Co., Baltimore, Md., or equivalent).
    Benzene, spectro grade (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If 
necessary, benzene may be purified by distillation or otherwise.
    Hexane, spectro grade (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 650 milliliters for the test. If 
necessary, hexane may be purified by distillation or otherwise.
    1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East 
Rutherford, N.J., or equivalent). Use 20 milliliters for test. If 
necessary, 1,2-dichloroethane may be purified by distillation.
    Eluting mixtures:
    1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of 
1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and 
adjust to volume with hexane, with mixing.
    2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene 
into a 1-liter glass-stoppered volumetric flask and adjust to volume 
with hexane, with mixing.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 5 milliliters with isooctane and determine the absorbance 
in a 1-centimeter cell compared to isooctane as reference between 280 
m-400m. The absorbance per centimeter path length 
shall not exceed 0.00 in this range. If necessary, n-hexadecane may be 
purified by percolation through activated silica gel or by distillation.
    Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore, 
Md., or equivalent). Activate as follows: Weigh about 900 grams into a 
1-gallon bottle, add 100 milliliters of de-ionized water, seal the 
bottle and shake and roll at intervals for 1 hour. Allow to equilibrate 
overnight in the sealed bottle. Activate the gel at 150 deg. C for 16 
hours, in a 2-inch  x  7-inch  x  12-inch porcelain pan loosely covered 
with aluminum foil, cool in a dessicator, transfer to a bottle and seal.

                                Procedure

    Determination of ultraviolet absorbance. Before proceeding with the 
analysis of a sample determine the absorbance in a 1-centimeter path 
cell for the reagent blank by carrying out the procedure without a 
sample. Record the absorbance in the wavelength range of 280 to 400 
millimicrons. Typical reagent blank absorbance in this range should not 
exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359 
millimicron

[[Page 94]]

range, and 0.01 in the 360 to 400 millimicron range. If the 
characteristic benzene peaks in the 250 to 260 millimicron region are 
present, remove the benzene by the procedure described above under 
``Reagents and Materials,'' ``Organic Solvents,'' and record absorbance 
again.
    Transfer 50 grams of silica gel to the chromatographic tube for 
sample analysis. Raise and drop the column on a semisoft, clean surface 
for about 1 minute to settle the gel. Pour 100 milliliters of hexane 
into the column with the stopcock open and allow to drain to about one-
half inch above the gel. Turn off the stopcock and allow the column to 
cool for 30 minutes. After cooling, vibrate the column to eliminate air 
and stir the top 1 to 2 inches with a small diameter stainless steel 
rod. Take care not to get the gel above the liquid and onto the sides of 
the column.
    Weigh out 40 grams plus-minus0.1 gram of the hydrocarbon 
solvent sample into a 250-milliliter beaker, add 50 milliliters of 
hexane, and pour the solution into the column. Rinse the beaker with 50 
milliliters of hexane and add this to the column. Allow the hexane 
sample solution to elute into a 500-milliliter beaker until the solution 
is about one-half inch above the gel. Rinse the column three times with 
50-milliliter portions of hexane. Allow each hexane rinse to separately 
elute to about one-half inch above the gel. Replace the eluate beaker 
(discard the hexane eluate) with a 250-milliliter beaker. Add two 
separate 25-milliliter portions of 10 percent 1,2-dichloroethane and 
allow each to separately elute as before. Finally, add 150 milliliters 
of 10 percent 1,2-dichloroethane for a total of 200 milliliters. When 
the final 10 percent 1,2-dichloroethane fraction is about one-half inch 
above the top of the gel bed, replace the receiving beaker (discard the 
1,2-dichloroethane eluate) with a 250-milliliter beaker containing 1 
milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters 
per minute, add two 25-milliliter portions of 40 percent benzene and 
allow each to separately elute as before to within about one-half inch 
of the gel bed. Finally, add 150 milliliters of 40 percent benzene for a 
total of 200 milliliters. Evaporate the benzene in the oven with vacuum 
and sufficient nitrogen flow to just ripple the top of the benzene 
solution. When the benzene is removed (as determined by a constant 
volume of hexadecane) add 5 milliliters of isooctane and evaporate. 
Repeat once to insure complete removal of benzene. Remove the beaker and 
cover with aluminum foil (previously rinsed with hexane) until cool.
    Quantitatively transfer the hexadecane residue to a 5-milliliter 
volumetric flask and dilute to volume with isooctane. Determine the 
absorbance of the solution in 1-centimeter path length cells between 280 
and 400 millimicrons using isooctane as a reference. Correct the 
absorbance values for any absorbance derived from reagents as determined 
by carrying out the procedure without a sample. If the corrected 
absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii) 
of this section, the sample meets the ultraviolet absorbance 
specifications for hydrocarbon solvent.

    (c) Synthetic fatty alcohols may be used as follows:
    (1) As substitutes for the corresponding naturally derived fatty 
alcohols permitted in food by existing regulations in this part or part 
173 of this chapter provided that the use is in compliance with any 
prescribed limitations.
    (2) As substitutes for the corresponding naturally derived fatty 
alcohols used as intermediates in the synthesis of food additives and 
other substances permitted in food.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.866   Synthetic glycerin produced by the hydrogenolysis of carbohydrates.

    Synthetic glycerin produced by the hydrogenolysis of carbohydrates 
may be safely used in food, subject to the provisions of this section:
    (a) It shall contain not in excess of 0.2 percent by weight of a 
mixture of butanetriols.
    (b) It is used or intended for use in an amount not to exceed that 
reasonably required to produce its intended effect.



Sec. 172.867  Olestra.

    Olestra, as identified in this section, may be safely used in 
accordance with the following conditions:
    (a) Olestra is a mixture of octa-, hepta-, and hexa-esters of 
sucrose with fatty acids derived from edible fats and oils or fatty acid 
sources that are generally recognized as safe or approved for use as 
food ingredients. The chain lengths of the fatty acids are no less than 
12 carbon atoms.
    (b) Olestra meets the following specifications:
    (1) The total content of octa-, hepta-, and hexa-esters is not less 
than 97 percent as determined by a method entitled ``Determination of 
Olestra by Size Exclusion Chromatography,'' dated December 19, 1995, 
which is incorporated

[[Page 95]]

by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies are available from the Office of Premarket Approval, Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (2) The content of octa-ester is not less than 70 percent as 
determined by a method entitled ``Measurement of the Relative Ester 
Distribution of Olestra Test Material'' dated December 19, 1995, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the Office of Premarket Approval, 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (3) The content of hexa-ester is not more than 1 percent as 
determined by the method listed in paragraph (b)(2) of this section.
    (4) The content of penta-ester is not more than 0.5 percent as 
determined by the method listed in paragraph (b)(2) of this section.
    (5) The unsaturated fatty acid content is not less than 25 percent 
(thus not more than 75 percent saturated fatty acid) and not more than 
83 percent as determined by a method entitled ``Measurement of the Fatty 
Acid Composition of Olestra Test Material,'' dated December 19, 1995, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C St. SW., Washington, DC, or may be 
examined at the Center for Food Safety and Applied Nutrition's Library, 
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (6) The content of C12 and C14 fatty acids is each not more than 1 
percent, and total C20 and longer fatty acids is not more than 20 
percent. C16 and C18 fatty acids make up the remainder with total 
content not less than 78 percent as determined by the method listed in 
paragraph (b)(5) of this section.
    (7) The free fatty acid content is not more than 0.5 percent as 
determined by a method entitled ``Free Fatty Acids'' published in the 
Official Methods and Recommended Practices of the American Oil Chemists' 
Society, 3d Ed. (1985) vol. 1, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the American Oil Chemists Society, 1608 Broadmoor Dr., Champaign, 
IL 61821, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (8) The residue on ignition (sulfated ash) is not more than 0.5 
percent.
    (9) Total methanol content is not more than 300 parts per million as 
determined by the ``Total Available Methanol Method,'' dated December 
19, 1995, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.
    (10) The total heavy metal content (as Pb) is not more than 10 parts 
per million.
    (11) Lead is not more than 0.1 part per million, as determined by a 
method entitled ``Atomic Absorption Spectrophotometric Graphite Furnace 
Method,'' Food Chemicals Codex, 3d Ed. 3d Supp. p. 168 (1992), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the National Research Council Press, 
2101

[[Page 96]]

Constitution Ave. NW., Washington, DC, or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 200 C St. SW., rm. 
3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (12) Water is not more than 0.1 percent, as determined by a method 
entitled ``Moisture,'' Official Methods and Recommended Practices of the 
American Oil Chemists' Society, 4th Ed. (1989), vol. 1, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the American Oil Chemists Society, 
1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (13) Peroxide value is not more than 10 meq/kg as determined by a 
method entitled ``Peroxide Value,'' Official Methods and Recommended 
Practices of the American Oil Chemists' Society, 4th Ed. (1989) vol. 1, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the American Oil Chemists 
Society, 1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 200 C St. 
SW., rm. 3321, Washington, DC, or at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (14) The stiffness is not less than 50 kiloPascals/second, as 
determined by a method entitled ``Method for Measurement of the 
Stiffness of Olestra,'' dated December 19, 1995, which is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies are available from the Office of Premarket Approval, Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., 
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
    (c) Olestra may be used in place of fats and oils in prepackaged 
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks. In 
such foods, the additive may be used in place of fats and oils for 
frying or baking, in dough conditioners, in sprays, in filling 
ingredients, or in flavors.
    (d) To compensate for any interference with absorption of fat 
soluble vitamins, the following vitamins shall be added to foods 
containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram 
olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or 
retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 g 
vitamin K1 per gram olestra.
    (e)(1) The label of a food containing olestra shall bear the 
following statement in the manner prescribed in paragraph (e)(2) of this 
section:
    This Product Contains Olestra. Olestra may cause abdominal cramping 
and loose stools. Olestra inhibits the absorption of some vitamins and 
other nutrients. Vitamins A, D, E, and K have been added.
    (2) The statement required by paragraph (e)(1) of this section 
shall:
    (i) Appear either on the principal display panel or on the 
information panel of the label;
    (ii) Be enclosed by a 0.5 point box rule with 2.5 points of space 
around the statement.
    (iii) Utilize at least one point leading;
    (iv) Have type that is kerned so the letters do not touch;
    (v) Be all black or one color type, printed on a white or other 
neutral contrasting background whenever possible;
    (vi) Utilize a single easy-to-read type style such as Helvetica 
Regular and upper and lower case letters; and
    (vii) Be in type size no smaller than 8 point.
    (3) The sentence ``This Product Contains Olestra.'' shall be 
highlighted by bold or extra bold type, such as Helvetica Black. The 
label shall appear as follows:

[[Page 97]]

[GRAPHIC] [TIFF OMITTED] TR30JA96.001


    (4) Vitamins A, D, E, and K present in foods as a result of the 
requirement in paragraph (d) of this section shall be declared in the 
listing of ingredients. Such vitamins shall not be considered in 
determining nutrient content for the nutritional label or for any 
nutrient claims, express or implied.
    (5) Olestra shall not be considered as a source of fat or calories 
for purposes of Secs. 101.9 and 101.13 of this chapter.
    (f) Consistent with its obligation to monitor the safety of all 
additives in the food supply, including olestra, the Food and Drug 
Administration will review and evaluate all data and information bearing 
on the safety of olestra received by the agency after the effective date 
of this regulation, and will present such data, information, and 
evaluation to the agency's Food Advisory Committee within 30 months of 
the effective date of this regulation. The purpose of such presentation 
will be to receive advice from the Committee on whether there continues 
to be reasonable certainty that use of olestra in compliance with this 
regulation is not harmful. The agency will hold such additional Food 
Advisory Committee meetings on olestra as the agency determines, in its 
discretion, to be necessary. Based upon the results of this entire 
process, the FDA will initiate any appropriate regulatory proceedings.

[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996]



Sec. 172.868  Ethyl cellulose.

    The food additive ethyl cellulose may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is a cellulose ether containing ethoxy 
(OC2H5) groups attached by an ether linkage and containing on 
an anhydrous basis not more than 2.6 ethoxy groups per anhydroglucose 
unit.
    (b) It is used or intended for use as follows:
    (1) As a binder and filler in dry vitamin preparations.
    (2) As a component of protective coatings for vitamin and mineral 
tablets.
    (3) As a fixative in flavoring compounds.



Sec. 172.870  Hydroxypropyl cellulose.

    The food additive hydroxypropyl cellulose may be safely used in 
food, except standardized foods that do not provide for such use, in 
accordance with the following prescribed conditions:

[[Page 98]]

    (a) The additive consists of one of the following:
    (1) A cellulose ether containing propylene glycol groups attached by 
an ether linkage which contains, on an anhydrous basis, not more than 
4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a 
minimum viscosity of 145 centipoises for 10 percent by weight aqueous 
solution at 25 deg. C.
    (2) A cellulose ether containing propylene glycol groups attached by 
an ether linkage having a hydroxypropoxy (OC3H6OH) content of 
5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 
to 0.4 hydroxypropyl groups per anhydroglucose unit. The common name for 
this form of the additive is low substituted hydroxypropyl cellulose.
    (b) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a)(1) of this section is 
used or intended for use as an emulsifier, film former, protective 
colloid, stabilizer, suspending agent, or thickener, in accordance with 
good manufacturing practice.
    (2) The additive identified in paragraph (a)(2) of this section is 
used or intended for use as a binder and disintegrator in tablets or 
wafers containing dietary supplements of vitamins and/or minerals. The 
additive is used in accordance with good manufacturing practice.

[46 FR 50065, Oct. 9, 1981]



Sec. 172.872   Methyl ethyl cellulose.

    The food additive methyl ethyl cellulose may be safely used in food 
in accordance with the following prescribed conditions.
    (a) The additive is a cellulose ether having the general formula 
[C6H(10-x-
y)O5(CH3)x(C2H5)y]n, where x is the 
number of methyl groups and y is the number of ethyl groups. The average 
value of x is 0.3 and the average value of y is 0.7.
    (b) The additive meets the following specifications:
    (1) The methoxy content shall be not less than 3.5 percent and not 
more than 6.5 percent, calculated as OCH3, and the ethoxy content 
shall be not less than 14.5 percent and not more than 19 percent, 
calculated as OC2H5, both measured on the dry sample.
    (2) The viscosity of an aqueous solution, 2.5 grams of the material 
in 100 milliliters of water, at 20 deg. C, is 20 to 60 centipoises.
    (3) The ash content on a dry basis has a maximum of 0.6 percent.
    (c) The food additive is used as an aerating, emulsifying, and 
foaming agent, in an amount not in excess of that reasonably required to 
produce its intended effect.



Sec. 172.874  Hydroxypropyl methylcellulose.

    The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-
65-3) may be safely used in food, except in standardized foods which do 
not provide for such use if:
    (a) The additive complies with the definition and specifications 
prescribed in the National Formulary, 12th edition.
    (b) It is used or intended for use as an emulsifier, film former, 
protective colloid, stabilizer, suspending agent, or thickener, in 
accordance with good manufacturing practice.
    (c) To insure safe use of the additive, the container of the 
additive, in addition to being labeled as required by the general 
provisions of the act, shall be accompanied by labeling which contains 
adequate directions for use to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 38273, Aug. 31, 1982]



Sec. 172.876   Castor oil.

    The food additive castor oil may be safely used in accordance with 
the following conditions:
    (a) The additive meets the specifications of the United States 
Pharmacopeia XX (1980).
    (b) The additive is used or intended for use as follows:

                           Use and Limitations

    Hard candy production--As a release agent and antisticking agent, 
not to exceed 500 parts per million in hard candy.
    Vitamin and mineral tablets--As a component of protective coatings.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.878   White mineral oil.

    White mineral oil may be safely used in food in accordance with the 
following conditions:
    (a) White mineral oil is a mixture of liquid hydrocarbons, 
essentially paraffinic and naphthenic in nature obtained from petroleum. 
It is refined to meet the following specifications:
    (1) It meets the test requirements of the United States Pharmacopeia 
XX (1980) for readily carbonizable substances (page 532).
    (2) It meets the test requirements of U.S.P. XVII for sulfur 
compounds (page 400).

[[Page 99]]

    (3) It meets the specifications prescribed in the ``Journal of the 
Association of Official Analytical Chemists,'' Volume 45, page 66 
(1962), which is incorporated by reference, after correction of the 
ultraviolet absorbance for any absorbance due to added antioxidants. 
Copies of the material incorporated by reference are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (b) White mineral oil may contain any antioxidant permitted in food 
by regulations issued in accordance with section 409 of the Act, in an 
amount not greater than that required to produce its intended effect.
    (c) White mineral oil is used or intended for use as follows:

------------------------------------------------------------------------
                                               Limitation (inclusive of 
                                              all petroleum hydrocarbons
                     Use                          that may be used in   
                                                combination with white  
                                                     mineral oil)       
------------------------------------------------------------------------
1. As a release agent, binder, and lubricant  Not to exceed 0.6% of the 
 in or on capsules and tablets containing      capsule or tablet.       
 concentrates of flavoring, spices,                                     
 condiments, and nutrients intended for                                 
 addition to food, excluding confectionery.                             
2. As a release agent, binder, and lubricant  Not to exceed 0.6% of the 
 in or on capsules and tablets containing      capsule or tablet.       
 food for special dietary use.                                          
3. As a float on fermentation fluids in the   In an amount not to exceed
 manufacture of vinegar and wine to prevent    good manufacturing       
 or retard access of air, evaporation, and     practice.                
 wild yeast contamination during                                        
 fermentation.                                                          
4. As a defoamer in food....................  In accordance with Sec.   
                                               173.340 of this chapter. 
5. In bakery products, as a release agent     Not to exceed 0.15% of    
 and lubricant.                                bakery products.         
6. In dehydrated fruits and vegetables, as a  Not to exceed 0.02% of    
 release agent.                                dehydrated fruits and    
                                               vegetables.              
7. In egg white solids, as a release agent..  Not to exceed 0.1% of egg 
                                               white solids.            
8. On raw fruits and vegetables, as a         In an amount not to exceed
 protective coating.                           good manufacturing       
                                               practice.                
9. In frozen meat, as a component of hot-     Not to exceed 0.095% of   
 melt coating.                                 meat.                    
10. As a protective float on brine used in    In an amount not to exceed
 the curing of pickles.                        good manufacturing       
                                               practice.                
11. In molding starch used in the             Not to exceed 0.3 percent 
 manufacture of confectionery.                 in the molding starch.   
12. As a release agent, binder, and           Not to exceed 0.15 percent
 lubricant in the manufacture of yeast.        of yeast.                
13. As an antidusting agent in sorbic acid    Not to exceed 0.25 percent
 for food use.                                 in the sorbic acid.      
14. As release agent and as sealing and       Not to exceed 0.2 percent 
 polishing agent in the manufacture of         of confectionery.        
 confectionery.                                                         
15. As a dust control agent for wheat, corn,  Applied at a level of no  
 soybean, barley, rice, rye, oats, and         more than 0.02 percent by
 sorghum.                                      weight of grain.         
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 
FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 
19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.880   Petrolatum.

    Petrolatum may be safely used in food, subject to the provisions of 
this section.
    (a) Petrolatum complies with the specifications set forth in the 
United States Pharmacopeia XX (1980) for white petrolatum or in the 
National Formulary XV (1980) for petrolatum.
    (b) Petrolatum meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in Sec. 172.886(b):

    Ultraviolet absorbance per centimeter path length:

------------------------------------------------------------------------
                        Millimicrons                            Maximum 
------------------------------------------------------------------------
280-289.....................................................        0.25
290-299.....................................................         .20
300-359.....................................................         .14
360-400.....................................................         .04
------------------------------------------------------------------------

    (c) Petrolatum is used or intended for use as follows:

[[Page 100]]



------------------------------------------------------------------------
                                           Limitation (inclusive of all 
                                         petroleum hydrocarbons that may
                  Use                      be used in combination with  
                                                   petrolatum)          
------------------------------------------------------------------------
In bakery products; as release agent     With white mineral oil, not to 
 and lubricant.                           exceed 0.15 percent of bakery 
                                          product.                      
In confectionery; as release agent and   Not to exceed 0.2 percent of   
 as sealing and polishing agent.          confectionery.                
In dehydrated fruits and vegetables; as  Not to exceed 0.02 percent of  
 release agent.                           dehydrated fruits and         
                                          vegetables.                   
In egg white solids; as release agent..  Not to exceed 0.1 percent of   
                                          egg white solids.             
On raw fruits and vegetables; as         In an amount not to exceed good
 protective coating.                      manufacturing practice.       
In beet sugar and yeast; as defoaming    As prescribed in Sec.  173.340 
 agent.                                   of this chapter.              
------------------------------------------------------------------------

    (d) Petrolatum may contain any antioxidant permitted in food by 
regulations issued in accordance with section 409 of the Act, in an 
amount not greater than that required to produce its intended effect.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.882  Synthetic isoparaffinic petroleum hydrocarbons.

    Synthetic isoparaffinic petroleum hydrocarbons may be safely used in 
food, in accordance with the following conditions:
    (a) They are produced by synthesis from petroleum gases and consist 
of a mixture of liquid hydrocarbons meeting the following 
specifications:

Boiling point 93-260 deg. C as determined by ASTM method D86-82, 
          ``Standard Method for Distillation of Petroleum Products,'' 
          which is incorporated by reference. Copies may be obtained 
          from the American Society for Testing Materials, 1916 Race 
          St., Philadelphia, PA 19103, or may be examined at the Office 
          of the Federal Register, 800 North Capitol Street, NW., suite 
          700, Washington, DC 20408.

Ultraviolet absorbance:

    260-319 millimicrons--1.5 maximum.
    320-329 millimicrons--0.08 maximum.
    330-350 millimicrons--0.05 maximum.

Nonvolatile residual: 0.002 gram per 100 milliliters maximum.

Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants 
          shall meet the specified ultraviolet absorbance limits after 
          correction for any absorbance due to the antioxidants. The 
          ultraviolet absorbance shall be determined by the procedure 
          described for application of mineral oil, disregarding the 
          last sentence of the procedure, under ``Specifications'' on 
          page 66 of the ``Journal of the Association of Official 
          Analytical Chemists,'' Volume 45 (February 1962), which is 
          incorporated by reference. Copies are available from the 
          Center for Food Safety and Applied Nutrition (HFS-200) Food 
          and Drug Administration, 200 C St. SW., Washington, DC 20204, 
          or available for inspection at the Office of the Federal 
          Register, 800 North Capitol Street, NW., suite 700, 
          Washington, DC 20408. For hydrocarbons boiling below 250 deg. 
          F, the nonvolatile residue shall be determined by ASTM method 
          D1353-78, ``Standard Test Method for Nonvolatile Matter in 
          Volatile Solvents for Use in Paint, Varnish, Lacquer, and 
          Related Products;'' for those boiling above 121 deg. C, ASTM 
          method D381-80, ``Standard Test Method for Existent Gum in 
          Fuels by Jet Evaporation'' shall be used. These methods are 
          incorporated by reference. Copies may be obtained from the 
          American Society for Testing Materials, 1916 Race St., 
          Philadelphia, PA 19103, or may be examined at the Office of 
          the Federal Register, 800 North Capitol Street, NW., suite 
          700, Washington, DC 20408.

    (b) Isoparaffinic petroleum hydrocarbons may contain antioxidants 
authorized for use in food in an amount not to exceed that reasonably 
required to accomplish the intended technical effect nor to exceed any 
prescribed limitations.
    (c) Synthetic isoparaffinic petroleum hydrocarbons are used or 
intended for use as follows:

[[Page 101]]



------------------------------------------------------------------------
                   Uses                              Limitations        
------------------------------------------------------------------------
1. In the froth-flotation cleaning of       In an amount not to exceed  
 vegetables.                                 good manufacturing         
                                             practice.                  
2. As a component of insecticide                Do.                     
 formulations for use on processed foods.                               
3. As a component of coatings on fruits         Do.                     
 and vegetables.                                                        
4. As a coating on shell eggs.............      Do.                     
5. As a float on fermentation fluids in         Do.                     
 the manufacture of vinegar and wine and                                
 on brine used in curing pickles, to                                    
 prevent or retard access of air,                                       
 evaporation, and contamination with wild                               
 organisms during fermentation.                                         
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.884   Odorless light petroleum hydrocarbons.

    Odorless light petroleum hydrocarbons may be safely used in food, in 
accordance with the following prescribed conditions:
    (a) The additive is a mixture of liquid hydrocarbons derived from 
petroleum or synthesized from petroleum gases. The additive is chiefly 
paraffinic, isoparaffinic, or naphthenic in nature.
    (b) The additive meets the following specifications:
    (1) Odor is faint and not kerosenic.
    (2) Initial boiling point is 300 deg. F minimum.
    (3) Final boiling point is 650 deg. F maximum.
    (4) Ultraviolet absorbance limits determined by method specified in 
Sec. 178.3620(b)(1)(ii) of this chapter, as follows:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                    Wavelength m                     centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280-289.....................................................         4.0
290-299.....................................................         3.3
300-329.....................................................         2.3
330-360.....................................................          .8
------------------------------------------------------------------------

    (c) The additive is used as follows:

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
As a coating on shell eggs................  In an amount not to exceed  
                                             good manufacturing         
                                             practice.                  
As a defoamer in processing beet sugar and  Complying with Sec.  173.340
 yeast.                                      of this chapter.           
As a float on fermentation fluids in the    In an amount not to exceed  
 manufacture of vinegar and wine to          good manufacturing         
 prevent or retard access of air,            practice.                  
 evaporation, and wild yeast contamination                              
 during fermentation.                                                   
In the froth-flotation cleaning of              Do.                     
 vegetables.                                                            
As a component of insecticide formulations      Do.                     
 used in compliance with regulations                                    
 issued in parts 170 through 189 of this                                
 chapter.                                                               
------------------------------------------------------------------------



Sec. 172.886   Petroleum wax.

    Petroleum wax may be safely used in or on food, in accordance with 
the following conditions:
    (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in 
nature, derived from petroleum, and refined to meet the specifications 
prescribed by this section.
    (b) Petroleum wax meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in this paragraph.

------------------------------------------------------------------------
                                                               Maximum  
                                                             ultraviolet
                                                              absorbance
                                                                 per    
                                                              centimeter
                                                             path length
------------------------------------------------------------------------
280-289 millimicrons.......................................         0.15
290-299 millimicrons.......................................         0.12
300-359 millimicrons.......................................         0.08
360-400 millimicrons.......................................         0.02
------------------------------------------------------------------------

               Analytical Specification for Petroleum Wax

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware, 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of wax samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

[[Page 102]]

                                apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Reservoir. 500-milliliter capacity, equipped with a 24/40 standard 
taper male fitting at the bottom and a suitable ball-joint at the top 
for connecting to the nitrogen supply. The male fitting should be 
equipped with glass hooks.
    Chromatographic tube. 180 millimeters in length, inside diameter to 
be 15.7 millimeters plus-minus0.1 millimeter, equipped with a 
coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and 
a female 24/40 standard tapered fitting at the opposite end. (Overall 
length of the column with the female joint is 235 millimeters.) The 
female fitting should be equipped with glass hooks.
    Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 
\3/16\-inch thick with a hole bored in the center to closely fit the 
stem of the chromatographic tube.
    Heating jacket. Conical, for 500-milliliter separatory funnel. (Used 
with variable transformer heat control.)
    Suction flask. 250-milliliter or 500-milliliter filter flask.
    Condenser. 24/40 joints, fitted with a drying tube, length optional.
    Evaporation flask (optional). 250-milliliter or 500-milliliter 
capacity all-glass flask equipped with standard taper stopper having 
inlet and outlet tubes to permit passage of nitrogen across the surface 
of contained liquid to be evaporated.
    Vacuum distillation assembly. All glass (for purification of 
dimethyl sulfoxide); 2-liter distillation flask with heating mantle; 
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters 
in length and distilling head with separable cold finger condenser. Use 
of tetrafluoroethylene polymer sleeves on the glass joints will prevent 
freezing. Do not use grease on stopcocks or joints.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5.000 centimeters plus-minus0.005 centimeter; also for 
checking spectrophotometer performance only, optical path length in the 
range 1.000 centimeter plus-minus0.005 centimeter. With distilled 
water in the cells, determine any absorbance differences.
    Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons 
with spectral slit width of 2 millimicrons or less, under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Absorbance accuracy,1 plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    1As determined by using potassium chromate for reference 
standard and described in National Bureau of Standards Circular 484, 
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is 
to be determined by comparison with the standard values at 290, 345, and 
400 millimicrons. Circular 484 is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    Wavelength repeatability, plus-minus0.2 millimicron.
    Wavelength accuracy, plus-minus1.0 millimicron.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane, benzene, acetone, and methyl alcohol designated in the list 
following this paragraph shall pass the following test:
    To the specified quantity of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a) loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains. (To the residue from benzene 
add a 10-milliliter portion of purified isooctane, reevaporate, and 
repeat once to insure complete removal of benzene.)
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted, and a stream of nitrogen is fed through the inlet tube while 
the outlet tube is connected to a solvent trap and vacuum line in such a 
way as to prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue (except for methyl 
alcohol) shall not exceed 0.01 per centimeter path length between 280 
and 400 m. For methyl alcohol this absorbance value shall be 
0.00.

[[Page 103]]

    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test 
described in the preceding paragraph. Purify, if necessary, by passage 
through a column of activated silica gel (Grade 12, Davison Chemical 
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in 
length and 5 centimeters to 8 centimeters in diameter.
    Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. 
Purify, if necessary, by distillation or otherwise.
    Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. 
Purify, if necessary, by distillation.
    Eluting mixtures:
    1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 500-milliliter glass-stoppered volumetric flask and adjust to 
volume with isooctane, with mixing.
    2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 250-milliliter glass-stoppered volumetric flask, and adjust to 
volume with isooctane, with mixing.
    3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 
milliliters of acetone and 200 milliliters of benzene, and mix.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference point between 
280 m-400 m. The absorbance per centimeter path length 
shall not exceed 0.00 in this range. Purify, if necessary, by 
percolation through activated silica gel or by distillation.
    Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl 
alcohol. Purify, if necessary, by distillation.
    Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18 deg. 
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 
milliliters of distilled water in a 500-milliliter separatory funnel, 
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane 
to the solution and extract by shaking the funnel vigorously for 2 
minutes. Draw off the lower aqueous layer into a second 500-milliliter 
separatory funnel and repeat the extraction with 40 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and Materials'' for preparation of filter), into a 250-milliliter 
Erlenmeyer flask, or optionally into the evaporating flask. Wash the 
first separatory funnel with the second 40-milliliter isooctane 
extractive, and pass through the sodium sulfate into the flask. Then 
wash the second and first separatory funnels successively with a 10-
milliliter portion of isooctane, and pass the solvent through the sodium 
sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate 
the isooctane on the steam bath under nitrogen. Discontinue evaporation 
when not over 1 milliliter of residue remains. To the residue, add a 10-
milliliter portion of isooctane and reevaporate to 1 milliliter of 
hexadecane. Again, add 10 milliliters of isooctane to the residue and 
evaporate to 1 milliliter of hexadecane to insure complete removal of 
all volatile materials. Dissolve the 1 milliliter of hexadecane in 
isooctane and make to 25-milliliter volume. Determine the absorbance in 
5-centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution should not exceed 0.02 per centimeter path 
length in the 280 m-400 m range. (Note.--Difficulty in 
meeting this absorbance specification may be due to organic impurities 
in the distilled water. Repetition of the test omitting the dimethyl 
sulfoxide will disclose their presence. If necessary to meet the 
specification, purify the water by redistillation, passage through an 
ion-exchange resin, or otherwise.)
    Purify, if necessary, by the following procedure: To 1,500 
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, 
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A 
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and 
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated 
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide 
through four thicknesses of fluted paper (18.5 centimeters, Schleicher & 
Schuell, No. 597, or equivalent). If the initial filtrate contains 
carbon fines, refilter through the same filter until a clear filtrate is 
obtained. Protect the sulfoxide from air and moisture during this 
operation by covering the solvent in the funnel and collection flask 
with a layer of isooctane. Transfer the filtrate to a 2-liter separatory 
funnel and draw off the dimethyl sulfoxide into the 2-liter distillation 
flask of the vacuum distillation assembly and distill at approximately 
3-millimeter Hg pressure or less. Discard the first 200-milliliter 
fraction of the distillate and replace the distillate collection flask 
with a clean one. Continue the distillation until approximately 1 liter 
of the sulfoxide has been collected.
    At completion of the distillation, the reagent should be stored in 
glass-stoppered bottles since it is very hygroscopic and will react with 
some metal containers in the presence of air.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Sodium borohydride. 98 percent.
    Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco 
Division, distributed by chemical supply firms, or equivalent). Place 
100 grams of the magnesium oxide in a large beaker, add 700 milliliters 
of distilled water to make a thin slurry, and heat on a steam bath for 
30 minutes with intermittent stirring. Stir well initially to insure 
that all

[[Page 104]]

the absorbent is completely wetted. Using a Buchner funnel and a filter 
paper (Schleicher & Schuell No. 597, or equivalent) of suitable 
diameter, filter with suction. Continue suction until water no longer 
drips from the funnel. Transfer the absorbent to a glass trough lined 
with aluminum foil (free from rolling oil). Break up the magnesia with a 
clean spatula and spread out the absorbent on the aluminum foil in a 
layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 
160 deg. C plus-minus1 deg.C. Pulverize the magnesia with mortar 
and pestle. Sieve the pulverized absorbent between 60-180 mesh. Use the 
magnesia retained on the 180-mesh sieve.
    Celite 545. Johns-Manville Company, diatomaceous earth, or 
equivalent.
    Magnesium oxide-Celite 545 mixture (2+ 1) by weight. Place the 
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, 
respectively, by weight in a glass-stoppered flask large enough for 
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture 
to a glass trough lined with aluminum foil (free from rolling oil) and 
spread it out on a layer about 1 centimeter to 2 centimeters thick. 
Reheat the mixture at 160 deg. C plus-minus 1 deg. C for 2 hours, 
and store in a tightly closed flask.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter path length 
between 280 m and 400 m when tested as prescribed 
under ``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.
    Before proceeding with analysis of a sample, determine the 
absorbance in a 5-centimeter path cell between 250 m and 400 
m for the reagent blank by carrying out the procedure, without 
a wax sample, at room temperature, recording the spectra after the 
extraction stage and after the complete procedure as prescribed. The 
absorbance per centimeter path length following the extraction stage 
should not exceed 0.040 in the wavelength range from 280 m to 
400 m; the absorbance per centimeter path length following the 
complete procedure should not exceed 0.070 in the wavelength range from 
280 m to 299 m, inclusive, nor 0.045 in the wavelength 
range from 300 m to 400 m. If in either spectrum the 
characteristic benzene peaks in the 250 m-260 m region 
are present, remove the benzene by the procedure under ``Organic 
solvents'' and record absorbance again.
    Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory 
funnel and add 75 milliliters of phosphoric acid. Mix the contents of 
the funnel and allow to stand for 10 minutes. (The reaction between the 
sulfoxide and the acid is exothermic. Release pressure after mixing, 
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake 
to preequilibrate the solvents. Draw off the individual layers and store 
in glass-stoppered flasks.
    Place a representative 1-kilogram sample of wax, or if this amount 
is not available, the entire sample, in a beaker of a capacity about 
three times the volume of the sample and heat with occasional stirring 
on a steam bath until the wax is completely melted and homogeneous. 
Weigh four 25-gram plus-minus0.2 gram portions of the melted wax in 
separate 100-milliliter beakers. Reserve three of the portions for later 
replicate analyses as necessary. Pour one weighed portion immediately 
after remelting (on the steam bath) into a 500-milliliter separatory 
funnel containing 100 milliliters of the preequilibrated sulfoxide-
phosphoric acid mixture that has been heated in the heating jacket at a 
temperature just high enough to keep the wax melted. (Note: In 
preheating the sulfoxide-acid mixture, remove the stopper of the 
separatory funnel at intervals to release the pressure.)
    Promptly complete the transfer of the sample to the funnel in the 
jacket with portions of the preequilibrated isooctane, warming the 
beaker, if necessary, and using a total volume of just 50 milliliters of 
the solvent. If the wax comes out of solution during these operations, 
let the stoppered funnel remain in the jacket until the wax redissolves. 
(Remove stopper from the funnel at intervals to release pressure.) When 
the wax is in solution, remove the funnel from the jacket and shake it 
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels 
with each containing 30 milliliters of preequilibrated isooctane. After 
separation of the liquid phases, allow to cool until the main portion of 
the wax-isooctane solution begins to show a precipitate. Gently swirl 
the funnel when precipitation first occurs on the inside surface of the 
funnel to accelerate this process. Carefully draw off the lower layer, 
filter it slowly through a thin layer of glass wool fitted loosely in a 
filter funnel into the first 250-milliliter separatory funnel, and wash 
in tandem with the 30-milliliter portions of isooctane contained in the 
250-milliliter separatory funnels. Shaking time for each wash is 1 
minute. Repeat the extraction operation with two additional portions of 
the sulfoxide-acid mixture, replacing the funnel in the jacket after 
each extraction to keep the wax in solution and washing each extractive 
in tandem through the same three portions of isooctane.

[[Page 105]]

    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter), containing 480 milliliters of 
distilled water, mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium Sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on 
the steam bath under nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the 
absorbance of the solution in the 5-centimeter path length cells 
compared to isooctane as reference between 280 m-400 m 
(take care to lose none of the solution in filling the sample cell). 
Correct the absorbance values for any absorbance derived from reagents 
as determined by carrying out the procedure without a wax sample. If the 
corrected absorbance does not exceed the limits prescribed in this 
paragraph (b), the wax meets the ultraviolet absorbance specifications. 
If the corrected absorbance per centimeter path length exceeds the 
limits prescribed in this paragraph (b), proceed as follows:
    Quantitatively transfer the isooctane solution to a 125-milliliter 
flask equipped with 24/40 joint and evaporate the isooctane on the steam 
bath under a stream of nitrogen to a volume of 1 milliliter of 
hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3 
gram of sodium borohydride. (Minimize exposure of the borohydride to the 
atmosphere. A measuring dipper may be used.) Immediately fit a water-
cooled condenser equipped with a 24/40 joint and with a drying tube into 
the flask, mix until the borohydride is dissolved, and allow to stand 
for 30 minutes at room temperature, with intermittent swirling. At the 
end of this period, disconnect the flask and evaporate the methyl 
alcohol on the steam bath under nitrogen until the sodium borohydride 
begins to come out of the solution. Then add 10 milliliters of isooctane 
and evaporate to a volume of about 2-3 milliliters. Again, add 10 
milliliters of isooctane and concentrate to a volume of approximately 5 
milliliters. Swirl the flask repeatedly to assure adequate washing of 
the sodium borohydride residues.
    Fit the tetrafluoroethylene polymer disc on the upper part of the 
stem of the chromatographic tube, then place the tube with the disc on 
the suction flask and apply the vacuum (approximately 135 millimeters Hg 
pressure). Weight out 14 grams of the 2:1 magnesium oxide-Celite 545 
mixture and pour the adsorbent mixture into the chromatographic tube in 
approximately 3-centimeter layers. After the addition of each layer, 
level off the top of the adsorbent with a flat glass rod or metal 
plunger by pressing down firmly until the adsorbent is well packed. 
Loosen the topmost few millimeters of each adsorbent layer with the end 
of a metal rod before the addition of the next layer. Continue packing 
in this manner until all the 14 grams of the adsorbent is added to the 
tube. Level off the top of the adsorbent by pressing down firmly with a 
flat glass rod or metal plunger to make the depth of the adsorbent bed 
approximately 12.5 centimeters in depth. Turn off the vacuum and remove 
the suction flask. Fit the 500-milliliter reservoir onto the top of the 
chromatographic column and prewet the column by passing 100 milliliters 
of isooctane through the column. Adjust the nitrogen pressure so that 
the rate of descent of the isooctane coming off of the column is between 
2-3 milliliters per minute. Discontinue pressure just before the last of 
the isooctane reaches the level of the adsorbent. (Caution: Do not allow 
the liquid level to recede below the adsorbent level at any time.) 
Remove the reservoir and decant the 5-milliliter isooctane concentrate 
solution onto the column and with slight pressure again allow the liquid 
level to recede to barely above the adsorbent level. Rapidly complete 
the transfer similarly with two 5-milliliter portions of isooctane, 
swirling the flask repeatedly each time to assure adequate washing of 
the residue. Just before the final 5-milliliter wash reaches the top of 
the adsorbent, add 100 milliliters of isooctane to the reservoir and 
continue the percolation at the 2-3 milliliter per minute rate. Just 
before the last of the isooctane reaches the adsorbent level, add 100 
milliliters of 10 percent benzene in isooctane to the reservoir and 
continue the percolation at the aforementioned rate. Just before the 
solvent mixture reaches adsorbent level, add 25 milliliters of 20 
percent benzene in isooctane to the reservoir and continue

[[Page 106]]

the percolation at 2-3 milliliters per minute until all this solvent 
mixture has been removed from the column. Discard all the elution 
solvents collected up to this point. Add 300 milliliters of the acetone-
benzene-water mixture to the reservoir and percolate through the column 
to elute the polynuclear compounds. Collect the eluate in a clean 1-
liter separatory funnel. Allow the column to drain until most of the 
solvent mixture is removed. Wash the eluate three times with 300-
milliliter portions of distilled water, shaking well for each wash. (The 
addition of small amounts of sodium chloride facilitates separation.) 
Discard the aqueous layer after each wash. After the final separation, 
filter the residual benzene through anhydrous sodium sulfate prewashed 
with benzene (see Sodium sulfate under ``Reagents and Materials'' for 
preparation of filter) into a 250-milliliter Erlenmeyer flask (or 
optionally into the evaporation flask). Wash the separatory funnel with 
two additional 20-milliliter portions of benzene which are also filtered 
through the sodium sulfate. Add 1 milliliter of n-hexadecane and 
completely remove the benzene by evaporation under nitrogen, using the 
special procedure to eliminate benzene as previously described under 
``Organic Solvents.'' Quantitatively transfer the residue with isooctane 
to a 25-milliliter volumetric flask and adjust to volume. Determine the 
absorbance of the solution in the 5-centimeter path length cells 
compared to isooctane as reference between 250 m-400 
m. Correct for any absorbance derived from the reagents as 
determined by carrying out the procedure without a wax sample. If either 
spectrum shows the characteristic benzene peaks in the 250 m-
260m region, evaporate the solution to remove benzene by the 
procedure under ``Organic Solvents.'' Dissolve the residue, transfer 
quantitatively, and adjust to volume in isooctane in a 25-milliliter 
volumetric flask. Record the absorbance again. If the corrected 
absorbance does not exceed the limits prescribed in this paragraph (b), 
the wax meets the ultraviolet absorbance specifications.

    (c) Petroleum wax may contain one or more of the following adjuvants 
in amounts not greater than that required to produce their intended 
effect:
    (1) Antioxidants permitted in food by regulations issued in 
accordance with section 409 of the act.
    (2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long 
chain (C16-C22) alcohols and acrylic acid, having: (i) A 
number average molecular weight between 40,000 and 100,000; (ii) a 
weight average molecular weight (MWw) to number average molecular 
weight (MWn) ratio (MWw/MWn) of not less than 3; and 
(iii) unreacted alkylacrylate monomer content not in excess of 14 
percent, as determined by a method entitled, ``Method for Determining 
Weight-Average and Number-Average Molecular Weight and for Determining 
Alkylacrylate Monomer Content of Poly(alkylacrylate) used as Processing 
Aid in Manufacture of Petroleum Wax,'' which is incorporated by 
reference (copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408). Petroleum 
wax shall contain not more than 1,050 parts per million of 
poly(alkylacrylate) residues as determined by a method entitled, 
``Method for Determining Residual Level of Poly(alkylacrylate) in 
Petroleum Wax,'' which is incorporated by reference. Copies are 
available from the address cited in this paragraph (c)(2).
    (d) Petroleum wax is used or intended for use as follows:

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
In chewing gum base, as a masticatory       In an amount not to exceed  
 substance.                                  good manufacturing         
                                             practice.                  
On cheese and raw fruits and vegetables as      Do.                     
 a protective coating.                                                  
As a defoamer in food.....................  In accordance with Sec.     
                                             173.340 of this chapter.   
As a component of microcapsules for spice-  In accordance with Sec.     
 flavoring substances.                       172.230 of this chapter.   
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 48123, July 18, 1980; 
47 FR 11838, Mar. 19, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May 
30, 1986; 54 FR 24897, June 12, 1989]



Sec. 172.888   Synthetic petroleum wax.

    Synthetic petroleum wax may be safely used in or on foods in 
accordance with the following conditions:
    (a) Synthetic petroleum wax is a mixture of solid hydrocarbons, 
paraffinic in nature, prepared by either catalytic polymerization of 
ethylene or copolymerization of ethylene with linear (C3 to 
C12) alpha-olefins, and refined to meet the specifications 
prescribed in this section.
    (b) Synthetic petroleum wax meets the ultraviolet absorbance limits 
of

[[Page 107]]

Sec. 172.886(b) when subjected to the analytical procedure described 
therein.
    (c) Synthetic petroleum wax has a number average molecular weight of 
not less than 500 nor greater than 1,200 as determined by vapor pressure 
osmometry.
    (d) Synthetic petroleum wax may contain any antioxidant permitted in 
food by regulations issued in accordance with section 409 of the act, in 
an amount not greater than that required to produce its intended effect.
    (e) Synthetic petroleum wax is used or intended for use as follows:

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
In chewing gum base, as a masticatory       In accordance with Sec.     
 substance.                                  172.615 in an amount not to
                                             exceed good manufacturing  
                                             practice.                  
On cheese and raw fruits and vegetables as  In an amount not to exceed  
 a protective coating.                       good manufacturing         
                                             practice.                  
As a defoamer in food.....................  In accordance with Sec.     
                                             173.340 of this chapter.   
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 59 FR 10986, Mar. 9, 1994]



Sec. 172.890   Rice bran wax.

    Rice bran wax may be safely used in food in accordance with the 
following conditions:
    (a) It is the refined wax obtained from rice bran and meets the 
following specifications:

    Melting point 75 deg. C to 80 deg. C.
    Free fatty acids, maximum 10 percent.
    Iodine number, maximum 20.
    Saponification number 75 to 120.

    (b) It is used or intended for use as follows:

------------------------------------------------------------------------
              Food                Limitation in food          Use       
------------------------------------------------------------------------
Candy...........................  50 p.p.m..........  Coating.          
Fresh fruits and fresh            ......do..........      Do.           
 vegetables.                                                            
Chewing gum.....................  2\1/2\ pct........  Plasticizing      
                                                       material.        
------------------------------------------------------------------------



Sec. 172.892   Food starch-modified.

    Food starch-modified as described in this section may be safely used 
in food. The quantity of any substance employed to effect such 
modification shall not exceed the amount reasonably required to 
accomplish the intended physical or technical effect, nor exceed any 
limitation prescribed. To insure safe use of the food starch-modified, 
the label of the food additive container shall bear the name of the 
additive ``food starch-modified'' in addition to other information 
required by the Act. Food starch may be modified by treatment prescribed 
as follows:
    (a) Food starch may be acid-modified by treatment with hydrochloric 
acid or sulfuric acid or both.
    (b) Food starch may be bleached by treatment with one or more of the 
following:

------------------------------------------------------------------------
                                                     Limitations        
------------------------------------------------------------------------
Active oxygen obtained from hydrogen        ............................
 peroxide and/or peracetic acid, not to                                 
 exceed 0.45 percent of active oxygen.                                  
Ammonium persulfate, not to exceed 0.075    ............................
 percent and sulfur dioxide, not to exceed                              
 0.05 percent.                                                          
Chlorine, as calcium hypochlorite, not to   The finished food starch-   
 exceed 0.036 percent of dry starch.         modified is limited to use 
                                             only as a component of     
                                             batter for commercially    
                                             processed foods.           
Chlorine, as sodium hypochlorite, not to    ............................
 exceed 0.0082 pound of chlorine per pound                              
 of dry starch.                                                         
Potassium permanganate, not to exceed 0.2   Residual manganese          
 percent.                                    (calculated as Mn), not to 
                                             exceed 50 parts per million
                                             in food starch-modified.   
Sodium chlorite, not to exceed 0.5 percent  ............................
------------------------------------------------------------------------

    (c) Food starch may be oxidized by treatment with chlorine, as 
sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of 
dry starch.
    (d) Food starch may be esterified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations        
------------------------------------------------------------------------
Acetic anhydride..........................  Acetyl groups in food starch-
                                             modified not to exceed 2.5 
                                             percent.                   
Adipic anhydride, not to exceed 0.12            Do.                     
 percent, and acetic anhydride.                                         
Monosodium orthophosphate.................  Residual phosphate in food  
                                             starch-modified not to     
                                             exceed 0.4 percent         
                                             calculated as phosphorus.  
1-Octenyl succinic anhydride, not to        ............................
 exceed 3 percent.                                                      
1-Octenyl succinic anhydride, not to        ............................
 exceed 2 percent, and aluminum sulfate,                                
 not to exceed 2 percent.                                               

[[Page 108]]

                                                                        
1-Octenyl succinic anhydride, not to        Limited to use as a         
 exceed 3 percent, followed by treatment     stabilizer or emulsifier in
 with a beta-amylase enzyme that is either   beverages and beverage     
 an approved food additive of is generally   bases as defined in Sec.   
 recognized as safe..                        170.3(n)(3) of this        
                                             chapter.                   
Phosphorus oxychloride, not to exceed 0.1   ............................
 percent.                                                               
Phosphorus oxychloride, not to exceed 0.1   Acetyl groups in food starch-
 percent, followed by either acetic          modified not to exceed 2.5 
 anhydride, not to exceed 8 percent, or      percent.                   
 vinyl acetate, not to exceed 7.5 percent.                              
Sodium trimetaphosphate...................  Residual phosphate in food  
                                             starch-modified not to     
                                             exceed 0.04 percent,       
                                             calculated as phosphorus.  
Sodium tripolyphosphate and sodium          Residual phosphate in food  
 trimetaphosphate.                           starch-modified not to     
                                             exceed 0.4 percent         
                                             calculated as phosphorus.  
Succinic anhydride, not to exceed 4         ............................
 percent.                                                               
Vinyl acetate.............................  Acetyl groups in food starch-
                                             modified not to exceed 2.5 
                                             percent.                   
------------------------------------------------------------------------

    (e) Food starch may be etherified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations        
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent.......  ............................
Epichlorohydrin, not to exceed 0.3 percent  ............................
Epichlorohydrin, not to exceed 0.1          Residual propylene          
 percent, and propylene oxide, not to        chlorohydrin not more than 
 exceed 10 percent, added in combination     5 parts per million in food
 or in any sequence.                         starch-modified.           
Epichlorohydrin, not to exceed 0.1              Do.                     
 percent, followed by propylene oxide, not                              
 to exceed 25 percent.                                                  
Propylene oxide, not to exceed 25 percent.      Do.                     
------------------------------------------------------------------------

    (f) Food starch may be esterified and etherified by treatment with 
one of the following:

------------------------------------------------------------------------
                                                     Limitations        
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent and     Acetyl groups in food starch-
 vinyl acetate, not to exceed 7.5 percent.   modified not to exceed 2.5 
                                             percent.                   
Epichlorohydrin, not to exceed 0.3          Acetyl groups in food starch-
 percent, and acetic anhydride.              modified not to exceed 2.5 
                                             percent.                   
Epichlorohydrin, not to exceed 0.3          ............................
 percent, and succinic anhydride, not to                                
 exceed 4 percent.                                                      
Phosphorus oxychloride, not to exceed 0.1   Residual propylene          
 percent, and propylene oxide, not to        chlorohydrin not more than 
 exceed 10 percent.                          5 parts per million in food
                                             starch-modified.           
------------------------------------------------------------------------

    (g) Food starch may be modified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations        
------------------------------------------------------------------------
Chlorine, as sodium hypochlorite, not to    Residual propylene          
 exceed 0.055 pound of chlorine per pound    chlorohydrin not more than 
 of dry starch; 0.45 percent of active       5 parts per million in food
 oxygen obtained from hydrogen peroxide;     starch-modified.           
 and propylene oxide, not to exceed 25                                  
 percent.                                                               
Sodium hydroxide, not to exceed 1 percent.  ............................
------------------------------------------------------------------------

    (h) Food starch may be modified by a combination of the treatments 
prescribed by paragraphs (a), (b), and/or (i) of this section and any 
one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g) 
of this section, subject to any limitations prescribed by the paragraphs 
named.
    (i) Food starch may be modified by treatment with the following 
enzyme:

                                                                        
------------------------------------------------------------------------
                  Enzyme                             Limitations        
------------------------------------------------------------------------
Alpha-amylase (E.C. 3.2.1.1)..............  The enzyme must be generally
                                             recognized as safe or      
                                             approved as a food additive
                                             for this purpose. The      
                                             resulting nonsweet         
                                             nutritive saccharide       
                                             polymer has a dextrose     
                                             equivalent of less than 20.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 11697, Mar. 21, 1978; 
46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, 
Apr. 19, 1993]



Sec. 172.894   Modified cottonseed products intended for human consumption.

    The food additive modified cottonseed products may be used for human 
consumption in accordance with the following prescribed conditions:
    (a) The additive is derived from:
    (1) Decorticated, partially defatted, cooked, ground cottonseed 
kernels; or
    (2) Decorticated, ground cottonseed kernels, in a process that 
utilizes n-hexane as an extracting solvent in such a way that no more 
than 60 parts per million of n-hexane residues and less than 1 percent 
fat by weight remain in the finished product; or
    (3) Glandless cottonseed kernels roasted to attain a temperature of 
not less than 250 deg. F in the kernel for not less than 5 minutes for 
use as a snack food, or in baked goods, or in soft candy; or
    (4) Raw glandless cottonseed kernels may be used in hard candy where 
the

[[Page 109]]

kernel temperature during cooking will exceed 250 deg. F for not less 
than 5 minutes.
    (b) The additive is prepared to meet the following specifications:
    (1) Free gossypol content not to exceed 450 parts per million.
    (2) It contains no added arsenic compound and therefore may not 
exceed a maximum natural background level of 0.2 part per million total 
arsenic, calculated as As.
    (c) To assure safe use of the additive, the label of the food 
additive container shall bear, in addition to other information required 
by the act, the name of the additive as follows:
    (1) The additive identified in paragraph (a)(1) of this section as 
``partially defatted, cooked cottonseed flour''.
    (2) The additive identified in paragraph (a)(2) of this section as 
``defatted cottonseed flour''.
    (3) The additive identified in paragraph (a)(3) of this section as 
``roasted glandless cottonseed kernels''.
    (4) The additive identified in paragraph (a)(4) of this section as 
``raw glandless cottonseed kernels for use in cooked hard candy''.
    (d) The Food and Drug Administration and the Environmental 
Protection Agency have determined that glandless cottonseed kernels 
permitted for use by this section are a distinct commodity from glanded 
cottonseed.



Sec. 172.896   Dried yeasts.

    Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis) 
and dried torula yeast (Candida utilis) may be safely used in food 
provided the total folic acid content of the yeast does not exceed 0.04 
milligram per gram of yeast (approximately 0.008 milligram of 
pteroyglutamic acid per gram of yeast).



Sec. 172.898   Bakers yeast glycan.

    Bakers yeast glycan may be safely used in food in accordance with 
the following conditions:
    (a) Bakers yeast glycan is the comminuted, washed, pasteurized, and 
dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed 
principally of long chain carbohydrates, not less than 85 percent on a 
dry solids basis. The carbohydrate is composed of glycan and mannan 
units in approximately a 2:1 ratio.
    (b) The additive meets the following specifications on a dry weight 
basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 
0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
    (c) The viable microbial content of the finished ingredient is:
    (1) Less than 10,000 organisms/gram by aerobic plate count.
    (2) Less than 10 yeasts and molds/gram.
    (3) Negative for Salmonella, E. coli, coagulase positive 
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any 
other recognized microbial pathogen or any harmful microbial toxin.
    (d) The additive is used or intended for use in the following foods 
when standards of identity established under section 401 of the Act do 
not preclude such use:

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
(1) In salad dressings as an emulsifier     Not to exceed a             
 and emulsifier salt as defined in Sec.      concentration of 5 percent 
 170.3(o)(8) of this chapter, stabilizer     of the finished salad      
 and thickener as defined in Sec.            dressing.                  
 170.3(o)(28) of this chapter, or                                       
 texturizer as defined in Sec.                                          
 170.3(o)(32) of this chapter.                                          
(2) In frozen dessert analogs as a          In an amount not to exceed  
 stabilizer and thickener as defined in      good manufacturing         
 Sec.  170.3(o)(28) of this chapter, or      practice.                  
 texturizer as defined in Sec.                                          
 170.3(o)(32) of this chapter.                                          
(3) In sour cream analogs as a stabilizer       Do.                     
 and thickener as defined in Sec.                                       
 170.3(o)(28) of this chapter, or                                       
 texturizer as defined in Sec.                                          
 170.3(o)(32) of this chapter.                                          
(4) In cheese spread analogs as a               Do.                     
 stabilizer and thickener as defined in                                 
 Sec.  170.3(o)(28) of this chapter, or                                 
 texturizer as defined in Sec.                                          
 170.3(o)(32) of this chapter.                                          
(5) In cheese-flavored and sour cream-          Do.                     
 flavored snack dips as a stabilizer and                                
 thickener as defined in Sec.                                           
 170.3(o)(28) of this chapter, or                                       
 texturizer as defined in Sec.                                          
 170.3(o)(32) of this chapter.                                          
------------------------------------------------------------------------

    (e) The label and labeling of the ingredient shall bear adequate 
directions to assure that use of the ingredient complies with this 
regulation.

[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5, 1980]

[[Page 110]]



PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents




 Subpart A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec.
173.5  Acrylate-acrylamide resins.
173.10  Modified polyacrylamide resin.
173.20  Ion-exchange membranes.
173.21   Perfluorinated ion exchange membranes.
173.25  Ion-exchange resins.
173.40  Molecular sieve resins.
173.45  Polymaleic acid and its sodium salt.
173.50  Polyvinylpolypyrrolidone.
173.55  Polyvinylpyrrolidone.
173.60  Dimethylamine-epichlorohydrin copolymer.
173.65  Divinylbenzene copolymer.
173.70  Chloromethylated aminated styrene-divinylbenzene resin.
173.73  Sodium polyacrylate.
173.75  Sorbitan monooleate.

            Subpart B--Enzyme Preparations and Microorganisms

173.110  Amyloglucosidase derived from Rhizopus niveus.
173.120  Carbohydrase and cellulase derived from Aspergillus niger.
173.130  Carbohydrase derived from Rhizopus oryzae.
173.135  Catalase derived from Microccocus lysodeikticus.
173.140  Esterase-lipase derived fron Mucor miehei.
173.145  Alpha-Galactosidase derived from Morteirella vinaceae var. 
          raffinoseutilizer.
173.150  Milk-clotting enzymes, microbial.
173.160  Candida guilliermondii.
173.165  Candida lipolytica.
173.170  Aminoglycoside 3'-phosphotransferase II.

 Subpart C--Solvents, Lubricants, Release Agents and Related Substances

173.210  Acetone.
173.220  1,3-Butylene glycol.
173.228  Ethyl acetate.
173.230  Ethylene dichloride.
173.240  Isopropyl alcohol.
173.250  Methyl alcohol residues.
173.255  Methylene chloride.
173.270  Hexane.
173.275  Hydrogenated sperm oil.
173.280  Solvent extraction process for citric acid.
173.290  Trichloroethylene.

                   Subpart D--Specific Usage Additives

173.300  Chlorine dioxide.
173.310  Boiler water additives.
173.315  Chemicals used in washing or to assist in the lye peeling of 
          fruits and vegetables.
173.320  Chemicals for controlling microorganisms in cane-sugar and 
          beet-sugar mills.
173.322  Chemicals used in delinting cottonseed.
173.340  Defoaming agents.
173.342  Chlorofluorocarbon 113 and perfluorohexane.
173.345  Chloropentafluoroethane.
173.350  Combustion product gas.
173.355  Dichlorodifluoromethane.
173.357  Materials used as fixing agents in the immobilization of enzyme 
          preparations.
173.360  Octafluorocyclobutane.
173.385  Sodium methyl sulfate.
173.395  Trifluoromethane sulfonic acid.
173.400  Dimethyldialkylammonium chloride.

    Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).


    Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.
    Editorial Note: Nomenclature changes to part 173 appear at 61 FR 
14482, Apr. 2, 1996.



 Subpart A--Polymer Substances and Polymer Adjuvants for Food Treatment



Sec. 173.5   Acrylate-acrylamide resins.

    Acrylate-acrylamide resins may be safely used in food under the 
following prescribed conditions:
    (a) The additive consists of one of the following:
    (1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is 
produced by the polymerization of acrylamide with partial hydrolysis, or 
by copolymerization of acrylamide and acrylic acid, with the greater 
part of the polymer being composed of acrylamide units.
    (2) Sodium polyacrylate-acrylamide resin is produced by the 
polymerization and subsequent hydrolysis of acrylonitrile in a sodium 
silicate-sodium hydroxide aqueous solution, with the greater part of the 
polymer being composed of acrylate units.

[[Page 111]]

    (b) The additive contains not more than 0.05 percent of residual 
monomer calculated as acrylamide.
    (c) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a) (1) of this section is 
used as a flocculent in the clarification of beet sugar juice and liquor 
or cane sugar juice and liquor or corn starch hydrolyzate in an amount 
not to exceed 5 parts per million by weight of the juice or 10 parts per 
million by weight of the liquor or the corn starch hydrolyzate.
    (2) The additive identified in paragraph (a)(2) of this section is 
used to control organic and mineral scale in beet sugar juice and liquor 
or cane sugar juice and liquor in an amount not to exceed 2.5 parts per 
million by weight of the juice or liquor.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981]



Sec. 173.10   Modified polyacrylamide resin.

    Modified polyacrylamide resin may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The modified polyacrylamide resin is produced by the 
copolymerization of acrylamide with not more than 5-mole percent 
-methacrylyloxyethy-ltrimethylammonium methyl sulfate.
    (b) The modified polyacrylamide resin contains not more than 0.05 
percent residual acrylamide.
    (c) The modified polyacrylamide resin is used as a flocculent in the 
clarification of beet or cane sugar juice in an amount not exceeding 5 
parts per million by weight of the juice.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to the other information required 
by the act, adequate directions to assure use in compliance with 
paragraph (c) of this section.



Sec. 173.20   Ion-exchange membranes.

    Ion-exchange membranes may be safely used in the processing of food 
under the following prescribed conditions:
    (a) The ion-exchange membrane is prepared by subjecting a 
polyethylene base conforming to Sec. 177.1520 of this chapter to 
polymerization with styrene until the polystyrene phase of the base is 
not less than 16 percent nor more than 30 percent by weight. The base is 
then modified by reaction with chloromethyl methyl ether, and by 
subsequent amination with trimethylamine, dimethylamine, 
diethylenetriamine, or dimethylethanolamine.
    (b) The ion-exchange membrane is manufactured so as to comply with 
the following extraction limitations when subjected to the described 
procedure: Separate square-foot samples of membrane weighing 
approximately 14 grams each are cut into small pieces and refluxed for 4 
hours in 150 cubic centimeters of the following solvents: Distilled 
water, 5 percent acetic acid, and 50 percent alcohol. Extraction from 
each sample will not exceed 0.4 percent by weight of sample.
    (c) The ion-exchange membrane will be used in the production of 
grapefruit juice to adjust the ratio of citric acid to total solids of 
the grapefruit juice produced.



Sec. 173.21  Perfluorinated ion exchange membranes.

    Substances identified in paragraph (a) of this section may be safely 
used as ion exchange membranes intended for use in the treatment of bulk 
quantities of liquid food under the following prescribed conditions:
    (a) Identity. The membrane is a copolymer of ethanesulfonyl 
fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-
tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that 
has been subsequently treated to hydrolyze the sulfonyl fluoride group 
to the sulfonic acid. The Chemical Abstracts Service name of this 
polymer is ethanesulfonic acid, 2-[1-[difluoro-
[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-
tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9).
    (b) Optional adjuvant substances. The basic polymer identified in 
paragraph (a) of this section may contain optional adjuvant substances 
required in the production of such basic polymer. These optional 
adjuvant substances

[[Page 112]]

may include substances used in accordance with Sec. 174.5 of this 
chapter.
    (c) Conditions of use. (1) Perfluorinated ion exchange membranes 
described in paragraph (a) of this section may be used in contact with 
all types of liquid foods at temperatures not exceeding 70  deg.C (158 
deg.F).
    (2) Maximum thickness of the copolymer membrane is 0.007 inch (0.017 
centimeter).
    (3) Perfluorinated ion exchange membranes shall be maintained in a 
sanitary manner in accordance with current good manufacturing practice 
so as to prevent microbial adulteration of food.
    (4) To assure their safe use, perfluorinated ionomer membranes shall 
be thoroughly cleaned prior to their first use in accordance with 
current good manufacturing practice.

[59 FR 15623, Apr. 4, 1994]



Sec. 173.25   Ion-exchange resins.

    Ion-exchange resins may be safely used in the treatment of food 
under the following prescribed conditions:
    (a) The ion-exchange resins are prepared in appropriate physical 
form, and consist of one or more of the following:
    (1) Sulfonated copolymer of styrene and divinylbenzene.
    (2) Sulfonated anthracite coal meeting the requirements of ASTM 
method D388-38, Class I, Group 2, ``Standard Specifications for 
Classification of Coal by Rank,'' which is incorporated by reference. 
Copies are available from University Microfilms International, 300 N. 
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (3) Sulfite-modified cross-linked phenol-formaldehyde, with 
modification resulting in sulfonic acid groups on side chains.
    (4) Methacrylic acid-divinylbenzene copolymer.
    (5) Cross-linked polystyrene, first chloromethylated then aminated 
with trimethylamine, dimethylamine, di-ethylenetriamine, or 
dimethylethanol-amine.
    (6) Diethylenetriamine, triethylene-tetramine, or 
tetraethylenepentamine cross-linked with epichlorohydrin.
    (7) Cross-linked phenol-formaldehyde activated with one or both of 
the following: Triethylene tetramine and tetraethylenepentamine.
    (8) Reaction resin of formaldehyde, acetone, and 
tetraethylenepentamine.
    (9) Completely hydrolyzed copolymers of methyl acrylate and 
divinylbenzene.
    (10) Completely hydrolyzed terpolymers of methyl acrylate, 
divinylbenzene, and acrylonitrile.
    (11) Sulfonated terpolymers of styrene, divinylbenzene, and 
acrylonitrile or methyl acrylate.
    (12) Methyl acrylate-divinylbenzene copolymer containing not less 
than 2 percent by weight of divinylbenzene, aminolyzed with 
dimethylaminopro-pylamine.
    (13) Methyl acrylate-divinylbenzene copolymer containing not less 
than 3.5 percent by weight of divinylbenzene, aminolyzed with 
dimethylaminopro-pylamine.
    (14) Epichlorohydrin cross-linked with ammonia.
    (15) Sulfonated tetrapolymer of styrene, divinylbenzene, 
acrylonitrile, and methyl acrylate derived from a mixture of monomers 
containing not more than a total of 2 percent by weight of acrylonitrile 
and methyl acrylate.
    (16) Methyl acrylate-divinylbenzenediethylene glycol divinyl ether 
terpolymer containing not less than 3.5 percent by weight of 
divinylbenzene and not more than 0.6 percent by weight of diethylene 
glycol divinyl ether, aminolyzed with dimethylaminopropylamine.
    (17) Styrene-divinylbenzene cross-linked copolymer, first 
chloromethylated then aminated with dimethylamine and oxidized with 
hydrogen peroxide whereby the resin contains not more than 15 percent by 
weight of vinyl N,N-dimethylbenzylamine-N-oxide and not more than 6.5 
percent by weight of nitrogen.
    (18) Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether 
terpolymer containing not less than 7 percent by weight of 
divinylbenzene and not more than 2.3 percent by weight of diethylene 
glycol divinyl ether, aminolyzed with

[[Page 113]]

dimethylaminopropylamine and quaternized with methyl chloride.
    (19) Epichlorohydrin cross-linked with ammonia and then quaternized 
with methyl chloride to contain not more than 18 percent strong base 
capacity by weight of total exchange capacity [Chemical Abstracts 
Service name: Oxirane (chloromethyl)-, polymer with ammonia, reaction 
product with chloromethane; CAS Reg. No. 68036-99-7].
    (20) Regenerated cellulose, cross-linked and alkylated with 
epichlorohydrin and propylene oxide, then sulfonated whereby the amount 
of epichlorohydrin plus propylene oxide employed does not exceed 61 
percent by weight of the starting quantity of cellulose.
    (b) Ion-exchange resins are used in the purification of foods, 
including potable water, to remove undesirable ions or to replace less 
desirable ions with one or more of the following: bicarbonate, calcium, 
carbonate, chloride, hydrogen, hydroxyl, magnesium, potassium, sodium, 
and sulfate except that: The ion-exchange resin identified in paragraph 
(a)(12) of this section is used only in accordance with paragraph (b)(1) 
of this section, the ion-exchange resin identified in paragraph (a)(13) 
of this section is used only in accordance with paragraph (b)(2) of this 
section, the resin identified in paragraph (a)(16) of this section is 
used only in accordance with paragraph (b)(1) or (b)(2) of this section, 
the ion-exchange resin identified in paragraph (a)(17) of this section 
is used only in accordance with paragraph (b)(3) of this section, the 
ion-exchange resin identified in paragraph (a)(18) of this section is 
used only in accordance with paragraph (b)(4) of this section, and the 
ion-exchange resin identified in paragraph (a)(20) of this section is 
used only in accordance with paragraphs (b)(5) and (d) of this section.
    (1) The ion-exchange resins identified in paragraphs (a) (12) and 
(16) of this section are used to treat water for use in the manufacture 
of distilled alcoholic beverages, subject to the following conditions:
    (i) The water is subjected to treatment through a mixed bed 
consisting of one of the resins identified in paragraph (a) (12) or (16) 
of this section and one of the strongly acidic cation-exchange resins in 
the hydrogen form identified in paragraphs (a) (1), (2), and (11) of 
this section; or
    (ii) The water is first subjected to one of the resins identified in 
paragraph (a) (12) or (16) of this section and is subsequently subjected 
to treatment through a bed of activated carbon or one of the strongly 
acidic cation-exchange resins in the hydrogen form identified in 
paragraphs (a) (1), (2), and (11) of this section.
    (iii) The temperature of the water passing through the resin beds 
identified in paragraphs (b)(1) (i) and (ii) of this section is 
maintained at 30 deg. C or less, and the flow rate of the water passing 
through the beds is not less than 2 gallons per cubic foot per minute.
    (iv) The ion-exchange resins identified in paragraph (a) (12) or 
(16) of this section are exempted from the requirements of paragraph 
(c)(4) of this section, but the strongly acidic cation-exchange resins 
referred to in paragraphs (b)(1) (i) and (ii) of this section used in 
the process meet the requirements of paragraph (c)(4) of this section, 
except for the exemption described in paragraph (d) of this section.
    (2) The ion-exchange resins identified in paragraphs (a) (13) and 
(16) of this section are used to treat water and aqueous food only of 
the types identified under Categories I, II, and VI-B in Table 1 of 
Sec. 176.170(c) of this chapter: Provided, That the temperature of the 
water or food passing through the resin beds is maintained at 50 deg. C 
or less and the flow rate of the water or food passing through the beds 
is not less than 0.5 gallon per cubic foot per minute.
    (3) The ion-exchange resin identified in paragraph (a)(17) of this 
section is used only for industrial application to treat bulk quantities 
of aqueous food, including potable water, or for treatment of municipal 
water supplies, subject to the condition that the temperature of the 
food or water passing through the resin bed is maintained at 25 deg. C 
or less and the flow rate of the food or water passing through the bed 
is not less than 2 gallons per cubic foot per minute.

[[Page 114]]

    (4) The ion-exchange resin identified in paragraph (a)(18) of this 
section is used to treat aqueous sugar solutions subject to the 
condition that the temperature of the sugar solution passing through the 
resin bed is maintained at 82  deg.C (179.6  deg.F) or less and the flow 
rate of the sugar solution passing through the bed is not less than 46.8 
liters per cubic meter (0.35 gallon per cubic foot) of resin bed volume 
per minute.
    (5) The ion-exchange resin identified in paragraph (a)(20) of this 
section is limited to use in aqueous process streams for the isolation 
and purification of protein concentrates and isolates. The pH range for 
the resin shall be no less than 3.5 and no more than 9, and the 
temperatures of water and food passing through the resin bed shall not 
exceed 25  deg.C.
    (c) To insure safe use of ion-exchange resins, each ion-exchange 
resin will be:
    (1) Subjected to pre-use treatment by the manufacturer and/or the 
user in accordance with the manufacturer's directions prescribed on the 
label or labeling accompanying the resins, to guarantee a food-grade 
purity of ion-exchange resins, in accordance with good manufacturing 
practice.
    (2) Accompanied by label or labeling to include directions for use 
consistent with the intended functional purpose of the resin.
    (3) Used in compliance with the label or labeling required by 
paragraph (c)(2) of this section.
    (4) Found to result in no more than 1 part per million of organic 
extractives obtained with each of the named solvents, distilled water, 
15 percent alcohol, and 5 percent acetic acid when, having been washed 
and otherwise treated in accordance with the manufacturer's directions 
for preparing them for use with food, the ion-exchange resin is 
subjected to the following test: Using a separate ion-exchange column 
for each solvent, prepare columns using 50 milliliters of the ready to 
use ion-exchange resin that is to be tested. While maintaining the 
highest temperature that will be encountered in use pass through these 
beds at the rate of 350-450 milliliters per hour the three test solvents 
distilled water, 15 percent (by volume) ethyl alcohol, and 5 percent (by 
weight) acetic acid. The first liter of effluent from each solvent is 
discarded, then the next 2 liters are used to determine organic 
extractives. The 2-liter sample is carefully evaporated to constant 
weight at 105 deg. C; this is total extractives. This residue is fired 
in a muffle furnace at 850 deg. C to constant weight; this is ash. Total 
extractives, minus ash equals the organic extractives. If the organic 
extractives are greater than 1 part per million of the solvent used, a 
blank should be run on the solvent and a correction should be made by 
subtracting the total extractives obtained with the blank from the total 
extractives obtained in the resin test. The solvents used are to be made 
as follows:

Distilled water (de-ionized water is distilled).
15 percent ethyl alcohol made by mixing 15 volumes of absolute ethyl 
alcohol A.C.S. reagent grade, with 85 volumes of distilled de-ionized 
water.
5 percent acetic acid made by mixing 5 parts by weight of A.C.S. reagent 
grade glacial acetic acid with 95 parts by weight of distilled de-
ionized water.

In addition to the organic extractives limitation prescribed in this 
paragraph, the ion-exchange resin identified in paragraph (a)(17) of 
this section, when extracted with each of the named solvents, distilled 
water, 50 percent alcohol, and 5 percent acetic acid, will be found to 
result in not more than 7 parts per million of nitrogen extractives 
(calculated as nitrogen) when the resin in the free-base form is 
subjected to the following test immediately before each use: Using a 
separate 1-inch diameter glass ion-exchange column for each solvent, 
prepare each column using 100 milliliters of ready to use ion-exchange 
resin that is to be tested. With the bottom outlet closed, fill each 
ion-exchange column with one of the three solvents at a temperature of 
25 deg. C until the solvent level is even with the top of the resin bed. 
Seal each column at the top and bottom and store in a vertical position 
at a temperature of 25 deg. C. After 96 hours, open the top of each 
column, drain the solvent into a collection vessel, and analyze each 
drained solvent and a solvent blank for nitrogen by a standard micro-
Kjeldahl method.
    (d)(1) The ion-exchange resins identified in paragraphs (a)(1), 
(a)(2), (a)(11),

[[Page 115]]

and (a)(15) of this section are exempted from the acetic acid extraction 
requirement of paragraph (c)(4) of this section.
    (2) The ion-exchange resin identified in paragraph (a)(20) of this 
section shall comply with the extraction requirement in paragraph (c)(4) 
of this section by using dilute sulfuric acid, pH 3.5, as a substitute 
for acetic acid.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981; 46 
FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Apr. 
22, 1991]



Sec. 173.40   Molecular sieve resins.

    Molecular sieve resins may be safely used in the processing of food 
under the following prescribed conditions:
    (a) The molecular sieve resins consist of purified dextran having an 
average molecular weight of 40,000, cross-linked with epichlorohydrin in 
a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a 
stable three dimensional structure. The resins have a pore size of 2.0 
to 3.0 milliliters per gram of dry resin (expressed in terms of water 
regain), and a particle size of 10 to 300 microns.
    (b) The molecular sieve resins are thoroughly washed with potable 
water prior to their first use in contact with food.
    (c) Molecular sieve resins are used as the gel filtration media in 
the final purification of partially delactosed whey. The gel bed shall 
be maintained in a sanitary manner in accordance with good manufacturing 
practice so as to prevent microbial build-up on the bed and adulteration 
of the product.



Sec. 173.45  Polymaleic acid and its sodium salt.

    Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS 
Reg. No. 70247-90-4) may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additives have a weight-average molecular weight in the 
range of 540 to 850 and a number-average molecular weight in the range 
of 520 to 650, calculated as the acid. Molecular weights shall be 
determined by a method entitled ``Determination of Molecular Weight 
Distribution of Poly(Maleic) Acid,'' March 17, 1992, produced by Ciba-
Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Division of Product Policy, 
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or are available 
for inspection at the Center for Food Safety and Applied Nutrition's 
Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of 
the Federal Register, 800 North Capitol St. NW., suite 700, Washington, 
DC.
    (b) The additives may be used, individually or together, in the 
processing of beet sugar juice and liquor or of cane sugar juice and 
liquor to control mineral scale.
    (c) The additives are to be used so that the amount of either or 
both additives does not exceed 4 parts per million (calculated as the 
acid) by weight of the beet or cane sugar juice or liquor process 
stream.

[51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996]



Sec. 173.50   Polyvinylpolypyrrolidone.

    The food additive polyvinylpolypyrrolidone may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive is a homopolymer of purified vinylpyrrolidone 
catalytically produced under conditions producing polymerization and 
cross-linking such that an insoluble polymer is produced.
    (b) The food additive is so processed that when the finished polymer 
is refluxed for 3 hours with water, 5 percent acetic acid, and 50 
percent alcohol, no more than 50 parts per million of extractables is 
obtained with each solvent.
    (c) It is used or intended for use as a clarifying agent in 
beverages and vinegar, followed by removal with filtration.



Sec. 173.55   Polyvinylpyrrolidone.

    The food additive polyvinylpyrroli-done may be safely used in 
accordance

[[Page 116]]

with the following prescribed conditions:
    (a) The additive is a polymer of purified vinylpyrrolidone 
catalytically produced, having an average molecular weight of 40,000 and 
a maximum unsaturation of 1 percent, calculated as the monomer, except 
that the polyvinylpyrrolidone used in beer is that having an average 
molecular weight of 360,000 and a maximum unsaturation of 1 percent, 
calculated as the monomer.
    (b) The additive is used or intended for use in foods as follows:

------------------------------------------------------------------------
              Food                              Limitations             
------------------------------------------------------------------------
Beer............................  As a clarifying agent, at a residual  
                                   level not to exceed 10 parts per     
                                   million.                             
Flavor concentrates in tablet     As a tableting adjuvent in an amount  
 form.                             not to exceed good manufacturing     
                                   practice.                            
Nonnutritive sweeteners in        As a stabilizer, bodying agent, and   
 concentrated liquid form.         dispersant, in an amount not to      
                                   exceed good manufacturing practice.  
Nonnutritive sweeteners in        As a tableting adjuvant in an amount  
 tablet form.                      not to exceed good manufacturing     
                                   practice.                            
Vitamin and mineral concentrates  As a stabilizer, bodying agent, and   
 in liquid form.                   dispersant, in an amount not to      
                                   exceed good manufacturing practice.  
Vitamin and mineral concentrates  As a tableting adjuvant in an amount  
 in tablet form.                   not to exceed good manufacturing     
                                   practice.                            
Vinegar.........................  As a clarifying agent, at a residual  
                                   level not to exceed 40 parts per     
                                   million.                             
Wine............................  As a clarifying agent, at a residual  
                                   level not to exceed 60 parts per     
                                   million.                             
------------------------------------------------------------------------



Sec. 173.60  Dimethylamine-epichlorohydrin copolymer.

    Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) 
may be safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is produced by copolymerization of 
dimethylamine and epichlorohydrin in which not more than 5 mole-percent 
of dimethylamine may be replaced by an equimolar amount of 
ethylenediamine, and in which the mole ratio of total amine to 
epichlorohydrin is approximately 1:1.
    (b) The additive meets the following specifications:
    (1) The nitrogen content of the copolymer is 9.4 to 10.8 weight 
percent on a dry basis.
    (2) A 50-percent-by-weight aqueous solution of the copolymer has a 
minimum viscosity of 175 centipoises at 25 deg. C as determined by LVT-
series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by 
another equivalent method).
    (3) The additive contains not more than 1,000 parts per million of 
1,3-dichloro-2-propanol and not more than 10 parts per million 
epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content 
is determined by an analytical method entitled ``The Determination of 
Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-
Epichlorohydrin Copolymer,'' which is incorporated by reference. Copies 
are available from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (4) Heavy metals (as Pb), 2 parts per million maximum.
    (5) Arsenic (as As), 2 parts per million maximum.
    (c) The food additive is used as a decolorizing agent and/or 
flocculant in the clarification of refinery sugar liquors and juices. It 
is added only at the defecation/clarification stage of sugar liquor 
refining at a concentration not to exceed 150 parts per million of 
copolymer by weight of sugar solids.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to other information required by 
the Act, adequate directions to assure use in compliance with paragraph 
(c) of this section.

[48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989]



Sec. 173.65  Divinylbenzene copolymer.

    Divinylbenzene copolymer may be used for the removal of organic 
substances from aqueous foods under the following prescribed conditions:

[[Page 117]]

    (a) The copolymer is prepared in appropriate physical form and is 
derived by the polymerization of a grade of divinylbenzene which 
comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-
percent ethylvinylbenzene, and no more than 4 weight-percent 
nonpolymerizable impurities.
    (b) In accordance with the manufacturer's directions, the copolymer 
described in paragraph (a) of this section is subjected to pre-use 
extraction with a water soluble alcohol until the level of 
divinylbenzene in the extract is less than 50 parts per billion as 
determined by a method titled, ``The Determination of Divinylbenzene in 
Alcohol Extracts of Amberlite XAD-4,'' which is incorporated by 
reference. Copies of this method are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408. The copolymer is then treated with water 
according to the manufacturer's recommendation to remove the extraction 
solvent to guarantee a food-grade purity of the resin at the time of 
use, in accordance with current good manufacturing practice.
    (c) The temperature of the aqueous food stream contacting the 
polymer is maintained at 79.4  deg.C (175  deg.F) or less.
    (d) The copolymer may be used in contact with food only of Types I, 
II, and VI-B (excluding carbonated beverages) described in Table 1 of 
paragraph (c) of Sec. 176.170 of this chapter.

[50 FR 61, Jan. 2, 1985]



Sec. 173.70  Chloromethylated aminated styrene-divinylbenzene resin.

    Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. 
No. 60177-39-1) may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additive is an aqueous dispersion of styrene-divinylbenzene 
copolymers, first chloromethylated then aminated with trimethylamine, 
having an average particle size of not more than 2.0 microns.
    (b) The additive shall contain no more than 3.0 percent nonvolatile, 
soluble extractives when tested as follows: One hundred grams of the 
additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear 
supernatant is removed from the compacted solids and concentrated to 
approximately 10 grams on a steam bath. The 10-gram sample is again 
centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble 
material. The supernatant from the second centrifugation is then removed 
from any compacted solids and dried to constant residual weight using a 
steam bath. The percent nonvolatile solubles is obtained by dividing the 
weight of the dried residue by the weight of the solids in the original 
resin dispersion.
    (c) The additive is used as a decolorizing and clarification agent 
for treatment of refinery sugar liquors and juices at levels not to 
exceed 500 parts of additive solids per million parts of sugar solids.

[50 FR 29209, July 18, 1985]



Sec. 173.73  Sodium polyacrylate.

    Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is produced by the polymerization of acrylic acid 
and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium 
hydroxide solution. As determined by a method entitled ``Determination 
of Weight Average and Number Average Molecular Weight of Sodium 
Polyacrylate'', which is incorporated by reference in accordance with 5 
U.S.C. 552(a), the additive has--
    (1) A weight average molecular weight of 2,000 to 2,300; and
    (2) A weight average molecular weight to number average molecular 
weight ratio of not more than 1.3. Copies of the method are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C Street SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (b) The additive is used to control mineral scale during the 
evaporation of

[[Page 118]]

beet sugar juice or cane sugar juice in the production of sugar in an 
amount not to exceed 3.6 parts per million by weight of the raw juice.

[53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988]



Sec. 173.75  Sorbitan monooleate.

    Sorbitan monooleate may be safely used in accordance with the 
following prescribed conditions:
    (a) The additive is produced by the esterification of sorbitol with 
commercial oleic acid.
    (b) It meets the following specifications:
    (1) Saponification number, 145-160.
    (2) Hydroxyl number, 193-210.
    (c) The additive is used or intended for use as follows:
    (1) As an emulsifier in polymer dispersions that are used in the 
clarification of cane or beet sugar juice or liquor in an amount not to 
exceed 7.5 percent by weight in the final polymer dispersion.
    (2) The additive is used in an amount not to exceed 0.70 part per 
million in sugar juice and 1.4 parts per million in sugar liquor.

[51 FR 11720, Apr. 7, 1986]



            Subpart B--Enzyme Preparations and Microorganisms



Sec. 173.110   Amyloglucosidase derived from Rhizopus niveus.

    Amyloglucosidase enzyme product, consisting of enzyme derived from 
Rhizopus niveus, and diatomaceous silica as a carrier, may be safely 
used in food in accordance with the following conditions:
    (a) Rhizopus niveus is classified as follows: Class, Phycomycetes; 
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus.
    (b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in 
man or other animals.
    (c) The enzyme is produced by a process which completely removes the 
organism Rhizopus niveus from the amyloglucosidase.
    (d) The additive is used or intended for use for degrading 
gelatinized starch into constituent sugars, in the production of 
distilled spirits and vinegar.
    (e) The additive is used at a level not to exceed 0.1 percent by 
weight of the gelatinized starch.



Sec. 173.120   Carbohydrase and cellulase derived from Aspergillus niger.

    Carbohydrase and cellulase enzyme preparation derived from 
Aspergillus niger may be safely used in food in accordance with the 
following prescribed conditions:
    (a) Aspergillus niger is classified as follows: Class, 
Deuteromycetes; order, Moniliales; family, Moniliaceae; genus, 
Aspergillus; species, niger.
    (b) The strain of Aspergillus niger is nonpathogenic and nontoxic in 
man or other animals.
    (c) The additive is produced by a process that completely removes 
the organism Aspergillus niger from the carbohydrase and cellulase 
enzyme product.
    (d) The additive is used or intended for use as follows:
    (1) For removal of visceral mass (bellies) in clam processing.
    (2) As an aid in the removal of the shell from the edible tissue in 
shrimp processing.
    (e) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect.



Sec. 173.130   Carbohydrase derived from Rhizopus oryzae.

    Carbohydrase from Rhizopus oryzae may be safely used in the 
production of dextrose from starch in accordance with the following 
prescribed conditions:
    (a) Rhizopus oryzae is classified as follows: Class, Phycomycetes; 
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus 
oryzae.
    (b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.
    (c) The carbohydrase is produced under controlled conditions to 
maintain nonpathogenicity and nontoxicity, including the absence of 
aflatoxin.
    (d) The carbohydrase is produced by a process which completely 
removes the organism Rhizopus oryzae from the carbohydrase product.
    (e) The carbohydrase is maintained under refrigeration from 
production to use and is labeled to include the necessity of 
refrigerated storage.

[[Page 119]]



Sec. 173.135   Catalase derived from Micrococcus lysodeikticus.

    Bacterial catalase derived from Micrococcus lysodeikticus by a pure 
culture fermentation process may be safely used in destroying and 
removing hydrogen peroxide used in the manufacture of cheese, in 
accordance with the following conditions.
    (a) The organism Micrococcus lysodeikticus from which the bacterial 
catalase is to be derived is demonstrated to be nontoxic and 
nonpathogenic.
    (b) The organism Micrococcus lysodeikticus is removed from the 
bacterial catalase prior to use of the bacterial catalase.
    (c) The bacterial catalase is used in an amount not in excess of the 
minimum required to produce its intended effect.



Sec. 173.140  Esterase-lipase derived from Mucor miehei.

    Esterase-lipase enzyme, consisting of enzyme derived from Mucor 
miehei var. Cooney et Emerson by a pure culture fermentation process, 
with maltodextrin or sweet whey as a carrier, may be safely used in food 
in accordance with the following conditions:
    (a) Mucor miehei var. Cooney et Emerson is classified as follows: 
Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, 
Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson.
    (b) The strain of Mucor miehei var. Cooney et Emerson is 
nonpathogenic and nontoxic in man or other animals.
    (c) The enzyme is produced by a process which completely removes the 
organism Mucor miehei var. Cooney et Emerson from the esterase-lipase.
    (d) The enzyme is used as a flavor enhancer as defined in 
Sec. 170.3(o)(12).
    (e) The enzyme is used at levels not to exceed current good 
manufacturing practice in the following food categories: cheeses as 
defined in Sec. 170.3(n)(5) of this chapter; fat and oils as defined in 
Sec. 170.(3)(n)(12) of this chapter; and milk products as defined in 
Sec. 170.(3)(n)(31) of this chapter. Use of this food ingredient is 
limited to nonstandarized foods and those foods for which the relevant 
standards of identity permit such use.
    (f) The enzyme is used in the minimum amount required to produce its 
limited technical effect.

[47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983]



Sec. 173.145   Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer.

    The food additive alpha-galactosidase and parent mycelial 
microorganism Mortierella vinaceae var. raffinoseutilizer may be safely 
used in food in accordance with the following conditions:
    (a) The food additive is the enzyme alpha-galactosidase and the 
mycelia of the microorganism Mortierella vinaceae var. raffinoseutilizer 
which produces the enzyme.
    (b) The nonpathogenic microorganism matches American Type Culture 
Collection (ATCC) No. 20034,1 and is classified as follows:
---------------------------------------------------------------------------

    1Available from: American Type Culture Collection, 12301 
Parklawn Drive, Rockville, MD 20852.

Class: Phycomycetes.
Order: Mucorales.
Family: Mortierellaceae.
Genus: Mortierella.
Species: vinaceae.
Variety: raffinoseutilizer.

    (c) The additive is used or intended for use in the production of 
sugar (sucrose) from sugar beets by addition as mycelial pellets to the 
molasses to increase the yield of sucrose, followed by removal of the 
spent mycelial pellets by filtration.
    (d) The enzyme removal is such that there are no enzyme or mycelial 
residues remaining in the finished sucrose.

[42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989]



Sec. 173.150   Milk-clotting enzymes, microbial.

    Milk-clotting enzyme produced by pure-culture fermentation process 
may be safely used in the production of cheese in accordance with the 
following prescribed conditions:
    (a) Milk-clotting enzyme is derived from one of the following 
organisms by a pure-culture fermentation process:
    (1) Endothia parasitica classified as follows: Class, Ascomycetes; 
order,

[[Page 120]]

Sphaeriales; family, Diaporthacesae; genus, Endothia; species, 
parasitica.
    (2) Bacillus cereus classified as follows: Class, Schizomycetes; 
order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species, 
cereus (Frankland and Frankland).
    (3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes; 
subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, 
Mucor; species, pusillus; variety, Lindt.
    (4) Mucor miehei Cooney et Emerson classified as follows: Class, 
Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, 
Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson.
    (b) The strains of organism identified in paragraph (a) of this 
section are nonpathogenic and nontoxic in man or other animals.
    (c) The additive is produced by a process that completely removes 
the generating organism from the milk-clotting enzyme product.
    (d) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect in the production of those 
cheeses for which it is permitted by standards of identity established 
pursuant to section 401 of the Act.

[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 173.160  Candida guilliermondii.

    The food additive Candida guilliermondii may be safely used as the 
organism for fermentation production of citric acid in accordance with 
the following conditions:
    (a) The food additive is the enzyme system of the viable organism 
Candida guilliermondii and its concomitant metabolites produced during 
the fermentation process.
    (b)(1) The nonpathogenic and nontoxicogenic organism descending from 
strain, American Type Culture Collection (ATCC) No. 20474,1 is 
classified as follows:
---------------------------------------------------------------------------

    1Available from: American Type Culture Collection, 12301 
Parklawn Drive, Rockville, MD 20852.

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: guilliermondii.
Variety: guilliermondii.

    (2) The toxonomic characteristics of the reference culture strain 
ATCC No. 20474 agree in the essentials with the standard description for 
Candida guilliermondii variety guilliermondii listed in ``The Yeasts--A 
Toxonomic Study;'' 2d Ed. (1970), by Jacomina Lodder, which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c)(1) The additive is used or intended for use as a pure culture in 
the fermentation process for the production of citric acid using an 
acceptable aqueous carbohydrate substrate.
    (2) The organism Candida quilliermondii is made nonviable and is 
completely removed from the citric acid during the recovery and 
purification process.
    (d) The additive is so used that the citric acid produced conforms 
to the specifications of the ``Food Chemicals Codex,'' 3d Ed. (1981), 
under ``Citric acid,'' pp. 86-87, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register., 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 173.165  Candida lipolytica.

    The food additive Candida lipolytica may be safely used as the 
organism for fermentation production of citric acid in accordance with 
the following conditions:
    (a) The food additive is the enzyme system of the organism Candida 
lipolytica and its concimitant metabolites produced during the 
fermentation process.

[[Page 121]]

    (b)(1) The nonpathogenic organism is classified as follows:

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: lipolytica.

    (2) The taxonomic characteristics of the culture agree in essential 
with the standard description for Candida lipolytica variety lipolytica 
listed in ``The Yeasts--A Toxonomic Study,'' 2d Ed. (1970), by Jacomina 
Lodder, which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) The additive is used or intended for use as a pure culture in 
the fermentation process for the production of citric acid from purified 
normal alkanes.
    (d) The additive is so used that the citric acid produced conforms 
to the specifications of the ``Food Chemicals Codex,'' 3d Ed. (1981), 
pp. 86-87, which is incorporated by reference. Copies may be obtained 
from the National Academy Press, 2101 Constitution Ave. NW., Washington, 
DC 20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Wasington, DC 20408. The additive 
meets the following ultraviolet absorbance limits when subjected to the 
analytical procedure described in this paragraph:

------------------------------------------------------------------------
      Ultraviolet absorbance per centimeter path length         Maximum 
------------------------------------------------------------------------
280 to 289 millimicrons.....................................        0.25
290 to 299 millimicrons.....................................        0.20
300 to 359 millimicrons.....................................        0.13
360 to 400 millimicrons.....................................        0.03
------------------------------------------------------------------------

                  Analytical Procedure for Citric Acid

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of citric acid samples in handling is 
essential to assure absence of any extraneous material arising from 
inadequate packaging. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                apparatus

    1. Aluminum foil, oil free.
    2. Separatory funnels, 500-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    3. Chromatographic tubes: (a) 80-millimeter ID x 900-millimeter 
length equipped with tetrafluoroethylene polymer stopcock and course 
fritted disk; (b) 18-millimeter ID x 300-millimeter length equipped with 
tetrafluoroethylene polymer stopcock.
    4. Rotary vacuum evaporator, Buchi or equivalent.
    5. Spectrophotometer--Spectral range 250-400 nanometers with 
spectral slit width of 2 nanometers or less; under instrument operating 
conditions for these absorbance measurements, the spectrophotometer 
shall also meet the following performance requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Wavelength repeatability, plus-minus0.2 nanometer.
    Wavelength accuracy, plus-minus1.0 nanometer.
    The spectrophotometer is equipped with matched 1 centimeter path 
length quartz microcuvettes with 0.5-milliliter volume capacity.
    6. Vacuum oven, minimum inside dimensions: 200 mm  x  200 mm  x  300 
mm deep.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
methyl alcohol, isooctane, benzene, hexane and 1,2-dichloroethane 
designated in the list following this paragraph shall pass the following 
test:
    The specified quantity of solvent is added to a 250-milliliter round 
bottom flask containing 0.5 milliliter of purified n-hexadecane and 
evaporated on the rotary evaporator at 45 deg. C to constant volume. Six 
milliliters of purified isooctane are added to this residue and 
evaporated under the same conditions as above for 5 minutes. Determine 
the absorbance of the residue compared to purified n-hexadecane as 
reference. The absorbance of the solution of the solvent residue shall 
not exceed 0.03 per centimeter

[[Page 122]]

path length between 280 and 299 nanometers and 0.01 per centimeter path 
length between 300 and 400 nanometers.
    Methyl alcohol, A.C.S. reagent grade. Use 100 milliliters for the 
test described in the preceding paragraph. If necessary, methyl alcohol 
may be purified by distillation through a Virgreaux column discarding 
the first and last ten percent of the distillate or otherwise.
    Benzene, spectrograde (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If 
necessary, benzene may be purified by distillation or otherwise.
    Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the 
test. If necessary, isooctane may be purified by passage through a 
column of activated silica gel, distillation or otherwise.
    Hexane, spectrograde (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 100 milliliters for the test. If 
necessary, hexane may be purified by distillation or otherwise.
    1,2-Dichloroethane, spectrograde (Matheson, Coleman and Bell, East 
Rutherford, N.J., or equivalent). Use 100 milliliters for the test. If 
necessary, 1,2-dichloroethane may be purified by distillation or 
otherwise.

                            eluting mixtures

    1. 10 percent 1,2-dichloroethane in hexane. Prepare by mixing the 
purified solvents in the volume ratio of 1 part of 1,2-dichloroethane to 
9 parts of hexane.
    2. 40 percent benzene in hexane. Prepare by mixing the purified 
solvents in the volume ratio of 4 parts of benzene to 6 parts of hexane.
    n-Hexadecane, 99 percent olefin-free. Determine the absorbance 
compared to isooctane as reference. The absorbance per centimeter path 
length shall not exceed 0.00 in the range of 280-400 nanometers. If 
necessary, n-hexadecane may be purified by percolation through activated 
silica gel, distillation or otherwise.
    Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore, 
MD, or equivalent). Activate as follows: Slurry 900 grams of silica gel 
reagent with 2 liters of purified water in a 3-liter beaker. Cool the 
mixture and pour into a 80  x  900 chromatographic column with coarse 
fritted disc. Drain the water, wash with an additional 6 liters of 
purified water and wash with 3,600 milliliters of purified methyl 
alcohol at a relatively slow rate. Drain all of the solvents and 
transfer the silica gel to an aluminum foil-lined drying dish. Place 
foil over the top of the dish. Activate in a vacuum oven at low vacuum 
(approximately 750 millimeters Mercury or 27 inches of Mercury below 
atmospheric pressure) at 173 deg. to 177 deg. C for at least 20 hours. 
Cool under vacuum and store in an amber bottle.
    Sodium sulfate, anhydrous, A.C.S. reagent grade. This reagent should 
be washed with purified isooctane. Check the purity of this reagent as 
described in Sec. 172.886 of this chapter.
    Water, purified. All water used must meet the specifications of the 
following test:
    Extract 600 milliliters of water with 50 milliliters of purified 
isooctane. Add 1 milliliter of purified n-hexadecane to the isooctane 
extract and evaporate the resulting solution to 1 milliliter. The 
absorbance of this residue shall not exceed 0.02 per centimeter path 
length between 300-400 nanometers and 0.03 per centimeter path length 
between 280-299 nanometers. If necessary, water may be purified by 
distillation, extraction with purified organic solvents, treatment with 
an absorbent (e.g., activated carbon) followed by filtration of the 
absorbent or otherwise.

                                procedure

    Separate portions of 200 milliliters of purified water are taken 
through the procedure for use as control blanks. Each citric acid sample 
is processed as follows: Weigh 200 grams of anhydrous citric acid into a 
500 milliliter flask and dissolve in 200 milliliters of pure water. Heat 
the solution to 60 deg. C and transfer to a 500 milliliter separatory 
funnel. Rinse the flask with 50 milliliters of isooctane and add the 
isooctane to the separatory funnel. Gently shake the mixture 90 times 
(caution: vigorous shaking will cause emulsions) with periodic release 
of the pressure caused by shaking.
    Allow the phases to separate for at least 5 minutes. Draw off the 
lower aqueous layer into a second 500-milliliter separatory funnel and 
repeat the extraction with a second aliquot of 50 milliliters of 
isooctane. After separation of the layers, draw off and discard the 
water layer. Combine both isooctane extracts in the funnel containing 
the first extract. Rinse the funnel which contained the second extract 
with 10 milliliters of isooctane and add this portion to the combined 
isooctane extract.
    A chromatographic column containing 5.5 grams of silica gel and 3 
grams of anhydrous sodium sulfate is prepared for each citric acid 
sample as follows: Fit 18  x  300 column with a small glass wool plug. 
Rinse the inside of the column with 10 milliliters of purified 
isooctane. Drain the isooctane from the column. Pour 5.5 grams of 
activated silica gel into the column. Tap the column approximately 20 
times on a semisoft, clean surface to settle the silica gel. Carefully 
pour 3 grams of anhydrous sodium sulfate onto the top of the silica gel 
in the column.
    Carefully drain the isooctane extract of the citric acid solution 
into the column in a series of additions while the isooctane is draining 
from the column at an elution rate of approximately 3 milliliters per 
minute. Rinse the separatory funnel with 10

[[Page 123]]

milliliters of isooctane after the last portion of the extract has been 
applied to the column and add this rinse to the column. After all of the 
extract has been applied to the column and the solvent layer reaches the 
top of the sulfate bed, rinse the column with 25 milliliters of 
isooctane followed by 10 milliliters of a 10-percent dichloroethane in 
hexane solution. For each rinse solution, drain the column until the 
solvent layer reaches the top of the sodium sulfate bed. Discard the 
rinse solvents. Place a 250-milliliter round bottom flask containing 0.5 
milliliter of purified n-hexadecane under the column. Elute the 
polynuclear aromatic hydrocarbons from the column with 30 milliliters of 
40-percent benzene in hexane solution. Drain the eluate until the 40-
percent benzene in the hexane solvent reaches the top of the sodium 
sulfate bed.
    Evaporate the 40-percent benzene in hexane eluate on the rotary 
vacuum evaporator at 45 deg. C until only the n-hexadecane residue of 
0.5 milliliter remains. Treat the n-hexadecane residue twice with the 
following wash step: Add 6 milliliters of purified isooctane and remove 
the solvents by vacuum evaporation at 45 deg. C to constant volume, 
i.e., 0.5 milliliter. Cool the n-hexadecane residue and transfer the 
solution to an 0.5-milliliter microcuvette. Determine the absorbance of 
this solution compared to purified n-hexadecane as reference. Correct 
the absorbance values for any absorbance derived from the control 
reagent blank. If the corrected absorbance does not exceed the limits 
prescribed, the samples meet the ultraviolet absorbance specifications.
    The reagent blank is prepared by using 200 milliliters of purified 
water in place of the citric acid solution and carrying the water sample 
through the procedure. The typical control reagent blank should not 
exceed 0.03 absorbance per centimeter path length between 280 and 299 
nanometers, 0.02 absorbance per centimeter path length between 300 and 
359 nanometers, and 0.01 absorbance per centimeter path length between 
360 and 400 nanometers.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 173.170  Aminoglycoside 3'-phosphotransferase II.

    The food additive aminoglycoside 3'-phosphotransferase II may be 
safely used in the development of genetically modified cotton, oilseed 
rape, and tomatoes in accordance with the following prescribed 
conditions:
    (a) The food additive is the enzyme aminoglycoside 3'-
phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the 
phosphorylation of certain aminoglycoside antibiotics, including 
kanamycin, neomycin, and gentamicin.
    (b) Aminoglycoside 3'-phosphotransferase II is encoded by the 
kanr gene originally isolated from transposon Tn5 of the 
bacterium Escherichia coli.
    (c) The level of the additive does not exceed the amount reasonably 
required for selection of plant cells carrying the kanr gene along 
with the genetic material of interest.

[59 FR 26711, May 23, 1994]



 Subpart C--Solvents, Lubricants, Release Agents and Related Substances



Sec. 173.210   Acetone.

    A tolerance of 30 parts per million is established for acetone in 
spice oleoresins when present therein as a residue from the extraction 
of spice.



Sec. 173.220   1,3-Butylene glycol.

    1,3-Butylene glycol (1,3-butanediol) may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The substance meets the following specifications:
    (1) 1,3-Butylene glycol content: Not less than 99 percent.
    (2) Specific gravity at 20/20 deg. C: 1.004 to 1.006.
    (3) Distillation range: 200 deg.-215 deg. C.
    (b) It is used in the minimum amount required to perform its 
intended effect.
    (c) It is used as a solvent for natural and synthetic flavoring 
substances except where standards of identity issued under section 401 
of the act preclude such use.



Sec. 173.228  Ethyl acetate.

    Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in 
accordance with the following conditions:
    (a) The additive meets the specifications of the Food Chemicals 
Codex,1

[[Page 124]]

(Ethyl Acetate; p. 372, 3d Ed., 1981), which are incorporated by 
reference.
---------------------------------------------------------------------------

    1 Copies may be obtained from: National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418 or examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
---------------------------------------------------------------------------

    (b) The additive is used in accordance with current good 
manufacturing practice as a solvent in the decaffeination of coffee and 
tea.

[47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984]



Sec. 173.230   Ethylene dichloride.

    A tolerance of 30 parts per million is established for ethylene 
dichloride in spice oleoresins when present therein as a residue from 
the extraction of spice; Provided, however, That if residues of other 
chlorinated solvents are also present the total of all residues of such 
solvents shall not exceed 30 parts per million.



Sec. 173.240   Isopropyl alcohol.

    Isopropyl alcohol may be present in the following foods under the 
conditions specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 50 parts per million.
    (b) In lemon oil as a residue in production of the oil, at a level 
not to exceed 6 parts per million.
    (c) In hops extract as a residue from the extraction of hops at a 
level not to exceed 2.0 percent by weight: Provided, That,
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of the 
isopropyl alcohol and provides for the use of the hops extract only as 
prescribed by paragraph (c)(1) of this section.



Sec. 173.250   Methyl alcohol residues.

    Methyl alcohol may be present in the following foods under the 
conditions specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 50 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent by weight; Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of methyl 
alcohol and provides for the use of the hops extract only as prescribed 
by paragraph (b)(1) of this section.



Sec. 173.255   Methylene chloride.

    Methylene chloride may be present in food under the following 
conditions:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 30 parts per million; Provided, That, if 
residues of other chlorinated solvents are also present, the total of 
all residues of such solvents shall not exceed 30 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent, Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract identifies the presence of the 
methylene chloride and provides for the use of the hops extract only as 
prescribed by paragraph (b)(1) of this section.
    (c) In coffee as a residue from its use as a solvent in the 
extraction of caffeine from green coffee beans, at a level not to exceed 
10 parts per million (0.001 percent) in decaffeinated roasted coffee and 
in decaffeinated soluble coffee extract (instant coffee).



Sec. 173.270   Hexane.

    Hexane may be present in the following foods under the conditions 
specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 25 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent by weight; Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of the 
hexane and provides for the use of the hops extract only as prescribed 
by paragraph (b)(1) of this section.



Sec. 173.275   Hydrogenated sperm oil.

    The food additive hydrogenated sperm oil may be safely used in 
accordance with the following prescribed conditions:

[[Page 125]]

    (a) The sperm oil is derived from rendering the fatty tissue of the 
sperm whale or is prepared by synthesis of fatty acids and fatty 
alcohols derived from the sperm whale. The sperm oil obtained by 
rendering is refined. The oil is hydrogenated.
    (b) It is used alone or as a component of a release agent or 
lubricant in bakery pans.
    (c) The amount used does not exceed that reasonably required to 
accomplish the intended lubricating effect.



Sec. 173.280   Solvent extraction process for citric acid.

    A solvent extraction process for recovery of citric acid from 
conventional Aspergillus niger fermentation liquor may be safely used to 
produce food-grade citric acid in accordance with the following 
conditions:
    (a) The solvent used in the process consists of a mixture of n-octyl 
alcohol meeting the requirements of Sec. 172.864 of this chapter, 
synthetic isoparaffinic petroleum hydrocarbons meeting the requirements 
of Sec. 172.882 of this chapter, and tridodecyl amine.
    (b) The component substances are used solely as a solvent mixture 
and in a manner that does not result in formation of products not 
present in conventionally produced citric acid.
    (c) The citric acid so produced meets the specifications of the 
``Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, which is 
incorporated by reference (copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408), and the polynuclear 
aromatic hydrocarbon specifications of Sec. 173.165.
    (d) Residues of n-octyl alcohol and synthetic isoparaffinic 
petroleum hydrocarbons are removed in accordance with good manufacturing 
practice. Current good manufacturing practice results in residues not 
exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm 
synthetic isoparaffinic petroleum hydrocarbons in citric acid.
    (e) Tridodecyl amine may be present as a residue in citric acid at a 
level not to exceed 100 parts per billion.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984]



Sec. 173.290   Trichloroethylene.

    Tolerances are established for residues of trichloroethylene 
resulting from its use as a solvent in the manufacture of foods as 
follows:

Decaffeinated ground coffee...............  25 parts per million.       
Decaffeinated soluble (instant) coffee      10 parts per million.       
 extract.                                                               
Spice oleoresins..........................  30 parts per million        
                                             (provided that if residues 
                                             of other chlorinated       
                                             solvents are also present, 
                                             the total of all residues  
                                             of such solvents in spice  
                                             oleoresins shall not exceed
                                             30 parts per million).     
                                                                        



                   Subpart D--Specific Usage Additives



Sec. 173.300   Chlorine dioxide.

    Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is generated by treating an aqueous solution of 
sodium chlorite with either chlorine gas or a mixture of sodium 
hypochlorite and hydrochloric acid. The generator effluent contains at 
least 90 percent (by weight) of chlorine dioxide with respect to all 
chlorine species as determined by Method 4500-ClO2 E in the 
``Standard Methods for the Examination of Water and Wastewater,'' 18th 
ed., 1992, or an equivalent method. Method 4500-ClO2 E is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food And Drug Administration, 200 C St., 
SW., Washington, DC 20204-0001 and The American Public Health 
Association, 1015 Fifteenth St., NW., Washington, DC 20005, or may be 
examined at the Office of the Federal Register, 800 North Capitol St., 
NW., suite 700, Washington, DC.
    (b) The additive may be used as an antimicrobial agent in water used 
in poultry processing in an amount not to

[[Page 126]]

exceed 3 parts per million (ppm) residual chlorine dioxide as determined 
by Method 4500-ClO2 E referenced above or an equivalent method.

[60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, 
as amended at 61 FR 14480, Apr. 2, 1996]



Sec. 173.310   Boiler water additives.

    Boiler water additives may be safely used in the preparation of 
steam that will contact food, under the following conditions:
    (a) The amount of additive is not in excess of that required for its 
functional purpose, and the amount of steam in contact with food does 
not exceed that required to produce the intended effect in or on the 
food.
    (b) The compounds are prepared from substances identified in 
paragraphs (c) and (d) of this section, and are subject to the 
limitations, if any, prescribed:
    (c) List of substances:

------------------------------------------------------------------------
             Substances                          Limitations            
------------------------------------------------------------------------
Acrylamide-sodium acrylate resin...  Contains not more than 0.05 percent
                                      by weight of acrylamide monomer.  
Acrylic acid/2-acrylamido-2-methyl   Total not to exceed 20 parts per   
 propane sulfonic acid copolymer      million (active) in boiler        
 having a minimum weight average      feedwater.                        
 molecular weight of 9,900 and a                                        
 minimum number average molecular                                       
 weight of 5,700 as determined by a                                     
 method entitled ``Determination of                                     
 Weight Average and Number Average                                      
 Molecular Weight of 60/40 AA/                                          
 AMPS'' (October 23, 1987), which                                       
 is incorporated by reference in                                        
 accordance with 5 U.S.C. 552(a).                                       
 Copies may be obtained from the                                        
 Center for Food Safety and Applied                                     
 Nutrition (HFS-200), Food and Drug                                     
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Office of the                                          
 Federal Register, 800 North                                            
 Capitol Street, NW., suite 700,                                        
 Washington, DC.                                                        
Ammonium alginate..................  ...................................
Cobalt sulfate (as catalyst).......  ...................................
1-hydroxyethylidene-1,1-             ...................................
 diphosphonic acid (CAS Reg. No.                                        
 2809-21-4) and its sodium and                                          
 potassium salts.                                                       
Lignosulfonic acid.................  ...................................
Monobutyl ethers of polyethylene-    Minimum mol. wt. 1,500.            
 polypropylene glycol produced by                                       
 random condensation of a 1:1                                           
 mixture by weight of ethylene                                          
 oxide and propylene oxide with                                         
 butanol.                                                               
Poly(acrylic acid-co-                Total not to exceed 1.5 parts per  
 hypophosphite), sodium salt (CAS     million in boiler feed water.     
 Reg. No. 71050-62-9), produced       Copolymer contains not more than  
 from a 4:1 to a 16:1 mixture by      0.5 percent by weight of acrylic  
 weight of acrylic acid and sodium    acid monomer (dry weight basis).  
 hypophosphite.                                                         
Polyethylene glycol................  As defined in Sec.  172.820 of this
                                      chapter.                          
Polymaleic acid [CAS Reg. No. 26099- Total not to exceed 1 part per     
 09-2], and/or its sodium salt.       million in boiler feed water      
 [CAS Reg. No. 30915-61-8 or CAS      (calculated as the acid).         
 Reg. No. 70247-90-4].                                                  
Polyoxypropylene glycol............  Minimum mol. wt. 1,000.            
Potassium carbonate................  ...................................
Potassium tripolyphosphate.........  ...................................
Sodium acetate.....................  ...................................
Sodium alginate....................  ...................................
Sodium aluminate...................  ...................................
Sodium carbonate...................  ...................................
Sodium carboxymethylcellulose......  Contains not less than 95 percent  
                                      sodium carboxymethylcellulose on a
                                      dry-weight basis, with maximum    
                                      substitution of 0.9               
                                      carboxymethylcellulose groups per 
                                      anhydroglucose unit, and with a   
                                      minimum viscosity of 15           
                                      centipoises for 2 percent by      
                                      weight aqueous solution at 25 C;  
                                      by method prescribed in the ``Food
                                      Chemicals Codex,'' 3d Ed. (1981), 
                                      pp. 280-282, which is incorporated
                                      by reference. Copies may be       
                                      obtained from the National Academy
                                      Press, 2101 Constitution Ave. NW.,
                                      Washington, DC 20418, or may be   
                                      examined at the Office of the     
                                      Federal Register, 800 North       
                                      Capitol Street, NW., suite 700,   
                                      Washington, DC 20408.             
Sodium glucoheptonate..............  Less than 1 part per million       
                                      cyanide in the sodium             
                                      glucoheptonate.                   
Sodium hexametaphosphate...........  ...................................
Sodium humate......................  ...................................
Sodium hydroxide...................  ...................................
Sodium lignosulfonate..............  ...................................
Sodium metabisulfite...............  ...................................
Sodium metasilicate................  ...................................

[[Page 127]]

                                                                        
Sodium nitrate.....................  ...................................
Sodium phosphate (mono-, di-, tri-)  ...................................
Sodium polyacrylate................  ...................................
Sodium polymethacrylate............  ...................................
Sodium silicate....................  ...................................
Sodium sulfate.....................  ...................................
Sodium sulfite (neutral or           ...................................
 alkaline).                                                             
Sodium tripolyphosphate............  ...................................
Tannin (including quebracho          ...................................
 extract).                                                              
Tetrasodium EDTA...................  ...................................
Tetrasodium pyrophosphate..........  ...................................
------------------------------------------------------------------------


------------------------------------------------------------------------
               Substances                           Limitations         
------------------------------------------------------------------------
Cyclohexylamine.........................  Not to exceed 10 parts per    
                                           million in steam, and        
                                           excluding use of such steam  
                                           in contact with milk and milk
                                           products.                    
Diethylaminoethanol.....................  Not to exceed 15 parts per    
                                           million in steam, and        
                                           excluding use of such steam  
                                           in contact with milk and milk
                                           products.                    
Hydrazine...............................  Zero in steam.                
Morpholine..............................  Not to exceed 10 parts per    
                                           million in steam, and        
                                           excluding use of such steam  
                                           in contact with milk and milk
                                           products.                    
Octadecylamine..........................  Not to exceed 3 parts per     
                                           million in steam, and        
                                           excluding use of such steam  
                                           in contact with milk and milk
                                           products.                    
Trisodium nitrilotriacetate.............  Not to exceed 5 parts per     
                                           million in boiler feedwater; 
                                           not to be used where steam   
                                           will be in contact with milk 
                                           and milk products.           
------------------------------------------------------------------------

    (e) To assure safe use of the additive, in addition to the other 
information required by the Act, the label or labeling shall bear:
    (1) The common or chemical name or names of the additive or 
additives.
    (2) Adequate directions for use to assure compliance with all the 
provisions of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 
FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 
1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 
15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 
1990; 61 FR 14245, Apr. 1, 1996]



Sec. 173.315   Chemicals used in washing or to assist in the lye peeling of fruits and vegetables.

    Chemicals may be safely used to wash or to assist in the lye peeling 
of fruits and vegetables in accordance with the following conditions:
    (a) The chemicals consist of one or more of the following:
    (1) Substances generally recognized as safe in food or covered by 
prior sanctions for use in washing fruits and vegetables.
    (2) Substances identified in this subparagraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
A mixture of alkylene oxide adducts of   May be used at a level not to  
 alkyl alcohols and phosphate esters of   exceed 0.2 percent in lye-    
 alkylene oxide adducts of alkyl          peeling solution to assist in 
 alcohols consisting of: -       the lye peeling of fruit and  
 alkyl (C12-C18)-omega-hydroxy-poly       vegetables.                   
 (oxyethylene) (7.5-8.5 moles)/poly                                     
 (oxypropylene) block copolymer having                                  
 an average molecular weight of 810;                                    
 -alkyl (C12-C18)-omega-                                       
 hydroxy-poly (oxyethylene) (3.3-3.7                                    
 moles) polymer having an average                                       
 molecular weight of 380, and                                           
 subsequently esterified with 1.25                                      
 moles phosphoric anhydride; and -alkyl (C10-C12)-omega-hydroxypoly                                   
 (oxyethylene) (11.9-12.9 moles)/poly                                   
 (oxypropylene) copolymer, having an                                    
 average molecular weight of 810, and                                   
 subsequently esterified with 1.25                                      
 moles phosphoric anhydride.                                            
Aliphatic acid mixture consisting of     May be used at a level not to  
 valeric, caproic, enanthic, caprylic,    exceed 1 percent in lye       
 and pelargonic acids.                    peeling solution to assist in 
                                          the lye peeling of fruits and 
                                          vegetables.                   
Polyacrylamide.........................  Not to exceed 10 p.p.m. in wash
                                          water. Contains not more than 
                                          0.2 percent acrylamide        
                                          monomer.                      
Potassium bromide......................                                 

[[Page 128]]

                                                                        
Sodium n-alkylbenzene-sulfonate (alkyl   Not to exceed 0.2 percent in   
 group predominantly C12 and C13 and      wash water. May be used in    
 not less than 95 percent C10 to C16).    washing or to assist in the   
                                          lye peeling of fruits and     
                                          vegetables.                   
Sodium dodecylbenzene-sulfonate (alkyl       Do.                        
 group predominantly C12 and not less                                   
 than 95% C10 to C16).                                                  
Sodium 2 ethyl-hexyl sulfate...........      Do.                        
Sodium hypochlorite....................  ...............................
Sodium mono- and di-methyl naphthalene   Not to exceed 0.2 percent in   
 sulfonates (mol. wt. 245-260).           wash water. May be used in the
                                          washing or to assist in the   
                                          lye peeling of fruits and     
                                          vegetables.                   
------------------------------------------------------------------------

    (3) Substances identified in this paragraph (a)(3) for use in flume 
water for washing sugar beets prior to the slicing operation and subject 
to the limitations as are provided for the level of the substances in 
the flume water:

------------------------------------------------------------------------
                 Substance                           Limitations        
------------------------------------------------------------------------
-Alkyl-omega-hydroxypoly-          Not to exceed 3 ppm.        
 (oxyethylene) produced by condensation of                              
 1 mole of C11-C15 straight chain randomly                              
 substituted secondary alcohols with an                                 
 average of 9 moles of ethylene oxide.                                  
Linear undecylbenzenesulfonic acid........      Do.                     
Dialkanolamide produced by condensing 1     Not to exceed 2 ppm.        
 mole of methyl laurate with 1.05 moles of                              
 diethanolamine..                                                       
Triethanolamine...........................      Do.                     
Ethylene glycol monobutyl ether...........  Not to exceed 1 ppm.        
Oleic acid conforming with Sec.  172.860        Do.                     
 of this chapter.                                                       
Tetrapotassium pyrophosphate..............  Not to exceed 0.3 ppm.      
Monoethanolamine..........................      Do.                     
Ethylene dichloride.......................  Not to exceed 0.2 ppm.      
Tetrasodium ethylenediaminetetraacetate...  Not to exceed 0.1 ppm.      
------------------------------------------------------------------------

    (b) The chemicals are used in amounts not in excess of the minimum 
required to accomplish their intended effect.
    (c) The use of the chemicals is followed by rinsing with potable 
water to remove, to the extent possible, residues of the chemicals.
    (d) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the act, the name of the 
additive or a statement of its composition.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to assure use in compliance with all provisions 
of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977; 
42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978]



Sec. 173.320  Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills.

    Agents for controlling microorganisms in cane-sugar and beet-sugar 
mills may be safely used in accordance with the following conditions:
    (a) They are used in the control of microorganisms in cane-sugar 
and/or beet-sugar mills as specified in paragraph (b) of this section.
    (b) They are applied to the sugar mill grinding, crusher, and/or 
diffuser systems in one of the combinations listed in paragraph (b) (1), 
(2), (3), or (5) of this section or as a single agent listed in 
paragraph (b)(4) or (6) of this section. Quantities of the individual 
additives in parts per million are expressed in terms of the weight of 
the raw cane or raw beets.
    (1) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                                  Parts 
                                                                   per  
                                                                 million
------------------------------------------------------------------------
Disodium cyanodithioimidocarbonate.............................      2.5
Ethylenediamine................................................      1.0
Potassium N-methyldithiocarbamate..............................      3.5
------------------------------------------------------------------------

    (2) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                                  Parts 
                                                                   per  
                                                                 million
------------------------------------------------------------------------
Disodium ethylenebisdithiocarbamate............................      3.0
Sodium dimethyldithiocarbamate.................................      3.0
------------------------------------------------------------------------

    (3) Combinations for cane-sugar mills and beet-sugar mills:

------------------------------------------------------------------------
                                                                  Parts 
                                                                   per  
                                                                 million
------------------------------------------------------------------------
(i) Disodium ethylenebisdithiocarbamate........................      3.0
Ethylenediamine................................................      2.0
Sodium dimethyldithiocarbamate.................................      3.0
(ii) Disodium cyanodithioimidocarbonate........................      2.9
Potassium N-methyldithiocarbamate..............................      4.1
------------------------------------------------------------------------


[[Page 129]]


    (4) Single additive for cane-sugar mills and beet-sugar mills.

                                                                        
------------------------------------------------------------------------
                                                 Parts per million      
------------------------------------------------------------------------
2,2-Dibromo-3-nitrilopropionamide (CAS     Not more than 10.0 and not   
 Reg. No. 10222-01-2). Limitations:         less than 2.0.              
 Byproduct molasses, bagasse, and pulp                                  
 containing residues of 2,2-dibromo-3-                                  
 nitrilopropionamide are not authorized                                 
 for use in animal feed..                                               
------------------------------------------------------------------------

    (5) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                             Parts per  
                                                              million   
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride.............  0.05
Sec. 173.322  Chemicals used in delinting cottonseed.

    Chemicals may be safely used to assist in the delinting of 
cottonseed in accordance with the following conditions:
    (a) The chemicals consist of one or more of the following:
    (1) Substances generally recognized as safe for direct addition to 
food.
    (2) Substances identified in this paragraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
alpha-Alkyl-omega-hydroxypoly-              May be used at an           
 (oxyethylene) produced by condensation of   application rate not to    
 a linear primary alcohol containing an      exceed 0.3 percent by      
 average chain length of 10 carbons with     weight of cottonseeds to   
 poly(oxyethylene) having an average of 5    enhance delinting of       
 ethylene oxide units.                       cottonseeds intended for   
                                             the production of          
                                             cottonseed oil. Byproducts 
                                             including lint, hulls, and 
                                             meal may be used in animal 
                                             feed.                      
An alkanomide produced by condensation of   May be used at an           
 coconut oil fatty acids and                 application rate not to    
 diethanolamine, CAS Reg. No. 068603-42-9.   exceed 0.2 percent by      
                                             weight of cottonseeds to   
                                             enhance delinting of       
                                             cottonseeds intended for   
                                             the production of          
                                             cottonseed oil. Byproducts 
                                             including lint, hulls, and 
                                             meal may be used in animal 
                                             feed.                      
------------------------------------------------------------------------


[47 FR 8346, Feb. 26, 1982]



Sec. 173.340   Defoaming agents.

    Defoaming agents may be safely used in processing foods, in 
accordance with the following conditions:
    (a) They consist of one or more of the following:
    (1) Substances generally recognized by qualified experts as safe in 
food or covered by prior sanctions for the use prescribed by this 
section.
    (2) Substances listed in this paragraph (a)(2) of this section, 
subject to any limitations imposed:

------------------------------------------------------------------------
             Substances                          Limitations            
------------------------------------------------------------------------
Dimethylpolysiloxane (substantially  10 parts per million in food, or at
 free from hydrolyzable chloride      such level in a concentrated food 
 and alkoxy groups; no more than 18   that when prepared as directed on 
 percent loss in weight after         the labels, the food in its ready-
 heating 4 hours at 200 deg. C;       for-consumption state will have   
 viscosity 300 to 1,050 centistokes   not more than 10 parts per million
 at 25 deg. C; refractive index       except as follows: Zero in milk;  
 1.400-1.404 at 25 deg. C).           110 parts per million in dry      
                                      gelatin dessert mixes labeled for 
                                      use whereby no more than 16 parts 
                                      per million is present in the     
                                      ready-to-serve dessert; 250 parts 
                                      per million in salt labeled for   
                                      cooking purposes, whereby no more 
                                      than 10 parts per million is      
                                      present in the cooked food.       
Formaldehyde.......................  As a preservative in defoaming     
                                      agents containing                 
                                      dimethylpolysiloxane, in an amount
                                      not exceeding 1.0 percent of the  
                                      dimethylpolysiloxane content.     

[[Page 130]]

                                                                        
-Hydro-omega-hydroxy-poly   For use as prescribed in Sec.      
 (oxyethylene)/poly(oxypropylene)     172.808(b)(3) of this chapter.    
 (minimum 15 moles)/                                                    
 poly(oxyethylene) block copolymer                                      
 (CAS Reg. No. 9003-11-6) as                                            
 defined in Sec.  172.808(a)(3) of                                      
 this chapter.                                                          
Polyacrylic acid, sodium salt......  As a stabilizer and thickener in   
                                      defoaming agents containing       
                                      dimethylpolysiloxane in an amount 
                                      reasonably required to accomplish 
                                      the intended effect.              
Polyethylene glycol................  As defined in Sec.  172.820 of this
                                      chapter.                          
Polyoxyethylene 40 monostearate....  As defined in U.S.P. XVI.          
Polysorbate 60.....................  As defined in Sec.  172.836 of this
                                      chapter.                          
Polysorbate 65.....................  As defined in Sec.  172.838 of this
                                      chapter.                          
Propylene glycol alginate..........  As defined in Sec.  172.858 of this
                                      chapter.                          
Silicon dioxide....................  As defined in Sec.  172.480 of this
                                      chapter.                          
Sorbitan monostearate..............  As defined in Sec.  172.842 of this
                                      chapter.                          
White mineral oil: Conforming with   As a component of defoaming agents 
 Sec.  172.878 of this chapter.       for use in wash water for sliced  
                                      potatoes at a level not to exceed 
                                      0.008 percent of the wash water.  
------------------------------------------------------------------------


------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
Aluminum stearate......................  As defined in Sec.  172.863 of 
                                          this chapter.                 
Butyl stearate.........................  ...............................
BHA....................................  As an antioxidant, not to      
                                          exceed 0.1 percent by weight  
                                          of defoamer.                  
BHT....................................      Do.                        
Calcium stearate.......................  As defined in Sec.  172.863 of 
                                          this chapter.                 
Fatty acids............................  As defined in Sec.  172.860 of 
                                          this chapter.                 
Formaldehyde...........................  As a preservative.             
Hydroxylated lecithin..................  As defined in Sec.  172.814 of 
                                          this chapter.                 
Isopropyl alcohol......................  ...............................
Magnesium stearate.....................  As defined in Sec.  172.863 of 
                                          this chapter.                 
Mineral oil: Conforming with Sec.        Not more than 150 p.p.m. in    
 172.878 of this chapter.                 yeast, measured as            
                                          hydrocarbons.                 
Odorless light petroleum hydrocarbons:   ...............................
 Conforming with Sec.  172.884 of this                                  
 chapter.                                                               
Petrolatum: Conforming with Sec.         ...............................
 172.880 of this chapter.                                               
Petroleum wax: Conforming with Sec.      ...............................
 172.886 of this chapter.                                               
Petroleum wax, synthetic...............  ...............................
Polyethylene glycol (400)dioleate:       As an emulsifier not to exceed 
 Conforming with Sec.  172.820(a)(2) of   10 percent by weight of       
 this chapter and providing the oleic     defoamer formulation.         
 acid used in the production of this                                    
 substance complies with Sec.  172.860                                  
 or Sec.  172.862 of this chapter.                                      
Synthetic isoparaffinic petroleum        ...............................
 hydrocarbons: Conforming with Sec.                                     
 172.882 of this chapter.                                               
Oleic acid derived from tall oil fatty   Complying with Sec.  172.862 of
 acids.                                   this chapter.                 
Oxystearin.............................  As defined in Sec.  172.818 of 
                                          this chapter.                 
Polyoxyethylene (600) dioleate.........  ...............................
Polyoxyethylene (600) monoricinoleate..  ...............................
Polypropylene glycol...................  Molecular weight range, 1,200- 
                                          3,000.                        
Polysorbate 80.........................  As defined in Sec.  172.840 of 
                                          this chapter.                 
Potassium stearate.....................  As defined in Sec.  172.863 of 
                                          this chapter.                 
Propylene glycol mono- and diesters of   As defined in Sec.  172.856 of 
 fats and fatty acids.                    this chapter.                 
Soybean oil fatty acids, hydroxylated..  ...............................
Tallow, hydrogenated, oxidized or        ...............................
 sulfated.                                                              
Tallow alcohol, hydrogenated...........  ...............................
------------------------------------------------------------------------


[[Page 131]]


    (4) The substance listed in this paragraph (a)(4), provided it is a 
component of defoaming agents limited to use in processing beet sugar 
only, and subject to the limitations imposed:

------------------------------------------------------------------------
                 Substance                           Limitations        
------------------------------------------------------------------------
n-Butoxypoly(oxyethylene)-                  Viscosity range, 4,850-5,350
 poly(oxypropylene)glycol.                   Saybolt Universal Seconds  
                                             (SUS) at 37.8 C (100 F).   
                                             The viscosity range is     
                                             determined by the method   
                                             ``Viscosity Determination  
                                             of n-                      
                                             butoxypoly(oxyethylene)-   
                                             poly(oxypropylene) glycol''
                                             dated April 26, 1995,      
                                             developed by Union Carbide 
                                             Corp., P.O. Box 670, Bound 
                                             Brook, NJ 08805, which is  
                                             incorporated by reference  
                                             in accordance with 5 U.S.C.
                                             552(a) and 1 CFR part 51.  
                                             Copies of the material     
                                             incorporated by reference  
                                             are available from the     
                                             Division of Petition       
                                             Control, Center for Food   
                                             Safety and Applied         
                                             Nutrition (HFS-215), Food  
                                             and Drug Administration,   
                                             200 C St. SW., Washington, 
                                             DC 20204, and may be       
                                             examined at the Center for 
                                             Food Safety and Applied    
                                             Nutrition's Library, 200 C 
                                             St. SW., rm. 3321,         
                                             Washington, DC, or at the  
                                             Office of the Federal      
                                             Register, 800 North Capitol
                                             St. NW., suite 700,        
                                             Washington, DC.            
------------------------------------------------------------------------

    (b) They are added in an amount not in excess of that reasonably 
required to inhibit foaming.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 
FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 
19, 1995; 61 FR 632, Jan. 9, 1996]



Sec. 173.342  Chlorofluorocarbon 113 and perfluorohexane.

    A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-
1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon 
113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No. 
355-42-0) may be safely used in accordance with the following prescribed 
conditions:
    (a) The additive chlorofluorocarbon 113 has a purity of not less 
than 99.99 percent.
    (b) The additive mixture is intended for use to quickly cool or 
crust-freeze chickens sealed in intact bags composed of substances 
regulated in parts 174, 175, 177, 178, and Sec. 179.45 of this chapter 
and conforming to any limitations or specifications in such regulations.


[55 FR 8913, Mar. 9, 1990]



Sec. 173.345   Chloropentafluoroethane.

    The food additive chloropentafluoroethane may be safely used in food 
in accordance with the following prescribed conditions:
    (a) The food additive has a purity of not less than 99.97 percent, 
and contains not more than 200 parts per million saturated fluoro 
compounds and 10 parts per million unsaturated fluoro compounds as 
impurities.
    (b) The additive is used or intended for use alone or with one or 
more of the following substances: Carbon dioxide, nitrous oxide, 
propane, and octafluorocyclobutane complying with Sec. 173.360, as an 
aerating agent for foamed or sprayed food products, with any propellant 
effect being incidental and no more than is minimally necessary to 
achieve the aerating function, except that use is not permitted for 
those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive
    (1) The label of the food additive container shall bear, in addition 
to the other information required by the act, the following:
    (i) The name of the additive, chloropentafluoroethane.
    (ii) The percentage of the additive present in the case of a 
mixture.
    (iii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978; 
43 FR 14644, Apr. 7, 1978]



Sec. 173.350   Combustion product gas.

    The food additive combustion product gas may be safely used in the 
processing and packaging of the foods designated in paragraph (c) of 
this section for the purpose of removing and displacing oxygen in 
accordance with the following prescribed conditions:

[[Page 132]]

    (a) The food additive is manufactured by the controlled combustion 
in air of butane, propane, or natural gas. The combustion equipment 
shall be provided with an absorption-type filter capable of removing 
possible toxic impurities, through which all gas used in the treatment 
of food shall pass; and with suitable controls to insure that any 
combustion products failing to meet the specifications provided in this 
section will be prevented from reaching the food being treated.
    (b) The food additive meets the following specifications:
    (1) Carbon monoxide content not to exceed 4.5 percent by volume.
    (2) The ultraviolet absorbance in isooctane solution in the range 
255 millimicrons to 310 millimicrons not to exceed one-third of the 
standard reference absorbance when tested as described in paragraph (e) 
of this section.
    (c) It is used or intended for use to displace or remove oxygen in 
the processing, storage, or packaging of beverage products and other 
food, except fresh meats.
    (d) To assure safe use of the additive in addition to the other 
information required by the act, the label or labeling of the combustion 
device shall bear adequate directions for use to provide a combustion 
product gas that complies with the limitations prescribed in paragraph 
(b) of this section, including instructions to assure proper filtration.
    (e) The food additive is tested for compliance with paragraph (b)(2) 
by the following empirical method:

    Spectrophotometric measurements. All measurements are made in an 
ultraviolet spectrophotometer in optical cells of 5 centimeters in 
length, and in the range of 255 millimicrons to 310 millimicrons, under 
the same instrumental conditions. The standard reference absorbance is 
the absorbance at 275 millimicrons of a standard reference solution of 
naphthalene (National Bureau of Standards Material No. 577 or equivalent 
in purity) containing a concentration of 1.4 milligrams per liter in 
purified isooctane, measured against isooctane of the same spectral 
purity in 5-centimeter cells. (This absorbance will be approximately 
0.30.)
    Solvent. The solvent used is pure grade isooctane having an 
ultraviolet absorbance not to exceed 0.05 measured against distilled 
water as a reference. Upon passage of purified inert gas through some 
isooctane under the identical conditions of the test, a lowering of the 
absorbance value has been observed. The absorbance of isooctane to be 
used in this procedure shall not be more than 0.02 lower in the range 
255 millimicrons to 310 millimicrons, inclusive, than that of the 
untreated solvent as measured in a 5-centimeter cell. If necessary to 
obtain the prescribed purities, the isooctane may be passed through 
activated silica gel.
    Apparatus. To assure reproducible results, the additive is passed 
into the isooctane solution through a gas-absorption train consisting of 
the following components and necessary connections:
    1. A gas flow meter with a range up to 30 liters per hour provided 
with a constant differential relay or other device to maintain a 
constant flow rate independent of the input pressure.
    2. An absorption apparatus consisting of an inlet gas dispersion 
tube inserted to the bottom of a covered cylindrical vessel with a 
suitable outlet on the vessel for effluent gas. The dimensions and 
arrangement of tube and vessel are such that the inlet tube introduces 
the gas at a point not above 5\1/4\ inches below the surface of the 
solvent through a sintered glass outlet. The dimensions of the vessel 
are such, and both inlet and vessel are so designed, that the gas can be 
bubbled through 60 milliliters of isooctane solvent at a rate up to 30 
liters per hour without mechanical loss of solvent. The level 
corresponding to 60 milliliters should be marked on the vessel.
    3. A cooling bath containing crushed ice and water to permit 
immersion of the absorption vessel at least to the solvent level mark.
    Caution. The various parts of the absorption train must be connected 
by gas-tight tubing and joints composed of materials which will neither 
remove components from nor add components to the gas stream. The gas 
source is connected in series to the flow-rate device, the flow meter, 
and the absorption apparatus in that order. Ventilation should be 
provided for the effluent gases which may contain carbon monoxide.
    Sampling procedure. Immerse the gas-absorption apparatus containing 
60 milliliters of isooctane in the coolant bath so that the solvent is 
completely immersed. Cool for at least 15 minutes and then pass 120 
liters of the test gas through the absorption train at a rate of 30 
liters per hour or less. Maintain the coolant bath at 0 deg. C 
throughout. Remove the absorption vessel from the bath, disconnect, and 
warm to room temperature. Add isooctane to bring the contents of the 
absorption vessel to 60 milliliters, and mix. Determine the absorbance 
of the solution in the 5-centimeter cell in the range 255 millimicrons 
to 310 millimicrons, inclusive, compared to isooctane. The absorbance of 
the solution of combustion product gas shall not exceed that of the 
isooctane solvent at any wavelength in the specified range by

[[Page 133]]

more than one-third of the standard reference absorbance.



Sec. 173.355   Dichlorodifluoromethane.

    The food additive dichlorodifluoromethane may be safely used in food 
in accordance with the following prescribed conditions:
    (a) The additive has a purity of not less than 99.97 percent.
    (b) It is used or intended for use, in accordance with good 
manufacturing practice, as a direct-contact freezing agent for foods.
    (c) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to the other 
information required by the act, the following:
    (i) The name of the additive, dichlorodifluoromethane, with or 
without the parenthetical name ``Food Freezant 12''.
    (ii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



Sec. 173.357  Materials used as fixing agents in the immobilization of enzyme preparations.

    Fixing agents may be safely used in the immobilization of enzyme 
preparations in accordance with the following conditions:
    (a) The materials consist of one or more of the following:
    (1) Substances generally recognized as safe in food.
    (2) Substances identified in this subparagraph and subject to such 
limitations as are provided:

                                                                        
------------------------------------------------------------------------
              Substances                          Limitations           
------------------------------------------------------------------------
Cellulose triacetate.................  May be used as a fixing material 
                                        in the immobilization of lactase
                                        for use in reducing the lactose 
                                        content of milk.                
Diethylaminoethyl-cellulose..........  May be used as a fixing material 
                                        in the immobilization of glucose
                                        isomerase enzyme preparations   
                                        for use in the manufacture of   
                                        high fructose corn syrup, in    
                                        accordance with Sec.  184.1372  
                                        of this chapter.                
Glutaraldehyde.......................      Do.                          
Periodic acid (CAS Reg. No. 10450-60-                                   
 9)..                                                                   
Polyethylenimine reaction product      May be used as a fixing material 
 with 1,2-dichloroethane (CAS Reg.No.   in the immobilization of        
 68130-97-2) is the reaction product    glucoamylase enzyme preparations
 of homopolymerization of               from  Aspergillus niger for use 
 ethylenimine in aqueous hydrochloric   in the manufacture of beer.     
 acid at 100 C and of cross-linking    May be used as a fixing material 
 with 1,2-dichloroethane. The           in the immobilization of:       
 finished polymer has an average        1. Glucose isomerase enzyme     
 molecular weight of 50,000 to 70,000   preparations for use in the     
 as determined by gel permeation        manufacture of high fructose    
 chromatography. The analytical         corn syrup, in accordance with  
 method is entitled ``Methodology for   Sec.  184.1372 of this chapter. 
 Molecular Weight Detection of          2. Glucoamylase enzyme          
 Polyethylenimine,'' which is           preparations from  Aspergillus  
 incorporated by reference in           niger for use in the manufacture
 accordance with 5 U.S.C. 552(a) and    of beer. Residual ethylenimine  
 1 CFR part 51. Copies may be           in the finished polyethylenimine
 obtained from the Division of          polymer will be less than 1 part
 Petition Control, Center for Food      per million as determined by gas
 Safety and Applied Nutrition (HFS-     chromatography-mass             
 215), 200 C St. SW., Washington, DC    spectrometry. The residual      
 20204, and may be examined at the      ethylenimine is determined by an
 Center for Food Safety and Applied     analytical method entitled      
 Nutrition's Library, 200 C St. SW.,    ``Methodology for Ethylenimine  
 rm. 3321, Washington, DC, or at the    Detection in Polyethylenimine,''
 Office of the Federal Register, 800    which is incorporated by        
 North Capitol St. NW., suite 700,      reference in accordance with 5  
 Washington, DC..                       U.S.C. 552(a) and 1 CFR part 51.
                                        Residual 1,2-dichloroethane in  
                                        the finished polyethylenimine   
                                        polymer will be less than 1 part
                                        per million as determined by gas
                                        chromatography. The residual 1,2-
                                        dichloroethane is determined by 
                                        an analytical method entitled,  
                                        ``Methodology for               
                                        Ethylenedichloride Detection in 
                                        Polyethylenimine,'' which is    
                                        incorporated by reference in    
                                        accordance with 5 U.S.C. 552(a) 
                                        and 1 CFR part 51. Copies may be
                                        obtained from the Division of   
                                        Petition Control, Center for    
                                        Food Safety and Applied         
                                        Nutrition (HFS-215), 200 C St.  
                                        SW., Washington, DC 20204, or   
                                        may be examined at the Center   
                                        for Food Safety and Applied     
                                        Nutrition's Library, 200 C St.  
                                        SW., rm. 3321, Washington, DC,  
                                        or the Office of the Federal    
                                        Register, 800 North Capitol St. 
                                        NW., suite 700, Washington, DC. 
------------------------------------------------------------------------

    (b) The fixed enzyme preparation is washed to remove residues of the 
fixing materials.

[48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 
FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 
1996]



Sec. 173.360   Octafluorocyclobutane.

    The food additive octafluorocyclo-butane may be safely used as a 
propellant and aerating agent in foamed or sprayed food products in 
accordance with the following conditions:

[[Page 134]]

    (a) The food additive meets the following specifications:

    99.99 percent octafluorocyclobutane.
    Less than 0.1 part per million fluoroolefins, calculated as 
perfluoroisobutylene.

    (b) The additive is used or intended for use alone or with one or 
more of the following substances: Carbon dioxide, nitrous oxide, and 
propane, as a propellant and aerating agent for foamed or sprayed food 
products, except for those standardized foods that do not provide for 
such use.
    (c) To assure safe use of the additive:
    (1) The label of the food additive container shall bear, in addition 
to the other information required by the act, the following:
    (i) The name of the additive, octafluorocyclobutane.
    (ii) The percentage of the additive present in the case of a 
mixture.
    (iii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



Sec. 173.385   Sodium methyl sulfate.

    Sodium methyl sulfate may be present in pectin in accordance with 
the following conditions.
    (a) It is present as the result of methylation of pectin by sulfuric 
acid and methyl alcohol and subsequent treatment with sodium 
bicarbonate.
    (b) It does not exceed 0.1 percent by weight of the pectin.



Sec. 173.395  Trifluoromethane sulfonic acid.

    Trifluoromethane sulfonic acid has the empirical formula CF!3 
SO!3 H (CAS Reg. No. 1493-13-6). The catalyst (Trifluoromethane 
sulfonic acid) may safely be used in the production of cocoa butter 
substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see 
Sec. 184.1259 of this chapter) in accordance with the following 
conditions:
    (a) The catalyst meets the following specifications:

Appearance, Clear liquid.
Color, Colorless to amber.
Neutralization equivalent, 147-151.
Water, 1 percent maximum.
Fluoride ion, 0.03 percent maximum.
Heavy metals (as Pb), 30 parts per million maximum.
Arsenic (as As), 3 parts per million maximum.

    (b) It is used at levels not to exceed 0.2 percent of the reaction 
mixture to catalyze the directed esterification.
    (c) The esterification reaction is quenched with steam and water and 
the catalyst is removed with the aqueous phase. Final traces of catalyst 
are removed by washing batches of the product three times with an 
aqueous solution of 0.5 percent sodium bicarbonate.
    (d) No residual catalyst may remain in the product at a detection 
limit of 0.2 part per million fluoride as determined by the method 
described in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' sections 25.049-25.055, 13th Ed. (1980), 
which is incorporated by reference. Copies may be obtained from the 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 
54 FR 24897, June 12, 1989]



Sec. 173.400  Dimethyldialkylammonium chloride.

    Dimethyldialkylammonium chloride may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is produced by one of the following methods:
    (1) Ammonolysis of natural tallow fatty acids to form amines that 
are subsequently reacted with methyl chloride to form the quaternary 
ammonium compounds consisting primarily of dimethyldioctadecylammonium 
chloride and dimethyldihexadecylammonium chloride. The additive may 
contain residues of isopropyl alcohol not in excess of 18 percent by 
weight when used as a processing solvent.
    (2) Ammonolysis of natural tallow fatty acids to form amines that 
are then reacted with 2-ethylhexanal, reduced, methylated, and 
subsequently reacted with methyl chloride to form the quaternary 
ammonium compound

[[Page 135]]

known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride 
and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium 
chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride.
    (b) The food additive described in paragraph (a)(1) of this section 
contains not more than a total of 2 percent by weight of free amine and 
amine hydrochloride. The food additive described in paragraph (a)(2) of 
this section contains not more than 3 percent by weight, each, of free 
amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, 
``Acid Value and Free Amine Value of Fatty Quaternary Ammonium 
Chlorides,'' 2d printing including additions and revisions 1990, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, and from the American Oil Chemists' Society, 
P.O. Box 5037, Station A, Champaign, IL 61820, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (c) The food additive is used as a decolorizing agent in the 
clarification of refinery sugar liquors under the following limitations:
    (1) The food additive described in paragraph (a)(1) of this section 
is added only at the defecation/clarification stage of sugar liquor 
refining in an amount not to exceed 700 parts per million by weight of 
sugar solids.
    (2) The food additive described in paragraph (a)(2) of this section 
is used under the following conditions:
    (i) The additive is adsorbed onto a support column composed of 
suitable polymers that are regulated for contact with aqueous food. 
Excess nonadsorbed additive shall be rinsed away with potable water 
prior to passage of sugar liquor through the column.
    (ii) The residue of the additive in the decolorized sugar liquor 
prior to crystallization shall not exceed 1 part per million of sugar as 
determined by a method entitled ``Colorimetric Determination of Residual 
Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar 
Solutions,'' June 13, 1990, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to other information required by 
the Federal Food, Drug, and Cosmetic Act, adequate directions to assure 
use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]



PART 174--INDIRECT FOOD ADDITIVES: GENERAL--Table of Contents




Sec.
174.5  General provisions applicable to indirect food additives.
174.6  Threshold of regulation for substances used in food-contact 
          articles.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).



Sec. 174.5   General provisions applicable to indirect food additives.

    (a) Regulations prescribing conditions under which food additive 
substances may be safely used predicate usage under conditions of good 
manufacturing practice. For the purpose of this part and parts 175, 176, 
and 177 of this chapter, good manufacturing practice shall be defined to 
include the following restrictions:
    (1) The quantity of any food additive substance that may be added to 
food as a result of use in articles that contact food shall not exceed, 
where no limits are specified, that which results from use of the 
substance in an amount not more than reasonably required to accomplish 
the intended physical or technical effect in the food-contact article; 
shall not exceed any prescribed limitations; and shall not be intended 
to accomplish any physical or technical effect in the food itself, 
except as such may be permitted by regulations in parts 170 through 189 
of this chapter.

[[Page 136]]

    (2) Any substance used as a component of articles that contact food 
shall be of a purity suitable for its intended use.
    (b) The existence in the subchapter B of a regulation prescribing 
safe conditions for the use of a substance as an article or component of 
articles that contact food shall not be construed to relieve such use of 
the substance or article from compliance with any other provision of the 
Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-
packaging material were found on appropriate test to impart odor or 
taste to a specific food product such as to render it unfit within the 
meaning of section 402(a)(3) of the Act, the regulation would not be 
construed to relieve such use from compliance with section 402(a)(3).
    (c) The existence in this subchapter B of a regulation prescribing 
safe conditions for the use of a substance as an article or component of 
articles that contact food shall not be construed as implying that such 
substance may be safely used as a direct additive in food.
    (d) Substances that under conditions of good manufacturing practice 
may be safely used as components of articles that contact food include 
the following, subject to any prescribed limitations:
    (1) Substances generally recognized as safe in or on food.
    (2) Substances generally recognized as safe for their intended use 
in food packaging.
    (3) Substances used in accordance with a prior sanction or approval.
    (4) Substances permitted for use by regulations in this part and 
parts 175, 176, 177, 178 and Sec. 179.45 of this chapter.

[42 FR 14534, Mar. 15, 1977]



Sec. 174.6  Threshold of regulation for substances used in food-contact articles.

    Substances used in food-contact articles (e.g., food-packaging or 
food-processing equipment) that migrate, or that may be expected to 
migrate, into food at negligible levels may be reviewed under 
Sec. 170.39 of this chapter. The Food and Drug Administration will 
exempt substances whose uses it determines meet the criteria in 
Sec. 170.39 of this chapter from regulation as food additives and, 
therefore, a food additive petition will not be required for the 
exempted use.

[60 FR 36596, July 17, 1995]



PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS--Table of Contents




                          Subpart A--[Reserved]

      Subpart B--Substances for Use Only as Components of Adhesives

Sec.
175.105  Adhesives.
175.125  Pressure-sensitive adhesives.

         Subpart C--Substances for Use as Components of Coatings

175.210  Acrylate ester copolymer coatings.
175.230  Hot-melt strippable food coatings.
175.250  Paraffin (synthetic).
175.260  Partial phosphoric acid esters of polyester resins.
175.270  Poly(vinyl fluoride) resins.
175.300  Resinous and polymeric coatings.
175.320  Resinous and polymeric coatings for polyolefin films.
175.350  Vinyl acetate/crotonic acid copolymer.
175.360  Vinylidene chloride copolymer coatings for nylon film.
175.365  Vinylidene chloride copolymer coatings for polycarbonate film.
175.380  Xylene-formaldehyde resins condensed with 4,4'-
          isopropylidenediphenol-epichlorohydrin epoxy resins.
175.390  Zinc-silicon dioxide matrix coatings.

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    Source: 42 FR 14534, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 175 appear at 61 FR 
14482, Apr. 2, 1996.



                          Subpart A  [Reserved]



      Subpart B--Substances for Use Only as Components of Adhesives



Sec. 175.105   Adhesives.

    (a) Adhesives may be safely used as components of articles intended 
for use in packaging, transporting, or holding food in accordance with 
the following prescribed conditions:
    (1) The adhesive is prepared from one or more of the optional 
substances

[[Page 137]]

named in paragraph (c) of this section, subject to any prescribed 
limitations.
    (2) The adhesive is either separated from the food by a functional 
barrier or used subject to the following additional limitations:
    (i) In dry foods. The quantity of adhesive that contacts packaged 
dry food shall not exceed the limits of good manufacturing practice.
    (ii) In fatty and aqueous foods. (a) The quantity of adhesive that 
contacts packaged fatty and aqueous foods shall not exceed the trace 
amount at seams and at the edge exposure between packaging laminates 
that may occur within the limits of good manufacturing practice.
    (b) Under normal conditions of use the packaging seams or laminates 
will remain firmly bonded without visible separation.
    (b) To assure safe usage of adhesives, the label of the finished 
adhesive container shall bear the statement ``food-packaging adhesive''.
    (c) Subject to any limitation prescribed in this section and in any 
other regulation promulgated under section 409 of the Act which 
prescribes safe conditions of use for substances that may be employed as 
constituents of adhesives, the optional substances used in the 
formulation of adhesives may include the following:
    (1) Substances generally recognized as safe for use in food or food 
packaging.
    (2) Substances permitted for use in adhesives by prior sanction or 
approval and employed under the specific conditions of use prescribed by 
such sanction or approval.
    (3) Flavoring substances permitted for use in food by regulations in 
this part, provided that such flavoring substances are volatilized from 
the adhesives during the packaging fabrication process.
    (4) Color additives approved for use in food.
    (5) Substances permitted for use in adhesives by other regulations 
in this subchapter and substances named in this subparagraph: Provided, 
however, That any substance named in this paragraph and covered by a 
specific regulation in this subchapter, must meet any specifications in 
such regulation.

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
Abietic acid...........................  ...............................
Acetone................................  ...............................
Acetone-formaldehyde condensate (CAS     ...............................
 Reg. No. 25619-09-4).                                                  
Acetone-urea-formaldehyde resin........  ...............................
N-Acetyl ethanolamine..................  ...............................
Acetyl tributyl citrate................  ...............................
Acetyl triethyl citrate................  ...............................
Albumin, blood.........................  ...............................
(2-Alkenyl) succinic anhydrides in       ...............................
 which the alkenyl groups are derived                                   
 from olefins which contain not less                                    
 than 78 percent C30 and higher groups                                  
 (CAS Reg. No. 70983-55-0).                                             
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy)      ...............................
 ethoxy]ethyl] disodium sulfosuccinate.                                 
1-Alkyl (C6-C18) amino-3-amino-propane   ...............................
 monoacetate.                                                           
Alkylated (C4 and/or C8) phenols.......  ...............................
Alkyl (C7-C12) benzene.................  ...............................
Alkyl (C10-C20) dimethylbenzyl ammonium  ...............................
 chloride.                                                              
n-Alkyl(C12, C14, C16, or C18) dimethyl  For use as preservative only.  
 (ethylbenzyl) ammonium                                                 
 cyclohexylsulfamate.                                                   
Alkyl ketene dimers as described in      ...............................
 Sec.  176.120 of this chapter.                                         
Alkyl (C7-C12) naphthalene.............  ...............................
alpha Olefin sulfonate [alkyl group is   ...............................
 in the range of C10-C18 with not less                                  
 than 50 percent C14-C16], ammonium,                                    
 calcium, magnesium, potassium, and                                     
 sodium salts.                                                          
2-[(2-aminoethyl)amino]ethanol (CAS      ...............................
 Reg. No. 111-41-1).                                                    
3-Aminopropanediol.....................  For use only in the preparation
                                          of polyurethane resins.       
Aluminum...............................  ...............................
Aluminum acetate.......................  ...............................
Aluminum di(2-ethylhexoate)............  ...............................
Aluminum potassium silicate............  ...............................
N--Aminoethyl-gamma-            ...............................
 aminopropyl trimethoxysilane.                                          
3-(Aminomethyl)-3,5,5-                   ...............................
 trimethylcyclohexylamine.                                              
Aminomethylpropanol....................  ...............................
Ammonium benzoate......................  For use as preservative only.  

[[Page 138]]

                                                                        
Ammonium bifluoride....................  For use only as bonding agent  
                                          for aluminum foil, stabilizer 
                                          or preservative. Total        
                                          fluoride from all sources not 
                                          to exceed 1 percent by weight 
                                          of the finished adhesive.     
Ammonium borate........................  ...............................
Ammonium citrate.......................  ...............................
Ammonium persulfate....................  ...............................
Ammonium polyacrylate..................  ...............................
Ammonium potassium hydrogen phosphate..  ...............................
Ammonium silico-fluoride...............  For use only as bonding agent  
                                          for aluminum foil, stabilizer,
                                          or preservative. Total        
                                          fluoride from all sources not 
                                          to exceed 1 percent by weight 
                                          of the finished adhesive.     
Ammonium sulfamate.....................  ...............................
Ammonium thiocyanate...................  ...............................
Ammonium thiosulfate...................  ...............................
Amyl acetate...........................  ...............................
Anhydroenneaheptitol...................  ...............................
Animal glue as described in Sec.         ...............................
 178.3120 of this chapter.                                              
2-Anthraquinone sulfonic acid, sodium    For use only as polymerization-
 salt.                                    control agent.                
Antimony oxide.........................  ...............................
Asbestos...............................  ...............................
Asphalt, paraffinic and naphthenic.....  ...............................
Azelaic acid...........................  ...............................
Azo-bis-isobutyronitrile...............  ...............................
Balata rubber..........................  ...............................
Barium acetate.........................  ...............................
Barium peroxide........................  ...............................
Barium sulfate.........................  ...............................
Bentonite..............................  ...............................
Benzene (benzol).......................  ...............................
1,4-Benzenedicarboxylic acid, bis[2-     For use as a stabilizer.       
 (1,1-dimethylethyl)-6-[[3-(1,1-                                        
 dimethylethyl)-2-hydroxy-5-                                            
 methylphenyl]methyl]-4-methyl-                                         
 phenyl]ester (CAS Reg. No. 57569-40-1)                                 
1,2-Benzisothiazolin-3-one (CAS          For use as preservative only.  
 Registry No. 2634-33-5).                                               
Benzothiazyldisulfide..................  ...............................
p-Benzoxyphenol........................  For use as preservative only.  
Benzoyl peroxide.......................  ...............................
Benzyl alcohol.........................  ...............................
Benzyl benzoate........................  ...............................
Benzyl bromoacetate....................  For use as preservative only.  
p-Benzyloxyphenol......................      Do.                        
BHA (butylated hydroxyanisole).........  ...............................
BHT (butylated hydroxytoluene).........  ...............................
Bicyclo[2.2.1]hept-2-ene-6-methyl        ...............................
 acrylate.                                                              
2-Biphenyl diphenyl phosphate..........  ...............................
Bis(benzoate-O)(2-propanolato)aluminum   For use only as a reactant in  
 (CAS Reg. No. 105442-85-1)               the preparation of polyester  
                                          resins.                       
1,2-Bis(3,5-di-tert-butyl-4-             For use at a level not to      
 hydroxyhydrocinnamoyl)hy-drazine (CAS    exceed 2 percent by weight of 
 Reg. No. 32687-78-8).                    the adhesive.                 
1,3-Bis(2-benzothiazolylmercaptomethyl)  ...............................
 urea.                                                                  
4,4'-Bis(,-            ...............................
 dimethylbenzyl)diphenylamine.                                          
2,6-Bis(1,1-dimethylethyl)-4-(1-         For use as an antioxidant and/ 
 methylpropyl)phenol (CAS Reg. No.        or stabilizer only.           
 17540-75-9).                                                           
2,6-Bis (1-methylheptadecyl)-p-cresol..  ...............................
4-[[4, 6-Bis(octylthio)6-                ...............................
 Bis(octylthio)6-Bis(octylthio)-s-                                      
 triazin-2-yl]amino]-2,6-di-tert-                                       
 butylphenol (CAS Reg. No. 991-84-4).                                   
Bis(tri-n-butyltin) oxide..............  For use as preservative only.  
Bis(trichloromethyl)sulfone C.A.             Do.                        
 Registry No. 3064-70-8.                                                
Borax..................................  ...............................
Boric acid.............................  ...............................
2-Bromo-2-nitro-1, 3-propanediol (CAS    For use only as an             
 Reg. No. 52-51-7).                       antibacterial preservative.   
1,3-Butanediol.........................  ...............................
1,4-Butanediol.........................  ...............................
1,4-Butanediol modified with adipic      ...............................
 acid.                                                                  
Butoxy polyethylene polyproplyene        ...............................
 glycol (molecular weight 900-4,200).                                   
Butyl acetate..........................  ...............................
Butyl acetyl ricinoleate...............  ...............................
Butyl alcohol..........................  ...............................
Butylated reaction product of p-cresol   As identified in Sec.          
 and dicyclopentadiene.                   178.2010(b) of this chapter.  
Butylated, styrenated cresols            ...............................
 identified in Sec.  178.2010(b) of                                     
 this chapter.                                                          
Butyl benzoate.........................  ...............................
Butyl benzyl phthalate.................  ...............................
Butyldecyl phthalate...................  ...............................

[[Page 139]]

                                                                        
1,3-Butylene glycoldiglycolic acid       ...............................
 copolymer.                                                             
tert-Butyl hydroperoxide...............  ...............................
4,4'-Butylidenebis(6-tert-butyl-m-       ...............................
 cresol).                                                               
Butyl lactate..........................  ...............................
Butyloctyl phthalate...................  ...............................
p-tert-Butylphenyl salicylate..........  ...............................
Butyl phthalate butyl glycolate........  ...............................
p-tert-Butylpyrocatechol...............  For use only as polymerization-
                                          control agent.                
Butyl ricinoleate......................  ...............................
Butyl rubber polymer...................  ...............................
Butyl stearate.........................  ...............................
Butyl titanate, polymerized............  ...............................
Butyraldehyde..........................  ...............................
Calcium ethyl acetoacetate.............  ...............................
Calcium nitrate........................  ...............................
Calcium metasilicate...................  ...............................
Camphor................................  ...............................
Camphor fatty acid esters..............  ...............................
Candelilla wax.........................  ...............................
epsilon-Caprolactam-(ethylene-ethyl      ...............................
 acrylate) graft polymer.                                               
Carbon black, channel process..........  ...............................
Carbon disulfide-1,1'-                   ...............................
 methylenedipiperidine reaction product.                                
Carbon tetrachloride...................  ...............................
Carboxymethylcellulose.................  ...............................
Castor oil, polyoxyethylated (4-84       ...............................
 moles ethylene oxide).                                                 
Cellulose acetate butyrate.............  ...............................
Cellulose acetate propionate...........  ...............................
Ceresin wax (ozocerite)................  ...............................
Cetyl alcohol..........................  ...............................
Chloracetamide.........................  ...............................
Chloral hydrate........................  ...............................
Chlorinated liquid n-paraffins with      ...............................
 chain lengths of C10-C17, containing                                   
 40-70 percent chlorine by weight.                                      
Chlorinated pyridine mixture with        For use as preservative only.  
 active ingredients consisting of                                       
 2,3,5,6-tetrachloro-4-(methylsulfonyl)                                 
 pyridine, 2,3,5,6-tetrachloro-4-                                       
 (methylsulfinyl) pyridine and                                          
 pentachloropyridine.                                                   
Chlorinated rubber polymer (natural      ...............................
 rubber polymer containing                                              
 approximately 67 percent chlorine).                                    
1-(3-Chloroallyl)-3,5,7-triaza-1-        For use as preservative only.  
 azoniaadamantane chloride.                                             
Chlorobenzene..........................  ...............................
4-Chloro-3,5-dimethylphenol (p-chloro-m- For use as preservative only.  
 xylenol).                                                              
4-Chloro-3-methylphenol................      Do.                        
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only as an             
 (CAS Reg. No. 26172-55-4) and 2-methyl-  antimicrobial agent in polymer
 4-isothiazolin-3-one (CAS Reg. No.       latex emulsions.              
 2682-20-4) mixture at a ratio of 3                                     
 parts to 1 part, manufactured from                                     
 methyl-3-mercaptopropionate (CAS Reg.                                  
 No. 2935-90-2). The mixture may                                        
 contain magnesium nitrate (CAS Reg.                                    
 No. 10377-60-3) at a concentration                                     
 equivalent to the isothiazolone active                                 
 ingredients (weight/weight).                                           
Chloroform.............................  ...............................
Chloroprene............................  ...............................
Chromium caseinate.....................  ...............................
Chromium nitrate.......................  ...............................
Chromium potassium sulfate.............  ...............................
Cobaltous acetate......................  ...............................
Coconut fatty acid amine salt of         For use as preservative only.  
 tetrachlorophenol.                                                     
Copal..................................  ...............................
Copper 8-quinolinolate.................  For use as preservative only.  
Coumarone-indene resin.................  ...............................
Cresyl diphenyl phosphate..............  ...............................
Cumene hydroperoxide...................  ...............................
Cyanoguanidine.........................  ...............................
Cyclized rubber as identified in Sec.    ...............................
 176.170(b)(2) of this chapter.                                         
Cyclohexane............................  ...............................
1,4-Cyclohexanedimethanoldibenzoate      ...............................
 (CAS Reg. No. 35541-81-2).                                             
Cyclohexanol...........................  ...............................
Cyclohexanone resin....................  ...............................
Cyclohexanone-formaldehyde condensate..  ...............................
N-Cyclohexyl p-toluene sulfonamide.....  ...............................
(5-Cyclopentadienyl)-(6-isopropylbenzene)iron(II)           photoinitiator.               
 hexafluorophosphate (CAS Reg. No.                                      
 32760-80-8).                                                           
Damar..................................  ...............................
Defoaming agents as described in Sec.    ...............................
 176.210 of this chapter.                                               
Dehydroacetic acid.....................  ...............................

[[Page 140]]

                                                                        
Diacetone alcohol......................  ...............................
Diacetyl peroxide......................  ...............................
N,N'-Dialkoyl-4,4'-                      ...............................
 diaminodiphenylmethane mixtures where                                  
 the alkoyl groups are derived from                                     
 marine fatty acids (C12-C24).                                          
2,5-Di-tert-amylhydroquinone...........  ...............................
Diamines derived from dimerized          ...............................
 vegetable oil acids.                                                   
Diaryl-p-phenylenediamine, where the     ...............................
 aryl group may be phenyl, tolyl, or                                    
 xylyl.                                                                 
1,2-Dibromo-2,4-dicyanobutane (CAS       For use as a preservative only.
 Registry No. 3569-65-7).                                               
Di(butoxyethyl) phthalate..............  ...............................
2,5-Di-tert-butylhydroquinone..........  ...............................
Dibutyl maleate........................  ...............................
2,6-Di-tert-butyl-4-methylphenol.......  For use as preservative only.  
Di(C7, C9-alkyl)adipate................  ...............................
Dibutyl phthalate......................  ...............................
Dibutyl sebacate.......................  ...............................
Dibutyltin dilaurate for use only as a   ...............................
 catalyst for polyurethane resins.                                      
1,2-Dichloroethylene (mixed isomers)...  ...............................
Dicumyl peroxide.......................  ...............................
Dicyclohexyl phthalate.................  ...............................
Diethanolamine.........................  ...............................
Diethanolamine condensed with animal or  ...............................
 vegetable fatty acids.                                                 
Diethylamine...........................  ...............................
Diethylene glycol......................  ...............................
Diethylene glycol adipic acid copolymer  ...............................
Diethylene glycol dibenzoate...........  ...............................
Diethylene glycol hydrogenated           ...............................
 tallowate monoester.                                                   
Diethylene glycol laurate..............  ...............................
Diethylene glycol monobutyl ether......  ...............................
Diethylene glycol monobutyl ether        ...............................
 acetate.                                                               
Diethylene glycol monoethyl ether......  ...............................
Diethylene glycol monoethyl ether        ...............................
 acetate.                                                               
Diethylene glycol monomethyl ether.....  ...............................
Diethylene glycol monooleate...........  ...............................
Diethylene glycol monophenyl ether.....  ...............................
Diethylene glycol copolymer of adipic    ...............................
 acid and phthalic anhydride.                                           
Di(2-ethylhexyl) adipate...............  ...............................
Di(2-ethylhexyl)hexahydrophthalate.....  ...............................
Di(2-ethylhexyl)phthalate..............  ...............................
Diethyl oxalate........................  ...............................
Diethyl phthalate......................  ...............................
Dihexyl phthalate......................  ...............................
Dihydroabietylphthalate................  ...............................
Di(2-hydroxy-5-tert-butylphenyl)         ...............................
 sulfide.                                                               
2,2'-Dihydroxy-5,5'-                     ...............................
 dichlorodiphenylmethane                                                
 (dichlorophene).                                                       
4,5-Dihydroxy-2-imidazolidinone........  ...............................
4-(Diiodomethylsulfonyl) toluene CA      For use as an antifungal       
 Registry No.: 20018-09-01.               preservative only.            
Diisobutyl adipate.....................  ...............................
Diisobutyl ketone......................  ...............................
Diisobutylphenoxyethoxyethyl dimethyl    ...............................
 benzyl ammonium chloride.                                              
Diisobutyl phthalate...................  ...............................
Diisodecyl adipate.....................  ...............................
Diisodecyl phthalate...................  ...............................
Diisooctyl phthalate...................  ...............................
Diisopropylbenzene hydroperoxide.......  ...............................
N,N-Dimethylcyclohexylamine              ...............................
 dibutyldithiocarbamate.                                                
Dimethyl formamide.....................  ...............................
Dimethyl hexynol.......................  ...............................
2,2-Dimethyl-1,3-propanediol dibenzoate  ...............................
Dimethyl octynediol....................  ...............................
N-(1,1-dimethyl-3-oxobutyl) acrylamide.  ...............................
Dimethyl phthalate.....................  ...............................
3,5-Dimethyl-1,3,5,2H-                   For use as preservative only.  
 tetrahydrothiadiazine-2-thione.                                        
Di--naphthyl-p-                 ...............................
 phenylenediamine.                                                      
4,6-Dinonyl-o-cresol...................  ...............................
Dinonylphenol..........................  ...............................
Di-n-octyldecyl adipate................  ...............................
Dioctyldiphenylamine...................  ...............................
Dioctylphthalate.......................  ...............................
Dioctylsebacate........................  ...............................
Dioxane................................  ...............................
Dipentaerythritol pentastearate........  ...............................
Dipentamethylene-thiuram-tetrasulfide..  ...............................
Dipentene..............................  ...............................

[[Page 141]]

                                                                        
Dipentene resins.......................  ...............................
Dipentene-beta-pinene-styrene resins...                                 
Dipentene-styrene resin (CAS Registry    ...............................
 No. 64536-06-7).                                                       
Diphenyl-2-ethylhexyl phosphate........  ...............................
Diphenyl, hydrogen ated................  ...............................
N,N'-Diphenyl-p-phenylenediamine.......  ...............................
Diphenyl phthalate.....................  ...............................
1,3-Diphenyl-2-thiourea................  ...............................
Dipropylene glycol.....................  ...............................
Dipropylene glycol dibenzoate..........  ...............................
Dipropylene glycol monomethyl ether....  ...............................
Dipropylene glycol copolymer of adipic   ...............................
 acid and phthalic anhydride.                                           
Disodium cyanodithioimidocarbonate.....  ...............................
Disodium 4-isodecyl sulfosuccinate (CAS  ...............................
 Reg. No. 37294-49-8).                                                  
N,N'-Distearoylethylenediamine.........  ...............................
Distearyl thiodipropionate.............  ...............................
3,5-Di-tert-butyl-4-                     For use as antioxidant only.   
 hydroxyhydrocinnamic acid triester                                     
 with 1,3,5-tris(2-hydroxyethyl)-s-                                     
 triazine-2,4,6(1H, 3H, 5H)-trione.                                     
4,4'-Dithiodimorpholine................  ...............................
n-Dodecylmercaptan.....................  ...............................
tert-Dodecylmercaptan..................  ...............................
Dodecylphenoxybenzene-disulfonic acid    ...............................
 and/or its calcium, magnesium, and                                     
 sodium salts.                                                          
Elemi gum..............................  ...............................
Epichlorohydrin-4,4'-                    ...............................
 isopropylidenediphenol resin.                                          
Epichlorohydrin-4,4'-sec-                ...............................
 butylidenediphenol resin.                                              
Epichlorohydrin-4,4'-isopropylidene-di-  ...............................
 o-cresol resin.                                                        
Epichlorohydrin-phenolformaldehyde       ...............................
 resin.                                                                 
Erucamide (erucylamide)................  ...............................
Ethanolamine...........................  ...............................
Ethoxylated primary linear alcohols of   ...............................
 greater than 10 percent ethylene oxide                                 
 by weight having molecular weights of                                  
 390 to 7,000 (CAS Reg. No. 97953-22-5).                                
Ethoxypropanol butyl ether.............  ...............................
Ethyl alcohol (ethanol)................  ...............................
5-Ethyl-1,3-diglycidyl-5-                ...............................
 methylhydantoin (CAS Reg. No. 15336-82-                                
 0).                                                                    
Ethylene-acrylic acid-carbon monoxide    ...............................
 copolymer (CAS Reg. No. 97756-27-9).                                   
Ethylene-acrylic acid copolymer,         ...............................
 partial sodium salt containing no more                                 
 than 20 percent acrylic acid by                                        
 weight, and no more than 16 percent of                                 
 the acrylic acid as the sodium salt                                    
 (CAS Reg. No. 25750-82-7).                                             
Ethylenediamine........................  ...............................
Ethylenediaminetetra-acetic acid,        ...............................
 calcium, ferric, potassium, or sodium                                  
 salts, single or mixed.                                                
Ethylene dichloride....................  ...............................
Ethylene glycol........................  ...............................
Ethylene glycol monobutyl ether........  ...............................
Ethylene glycol monobutyl ether acetate  ...............................
Ethylene glycol monoethyl ether........  ...............................
Ethylene glycol monoethyl ether acetate  ...............................
Ethylene glycol monoethyl ether          ...............................
 ricinoleate.                                                           
Ethylene glycol monomethyl ether.......  ...............................
Ethylene glycol monophenyl ether.......  ...............................
Ethylene-carbon monoxide copolymer (CAS                                 
 Reg. No. 25052-62-4) containing not                                    
 more than 30 weight percent of the                                     
 units derived from carbon monoxide.                                    
Ethylene-maleic anhydride copolymer,     ...............................
 ammonium or potassium salt.                                            
Ethylene-methacrylic acid copolymer      ...............................
 partial salts: Ammonium, calcium,                                      
 magnesium, sodium, and/or zinc.                                        
Ethylene-methacrylic acid-vinyl acetate  ...............................
 copolymer partial salts: Ammonium,                                     
 calcium, magnesium, sodium, and/or                                     
 zinc.                                                                  
Ethylene-octene-1 copolymers containing                                 
 not less than 70 weight percent                                        
 ethylene (CAS Reg. No. 26221-73-8).                                    
Ethylene-propylene-dicyclopentadiene     ...............................
 copolymer rubber.                                                      
Ethylene, propylene, 1,4-hexadiene and   ...............................
 2,5-norbornadiene tetrapolymer.                                        
Ethylene-vinyl acetate carbon monoxide   ...............................
 terpolymer (CAS Registry No. 26337-35-                                 
 9) containing not more than 15 weight                                  
 percent of units derived from carbon                                   
 monoxide.                                                              
2,2'-Ethylidenebis (4,6-di-tert-         ...............................
 butylphenol) (CAS Reg. No. 35958-30-6).                                
Ethyl-p-hydroxybenzoate................  For use as preservative only.  
Ethyl hydroxyethylcellulose............  ...............................
Ethyl lactate..........................  ...............................
Ethyl phthalyl ethyl glycolate.........  ...............................
Ethyl-p-toluene sulfonamide............  ...............................

[[Page 142]]

                                                                        
Fats and oils derived from animal or     ...............................
 vegetable sources, and the                                             
 hydrogenated, sulfated, or sulfonated                                  
 forms of such fats and oils.                                           
Fatty acids derived from animal or                                      
 vegetable fats and oils; and salts of                                  
 such acids, single or mixed, as                                        
 follows:                                                               
  Aluminum.............................  ...............................
  Ammonium.............................  ...............................
  Calcium..............................  ...............................
  Magnesium............................  ...............................
  Potassium............................  ...............................
  Sodium...............................  ...............................
  Zinc.................................  ...............................
Ferric chloride........................  ...............................
Fluosilicic acid (hydrofluosilicic       For use only as bonding agent  
 acid).                                   for aluminum foil, stabilizer,
                                          or preservative. Total        
                                          fluoride from all sources not 
                                          to exceed 1 percent by weight 
                                          of the finished adhesive.     
Formaldehyde...........................  ...............................
Formaldehyde o- and p-toluene            ...............................
 sulfonamide.                                                           
Formamide..............................  ...............................
Fumaratochromium (III) nitrate.........  ...............................
Furfural...............................  ...............................
Furfuryl alcohol.......................  ...............................
Fumaric acid...........................  ...............................
gamma-Aminopropyltrimethoxysilane (CAS   ...............................
 Reg. No. 13822-56-5).                                                  
Glutaraldehyde.........................  ...............................
Glycerides, di- and monoesters.........  ...............................
Glycerol polyoxypropylene triol,         For use only in the preparation
 minimum average molecular weight 250     of polyester and polyurethane 
 (CAS Reg. No. 25791-96-2).               resins in adhesives.          
Glyceryl borate (glycol boriborate       ...............................
 resin).                                                                
Glyceryl ester of damar, copal, elemi,   ...............................
 and sandarac.                                                          
Glyceryl monobutyl ricinoleate.........  ...............................
Glyceryl monohydroxy stearate..........  ...............................
Glyceryl monohydroxy tallowate.........  ...............................
Glyceryl polyoxypropylene triol          ...............................
 (average molecular weight 1,000).                                      
Glyceryl tribenzoate...................  ...............................
Glycol diacetate.......................  ...............................
Glyoxal................................  ...............................
Heptane................................  ...............................
Hexamethylenetetramine.................  ...............................
Hexane.................................  ...............................
Hexanetriols...........................  ...............................
Hexylene glycol........................  ...............................
Hydroabietyl alcohol...................  ...............................
Hydrocarbon resins (produced by          ...............................
 polymerization of mixtures of mono-                                    
 and di-unsaturated hydrocarbons of the                                 
 aliphatic, alicyclic, and                                              
 monobenzenoid type derived both from                                   
 cracked petroleum and terpene stocks)                                  
 (CAS Reg. No. 68239-99-6).                                             
Hydrocarbon resins (produced by the      ...............................
 polymerization of styrene and alpha-                                   
 methyl styrene), hydrogenated (CAS                                     
 Reg. No. 68441-37-2).                                                  
Hydrofluoric acid......................  For use only as bonding agent  
                                          for aluminum foil, stabilizer,
                                          or preservative. Total        
                                          fluoride from all sources not 
                                          to exceed 1 percent by weight 
                                          of the finished adhesive.     
Hydrogen peroxide......................  ...............................
Hydrogenated dipentene resin (CAS Reg.   ...............................
 No. 106168-39-2).                                                      
Hydrogenated dipentene-styrene           ...............................
 copolymer resin (CAS Reg. No. 106168-                                  
 36-9).                                                                 
Hydrogenated-beta-pinene-alpha-pinene-   ...............................
 dipentene copolymer resin (CAS Reg.                                    
 No. 106168-37-0).                                                      
a-Hydro-omega-hydroxypoly-               For use only in the preparation
 (oxytetramethylene).                     of polyurethane resins.       
Hydroquinone...........................  ...............................
Hydroquinone monobenzyl ether..........  ...............................
Hydroquinone monoethyl ether...........  ...............................
2(2'-Hydroxy-3',5' di-tert-amylphenyl)   ...............................
 benzotriazole.                                                         
Hydroxyacetic acid.....................  ...............................
7-Hydroxycoumarin......................  ...............................
Hydroxyethylcellulose..................  ...............................
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2   ...............................
 alkyl (C6-C17) imidazolinium chloride.                                 
Hydroxyethyldiethylenetriamine.........  ...............................
-Hydroxyethyl pyridinium 2-     ...............................
 mercaptobenzothiazol.                                                  
Hydroxyethyl starch....................  ...............................
Hydroxyethylurea.......................  ...............................

[[Page 143]]

                                                                        
Hydroxylamine sulfate..................  ...............................
5-Hydroxymethoxymethyl-1-aza-3,7-        For use only as an             
 dioxabicyclo[3.3.0]octane, 5-            antibacterial preservative.   
 hydroxymethyl-1-aza-3,7-                                               
 dioxabicyclo[3.3.0]octane, and 5-                                      
 hydroxypoly-[methyleneoxy]methyl-1-aza-                                
 3,7-dioxabicyclo[3.3.0] octane mixture.                                
Hydroxypropyl methylcellulose..........  ...............................
2-(Hydroxymethyl)-2-methyl-1,3-          ...............................
 propanediol tribenzoate.                                               
2-Imidazolidinone......................  ...............................
3-Iodo-2-propynyl-N-butyl carbamate       For use only as an antifungal 
 (CAS Reg. No. 55406-53-6).               preservative.                 
Iodoform...............................  For use only as polymerization-
                                          control agent.                
Isoascorbic acid.......................  ...............................
Isobuytl alcohol (isobutanol)..........  ...............................
Isobutylene-isoprene copolymer.........  ...............................
Isodecyl benzoate (CAS Reg. No. 131298-  ...............................
 44-77).                                                                
Isophorone.............................  ...............................
Isopropanolamine (mono-, di-, tri-)....  ...............................
Isopropyl acetate......................  ...............................
Isopropyl alcohol (isopropanol)........  ...............................
Isopropyl-m- and p-cresol (thymol        ...............................
 derived).                                                              
4,4'-Isopropylidenediphenol............  ...............................
4,4'-Isopropylidenediphenol,             For use as preservative only.  
 polybutylated mixture.                                                 
Isopropyl peroxydicarbonate............  ...............................
p-Isopropoxy diphenylamine.............  ...............................
4,4'-Isopropylidene-bis(p-phenyleneoxy)- ...............................
 di-2-propanol.                                                         
Itaconic acid..........................  ...............................
Japan wax..............................  ...............................
Kerosene...............................  ...............................
Lauroyl peroxide.......................  ...............................
Lauroyl sulfate salts:                                                  
  Ammonium.............................  ...............................
  Magnesium............................  ...............................
  Potassium............................  ...............................
  Sodium...............................  ...............................
Lauryl alcohol.........................  ...............................
Lauryl pyridinium 5-chloro-2-            ...............................
 mercaptobenzothiazole.                                                 
Lignin calcium sulfonate...............  ...............................
Lignin sodium sulfonate................  ...............................
Linoleamide (linoleic acid amide)......  ...............................
Magnesium fluoride.....................  For use only as bonding agent  
                                          for aluminum foil, stabilizer,
                                          or preservative. Total        
                                          fluoride from all sources not 
                                          to exceed 1 percent by weight 
                                          of the finished adhesives.    
Magnesium glycerophosphate.............  ...............................
Maleic acid............................  ...............................
Maleic anhydride-diisobutylene           ...............................
 copolymer, ammonium or sodium salt.                                    
Manganese acetate......................  ...............................
Marine oil fatty acid soaps,             ...............................
 hydrogenated.                                                          
Melamine...............................  ...............................
Melamine-formaldehyde copolymer........  ...............................
2-Mercaptobenzothiazole................  ...............................
2-Mercaptobenzothiazole and dimethyl     For use as preservative only.  
 dithiocarbamic acid mixture, sodium                                    
 salt.                                                                  
2-Mercaptobenzothiazole, sodium or zinc  For use as preservative only.  
 salt.                                                                  
Methacrylate-chromic chloride complex,   ...............................
 ethyl or methyl ester.                                                 
p-Menthane hydroperoxide...............  ...............................
Methyl acetate.........................  ...............................
Methyl acetyl ricinoleate..............  ...............................
Methyl alcohol (methanol)..............  ...............................
Methylcellulose........................  ...............................
Methylene chloride.....................  ...............................
4,4'-Methylenebis(2,6-di-tert-           ...............................
 butylphenol).                                                          
2,2-Methylenebis (4-ethyl-6-tert-        ...............................
 butylphenol).                                                          
2,2-Methylenebis (4-methyl-6-            ...............................
 nonylphenol).                                                          
2,2-Methylenebis (4-methyl-6-tert-       ...............................
 butylphenol).                                                          
Methyl ethyl ketone....................  ...............................
Methyl ethyl ketone-formaldehyde         ...............................
 condensate.                                                            
2-Methylhexane.........................  ...............................
1-Methyl-2-hydroxy-4-isopropyl benzene.  ...............................
Methyl isobutyl ketone.................  ...............................
Methyl oleate..........................  ...............................
Methyl oleate-palmitate mixture........  ...............................
Methyl phthalyl ethyl glycolate........  ...............................
Methyl ricinoleate.....................  ...............................
Methyl salicylate......................  ...............................
a-Methylstyrene-vinyltoluene copolymer   ...............................
 resins (molar ratio 1 a methylstyrene                                  
 to 3 vinyltoluene).                                                    

[[Page 144]]

                                                                        
Methyl tallowate.......................  ...............................
Mineral oil............................  ...............................
Monochloracetic acid...................  ...............................
Monooctyldiphenylamine.................  ...............................
Montan wax.............................  ...............................
Morpholine.............................  ...............................
Myristic acid-chromic chloride complex.  ...............................
Myristyl alcohol.......................  ...............................
Naphtha................................  ...............................
Naphthalene, monosulfonated............  ...............................
Naphthalene sulfonic acid-formaldehyde   ...............................
 condensate, sodium salt.                                               
-Naphthylamine................  ...............................
,','',-Nitrobiphenyl................  ...............................
Nitrocellulose.........................  ...............................
2-Nitropropane.........................  ...............................
-(p-Nonylphenyl)-omega-         ...............................
 hydroxypoly (oxyethylene) mixture of                                   
 dihydrogen phosphate and monohydrogen                                  
 phosphate esters; the nonyl group is a                                 
 propylene trimer isomer and the poly                                   
 (oxyethylene) content averages 6-9                                     
 moles or 50 moles.                                                     
(p-Nonylphenyl)-omega-          ...............................
 hydroxypoly (oxyethylene) produced by                                  
 the condensation of 1 mole of p-                                       
 nonylphenol (nonyl group is a                                          
 propylene trimer isomer) with an                                       
 average of 1-40 moles of ethylene                                      
 oxide.                                                                 
-(p-Nonylphenyl)-omega-         ...............................
 hydroxypoly (oxyethylene) sulfate,                                     
 ammonium salt: the nonyl group is a                                    
 propylene trimer isomer and the poly                                   
 (oxyethylene) content averages 9 or 30                                 
 moles.                                                                 
endo-cis-5-Norbornene-2,3-dicarboxylic   ...............................
 anhydride.                                                             
-cis-9-Octadecenyl-omega-       ...............................
 hydroxypoly (oxyethylene); the                                         
 octadecenyl group is derived from                                      
 oleyl alcohol and the poly                                             
 (oxyethylene) content averages 20                                      
 moles.                                                                 
Octadecyl 3,5-di-tert-butyl-4-           ...............................
 hydroxyhydrocinnamate.                                                 
Octyl alcohol..........................  ...............................
Octyldecyl phthalate...................  ...............................
Octylphenol............................  ...............................
Octylphenoxyethanols...................  ...............................
Octylphenoxypolyethoxy-                  ...............................
 polypropoxyethanol (13 moles of                                        
 ethylene oxide and propylene oxide).                                   
Odorless light petroleum hydrocarbons..  ...............................
Oleamide (oleic acid amide)............  ...............................
Oleic acid, sulfated...................  ...............................
2,2'-Oxamidobis[ethyl 3-(3,5-di-tert-    ...............................
 butyl-4-hydroxyphenyl)propionate] (CAS                                 
 Reg. No. 70331-94-1).                                                  
Oxazoline..............................  ...............................
n-Oxydiethylene-benzothiazole..........  ...............................
Palmitamide (palmitic acid amide)......  ...............................
Paraffin (C12-C20) sulfonate...........  ...............................
Paraformaldehyde.......................  ...............................
Pentachlorophenol......................  ...............................
Pentaerythritol ester of maleic          ...............................
 anhydride.                                                             
Pentaerythritol monostearate...........  For use as preservative only.  
Pentaerythritol tetrabenzoate [CAS       ...............................
 Registry No. 4196-86-5].                                               
Pentaerythritol tetrastearate..........  ...............................
2,4-Pentanedione.......................  ...............................
Pentasodium                                                             
 diethylenetriaminepentaacetate (CAS                                    
 Reg. No. 140-01-2).                                                    
Perchloroethylene......................  ...............................
Petrolatum.............................  ...............................
Petroleum hydrocarbon resin              ...............................
 (cyclopentadiene type), hydrogenated.                                  
Petroleum hydrocarbon resin (produced    ...............................
 by the catalytic polymerization and                                    
 subsequent hydrogenation of styrene,                                   
 vinyltoluene, and indene types from                                    
 distillates of cracked petroleum                                       
 stocks).                                                               
Petroleum hydrocarbon resins (produced   ...............................
 by the homo-and copolymerization of                                    
 dienes and olefins of the aliphatic,                                   
 alicyclic, and monobenzenoid                                           
 arylalkene types from distillates of                                   
 cracked petroleum stocks).                                             
Phenol.................................  For use as preservative only.  
Phenol-coumarone-indene resin..........  ...............................
Phenolic resins as described in Sec.     ...............................
 175.300(b)(3)(vi).                                                     
Phenothiazine..........................  For use only as polymerization-
                                          control agent.                
Phenyl--naphthylamine (free of  ...............................
 -naphthylamine).                                              
o-Phenylphenol.........................  For use as preservative only.  
o-Phthalic acid........................  ...............................
Pimaric acid...........................  ...............................

[[Page 145]]

                                                                        
Pine oil...............................  ...............................
Piperazine.............................  ...............................
Piperidinium                             ...............................
 pentamethylenedithiocarbamate.                                         
Poly(acrylamide-[2-acrylamide-2-         ...............................
 methylpropylsulfonate]-                                                
 dimethylidiallyl ammonium chloride)                                    
 sodium salt (CAS Reg. No. 72275-68-4).                                 
Poly(ethyloxazoline) (CAS Reg. No.       ...............................
 25805-17-8).                                                           
Polyamides derived from reaction of one                                 
 or more of the following acids with                                    
 one or more of the following amines:                                   
    Acids:                                                              
        Azelaic acid...................  ...............................
        Dimerized vegetable oil acids..  ...............................
    Amines:                                                             
        Bis(hexamethylene) triamine and  ...............................
         higher homologues.                                             
        Diethylenetriamine.............  ...............................
        Diphenylamine..................  ...............................
        Ethylenediamine................  ...............................
        Hexamethylenediamine...........  ...............................
        Poly(oxypropylene)diamine        ...............................
         (weight average molecular                                      
         weight 2010) (CAS Reg. No.                                     
         9046-10-0).                                                    
        Poly(oxypropylene)diamine        ...............................
         (weight average molecular                                      
         weight 440) (CAS Reg. No. 9046-                                
         10-0).                                                         
        Tetraethylenepentamine.........  ...............................
        Triethylenetetramine...........  ...............................
Polybutene, hydrogenated...............  ...............................
Polybutylene glycol (molecular weight    ...............................
 1,000).                                                                
Poly [2(diethylamino) ethyl              ...............................
 methacrylate] phosphate.                                               
Polyester of adipic acid, phthalic       ...............................
 acid, and propylene glycol, terminated                                 
 with butyl alcohol.                                                    
Polyester of diglycolic acid and         ...............................
 propylene glycol containing ethylene                                   
 glycol monobutyl ether as a chain                                      
 stopper.                                                               
Polyester resins (including alkyd                                       
 type), as the basic polymer, formed as                                 
 esters when one or more of the                                         
 following acids are made to react with                                 
 one or more of the following alcohols:                                 
    Acids:                                                              
        Azelaic acid...................  ...............................
        Dimethyl-5-sulfoisophthalic      ...............................
         acid (CAS Reg. No. 50975-82-1)                                 
         and/or its sodium salt (CAS                                    
         Reg. No. 3965-55-7).                                           
        Polybasic and monobasic acids    ...............................
         identified in Sec.                                             
         175.300(b)(3)(vii)(a) and (b).                                 
        5-sulfo-1,3-benzenedicarboxylic  ...............................
         acid, monosodium salt (CAS                                     
         Reg. No. 6362-79-4).                                           
        Tetrahydrophthalic acid........  ...............................
    Alcohols:                                                           
        1,4-Cyclohexanedimethanol......  ...............................
        2,2-Dimethyl-1,3-propanediol...  ...............................
        1,6-Hexanediol (CAS Reg. No.     ...............................
         629-11-8).                                                     
        Polyhydric and monohydric        ...............................
         alcohols identified in Sec.                                    
         175.300(b)(3)(vii)(c) and (d).                                 
Polyethyleneadipate modified with        For use only in the preparation
 ethanolamine with the molar ratio of     of polyurethan resins.        
 the amine to the adipic acid less than                                 
 0.1 to 1.                                                              
Polyethylene glycol (molecular weight    ...............................
 200-6,000).                                                            
Polyethylene, oxidized.................  ...............................
Polyethylene resins, carboxyl modified,  ...............................
 identified in Sec.  177.1600 of this                                   
 chapter.                                                               
Polyethylenimine.......................  ...............................
Polyethylenimine-epichlorohydrin resins  ...............................
Polyisoprene...........................  ...............................
Polymeric esters of polyhydric alcohols  ...............................
 and polycarboxylic acids prepared from                                 
 glycerin and phthalic anhydride and                                    
 modified with benzoic acid, castor                                     
 oil, coconut oil, linseed oil, rosin,                                  
 soybean oil, styrene, and vinyl                                        
 toluene.                                                               
Polymers: Homopolymers and copolymers                                   
 of the following monomers:.                                            
  Acrylamide...........................  ...............................
  Acrylic acid.........................  ...............................
  Acrylonitrile........................  ...............................
  Allylmethacrylate (CAS Reg. No. 00096- ...............................
   05-09).                                                              
  Butadiene............................  ...............................
  Butene...............................  ...............................
  N-tert-Butylacrylamide...............  ...............................
  Butyl acrylate.......................  ...............................
  1,3-Butylene glycol dimethacrylate...  ...............................
  Butyl methacrylate...................  ...............................
  Crotonic acid........................  ...............................

[[Page 146]]

                                                                        
  Decyl acrylate.......................  ...............................
  Diallyl fumarate.....................  ...............................
  Diallyl maleate......................  ...............................
  Diallyl phthalate....................  ...............................
  Dibutyl fumarate.....................  ...............................
  Dibutyl itaconate....................  ...............................
  Dibutyl maleate......................  ...............................
  Di(2-ethylhexyl) maleate.............  ...............................
  Dimethyl--methylstyrene.....  ...............................
  Dioctyl fumarate.....................  ...............................
  Dioctyl maleate......................  ...............................
  Divinylbenzene.......................  ...............................
  Ethyl acrylate.......................  ...............................
  Ethylene.............................  ...............................
  Ethylene cyanohydrin.................  ...............................
  2-Ethylhexyl acrylate................  ...............................
  Ethyl methacrylate...................  ...............................
  Fumaric acid and/or its methyl,        ...............................
   ethyl, propyl, butyl, amyl hexyl,                                    
   heptyl and octyl esters.                                             
  Glycidyl methacrylate................  ...............................
  1-Hexene (CAS Reg. No. 592-41-6).....  ...............................
  2-Hydroxyethyl acrylate..............  ...............................
  2-Hydroxyethyl methacrylate..........  ...............................
  2-Hydroxypropyl methacrylate.........  ...............................
  Isobutyl acrylate....................  ...............................
  Isobutylene..........................  ...............................
  Itaconic acid........................  ...............................
  Maleic acid, diester with 2-           ...............................
   hydroxyethanesulfonic acid, sodium                                   
   salt.                                                                
  Maleic anhydride.....................  ...............................
  Methacrylic acid.....................  ...............................
  Methyl acrylate......................  ...............................
  N,N'-Methylenebisacrylamide..........  ...............................
  Methyl methacrylate..................  ...............................
  N-Methylolacrylamide.................  ...............................
  Methyl styrene.......................  ...............................
  -Methyl styrene......................  ...............................
  Monoethyl maleate....................  ...............................
  Monomethyl maleate...................  ...............................
  Mono (2-ethylhexyl) maleate..........  ...............................
  5-Norbornene-2 3-dicarboxylic acid,    ...............................
   mono-n-butyl ester.                                                  
  Propyl acrylate......................  ...............................
  Propylene............................  ...............................
  Styrene..............................  ...............................
  Triallyl cyanurate...................  ...............................
  Vinyl acetate........................  ...............................
  Vinyl alcohol (from alcoholysis or     ...............................
   hydrolysis of vinyl acetate units).                                  
  Vinyl butyrate.......................  ...............................
  Vinyl chloride.......................  ...............................
  Vinyl crotonate......................  ...............................
  Vinyl ethyl ether....................  ...............................
  Vinyl hexoate........................  ...............................
  Vinylidene chloride..................  ...............................
  Vinyl methyl ether...................  ...............................
  Vinyl pelargonate....................  ...............................
  Vinyl propionate.....................  ...............................
  Vinyl pyrrolidone....................  ...............................
  Vinyl stearate.......................  ...............................
Polyoxyalkylated-phenolic resin          ...............................
 (phenolic resin obtained from                                          
 formaldehyde plus butyl- and/or                                        
 amylphenols, oxyalkylated with                                         
 ethylene oxide and/or propylene oxide).                                
Poly(oxycaproyl) diols and triols        ...............................
 (minimum molecular weight 500).                                        
Polyoxyethylated (40 moles) tallow       ...............................
 alcohol sulfate, sodium salt.                                          
Polyoxyethylene (20 mol)--anhydrous      ...............................
 lanolin adduct.                                                        
Polyoxyethylene (molecular weight 200)   ...............................
 dibenzoate.                                                            
Polyoxyethylene (molecular weight 200-   ...............................
 600) esters of fatty acids derived                                     
 from animal or vegetable fats and oils                                 
 (including tall oil).                                                  
Polyoxyethylene (15 moles) ester of      ...............................
 rosin.                                                                 
Polyoxyethylene (4-5 moles) ether of     ...............................
 phenol.                                                                
Polyoxyethylene (25 moles)--glycerol     ...............................
 adduct.                                                                
Polyoxyethylene (40 moles) stearate....  ...............................
Polyoxyethylene (5-15 moles) tridecyl    ...............................
 alcohol.                                                               
Polyoxypropylene (3 moles) tridecyl      ...............................
 alcohol sulfate.                                                       
Polyoxypropylene (20 moles) butyl ether  ...............................
Polyoxypropylene (40 moles) butyl ether  ...............................

[[Page 147]]

                                                                        
Polyoxypropylene (20 moles) oleate       ...............................
 butyl ether.                                                           
Polyoxypropylene-polyoxyethylene         ...............................
 condensate (minimum molecular weight                                   
 1,900).                                                                
Polypropylene glycol (minimum molecular  ...............................
 weight 150).                                                           
Polypropylene glycol (3-4 moles)         ...............................
 triether with 2-ethyl-2-                                               
 (hydroxymethyl)-1,3-propane-diol,                                      
 average molecular weight 730.                                          
Polypropylene glycol dibenzoate (CAS     For use as a plasticizer at    
 Reg. No. 72245-46-6).                    levels not to exceed 20       
                                          percent by weight of the      
                                          finished adhesive.            
Polypropylene, noncrystalline..........  ...............................
Polysiloxanes:                                                          
  Diethyl polysiloxane.................  ...............................
  Dihydrogen polysiloxane..............  ...............................
  Dimethyl polysiloxane................  ...............................
  Diphenyl polysiloxane................  ...............................
  Ethyl hydrogen polysiloxane..........  ...............................
  Ethyl phenyl polysiloxane............  ...............................
  Methyl ethyl polysiloxane............  ...............................
  Methyl hydrogen polysiloxane.........  ...............................
  Methyl phenyl polysiloxane...........  ...............................
  Phenyl hydrogen polysiloxane.........  ...............................
Polysorbate 60.........................  ...............................
Polysorbate 80.........................  ...............................
Polysorbate 20 (polyoxyethylene (20)     ...............................
 sorbitan monolaurate).                                                 
Polysorbate 40 (polyoxyethylene (20)     ...............................
 sorbitan monopalmitate).                                               
Poly[styrene-co-disodium maleate-co-     ...............................
 -(p-nonyl-phenyl)-omega-(p-                                   
 vinyl-benzyl)poly(oxyethylene)]                                        
 terpolymer.                                                            
Polytretrafluoroethylene...............  ...............................
Polyurethane resins produced by: (1)     ...............................
 reacting diisocyanates with one or                                     
 more of the polyols or polyesters                                      
 named in this paragraph, or (2)                                        
 reacting the chloroformate derivatives                                 
 of one or more of the polyols or                                       
 polyesters named in this paragraph                                     
 with one or more of the polyamines                                     
 named in this paragraph, or (3)                                        
 reacting toluene diisocyanate or 4,4'-                                 
 methylenebis (cyclohexylisocyanate)                                    
 (CAS Reg. No. 5124-30-1) with one or                                   
 more of the polyols or polyesters                                      
 named in this paragraph and with                                       
 either N-methyldiethanolamine (CAS                                     
 Reg. No. 105-59-9) and dimethyl                                        
 sulfate (CAS Reg. No. 77-78-1) or                                      
 dimethylolpropionic acid (CAS Reg. No.                                 
 4767-03-7) and triethylamine (CAS Reg.                                 
 No. 121-44-8), or (4) reacting meta-                                   
 tetramethylxylene diisocyanate (CAS                                    
 Reg. No. 2778-42-9) with one or more                                   
 of the polyols and polyesters listed                                   
 in this paragraph and with                                             
 dimethylolpropionic acid (CAS Reg. No.                                 
 4767-03-7) and triethylamine (CAS Reg.                                 
 No. 121-44-8), N-methyldiethanolamine                                  
 (CAS Reg. No. 105-59-9), 2-                                            
 dimethylaminoethanol (CAS Reg. No. 108-                                
 01-0), 2-dimethylamino-2-methyl-1-                                     
 propanol (CAS Reg. No. 7005-47-2), and/                                
 or 2-amino-2-methyl-1-propanol (CAS                                    
 Reg. No. 124-68-5).                                                    
Polyvinyl alcohol modified so as to      ...............................
 contain not more than 3 weight percent                                 
 of comonomer units derived from 1-                                     
 alkenes having 12 to 20 carbon atoms.                                  
Polyvinyl butyral......................  ...............................
Polyvinyl formal.......................  ...............................
Potassium ferricyanide.................  For use only as polymerization-
                                          control agent.                
Potassium N-methyldithiocarbamate......  ...............................
Potassium pentachlorophenate...........  For use as preservative only.  
Potassium permanganate.................  ...............................
Potassium persulfate...................  ...............................
Potassium phosphates (mono-, di-,        ...............................
 tribasic).                                                             
Potassium tripolyphosphate.............  ...............................
, ', ''-      ...............................
 1,2,3-Propanetriyltris [omega-(2,3-                                    
 epoxypropoxy) poly (oxypropylene) (24                                  
 moles)].                                                               
-Propiolactone................  ...............................
Propyl alcohol (propanol)..............  ...............................
Propylene carbonate....................  ...............................
Propylene glycol and p-p'-               ...............................
 isopropylidenediphenol diether.                                        
Propylene glycol dibenzoate (CAS Reg.    For use as a plasticizer at    
 No. 19224-26-1).                         levels not to exceed 20       
                                          percent by weight of the      
                                          finished adhesive.            
Propylene glycol esters of coconut       ...............................
 fatty acids.                                                           
Propylene glycol monolaurate...........  ...............................
Propylene glycol monomethyl ether......  ...............................
Propylene glycol monostearate..........  ...............................
, ', ''-      ...............................
 [Propylidynetris (methylene)] tris                                     
 [omega-hydroxypoly (oxypropylene) (1.5                                 
 moles minimum)], minimum molecular                                     
 weight 400.                                                            
Quaternary ammonium chloride             For use as preservative only.  
 (hexadecyl, octadecyl derivative).                                     

[[Page 148]]

                                                                        
Rosin (wood, gum, and tall oil rosin),                                  
 rosin dimers, decarboxylated rosin                                     
 (including rosin oil,                                                  
 disproportionated rosin, and these                                     
 substances as modified by one or more                                  
 of the following reactants:.                                           
  Alkyl (C1-C9) phenolformaldehyde.....  ...............................
  Ammonia..............................  ...............................
  Ammonium caseinate-p-                  ...............................
   Cyclohexylphenolformaldehyde.                                        
  Diethylene glycol....................  ...............................
  Dipentaerythritol....................  ...............................
  Ethylene glycol......................  ...............................
  Formaldehyde.........................  ...............................
  Fumaric acid.........................  ...............................
  Glycerin.............................  ...............................
  Hydrogen.............................  ...............................
  Isophthalic acid.....................  ...............................
  4,4'-Isopropylidenediphenol-           ...............................
   epichlorohydrin (epoxy).                                             
  4,4'-Isopropylidenediphenol-           ...............................
   formaldehyde.                                                        
  Maleic anhydride.....................  ...............................
  Methyl alcohol.......................  ...............................
  Pentaerythritol......................  ...............................
  Phthalic anhydride...................  ...............................
  Polyethylene glycol..................  ...............................
  Phenol-formaldehyde..................  ...............................
  Phenyl -cresol-formaldehyde.  ...............................
  p-Phenylphenol-formaldehyde..........  ...............................
  Sulfuric acid........................  ...............................
  Triethylene glycol...................  ...............................
  Xylenol-formaldehyde.................  ...............................
Rosin salts (salts of wood, gum, and                                    
 tall oil rosin, and the dimers                                         
 thereof, decarboxylated rosin                                          
 disproportionated rosin, hydrogenated                                  
 rosin):                                                                
  Aluminum.............................  ...............................
  Ammonium.............................  ...............................
  Calcium..............................  ...............................
  Magnesium............................  ...............................
  Potassium............................  ...............................
  Sodium...............................  ...............................
  Zinc.................................  ...............................
Rosin, gasoline-insoluble fraction.....  ...............................
Rubber hydrochloride polymer...........  ...............................
Rubber latex, natural..................  ...............................
Salicylic acid.........................  For use as preservative only.  
Sandarac...............................  ...............................
Sebacic acid...........................  ...............................
Shellac................................  ...............................
Silicon dioxide as defined in Sec.       ...............................
 172.480(a) of this chapter.                                            
Sodium alkyl (C2-C13.5 aliphatic)        ...............................
 benezenesulfonate.                                                     
Sodium aluminum pyrophosphate..........  ...............................
Sodium aluminum sulfate................  ...............................
Sodium bisulfate.......................  ...............................
Sodium calcium silicate................  ...............................
Sodium capryl polyphosphate............  ...............................
Sodium carboxymethylcellulose..........  ...............................
Sodium chlorate........................  ...............................
Sodium chlorite........................  ...............................
Sodium chromate........................  ...............................
Sodium decylsulfate....................  ...............................
Sodium dehydroacetate..................  For use as preservative only.  
Sodium di-(2-ethylhexoate).............  ...............................
Sodium di-(2-ethylhexyl) pyrophosphate.  ...............................
Sodium dihexylsulfosuccinate...........  ...............................
Sodium dissobutylphenoxydiethoxyethyl    ...............................
 sulfonate.                                                             
Sodium diisobutylphenoxymonoethoxyethyl  ...............................
 sulfonate.                                                             
Sodium diisopropyl- and                  ...............................
 triisopropylnaphthalenesulfonate.                                      
Sodium dimethyldithiocarbamate.........  ...............................
Sodium dioctylsulfosuccinate...........  ...............................
Sodium n-dodecylpolyethoxy (50 moles)    ...............................
 sulfate.                                                               
Sodium ethylene ether of nonylphenol     ...............................
 sulfate.                                                               
Sodium 2-ethylhexyl sulfate............  ...............................
Sodium fluoride........................  For use only as bonding agent  
                                          for aluminum foil, stabilizer,
                                          or preservative. Total        
                                          fluoride for all sources not  
                                          to exceed 1 percent by weight 
                                          of the finished adhesive.     
Sodium formaldehyde sulfoxylate........  ...............................
Sodium formate.........................  ...............................
Sodium heptadecylsulfate...............  ...............................

[[Page 149]]

                                                                        
Sodium hypochlorite....................  ...............................
Sodium isododecylphenoxypolyethoxy (40   ...............................
 moles) sulfate.                                                        
Sodium N-lauroyl sarcosinate...........  ...............................
Sodium metaborate......................  ...............................
Sodium -naphthalene sulfonate.  ...............................
Sodium nitrate.........................  ...............................
Sodium nitrite.........................  ...............................
Sodium oleoyl isopropanolamide           ...............................
 sulfosuccinate.                                                        
Sodium pentachlorophenate..............  For use as preservative only.  
Sodium perborate.......................  ...............................
Sodium persulfate......................  ...............................
Sodium -phenylphenate.........  For use as preservative only.  
Sodium polyacrylate....................  ...............................
Sodium polymethacrylate................  ...............................
Sodium polystyrene sulfonate...........  ...............................
Sodium salicylate......................  For use as preservative only.  
Sodium salt of 1-hydroxy 2(1H)-pyridine      Do.                        
 thione.                                                                
Sodium tetradecylsulfate...............  ...............................
Sodium thiocyanate.....................  ...............................
Sodium bis-tridecylsulfosuccinate......  ...............................
Sodium xylene sulfonate................  ...............................
Sorbitan monooleate....................  ...............................
Sorbitan monostearate..................  ...............................
Soybean oil, epoxidized................  ...............................
Spermaceti wax.........................  ...............................
Sperm oil wax..........................  ...............................
Stannous 2-ethylhexanoate..............  For use only as a catalyst for 
                                          polyurethane resins.          
Stannous stearate......................  ...............................
Starch hydrolysates....................  ...............................
Starch or starch modified by one or      ...............................
 more of the treatments described in                                    
 Secs.  172.892 and 178.3520 of this                                    
 chapter.                                                               
Starch, reacted with a urea-             ...............................
 formaldehyde resin.                                                    
Starch, reacted with formaldehyde......  ...............................
Stearamide (stearic acid amide)........  ...............................
Stearic acid...........................  ...............................
Stearic acid-chromic chloride complex..  ...............................
Stearyl-cetyl alcohol, technical grade,  ...............................
 approximately 65 percent-80 percent                                    
 stearyl and 20 percent-35 percent                                      
 cetyl.                                                                 
Strontium salicylate...................  ...............................
Styrenated phenol......................  ...............................
Styrene block polymers with 1,3-         ...............................
 butadiene.                                                             
Styrene-maleic anhydride copolymer,      ...............................
 ammonium or potassium salt.                                            
Styrene-maleic anhydride copolymer       ...............................
 (partially methylated) sodium salt.                                    
Styrene-methacrylic acid copolymer,      ...............................
 potassium salt.                                                        
Sucrose acetate isobutyrate............  ...............................
Sucrose benzoate.......................  ...............................
Sucrose octaacetate....................  ...............................
2-sulfoethyl methacrylate (CAS Registry  For use at levels not to exceed
 No. 10595-80-9).                         2 percent by weight of the dry
                                          adhesive.                     
-Sulfo-omega-(dodecyloxy)poly   ...............................
 (oxyethylene), ammonium salt.                                          
Sulfonated octadecylene (sodium form)..  ...............................
Sulfosuccinic acid 4-ester with          ...............................
 polyethylene glycol dodecyl ether                                      
 disodium salt (alcohol moiety produced                                 
 by condensation of 1 mole of n-dodecyl                                 
 alcohol and an average of 5-6 moles of                                 
 ethylene oxide, Chemical Abstracts                                     
 Service Registry No. 039354-45-5).                                     
Sulfosuccinic acid 4-ester with                                         
 polyethylene glycol nonylphenyl ether,                                 
 disodium salt (alcohol moiety produced                                 
 by condensation of 1 mole of                                           
 nonylphenol and an average of 9-10                                     
 moles of ethylene oxide) (CAS Reg. No.                                 
 9040-38-4).                                                            
Sulfur.................................  ...............................
Synthetic primary linear aliphatic       ...............................
 alcohols whose weight average                                          
 molecular weight is greater than 400                                   
 (CAS Reg. No. 71750-71-5).                                             
Synthetic wax polymer as described in    ...............................
 Sec.  176.170(a)(5) of this chapter.                                   
Tall oil...............................  ...............................
Tall oil fatty acids, linoleic and       ...............................
 oleic.                                                                 
Tall oil fatty acid methyl ester.......  ...............................
Tall oil, methyl ester.................  ...............................
Tall oil pitch.........................  ...............................
Tall oil soaps.........................  ...............................
Tallow alcohol (hydrogenated)..........  ...............................
Tallow amine, secondary (hexadecyl,      ...............................
 octadecyl), of hard tallow.                                            
Tallow, blown (oxidized)...............  ...............................
Tallow, propylene glycol ester.........  ...............................
Terpene resins (-and - ...............................
 pinene) homopolymers, copolymers, and                                  
 condensates with phenol, formaldehyde,                                 
 coumarone, and/or indene.                                              

[[Page 150]]

                                                                        
Terphenyl..............................  ...............................
Terphenyl, hydrogenated................  ...............................
Terpineol..............................  ...............................
Tetraethylene pentamine................  ...............................
Tetraethylthiuram disulfide............  ...............................
Tetrahydrofuran........................  ...............................
Tetrahydrofurfuryl alcohol.............  ...............................
Tetra-isopropyl titanate...............  ...............................
Tetrakis[methylene (3,5-di-tert-butyl-4- ...............................
 hydroxy-hydro-cinnamate)] methane.                                     
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-  ...............................
 omega-hydroxypoly-(oxyethylene)                                        
 produced by the condensation of 1 mole                                 
 of p-(1,1,3,3-tetramethylbutyl) phenol                                 
 with an average of 1-40 moles of                                       
 ethylene oxide.                                                        
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]- ...............................
 omega-hydroxy-poly(oxyethylene)                                        
 mixture of dihydrogen phosphate and                                    
 monohydrogen phosphate esters and                                      
 their sodium, potassium, and ammonium                                  
 salts having a poly(oxyethylene)                                       
 content averaging 6-9 or 40 moles.                                     
Tetramethyl decanediol.................  ...............................
Tetramethyl decynediol.................  ...............................
Tetramethyl decynediol plus 1-30 moles   ...............................
 of ethylene oxide.                                                     
Tetramethylthiuram monosulfide.........  ...............................
Tetrasodium N-(1,2-dicarboxyethyl)N-     ...............................
 octadecylsulfosuccinamate.                                             
4,4'-Thiobis-6-tert-butyl-m-cresol.....  ...............................
Thiodiethylene-bis(3,5-di-tert-butyl-4-  ...............................
 hydroxyhydrocinnamate).                                                
2,2'-(2,5-Thiophenediyl) bis[5-tert-     ...............................
 butylbenzoxazole].                                                     
Thiram.................................  ...............................
Thymol.................................  For use as preservative only.  
Titanium dioxide.......................  ...............................
Titanium dioxide-barium sulfate........  ...............................
Titanium dioxide-calcium sulfate.......  ...............................
Titanium dioxide-magnesium silicate....  ...............................
Toluene................................  ...............................
Toluene 2,4-diisocyanate...............  ...............................
Toluene 2,6-diisocyanate...............  ...............................
o- and p-Toluene ethyl sulfonamide.....  ...............................
o- and p-Toluene sulfonamide...........  ...............................
p-Toluene sulfonic acid................  ...............................
p- (p'-Toluene-sulfonylamide)-           ...............................
 diphenylamide.                                                         
Triazine-formaldehyde resins as          ...............................
 described in Sec.  175.300(b)(3)(xiii).                                
Tributoxyethyl phosphate...............  ...............................
Tributylcitrate........................  ...............................
Tri-tert-butyl-p-phenyl phenol.........  For use as preservative only.  
Tributyl phosphate.....................  ...............................
Tributyltin chloride complex of          For use as preservative only.  
 ethylene oxide condensate of                                           
 dehydroabietylamine.                                                   
Tri-n-butyltin acetate.................  For use as preservative only.  
Tri-n-butyltin neodecanoate............      Do.                        
1,1,1-Trichloroethane..................  ...............................
1,1,2-Trichloroethane..................  ...............................
Trichloroethylene......................  ...............................
Tri--chloroethylphosphate.....  ...............................
Tridecyl alcohol.......................  ...............................
Triethanolamine........................  ...............................
3-(Triethoxysilyl) propylamine.........  ...............................
Triethylene glycol.....................  ...............................
Triethylene glycol dibenzoate..........  ...............................
Triethylene glycol di(2-ethylhexoate)..  ...............................
Triethylene glycol polyester of benzoic  ...............................
 acid and phthalic acid.                                                
Triethylhexyl phosphate................  ...............................
Triethylphosphate......................  ...............................
2,4,5-Trihydroxy butyrophenone.........  ...............................
Triisopropanolamine....................  ...............................
Trimethylol propane....................  ...............................
2,2,4-Trimethylpentanediol-1,3-          ...............................
 diisobutyrate.                                                         
Trimeric aromatic amine resin from       ...............................
 diphenylamine and acetone of molecular                                 
 weight approximately 500.                                              
Tri(nonylphenyl) phosphite-formaldehyde  As identified in Sec.          
 resins.                                  177.2600(c)(4)(iii) of this   
                                          chapter. For use only as a    
                                          stabilizer.                   
Triphenylphosphate.....................  ...............................
Tripropylene glycol monomethyl ether...  ...............................
1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy- ...............................
 benzyl)-triazine-2,4,6 (1H,3H,5H)-                                     
 trione.                                                                
Tris (p-tertiary butyl phenyl)           ...............................
 phosphate.                                                             
Tris(2-methyl-4-hydroxy-5-tert-butyl-    ...............................
 phenyl)butane.                                                         

[[Page 151]]

                                                                        
Trisodium N-                                                            
 hydroxyethylethylenediaminetriacetate                                  
 (CAS Reg. No. 139-89-9).                                               
Turpentine.............................  ...............................
Urea-formaldehyde resins as described    ...............................
 in Sec.  175.300(b)(3)(xii).                                           
Vegetable oil, sulfonated or sulfated,   ...............................
 potassium salt.                                                        
Vinyl acetate-maleic anhydride           ...............................
 copolymer, sodium salt.                                                
Waxes, petroleum.......................  ...............................
Wax, petroleum, chlorinated (40% to 70%  ...............................
 chlorine).                                                             
Waxes, synthetic paraffin (Fischer-      ...............................
 Tropsch process).                                                      
3-(2-Xenolyl)-1,2-epoxypropane.........  ...............................
Xylene.................................  ...............................
Xylene (or toluene) alkylated with       ...............................
 dicyclopentadiene.                                                     
Zein...................................  ...............................
Zinc acetate...........................  ...............................
Zinc ammonium chloride.................  ...............................
Zinc dibenzyl dithiocarbamate..........  ...............................
Zinc dibutyldithiocarbamate............  ...............................
Zinc diethyldithiocarbamate............  ...............................
Zinc di(2-ethylhexoate)................  ...............................
Zinc formaldehyde sulfoxylate..........  ...............................
Zinc naphthenate and                     ...............................
 dehydroabietylamine mixture.                                           
Zinc nitrate...........................  ...............................
Zinc orthophosphate....................  ...............................
Zinc resinate..........................  ...............................
Zinc sulfide...........................  ...............................
Zineb (zinc ethylenebis-                 ...............................
 dithiocarbamate).                                                      
Ziram (zinc dimethyldithiocarbamate)...  ...............................
------------------------------------------------------------------------

[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 175.105, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 175.125   Pressure-sensitive adhesives.

    Pressure-sensitive adhesives may be safely used as the food-contact 
surface of labels and/or tapes applied to food, in accordance with the 
following prescribed conditions:
    (a) Pressure-sensitive adhesives prepared from one or a mixture of 
two or more of the substances listed in this paragraph may be used as 
the food-contact surface of labels and/or tapes applied to poultry, dry 
food, and processed, frozen, dried, or partially dehydrated fruits or 
vegetables.
    (1) Substances generally recognized as safe in food.
    (2) Substances used in accordance with a prior sanction or approval.
    (3) Color additives listed for use in or on food in parts 73 and 74 
of this chapter.
    (4) Substances identified in Sec. 172.615 of this chapter other than 
substances used in accordance with paragraph (a)(2) of this section.
    (5) Polyethylene, oxidized; complying with the identity prescribed 
in Sec. 177.1620(a) of this chapter.
    (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-
butylphenol (CAS Reg. No. 991-84-4) as an antioxidant/stabilizer at a 
level not to exceed 1.5 percent by weight of the finished pressure-
sensitive adhesive.
    (b) Pressure-sensitive adhesives prepared from one or a mixture of 
two or more of the substances listed in this paragraph may be used as 
the food-contact surface of labels and/or tapes applied to raw fruit and 
raw vegetables.
    (1) Substances listed in paragraphs (a)(1), (2), (3), (5), and (6) 
of this section, and those substances prescribed by paragraph (a)(4) of 
this section that are not identified in paragraph (b)(2) of this 
section.
    (2) Substances identified in this subparagraph and subject to the 
limitations provided:

BHA.
BHT.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated natural rubber.
Isobutylene-styrene copolymer.
Petrolatum.
Polybutene-1.

[[Page 152]]

Polybutene, hydrogenated; complying with the identity prescribed under 
Sec. 178.3740(b) of this chapter.
Polyisobutylene.
cis-1,4-Polyisoprene.
Polystyrene.
Propyl gallate.
Rapeseed oil, vulcanized.
Rosins and rosin derivatives as provided in Sec. 178.3870 of this 
chapter.
Rubber hydrochloride.
Rubber (natural latex solids or crepe, smoked or unsmoked).
Terpene resins (- and -pinene), homopolymers, 
copolymers, and condensates with phenol, formaldehyde, coumarone, and/or 
indene.
Tetrasodium ethylenediaminetetraacetate.
Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more 
than 1 percent by weight of triisopropanolamine).

    (c) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 
48 FR 15617, Apr. 12, 1983]



         Subpart C--Substances for Use as Components of Coatings



Sec. 175.210   Acrylate ester copolymer coating.

    Acrylate ester copolymer coating may safely be used as a food-
contact surface of articles intended for packaging and holding food, 
including heating of prepared food, subject to the provisions of this 
section:
    (a) The acrylate ester copolymer is a fully polymerized copolymer of 
ethyl acrylate, methyl methacrylate, and methacrylic acid applied in 
emulsion form to molded virgin fiber and heat-cured to an insoluble 
resin.
    (b) Optional substances used in the preparation of the polymer and 
in the preparation and application of the emulsion may include 
substances named in this paragraph, in an amount not to exceed that 
required to accomplish the desired technical effect and subject to any 
limitation prescribed: Provided, however, That any substance named in 
this paragraph and covered by a specific regulation in subchapter B of 
this chapter must meet any specifications in such regulation.

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Aluminum stearate.........................  ............................
Ammonium lauryl sulfate...................  ............................
Borax.....................................  Not to exceed the amount    
                                             required as a preservative 
                                             in emulsion defoamer.      
Disodium hydrogen phosphate...............      Do.                     
Formaldehyde..............................  ............................
Glyceryl monostearate.....................  ............................
Methyl cellulose..........................  ............................
Mineral oil...............................  ............................
Paraffin wax..............................  ............................
Potassium hydroxide.......................  ............................
Potassium persulfate......................  ............................
Tallow....................................  ............................
Tetrasodium pyrophosphate.................  ............................
Titanium dioxide..........................  ............................
------------------------------------------------------------------------

    (c) The coating in the form in which it contacts food meets the 
following tests:
    (1) An appropriate sample when exposed to distilled water at 
212 deg. F for 30 minutes shall yield total chloroform-soluble 
extractables not to exceed 0.5 milligram per square inch.
    (2) An appropriate sample when exposed to n-heptane at 120 deg. F 
for 30 minutes shall yield total chloroform-soluble extractables not to 
exceed 0.5 milligram per square inch.



Sec. 175.230   Hot-melt strippable food coatings.

    Hot-melt strippable food coatings may be safely applied to food, 
subject to the provisions of this section.
    (a) The coatings are applied to and used as removable coatings for 
food.
    (b) The coatings may be prepared, as mixtures, from the following 
substances:
    (1) Substances generally recognized as safe in food.
    (2) Substances identified in this subparagraph.

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Acetylated monoglycerides.................  Complying with 172.828 of   
                                             this chapter.              
Cellulose acetate butyrate................  ............................
Cellulose acetate propionate..............  ............................
Mineral oil, white........................  For use only as a component 
                                             of hot-melt strippable food
                                             coatings applied to frozen 
                                             meats and complying with   
                                             Sec.  172.878 of this      
                                             chapter.                   
------------------------------------------------------------------------



Sec. 175.250   Paraffin (synthetic).

    Synthetic paraffin may be safely used as an impregnant in, coating 
on, or component of coatings on articles used in producing, 
manufacturing,

[[Page 153]]

packing, processing, preparing, treating, packaging, transporting, or 
holding food in accordance with the following prescribed conditions:
    (a) The additive is synthesized by the Fischer-Tropsch process from 
carbon monoxide and hydrogen, which are catalytically converted to a 
mixture of paraffin hydrocarbons. Lower molecular-weight fractions are 
removed by distillation. The residue is hydrogenated and may be further 
treated by percolation through activated charcoal. This mixture can be 
fractionated into its components by a solvent separation method, using 
synthetic isoparaffinic petroleum hydrocarbons complying with 
Sec. 178.3530 of this chapter.
    (b) Synthetic paraffin shall conform to the following 
specifications:
    (1) Congealing point. There is no specification for the congealing 
point of synthetic paraffin components, except those components that 
have a congealing point below 50 deg. C when used in contact with food 
Types III, IVA, V, VIIA, and IX identified in Table 1 of Sec. 176.170(c) 
of this chapter and under conditions of use E, F, and G described in 
Table 2 of Sec. 176.170(c) of this chapter shall be limited to a 
concentration not exceeding 15 percent by weight of the finished 
coating. The congealing point shall be determined by ASTM method D938-71 
(Reapproved 1981), ``Standard Test Method for Congealing Point of 
Petroleum Waxes, Including Petrolatum,'' which is incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Oil content. The substance has an oil content not exceeding 2.5 
percent as determined by ASTM method D721-56T, ``Tentative Method of 
Test for Oil Content of Petroleum Waxes'' (Revised 1956), which is 
incorporated by reference. See paragraph (b)(1) of this section for 
availability of the incorporation by reference.
    (3) Absorptivity. The substance has an absorptivity at 290 
millimicrons in decahydronaphthalene at 88 deg. C not exceeding 0.01 as 
determined by ASTM method E131-81a, ``Standard Definitions of Terms and 
Symbols Relating to Molecular-Spectroscopy,'' which is incorporated by 
reference. See paragraph (b)(1) of this section for availability of the 
incorporation by reference.
    (c) The provisions of this section are not applicable to synthetic 
paraffin used in food-packaging adhesives complying with Sec. 175.105.

[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, 
Aug. 3, 1995]



Sec. 175.260   Partial phosphoric acid esters of polyester resins.

    Partial phosphoric acid esters of polyester resins identified in 
this section and applied on aluminum may be safely used as food-contact 
coatings, in accordance with the following prescribed conditions:
    (a) For the purpose of this section, partial phosphoric acid esters 
of polyester resins are prepared by the reaction of trimellitic 
anhydride with 2,2-dimethyl-1,3-propanediol followed by reaction of the 
resin thus produced with phosphoric acid anhydride to produce a resin 
having an acid number of 81 to 98 and a phosphorus content of 4.05 to 
4.65 percent by weight.
    (b) The coating is chemically bonded to the metal and cured at 
temperatures exceeding 450 deg. F.
    (c) The finished food-contact coating, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use, as determined from tables 1 and 2 of Sec. 175.300(d), 
yields total extractives in each extracting solvent not to exceed 0.3 
milligrams per square inch of food-contact surface, as determined by the 
methods described in Sec. 175.300(e), and the coating yields 2,2-
dimethyl-1,3-propanediol in each extracting solvent not to exceed 0.3 
micrograms per square inch of food-contact surface. In testing the 
finished food-contact articles, a separate test sample is to be used for 
each required extracting solvent.

[[Page 154]]



Sec. 175.270   Poly(vinyl fluoride) resins.

    Poly(vinyl fluoride) resins identified in this section may be safely 
used as components of food-contact coatings for containers having a 
capacity of not less than 5 gallons, subject to the provisions of this 
section.
    (a) For the purpose of this section, poly(vinyl fluoride) resins 
consist of basic resins produced by the polymerization of vinyl 
fluoride.
    (b) The poly(vinyl fluoride) basic resins have an intrinsic 
viscosity of not less than 0.75 deciliter per gram as determined by ASTM 
method D1243-79, ``Standard Test Method for Dilute Solution Viscosity of 
Vinyl Chloride Polymers,'' which is incorporated by reference. Copies 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (1) Solvent. N,N-Dimethylacetamide, technical grade.
    (2) Solution. Powdered resin and solvent are heated at 120 deg. C 
until the resin is dissolved.
    (3) Temperature. Flow times of the solvent and solution are 
determined at 110 deg. C.
    (4) Viscometer. Cannon-Ubbelohde size 50 semimicro dilution 
viscometer (or equivalent).
    (5) Calculation. The calculation method used is that described in 
appendix X 1.3 (ASTM method D1243-79, ``Standard Test Method for Dilute 
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated 
by reference; see paragraph (b) of this section for availability of the 
incorporation by reference) with the reduced viscosity determined for 
three concentration levels not greater than 0.5 gram per deciliter and 
extrapolated to zero concentration for intrinsic viscosity. The 
following formula is used for determining reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.387

Where:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.

[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 
49 FR 10107, Mar. 19, 1984]



Sec. 175.300  Resinous and polymeric coatings.

    Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The coating is applied as a continuous film or enamel over a 
metal substrate, or the coating is intended for repeated food-contact 
use and is applied to any suitable substrate as a continuous film or 
enamel that serves as a functional barrier between the food and the 
substrate. The coating is characterized by one or more of the following 
descriptions:
    (1) Coatings cured by oxidation.
    (2) Coatings cured by polymerization, condensation, and/or cross-
linking without oxidation.
    (3) Coatings prepared from prepolymerized substances.
    (b) The coatings are formulated from optional substances that may 
include:
    (1) Substances generally recognized as safe in food.
    (2) Substances the use of which is permitted by regulations in this 
part or which are permitted by prior sanction or approval and employed 
under the specific conditions, if any, of the prior sanction or 
approval.
    (3) Any substance employed in the production of resinous and 
polymeric coatings that is the subject of a regulation in Subchapter B 
of this chapter and conforms with any specification in such regulation. 
Substances named in this paragraph (b)(3) and further identified as 
required:
    (i) Drying oils, including the triglycerides or fatty acids derived 
therefrom:

Beechnut.
Candlenut.
Castor (including dehydrated).
Chinawood (tung).
Coconut.
Corn.

[[Page 155]]

Cottonseed.
Fish (refined).
Hempseed.
Linseed.
Oiticica.
Perilla.
Poppyseed.
Pumpkinseed.
Safflower.
Sesame.
Soybean.
Sunflower.
Tall oil.
Walnut.

The oils may be raw, heat-bodied, or blown. They may be refined by 
filtration, degumming, acid or alkali washing, bleaching, distillation, 
partial dehydration, partial polymerization, or solvent extraction, or 
modified by combination with maleic anhydride.
    (ii) Reconstituted oils from triglycerides or fatty acids derived 
from the oils listed in paragraph (b)(3)(i) of this section to form 
esters with:

Butylene glycol.
Ethylene glycol.
Pentaerythritol.
Polyethylene glycol.
Polypropylene glycol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.

    (iii) Synthetic drying oils, as the basic polymer:

Butadiene and methylstyrene copolymer.
Butadiene and styrene copolymer, blown or unblown.
Maleic anhydride adduct of butadiene styrene.
Polybutadiene.

    (iv) Natural fossil resins, as the basic resin:

Copal.
Damar.
Elemi.
Gilsonite.
Glycerol ester of damar, copal, elemi, and sandarac.
Sandarac.
Shellac.
Utah coal resin.

    (v) Rosins and rosin derivatives, with or without modification by 
polymerization, isomerization, incidental decarboxylation, and/or 
hydrogenation, as follows:
    (a) Rosins, refined to color grade of K or paler:

Gum rosin.
Tall oil rosin.
Wood rosin.

    (b) Rosin esters formed by reacting rosin (paragraph (b)(3) (v)(a) 
of this section) with:

4,4'-sec-Butylidenediphenol-epichlorohydrin (epoxy).
Diethylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epichlorohydrin (epoxy).
Methyl alcohol.
Pentaerythritol.

    (c) Rosin esters (paragraph (b)(3) (v)(b) of this section) modified 
by reaction with:

Maleic anhydride.
o-, m-, and p-substituted phenol-formaldehydes listed in paragraph 
(b)(3)(vi) of this section.
Phenol-formaldehyde.

    (d) Rosin salts:

Calcium resinate (limed rosin).
Zinc resinate.

    (vi) Phenolic resins as the basic polymer formed by reaction of 
phenols with formaldehyde:
    (a) Phenolic resins formed by reaction of formaldehyde with:

Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols.
p-tert-Amylphenol.
4,4'-sec-Butylidenediphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Cyclohexylphenol.
4,4'-Isopropylidenediphenol.
p-Nonylphenol.
p-Octylphenol.
3-Pentadecyl phenol mixture obtained from cashew nut shell liquid.
Phenol.
Phenyl o-cresol.
p-Phenylphenol.
Xylenol.

    (b) Adjunct for phenolic resins: Aluminum butylate.
    (vii) Polyester resins (including alkyd-type), as the basic 
polymers, formed as esters of acids listed in paragraph (b)(3)(vii) (a) 
and (b) of this section by reaction with alcohols in paragraph (b)(3) 
(vii) (c) and (d) of this section.

[[Page 156]]

    (a) Polybasic acids:

Adipic.
Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of 
this section.
Fumaric.
Isophthalic.
Maleic.
Orthophthalic.
Sebacic.
Terephthalic.
Terpene-maleic acid adduct.
Trimellitic.

    (b) Monobasic acids:

Benzoic acid.
4,4-Bis(4'-hydroxyphenyl)-pentanoic acid.
tert-Butyl benzoic acid.
Fatty acids derived from oils listed in paragraph (b)(3)(i) of this 
section.
Rosins listed in paragraph (b)(3)(v)(a) of this section, for use only as 
reactants in oil-based or fatty acid-based alkyd resins.

    (c) Polyhydric alcohols:

Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins 
for coatings intended for use in contact with non-alcoholic foods.
Ethylene glycol.
Glycerol.
Mannitol.
-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Triethylene glycol, for use as a component in polyester resins for 
coatings not exceeding a coating weight of 4 milligrams per square inch 
and that are intended for contact under conditions of use D, E, F or G 
described in table 2 of paragraph (d) of this section with alcoholic 
beverages containing less than 8 percent alcohol.
Trimethylol ethane.
Trimethylol propane.

    (d) Monohydric alcohols:

Cetyl alcohol.
Decyl alcohol.
Lauryl alcohol.
Myristyl alcohol.
Octyl alcohol.
Stearyl alcohol.
    (e) Catalysts:

Dibutyltin oxide (CAS Reg. No. 818-08-6), not to exceed 0.2 percent of 
the polyester resin.
Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0), not to exceed 0.2 
percent of the polyester resin.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4), not to 
exceed 0.2 percent of the polyester resin.

    (viii) Epoxy resins, catalysts, and adjuncts:
    (a) Epoxy resins, as the basic polymer:

(Alkoxy C10-C16)-2,3-epoxypropane, in which the alkyl groups 
are even numbered and consist of a maximum of 1 percent C10 carbon 
atoms and a minimum of 48 percent C12 carbon atoms and a minimum of 
18 percent C14 carbon atoms, for use only in coatings that are 
intended for contact with dry bulk foods at room temperature.
4,4'-sec-Butylidenediphenol-epichlorohydrin.
4,4'-sec-Butylidenediphenol-epichlorohydrin reacted with one or more of 
the drying oils or fatty acids listed in paragraph (b)(3)(i) of this 
section.
4,4'-sec-Butylidenediphenol-epichlorohydrin chemically treated with one 
or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
Phenol-formaldehyde.
Urea-formaldehyde.
Epoxidized polybutadiene.
Glycidyl ethers formed by reacting phenolnovolak resins with 
epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin reacted with one or more of 
the drying oils or fatty acids listed in paragraph (b)(3)(i) of this 
section.
4,4'-Isopropylidenediphenol-epichlorohydrin chemically treated with one 
or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
Phenol-formaldehyde.
Urea-formaldehyde.

    (b) Catalysts and cross-linking agents for epoxy resins:

3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine reacted with phenol and 
formaldehyde in a ratio of 2.6:1.0:2.0, for use only in coatings 
intended for repeated use in contact with foods only of the types 
identified in paragraph (d) of this section, Table 1, under Category I 
and Category VIII, at temperatures not exceeding 88 deg. C (190 deg. F).
    N-Beta-(aminoethyl)-gamma-aminopropyltrimethoxysilane (CAS Reg. No. 
1760-24-3), for use only in coatings at a level not to exceed 1.3 
percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of

[[Page 157]]

this section, Table 1, under Types I, II, and III, under conditions of 
use C, D, E, or F as described in Table 2 of paragraph (d) of this 
section; or when such coatings are intended for repeated use in contact 
with foods of the types identified in paragraph (d) of this section, 
Table 1, under Types V, VI, VII, and VIII, under conditions of use E or 
F as described in Table 2 of paragraph (d) of this section. Use shall be 
limited to coatings for tanks of capacity greater than 530,000 gallons.
    Benzyl alcohol (CAS Reg. No. 100-51-6), for use only in coatings at 
a level not to exceed 4 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, Table 1, under Types 
I, II, and III, under conditions of use C, D, E, or F as described in 
Table 2 of paragraph (d) of this section; or when such coatings are 
intended for repeated use in contact with foods of the types identified 
in paragraph (d) of this section, Table 1, under Types V, VI, VII, and 
VIII, under conditions of use E or F as described in Table 2 of 
paragraph (d) of this section. Use shall be limited to coatings for 
tanks of capacity greater than 530,000 gallons.
Cyanoguanidine.
Dibutyl phthalate, for use only in coatings for containers having a 
capacity of 1,000 gallons or more when such containers are intended for 
repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
    3-Diethylaminopropylamine (CAS Reg. No. 104-78-9), for use in 
coatings at a level not to exceed 6 percent by weight of the resin when 
such coatings are intended for repeated use in contact with foods only 
of the types identified in paragraph (d) of this section, Table 1, under 
Types I, II, and III, under conditions of use C, D, E, or F as described 
in Table 2 of paragraph (d) of this section; or when such coatings are 
intended for repeated use in contact with foods of the types identified 
in paragraph (d) of this section, Table 1, under Types V, VI, VII, and 
VIII, under conditions of use E or F as described in Table 2 of 
paragraph (d) of this section. Use shall be limited to coatings for 
tanks of capacity greater than 530,000 gallons.
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Isophthalyl dihydrazide for use only in coatings subject to the 
provisions of paragraph (c) (3) or (4) of this section.
4,4'-Methylenedianiline, for use only in coatings for containers having 
a capacity of 1,000 gallons or more when such containers are intended 
for repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
N-Oleyl-1,3-propanediamine with not more than 10 percent by weight of 
diethylaminoethanol.
Polyamine produced when 1 mole of the chlorohydrin diether of 
polyethylene glycol 400 is made to react under dehydrohalogenating 
conditions with 2 moles of N-octadecyltrimethylenediamine for use only 
in coatings that are subject to the provisions of paragraph (c) (3) or 
(4) of this section and that contact food at temperatures not to exceed 
room temperature.
Salicylic acid, for use only in coatings for containers having a 
capacity of 1,000 gallons or more when such containers are intended for 
repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
    Salicylic acid (CAS Reg. No. 69-72-7), for use only in coatings at a 
level not to exceed 0.35 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, Table 1, under Types 
I, II, and III, under conditions of use C, D, E, or F as described in 
Table 2 of paragraph (d) of this section; or when such coatings are 
intended for repeated use in contact with foods of the types identified 
in paragraph (d) of this section, Table 1, under Types V, VI, VII, and 
VIII, under conditions of use E or F as described in Table 2 of 
paragraph (d) of this section. Use shall be limited to coatings for 
tanks of capacity greater than 530,000 gallons.
Stannous 2-ethylhexanoate for use only as a catalyst at a level not to 
exceed 1 percent by weight of the resin used in coatings that are 
intended for contact with food under conditions of use D, E, F, and G 
described in Table 2 of paragraph (d) of this section.
Styrene oxide, for use only in coatings for containers having a capacity 
of 1,000 gallons or more when such containers are intended for repeated 
use in contact with alcoholic beverages containing up to 8 percent of 
alcohol by volume.
Tetraethylenepentamine.
Tetraethylenepentamine reacted with equimolar quantities of fatty acids.
Tri(dimethylaminomethyl) phenol and its salts prepared from the fatty 
acid moieties of the salts listed in paragraph (b)(3)(xxii)(b) of this 
section, for use only in coatings subject to the provisions of paragraph 
(c) (3) or (4) of this section.
Triethylenetetramine.
Trimellitic anhydride (CAS Reg. No. 552-30-7) for use only as a cross-
linking agent at a level not to exceed 15 percent by weight of the resin 
in contact with food under all conditions of use, except that resins 
intended for use with foods containing more than 8 percent alcohol must 
contact such food only under conditions of use D, E, F,

[[Page 158]]

and G described in Table 2 of paragraph (d) of this section.
Trimellitic anhydride adducts of ethylene glycol and glycerol, prepared 
by the reaction of 1 mole of trimellitic anhydride with 0.4-0.6 mole of 
ethylene glycol and 0.04-0.12 mole of glycerol, for use only as a cross-
linking agent at a level not to exceed 10 percent by weight of the cured 
coating, provided that the cured coating only contacts food containing 
not more than 8 percent alcohol.
    Meta-Xylylenediamine (1,3-benzenedimethanamine, CAS Reg. No. 1477-
55-0), for use only in coatings at a level not to exceed 3 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of this 
section, Table 1, under Types I, II, and III, under conditions of use C, 
D, E or F as described in Table 2 of paragraph (d) of this section; or 
when such coatings are intended for repeated use in contact with foods 
of the types identified in paragraph (d) of this section, Table 1, under 
Types V, VI, VII, and VIII, under conditions of use E or F as described 
in Table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.
    Para-Xylylenediamine (1,4 benzenedimethanamine, CAS Reg. No. 539-48-
0), for use only in coatings at a level not to exceed 0.6 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of this 
section, Table 1, under Types I, II, III, under conditions of use C, D, 
E, or F as described in Table 2 of paragraph (d) of this section; or 
when such coatings are intended for repeated use in contact with foods 
of the types identified in paragraph (d) of this section, Table 1, under 
Types V, VI, VII, and VIII, under conditions of use E and F as described 
in Table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.

    (c) Adjuncts for epoxy resins:

Aluminum butylate.
 Benzoic acid, for use as a component in epoxy resins for coatings not 
exceeding a coating weight of 4 milligrams per square inch and that are 
intended for contact under conditions of use D, E, F or G described in 
Table 2 of paragraph (d) of this section with alcoholic beverages 
containing less than 8 percent alcohol.
Polyamides from dimerized vegetable oils and the amine catalysts listed 
in paragraph (b)(3)(viii)(b) of this section, as the basic polymer.
Silane coupled silica, prepared from the reaction of microcrystalline 
quartz with N-beta-(N-vinylbenzylamino) ethyl-gamma-
aminopropyltrimethoxy silane, monohydrogen chloride, for use only in 
coatings intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, Table 1, under 
Category I and Category VIII, at temperatures not exceeding 88 deg. C 
(190 deg. F).
Succinic anhydride, for use as a component in epoxy resins for coatings 
not exceeding a coating weight of 4 milligrams per square inch, and that 
are intended for contact under conditions of use D, E, F or G described 
in Table 2 of paragraph (d) of this section with alcoholic beverages 
containing less than 8 percent alcohol.

    (ix) Coumarone-indene resin, as the basic polymer.
    (x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic 
polymer.
    (xi) Terpene resins, as the basic polymer, from one or more of the 
following:

Dipentene.
Hydrogenated dipentene resin (CAS Reg. No. 106168-39-2). For use only 
with coatings in contact with acidic and aqueous foods.
Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS 
Reg. No. 106168-37-0). For use only with coatings in contact with acidic 
and aqueous foods.
-Pinene.
-Pinene.

    (xii) Urea-formaldehyde, resins and their curing catalyst:
    (a) Urea-formaldehyde resins, as the basic polymer:

Urea-formaldehyde.
Urea-formaldehyde chemically modified with methyl, ethyl, propyl, 
isopropyl, butyl, or isobutyl alcohol.
Urea-formaldehyde chemically modified with one or more of the amine 
catalysts listed in paragraph (b)(3)(viii)(b) of this section.

    (b) Curing (cross-linking) catalyst for urea-formaldehyde resins:

Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).

    (xiii) Triazine-formaldehyde resins and their curing catalyst:
    (a) Triazine-formaldehyde resins, as the basic polymer:

Benzoguanamine-formaldehyde.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the 
following amine catalysts:
    Amine catalysts listed in paragraph (b)(3)(viii)(b) of this section.
    Dimethylamine-2-methyl-1-propanol.

[[Page 159]]

    Methylpropanolamine.
    Triethanolamine.
Melamine-formaldehyde chemically modified with methyl, ethyl, propyl, 
isopropyl, butyl, or isobutyl alcohol.

    (b) Curing (cross-linking) catalyst for triazine-formaldehyde 
resins:

Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).

    (xiv) Modifiers (for oils and alkyds, including polyesters), as the 
basic polymer:

Butyl methacrylate.
Cyclopentadiene.
Methyl, ethyl, butyl, or octyl esters of acrylic acid.
Methyl methacrylate.
Styrene.
Vinyl toluene.

    (xv) Vinyl resinous substance, as the basic polymers:

Polyvinyl acetate.
Polyvinyl alcohol.
Polyvinyl butyral.
Polyvinyl chloride.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Vinyl chloride-acetate-2,3-epoxypropyl methacrylate copolymers 
containing not more than 10 weight percent of total polymer units 
derived from 2,3-epoxypropyl methacrylate and not more than 0.1 weight 
percent of unreacted 2,3-epoxypropyl methacrylate monomer for use in 
coatings for containers.
Vinyl chloride-acetate, hydroxyl-modified copolymer.
Vinyl chloride-acetate, hydroxyl-modified copolymer, reacted with 
trimellitic anhydride.
Vinyl chloride copolymerized with acrylamide and ethylene in such a 
manner that the finished copolymers have a minimum weight average 
molecular weight of 30,000 and contain not more than 3.5 weight percent 
of total polymer units derived from acrylamide; the acrylamide portion 
may or may not be subsequently partially hydrolyzed.
Vinyl chloride copolymerized with one or more of the following 
substances:
    Acrylonitrile.
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, 
heptyl, or octyl esters.
Maleic acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, 
heptyl, or octyl esters.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester; for use such 
that the finished vinyl chloride copolymers contain not more than 4 
weight percent of total polymer units derived from this comonomer.
    Vinyl acetate.
    Vinylidene chloride.
Vinyl chloride-vinylidene chloride-2,3-epoxypropyl methacrylate 
copolymers containing not more than 10 weight percent of total polymer 
units derived from 2,3-epoxypropyl methacrylate and not more than 0.05 
weight percent of unreacted 2,3-epoxypropyl methacrylate monomer based 
on polymer solids for use only in coatings for containers intended for 
contact with foods under conditions B, C, D, E, F, G, or H described in 
Table 2 of paragraph (d) of this section.

    (xvi) Cellulosics, as the basic polymer:

Carboxymethylcellulose.
Cellulose acetate.
Cellulose acetate-butyrate.
Cellulose acetate-propionate.
Ethylcellulose.
Ethyl hydroxyethylcellulose.
Hydroxyethylcellulose.
Hydroxypropyl methylcellulose.
Methylcellulose.
Nitrocellulose.

    (xvii) Styrene polymers, as the basic polymer:

Polystyrene.
-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
    Acrylonitrile.
    -Methylstyrene.

    (xviii) Polyethylene and its copolymers as the basic polymer:

Ethylene-ethyl acrylate copolymer.
Ethylene-isobutyl acrylate copolymers containing no more than 35 weight 
percent of total polymer units derived from isobutyl acrylate.
Ethylene-vinyl acetate copolymer.
Polyethylene.

    (xix) Polypropylene as the basic polymer:

Polypropylene.
Maleic anhydride adduct of polypropylene The polypropylene used in the 
manufacture of the adduct complies with Sec. 177.1520(c), item 1.1; and 
the adduct has a maximum combined maleic anhydride content of 0.8 
percent and a minimum intrinsic viscosity of 0.9, determined at 135 deg. 
C on a 0.1 percent solution of the modified polypropylene in 
decahydronaphthalene as determined by a method titled ``Method for 
Determination of Intrinsic Viscosity of

[[Page 160]]

Maleic Anhydride Adduct of Polypropylene,'' which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

    (xx) Acrylics and their copolymers, as the basic polymer:

Acrylamide with ethylacrylate and/or styrene and/or methacrylic acid, 
subsequently reacted with formaldehyde and butanol.
Acrylic acid and the following esters thereof:
  Ethyl.
  Methyl.
Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate 
copolymers containing no more than 20 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 7 weight 
percent of total polymer units derived from hydroxyethyl methacrylate; 
for use only in coatings that are applied by electrodeposition to metal 
substrates.
Butyl acrylate-styrene-methacrylic acid-hydroxypropyl methacrylate 
copolymers containing no more than 20 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 7 weight 
percent of total polymer units derived from hydroxypropyl methacrylate; 
for use only in coatings that are applied by electrodeposition to metal 
substrates and that are intended for contact, under condition of use D, 
E, F, or G described in Table 2 of paragraph (d) of this section, with 
food containing no more than 8 percent of alcohol.
Ethyl acrylate-styrene-methacrylic acid copolymers for use only as 
modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this 
section.
Ethyl acrylate-methyl methacrylate-styrene-methacrylic acid copolymers 
for use only as modifiers for epoxy resins listed in paragraph 
(b)(3)(viii)(a) of this section.
2-Ethylhexyl acrylate-ethyl acrylate copolymers prepared by 
copolymerization of 2-ethylhexyl acrylate and ethyl acrylate in a 7/3 
weight ratio and having a number average molecular weight range of 5,800 
to 6,500 and a refractive index, nD25 deg. (40 percent in 
2,2,4-trimethyl pentane) of 1.4130-1.4190; for use as a modifier for 
nylon resins complying with Sec. 177.1500 of this chapter and for 
phenolic and epoxy resins listed in paragraph (b)(3) (vi) and (viii) of 
this section, respectively, at a level not to exceed 1.5 percent of the 
coating.
2-Ethylhexyl acrylate-methyl methacrylate-acrylic acid copolymers for 
use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii) 
of this section.
Methacrylic acid and the following esters thereof:
    Butyl.
    Ethyl.
    Methyl.
Methacrylic acid or its ethyl and methyl esters copolymerized with one 
          or more of the following:
    Acrylic acid.
    Ethyl acrylate.
    Methyl acrylate.
n-Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate 
copolymers containing no more than 2 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 9.5 
weight percent of total polymer units derived from hydroxyethyl 
methacrylate; for use only in coatings in contact with dry food (food 
type VIII in Table 1 of paragraph (d) of this section). 2-
(Dimethylamino) ethanol (C.A.S. Registry No. 108-01-0) may be employed 
as an optional adjuvant substance limited to no more than 2 weight 
percent based on polymer solids in the coating emulsion.
Styrene polymers made by the polymerization of any combination of 
styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-
ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The 
styrene and alpha methyl styrene, individually, may constitute from 0 to 
80 weight percent of the polymer. The other monomers, individually, may 
be from 0 to 40 weight percent of the polymer. The polymer number 
average molecular weight (Mn) shall be at least 2,000 (as 
determined by gel permeation chromatography). The acid number of the 
polymer shall be less than 250. The monomer content shall be less than 
0.5 percent. The polymers are for use only in contact with food of Types 
IV-A, V, VII in table 1 of paragraph (d) of this section, under use 
conditions E through G in table 2 of paragraph (d), and with food of 
Type VIII without use temperature restriction.

    (xxi) Elastomers, as the basic polymer:

Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated rubber.
2-Chloro-1,3-butadiene (neoprene).
Natural rubber (natural latex or natural latex solids, smoked or 
unsmoked).
Polyisobutylene.
Rubber hydrochloride.
Styrene-isobutylene copolymer.

    (xxii) Driers made by reaction of a metal from paragraph 
(b)(3)(xxii)(a) of

[[Page 161]]

this section with acid, to form the salt listed in paragraph 
(b)(3)(xxii)(b) of this section:
    (a) Metals:

Aluminum.
Calcium.
Cerium.
Cobalt.
Iron.
Lithium.
Magnesium.
Manganese.
Zinc.
Zirconium.

    (b) Salts:

Caprate.
Caprylate.
Isodecanoate.
Linoleate.
Naphthenate.
Neodecanoate.
Octoate (2-ethylhexoate).
Oleate.
Palmitate.
Resinate.
Ricinoleate.
Soyate.
Stearate.
Tallate.

    (xxiii) Waxes:

Paraffin, Type I.
Paraffin, Type II.
Polyethylene.
Sperm oil.
Spermaceti.

    (xxiv) Plasticizers:

Acetyl tributyl citrate.
Acetyl triethyl citrate.
Butyl phthalyl butyl glycolate.
Butyl stearate.
p-tert-Butyl phenyl salicylate.
Dibutyl sebacate.
Diethyl phthalate.
Diisobutyl adipate.
Diisooctyl phthalate.
Epoxidized soybean oil (iodine number maximum 14; oxirane oxygen content 
6% minimum), as the basic polymer.
Ethyl phthalyl ethyl glycolate.
2-Ethylhexyl diphenyl phosphate.
di-2-Ethylhexyl phthalate.
Glycerol.
Glyceryl monooleate.
Glyceryl triacetate.
Monoisopropyl citrate.
Propylene glycol.
Sorbitol.
Mono-, di-, and tristearyl citrate.
Triethyl citrate.
Triethylene glycol.
3-(2-Xenolyl)-1,2-epoxypropane.

    (xxv) Release agents, as the basic polymer, when applicable:

N, N'-Dioleoylethylenediamine (CAS Reg. No. 110-31-6) for use only in 
ionomeric resins complying with Sec. 177.1330 of this chapter and in 
ethylene vinyl acetate copolymers complying with Sec. 177.1350 of this 
chapter at a level not to exceed 0.0085 milligram per square centimeter 
(0.055 milligram per square inch) in the finished food-contact article.
N,N'-Distearoyl ethylenediamine.
Linoleic acid amide.
Oleic acid amide.
Palmitic acid amide.
Petrolatum.
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene 
glycol moiety greater than 300).
Polytetrafluoroethylene.
Silicones (not less than 300 centistokes viscosity): 
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl-
phenylpolysiloxanes contain not more than 2.0 percent by weight of 
cyclosiloxanes having up to and including 4 siloxy units.
Silicones (not less than 100 centistokes viscosity): 
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use 
only on metal substrates. The methylphenylpolysiloxanes contain not more 
than 2.0 percent by weight of cyclosiloxanes having up to and including 
4 siloxy units.

    (xxvi) Colorants used in accordance with Sec. 178.3297 of this 
chapter.
    (xxvii) Surface lubricants:

Cottonseed oil and other edible oils.
Dibutyl sebacate.
Dioctyl sebacate.
Glyceryl monostearate.
Lanolin.
Mineral oil, white.
Palm oil.
Paraffin, Type I.
Paraffin, Type II.
Petrolatum.
Stearic acid.

    (xxviii) Silicones and their curing catalysts:
    (a) Silicones as the basic polymer:

Siloxane resins originating from methyl hydrogen polysiloxane, dimethyl 
polysiloxane, and methylphenyl polysiloxane.

    (b) Curing (cross-linking) catalysts for silicones (the maximum 
amount of tin catalyst used shall be that required to effect optimum 
cure but shall not exceed 1 part of tin per 100 parts of siloxane resins 
solids):


[[Page 162]]


Dibutyltin dilaurate.
Stannous oleate.
Tetrabutyl titanate.

    (xxix) Surface active agents:

Ethylene oxide adduct of 2,4,7,9-tetramethyl-5-decyn-4,7-diol (CAS Reg. 
No. 9014-85-1).
Poly[2-(diethylamino) ethyl methacrylate] phosphate (minimum intrinsic 
viscosity in water at 25 deg. C is not less than 9.0 deciliters per gram 
as determined by ASTM method D1243-79, ``Standard Test Method for Dilute 
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated 
by reference (copies may be obtained from the American Society for 
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408), for use only as a 
suspending agent in the manufacture of vinyl chloride copolymers and 
limited to use at levels not to exceed 0.1 percent by weight of the 
copolymers.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. Reg. No. 126-86-3), for use 
only in can coatings which are subsequently dried and cured at 
temperatures of at least 193 deg. C (380 deg. F) for 4 minutes.

    (xxx) Antioxidants:

Butylated hydroxyanisole.
Butylated hydroxytoluene.
Gum guaiac.
Dilauryl thiodipropionate.
Nordihydroguaiaretic acid.
Propyl gallate.
Distearyl thiodipropionate.
Thiodipropionic acid.
2,4,5-Trihydroxybutyrophenone.

    (xxxi) Can end cements (sealing compounds used for sealing can ends 
only): In addition to the substances listed in paragraph (b) of this 
section and those listed in Sec. 177.1210(b)(5) of this chapter, the 
following may be used:

Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 26471-45-4) for 
use only at levels not to exceed 23.8 percent by weight of the cement 
solids in can end cements.
Butadiene-styrene-fumaric acid copolymer.
4,4'-Butylidenebis (6-tert-butyl-m-cresol).
Dibenzamido phenyl disulfide.
Di--naphthyl phenylenediamine.
Dipentamethylene thiuram tetrasulfide.
Isobutylene-isoprene-divinylbenzene copolymers for use only at levels 
not to exceed 15 percent by weight of the dry cement composition.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt, for use 
only at levels not to exceed 0.6 percent by weight of the cement solids 
in can end cements for containers having a capacity of not less than 5 
gallons.
Sodium decylbenzene sulfonate.
Sodium nitrite for use only at levels not to exceed 0.3 percent by 
weight of the cement solids in can end cements for containers having a 
capacity of not less than 5 gallons.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by 
weight in can-sealing compounds on containers having a capacity of 5 
gallons or more.
Sodium phenylphenate.
Styrene-maleic anhydride resin, partial methyl and butyl (sec- or iso-) 
esters, for use only at levels not in excess of 3 percent of the cement 
solids in can end cement formulations.
Tetrasodium EDTA (tetrasodium ethylene-diaminetetraacetate).
Tri (mixed mono- and dinonylphenyl) phosphite.
Zinc dibutyldithiocarbamate.

    (xxxii) Side seam cements: In addition to the substances listed in 
paragraph (b)(3) (i) to (xxx), inclusive, of this section, the following 
may be used.

p-tert-Butyl perbenzoate as a catalyst for epoxy resin.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Dicumyl peroxide for use only as polymerization catalyst.
4-(Diiodomethysulfonyl) toluene (CAS Reg. No. 20018-09-1) for use as a 
preservative at a level not to exceed 0.3 percent by weight in can-
sealing cements.
Diisodecyl phthalate for use only as plasticizer in side seam cements 
for containers intended for use in contact with food only of the types 
identified in paragraph (d) of this section, Table 1, under Categories 
I, II, and VI.
4,4'-Bis(alpha,alpha-dimethylbenzyl)diphenylamine, CAS Reg. No. 10081-
67-1.
Ethyl toluene sulfonamide.
N,N'-Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamide), CAS 
Reg. No. 23128-74-7.
Polyamides consisting of the following:
    Copolymer of omega-laurolactam and espilon-caprolactam, CAS Reg. No. 
25191-04-2 (Nylon 12/6).
    Homopolymer of omega-aminododecanoic acid, CAS Reg. No. 24937-16-4.
    Homopolymer of omega-laurolactam, CAS Reg. No. 25038-74-8 (Nylon 
12).
Polyamides derived from the following acids and amines:
    Acids:
Adipic.
Azelaic.

[[Page 163]]

Sebacic.
Vegetable oil acids (with or without dimerization).
    Amines:
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Tetraethylenepentamine.
Triethylenetetramine.
Polypropylene glycol CAS Reg. No. 25322-69-4.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by 
weight in can-sealing compounds on containers having a capacity of 5 
gallons or more.
Tetrakis [methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]methane, 
CAS Reg. No. 6683-19-8.
Toluene sulfonamide formaldehyde resin (basic polymer).
Triethylene glycol methacrylate for use only as polymerization cross-
linking agent in side seam cements for containers intended for use in 
contact with food only of the types identified in paragraph (d) of this 
section, Table 1, under Categories I, II, and VI.
Urea.

    (xxxiii) Miscellaneous materials:

Ammonium citrate.
Ammonium potassium phosphate.
Bentonite, modified by reaction with benzyl dimethyl alkyl ammonium 
chloride, where the alkyl groups are derived from hydrogenated tallow 
(CAS Reg. No. 71011-24-0). For use only as a rheological agent in 
coatings intended to contact food under repeated use conditions.
Bentonite, modified by reaction with sodium stearate and benzyl dimethyl 
alkyl ammonium chloride, where the alkyl groups are derived from 
hydrogenated tallow (CAS Reg. No. 121888-68-4). For use as a rheological 
agent only in coatings intended to contact dry food under repeated-use 
conditions.
Calcium acetate.
Calcium ethyl acetoacetate.
Calcium glycerophosphate.
Calcium, sodium, and potassium oleates.
Calcium, sodium, and potassium ricinoleates.
Calcium, sodium, and potassium stearates.
Castor oil, hydrogenated.
    Castor oil, hydrogenated polymer with ethylenediamine, 12-
hydroxyoctadecanoic acid and sebacic acid (CAS Reg. No. 68604-06-8). The 
condensation product formed by the reaction of hydrogenated castor oil 
with polyamide derived from ethylenediamine, sebacic acid and 12-
hydroxystearic acid, for use only in coatings at a level not to exceed 
3.2 percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of this section, Table 1, under Types I, II, and III, 
under conditions of use C, D, E, or F as described in Table 2 of 
paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, Table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in Table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons.
Castor oil, sulfated, sodium salt (CAS Reg. No. 68187-76-8), for use 
only in coatings for containers intended for repeated use.
Cetyl alcohol.
Cyclohexanone-formaldehyde resin produced when 1 mole of cyclohexanone 
is made to react with 1.65 moles of formaldehyde such that the finished 
resin has an average molecular weight of 600-610 as determined by ASTM 
method D2503-82, ``Standard Test Method for Molecular Weight (Relative 
Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor 
Pressure,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408. For use only in contact with nonalcoholic and nonfatty foods 
under conditions of use E, F, and G, described in Table 2 of paragraph 
(d) this section.
Decyl alcohol.
Disodium hydrogen phosphate.
Ethyl acetoacetate.
Hectorite, modified by reaction with a mixture of benzyl methyl dialkyl 
ammonium chloride and dimethyl dialkyl ammonium chloride, where the 
alkyl groups are derived from hydrogenated tallow (CAS Reg. No. 121888-
67-3). For use as a rheological agent only in coatings intended to 
contact dry food under repeated-use conditions.
Lauryl alcohol.
Lecithin.
Magnesium, sodium, and potassium citrate.
Magnesium glycerophosphate.
Magnesium stearate.
Mono-, di-, and tricalcium phosphate.
Monodibutylamine pyrophosphate as sequestrant for iron.
Mono-, di-, and trimagnesium phosphate.
Myristyl alcohol.
Octyl alcohol.
Phosphoric acid.
Polybutene, hydrogenated; complying with the identity and limitations 
prescribed by Sec. 178.3740 of this chapter.
Poly(ethylene oxide).
Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated, 
diesters with poly(2-oxepanone), diacetates (CAS

[[Page 164]]

Reg. No. 116810-47-0) at a level not to exceed 0.025 weight percent of 
the finished coating having no greater than a 0.5 mil thickness for use 
as a component of polyester, epoxy, and acrylic coatings complying with 
paragraphs (b)(3)(vii), (viii), and (xx) of this section, respectively.
Silver chloride-coated titanium dioxide for use only as a preservative 
in latex emulsions at a level not to exceed 2.2 parts per million (based 
on silver ion concentration) in the dry coating.
Sodium pyrophosphate.
Stannous chloride.
Stannous stearate.
Stannous sulfate.
Stearyl alcohol.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For use 
only in copolymer coatings on metal under conditions of use E, F, and G 
described in Table 2 of paragraph (d) of this section, and limited to 
use at a level not to exceed 2.0 percent by weight of the dry copolymer 
coating.
Tetrasodium pyrophosphate.
Tridecyl alcohol produced from tetrapropylene by the oxo process, for 
use only as a processing aid in polyvinyl chloride resins.
Trimethylolpropane (CAS Reg. No. 77-99-6). For use as a pigment 
dispersant at levels not to exceed 0.45 percent by weight of the 
pigment.
Vinyl acetate-dibutyl maleate copolymers produced when vinyl acetate and 
dibutyl maleate are copolymerized with or without one of the monomers: 
Acrylic acid or glycidyl methacrylate. For use only in coatings for 
metal foil used in contact with foods that are dry solids with the 
surface containing no free fat or oil. The finished copolymers shall 
contain at least 50 weight-percent of polymer units derived from vinyl 
acetate and shall contain no more than 5 weight-percent of total polymer 
units derived from acrylic acid or glycidyl methacrylate.

    (xxxiv) Polyamide resins derived from dimerized vegetable oil acids 
(containing not more than 20 percent of monomer acids) and 
ethylenediamine, as the basic resin, for use only in coatings that 
contact food at temperatures not to exceed room temperature.
    (xxxv) Polyamide resins having a maximum acid value of 5 and a 
maximum amine value of 8.5 derived from dimerized vegetable oil acids 
(containing not more than 10 percent of monomer acids), ethylenediamine, 
and 4,4-bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed 
10 percent by weight of said polyamide resins); as the basic resin, for 
use only in coatings that contact food at temperatures not to exceed 
room temperature provided that the concentration of the polyamide resins 
in the finished food-contact coating does not exceed 5 milligrams per 
square inch of food-contact surface.
    (xxxvi) Methacrylonitrile grafted polybutadiene copolymers 
containing no more than 41 weight percent of total polymer units derived 
from methacrylonitrile; for use only in coatings that are intended for 
contact, under conditions of use D, E, F, or G described in Table 2 of 
paragraph (d) of this section, with food containing no more than 8 
percent of alcohol.
    (xxxvii) Polymeric resin as a coating component prepared from 
terephthalic acid, isophthalic acid, succinic anhydride, ethylene 
glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol for use in 
contact with aqueous foods and alcoholic foods containing not more than 
20 percent (by volume) of alcohol under conditions of use D, E, F, and G 
described in Table 2 of Sec. 176.170 of this chapter. The resin shall 
contain no more than 30 weight percent of 2,2-dimethyl-1,3-propanediol.
    (c) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from Tables 1 and 2 of 
paragraph (d) of this section, shall yield chloroform-soluble 
extractives, corrected for zinc extractives as zinc oleate, not to 
exceed the following:
    (1) From a coating intended for or employed as a component of a 
container not to exceed 1 gallon and intended for one-time use, not to 
exceed 0.5 milligram per square inch nor to exceed that amount as 
milligrams per square inch that would equal 0.005 percent of the water 
capacity of the container, in milligrams, divided by the area of the 
food-contact surface of the container in square inches. From a 
fabricated container conforming with the description in this paragraph 
(c)(1), the extractives shall not exceed 0.5 milligram per square inch 
of food-contact surface nor exceed 50 parts per million of the water 
capacity of the container

[[Page 165]]

as determined by the methods provided in paragraph (e) of this section.
    (2) From a coating intended for or employed as a component of a 
container having a capacity in excess of 1 gallon and intended for one-
time use, not to exceed 1.8 milligrams per square inch nor to exceed 
that amount as milligrams per square inch that would equal 0.005 percent 
of the water capacity of the container in milligrams, divided by the 
area of the food-contact surface of the container in square inches.
    (3) From a coating intended for or employed as a component of a 
container for repeated use, not to exceed 18 milligrams per square inch 
nor to exceed that amount as milligrams per square inch that would equal 
0.005 percent of the water capacity of the container in milligrams, 
divided by the area of the food-contact surface of the container in 
square inches.
    (4) From coating intended for repeated use, and employed other than 
as a component of a container, not to exceed 18 milligrams per square 
inch of coated surface.
    (d) Tables:

                         Table 1--Types of Food                         
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar  
 or both, and including oil-in-water emulsions of low- or high-fat      
 content.                                                               
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or     
 sugar or both, and including oil-in-water emulsions of low- or high-fat
 content.                                                               
III. Aqueous, acid or nonacid products containing free oil or fat; may  
 contain salt, and including water-in-oil emulsions of low- or high-fat 
 content.                                                               
IV. Dairy products and modifications:                                   
  A. Water-in-oil emulsion, high- or low-fat.                           
  B. Oil-in-water emulsion, high- or low-fat.                           
V. Low moisture fats and oils.                                          
VI. Beverages:                                                          
  A. Containing alcohol.                                                
  B. Nonalcoholic.                                                      
VII. Bakery products.                                                   
VIII. Dry solids (no end test required).                                
------------------------------------------------------------------------
                                                                        


  Table 2--Test Procedures for Determining the Amount of Extractives From Resinous or Polymeric Coatings, Using 
                                Solvents Simulating Types of Foods and Beverages                                
----------------------------------------------------------------------------------------------------------------
                                                                              Extractant                        
                                                     -----------------------------------------------------------
        Condition of use          Types of food (see                        Heptane \1\ \2\    8 percent alcohol
                                       table 1)         Water (time and        (time and           (time and    
                                                         temperature)        temperature)        temperature)   
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-         I, IV-B...........  250 deg. F, 2 hr..  ..................                    
 sterilized (e.g., over 212 deg.  III, IV-A, VII....  ......do..........  150 deg. F, 2 hr..                    
 F).                                                                                                            
B. Boiling water sterilized.....  II................  212 deg. F, 30 min  ..................                    
                                  III, VII..........  ......do..........  120 deg. F, 30 min                    
C. Hot filled or pasteurized      II, IV-B..........  Fill boiling, cool  ..................                    
 above 150 deg. F.                                     to 100 deg. F.                                           
                                  III, IV-A.........  ......do..........  120 deg. F, 15 min                    
                                  V.................  ..................  ......do..........                    
D. Hot filled or pasteurized      II, IV-B, VI-B....  150 deg. F, 2 hr..  ..................  ..................
 below 150 deg. F.                III, IV-A.........  ......do..........  100 deg. F, 30 min  ..................
                                  V.................  ..................  ......do..........  ..................
                                  VI-A..............  ..................  ..................  150 deg. F, 2 hr  
E. Room temperature filled and    I, II, IV-B, VI-B.  120 deg. F, 24 hr.  ..................  ..................
 stored (no thermal treatment in  III, IV-A.........  ......do..........  70 deg. F, 30 min.  ..................
 the container).                  V, VII............  ..................  ......do..........  ..................
                                  VI-A..............  ..................  ..................  120 deg. F, 24 hr 
F. Refrigerated storage, no       I, II, III, IV-A,   70 deg. F, 48 hr..  ..................                    
 thermal treatment in the          IV-B, VI-B, VII.                                                             
 container).                                                                                                    
                                  VI-A..............  ..................  ..................  70 deg. F, 48 hr  
G. Frozen storage (no thermal     I, II, III, IV-B,   70 deg. F, 24 hr..  ..................                    
 treatment in the container).      VII.                                                                         
H. Frozen storage: Ready-                                                                                       
 prepared foods intended to be                                                                                  
 reheated in container at time                                                                                  
 of use:.                                                                                                       
  1. Aqueous or oil in water      I, II, IV-B.......  212 deg. F, 30 min  ..................                    
   emulsion of high or low fat.                                                                                 
  2. Aqueous, high or low free    III, IV-A, VII....  ......do..........  120 deg. F, 30 min  ..................
   oil or fat.                                                                                                  
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractant not to be used on wax-lined containers.                                                  
\2\ Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food 
  product.                                                                                                      

    (e) Analytical methods--(1) Selection of extractability conditions. 
First ascertain the type of food product (Table 1, paragraph (d) of this 
section) that is being

[[Page 166]]

packed commercially in the test container and the normal conditions of 
thermal treatment used in packaging the type of food involved. Using 
Table 2 (paragraph (d) of this section), select the food-simulating 
solvent or solvents (demineralized distilled water, heptane, and/or 8 
percent ethyl alcohol) and the time-temperature exaggerations of the 
container-use conditions. Aqueous products (Types I, II, IV-B, and VI-B) 
require only a water-extractability test at the temperature and time 
conditions shown for the most severe ``conditions of use.'' Aqueous 
products with free oil or fat, and water-oil emulsions (types III, IV-A, 
and VII) will require determinations of both water extractability and 
heptane extractability. Low-moisture fats and oils (type V with no free 
water) require only the heptane extractability. Alcoholic beverages 
(type VI-A) require only the 8 percent alcohol extractant. Having 
selected the appropriate extractant or extractants simulating various 
types of foods and beverages and the time-temperature exaggerations over 
normal use, follow the applicable extraction procedure. Adapt the 
procedure, when necessary, for containers having a capacity of over 1 
gallon.
    (2) Selection of coated-container samples. For consumer-sized 
containers up to 1 gallon, quadruplicate samples of representative 
containers (using for each replicate sample the number of containers 
nearest to an area of 180 square inches) should be selected from the lot 
to be examined.
    (3) Cleaning procedure preliminary to determining the amount of 
extractables from coated containers. Quadruplicate samples of 
representative containers should be selected from the lot to be examined 
and must be carefully rinsed to remove extraneous material prior to the 
actual extraction procedure. Soda fountain pressure-type hot water 
rinsing equipment, consisting in its simplest form of a \1/8\-inch-\1/
4\-inch internal diameter metal tube attached to a hot water line and 
bent so as to direct a stream of water upward, may be used. Be sure hot 
water has reached a temperature of 190 deg. F-200 deg. F before starting 
to rinse the container. Invert the container over the top of the 
fountain and direct a strong stream of hot water against the bottom and 
all sides for 1 minute, drain, and allow to dry.
    (4) Exposure conditions--(i) Water (250 deg. F for 2 hours), 
simulating high-temperature heat sterilization. Fill the container 
within \1/4\-inch of the top with a measured volume of demineralized 
distilled water. Cover the container with clean aluminum foil and place 
the container on a rack in a pressure cooker. Add a small amount of 
demineralized distilled water to the pressure cooker, but do not allow 
the water to touch the bottom of the container. Close the cooker 
securely and start to heat over a suitable burner. When a steady stream 
of steam emerges from the vent, close the vent and allow the pressure to 
rise to 15 pounds per square inch (250 deg. F) and continue to maintain 
this pressure for 2 hours. Slowly release the pressure, open the 
pressure cooker when the pressure reads zero, and composite the water of 
each replicate immediately in a clean Pyrex flask or beaker. Proceed 
with the determination of the amount of extractives by the method 
described in paragraph (e)(5) of this section.
    (ii) Water (212 deg. F for 30 minutes), simulating boiling water 
sterilization. Fill the container within \1/4\-inch of the top with a 
measured volume of boiling, demineralized distilled water. Cover the 
container with clean aluminum foil and place the container on a rack in 
a pressure cooker in which a small amount of demineralized distilled 
water is boiling. Do not close the pressure vent, but operate at 
atmospheric pressure so that there is a continuous escape of a small 
amount of steam. Continue to heat for 30 minutes, then remove the test 
container and composite the contents of each replicate immediately in a 
clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (iii) Water (from boiling to 100 deg. F), simulating hot fill or 
pasteurization above 150 deg. F. Fill the container within \1/4\-inch of 
the top with a measured volume of boiling, demineralized distilled 
water. Insert a thermometer in the water and allow the uncovered 
container to stand in a room at 70 deg. F-85 deg. F. When the 
temperature reads 100 deg. F, composite the

[[Page 167]]

water from each replicate immediately in a clean Pyrex flask or beaker. 
Proceed with the determination of the amount of extractives by the 
method described in paragraph (e)(5) of this section.
    (iv) Water (150 deg. F for 2 hours), simulating hot fill or 
pasteurization below 150 deg. F. Preheat demineralized distilled water 
to 150 deg. F in a clean Pyrex flask. Fill the container within \1/4\-
inch of the top with a measured volume of the 150 deg. F water and cover 
with clean aluminum foil. Place the test container in an oven maintained 
at 150 deg. F. After 2 hours, remove the test container from the oven 
and immediately composite the water of each replicate in a clean Pyrex 
flask or beaker. Proceed with the determination of the amount of 
extractives by the method described in paragraph (e)(5) of this section.
    (v) Water (120 deg. F for 24 hours), simulating room temperature 
filling and storage. Preheat demineralized distilled water to 120 deg. F 
in a clean Pyrex flask. Fill the container within \1/4\-inch of the top 
with a measured volume of the 120 deg. F water and cover with clean 
aluminum foil. Place the test container in an incubator or oven 
maintained at 120 deg. F. After 24 hours, remove the test container from 
the incubator and immediately composite the water of each replicate in a 
clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (vi) Water (70 deg. F for 48 hours), simulating refrigerated 
storage. Bring demineralized distilled water to 70 deg. F in a clean 
Pyrex flask. Fill the container within \1/4\-inch of the top with a 
measured volume of the 70 deg. F water, and cover with clean aluminum 
foil. Place the test container in a suitable room maintained at 70 deg. 
F. After 48 hours, immediately composite the water of each replicate in 
a clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (vii) Water (70 deg. F for 24 hours), simulating frozen storage. 
Bring demineralized distilled water to 70 deg. F in a clean Pyrex flask. 
Fill the container within \1/4\-inch of the top with a measured volume 
of the 70 deg. F water and cover with clean aluminum foil. Place the 
container in a suitable room maintained at 70 deg. F. After 24 hours, 
immediately composite the water of each replicate in a clean Pyrex flask 
or beaker. Proceed with the determination of the amount of extractives 
by the method described in paragraph (e)(5) of this section.
    (viii) Water (212 deg. F for 30 minutes), simulating frozen foods 
reheated in the container. Fill the container to within \1/4\-inch of 
the top with a measured volume of boiling, demineralized distilled 
water. Cover the container with clean aluminum foil and place the 
container on a rack in a pressure cooker in which a small amount of 
demineralized distilled water is boiling. Do not close the pressure 
vent, but operate at atmospheric pressure so that there is a continuous 
escape of a small amount of steam. Continue to heat for 30 minutes, then 
remove the test container and composite the contents of each replicate 
immediately in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (ix) Heptane (150 deg. F for 2 hours) simulating high-temperature 
heat sterilization for fatty foods only. Preheat redistilled reagent-
grade heptane (boiling point 208 deg. F) carefully in a clean Pyrex 
flask on a water bath or nonsparking hot plate in a well-ventilated hood 
to 150 deg. F. At the same time preheat a pressure cooker or equivalent 
to 150 deg. F in an incubator. This pressure cooker is to serve only as 
a container for the heptane-containing test package inside the incubator 
in order to minimize the danger of explosion. Fill the test container 
within \1/4\-inch of the top with a measured volume of the 150 deg. F 
heptane and cover with clean aluminum foil. Place the test container in 
the preheated pressure cooker and then put the assembly into a 150 deg. 
F incubator. After 2 hours, remove the pressure cooker from the 
incubator, open the assembly, and immediately composite the heptane of 
each replicate in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.

[[Page 168]]

    (x) Heptane (120 deg. F for 30 minutes), simulating boiling water 
sterilization of fatty foods only. Preheat redistilled reagent-grade 
heptane (boiling point 208 deg. F) carefully in a clean Pyrex flask on a 
water bath or nonsparking hot plate in a well-ventilated hood to 
120 deg. F. At the same time, preheat a pressure cooker or equivalent to 
120 deg. F in an incubator. This pressure cooker is to serve only as a 
vented container for the heptane-containing test package inside the 
incubator in order to minimize the danger of explosion. Fill the test 
container within \1/4\-inch of the top with a measured volume of the 
120 deg. F heptane and cover with clean aluminum foil. Place the test 
container in the preheated pressure cooker and then put the assembly 
into a 120 deg. F incubator. After 30 minutes, remove the pressure 
cooker from the incubator, open the assembly, and immediately composite 
the heptane of each replicate in a clean Pyrex flask or beaker. Proceed 
with the determination of the amount of extractives by the method 
described in paragraph (e)(5) of this section.
    (xi) Heptane (120 deg. F for 15 minutes), simulating hot fill or 
pasteurization above 150 deg. F for fatty foods only. Preheat 
redistilled reagent-grade heptane (boiling point 208 deg. F) carefully 
in a clean Pyrex flask on a water bath or nonsparking hot plate in a 
well-ventilated hood to 120 deg. F. At the same time, preheat a pressure 
cooker or equivalent to 120 deg. F in an incubator. This pressure cooker 
is to serve only as a container for the heptane-containing test package 
inside the incubator in order to minimize the danger of explosion. Fill 
the test container within \1/4\-inch of the top with a measured volume 
of the 120 deg. F heptane and cover with clean aluminum foil. Place the 
test container in the preheated pressure cooker and then put the 
assembly into a 120 deg. F incubator. After 15 minutes, remove the 
pressure cooker from the incubator, open the assembly, and immediately 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xii) Heptane (100 deg. F for 30 minutes), simulating hot fill or 
pasteurization below 150 deg. F for fatty foods only. Preheat 
redistilled reagent-grade heptane (boiling point 208 deg. F) carefully 
in a clean Pyrex flask on a water bath or nonsparking hot plate in a 
well-ventilated hood to 100 deg. F. At the same time, preheat a pressure 
cooker or equivalent to 100 deg. F in an incubator. This pressure cooker 
is to serve only as a container for the heptane-containing test package 
inside the incubator in order to minimize the danger of explosion. Fill 
the test container within \1/4\-inch of the top with a measured volume 
of the 100 deg. F heptane and cover with clean aluminum foil. Place the 
test container in the preheated pressure cooker and then put the 
assembly into a 100 deg. F incubator. After 30 minutes, remove the 
pressure cooker from the incubator, open the assembly and immediately 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xiii) Heptane (70 deg. F for 30 minutes), simulating room 
temperature filling and storage of fatty foods only. Fill the test 
container within \1/4\-inch of the top with a measured volume of the 
70 deg. F heptane and cover with clean aluminum foil. Place the test 
container in a suitable room maintained at 70 deg. F. After 30 minutes, 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xiv) Heptane (120 deg. F for 30 minutes), simulating frozen fatty 
foods reheated in the container. Preheat redistilled reagent-grade 
heptane (boiling point 208 deg. F) carefully in a clean Pyrex flask on a 
water bath or hot plate in a well-ventilated hood to 120 deg. F. At the 
same time, preheat a pressure cooker to 120 deg. F in an incubator. This 
pressure cooker is to serve only as a container for the heptane-
containing test package inside the incubator in order to minimize the 
danger of explosion. Fill the test container within \1/4\-inch of the 
top with a measured volume of the 120 deg. F heptane and cover with 
clean aluminum foil. Place the test container in the preheated pressure 
cooker and then put the assembly into a 120 deg. F incubator. After 30 
minutes, remove the pressure

[[Page 169]]

cooker from the incubator, open the assembly and immediately composite 
the heptane from each replicate into a clean Pyrex flask. Proceed with 
the determination of the amount of extractives by the method described 
in paragraph (e)(5) of this section.
    (xv) Alcohol--8 percent (150 deg. F for 2 hours), simulating 
alcoholic beverages hot filled or pasteurized below 150 deg. F. Preheat 
8 percent (by volume) ethyl alcohol in demineralized distilled water to 
150 deg. F in a clean Pyrex flask. Fill the test container with within 
\1/4\-inch of the top with a measured volume of the 8 percent alcohol. 
Cover the container with clean aluminum foil and place in an oven 
maintained at 150 deg. F. After 2 hours, remove the container from the 
oven and immediately composite the alcohol from each replicate in a 
clean Pyrex flask. Proceed with the determination of the amount of 
extractives by the method described in paragraph (e)(5) of this section.
    (xvi) Alcohol--8 percent (120 deg. F for 24 hours), simulating 
alcoholic beverages room-temperature filled and stored. Preheat 8 
percent (by volume) ethyl alcohol in demineralized distilled water to 
120 deg. F in a clean Pyrex flask. Fill the test container within \1/4\-
inch of the top with a measured volume of the 8 percent alcohol, cover 
the container with clean aluminum foil and place in an oven or incubator 
maintained at 120 deg. F. After 24 hours, remove the container from the 
oven or incubator and immediately composite the alcohol from each 
replicate into a clean Pyrex flask. Proceed with the determination of 
the amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (xvii) Alcohol--8 percent (70 deg. F for 48 hours), simulating 
alcoholic beverages in refrigerated storage. Bring 8 percent (by volume) 
ethyl alcohol in demineralized distilled water to 70 deg. F in a clean 
Pyrex flask. Fill the test container within \1/4\-inch of the top with a 
measured volume of the 8 percent alcohol. Cover the container with clean 
aluminum foil. Place the test container in a suitable room maintained at 
70 deg. F. After 48 hours, immediately composite the alcohol from each 
replicate into a clean Pyrex flask. Proceed with the determination of 
the amount of extractives by the method described in paragraph (e)(5) of 
this section.

    Note: The tests specified in paragraph (e)(4) (i) through (xvii) of 
this section are applicable to flexible packages consisting of coated 
metal contacting food, in which case the closure end is double-folded 
and clamped with metal spring clips by which the package can be 
suspended.

    (5) Determination of amount of extractives--(i) Total residues. 
Evaporate the food-simulating solvents from paragraph (e)(4) (i) to 
(xvii), inclusive, of this section to about 100 milliliters in the Pyrex 
flask and transfer to a clean, tared platinum dish, washing the flask 
three times with the solvent used in the extraction procedure, and 
evaporate to a few milliliters on a nonsparking low-temperature 
hotplate. The last few milliliters should be evaporated in an oven 
maintained at a temperature of 212 deg. F. Cool the platinum dish in a 
desiccator for 30 minutes and weigh the residue to the nearest 0.1 
milligram (e). Calculate the extractives in milligrams per square inch 
and in parts per million for the particular size of container being 
tested and for the specific food-simulating solvent used.
    (a) Water and 8-percent alcohol.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.388
    
    [GRAPHIC] [TIFF OMITTED] TR01JA93.389
    
    (b) Heptane.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.390
    
    [GRAPHIC] [TIFF OMITTED] TR01JA93.391
    
Where:
Ex=Extractives residue in ppm for any container size.
e=Milligrams extractives per sample tested.
a=Total coated area, including closure in square inches.
c=Water capacity of container, in grams.
s=Surface of coated area tested, in square inches.
F=Five, the ratio of the amount of extractives removed from a coated 
container by heptane under exaggerated time-

[[Page 170]]

temperature test conditions compared to the amount extracted by a fat or 
oil from a container tested under exaggerated conditions of thermal 
sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Zinc corrected chloroform-soluble extractive residue.
e' or ee' is substituted for e in the above equations when necessary.

If when calculated by the equations in paragraph (e)(5)(i) (a) and (b) 
of this section, the concentration of extractives residue (Ex) exceeds 
50 parts per million or the extractives in milligrams per square inch 
exceed the limitations prescribed in paragraph (c) of this section for 
the particular container size, proceed to paragraph (e)(5)(ii) of this 
section (method for determining the amount of chloroform-soluble 
extractives residue).
    (ii) Chloroform-soluble extractives residue. Add 50 milliliters of 
chloroform (freshly distilled reagent grade or a grade having an 
established consistently low blank) to the dried and weighed residue, 
(e), in the platinum dish, obtained in paragraph (e)(5)(i) of this 
section. Warm carefully, and filter through Whatman No. 41 filter paper 
in a Pyrex funnel, collecting the filtrate in a clean, tared platinum 
dish. Repeat the chloroform extraction, washing the filter paper with 
this second portion of chloroform. Add this filtrate to the original 
filtrate and evaporate the total down to a few milliliters on a low-
temperature hotplate. The last few milliliters should be evaporated in 
an oven maintained at 212 deg. F. Cool the platinum dish in a desiccator 
for 30 minutes and weigh to the nearest 0.1 milligram to get the 
chloroform-soluble extractives residue (e'). This e' is substituted for 
e in the equations in paragraph (e)(5)(i) (a) and (b) of this section. 
If the concentration of extractives (Ex) still exceeds 50 parts per 
million or the extractives in milligrams per square inch exceed the 
limitations prescribed in paragraph (c) of this section for the 
particular container size, proceed as follows to correct for zinc 
extractives (``C'' enamels only): Ash the residue in the platinum dish 
by heating gently over a Meeker-type burner to destroy organic matter 
and hold at red heat for about 1 minute. Cool in the air for 3 minutes, 
and place the platinum dish in the desiccator for 30 minutes and weigh 
to the nearest 0.1 milligram. Analyze this ash for zinc by standard 
Association of Official Agricultural Chemists methods or equivalent. 
Calculate the zinc in the ash as zinc oleate, and subtract from the 
weight of chloroform-soluble extractives residue (e') to obtain the 
zinc-corrected chloroform-soluble extractives residue (ee'). This ee' is 
substituted for e in the formulas in paragraph (e)(5)(i) (a) and (b) of 
this section. To comply with the limitations in paragraph (c) of this 
section, the chloroform-soluble extractives residue (but after 
correction for the zinc extractives in case of ``C'' enamels) must not 
exceed 50 parts per million and must not exceed in milligrams per square 
inch the limitations for the particular article as prescribed in 
paragraph (c) of this section.
    (f) Equipment and reagent requirements--(1) Equipment.

    Rinsing equipment, soda fountain pressure-type hot water, consisting 
in simplest form of a \1/8\-inch-\1/4\-inch inside diameter metal tube 
attached to a hot water line delivering 190 deg. F-200 deg. F water and 
bent so as to direct a stream of water upward.
    Pressure cooker, 21-quart capacity with pressure gage, safety 
release, and removable rack, 12.5 inches inside diameter  x  11 inches 
inside height, 20 pounds per square inch safe operating pressure.
    Oven, mechanical convection, range to include 120 deg. F-212 deg. F 
explosion-proof, inside dimensions (minimum), 19''  x  19''  x  19'', 
constant temperature to plus-minus2 deg. F (water bath may be 
substituted).
    Incubator, inside dimensions (minimum) 19''  x  19''  x  19'' for 
use at 100 deg. Fplus-minus2 deg. F explosion proof (water bath may 
be substituted).
    Constant-temperature room or chamber 70 deg. Fplus-minus2 deg. 
F minimum inside dimensions 19''  x  19''  x  19''.
    Hot plate, nonsparking (explosion proof), top 12''  x  20'', 2,500 
watts, with temperature control.
    Platinum dish, 100-milliliter capacity minimum.
    All glass, Pyrex or equivalent.

    (2) Reagents.

    Water, all water used in extraction procedure should be freshly 
demineralized (deionized) distilled water.
    Heptane, reagent grade, freshly redistilled before use, using only 
material boiling at 208 deg. F.
    Alcohol, 8 percent (by volume), prepared from undenatured 95 percent 
ethyl alcohol

[[Page 171]]

diluted with demineralized or distilled water.
    Chloroform, reagent grade, freshly redistilled before use, or a 
grade having an established, consistently low blank.
    Filter paper, Whatman No. 41 or equivalent.

    (g) In accordance with good manufacturing practice, finished 
coatings intended for repeated food-contact use shall be thoroughly 
cleansed prior to their first use in contact with food.
    (h) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 175.300, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 175.320   Resinous and polymeric coatings for polyolefin films.

    Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from one or more of the basic olefin 
polymers complying with Sec. 177.1520 of this chapter. The base 
polyolefin film may contain optional adjuvant substances permitted for 
use in polyolefin film by applicable regulations in parts 170 through 
189 of this chapter.
    (b) The coatings are formulated from optional substances which are:
    (1) Substances generally recognized as safe for use in or on food.
    (2) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, by prior 
sanctions, or approvals.
    (3) Substances identified in this paragraph (b)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
(i) Resins and polymers:                                                
  Acrylic acid polymer and its ethyl or  ...............................
   methyl esters.                                                       
  Acrylamide copolymerized with ethyl    ...............................
   acrylate and/or styrene and/or                                       
   methacrylic acid, and the copolymer                                  
   subsequently reacted with                                            
   formaldehyde and butanol.                                            
  Butadiene-acrylonitrile copolymer....  ...............................
  Butadiene-acrylonitrile-styrene        ...............................
   terpolymer.                                                          
  Butyl rubber.........................  ...............................
  N,N'-Diphenyl-p-phenylenediamine.....  For use only as a              
                                          polymerization inhibitor in 2-
                                          sulfoethyl methacrylate,      
                                          sodium salt.                  
  2-Ethylhexyl acrylate copolymerized                                   
   with one or more of the following:                                   
    Acrylonitrile......................  ...............................
    Itaconic acid......................  ...............................
    Methacrylonitrile..................  ...............................
    Methyl acrylate....................  ...............................
    Methyl methacrylate................  ...............................
  4,4'-                                  ...............................
   Isopropylidenediphenolepichlorohydri                                 
   n average molecular weight 900.                                      
  Melamine-formaldehyde as the basic     ...............................
   polymer or chemically modified with                                  
   methyl alcohol.                                                      
  Methacrylic acid and its ethyl or                                     
   methyl esters copolymerized with one                                 
   or more of the following:                                            
    Acrylic acid.......................  ...............................
    Ethyl acrylate.....................  ...............................
    Methyl acrylate....................  ...............................
  -Methyl styrene polymer.....  ...............................
  -Methylstyrene-vinyltoluene   For use only in coatings that  
   copolymer resins (molar ratio 1        contact food under conditions 
   -methylstyrene to 3           of use D, E, F, or G described
   vinyltoluene).                         in Table 2 of Sec.  176.170(c)
                                          of this chapter, provided that
                                          the concentration of -
                                          methylstyrene-vinyltoluene    
                                          copolymer resins in the       
                                          finished food-contact coating 
                                          does not exceed 1.0 milligram 
                                          per square inch of food-      
                                          contact surface.              
  Petroleum alicyclic hydrocarbon        As defined in Sec.  176.170 of 
   resins.                                this chapter. Blended with    
                                          butyl rubber for use as a     
                                          component of coatings on      
                                          polyolefin fabric for bulk    
                                          packaging of raw fruits and   
                                          vegetables and used at a level
                                          not to exceed 30 percent by   
                                          weight of the total coating   
                                          solids.                       

[[Page 172]]

                                                                        
  Polyamide resins (CAS Reg. No. 68139-  For use only in coatings for   
   70-8), as the basic resin, derived     polypropylene films that      
   from:                                  contact food at temperatures  
                                          not to exceed room            
                                          temperature.                  
    Dimerized vegetable oil or tall oil  ...............................
     acids containing not more than 20                                  
     percent of monomer acids.                                          
    Azelaic acid (CAS Reg. No. 123-99-   ...............................
     9) in an amount not to exceed 3.7                                  
     percent by weight of the polyamide                                 
     resin.                                                             
    Ethylenediamine (CAS Reg. No. 107-   ...............................
     15-3).                                                             
    Piperazine (CAS Reg. No. 110-85-0)   ...............................
     in an amount not to exceed 6.4                                     
     percent by weight of the polyamide                                 
     resin.                                                             
  Polyamide resins, derived from         For use only in coatings for   
   dimerized vegetable oil acids          polyolefin films that contact 
   (containing not more than 20% of       food at temperatures not to   
   monomer acids) and ethylenediamine,    exceed room temperature.      
   as the basic resin.                                                  
  Polyamide resins having a maximum      For use only in coatings that  
   acid value of 5 and a maximum amine    contact food at temperatures  
   value of 8.5 derived from dimerized    not to exceed room temperature
   vegetable oil acids (containing not    provided that the             
   more than 10 percent of monomer        concentration of the polyamide
   acids), ethylenediamine, and 4,4-bis   resins in the finished food-  
   (4-hydroxyphenyl) pentanoic acids      contact coating does not      
   (in an amount not to exceed 10         exceed 5 milligrams per square
   percent by weight of said polyamide    inch of food-contact surface. 
   resins); as the basic resin.                                         
  Polyester resins formed by reaction                                   
   of one or more of the following                                      
   polybasic acids and monobasic acids                                  
   with one or more of the following                                    
   polyhydric alcohols:                                                 
    Polybasic acids:                                                    
      Adipic...........................  ...............................
      Azelaic..........................  For use in forming polyester   
                                          resins intended for use in    
                                          coatings that contact food    
                                          only of the type identified in
                                          Sec.  176.170(c) of this      
                                          chapter, Table 1, under       
                                          Category VIII, and under      
                                          conditions of use E, F, or G, 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter.   
      Dimerized fatty acids derived                                     
       from:                                                            
        Animal, marine or vegetable      ...............................
         fats and oils.                                                 
        Tall oil.......................  ...............................
      Fumaric..........................  ...............................
      Isophthalic......................  ...............................
      Maleic...........................  ...............................
      o-Phthalic.......................  ...............................
      Sebacic..........................  ...............................
      Terephthalic.....................  ...............................
      Trimellitic......................  ...............................
    Monobasic acids:                                                    
      Fatty acids derived from:                                         
        Animal, marine, or vegetable     ...............................
         fats and oils.                                                 
        Gum rosin......................  As defined in Sec.  178.3870 of
        Tall oil.......................   this chapter. For use in      
                                          forming polyester resins      
                                          intended for use in coatings  
                                          that contact food only of the 
                                          type identified in Sec.       
                                          176.170(c) of this chapter,   
                                          Table 1, under Category VIII, 
                                          and under conditions of use E,
                                          F, or G described in Table 2  
                                          of Sec.  176.170(c) of this   
                                          chapter.                      
    Polyhydric alcohols:                                                
      1,3-Butylene gylcol..............  ...............................
      Diethylene glycol................  ...............................
      2,2-Dimethyl-1,3-propanediol.....  ...............................
      Dipropylene glycol...............  ...............................
      Ethylene glycol..................  ...............................
      Glycerol.........................  ...............................
      Mannitol.........................  ...............................
      -Methyl glucoside.......  ...............................
      Pentaerythritol..................  ...............................
      Propylene glycol.................  ...............................
      Sorbitol.........................  ...............................
      Trimethylol ethane...............  ...............................
      Trimethylol propane..............  ...............................
  Polyethylenimine.....................  For use only as a primer       
                                          subcoat to anchor epoxy       
                                          surface coatings to the base  
                                          sheet.                        
  Polystyrene..........................  ...............................
  Polyvinyl acetate....................  ...............................
  Polyvinyl chloride...................  ...............................

[[Page 173]]

                                                                        
Siloxanes and silicones; platinum-       Platinum content not to exceed 
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a surface coating     
 Reg. Nos. 68083-19-2 and 68083-18-1),    under the following           
 with methyl hydrogen polysiloxane (CAS   conditions:                   
 Reg. No. 63148-57-2). Dimethyl maleate  1. In coatings for olefin      
 (CAS Reg. No. 624-48-6) and vinyl        polymers provided the coating 
 acetate (CAS Reg. No. 108-05-4) may be   contacts food only of the     
 used as optional polymerization          types identified in Sec.      
 inhibitors..                             176.170(c) of this chapter,   
                                          Table 1, under Types I, II,   
                                          VI, and VII-B when used under 
                                          conditions of use E, F, and G 
                                          described in Table 2 in Sec.  
                                          176.170(c) of this chapter.   
                                         2. In coatings for olefin      
                                          polymers provided the coating 
                                          contacts food only of the     
                                          types identified in Sec.      
                                          176.170(c) of this chapter,   
                                          Table 1, under Types III, IV, 
                                          V, VII-A, VIII, and IX when   
                                          used under conditions of use A
                                          through H described in Table 2
                                          in Sec.  176.170(c) of this   
                                          chapter.                      
Siloxanes and silicones; platinum-       Platinum content not to exceed 
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for 
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives. 
 with methyl hydrogen polysiloxane (CAS                                 
 Reg. No. 63148-57-2). Dimethyl maleate                                 
 (CAS Reg. No. 624-48-6), vinyl acetate                                 
 (CAS Reg. No. 108-05-4), dibutyl                                       
 maleate (CAS Reg. No. 105-76-0) and                                    
 diallyl maleate (CAS Reg. No. 999-21-                                  
 3) may be used as optional                                             
 polymerization inhibitors. The polymer                                 
 may also contain C16-C18 olefins (CAS                                  
 Reg. No. 68855-60-7) as a control                                      
 release agent..                                                        
  Styrene copolymerized with one or                                     
   more of the following:                                               
    Acrylonitrile......................  ...............................
    -Methyl styrene...........  ...............................
  Styrene polymers made by the           For use only in contact with   
   polymerization of any combination of   foods of Types IV-A, V, and   
   styrene or alpha methyl styrene with   VII in table 1 of Sec.        
   acrylic acid, methacrylic acid, 2-     176.170(c) of this chapter,   
   ethyl hexyl acrylate, methyl           under use conditions E through
   methacrylate, and butyl acrylate.      G in table 2 of Sec.          
   The styrene and alpha methyl           176.170(c), and with foods of 
   styrene, individually, may             Types VIII and IX without use 
   constitute from 0 to 80 weight         temperature restriction.      
   percent of the polymer. The other                                    
   monomers, individually, may be from                                  
   0 to 40 weight percent of the                                        
   polymer. The polymer number average                                  
   molecular weight (Mn) shall be at                                    
   least 2,000 (as determined by gel                                    
   permeation chromatography). The acid                                 
   number of the polymer shall be less                                  
   than 250. The monomer content shall                                  
   be less than 0.5 percent.                                            
  Styrene-isobutylene copolymer........  ...............................
  Terpene resins consisting of polymers  ...............................
   of -pinene, -                                      
   pinene, and/or dipentene; acid value                                 
   less than 5, saponification number                                   
   less than 5, and color less than 4                                   
   on the Gardner scale as measured in                                  
   50 percent mineral spirits solution.                                 
  2-Sulfoethyl metacrylate, sodium salt  For use only in copolymer      
   Chemical Abstracts Service No. 1804-   coatings under conditions of  
   87-1].                                 use E, F, and G described in  
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter and limited to   
                                          use at a level not to exceed  
                                          2.0 percent by weight of the  
                                          dry copolymer coating.        
  Vinyl chloride-acetate, hydroxyl-      ...............................
   modified copolymer or maleic acid-                                   
   modified copolymer.                                                  
  Vinyl chloride copolymerized with one                                 
   or more of the following:                                            
    Acrvlonitrile......................  ...............................
    Vinyl acetate......................  ...............................
    Vinylidene chloride................  ...............................
  Vinylidene chloride copolymerized                                     
   with one or more of the following:                                   
    Acrylic acid and its methyl, ethyl,  ...............................
     propyl, butyl, or octyl esters.                                    
    Acrylonitrile......................  ...............................
    Itaconic acid......................  ...............................
    Methacrylic acid and its methyl,     ...............................
     ethyl, propyl, butyl, or octyl                                     
     esters.                                                            
    Methacrylonitrile..................  ...............................
    Vinyl chloride.....................  ...............................
(ii) Plasticizers:                                                      
  Acetyl tributyl citrate..............  ...............................
  Acetyl triethyl citrate..............  ...............................
  Butyl phthalyl butyl glycolate.......  ...............................
  Butyl stearate.......................  ...............................
  Dibutyl sebacate.....................  ...............................
  Diethyl phthalate....................  ...............................
  2-Ethylhexyl diphenyl phosphate......  ...............................
  Ethyl phthalyl ethyl glycolate.......  ...............................
  Glycerol monooleate..................  ...............................

[[Page 174]]

                                                                        
  Glycerol triacetate..................  ...............................
  Triethyl citrate.....................  ...............................
(iii) Adjuvants (release agents, waxes,                                 
 and dispersants):                                                      
  Acetone..............................  ...............................
  Amides (unsubstituted) of fatty acids  ...............................
   from vegetable or animal oils.                                       
  n-Butyl acetate......................  ...............................
  n-Butyl alcohol......................  ...............................
  Candelilla wax.......................  ...............................
  Carnauba wax.........................  ...............................
  Ethyl acetate........................  ...............................
  Fatty acids from vegetable or animal   ...............................
   oils and their aluminum, ammonium,                                   
   calcium, magnesium, and sodium salts.                                
  Hexane...............................  ...............................
  Methyl ethyl ketone..................  ...............................
  N,N'-Dioleoylethylenediamine (CAS      For use only in ionomeric      
   Reg. No. 110-31-6).                    resins complying with Sec.    
                                          177.1330 of this chapter and  
                                          in ethylene vinyl acetate     
                                          copolymers complying with Sec.
                                           177.1350 of this chapter at a
                                          level not to exceed 0.0085    
                                          milligram per square          
                                          centimeter (0.055 milligram   
                                          per square inch) in the       
                                          finished food-contact article.
  Petroleum waxes conforming to          ...............................
   specifications included in a                                         
   regulation in subchapter B of this                                   
   chapter.                                                             
  Polyvinyl alcohol, minimum viscosity   For use only as a dispersing   
   of 4% aqueous solution at 20 deg. C    agent at levels not to exceed 
   of 4 centipoises and percent           6% of total coating weight in 
   alcoholysis of 87-100.                 coatings for pol-yolefin films
                                          provided the finished         
                                          polyolefin films contact food 
                                          only of the types identified  
                                          in Sec.  176.170(c) of this   
                                          chapter, Table 1, under Types 
                                          V, VIII, and IX.              
  Sodium dioctyl sulfosuccinate........  ...............................
  Sodium dodecylbenzenesulfonate.......  ...............................
  Sodium lauryl sulfate................  ...............................
  Sorbitan and sorbitol esters of fatty  ...............................
   acids from vegetable or animal oils.                                 
  Spermaceti wax.......................  ...............................
  Tetrahydrofuran......................  ...............................
  Toluene..............................  ...............................
------------------------------------------------------------------------

    (c) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from Tables 1 and 2 of 
Sec. 176.17(c) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of coated 
surface.
    (d) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 
FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept. 
18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR 
14246, Apr. 1, 1996]



Sec. 175.350   Vinyl acetate/crotonic acid copolymer.

    A copolymer of vinyl acetate and crotonic acid may be safely used as 
a coating or as a component of a coating which is the food-contact 
surface of polyolefin films intended for packaging food, subject to the 
provisions of this section.
    (a) The copolymer may contain added optional substances to impart 
desired properties.
    (b) The quantity of any optional substance does not exceed the 
amount reasonably required to accomplish the intended physical or 
technical effect nor any limitations further provided.
    (c) Any optional substance that is the subject of a regulation in 
parts 174, 175, 176, 177, 178, and Sec. 179.45 of this chapter conforms 
with any specifications in such regulation.
    (d) Optional substances as provided in paragraph (a) of this section 
include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for uses with a 
copolymer of vinyl acetate and crotonic acid and used in accordance with 
such sanction or approval.

[[Page 175]]

    (3) Substances identified in this subparagraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Silica....................................  ............................
Japan wax.................................  ............................
------------------------------------------------------------------------

    (e) Copolymer of vinyl acetate and crotonic acid used as a coating 
or as a component of a coating conforming with the specifications of 
paragraph (e)(1) of this section are used as provided in paragraph 
(e)(2) of this section.
    (1) Specifications. (i) The chloroform-soluble portion of the water 
extractives of the coated film obtained with distilled water at 120 deg. 
F for 24 hours does not exceed 0.5 milligram per square inch of coated 
surface.
    (ii) The chloroform-soluble portion of the n-heptane extractives of 
the coated film obtained with n-heptane at 70 deg. F for 30 minutes does 
not exceed 0.5 milligram per square inch of coated surface.
    (2) Conditions of use. The copolymer of vinyl acetate and crotonic 
acid is used as a coating or as a component of a coating for polyolefin 
films for packaging bakery products and confectionery.



Sec. 175.360   Vinylidene chloride copolymer coatings for nylon film.

    Vinylidene chloride copolymer coatings identified in this section 
and applied on nylon film may be safely used as food-contact surfaces, 
in accordance with the following prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from nylon resins complying with 
Sec. 177.1500 of this chapter.
    (b) The coatings are prepared from vinylidene chloride copolymers 
produced by copolymerizing vinylidene chloride with one or more of the 
monomers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid, 
methyl acrylate, methyl methacrylate (CAS Reg. No. 80-62-6; maximum use 
level 6 weight percent) and 2-sulfoethyl methacrylate (CAS Reg. No. 
10595-80-9; maximum use level 1 weight percent). The finished copolymers 
contain at least 50 weight percent of polymer units derived from 
vinylidene chloride. The finished coating produced from vinylidene 
chloride copolymers produced by copolymerizing vinylidene chloride with 
methyl methacrylate and/or 2-sulfoethyl methacrylate, or with methyl 
methacrylate and/or 2-sulfoethyl methacrylate together with one or more 
of the other monomers from this section, is restricted to use at or 
below room temperature.
    (c) Optional adjuvant substances employed in the production of the 
coatings or added thereto to impart desired properties may include 
sodium dodecylbenzenesulfonate.
    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from Tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of coated 
surface when tested by the methods described in Sec. 176.170(d) of this 
chapter.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 
FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982]



Sec. 175.365   Vinylidene chloride copolymer coatings for polycarbonate film.

    Vinylidene chloride copolymer coatings identified in this section 
and applied on polycarbonate film may be safely used as food-contact 
surfaces, in accordance with the following prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from polycarbonate resins complying with 
Sec. 177.1580 of this chapter.
    (b) The coatings are prepared from vinylidene chloride copolymers 
produced by copolymerizing vinylidene chloride with acrylonitrile, 
methyl acrylate, and acrylic acid. The finished copolymers contain at 
least 50 weight-percent of polymer units derived from vinyldene 
chloride.

[[Page 176]]

    (c) Optional adjuvant substances employed in the production of the 
coatings or added thereto to impart desired properties may include 
sodium dodecylbenzenesulfonate in addition to substances described in 
Sec. 174.5(d) of this chapter.
    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under the conditions of time and temperature characterizing 
the conditions of its intended use as determined from Tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble 
extractives in each extracting solvent not to exceed 0.5 milligram per 
square inch of coated surface as determined by the methods described in 
Sec. 176.170(d) of this chapter. In testing the finished food-contact 
articles, a separate test sample is to be used for each required 
extracting solvent.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisons of Sec. 180.22 of this chapter.



Sec. 175.380   Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins.

    The resins identified in paragraph (a) of this section may be safely 
used as a food-contact coating for articles intended for use in contact 
with food, in accordance with the following prescribed conditions.
    (a) The resins are produced by the condensation of xylene-
formaldehyde resin and 4,4'-isopropylidenediphenol-epichlorohydrin epoxy 
resins, to which may have been added certain optional adjuvant 
substances required in the production of the resins or added to impart 
desired physical and technical properties. The optional adjuvant 
substances may include resins produced by the condensation of allyl 
ether of mono-, di-, or trimethylol phenol and capryl alcohol and also 
may include substances identified in Sec. 175.300(b)(3), with the 
exception of paragraph (b)(3)(xxxi) and (xxxii) of that section.
    (b) The resins identified in paragraph (a) of this section may be 
used as a food-contact coating for articles intended for contact at 
temperatures not to exceed 160 deg. F with food of Types I, II, VI-A and 
B, and VIII described in Table 1 of Sec. 176.170(c) of this chapter 
provided that the coating in the finished form in which it is to contact 
food meets the following extractives limitations when tested by the 
methods provided in Sec. 175.300(e):
    (1) The coating when extracted with distilled water at 180 deg. F 
for 24 hours yields total extractives not to exceed 0.05 milligram per 
square inch of food-contact surface.
    (2) The coating when extracted with 8 percent (by volume) ethyl 
alcohol in distilled water at 160 deg. F for 4 hours yields total 
extractives not to exceed 0.05 milligram per square inch of food-contact 
surface.
    (c) The resins identified in paragraph (a) of this section may be 
used as a food-contact coating for articles intended for contact at 
temperatures not to exceed room temperature with food of Type VI-C 
described in Table 1 of Sec. 176.170(c) of this chapter provided the 
coating in the finished form in which it is to contact food meets the 
following extractives limitations when tested by the methods provided in 
Sec. 175.300(e):
    (1) The coating when extracted with distilled water at 180 deg. F 
for 24 hours yields total extractives not to exceed 0.05 milligram per 
square inch of food-contact surface.
    (2) The coating when extracted with 50 percent (by volume) ethyl 
alcohol in distilled water at 180 deg. F for 24 hours yields total 
extractives not to exceed 0.05 milligram per square inch.



Sec. 175.390   Zinc-silicon dioxide matrix coatings.

    Zinc-silicon dioxide matrix coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, subject to the provisions of this 
section;
    (a) The coating is applied to a metal surface, cured, and washed 
with water to remove soluble substances.
    (b) The coatings are formulated from optional substances which 
include:
    (1) Substances generally recognized as safe.

[[Page 177]]

    (2) Substances for which safe conditions of use have been prescribed 
in Sec. 175.300.
    (3) Substances identified in paragraph (c) of this section, subject 
to the limitations prescribed.
    (c) The optional substances permitted are as follows:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Ethylene glycol...........................  As a solvent removed by     
                                             water washing.             
Iron oxide................................  ............................
Lithium hydroxide.........................  Removed by water washing.   
Methyl orange.............................  As an acid-base indicator.  
Potassium dichromate......................  Removed by water washing.   
Silica gel................................  ............................
Sodium silicate...........................  ............................
Zinc, as particulate metal................  ............................
------------------------------------------------------------------------

    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under the conditions of its intended use as shown in Tables 1 
and 2 of Sec. 175.300(d) (using 20 percent alcohol as the solvent when 
the type of food contains approximately 20 percent alcohol) shall yield 
total extractives not to exceed those prescribed in Sec. 175.300(c)(3); 
lithium extractives not to exceed 0.025 milligram per square inch of 
surface; and chromium extractives not to exceed 0.05 microgram per 
square inch of surface.
    (e) The coatings are used as food-contact surfaces for bulk reusable 
containers intended for storing, handling, and transporting food.



PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table of Contents




                          Subpart A [Reserved]

Subpart B--Substances for Use Only as Components of Paper and Paperboard

Sec.
176.110  Acrylamide-acrylic acid resins.
176.120  Alkyl ketene dimers.
176.130  Anti-offset substances.
176.150  Chelating agents used in the manufacture of paper and 
          paperboard.
176.160  Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane 
          sulfonyl glycine.
176.170  Components of paper and paperboard in contact with aqueous and 
          fatty foods.
176.180  Components of paper and paperboard in contact with dry food.
176.200  Defoaming agents used in coatings.
176.210  Defoaming agents used in the manufacture of paper and 
          paperboard.
176.230  3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
176.250  Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
176.260  Pulp from reclaimed fiber.
176.300  Slimicides.
176.320  Sodium nitrate-urea complex.
176.350  Tamarind seed kernel powder.

    Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).

    Source: 42 FR 14554, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 176 appear at 61 FR 
14482, Apr. 2, 1996.



                          Subpart A [Reserved]



Subpart B--Substances for Use Only as Components of Paper and Paperboard



Sec. 176.110   Acrylamide-acrylic acid resins.

    Acrylamide-acrylic acid resins may be safely used as components of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section.
    (a) Acrylamide-acrylic acid resins are produced by the 
polymerization of acrylamide with partial hydrolysis or by the 
copolymerization of acrylamide and acrylic acid.
    (b) The acrylamide-acrylic acid resins contain less than 0.2 percent 
residual monomer.
    (c) The resins are used as adjuvants in the manufacture of paper and 
paperboard in amounts not to exceed that necessary to accomplish the 
technical effect and not to exceed 2 percent by weight of the paper or 
paperboard.



Sec. 176.120   Alkyl ketene dimers.

    Alkyl ketene dimers may be safely used as a component of articles 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of this section.
    (a) The alkyl ketene dimers are manufactured by the 
dehydrohalogenation of the acyl halides derived from the

[[Page 178]]

fatty acids of animal or vegetable fats and oils.
    (b) The alkyl ketene dimers are used as an adjuvant in the 
manufacture of paper and paperboard under such conditions that the alkyl 
ketene dimers and their hydrolysis products dialkyl ketones do not 
exceed 0.4 percent by weight of the paper or paperboard.
    (c) The alkyl ketene dimers may be used in the form of an aqueous 
emulsion which may contain sodium lignosulfonate as a dispersant.



Sec. 176.130   Anti-offset substances.

    Substances named in paragraphs (b) and (c) of this section may be 
safely used to prevent the transfer of inks employed in printing and 
decorating paper and paperboard used for food packaging in accordance 
with the provisions of this section:
    (a) The substances are applied to the nonfood contact, printed side 
of the paper or paperboard in an amount not greater than that required 
to accomplish the technical effect nor greater than any specific 
limitations, where such are provided.
    (b) Anti-offset powders are prepared from substances that are 
generally recognized as safe in food, substances for which prior 
sanctions or approvals were granted and which are used in accordance 
with the specific provisions of such sanction or approval, and 
substances named in paragraph (c) of this section.
    (c) The substances permitted are as follows:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Carbon tetrachloride......................  ............................
Methyl hydrogen polysiloxanes.............  ............................
Industrial starch--modified...............  Complying with Sec.         
                                             178.3520 of this chapter.  
Stannous oleate...........................  ............................
Zinc-2-ethyl hexoate......................  ............................
------------------------------------------------------------------------



Sec. 176.150   Chelating agents used in the manufacture of paper and paperboard.

    The substances named in paragraph (a) of this section may be safely 
used in the manufacture of paper and paperboard, in accordance with the 
conditions prescribed in paragraphs (b) and (c) of this section:
    (a) Chelating agents: 04

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Ammonium fructoheptonate..................  ............................
Ammonium glucoheptonate...................  ............................
Disodium ethylenediamine tetraacetate.....  ............................
Pentasodium salt of diethylenetriamine      ............................
 pentaacetate.                                                          
Sodium fructoheptonate....................  ............................
Sodium glucoheptonate.....................  ............................
Tetrasodium ethylenediamine tetraacetate..  ............................
Trisodium N-hydroxyethyl ethylenediamine    ............................
 triacetate.                                                            
------------------------------------------------------------------------

    (b) Any one or any combination of the substances named is used or 
intended for use as chelating agents.
    (c) The substances are added in an amount not greater than that 
required to accomplish the intended technical effect nor greater than 
any specific limitation, where such is provided.



Sec. 176.160  Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.

    The chromium (Cr III) complex of N-ethyl - N - heptadecylfluoro-
octane sulfonyl glycine containing up to 20 percent by weight of the 
chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may 
be safely used as a component of paper for packaging dry food when used 
in accordance with the following prescribed conditions.
    (a) The food additive is used as a component of paper in an amount 
not to exceed 0.5 percent by weight of the paper.
    (b)(1) The food-contact surface of the paper is overcoated with a 
polymeric or resinous coating at least \1/3\-mil in thickness, that 
meets the provision of Sec. 176.170; or
    (2) The treated paper forms one or more plies of a paper in a 
multiwall bag and is separated from the food by at least one ply of 
packaging films or grease-resistant papers which serves as a functional 
barrier between the food additive and the food. Such packaging films or 
grease-resistant papers conform with appropriate food additive 
regulations.
    (c) The labeling of the food additive shall contain adequate 
directions for its use to insure compliance with the requirements of 
paragraphs (a) and (b) of this section.

[[Page 179]]



Sec. 176.170   Components of paper and paperboard in contact with aqueous and fatty foods.

    Substances identified in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packaging, 
processing, preparing, treating, packing, transporting, or holding 
aqueous and fatty foods, subject to the provisions of this section. 
Components of paper and paperboard in contact with dry food of the type 
identified under Type VIII of Table 1 in paragraph (c) of this section 
are subject to the provisions of Sec. 176.180.
    (a) Substances identified in paragraph (a)(1) through (5) of this 
section may be used as components of the food-contact surface of paper 
and paperboard. Paper and paperboard products shall be exempted from 
compliance with the extractives limitations prescribed in paragraph (c) 
of this section: Provided, That the components of the food-contact 
surface consist entirely of one or more of the substances identified in 
this paragraph: And provided further, That if the paper or paperboard 
when extracted under the conditions prescribed in paragraph (c) of this 
section exceeds the limitations on extractives contained in paragraph 
(c) of this section, information shall be available from manufacturing 
records from which it is possible to determine that only substances 
identified in this paragraph (a) are present in the food-contact surface 
of such paper or paperboard.
    (1) Substances generally recognized as safe in food.
    (2) Substances generally recognized as safe for their intended use 
in paper and paperboard products used in food packaging.
    (3) Substances used in accordance with a prior sanction or approval.
    (4) Substances that by regulation in parts 170 through 189 of this 
chapter may be safely used without extractives limitations as components 
of the uncoated or coated food-contact surface of paper and paperboard 
in contact with aqueous or fatty food, subject to the provisions of such 
regulation.
    (5) Substances identified in this paragraph, as follows:

------------------------------------------------------------------------
           List of Substances                      Limitations          
------------------------------------------------------------------------
Acetyl peroxide........................  For use only as polymerization 
                                          catalyst.                     
Acrylamide-methacrylic acid-maleic       For use only as a retention aid
 anhydride copolymers containing not      employed prior to the sheet-  
 more than 0.2 percent of residual        forming operation in the      
 acrylamide monomer and having an         manufacture of paper and      
 average nitrogen content of 14.9         paperboard in such an amount  
 percent such that a 1 percent by         that the finished paper and   
 weight aqueous solution has a minimum    paperboard will contain the   
 viscosity of 600 centipoises at 75 F,    additive at a level not in    
 as determined by LVG-series Brookfield   excess of 0.05 percent by     
 viscometer (or equivalent) using a No.   weight of dry fibers in the   
 2 spindle at 30 r.p.m.                   finished paper and paperboard.
Acrylamide--                    For use only as a retention aid
 methacrylyloxyethyltrimethylammonium     and flocculant employed prior 
 methyl sulfate copolymer resins          to the sheet-forming operation
 containing not more than 10 molar        in the manufacture of paper   
 percent of -                    and paperboard.               
 methacrylyloxyethyltrimethylammonium                                   
 methyl sulfate and containing less                                     
 than 0.2% of residual acrylamide                                       
 monomer.                                                               
Acrylic acid copolymer with 2-           For use only as a scale        
 acrylamido-2-methylpropane-sulfonic      inhibitor prior to the sheet- 
 acid (CAS Reg. No. 40623-75-4) and/or    forming operation in the      
 its ammonium/alkali metal mixed salts.   manufacture of paper and      
 The copolymer is produced by poly-       paperboard and used at a level
 merization of acrylic acid and 2-        not to exceed 1.0 kilogram    
 acrylamido-2-methylpropane-sulfonic      (2.2 pounds) of copolymer per 
 acid in a weight ratio of 60/40, such    907 kilograms (1 ton) of dry  
 that a 28 percent by weight aqueous      paper and paperboard fibers.  
 solution of the polymer has a                                          
 viscosity of 75-150 centipoises at 25                                  
 C as determined by LV-series                                           
 Brookfield viscometer (or equivalent)                                  
 using a No. 2 spindle at 60 r.p.m.                                     
Acrylonitrile polymer, reaction product  For use only as a size promoter
 with ethylenediamine sulfate having a    and retention aid at a level  
 nitrogen content of 22.5-25.0 percent    not to exceed 0.5 percent by  
 (Kjeldahl dry basis) and containing no   weight of the dry paper and   
 more than 0.075 percent monomer as       paperboard.                   
 ethylenediamine. The finished resin in                                 
 a 24 percent by weight aqueous                                         
 solution has a viscosity of 1,000-                                     
 2,000 centipoises at 25 C as                                           
 determined by LVT-series Brookfield                                    
 viscometer using a No. 4 spindle at 50                                 
 r.p.m. (or by other equivalent method).                                

[[Page 180]]

                                                                        
Acrylonitrile polymer with styrene,      1. For use only as a sizing    
 reaction product with ethylenediamine    material applied after the    
 acetate, having a nitrogen content of    sheet-forming operation in the
 7.4-8.3 percent (Kjeldahl dry basis)     manufacture of paper and      
 and containing no more than 0.25         paperboard in such amount that
 percent monomer as ethylenediamine.      the paper and paperboard will 
                                          contain the additive at a     
                                          level not in excess of 0.25   
                                          percent by weight of the dry  
                                          paper and paperboard.         
                                         2. For use only as a sizing    
                                          material applied prior to the 
                                          sheet-forming operation in the
                                          manufacture of paper and      
                                          paperboard in such amount that
                                          the paper and paperboard will 
                                          contain the additive at a     
                                          level not in excess of 1.0    
                                          percent by weight of the dry  
                                          paper and paperboard.         
1-Alkenyl olefins, containing not less   For use only under the         
 than 72 percent of C30 and higher        following conditions:         
 olefins.                                1. In coatings for paper and   
                                          paperboard with food of Types 
                                          I, II, IV-B, and VII-B        
                                          described in Table 1 of       
                                          paragraph (c) of this section 
                                          under conditions of use E, F, 
                                          and G described in Table 2 of 
                                          paragraph (c) of this section.
                                         2. In coatings for paper and   
                                          paperboard with food of Type  
                                          VIII described in Table I of  
                                          paragraph (c) of this section 
                                          under conditions of use A     
                                          through H described in Table 2
                                          of paragraph (c) of this      
                                          section.                      
(2-Alkenyl) succinic anhydrides          For use only as a sizing agent 
 mixture, in which the alkenyl groups     employed prior to the sheet-  
 are derived from olefins which contain   forming operation in the      
 not less than 95 percent of C15-C21      manufacture of paper and      
 groups.                                  paperboard and limited to use 
                                          at a level not to exceed 1    
                                          percent by weight of the      
                                          finished dry paper and        
                                          paperboard fibers.            
Alkyl(C12-C20)methacrylatemethacrylic    For use only as stabilizers    
 acid copolymers (CAS Reg. No. 27401-06-  employed prior to the sheet-  
 5).                                      forming operation in the      
                                          manufacture of paper and      
                                          paperboard.                   
tert-Alkyl(C8-C16)mercaptans...........  For use only as polymerization-
                                          control agent.                
Aluminum acetate.......................  ...............................
2-Amino-2-methyl-1-propanol (CAS Reg.    For use as a dispersant for    
 No. 124-68-5).                           pigment suspension at a level 
                                          not to exceed 0.25 percent by 
                                          weight of pigment. The        
                                          suspension is used as a       
                                          component of coatings for     
                                          paper and paperboard under    
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          Table 2, conditions of use E  
                                          through G.                    
Ammonium bis(N-ethyl-2-                  For use only as an oil and     
 perfluoroalkylsulfonamido ethyl)         water repellant at a level not
 phosphates, containing not more than     to exceed 0.17 pound (0.09    
 15% ammonium mono (N-ethyl-2-            pound of fluorine) per 1,000  
 perfluoroalkylsulfonamido ethyl)         square feet of treated paper  
 phosphates, where the alkyl group is     or paperboard of a sheet basis
 more than 95% C8 and the salts have a    weight of 100 pounds or less  
 fluorine content of 50.2% to 52.8% as    per 3,000 square feet of paper
 determined on a solids basis.            or paperboard, and at a level 
                                          not to exceed 0.5 pound (0.26 
                                          pound of fluorine) per 1,000  
                                          square feet of treated paper  
                                          or paperboard having a sheet  
                                          basis weight greater than 100 
                                          lb. per 3,000 square feet as  
                                          determined by analysis for    
                                          total fluorine in the treated 
                                          paper or paperboard without   
                                          correction for any fluorine   
                                          that might be present in the  
                                          untreated paper or paperboard,
                                          when such paper or paperboard 
                                          is used as follows:           
                                         1. In contact, under conditions
                                          of use C, D, E, F, G, or H    
                                          described in Table 2 of       
                                          paragraph (c) of this section,
                                          with nonalcoholic food.       
                                         2. In contact with bakery      
                                          products of Type VII, VIII,   
                                          and IX described in Table I of
                                          paragraph (c) of this section 
                                          under good manufacturing      
                                          practices of commercial and   
                                          institutional baking.         
Ammonium persulfate....................  ...............................
Ammonium thiosulfate...................  ...............................
Ammonium zirconium carbonate (CAS Reg.   For use only as an             
 No. 32535-84-5) and its tartaric acid    insolubilizer for binders used
 adduct.                                  in coatings for paper and     
                                          paperboard, and limited to use
                                          at a level not to exceed 2.5  
                                          percent by weight of coating  
                                          solids.                       
Ammonium zirconium citrate (CAS Reg.     For use as insolubilizers only 
 No. 149564-62-5), ammonium zirconium     for clay coatings with protein
 lactate-citrate (CAS Reg. No. 149564-    binders in coatings for paper 
 64-7), ammonium zirconium lactate (CAS   and paperboard, at a level not
 Reg. No. 149564-63-6).                   to exceed 1.4 percent by      
                                          weight of coating solids.     
Anionic polyurethane, produced by        For use only as a surface      
 reacting the preliminary adduct formed   sizing agent at a level not to
 from the reaction of glyceryl            exceed 0.1 percent by weight  
 monostearate and 2,4-                    of dry paper and paperboard.  
 toluenediisocyanate with not more than                                 
 10 mole percent N-methyldiethanolamine                                 
 and not less than 90 mole percent                                      
 dimethylolpropionic acid. The final                                    
 product is a 15 to 20 percent by                                       
 weight aqueous solution, having a                                      
 Brookfield viscosity of 25 to 100                                      
 centipoises at 24 C (75 F).                                            
9,10-Anthraquinone (Chemical Abstracts   For use only as a pulping aid  
 Service Registry No. 84-65-1) which      in the alkaline pulping of    
 has a purity of not less than 98         lignocellulosic material at   
 percent.                                 levels not to exceed 0.1      
                                          percent by weight of the raw  
                                          lignocellulosic material.     

[[Page 181]]

                                                                        
Aromatic petroleum hydrocarbon resin,    For use only as modifiers in   
 hydrogenated (CAS Reg. No. 88526-47-     wax polymer blend coatings for
 0), produced by the catalytic            paper and paperboard at a     
 polymerization of aromatic substituted   level not to exceed 50 weight-
 olefins from low boiling distillates     percent of the coating solids 
 of cracked petroleum stocks with a       under conditions of use E, F, 
 boiling point no greater than 220 C      and G identified in Table 2 of
 (428 F), and the subsequent catalytic    paragraph (c) of this section.
 reduction of the resulting aromatic                                    
 petroleum hydrocarbon resin. The resin                                 
 meets the following specifications:                                    
 softening point 85 C (185 F) minimum,                                  
 as determined by ASTM Method E 28-67                                   
 (Reapproved 1982), ``Standard Test                                     
 Method for Softening Point by Ring-and-                                
 Ball Apparatus,'' and aniline point 70                                 
 C (158 F) minimum, as determined by                                    
 ASTM Method D 611-82, ``Standard Test                                  
 Methods for Aniline Point and Mixed                                    
 Aniline Point of Petroleum Products                                    
 and Hydrocarbon Solvents,'' which are                                  
 incorporated by reference in                                           
 accordance with 5 U.S.C. 552(a) and 1                                  
 CFR part 51. Copies may be obtained                                    
 from the American Society for Testing                                  
 and Materials, 1916 Race St.,                                          
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC.                                        
Azo-bisisobutyronitrile................  For use only as polymerization 
                                          catalyst.                     
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative 
 Registry No. 2634-33-5).                 in paper coating compositions 
                                          and limited to use at a level 
                                          not to exceed 0.01 mg/in2     
                                          (0.0016 mg/cm2) of the        
                                          finished paper and paperboard.
Benzoyl peroxide.......................      Do.                        
N,N-Bis(2-hydroxyethyl)alkyl (C12-       For use only as an adjuvant to 
 C18)amide.                               control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet 
                                          forming operation.            
Bis(methoxymethyl)tetrakis-              For use only under the         
 [(octadecyloxy)-methyl]melamine resins   following conditions:         
 having a 5.8-6.5 percent nitrogen                                      
 content (CAS Reg. No. 68412-27-1).                                     
                                           1. As a water repellant      
                                          employed prior to the sheet-  
                                          forming operation in the      
                                          manufacture of paper and      
                                          paperboard in such amount that
                                          the finished paper and        
                                          paperboard will contain the   
                                          additive at a level not in    
                                          excess of 1.6 percent by      
                                          weight of the finished dry    
                                          paper and paperboard fibers.  
                                           2. The finished paper and    
                                          paperboard will be used in    
                                          contact with nonalcoholic     
                                          foods only.                   
                                           3. As a water repellant      
                                          employed after the sheet-     
                                          forming operation in the      
                                          manufacture of paper and      
                                          paperboard in such amount that
                                          the finished paper and        
                                          paperboard will contain the   
                                          additive at a level not to    
                                          exceed 1.6 percent by weight  
                                          of the finished dry paper and 
                                          paperboard fibers. The        
                                          finished paper and paperboard 
                                          will be used only in contact  
                                          with food of Types I, II, IV- 
                                          B, VI, VII-B, and VIII        
                                          described in Table 1 of       
                                          paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS     For use only as an             
 Reg. No. 52-51-7).                       antimicrobial/preservative in 
                                          fillers, pigment slurries,    
                                          starch sizing solutions, and  
                                          latex coatings at levels not  
                                          to exceed 0.01 percent by     
                                          weight of those components.   
tert-Butyl hydroperoxide...............  For use only as polymerization 
                                          catalyst.                     
tert-Butyl peroxide....................      Do.                        
Calcium isostearate....................  For use only with n-decyl      
                                          alcohol as a stabilizing      
                                          material for aqueous calcium  
                                          stearate dispersions intended 
                                          for use as components of      
                                          coatings for paper and        
                                          paperboard.                   
Carrageenan and salts of carrageenan as  ...............................
 described in Secs.  172.620 and                                        
 172.626 of this chapter.                                               
Castor oil, hydrogenated...............  ...............................
Castor oil, sulfated, ammonium,          ...............................
 potassium, or sodium salt.                                             
Cellulose, regenerated.................  ...............................
Chloracetamide.........................  For use only as polymerization-
                                          control agent.                
Cobaltous acetate......................  For use only as polymerization 
                                          catalyst.                     
Cumene hydroperoxide...................      Do.                        
Cyanoguanidine.........................  For use only:                  
                                           1. As a modifier for amino   
                                          resins.                       
                                           2. As a fluidizing agent in  
                                          starch and protein coatings   
                                          for paper and paperboard.     
n-Decyl alcohol........................  For use only with calcium      
                                          isostearate as a stabilizing  
                                          material for aqueous calcium  
                                          stearate dispersions intended 
                                          for use as components of      
                                          coatings for paper and        
                                          paperboard.                   
Dialdehyde guar gum....................  For use only as a wet-strength 
                                          agent employed prior to the   
                                          sheet-forming operation in the
                                          manufacture of paper and      
                                          paperboard and used at a level
                                          not to exceed 1% by weight of 
                                          the finished dry paper and    
                                          paperboard fibers.            
Dialdehyde locust bean gum.............      Do.                        

[[Page 182]]

                                                                        
Dialkyl(C16-C18)carbamoyl chloride (CAS  For use as a sizing agent at a 
 Reg. No. 41319-54-4) manufactured by     level not to exceed 0.2       
 the reaction of secondary amines         percent by weight of the dry  
 derived from fatty acids of animal or    fiber.                        
 vegetable sources with phosgene.                                       
Diallyldimethyl ammonium chloride        For use only as a retention and/
 polymer with acrylamide and potassium    or drainage aid employed prior
 acrylate, produced by copolymerizing     to the sheet-forming          
 either (1) diallyldimethyl ammonium      operations in the manufacture 
 chloride and acrylamide in a weight      of paper and paperboard and   
 ratio of 50/50, with 4.4 percent of      limited to use at a level not 
 the acrylamide subsequently hydrolyzed   to exceed 0.05 percent by     
 to potassium acrylate or (2)             weight of the finished paper  
 polymerized diallyldimethyl ammonium     and paperboard.               
 chloride, acrylamide and potassium                                     
 acrylate (as acrylic acid) in a weight                                 
 ratio of 50/47.8/2.2, respectively, so                                 
 that the finished resin in a 1 percent                                 
 by weight aqueous solution (active                                     
 polymer) has a viscosity of more than                                  
 22 centipoises at 22 C (72 F) as                                       
 determined by LVF series, Brookfield                                   
 Viscometer using No. 1 spindle at 60                                   
 RPM (or by other equivalent method)                                    
 (CAS Reg. No. 25136-75-8).                                             
Diallyldimethylammonium chloride with    For use only as a drainage and/
 acrylamide (CAS Reg. No. 26590-05-6).    or retention aid employed     
 The copolymer is produced by             prior to the sheet-forming    
 copolymerizing diallyldimethylammonium   operation in the manufacture  
 chloride with acrylamide in a weight     of paper and paperboard and   
 ratio of 50-50 so that the finished      limited to use at a level not 
 resin in a 1 percent by weight aqueous   to exceed 0.05 percent by     
 solution (active polymer) has a          weight of the finished paper  
 viscosity of more than 22 centipoises    and paperboard.               
 at 22 C (71.6 F), as determined by LVF-                                
 series Brookfield viscometer using a                                   
 No. 1 spindle at 60 r.p.m. (or by                                      
 other equivalent method).                                              
Diallyldiethylammonium chloride polymer                                 
 with acrylamide, and                                                   
 diallyldimethylammonium chloride,                                      
 produced by copolymerizing acrylamide,                                 
 diallyldiethylammonium chloride, and                                   
 diallyldimethylammonium chloride,                                      
 respectively, in the following weight                                  
 ratios and having viscosities                                          
 determined at 22 C, by LVF-series                                      
 Brookfield viscometer using a No. 1                                    
 spindle at 60 r.p.m. (or by other                                      
 equivalent method), as follows:.                                       
  1. Weight ratio: 50-2.5-47.5. The      For use only as a retention aid
   finished resin in a 1 percent by       employed prior to the sheet-  
   weight aqueous solution has a          forming operation in the      
   minimum viscosity of 22 centipoises.   manufacture of paper and      
                                          paperboard and limited to use 
                                          at a level not to exceed 0.05 
                                          percent by weight of the      
                                          finished paper and paperboard.
  2. Weight ratio: 25-2.5-72.5. The      For use only as a drainage and/
   finished resin in a 0.20 percent by    or retention aid employed     
   weight aqueous solution has a          prior to the sheet-forming    
   minimum viscosity of 20 centipoises.   operation in the manufacture  
                                          of paper and paperboard and   
                                          limited to use at a level not 
                                          to exceed 0.075 percent by    
                                          weight of the finished paper  
                                          and paperboard.               
  3. Weight ratio: 80-2.5-17.5. The      For use only as a drainage and/
   finished resin in a 0.30 percent by    or retention aid employed     
   weight aqueous solution has a          prior to the sheet-forming    
   minimum viscosity of 50 centipoises.   operation in the manufacture  
                                          of paper and paperboard and   
                                          limited to use at a level not 
                                          to exceed 0.075 percent by    
                                          weight of the finished paper  
                                          and paperboard.               
Diallyldiethylammonium chloride polymer  For use only as a retention aid
 with acrylamide, potassium acrylate,     employed prior to the sheet-  
 and diallyldimethylammonium chloride.    forming operation in the      
 The polymer is produced by               manufacture of paper and      
 copolymerizing either: (1) acrylamide,   paperboard and limited to use 
 diallyldiethylammonium chloride, and     at a level not to exceed 0.05 
 diallyldimethylammonium chloride in a    percent by weight of the      
 weight ratio of 50-2.5-47.5,             finished paper and paperboard.
 respectively, with 4.4 percent of the                                  
 acrylamide subsequently hydrolyzed to                                  
 potassium acrylate, or (2) acrylamide,                                 
 potassium acrylate (as acrylic acid),                                  
 diallyldiethylammonium chloride, and                                   
 diallyldimethylammonium chloride in a                                  
 weight ratio of 47.8-2.2-2.5-47.5, so                                  
 that the finished resin in a 1 percent                                 
 by weight aqueous solution has a                                       
 minimum viscosity of 22 centipoises at                                 
 22 C, as determined by LVF-series                                      
 Brookfield viscometer using a No. 1                                    
 spindle at 60 r.p.m. (or by other                                      
 equivalent method).                                                    
Diallyldimethylammonium chloride         For use only as a dry and wet  
 polymer with acrylamide, reaction        strength agent employed prior 
 product with glyoxal, produced by        to the sheet-forming operation
 copolymerizing not less than 90 weight   in the manufacture of paper   
 percent of acrylamide and not more       and paperboard in such an     
 than 10 weight percent of                amount that the finished paper
 diallyldimethylammonium chloride,        and paperboard will contain   
 which is then cross-linked with not      the additive at a level not in
 more than 30 weight percent of           excess of 2 percent by weight 
 glyoxal, such that a 10 percent          of the dry fibers in the      
 aqueous solution has a minimum           finished paper and paperboard.
 viscosity of 25 centipoises at 25 C as                                 
 determined by Brookfield viscometer                                    
 Model RVF, using a No. 1 spindle at                                    
 100 r.p.m.                                                             

[[Page 183]]

                                                                        
2,5Di-tert-butyl hydroquinone..........  For use only as an antioxidant 
                                          for fatty based coating       
                                          adjuvants provided it is used 
                                          at a level not to exceed      
                                          0.005% by weight of coating   
                                          solids.                       
Diethanolamine.........................  For use only as an adjuvant to 
                                          control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Diethanolamine salts of mono- and bis    For use only as an oil and     
 (1H,1H,2H,2H-perfluoroalkyl)             water repellant at a level not
 phosphates where the alkyl group is      to exceed 0.17 pound (0.09    
 even-numbered in the range C8-C18 and    pound of fluorine) per 1,000  
 the salts have a fluorine content of     square feet of treated paper  
 52.4% to 54.4% as determined on a        or paperboard, as determined  
 solids basis.                            by analysis for total fluorine
                                          in the treated paper or       
                                          paperboard without correction 
                                          for any fluorine which might  
                                          be present in the untreated   
                                          paper or paperboard, when such
                                          paper or paperboard is used in
                                          contact with nonalcoholic     
                                          foods under the conditions of 
                                          use described in paragraph (c)
                                          of this section, Table 2,     
                                          conditions of use (B) through 
                                          (H).                          
Diethyl(2-hydroxyethyl) methylammonium   For use only as a retention aid
 methyl sulfate, acrylate, polymer with   and drainage aid employed     
 acrylamide, chemical abstract service    prior to the sheet-forming    
 registry No. [26796-75-8] having 90-95   operation in the manufacture  
 mole pct. acrylamide, a nitrogen         of paper and paperboard at a  
 content of not more than 19.7 pct.       level not to exceed 0.15 pct. 
 (Kjeldahl, dry basis), and a residual    by weight of finished dry     
 acrylamide monomer content of not more   paper and paperboard fibers.  
 than 0.1 pct. The finished polymer in                                  
 a 1 pct. by weight aqueous solution                                    
 has a minimum viscosity of 900                                         
 centipoises at 25 C as determined by                                   
 LVT-series Brookfield viscometer using                                 
 a No. 2 spindle at 12 r.p.m. (or by                                    
 equivalent method).                                                    
Diethylenetriamine.....................  For use only as a modifier for 
                                          amino resins.                 
N,N-Diisopropanolamide of tallow fatty   For use only as an adjuvant to 
 acids.                                   control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Dimethylamine-epichlorohydrin copolymer  For use only:                  
 in which not more than 5 mole-percent     1. As a retention aid        
 of dimethylamine may be replaced by an   employed before the sheet-    
 equimolar amount of ethylenediamine      forming operation in the      
 and in which the ratio of total amine    manufacture of paper and      
 to epichlorohydrin does not exceed       paperboard and limited to use 
 1:1. The nitrogen content of the         at a level not to exceed 1    
 copolymer shall be 9.4 to 10.8 weight    percent by weight of the      
 percent on a dry basis and a 10          finished paper and paperboard.
 percent by weight aqueous solution of     2. At the size press at a    
 the final product has a minimum          level not to exceed 0.017     
 viscosity of 5.0 centipoises at 25 C,    percent by weight of the      
 as determined by LVT-series Brookfield   finished paper and paperboard.
 viscometer using a No. 1 spindle at 60                                 
 r.p.m. (or by other equivalent method).                                
N-[(Dimethylamino)methyl]-acrylamide     For use only as a dry-strength 
 polymer with acrylamide and styrene      agent employed prior to the   
 having a nitrogen content of not more    sheet-forming operation in the
 than 16.9 percent and a residual         manufacture of paper and      
 acrylamide monomer content of not more   paperboard and used at a level
 than 0.2 percent on a dry basis.         not to exceed 1 percent by    
                                          weight of finished dry paper  
                                          or paperboard fibers.         
N,N'-Dioleoylethylenediamine...........  ...............................
Diphenylamine..........................  For use only as an antioxidant 
                                          for fatty based coating       
                                          adjuvants provided it is used 
                                          at a level not to exceed      
                                          0.005% by weight of coating   
                                          solids.                       
Dipropylene glycol.....................  ...............................
Disodium salt of 1,4-dihydro-9,10-       For use only as a catalyst in  
 dihydroxyanthracene (CAS Reg. No.        the alkaline pulping of       
 73347-80-5).                             lignocellulosic materials at  
                                          levels not to exceed 0.1      
                                          percent by weight of the raw  
                                          lignocellulosic materials.    
N,N'-Distearoylethylenediamine.........  ...............................
n-Dodecylguanidine acetate.............  For use only as an             
                                          antimicrobial agent in paper  
                                          and paperboard under the      
                                          following conditions:         
                                           1. For contact only with     
                                          nonalcoholic food having a pH 
                                          above 5 and provided it is    
                                          used at a level not to exceed 
                                          0.4 percent by weight of the  
                                          paper and paperboard.         
                                           2. For use in the outer ply  
                                          of multiwall paper bags for   
                                          contact with dry food of Type 
                                          VIII described in Table I of  
                                          paragraph (c) of this section 
                                          and provided it is used at a  
                                          level of 0.8 percent by weight
                                          of the paper.                 
n-Dodecylguanidine hydrochloride.......  For use only as an             
                                          antimicrobial agent in paper  
                                          and paperboard under the      
                                          following conditions:         
                                           1. For contact only with     
                                          nonalcoholic food having a pH 
                                          above 5 and provided it is    
                                          used at a level not to exceed 
                                          0.4 percent by weight of the  
                                          paper and paperboard.         
                                           2. For use in the outer ply  
                                          of multiwall paper bags for   
                                          contact with dry food of Type 
                                          VIII described in Table I of  
                                          paragraph (c) of this section 
                                          and provided it is used at a  
                                          level of 0.8 percent by weight
                                          of the paper.                 
Fatty acids derived from animal and                                     
 vegetable fats and oils and salts of                                   
 such acids, single or mixed, as                                        
 follows:                                                               
  Aluminum.                              ...............................
  Ammonium.                              ...............................
  Calcium.                               ...............................

[[Page 184]]

                                                                        
  Magnesium.                             ...............................
  Potassium.                             ...............................
  Sodium.                                ...............................
  Zinc.                                  ...............................
Ferric chloride........................  ...............................
Ferrous ammonium sulfate...............  ...............................
Fish oil, hydrogenated.................  ...............................
Fish oil, hydrogenated, potassium salt.  ...............................
Furcelleran and salts of furcelleran as  ...............................
 described in Secs.  172.655 and                                        
 172.660 of this chapter.                                               
Glutaraldehyde (CAS Reg. No. 111-30-8).  For use only as an             
                                          antimicrobial agent in pigment
                                          and filler slurries used in   
                                          the manufacture of paper and  
                                          paperboard at levels not to   
                                          exceed 300 parts per million  
                                          by weight of the slurry       
                                          solids.                       
Glyceryl lactostearate.................  ...............................
Glyceryl mono-1,2-hydroxystearate......  ...............................
Glyceryl monoricinoleate...............  ...............................
Guar gum modified by treatment with      For use only as a retention aid
 -diethylamino- ethyl chloride   and/or drainage aid employed  
 hydrochloride.                           prior to the sheet-forming    
                                          operation in the manufacture  
                                          of paper and paperboard.      
Guar gum modified by treatment with not  For use only as a retention aid
 more than 25 weight percent of 2,3-      and/or internal size employed 
 epoxypropyltri-methylammonium chloride   prior to the sheet-forming    
 such that the finished product has a     operation in the manufacture  
 maximum chlorine content of 4.5          of paper and paperboard, and  
 percent, a maximum nitrogen content of   limited to use at a level: (1)
 3.0 percent, and a minimum viscosity     Not to exceed 0.15 percent by 
 in 1-percent-by-weight aqueous           weight of the finished dry    
 solution of 1,000 centipoises at 77 F,   paper and paperboard fibers   
 as determined by RV-series Brookfield    intended for use in contact   
 viscometer (or equivalent) using a No.   with all types of foods,      
 3 spindle at 20 r.p.m.                   except (2) not to exceed 0.30 
                                          pct. by weight of the finished
                                          dried paper and paperboard    
                                          fibers for use with           
                                          nonalcoholic and nonfatty food
                                          of types identified under     
                                          Types I, II, IV-B, VI-B, VII- 
                                          B, and VIII of Table I in par.
                                          (c) of this section.          
N, N, N', N', N'', N''-Hexakis           For use only as a water-       
 (methoxymethyl)-1,3,5-triazine-2,4,6-    repellent applied to the      
 triamine polymer with stearyl alcohol,   surface of paper and          
 -octadecenyl--        paperboard at levels not to   
 hydroxypoly(oxy-1,2-ethanediyl), and     exceed 1 percent by weight of 
 alkyl (C20+) alcohols (CAS Reg. No.      the finished dry paperboard   
 130328-24-4).                            fibers. The finished paper and
                                          paperboard will be used in    
                                          contact with aqueous foods    
                                          under conditions of use B     
                                          through G as described in     
                                          Table 2 of paragraph (c) of   
                                          this section.                 
Hexamethylenetetramine.................  For use only as polymerization 
                                          cross-linking agent for       
                                          protein, including casein.    
Hydroquinone and the monomethyl or       For use only as an inhibitor   
 monoethyl ethers of hydroquinone.        for monomers.                 
Hydroxypropyl guar gum having a minimum  For use only as a dry strength 
 viscosity of 5,000 centipoises at 25     and formation aid agent       
 C., as determined by RV-series           employed prior to the sheet-  
 Brookfield viscometer using a No. 4      forming operation in the      
 spindle at 20 r.p.m. (or other           manufacture of paper and      
 suitable method) and using a test        paperboard and used at a level
 sample prepared by dissolving 5 grams    not to exceed 1.5 percent by  
 of moisture-free hydroxypropyl guar      weight of finished dry paper  
 gum in 495 milliliters of a 70 percent   or paperboard fibers.         
 by weight aqueous propylene glycol                                     
 solution.                                                              
12-Hydroxystearic acid-polyethylene      For use only as a surfactant   
 glycol block copolymers (CAS Reg. No.    for dispersions of            
 70142-34-6) produced by the reaction     polyacrylamide retention and  
 of polyethylene glycol (minimum          drainage aids employed prior  
 molecular weight 1500) with 12-          to the sheet forming operation
 hydroxystearic acid.                     in the manufacture of paper   
                                          and paperboard.               
Isopropyl m- and p-cresols (thymol       For use only as an antioxidant 
 derived).                                for fatty based coating       
                                          adjuvants provided it is used 
                                          as a level not to exceed      
                                          0.005% by weight of coating   
                                          solids.                       
Isopropyl peroxydicarbonate............  For use only as polymerization 
                                          catalyst.                     
Japan wax..............................  ...............................
Lanolin................................  ...............................
Lauryl peroxide........................  For use only as polymerization 
                                          catalyst.                     
Lauryl sulfate salts:                                                   
  Ammonium.                              ...............................
  Magnesium.                             ...............................
  Potassium.                             ...............................
  Sodium.                                ...............................
Lecithin, hydroxylated.................  ...............................
Lignin sulfonate and its calcium,        ...............................
 potassium, and sodium salts.                                           
Maleic anhydride, polymer with ethyl     For use only as a deposit      
 acrylate and vinyl acetate, hydrolyzed   control additive prior to the 
 (CAS Reg. No. 113221-69-5) and/or its    sheet forming operation to    
 ammonium, potassium, and sodium salts.   prevent scale buildup in the  
                                          manufacture of paper and      
                                          paperboard in contact with    
                                          food, at a level not to exceed
                                          0.075 percent (as the acid) by
                                          weight of the dry paper and   
                                          paperboard.                   
Methacrylic acid-acrylic acid copolymer  For use only as a boiler water 
 (CAS Reg. No. 25751-21-7).               additive at a level not to    
                                          exceed 50 parts per million in
                                          the boiler water.             

[[Page 185]]

                                                                        
N-methyldiallylamine hydrochloride       For use only as a retention    
 polymer with epichlorohydrin having a    aid, flocculating agent, and  
 nitrogen content of 4.8 to 5.9 percent   wet-strength agent employed in
 (Kjeldahl dry basis) such that a 20      the manufacture of paper and  
 percent by weight aqueous solution has   paperboard prior to the sheet-
 a minimum viscosity of 30 centipoises    forming operation and limited 
 and maximum viscosity of 100             to use at a level not to      
 centipoises at 25 C, as determined by    exceed 1.5 percent by weight  
 LVF Model Brookfield viscometer using    of the dry paper and          
 a No. 1 spindle at 60 r.p.m. (or         paperboard.                   
 equivalent method).                                                    
Methyl naphthalene sulfonic acid-        For use only as an adjuvant to 
 formaldehyde condensate, sodium salt.    control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
N-methyl-N-(tall oil acyl) taurine,      For use only to control scale  
 sodium salt (CAS Reg. No. 61791-41-1).   formation in the manufacture  
                                          of paper and paperboard prior 
                                          to the sheetforming operation 
                                          at a level not to exceed 0.015
                                          percent by weight of the dry  
                                          paper and paperboard.         
Mineral oil, white.....................  ...............................
Mono-, di-, tri-(1-methyl-1-             For use only as an emulsifier  
 phenylethyl)-phenol, ethoxylated,        for rosin based sizing at a   
 sulfated, ammonium salt with an          level not to exceed 0.03      
 average of 12 to 16 moles of ethylene    percent by weight of the      
 oxide (CAS Reg. No. 68130-71-2).         finished dry paper and        
                                          paperboard.                   
Monoglyceride citrate..................  ...............................
Mustardseed oil, sulfated, ammonium,     ...............................
 potassium, or sodium salt.                                             
Naphthalene sulfonic acid-formaldehyde   For use only as an adjuvant to 
 condensate, sodium salt.                 control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Nitrocellulose, 10.9-12.2% nitrogen....  ...............................
Oleic acid, sulfated, ammonium,          ...............................
 potassium, or sodium salt.                                             
N-Oleoyl-N'-stearoylethylenediamine....  ...............................
Oxystearin.............................  ...............................
Paraformaldehyde.......................  For use only as setting agent  
                                          for protein.                  
Pentanoic acid, 4,4-bis [(gamma-omega-   For use only as an oil and     
 perfluoro-C8-20-alkyl)thio]              water repellent and used at a 
 derivatives, compounds with              level not to exceed 8 pounds  
 diethanolamine (CAS Reg. No. 71608-61-   per ton of the finished paper 
 2).                                      or paperboard when such paper 
                                          or paperboard is used in      
                                          contact with nonalcoholic     
                                          foods under conditions of use 
                                          E through H described in Table
                                          2 of paragraph (c) of this    
                                          section.                      
Perfluoroalkyl acrylate copolymer (CAS   For use only as an oil and     
 Reg. No. 92265-81-1) containing 35 to    water repellent at a level not
 40 weight percent fluorine, produced     to exceed 0.5 percent by      
 by the copolymerization of               weight of the finished paper  
 ethanaminium, N,N,N-trimethyl-2-[(2-     and paperboard in contact with
 methyl-1-oxo-2-propenyl)-oxy]-,          nonalcoholic foods under      
 chloride; 2-propenoic acid, 2-methyl-,   conditions of use C, D, E, F, 
 oxiranylmethyl ester; 2-propenoic        G, or H described in table 2  
 acid, 2-ethoxyethyl ester; and 2-        of paragraph (c) of this      
 propenoic acid, 2[[(heptadecafluoro-     section.                      
 octyl)sulfonyl] methyl amino]ethyl                                     
 ester.                                                                 
Perfluoroalkyl substituted phosphate     For use only as an oil and     
 ester acids, ammonium salts formed by    water repellant at a level not
 the reaction of 2,2-bis[ (,-perfluoroC4-20alkylthio)   perfluoroalkyl actives by     
 methyl]-1,3-propanediol,                 weight of the finished paper  
 polyphosphoric acid and ammonium         and paperboard in contact with
 hydroxide.                               non-alcoholic foods under     
                                          condition of use H as         
                                          described in Table 2 of       
                                          paragraph (c) of this section.
Petrolatum.............................  Complying with Sec.  178.3700  
                                          of this chapter.              
Petroleum asphalt, steam and vacuum      For use only as a component of 
 refined to meet the following            internal sizing of paper and  
 specifications: Softening point 88 C     paperboard intended for use in
 to 93 C, as determined by ASTM method    contact only with raw fruits, 
 D36-76, ``Standard Test Method for       raw vegetables, and dry food  
 Softening Point of Bitumen (Ring-and-    of the type identified under  
 Ball Apparatus);'' penetration at 25 C   Type VIII of Table 1 in       
 not to exceed 0.3 mm, as determined by   paragraph (c) of this section,
 ASTM method D5-73 (Reapproved 1978),     and provided that the asphalt 
 ``Standard Test Method for Penetration   is used at a level not to     
 of Bituminous Materials,'' which are     exceed 5% by weight of the    
 incorporated by reference (copies may    finished dry paper and        
 be obtained from the American Society    paperboard fibers.            
 for Testing Materials, 1916 Race St.,                                  
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC 20408);                                 
 and maximum weight loss not to exceed                                  
 3% when distilled to 371 C, nor to                                     
 exceed an additional 1.1% when further                                 
 distilled between 371 C and thermal                                    
 decomposition.                                                         
Petroleum wax, synthetic...............  Complying with Sec.  178.3720  
                                          of this chapter.              
Phenothiazine..........................  For use only as antioxidant in 
                                          dry rosin size.               
Phenyl acid phosphate..................  For use only as polymerization 
                                          catalyst in melamine-         
                                          formaldehyde modified alkyd   
                                          coatings and limited to use at
                                          a level not to exceed 2% by   
                                          weight of the coating solids. 
Phenyl--naphthylamine.........  For use only as antioxidant in 
                                          dry rosin size and limited to 
                                          use at a level not to exceed  
                                          0.4% by weight of the dry     
                                          rosin size.                   

[[Page 186]]

                                                                        
Phosphoric acid esters and polyesters    For use as an adjuvant prior to
 (and their sodium salts) of              the sheet forming operation to
 triethanolamine formed by the reaction   control pitch and scale       
 of triethanolamine with polyphosphoric   formation in the manufacture  
 acid to produce a mixture of esters      of paper and paperboard       
 having an average nitrogen content of    intended for use in contact   
 1.5 percent and an average phosphorus    with food only of the types   
 content of 32 percent (as PO4).          identified in paragraph (c) of
                                          this section, Table 1, under  
                                          Types I, IV, V, VII, VIII, and
                                          IX, and used at a level not to
                                          exceed 0.075 percent by weight
                                          of dry paper or paperboard    
                                          fibers.                       
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid 
 (dimethyl-aminomethyl)acryl-  amide],    and retention aid employed    
 produced by reacting 2.40 to 3.12        prior to the sheet-forming    
 parts by weight of polyacrylamide with   operation in the manufacture  
 1.55 parts dimethylamine and 1 part      of paper and paperboard for   
 formaldehyde, and containing no more     use in contact with fatty     
 than 0.2 percent monomer as acrylamide.  foods under conditions of use 
                                          described in paragraph (c) of 
                                          this section, Table 2,        
                                          conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2- For use only as a retention and
 hydroxypropyl acrylate) produced when    drainage aid employed prior to
 one mole of hydroxypropyl acrylate and   the sheet-forming operation in
 three moles of acrylic acid are          the manufacture of paper and  
 reacted with three moles of              paperboard at a level not to  
 ethylenimine and three moles of nitric   exceed 0.2 percent by weight  
 acid, such that a 35 percent by weight   of dry paper or paperboard    
 aqueous solution has a minimum           fiber.                        
 viscosity of 150 centipoises at 72 F.,                                 
 as determined by RVF-series Brookfield                                 
 viscometer (or equivalent) using a No.                                 
 2 spindle at 20 r.p.m.                                                 
Polyacrolein (1 part) -sodium bisulfite  For use only as an agent in    
 (0.7 part) adduct, containing excess     modifying starches and starch 
 bisulfite (ratio of excess bisulfite     gums used in the production of
 to adduct not to exceed 1.5 to 1).       paper and paperboard and      
                                          limited to use at a level not 
                                          to exceed 0.09 mg/in2 of the  
                                          finished paper and paperboard.
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid,
 (dimethylaminomethyl) acrylamide]        retention aid, or dry-strength
 (C.A. Registry No. 53800-41-2),          agent employed prior to the   
 produced by reacting 9.6-16.4 parts by   sheet-forming operation in the
 weight of polyacrylamide with 1.6        manufacture of paper and      
 parts dimethylamine and 1 part           paperboard at a level not to  
 formaldehyde, and containing no more     exceed 0.25 percent by weight 
 than 0.2% monomer as acrylamide, such    of finished dry paper and     
 that a 20% aqueous solution has a        paperboard fibers, when such  
 minimum viscosity of 4,000 cP at 25      paper or paperboard is used in
 C., as determined by Brookfield          contact with fatty foods under
 viscometer model RVT, using a No. 5      conditions of use described in
 spindle at 20 r/min (or equivalent       paragraph (c) of this section,
 method).                                 Table 2, conditions of use E, 
                                          F, and G.                     
Polyamide-epichlorohydrin modified       For use only as a retention aid
 resin produced by reacting adipic acid   and flocculant employed prior 
 with diethylene triamine to produce a    to the sheet-forming operation
 basic polyamide which is modified by     in the manufacture of paper   
 reaction with formic acid and            and paperboard and used at a  
 formaldehyde and further reacted with    level not to exceed 0.2       
 epichlorohydrin in the presence of       percent dry resin by weight of
 ammonium hydroxide to form a water-      finished dry paper or         
 soluble cationic resin having a          paperboard fibers.            
 nitrogen content of 13-16 percent                                      
 (Kjeldahl, dry basis) such that a 35                                   
 percent by weight aqueous solution has                                 
 a minimum viscosity of 75 centipoises                                  
 at 25 C, as determined by Brookfield                                   
 viscometer using a No. 1 spindle at 12                                 
 r.p.m.                                                                 
Polyamide-epichlorohydrin water-soluble  For use only under the         
 thermosetting resins [CAS Reg. No.       following conditions:         
 68583-79-9] prepared by reacting          1. As a retention aid        
 adipic acid with diethylenetriamine to   employed prior to the sheet-  
 form a basic polyamide and further       forming operation in the      
 reacting the polyamide with an           manufacture of paper and      
 epichlorohydrin and dimethylamine        paperboard and limited to use 
 mixture such that the finished resins    at a level not to exceed 0.12 
 have a nitrogen content of 17.0 to       percent by weight of dry paper
 18.0 percent of a dry basis, and that    or paperboard.                
 a 30-percent-by-weight aqueous            2. The finished paper or     
 solution has a minimum viscosity of      paperboard will be used in    
 350 centipoises at 20 C, as determined   contact with food only of the 
 by a Brookfield viscometer using a No.   types identified in paragraph 
 3 spindle at 30 r.p.m. (or equivalent    (c) of this section, Table 1, 
 method).                                 under types I and IV-B and    
                                          under conditions of use       
                                          described in paragraph (c) of 
                                          this section, Table 2,        
                                          conditions of use F and G.    
Polyamide-epichlorohydrin water-soluble  For use only as a wet strength 
 thermosetting resin (CAS Reg. No.        agent and/or retention aid    
 96387-48-3) prepared by reacting N-      employed prior to the sheet-  
 methyl-bis(3-aminopropyl) amine with     forming operation in the      
 oxalic acid and urea to form a basic     manufacture of paper and      
 polyamide and further reacting the       paperboard and used at a level
 polyamide with epichlorohydrin.          not to exceed 1.5 percent by  
                                          weight of dry paper and       
                                          paperboard fibers.            

[[Page 187]]

                                                                        
Polyamide-epichlorohydrin water-soluble  For use only in the manufacture
 thermosetting resins prepared by         of paper and paperboard under 
 reacting adipic acid, isophthalic        conditions such that the      
 acid, itaconic acid or dimethyl          resins do not exceed 1.5      
 glutarate with diethylenetriamine to     percent by weight of the paper
 form a basic polyamide and further       or paperboard.                
 reacting the polyamide with one of the                                 
 following:                                                             
  Epichlorohydrin.                       ...............................
  Epichlorohydrin and ammonia mixture.   ...............................
  Epichlorohydrin and sodium             ...............................
   hydrosulfite mixture.                                                
Polyamidol-epichlorohydrin modified      For use only as a wet strength 
 resin produced by reacting glutaric      agent employed prior to the   
 acid dimethyl ester with diethylene-     sheet-forming operation in the
 triamine to produce a basic polyamide    manufacture of paper and      
 which is modified by reaction with       paperboard, and used at a     
 formaldehyde and further reacted with    level not to exceed 2.5       
 epicholorohydrin to form a water         percent by weight of dry paper
 soluble cationic resin having a          and paperboard fibers when    
 nitrogen content of 10.9-11.9 percent    such paper or paperboard is   
 and a chlorine content of 13.8-14.8      used in contact with food     
 percent, on a dry basis, and a minimum   under conditions of use E     
 viscosity, in 12.5 percent by weight     through G described in Table 2
 aqueous solution, of 10 centipoises at   of paragraph (c) of this      
 25C, as determined by a Brookfield       section.                      
 Model LVF viscometer using a No. 1                                     
 spindle at 60 r.p.m. (or equivalent                                    
 method).                                                               
Polyamine-epichlorohydrin resin          For use only as a flocculant,  
 produced by the reaction of              drainage aid, formation aid,  
 epichlorohydrin with monomethylamine     retention aid, or strength    
 to form a prepolymer and further         additive employed prior to the
 reaction of this prepolymer with         sheet-forming operation in the
 N,N,N',N'-tetramethylethylenediamine     manufacture of paper and      
 such that the finished resin having a    paperboard, and used at a     
 nitrogen content of 11.6 to 14.8         level not to exceed 0.12      
 percent and a chlorine content of 20.8   percent by weight of dry paper
 to 26.4 percent and a minimum            and paperboard fibers.        
 viscosity, in 25 percent by weight                                     
 aqueous solution, of 500 centipoises                                   
 at 25C, as determined by LV-series                                     
 Brookfield viscometer using a No. 2                                    
 spindle at 12 r.p.m. (or by other                                      
 equivalent method).                                                    
Polyamine-epichlorohydrin resin          For use only as a clarifier in 
 produced by the reaction of N,N-         the treatment of influent     
 dimethyl-1,3-propanediamine with         water to be used in the       
 epichlorohydrin and further reacted      manufacture of paper and      
 with sulfuric acid, Chemical Abstracts   paperboard, and used at a     
 Service Registry Number [27029-41-0],    level not to exceed 20 parts  
 such that the finished resin has a       per million of the influent   
 maximum nitrogen content of 14.4         water.                        
 percent (dry basis) and a minimum                                      
 viscosity in 30 percent by weight                                      
 aqueous solution (pH 4-6) of 50                                        
 centipoises at 25 C, as determined by                                  
 Brookfield LVT model viscometer, using                                 
 a No. 1 spindle at 12 r.p.m. (or                                       
 equivalent method).                                                    
Polyamine-epichlorohydrin water-soluble  For use only as a wetstrength  
 thermosetting resin produced by          agent and/or retention aid    
 reacting epichlorohydrin with: (i)       employed prior to the sheet-  
 polyamines comprising at least 95        forming operation in the      
 percent by weight C4 to C6 aliphatic     manufacture of paper and      
 diamines and/or their self-              paperboard, and used at a     
 condensation products, and/or (ii)       level not to exceed 1 percent 
 prepolymers produced by reacting 1,2-    by weight of dry paper and    
 dichloroethane with the polyamines in    paperboard fibers.            
 (i). The finished resin has a nitrogen                                 
 content of 5.0 to 9.0 percent, a                                       
 chlorine content of 18.0 to 35.0                                       
 percent on a dry basis, and a minimum                                  
 viscosity, in a 25 percent by weight                                   
 aqueous solution, of 50 centipoises at                                 
 20 C (68 F), as determined by                                          
 Brookfield HAT model viscometer using                                  
 a No. 1H spindle at 50 r.p.m. (or                                      
 equivlent method)..                                                    
Polyamine-epichlorohydrin water-soluble  For use only as a wet-strength 
 thermosetting resin produced by          agent and/or retention aid    
 reacting epichlorohydrin with: (i)       employed prior to the sheet-  
 polyamines comprising at least 95        forming operation in the      
 percent by weight C4 to C6 aliphatic     manufacture of paper and      
 diamines and/or their seIf-              paperboard, and used at a     
 condensation products and/or (ii)        level not to exceed 1 percent 
 hexamethylenediamine, and/or (iii)       by weight of dry paper and    
 bis(hexamethylene) triamine and higher   paperboard fibers.            
 homologues, and/or (iv) prepolymers                                    
 produced by reacting 1,2-                                              
 dichloroethane with the polyamines in                                  
 (i) and/or (ii) and/or (iii). The                                      
 finished resin has a nitrogen content                                  
 of 5.0 to 9.0 percent, a chlorine                                      
 content of 18.0 to 35.0 percent on a                                   
 dry basis, and a minimum viscosity, in                                 
 a 25 percent by weight aqueous                                         
 solution, of 50 centipoises at 20 C                                    
 (68 F), as determined by Brookfield                                    
 HAT model viscometer using a No. 1H                                    
 spindle at 50 r.p.m. (or equivalent                                    
 method).                                                               

[[Page 188]]

                                                                        
Polyamine-epichlorohydrin water soluble  For use only as a wet-strength 
 thermosetting resin prepared by          agent and/or retention aid    
 reacting hexamethylenediamine with 1,2-  employed prior to the sheet-  
 dichloroethane to form a prepolymer      forming operation in the      
 and further reacting this prepolymer     manufacture of paper and      
 with epichlorohydrin. This resin is      paperboard, and used at a     
 then reacted with nitrilotris            level not to exceed 1 percent 
 (methylene-phosphonic acid),             by weight of dry paper and    
 pentasodium salt, such that the          paperboard fibers.            
 finished resin has a nitrogen content                                  
 of 5.0-5.3 percent; a chlorine content                                 
 of 29.7-31.3 percent; and a phosphorus                                 
 content of 2.0-2.2 percent, on a dry                                   
 basis, and a minimum viscosity, in 25                                  
 percent by weight aqueous solution, of                                 
 50 centipoises at 25 C., as determined                                 
 on a Brookfield HAT model viscometer                                   
 using a No. 1H spindle at 50 r.p.m.                                    
 (or equivalent method).                                                
Polyamine resin produced by the          For use only as a retention aid
 reaction of 1,2-dichloroethane with      and/or flocculent employed    
 bis(hexamethylene)triamine and higher    prior to the sheet-forming    
 homologues such that the finished        operation in the manufacture  
 resin has a nitrogen content of 13.0-    of paper and paperboard and   
 15.0 percent on a dry basis, and a       used at a level not to exceed 
 minimum viscosity in 25-percent-by-      0.1 percent by weight of dry  
 weight aqueous solution of 75            paper or paperboard fibers.   
 centipoises at 25 C., as determined by                                 
 Brookfield HAT model viscometer using                                  
 a No. 1 spindle at 50 r.p.m. (or                                       
 equivalent method).                                                    
Polyaminoamide-epichlorohydrin modified  For use only as a wet-strength 
 resin produced by reacting adipic acid   agent and/or retention aid    
 with diethylenetriamine to produce a     employed prior to the sheet-  
 polyamide which is modified by           forming operation in the      
 reaction with diethylaminopropylamine    manufacture of paper and      
 and further reacted with dichloroethyl   paperboard, and used at a     
 ether to form a polyamide                level not to exceed 0.5       
 intermediate. This polyamide             percent by weight of the      
 intermediate is then reacted with        finished dry paper and        
 epichlorohydrin such that the finished   paperboard.                   
 resins have a nitrogen content of 10.9-                                
 12.4 percent (Kjeldahl, dry basis) and                                 
 a minimum viscosity in 40 percent-by-                                  
 weight aqueous solution of 250                                         
 centipoises at 22 C, as determined by                                  
 a Brookfield Model LVT viscometer                                      
 using a No. 2 spindle at 30 r.p.m. (or                                 
 equivalent method).                                                    
Polybutene, hydrogenated; complying      For use only as provided in    
 with the identity prescribed under       Secs.  175.300, 178.3740 and  
 Sec.  178.3740(b) of this chapter.       178.3860 of this chapter.     
Poly(diallyldimethylammonium chloride)   For use only:                  
 (CAS Reg. No. 26062-79-3) produced by   1. As a pigment dispersant and/
 the polymerization of                    or retention aid prior to the 
 (diallyldimethylammonium chloride) so    sheet-forming operation in the
 that the finished resin has a nitrogen   manufacture of paper and      
 content of 8.660.4 percent   paperboard, and used at a     
 on a dry weight basis and a minimum      level not to exceed 10 pounds 
 viscosity in a 40 percent by weight      of active polymer per ton of  
 aqueous solution of 1,000 centipoises    finished paper and paperboard.
 at 25 C (77 F), determined by LVF       2. As a pigment dispersant in  
 Model Brookfield Viscometer using a      coatings at a level not to    
 No. 3 spindle at 30 r.p.m. (or           exceed 3.5 pounds of active   
 equivalent method). The level of         polymer per ton of finished   
 residual monomer is not to exceed 1      paper and paperboard.         
 percent by weight of the polymer (dry                                  
 basis).                                                                
Poly (diallyldimethylammonium chloride)  For use only as a flocculant   
 (CAS Reg. No. 26062-79-3) produced by    employed prior to the sheet-  
 the polymerization of                    forming operation in the      
 diallyldimethylammonium chloride so      manufacture of paper and      
 that the finished resin has a nitrogen   paperboard, and used at a     
 content of 8.66 0.4          level not to exceed 10 mg/L   
 percent on a dry basis and a minimum     (10 parts per million) of     
 viscosity in a 15 weight-percent         influent water.               
 aqueous solution of 10 centipoises at                                  
 25 C (77 F), as determined by LVF                                      
 Model Brookfield viscometer using a                                    
 No. 1 spindle at 60 r/min (or                                          
 equivalent method). The level of                                       
 residual monomer is not to exceed 1                                    
 weight-percent of the polymer (dry                                     
 basis)..                                                               
Poly(1,2-dimethyl-5-vinylpyridinium      For use only as an adjuvant    
 methyl sulfate) having a nitrogen        employed in the manufacture of
 content of 5.7 to 7.3 percent and a      paper and paperboard prior to 
 sulfur content of 11.7 to 13.3 percent   the sheet-forming operation.  
 by weight on a dry basis and having a                                  
 minimum viscosity in 30-percent-by-                                    
 weight aqueous solution of 2,000                                       
 centipoises at 25 C., as determined by                                 
 LV-series Brookfield viscometer (or                                    
 equivalent) using a No. 4 spindle at                                   
 60 r.p.m.                                                              
Polyester resin produced by reacting     For use only as a surface-     
 dimethylolpropionic acid (CAS Registry   sizing compound applied after 
 No. 4767-03-7) as a comonomer, at no     the sheet-forming operation in
 more than 30 percent by weight of        the manufacture of paper and  
 total polymer solids in reaction with    paperboard and limited to use 
 2,2-dimethyl-1,3-propanediol, phthalic   at levels not to exceed 0.1   
 anhydride and isophthalic acid, such     percent by weight of finished 
 that the polyester resin has a           dry paper or paperboard.      
 viscosity of 200-600 centipoises at 80                                 
 F as determined by a Brookfield RVT                                    
 viscometer using a number 3 spindle at                                 
 50 rpm (or equivalent method).                                         
Polyethylene, oxidized; complying with   For use only as component of   
 the identity prescribed in Sec.          coatings that contact food    
 177.1620(a) of this chapter.             only of the type identified   
                                          under Type VII-B of Table 1 in
                                          paragraph (c) of this section,
                                          and limited to use at a level 
                                          not to exceed 50 percent by   
                                          weight of the coating solids. 

[[Page 189]]

                                                                        
Polyethyleneamine mixture produced when  For use only as a retention aid
 1 mole of ethylene dichloride, 1.05      employed prior to the sheet-  
 moles of ammonia, and 2 moles of         forming operation in the      
 sodium hydroxide are made to react so    manufacture of paper and      
 that a 10 percent aqueous solution has   paperboard.                   
 a minimum viscosity of 40 centipoises                                  
 at 77 F, as determined by Brookfield                                   
 viscometer using a No. 1 spindle at 60                                 
 r.p.m.                                                                 
Polyethylene glycol (200) dilaurate....  For use only as an adjuvant    
                                          employed in the manufacture of
                                          paper and paperboard prior to 
                                          the sheet-forming operation.  
Polyethylene glycol (400) dioleate.....  ...............................
Polyethylene glycol (400) esters of      ...............................
 coconut oil fatty acids.                                               
Polyethylene glycol (600) esters of      ...............................
 tall oil fatty acids.                                                  
Polyethylene glycol (400) monolaurate..  ...............................
Polyethylene glycol (600) monolaurate..  ...............................
Polyethylene glycol (400) monooleate...  ...............................
Polyethylene glycol (600) monooleate...  ...............................
Polyethylene glycol (400) monostearate.  ...............................
Polyethylene glycol (600) monostearate.  ...............................
Polyethylene glycol (3,000)              ...............................
 monostearate.                                                          
Polyethylenimine, produced by the        For use only as an adjuvant    
 polymerization of ethylenimine.          employed prior to sheet       
                                          formation in paper-making     
                                          systems operated at a pH of   
                                          4.5 or higher, and limited to 
                                          use at a level not to exceed  
                                          5% by weight of finished dry  
                                          paper or paperboard fibers.   
Poly(isobutene)/maleic anhydride         For use only as a surfactant   
 adduct, diethanolamine reaction          for dispersions of            
 product. The mole ratio of               polyacrylamide retention and  
 poly(isobutene)/maleic anydride adduct   drainage aids employed prior  
 to diethanolamine is 1:1.                to the sheet formation        
                                          operation in the manufacture  
                                          of paper and paperboard.      
Polymethacrylic acid, sodium salt,       For use only as a coating      
 having a viscosity in 30-percent-by-     adjuvant for controlling      
 weight aqueous solution of 125-325       viscosity when used at a level
 centipoises at 25 C as determined by     not to exceed 0.3% by weight  
 LV-series Brookfield viscometer (or      of coating solids.            
 equivalent) using a No. 2 spindle at                                   
 60 r.p.m.                                                              
Polymethacrylic acid, sodium salt,       For use only as a coating      
 having a viscosity in 40-percent-by-     adjuvant for controlling      
 weight aqueous solution of 400-700       viscosity when used at a level
 centipoises at 25 C, as determined by    not to exceed 0.1% by weight  
 LV-series Brookfield viscometer (or      of coating solids.            
 equivalent) using a No. 2 spindle at                                   
 30 r.p.m.                                                              
Poly[(methylimino)(2-                    For use only as a retention aid
 hydroxytrimethylene)hydrochloride]       employed prior to the sheet-  
 produced by reaction of 1:1 molar        forming operation in such an  
 ratio of methylamine and                 amount that finished paper and
 epichlorohydrin so that a 31-percent     paperboard will contain the   
 aqueous solution at 25 C has a Stokes    additive at a level not in    
 viscosity range of 2.5-4.0 as            excess of 1 percent by weight 
 determined by ASTM method D1545-76       of the dry paper and          
 (Reapproved; 1981), ``Standard Test      paperboard.                   
 Method for Viscosity of Transparent                                    
 Liquids by Bubble Time Method,'' which                                 
 is incorporated by reference. Copies                                   
 may be obtained from the American                                      
 Society for Testing Materials, 1916                                    
 Race St., Philadelphia, PA 19103, or                                   
 may be examined at the Office of the                                   
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC                                 
 20408..                                                                
Poly[oxyethylene (dimethyliminio)        For use only to improve dry-   
 ethylene (dimethyliminio) ethylene       strength of paper and         
 dichloride] produced by reacting         paperboard and as a retention 
 equimolar quantities of N,N,N,N-         and drainage aid employed     
 tetramethylethylene-diamine and          prior to the sheet-forming    
 dichlorethyl ether to yield a solution   operation in the manufacture  
 of the solid polymer in distilled        of paper and paperboard and   
 water at 25 C with a reduced viscosity   limited to use at a level not 
 of not less than 0.15 deciliter per      to exceed 0.1 percent by      
 gram as determined by ASTM method        weight of the finished dry    
 D1243-79, ``Standard Test Method for -   paper and paperboard fibers.  
 Dilute Solution Viscosity of Vinyl                                     
 Chloride Polymers,'' which is                                          
 incorporated by reference. Copies may                                  
 be obtained from the American Society                                  
 for Testing Materials, 1916 Race St.,                                  
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC 20408).                                 
 The following formula is used for                                      
 determining reduced viscosity:.                                        
  Reduced viscosity in terms of                                         
 deciliters per gram=(t-t0)/(t-C),                                      
  where:                                                                
  t=Solution efflux time                 ...............................
  to=Water efflux time                   ...............................
  C=Concentration of solution in terms   ...............................
   of grams per deciliter                                               
Polypropylene glycol (minimum molecular  ...............................
 weight 1,000).                                                         
Potassium persulfate...................  ...............................
2-Propenoic acid, telomer with sodium 2- For use only as a deposit      
 methyl-2-[(1-oxo-2-propenyl)amino]-1-    control additive employed     
 propane sulfonate and sodium             prior to the sheet forming    
 phosphinate (CAS Reg. No. 110224-99-2).  operation in the manufacture  
                                          of paper and paperboard and at
                                          a level not to exceed 0.15    
                                          percent by weight of the dry  
                                          paper and paperboard.         
Propylene glycol alginate..............  ...............................
Protein hydrolysate from animal hides    ...............................
 or soybean protein condensed with                                      
 oleic and/or stearic acid.                                             

[[Page 190]]

                                                                        
Rapeseed oil, sulfated ammonium,         ...............................
 potassium, or sodium salt.                                             
Ricebran oil, sulfated ammonium,         ...............................
 potassium, or sodium salt.                                             
Rosin and rosin derivatives............  As provided in Sec.  178.3870  
                                          of this chapter.              
Silver chloride-coated titanium dioxide  For use only as a preservative 
                                          in polymer latex emulsions at 
                                          a level not to exceed 2.2     
                                          parts per million (based on   
                                          silver ion concentration) in  
                                          the dry coating.              
Sodium carboxymethyl guar gum having a   For use only as a dry-strength 
 minimum viscosity of 2,700 centipoises   and formation-aid agent       
 at 25 C after 24 hours as determined     employed prior to the sheet-  
 by RV-series Brookfield viscometer (or   forming operation in the      
 equivalent) using a No. 4 spindle at     manufacture of paper and      
 20 r.p.m. and using a test sample        paperboard and used at a level
 prepared by dissolving 8 grams of        not to exceed 1% by weight of 
 sodium carboxymethyl guar gum in 392     finished dry paper or         
 milliliters of 0.2-percent-by-weight     paperboard fibers.            
 aqueous sodium o-phenylphenate                                         
 solution.                                                              
Sodium dioctyl sulfosuccinate..........  ...............................
Sodium formaldehyde sulfoxylate........  For use only as polymerization 
                                          catalyst.                     
Sodium hypochlorite....................  ...............................
Sodium N-methyl-N-oleyltaurate.........  For use only as an adjuvant to 
                                          control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Sodium nitrite.........................  For use only:                  
                                           1. At levels not to exceed   
                                          0.2% by weight of lubricants  
                                          or release agents applied at  
                                          levels not to exceed 1 lb. per
                                          ton of finished paper or      
                                          paperboard.                   
                                           2. As an anticorrosion agent 
                                          at levels not to exceed 0.2%  
                                          by weight of wax emulsions    
                                          used as internal sizing in the
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Sodium persulfate......................  ...............................
Sodium polyacrylate....................  For use only:                  
                                           1. As a thickening agent for 
                                          natural rubber latex coatings,
                                          provided it is used at a level
                                          not to exceed 2 percent by    
                                          weight of coating solids.     
                                           2. As a pigment dispersant in
                                          coatings at a level not to    
                                          exceed 0.25 percent by weight 
                                          of pigment.                   
Sodium poly(isopropenylphosphonate)      For use only in paper mill     
 (CAS Reg. No. 118632-18-1).              boilers.                      
Sodium zinc potassium polyphosphate      For use only as a pigment      
 (CAS Reg. No. 65997-17-3).               dispersant in coatings at a   
                                          level not to exceed 1 percent 
                                          by weight of pigment.         
Sperm oil, sulfated, ammonium,           ...............................
 potassium, or sodium salt.                                             
Stannous oleate........................  ...............................
Stearyl-2-lactylic acid and its calcium  ...............................
 salt.                                                                  
Styrene-butadiene copolymers produced    ...............................
 by copolymerizing styrene-butadiene                                    
 with one or more of the monomers:                                      
 acrylamide, acrylic acid, fumaric                                      
 acid, 2-hydroxyethyl acrylate,                                         
 itaconic acid, methacrylic acid, and N-                                
 methylolacrylamide (CAS Reg. No. 53504-                                
 31-7). The finished copolymers shall                                   
 contain not more than 10 weight                                        
 percent of total polymer units derived                                 
 from acrylic acid, fumaric acid, 2-                                    
 hydroxyethyl acrylate, itaconic acid,                                  
 and methacrylic acid, and shall                                        
 contain not more than 3 weight percent                                 
 of total polymer units derived from N-                                 
 methylolacrylamide, and shall contain                                  
 not more than 2 weight percent of                                      
 polymer units derived from acrylamide..                                
Styrene-maleic anhydride copolymer,      For use only as a surface size 
 amidated, ammonium sodium salt;          at a level not to exceed 1    
 having, in a 25 percent by weight        percent by weight of paper or 
 aqueous solution at pH 8.8, a minimum    paperboard substrate.         
 viscosity of 600 centipoises at 25 C                                   
 as determined by Brookfield model LVT                                  
 viscometer using a No. 3 spindle at 60                                 
 r.p.m. (or equivalent method).                                         
Styrene-maleic anhydride copolymer,      For use only:                  
 sodium salt (minimum molecular weight                                  
 30,000).                                                               
                                           1. As a coating thickening   
                                          agent at a level not to exceed
                                          1% by weight of coating       
                                          solids.                       
                                           2. As surface size at a level
                                          not to exceed 1% by weight of 
                                          paper or paperboard substrate.
Styrene-methacrylic acid copolymer,      For use only as a coating      
 potassium salt (minimum molecular        thickening agent at a level   
 weight 30,000).                          not to exceed 1% by weight of 
                                          coating solids.               

[[Page 191]]

                                                                        
Synthetic wax polymer prepared by the    For use only as a component of 
 catalytic polymerization of alpha        petroleum wax and/or synthetic
 olefins such that the polymer has a      petroleum wax complying with  
 maximum iodine number of 18 and a        Sec.  178.3710 or Sec.        
 minimum number average molecular         178.3720 of this chapter at   
 weight of 2,400.                         levels not to exceed 5 percent
                                          by weight of the wax:         
                                         1. Under conditions of use F   
                                          and G described in Table 2 of 
                                          paragraph (c) of this section 
                                          for all foods.                
                                         2. Under conditions of use E   
                                          described in Table 2 of       
                                          paragraph (c) of this section 
                                          for food Types I, II, IV-B,   
                                          VI, VII-B and VIII as         
                                          described in Table 1 of       
                                          paragraph (c) of this section.
Tallow.................................  ...............................
Tallow alcohol.........................  ...............................
Tallow alcohol, hydrogenated...........  ...............................
Tallow fatty acid, hydrogenated........  ...............................
Tallow hydrogenated....................  ...............................
Tallow sulfated, ammonium, potassium,    ...............................
 or sodium salt.                                                        
Tetraethylenepentamine.................  For use only as a modifier for 
                                          amino resins.                 
1,4,4a,9a-Tetrahydro-9, 10-              For use only as a catalyst in  
 anthracenedione (CAS Reg. No. 56136-14-  the alkaline pulping of       
 2).                                      lignocellulosic materials at  
                                          levels not to exceed 0.1      
                                          percent by weight of the raw  
                                          lignocellulosic materials.    
N,N,N', N'-Tetramethylethylenediamine    For use only as a flocculent,  
 polymer with bis-(2-chloroethyl)         drainage aid or retention aid 
 ether, first reacted with not more       employed prior to the sheet   
 than 5 percent by weight 1-chloro-2,3-   forming operation in the      
 epoxypropane and then reacted with not   manufacture of paper and      
 more than 5 percent by weight poly       paperboard and limited to use 
 (acrylic acid) such that a 50 percent    at a level not to exceed 0.2  
 by weight aqueous solution of the        percent by weight of the      
 product has a nitrogen content of 4.7-   finished dry paper and        
 4.9 percent and viscosity of 350-700     paperboard fibers.            
 centipoises at 25 C as determined by                                   
 LV series Brookfield viscometer using                                  
 a No. 2 spindle at 60 r.p.m. (or by                                    
 other equivalent method).                                              
Tetrasodium N- (1,2-dicarboxyethyl) - N  For use only as an emulsifier  
 - octadecylsulfo-succinamate.            in aqueous dispersions of     
                                          rosin sizes complying with    
                                          Sec.  178.3870(a)(4) of this  
                                          chapter and limited to use    
                                          prior to the sheet-forming    
                                          operation in the manufacture  
                                          of paper and paperboard at a  
                                          level not to exceed 0.02 pct  
                                          by weight of finished paper   
                                          and paperboard.               
Triethanolamine........................  For use only to adjust pH      
                                          during the manufacture of     
                                          amino resins permitted for use
                                          as components of paper and    
                                          paperboard.                   
Triethylene glycol adipic acid           For use only as a curl-control 
 monoester produced by reacting           agent at a level not to exceed
 equimolar quantities of triethylene      2% by weight of coated or     
 glycol and adipic acid.                  uncoated paper and paperboard.
Triethylenetetramine...................  For use only as a modifier for 
                                          amino resins.                 
1,3,5-Triethylhexahydro-1,3,5-triazine   For use only as an             
 (CAS Registry No. 7779-27-3).            antimicrobial agent for       
                                          coating, binder, pigment,     
                                          filler, sizing, and similar   
                                          formulations added prior to   
                                          the heat drying step in the   
                                          manufacture of paper and      
                                          paperboard and limited to use 
                                          at a level between 0.05 and   
                                          0.15 percent by weight of the 
                                          formulation.                  
Undecafluorocyclohexanemethanol ester    For use only as an oil         
 mixture of dihydrogen phosphate,         repellent at a level not to   
 compound with 2,2' iminodiethanol        exceed 0.087 lb (0.046 lb of  
 (1:1); hydrogen phosphate, compound      fluorine) per 1,000 ft2 of    
 with 2,2'-iminodiethanol (1:1); and      treated paper or paperboard,  
 P,P'-dihydrogen pyrophosphate,           as determined by analysis for 
 compound with 2,2'-iminodiethanol        total fluorine in the treated 
 (1:2); where the ester mixture has a     paper or paperboard without   
 fluorine content of 48.3 pct to 53.1     correction for any fluorine   
 pct as determined on a solids basis.     which might be present in the 
                                          untreated paper or paperboard,
                                          when such paper or paperboard 
                                          is used in contact with food  
                                          only of the types identified  
                                          in paragraph (c) of this      
                                          section, Table 1, under Types 
                                          IVA, V, VIIA, VIII, and IX,   
                                          and under the conditions of   
                                          use B through G described in  
                                          Table 2 of paragraph (c) of   
                                          this section.                 
Viscose rayon fibers...................  ...............................
Wax, petroleum.........................  Complying with Sec.  178.3710  
                                          of this chapter.              
Xanthan gum, conforming to the identity  For use only at a maximum level
 and specifications prescribed in Sec.    of 0.125 percent by weight of 
 172.695 of this chapter, except that     finished paper as a suspension
 the residual isopropyl alcohol shall     aid or stabilizer for aqueous 
 not exceed 6,000 parts per million.      pigment slurries employed in  
                                          the manufacture of paper and  
                                          paperboard.                   
Xylene sulfonic acid-formaldehyde        For use only as an adjuvant to 
 condensate, sodium salt.                 control pulp absorbency and   
                                          pitch content in the          
                                          manufacture of paper and      
                                          paperboard prior to the sheet-
                                          forming operation.            
Zeolite Na-A (CAS Reg. No. 68989-22-0).  For use as a pigment extender  
                                          at levels not to exceed 5.4   
                                          percent by weight of the      
                                          finished paper and paperboard.
Zinc formaldehyde sulfoxylate..........  For use only as polymerization 
                                          catalyst.                     
Zinc octoate...........................                                 
Zirconium oxide........................  For use only as a component of 
                                          waterproof coatings where the 
                                          zirconium oxide is present at 
                                          a level not to exceed 1       
                                          percent by weight of the dry  
                                          paper or paperboard fiber and 
                                          where the zirconium oxide is  
                                          produced by hydrolysis of     
                                          zirconium acetate.            
------------------------------------------------------------------------


[[Page 192]]


    (b) Substances identified in paragraphs (b) (1) and (2) of this 
section may be used as components of the food-contact surface of paper 
and paperboard, provided that the food-contact surface of the paper or 
paperboard complies with the extractives limitations prescribed in 
paragraph (c) of this section.
    (1) Substances identified in Sec. 175.300(b)(3) of this chapter with 
the exception of those identified in paragraphs (b)(3) (v), (xv), (xx), 
(xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of this 
section.
    (2) Substances identified in this paragraph (b)(2) follow:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Acrylamide copolymerized with ethyl      ...............................
 acrylate and/or stryene and/or                                         
 methacrylic acid, subsequently reacted                                 
 with formaldehyde and butyl alcohol.                                   
Acrylamide copolymerized with ethylene   For use only as coatings or    
 and vinyl chloride in such a manner      components of coatings.       
 that the finished copolymers have a                                    
 minimum weight average molecular                                       
 weight of 30,000 and contain not more                                  
 than 3.5 weight percent of total                                       
 polymer units derived from acrylamide,                                 
 and in such a manner that the                                          
 acrylamide portion may or may not be                                   
 subsequently partially hydrolyzed.                                     
Acrylic and modified acrylic polymers..  Complying with Sec.  177.1010  
                                          of this chapter.              
Acrylic copolymers produced by           ...............................
 copolymerizing 2 or more of the                                        
 acrylate monomers butyl acrylate,                                      
 ethyl acrylate, ethyl methacrylate,                                    
 methyl acrylate, methyl methacrylate,                                  
 and n-propyl methacrylate, or produced                                 
 by copolymerizing one or more of such                                  
 acrylate monomers together with one or                                 
 more of the monomers acrylic acid,                                     
 acrylonitrile, butadiene, 2-ethyl-                                     
 hexyl acrylate, fumaric acid, glycidyl                                 
 methacrylate, n-hexyl-methacrylate,                                    
 itaconic acid, methacrylic acid,                                       
 styrene, vinyl acetate, vinyl                                          
 chloride, and vinylidene chloride. The                                 
 finished copolymers shall contain at                                   
 least 50 weight percent of polymer                                     
 units derived from one or more of the                                  
 monomers butyl acrylate, ethyl                                         
 acrylate, ethyl methacrylate, methyl                                   
 acrylate, methyl methacrylate, and n-                                  
 propyl methacrylate; and shall contain                                 
 not more than 5 weight percent of                                      
 total polymer units derived from                                       
 acrylic acid, fumaric acid, glycidyl                                   
 methacrylate, n-hexyl methacrylate,                                    
 itaconic acid, and methacrylic acid.                                   
 The provision limiting the finished                                    
 acrylic copolymers to not more than 5                                  
 units derived from acrylic acid,                                       
 fumaric acid, glycidyl methacrylate, n-                                
 hexyl methacrylate, itaconic acid, and                                 
 methacrylic acid is not applicable to                                  
 finished acrylic copolymers used as                                    
 coating adjuvants at a level not                                       
 exceeding 2 weight percent of total                                    
 coating solids.                                                        
Alkyl mono- and disulfonic acids,        xlFor use only:                
 sodium salts (produced from n-alkanes   oi21. As emulsifiers for       
 in the range of C10-C18 with not less    vinylidene chloride copolymer 
 than 50 percent C14-C16)..               coatings and limited to use at
                                          levels not to exceed 2 percent
                                          by weight of the coating      
                                          solids.                       
                                         oi22. As emulsifiers for       
                                          vinylidene chloride copolymer 
                                          or homopolymer coatings at    
                                          levels not to exceed a total  
                                          of 2.6 percent by weight of   
                                          coating solids. The finished  
                                          polymer contacts food only of 
                                          types identified in paragraph 
                                          (c) of this section, Table 1, 
                                          under Types I, II, III, IV, V,
                                          VIA, VIB, VII, VIII, and IX   
                                          and under conditions of use E,
                                          F, and G described in Table 2 
                                          of paragraph (c) of this      
                                          section.                      
2-Bromo-4'-hydroxyacetophenone.........  For use only as a preservative 
                                          for coating formulations,     
                                          binders, pigment slurries, and
                                          sizing solutions at a level   
                                          not to exceed 0.006 percent by
                                          weight of the coating,        
                                          solution, slurry or emulsion. 
Butylbenzyl phthalate..................  Complying with Sec.  178.3740  
                                          of this chapter.              
Butyl oleate, sulfated, ammonium,                                       
 potassium, or sodium salt.                                             
Butyraldehyde..........................  ...............................
Captan (N-trichloromethylmercapto-4-     For use only as a mold- and    
 cyclohexene-1, 2-dicarboximide).         mildew-proofing agent in      
                                          coatings intended for use in  
                                          contact with food only of the 
                                          types identified in paragraph 
                                          (c) of this section, Table 1, 
                                          under Type I, II, VI-B, and   
                                          VIII.                         
Castor Oil, polyoxyethylated (42 moles   For use only as an emulsifier  
 ethylene oxide).                         in nitrocellulose coatings for
                                          paper and paperboard intended 
                                          for use in contact with food  
                                          only of the types identified  
                                          in paragraph (c) of this      
                                          section, Table 1, under Types 
                                          IV A, V, VII A, VIII, and IX; 
                                          and limited to use at a level 
                                          not to exceed 8 percent by    
                                          weight of the coating solids. 

[[Page 193]]

                                                                        
1-(3-Chloroallyl)-3,5,7-triaza-1-        For use only:                  
 azoniaadamantane chloride (CAS Reg.     1. As a preservative at a level
 No. 4080-31-3).                          of 0.3 weight percent in      
                                          latexes used as pigment       
                                          binders in paper and          
                                          paperboard intended for use in
                                          contact with nonacidic,       
                                          nonalcoholic food and under   
                                          the conditions of use         
                                          described in paragraph (c) of 
                                          this section, Table 2,        
                                          conditions of use E, F, and G.
                                         2. As a preservative at a level
                                          not to exceed 0.07 weight     
                                          percent in latexes and 0.05   
                                          weight percent in pigment     
                                          slurries used as components of
                                          coatings for paper and        
                                          paperboard intended for use in
                                          contact with food.            
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only:                  
 (CAS Reg. No. 26172-55-4) and 2-methyl-   1. As an antimicrobial agent 
 4-isothiazolin-3-one (CAS Reg. No.         for polymer latex emulsions 
 2682-20-4) mixture at a ratio of 3         in paper coatings at a level
 parts to 1 part, manufactured from         not to exceed 50 parts per  
 methyl-3-mercaptopropionate (CAS Reg.      million (based on           
 No. 2935-90-2). The mixture may            isothiazolone active        
 contain magnesium nitrate (CAS Reg.        ingredients) in the coating 
 No. 10377-60-3) at a concentration         formulation.                
 equivalent to the isothiazolone active    2. As an antimicrobial agent 
 ingredients (weight/weight).               for finished coating        
                                            formulations and for        
                                            additives used in the       
                                            manufacture of paper and    
                                            paperboard including        
                                            fillers, binders, pigment   
                                            slurries, and sizing        
                                            solutions at a level not to 
                                            exceed 25 parts per million 
                                            (based on isothiazolone     
                                            active ingredients) in the  
                                            coating formulations and    
                                            additives.                  
Copper 8-quinolinolate.................  For use only as preservative   
                                          for coating formulations.     
Cyclized rubber produced when natural    For use only in coatings for   
 pale crepe rubber dissolved in phenol    paper and paperboard intended 
 is catalytically cyclized so that the    for use in contact with food  
 finished cyclized rubber has a melting   only of the types identified  
 point of 145 C to 155 C as determined    in paragraph (c) of this      
 by ASTM method E28-67 (Reapproved        section, Table 1, under Types 
 1982), ``Standard Test Method for        VIII and IX.                  
 Softening Point by Ring-and-Ball                                       
 Apparatus,'' which is incorporated by                                  
 reference (copies may be obtained from                                 
 the American Society for Testing                                       
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC 20408),                                 
 and contains no more than 4000 ppm of                                  
 residual-free phenol as determined by                                  
 a gas liquid chromatographic procedure                                 
 titled ``Determination of Free Phenol                                  
 in Cyclized Rubber Resin,'' which is                                   
 incorporated by reference. Copies are                                  
 available from the Center for Food                                     
 Safety and Applied Nutrition (HFS-                                     
 200), Food and Drug Administration,                                    
 200 C St. SW., Washington, DC 20204,                                   
 or available for inspection at the                                     
 Office of the Federal Register, 800                                    
 North Capitol Street, NW., suite 700,                                  
 Washington, DC 20408.                                                  
1,2-Dibromo-2,4-dicyanobutane (CAS Reg.  For use only as a preservative 
 No. 35691-65-7).                         at levels not more than 0.05  
                                          weight percent and not less   
                                          than 0.01 weight percent: in  
                                          latexes used as pigment       
                                          binders in coatings; in       
                                          pigment slurries used in      
                                          coatings; and/or in coatings  
                                          themselves. The total level of
                                          the preservative in the       
                                          finished coating shall not    
                                          exceed 0.04 weight percent of 
                                          the finished coating solids.  
Dibutyl phthalate......................  ...............................
Dibutyl sebacate.......................  ...............................
Di(C7,C9-alkyl) adipate................  Complying with Sec.  178.3740  
                                          of this chapter.              
Dicyclohexyl phthalate.................  ...............................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer  
 No. 120-55-8).                           for polyvinyl acetate coatings
                                          at a level not to exceed 5    
                                          percent by weight of the      
                                          coating solids under          
                                          conditions described in       
                                          paragraph (c) of this section,
                                          table 2, conditions of use E, 
                                          F, and G.                     
Diethylene glycol ester of the adduct    ...............................
 of terpene and maleic anhydride.                                       
Dihydroxy dichlorodiphenyl methane.....  For use only as preservative   
                                          for coating formulations.     
Dimethylpolysiloxane, 100 centistokes    ...............................
 viscosity.                                                             
Dimethylpolysiloxane-beta-phenylethyl    ...............................
 methyl polysiloxane copolymer (2:1),                                   
 200 to 400 centistokes viscosity.                                      
N,N-Diphenyl-p-phenylenediamine........  For use only as polymerization 
                                          inhibitor in 2-sulfoethyl     
                                          methacrylate, sodium salt.    
Dipropylene glycol dibenzoate (CAS Reg.  1. For use only as a           
 No. 27138-31-4).                         plasticizer for polyvinyl     
                                          acetate coatings at a level   
                                          not to exceed 5 percent by    
                                          weight of the coating solids  
                                          under conditions described in 
                                          paragraph (c) of this section,
                                          table 2, condition of use E.  
                                         2. For use only as a           
                                          plasticizer for polyvinyl     
                                          acetate coatings at a level   
                                          not to exceed 10 percent by   
                                          weight of the coating solids  
                                          under conditions described in 
                                          paragraph (c) of this section,
                                          table 2, conditions of use F  
                                          and G.                        

[[Page 194]]

                                                                        
Disodium N-octadecylsulfosuccinamate...  For use only as an emulsifier  
                                          in resin latex coatings and   
                                          limited to use at a level not 
                                          to exceed 0.05% by weight of  
                                          the coating solids.           
EDTA (ethylenediaminetetraacetic acid)   ...............................
 and its sodium and/or calcium salts.                                   
Ethanedial, polymer with tetrahydro-4-   For use only as an             
 hydroxy-5-methyl-2(1H)pyrimidinone,      insolubilizer for starch-based
 propoxylated (CAS Reg. No. 118299-90-    coatings and limited to use at
 4).                                      a level not to exceed 5.0     
                                          percent by weight of the      
                                          coating.                      
Ethylene-acrylic acid copolymers         ...............................
 produced by the copolymerization of                                    
 ethylene and acrylic acid and/or their                                 
 partial ammonium salts. The finished                                   
 copolymer shall contain no more than                                   
 25 weight percent of polymer units                                     
 derived from acrylic acid and no more                                  
 than 0.35 weight percent of residual                                   
 monomeric acrylic acid, and have a                                     
 melt index not to exceed 350 as                                        
 determined by ASTM method D1238-82,                                    
 ``Standard Test Method for Flow Rates                                  
 of Thermoplastics by Extrusion                                         
 Plastometer,'' which is incorporated                                   
 by reference. Copies may be obtained                                   
 from the American Society for Testing                                  
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC 20408.                                  
Formaldehyde...........................  For use only as preservative   
                                          for coating formulations.     
Glyoxal................................  For use only as an             
                                          insolubilizing agent in starch-
                                           and protein-based coatings   
                                          that contact nonalcoholic     
                                          foods, and limited to use at a
                                          level not to exceed 6 percent 
                                          by weight of the starch or    
                                          protein fraction of the       
                                          coating solids.               
Glyceryl monobutyl ricinoleate.........  ...............................
Hydroxymethyl derivatives (mixture of    For use only as a comonomer in 
 mono and poly) of [N-(1, 1-dimethyl-3-   polyvinyl acetate latex       
 oxobutyl) acrylamide] produced by        coatings and limited to use at
 reacting 1 mole of the [N-(1,1-          a level not to exceed 1       
 dimethyl-3-oxobutyl) acrylamide] with    percent by weight of dry      
 3 moles of formaldehyde such that the    polymer solids.               
 finished product has a maximum                                         
 nitrogen content of 6.2 percent and a                                  
 maximum hydroxyl content of 15 percent                                 
 by weight on a dry basis.                                              
Isobutyl oleate, sulfated, ammonium,     ...............................
 potassium, or sodium salt.                                             
Maleic anhydride adduct of butadiene-    ...............................
 styrene copolymer.                                                     
-Methylstyrene-vinyltoluene     ...............................
 copolymer resins (molar ratio 1-methylstyrene to 3 vinyltoluene).                                   
Modified kaolin clay (CAS Reg. No. 1344- For use only as a component of 
 00-9) is produced by the reaction of     coatings in paper and         
 sodium silicate (CAS Reg. No. 1344-09-   paperboard products at a level
 8) and kaolinite clay (CAS Reg. No.      not to exceed 9 percent by    
 1332-58-7) under hydrothermal            weight of the coating intended
 conditions. The reaction product has a   for use in contact with food  
 molecular weight between 246 and 365     of Types I through IX         
 and consists of 46 to 55 percent         described in Table 1 of       
 silicon dioxide (Si02), 28 to 42         paragraph (c) of this section 
 percent aluminum oxide (A1203), and 2    under conditions of use C     
 to 7 percent of sodium oxide (Na20).     through H described in Table 2
 The reaction product will not consist    of paragraph (c) of this      
 of more than 70 percent modified         section.                      
 kaolin clay.                                                           
Naphthalene sulfonic acid-formaldehyde   ...............................
 condensate, sodium salt.                                               
Oleyl alcohol..........................  ...............................
Oxazolidinylethylmethacrylate (CAS       For use only as a binder for   
 Registry No. 46236-15-1) copolymer       pigment coatings as a binder  
 with ethyl acrylate and methyl           level not to exceed 4.0       
 methacrylate, and containing not more    percent by weight of dry paper
 than 6 percent by weight of              or paperboard.                
 oxazolidinylethylmethacrylate. Maximum                                 
 nitrogen content shall be 0.5 percent                                  
 and number average molecular weight of                                 
 that portion of the copolymer soluble                                  
 in tetrahydrofuran shall be not less                                   
 than 50,000.                                                           
Pentaerythritol tetrastearate..........  ...............................

[[Page 195]]

                                                                        
Petroleum alicyclic hydrocarbon resins,  For use only as modifiers in   
 or the hydrogenated product thereof,     waxpolymer blend coatings for 
 meeting the following specifications:    corrugated paperboard intended
 Softening point 97 C minimum, as         for use in bulk packaging or  
 determined by ASTM method E28-67         raw fruits, raw vegetables,   
 (Reapproved 1982), ``Standard Test       iced meat, iced fish, and iced
 Method for Softening Point by Ring and   poultry; and limited to use at
 Ball Apparatus;'' aniline point 120 C    a level not to exceed 30      
 minimum, as determined by ASTM method    weight-percent of the coating 
 D611-82, ``Standard Test Methods for     solids.                       
 Aniline Point and Mixed Aniline Point                                  
 of Petroleum Products and Hydrocarbon                                  
 Solvents,'' which are incorporated by                                  
 reference (copies may be obtained from                                 
 the American Society for Testing                                       
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC 20408).                                 
 Specific gravity 0.96-0.99 (20 C/20                                    
 C). Such petroleum hydrocarbon resins                                  
 are produced by the catalytic                                          
 polymerization of dienes and olefins                                   
 from low-boiling distillates of                                        
 cracked petroleum stocks that contain                                  
 no material boiling over 200 C and                                     
 that meet the ultraviolet absorbance                                   
 limits prescribed in Sec.  172.880(b)                                  
 of this chapter when subjected to the                                  
 analytical procedure described in Sec.                                 
  172.886(b) of this chapter, modified                                  
 as follows: Treat the product as in                                    
 the first paragraph under                                              
 ``Procedure'' in Sec.  172.250(b)(3)                                   
 of this chapter. Then proceed with                                     
 Sec.  172.886(b) of this chapter,                                      
 starting with the paragraph commencing                                 
 with ``Promptly complete transfer of                                   
 the sample * * *''.                                                    
Polyester resin formed by the reaction   ...............................
 of the methyl ester of rosin, phthalic                                 
 anhydride, maleic anhydride and                                        
 ethylene glycol, such that the                                         
 polyester resin has an acid number of                                  
 4 to 11, a drop-softening point of 70                                  
 C-92 C., and a color of K or paler.                                    
Polyester resin produced by reacting     ...............................
 the acid groups in montan wax with                                     
 ethylene glycol.                                                       
Polyethylene, oxidized.................  Complying with Sec.  177.1620  
                                          of this chapter.              
Polyethylene reacted with maleic         ...............................
 anhydride such that the modified                                       
 polyethylene has a saponification                                      
 number not in excess of 6 after                                        
 Soxhlet extraction for 24 hours with                                   
 anhydrous ethyl alcohol.                                               
Polyoxyethylated (40 moles) tallow       Not to exceed 300 p.p.m. in    
 alcohol sulfate, solium salt.            finished coated paper or      
                                          paperboard.                   
Polyoxypropylene-polyoxyethylene block   ...............................
 polymers (minimum molecular weight                                     
 6,800).                                                                
Polyvinyl acetate......................  ...............................
Polyvinyl alcohol (minimum viscosity of  ...............................
 4% aqueous solution at 20 C. of 4                                      
 centipoises).                                                          
Polyvinyl butyral......................  ...............................
Polyvinyl formal.......................  ...............................
Polyvinylidene chloride................  ...............................
Polyvinyl pyrrolidone..................  ...............................
Polyvinyl stearate.....................  ...............................
Propylene glycol mono- and diesters of   ...............................
 fats and fatty acids.                                                  
 Siloxanes (silicones), dimethyl,         For use only as a component of
 isopropyl methyl, methyl 1-methyl-C9-    polyolefin coatings with Sec. 
 49-alkyl (CAS Reg. No. 144635-08-5).     177.1520 of this chapter at a 
                                          level not to exceed 3 percent 
                                          by weight. The finished       
                                          coating will be used only for 
                                          paper and paperboard that     
                                          contact food of types VI-A and
                                          VI-B of Table 1 in paragraph  
                                          (c) of this section, and under
                                          conditions of use C, D, and E,
                                          as described in Table 2 in    
                                          paragraph (c) of this section,
                                          with a maximum hot fill       
                                          temperature of 200 F (94 C).  

[[Page 196]]

                                                                        
Siloxanes and silicones; platinum-       Platinum content not to exceed 
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a surface coating     
 Reg. Nos. 68083-19-2 and 68083-18-1),    under the following           
 with methyl hydrogen polysiloxane (CAS   conditions:                   
 Reg. No. 63148-57-2). Dimethyl maleate  1. In coatings for paper and   
 (CAS Reg. No. 624-48-6) and vinyl        paperboard provided the       
 acetate (CAS Reg. No. 108-05-4) may be   coating contacts food only of 
 used as optional polymerization          the types identified in       
 inhibitors..                             paragraph (c) of this section,
                                          Table 1, under Types I, II,   
                                          VI, and VII-B when used under 
                                          conditions of use E, F, and G 
                                          described in Table 2 of       
                                          paragraph (c) of this section.
                                         2. In coatings for paper and   
                                          paperboard provided the       
                                          coating contacts food only of 
                                          the types identified in       
                                          paragraph (c) of this section,
                                          Table 1, under Types III, IV, 
                                          V, VII-A, VIII, and IX when   
                                          used under conditions of use A
                                          through H described in Table 2
                                          of paragraph (c) of this      
                                          section.                      
Siloxanes and silicones; platinum-       Platinum content not to exceed 
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for 
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives. 
 with methyl hydrogen polysiloxane (CAS                                 
 Reg. No. 63148-57-2). Dimethyl maleate                                 
 (CAS Reg. No. 624-48-6), vinyl acetate                                 
 (CAS Reg. No. 108-05-4), dibutyl                                       
 maleate (CAS Reg. No. 105-76-0) and                                    
 diallyl maleate (CAS Reg. No. 999-21-                                  
 3) may be used as optional                                             
 polymerization inhibitors. The polymer                                 
 may also contain C16-C18 olefins (CAS                                  
 Reg. No. 68855-60-7) as a control                                      
 release agent..                                                        
Sodium decylbenzenesulfonate...........  ...............................
Sodium dihexyl sulfosuccinate..........  ...............................
Sodium n-dodecylpolyethoxy (50 moles)    For use only as an emulsifier  
 sulfate-sodium                           in coatings that contact food 
 isododecylphenoxypolyethoxy (40 moles)   only of the types identified  
 sulfate mixtures.                        in paragraph (c) of this      
                                          section, Table 1, under Types 
                                          IV-A, V, VII, VIII, and IX;   
                                          and limited to use at levels  
                                          not to exceed 0.75 percent by 
                                          weight of the coating solids. 
Sodium 2-ethylhexyl sulfate............  ...............................
Sodium oleoyl isopropanolamide           ...............................
 sulfosuccinate.                                                        
Sodium pentachlorophenate..............  For use only as preservative   
                                          for coating formulations.     
Sodium o-phenylphenate.................      Do.                        
Sodium vinyl sulfonate polymerized.....  ...............................
Styrene copolymers produced by           For use only as a coating or   
 copolymerizing styrene with maleic       component of coatings and     
 anhydride and its methyl and butyl       limited to use at a level not 
 (sec- or iso-) esters. Such copolymers   to exceed 1% by weight of     
 may contain -nitrostyrene as    paper or paperboard substrate.
 a polymerization chain terminator.                                     
Styrene polymers made by the             For use only in contact with   
 polymerization of any combination of     foods of Types IV-A, V, and   
 styrene or alpha methyl styrene with     VII in table 1 of paragraph   
 acrylic acid, methacrylic acid, 2-       (c) of this section, under use
 ethyl hexyl acrylate, methyl             conditions E through G in     
 methacrylate, and butyl acrylate. The    table 2 of paragraph (c), and 
 styrene and alpha methyl styrene,        with foods of Types VIII and  
 individually, may constitute from 0 to   IX without use temperature    
 80 weight percent of the polymer. The    restriction.                  
 other monomers, individually, may be                                   
 from 0 to 40 weight percent of the                                     
 polymer. The polymer number average                                    
 molecular weight (Mn) shall be at                                      
 least 2,000 (as determined by gel                                      
 permeation chromatography). The acid                                   
 number of the polymer shall be less                                    
 than 250. The monomer content shall be                                 
 less than 0.5 percent.                                                 
Styrene-acrylic copolymers (CAS Reg.     For use only as a component of 
 No. 25950-40-7 produced by               coatings and limited to use at
 polymerizing 77 to 83 parts by weight    a level not to exceed 20      
 of styrene with 13 to 17 parts of        percent by weight of the      
 methyl methacrylate, 3 to 4 parts of     coating solids.               
 butyl methacrylate, 0.5 to 2.5 parts                                   
 of methacrylic acid, and 0.1 to 0.3                                    
 part of butyl acrylate such that the                                   
 finished copolymers have a minimum                                     
 number average molecular weight                                        
 greater than 100,000 and a level of                                    
 residual styrene monomer in the                                        
 polymer not to exceed 0.1 percent by                                   
 weight.                                                                
Styrene-butadiene copolymers produced    ...............................
 by copolymerizing styrene-butadiene                                    
 with one or more of the monomer:                                       
 acrylamide, acrylic acid, fumaric                                      
 acid, 2-hydroxyethyl acrylate,                                         
 itaconic acid, and methacrylic acid.                                   
 The finished copolymers shall contain                                  
 not more than 10 weight percent of                                     
 total polymer units derived from                                       
 acrylic acid, fumaric acid, 2-                                         
 hydroxyethyl acrylate, itaconic acid                                   
 and methacrylic acid, and shall                                        
 contain not more than 2 weight percent                                 
 of polymer units derived from                                          
 acrylamide.                                                            
Styrene-butadiene copolymers with 2-     ...............................
 hydroxyethyl acrylate and acrylic acid                                 
 containing not more than 15 weight                                     
 percent acrylic acid and no more than                                  
 20 weight percent of a combination of                                  
 2-hydroxyethyl acrylate and acrylic                                    
 acid.                                                                  
Styrene-butadiene-vinylidene chloride    For use only as coatings or    
 copolymers containing not more than 40   components of coatings.       
 weight percent of vinylidene chloride                                  
 in the finished copolymers. The                                        
 finished copolymers may contain not                                    
 more than 10 weight percent of total                                   
 polymer units derived from acrylic                                     
 acid, fumaric acid, 2-hydroxyethyl                                     
 acrylate, itaconic acid, and/or                                        
 methacrylic acid.                                                      

[[Page 197]]

                                                                        
Styrene-dimethylstyrene--       For use only in coatings for   
 methylstyrene copolymers produced by     paper and paperboard intended 
 polymerizing equimolar ratios of the     for use in contact with       
 three comonomers such that the           nonfatty food and limited to  
 finished copolymers have a minimum       use at a level not to exceed  
 average molecular weight of 835 as       50% by weight of the coating  
 determined by ASTM method D2503-82,      solids.                       
 ``Standard Test Method for Molecular                                   
 Weight (Relative Molecular Mass) of                                    
 Hydrocarbons by Thermoelectric                                         
 Measurement of Vapor Pressure,'' which                                 
 is incorporated by reference. Copies                                   
 may be obtained from the American                                      
 Society for Testing Materials, 1916                                    
 Race St., Philadelphia, PA 19103, or                                   
 may be examined at the Office of the                                   
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC                                 
 20408.                                                                 
Styrene-isobutylene copolymers (weight   For use only in coatings for   
 average molecular weight not less than   paper and paperboard intended 
 6,300).                                  for use in contact under      
                                          conditions of use D G         
                                          described in Table 2 of       
                                          paragraph (c) of this section,
                                          with food of Types I, II, IV- 
                                          B, VI-B, VII-B, and VIII      
                                          described in Table 1 of       
                                          paragraph (c) of this section;
                                          and limited to use at a level 
                                          not to exceed 40 percent by   
                                          weight of the coating solids. 
Styrene-maleic anhydride copolymers....  For use only as a coating or   
                                          component of coatings and     
                                          limited for use at a level not
                                          to exceed 2 percent by weight 
                                          of paper or paperboard        
                                          substrate.                    
Styrene-methacrylic acid copolymers      ...............................
 containing no more than 5 weight                                       
 percent of polymer units derived from                                  
 methacrylic acid.                                                      
Styrene-vinylidene chloride copolymers   For use only as coatings or    
 containing not more than 40 weight       components of coatings.       
 percent of vinylidene chloride in the                                  
 finished copolymers. The finished                                      
 copolymers may contain not more than 5                                 
 weight percent of total polymer units                                  
 derived from acrylic acid, fumaric                                     
 acid, itaconic acid, and/or                                            
 methacrylic acid.                                                      
2-Sulfoethyl methacrylate, sodium salt   For use only in copolymer      
 [Chemical Abstracts Service No. 1804-    coatings under conditions of  
 87-1].                                   use E, F, and G described in  
                                          paragraph (c) of this section,
                                          Table 2, and limited to use at
                                          a level not to exceed 2.0     
                                          percent by weight of the dry  
                                          copolymer coating.            
[p-(1,1,3,3-Tetramethylbutyl)   For use only as a surface-     
 phenyl]-omega-hydroxypoly                active agent at levels not to 
 (oxyethylene) hydrogen sulfate, sodium   exceed 3 percent by weight of 
 salt mixture with -[p-          vinyl acetate polymer with    
 (1,1,3,3-tetramethylbutyl)-phenyl]-      ethylene and N-(hydroxymethyl)
 omega-hydroxypoly (oxyethylene) with     acrylamide intended for use in
 both substances having a                 coatings for paper and        
 poly(oxyethylene) content averaging 3    paperboard intended for use in
 moles.                                   contact with foods:           
                                           1. Of the types identified in
                                          paragraph (c) of this section,
                                          Table 1, under Types I, II,   
                                          III, IV, VI-B, and VII, and   
                                          under the conditions of use   
                                          described in paragraph (c) of 
                                          this section, Table 2,        
                                          conditions of use E, F, and G.
                                           2. Of the types identified in
                                          paragraph (c) of this section,
                                          Table 1, under Types V, VIII  
                                          and IX and under the          
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          Table 2, conditions of use C, 
                                          D, E, F, and G.               
Tetrasodium N-(1,2-dicarboxyethyl)-N-    For use only as an emulsifier  
 octadecylsulfo-succinamate.              in resin latex coatings, and  
                                          limited to use at a level not 
                                          to exceed 0.05% by weight of  
                                          the coating solids.           
Toluenesulfonamide-formaldehyde resins.  ...............................
Vinyl acetate copolymers produced by                                    
 copolymerizing vinyl acetate with one                                  
 or more of the monomers acrylamide,                                    
 acrylic acid, acrylonitrile, bicyclo-                                  
 [2.2.1]hept-2-ene-6-methylacrylate,                                    
 butyl acrylate, crotonic acid, decyl                                   
 acrylate, diallyl fumarate, diallyl                                    
 maleate, diallyl phthalate, dibutyl                                    
 fumarate, dibutyl itaconate,                                           
 dibutylmaleate, di(2-ethylhexyl)                                       
 maleate, divinyl benzene, ethyl                                        
 acrylate, 2-ethyl-hexyl acrylate,                                      
 fumaric acid, itaconic acid, maleic                                    
 acid, methacrylic acid, methyl                                         
 acrylate, methyl methacrylate, mono(2-                                 
 ethylhexyl) maleate, monoethyl                                         
 maleate, styrene, vinyl butyrate,                                      
 vinyl crotonate, vinyl hexoate,                                        
 vinylidene chloride, vinyl                                             
 pelargonate, vinyl propionate, vinyl                                   
 pyrrolidone, vinyl stearate, and vinyl                                 
 sulfonic acid. The finished copolymers                                 
 shall contain at least 50 weight                                       
 percent of polymer units derived from                                  
 vinyl acetate and shall contain no                                     
 more than 5 weight percent of total                                    
 polymer units derived from acrylamide,                                 
 acrylic acid, crotonic acid, decyl                                     
 acrylate, dibutyl itaconate, di(2-                                     
 ethylhexyl) maleate, fumaric acid,                                     
 itaconic acid, maleic acid,                                            
 methacrylic acid, mono(2-ethylhexyl)                                   
 maleate, monoethyl maleate, vinyl                                      
 butyrate, vinyl hexoate, vinyl                                         
 pelargonate, vinyl propionate, vinyl                                   
 stearate, and vinyl sulfonic acid.                                     

[[Page 198]]

                                                                        
Vinyl acetate polymer with ethylene and  For use only in coatings for   
 N-(hydroxymethyl) acrylamide             paper and paperboard intended 
 containing not more than 6 weight        for use in contact with foods:
 percent of total polymer units derived                                 
 from N-(hydroxymethyl) acrylamide.                                     
                                           1. Of the types identified in
                                          paragraph (c) of this section,
                                          Table 1, under Types I, II,   
                                          III, IV, VI B, and VII and    
                                          under the conditions of use   
                                          described in paragraph (c) of 
                                          this section, Table 2,        
                                          conditions of use E, F, and G.
                                           2. Of the types identified in
                                          paragraph (c) of this section,
                                          Table 1, under Types V, VIII, 
                                          and IX and under the          
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          Table 2, conditions of use C, 
                                          D, E, F, and G.               
Vinyl chloride copolymers produced by    ...............................
 copolymerizing vinyl chloride with one                                 
 or more of the monomers acrylonitrile;                                 
 fumaric acid and its methyl, ethyl,                                    
 propyl, butyl, amyl, hexyl, heptyl, or                                 
 octyl esters; maleic acid and its                                      
 methyl, ethyl, propyl, butyl, amyl,                                    
 hexyl, heptyl, or octyl esters; maleic                                 
 anhydride; 5-norbornene-2, 3-                                          
 dicarboxylic acid; mono-n-butyl ester;                                 
 vinyl acetate-and vinylidene chloride.                                 
 The finished copolymers shall contain                                  
 at least 50 weight percent of polymer                                  
 units derived from vinyl chloride:                                     
 shall contain no more than 5 weight                                    
 percent of total polymer units derived                                 
 from fumaric and/or maleic acid and/or                                 
 their methyl, ethyl, propyl, butyl,                                    
 amyl, heptyl, or octyl monoesters or                                   
 from maleic anhydride or from mono-n-                                  
 butyl ester of 5-norbornene-2, 3-                                      
 dicarboxylic acid (however, in any                                     
 case the finished copolymers shall                                     
 contain no more than 4 weight percent                                  
 of total polymer units derived from                                    
 mono-n-butyl ester of 5-norbornene-2,3-                                
 dicarboxylic acid).                                                    
Vinyl chloride-vinyl acetate hydroxyl-   ...............................
 modified copolymers.                                                   
Vinyl chloride-vinyl acetate hydroxyl-   ...............................
 modified copolymers reacted with                                       
 trimellitic anhydride.                                                 
Vinylidene chloride copolymers produced  ...............................
 by copolymerizing vinylidene chloride                                  
 with one or more of the monomers                                       
 acrylamide acrylic acid,                                               
 acrylonitrile, butyl acrylate, butyl                                   
 methacrylate ethyl acrylate, ethyl                                     
 methacrylate, fumaric acid, itaconic                                   
 acid, methacrylic acid, methyl                                         
 acrylate, methyl methacrylate,                                         
 octadecyl methacrylate, propyl                                         
 acrylate, propyl methacrylate, vinyl                                   
 chloride and vinyl sulfonic acid. The                                  
 finished copolymers shall contain at                                   
 least 50 weight percent of polymer                                     
 units derived from vinylidene                                          
 chloride; and shall contain no more                                    
 than 5 weight percent of total polymer                                 
 units derived from acrylamide, acrylic                                 
 acid, fumaric acid, itaconic acid,                                     
 methacrylic acid, octadecyl                                            
 methacrylate, and vinyl sulfonic acid.                                 
Colorants:.............................                                 
  Aluminum.............................  For use as a colorant only.    
  Aluminum hydrate.....................    Do.                          
  Aluminum and potassium silicate          Do.                          
   (mica).                                                              
  Aluminum mono-, di-, and tristearate.    Do.                          
  Aluminum silicate (China clay).......    Do.                          
  Barium sulfate.......................    Do.                          
  Bentonite............................    Do.                          
  Bentonite, modified with                 Do.                          
   dimethyldioctadecylammonium ion.                                     
  Burnt umber..........................    Do.                          
  Calcium carbonate....................    Do.                          
  Calcium silicate.....................    Do.                          
  Calcium sulfate......................    Do.                          
  Carbon black (channel process).......    Do.                          
  Cobalt aluminate.....................    Do.                          
  Diatomaceous earth...................    Do.                          
  Iron oxides..........................    Do.                          
  Magnesium oxide......................    Do.                          
  Magnesium silicate (talc)............    Do.                          
  Phthalocyanine blue (C.I. pigment        Do.                          
   blue 15, 15:1, 15:2, 15:3, and 15:4;                                 
   C.I. No. 74160; CAS Reg. No. 147-14-                                 
   8).                                                                  
  Raw sienna...........................    Do.                          
  Silica...............................    Do.                          
  Tartrazine lake (certified FD&C          Do.                          
   Yellow No. 5 only).                                                  
  Titanium dioxide.....................    Do.                          
  Titanium dioxide-barium sulfate......    Do.                          
  Titanium dioxide-magnesium...........    Do.                          
    silicate...........................                                 
  Zinc carbonate.......................    Do.                          

[[Page 199]]

                                                                        
  Zinc oxide...........................    Do.                          
------------------------------------------------------------------------

    (c) The food-contact surface of the paper and paperboard in the 
finished form in which it is to contact food, when extracted with the 
solvent or solvents characterizing the type of food, and under 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of this paragraph, shall 
yield net chloroform-soluble extractives (corrected for wax, petrolatum, 
mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 
milligram per square inch of food-contact surface as determined by the 
methods described in paragraph (d) of this section.

                Table 1--Types of Raw and Processed Foods

I. Nonacid, aqueous products; may contain salt or sugar or both (pH 
          above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and 
          including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may 
          contain salt, and including water-in-oil emulsions of low- or 
          high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of 
          this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end 
          test required).
IX. Dry solids with the surface containing free fat or oil.

[[Page 200]]


 Table 2--Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food- 
    Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and    
                                                    Beverages                                                   
----------------------------------------------------------------------------------------------------------------
                                                                    Food-simulating solvents                    
                                              ------------------------------------------------------------------
                                                    Water          Heptane\1\       8 percent       50 percent  
      Condition of use         Types of food  ----------------------------------     alcohol          alcohol   
                               (see Table 1)                                    --------------------------------
                                                   Time and         Time and         Time and        Time and   
                                                 temperature      temperature      temperature      temperature 
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-     I, IV-B, VII-B.  250 F, 2 hr....  150 F, 2 hr....  ...............  ..............
 sterilized (e.g., over 212   III, IV-A, VII-  ......do.......                                                  
 F).                           A.                                                                               
B. Boiling water sterilized.  II, VII-B......  212 F, 30 min..  ...............  ...............  ..............
                              III, VII-A.....  ......do.......  120 F, 30 min..  ...............  ..............
C. Hot filled or pasteurized  II, IV-B, VII-B  Fill boiling,    ...............  ...............  ..............
 above 150 F.                                   cool to 100 F.                                                  
                              III, IV-A, VII-  ......do.......  120 F, 15 min..  ...............  ..............
                               A.                                                                               
                              V, IX..........  ...............  ......do.......  ...............  ..............
D. Hot filled or pasteurized  II, IV-B, VI-B,  ...............  ...............  ...............  ..............
 below 150 F.                                                                                                   
                              VII-B..........  150 F, 2 hr....  ...............  ...............  ..............
                              III, IV-A, VII-  ......do.......  100 F, 30 min..  ...............  ..............
                               A.                                                                               
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  150 F, 2 hr....  ..............
                              VI-C...........  ...............  ...............  ...............    150 F, 2 hr.
E. Room temperature filled    I, II, IV-B, VI- 120 F, 24 hr...  ...............  ...............  ..............
 and stored (no thermal        B, VII-B.                                                                        
 treatment in the container).                                                                                   
                              III, IV-A, VII-  ......do.......  70 F, 30 min...  ...............  ..............
                               A.                                                                               
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  120 F, 24 hr...  ..............
                              VI-C...........  ...............  ...............  ...............   120 F, 24 hr.
F. Refrigerated storage (no   III, IV-A, VII-  70 F, 48 hr....  70 F, 30 min...  ...............  ..............
 thermal treatment in the      A.                                                                               
 container).                                                                                                    
                              I, II, IV-B, VI- ......do.......  ...............  ...............  ..............
                               B, VII-B.                                                                        
                              VI-A...........  ...............  ...............  70 F, 48 hr....  ..............
                              VI-C...........  ...............  ...............  ...............    70 F, 48 hr.
G. Frozen storage (no         I, II, IV-B,     70 F, 24 hr....  ...............  ...............  ..............
 thermal treatment in the      VII-B.          ......do.......  70 F, 30 min...  ...............  ..............
 container).                  III, VII-A.....                                                                   
H. Frozen or refrigerated     ...............  ...............  ...............  ...............  ..............
 storage: Ready-prepared                                                                                        
 foods intended to be                                                                                           
 reheated in container at                                                                                       
 time of use:.                                                                                                  
  1. Aqueous or oil-in-water  I, II, IV-B,     212 F, 30 min..  ...............  ...............  ..............
 emulsion of high- or low-     VII-B.                                                                           
 fat.                                                                                                           
  2. Aqueous, high- or low-   III, IV-A, VII-  ......do.......  120 F, 30 min..  ...............  ..............
 free oil or fat.              A, IX.                                                                           
----------------------------------------------------------------------------------------------------------------
\1\Heptane extractability results must be divided by a factor of five in arriving at the extractability for a   
  food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required 
  in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk       
  packaging of iced meat, iced fish, and iced poultry.                                                          

    (d) Analytical methods--(1) Selection of extractability conditions. 
First ascertain the type of food product (Table 1, paragraph (c) of this 
section) that is being packed commercially in the paper or paperboard 
and the normal conditions of thermal treatment used in packaging the 
type of food involved. Using Table 2, paragraph (c) of this section, 
select the food-simulating solvent or solvents and the time-temperature 
exaggerations of the paper or paperboard use conditions. Having selected 
the appropriate food-simulating solvent or solvents and the time-
temperature exaggeration over normal use, follow the applicable 
extraction procedure.
    (2) Reagents--(i) Water. All water used in extraction procedures 
should be freshly demineralized (deionized) distilled water.
    (ii) n-Heptane. Reagent grade, freshly redistilled before use, using 
only material boiling at 208 deg. F.
    (iii) Alcohol. 8 or 50 percent (by volume), prepared from 
undenatured 95 percent ethyl alcohol diluted with demineralized 
(deionized) distilled water.
    (iv) Chloroform. Reagent grade, freshly redistilled before use, or a 
grade having an established consistently low blank.
    (3) Selection of test method. Paper or paperboard ready for use in 
packaging shall be tested by use of the extraction cell described in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th Ed. (1980), sections 21.010-21.015, under ``Exposing 
Flexible Barrier Materials for Extraction,'' which is incorporated by 
reference (copies may be obtained from the Association of Official 
Analytical Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408); also described in ASTM method F34-76 (Reapproved 1980), 
``Standard Test Method for Liquid Extraction of Flexible Barrier 
Materials,'' which is incorporated by reference (copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office

[[Page 201]]

of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408), except that formed paper and paperboard products 
may be tested in the container by adapting the in-container methods 
described in Sec. 175.300(e) of this chapter. Formed paper and 
paperboard products such as containers and lids, that cannot be tested 
satisfactorily by any of the above methods may be tested in specially 
designed extraction equipment, usually consisting of clamping devices 
that fit the closure or container so that the food-contact surface can 
be tested, or, if flat samples can be cut from the formed paper or 
paperboard products without destroying the integrity of the food-contact 
surface, they may be tested by adapting the following ``sandwich'' 
method:
    (i) Apparatus. (a) Thermostated (plus-minus1.0 deg. F) water 
bath, variable between 70 deg. F and 120 deg. F water bath cover capable 
of holding at least one 800-milliliter beaker partially submersed in 
bath.
    (b) Analytical balance sensitive to 0.1 milligram with an 
approximate capacity of 100 grams.
    (c) Tongs.
    (d) Hood and hot-plate facilities.
    (e) Forced draft oven.

For each extraction, the following additional apparatus is necessary:
    (f) One No. 2 paper clip.
    (g) One 800-milliliter beaker with watch-glass cover.
    (h) One 250-milliliter beaker.
    (i) Five 2\1/2\-inch-square aluminum screens (standard aluminum 
window screening is acceptable).
    (j) One wire capable of supporting sample stack.
    (ii) Procedure. (a) For each extraction, accurately cut eight 2\1/
2\-inch-square samples from the formed paper or paperboard product to be 
tested.
    (b) Carefully stack the eight 2\1/2\-inch-square samples and the 
five 2\1/2\-inch-square aluminum screens in sandwich form such that the 
food-contact side of each sample is always next to an aluminum screen, 
as follows: Screen, sample, sample, screen, sample, sample, screen, etc. 
Clip the sandwich together carefully with a No. 2 paper clip, leaving 
just enough space at the top to slip a wire through.
    (c) Place an 800-milliliter beaker containing 100-milliliters of the 
appropriate food-simulating solvent into the constant temperature bath, 
cover with a watch glass and condition at the desired temperature.
    (d) After conditioning, carefully lower the sample sandwich with 
tongs into the beaker.
    (e) At the end of the extraction period, using the tongs, carefully 
lift out the sample sandwich and hang it over the beaker with the wire.
    (f) After draining, pour the food-simulating solvent solution into a 
tared 250-milliliter beaker. Rinse the 800-milliliter beaker three 
times, using a total of not more than 50 milliliters of the required 
solvent.
    (g) Determine total nonvolatile extractives in accordance with 
paragraph (d)(5) of this section.
    (4) Selection of samples. Quadruplicate samples should be tested, 
using for each replicate sample the number of cups, containers, or 
preformed or converted products nearest to an area of 100 square inches.
    (5) Determination of amount of extractives--(i) Total residues. At 
the end of the exposure period, remove the test container or test cell 
from the oven and combine the solvent for each replicate in a clean 
Pyrex (or equivalent) flask or beaker being sure to rinse the test 
container or cell with a small quantity of clean solvent. Evaporate the 
food-simulating solvents to about 100 milliliters in the flask or 
beaker, and transfer to a clean, tared evaporating dish (platinum or 
Pyrex), washing the flask three times with small portions of solvent 
used in the extraction procedure, and evaporate to a few milliliters on 
a nonsparking, low-temperature hotplate. The last few milliliters should 
be evaporated in an oven maintained at a temperature of approximately 
221 deg. F. Cool the evaporating dish in a desiccator for 30 minutes and 
weigh the residue to the nearest 0.1 milligram, (e). Calculate the 
extractives in milligrams per square inch of the container or sheeted 
paper or paperboard surface.
    (a) Water and 8- and 50-percent alcohol. Milligrams extractives per 
square inch=(e)/(s).

[[Page 202]]

    (b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)

Where:

    e=Milligrams extractives per sample tested.
    s=Surface area tested, in square inches.
    F=Five, the ratio of the amount of extractives removed by heptane 
under exaggerated time-temperature test conditions compared to the 
amount extracted by a fat or oil under exaggerated conditions of thermal 
sterilization and use.
    e'=Chloroform-soluble extractives residue.
    ee'=Corrected chloroform-soluble extractives residue.
    e' or ee' is substituted for e in the above equations when 
necessary.

If when calculated by the equations in paragraph (d)(5)(i) (a) and (b) 
of this section, the extractives in milligrams per square inch exceeds 
the limitations prescribed in paragraph (c) of this section, proceed to 
paragraph (d)(5)(ii) of this section (method for determining the amount 
of chloroform-soluble extractives residues).
    (ii) Chloroform-soluble extractives residue. Add 50 milliliters of 
chloroform (freshly distilled reagent grade or a grade having an 
established consistently low blank) to the dried and weighed residue, 
(e), in the evaporating dish obtained in paragraph (d)(5)(i) of this 
section. Warm carefully, and filter through Whatman No. 41 filter paper 
(or equivalent) in a Pyrex (or equivalent) funnel, collecting the 
filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat 
the chloroform extraction, washing the filter paper with this second 
portion of chloroform. Add this filtrate to the original filtrate and 
evaporate the total down to a few milliliters on a low-temperature 
hotplate. The last few milliliters should be evaporated in an oven 
maintained at approximately 221 deg. F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get 
the chloroform-soluble extractives residue (e'). This e' is substituted 
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this 
section. If the chloroform-soluble extractives in milligrams per square 
inch still exceeds the limitation prescribed in paragraph (c) of this 
section, proceed to paragraph (d)(5)(iii) of this section (method for 
determining corrected chloroform-soluble extractives residue).
    (iii) Corrected chloroform-soluble extractives residue--(a) 
Correction for zinc extractives. Ash the residue in the evaporating dish 
by heating gently over a Meker-type burner to destroy organic matter and 
hold at red heat for about 1 minute. Cool in the air for 3 minutes, and 
place the evaporating dish in the desiccator for 30 minutes and weigh to 
the nearest 0.1 milligram. Analyze this ash for zinc by standard 
Association of Official Agricultural Chemists methods or equivalent. 
Calculate the zinc in the ash as zinc oleate, and subtract from the 
weight of chloroform-soluble extractives residue (e') to obtain the 
zinc-corrected chloroform-soluble extractives residue (ee'). This ee' is 
substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of 
this section.
    (b) Correction for wax, petrolatum, and mineral oil--(1) Apparatus. 
Standard 10 millimeter inside diameter x 60 centimeter chromatographic 
column (or standard 50-milliliter buret with an inside diameter of 10-11 
millimeters) with a stopcock of glass, perfluorocarbon resin, or 
equivalent material. The column (or buret) may be optionally equipped 
with an integral coarse, fritted glass disc and the top of the column 
(or buret) may be optionally fitted with a 100-millimeter solvent 
reservoir.
    (2) Preparation of column. Place a snug pledget of fine glass wool 
in the bottom of the column (or buret) if the column (or buret) is not 
equipped with integral coarse, fritted glass disc. Overlay the glass 
wool pledget (or fritted glass disc) with a 15-20 millimeter deep layer 
of fine sand. Measure in a graduated cylinder 15 milliliters of 
chromatographic grade aluminum oxide (80-200 mesh) that has been tightly 
settled by tapping the cylinder. Transfer the aluminum oxide to the 
chromatographic tube, tapping the tube during and after the transfer so 
as to tightly settle the aluminum oxide. Overlay the layer of aluminum 
oxide with a 1.0-1.5 centimeter deep layer of anhydrous sodium sulfate 
and on top of this place an 8-10 millimeter thick plug of fine glass 
wool. Next carefully add about 25 milliliters of heptane to the

[[Page 203]]

column with stopcock open, and allow the heptane to pass through the 
column until the top level of the liquid just passes into the top glass 
wool plug in the column, and close stopcock.
    (3) Chromatographing of sample extract--(i) For chloroform residues 
weighing 0.5 gram or less. To the dried and weighed chloroform-soluble 
extract residue in the evaporating dish, obtained in paragraph 
(d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If 
necessary, heat carefully to dissolve the residue. Additional heptane 
not to exceed a total volume of 50 milliliters may be used if necessary 
to complete dissolving. Cool to room temperature. (If solution becomes 
cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this 
section to obtain an aliquot of heptane solution calculated to contain 
0.1-0.5 gram of chloroform-soluble extract residue.) Transfer the clear 
liquid solution to the column (or buret). Rinse the dish with 10 
millimeters of additional heptane and add to column. Allow the liquid to 
pass through the column into a clean, tared evaporating dish (platinum 
or Pyrex) at a dropwise rate of about 2 milliliters per minute until the 
liquid surface reaches the top glass wool plug; then close the stopcock 
temporarily. Rinse the Pyrex flask which contained the filtrate with an 
additional 10-15 milliliters of heptane and add to the column. Wash 
(elute) the column with more heptane collecting about 100 milliliters of 
total eluate including that already collected in the evaporating dish. 
Evaporate the combined eluate in the evaporating dish to dryness on a 
steam bath. Dry the residue for 15 minutes in an oven maintained at a 
temperature of approximately 221 deg. F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh the residue to the nearest 0.1 
milligram. Subtract the weight of the residue from the weight of 
chloroform-soluble extractives residue (e') to obtain the wax-, 
petrolatum-, and mineral oil-corrected chloroform-soluble extractives 
residue (ee'). This ee' is substituted for e in the equations in 
paragraph (d)(5)(i) (a) and (b) of this section.
    (ii) For chloroform residues weighing more than 0.5 gram. Redissolve 
the dried and weighed chloroform-soluble extract residue as described in 
paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately 
larger quantities of heptane. Transfer the heptane solution to an 
appropriate-sized volumetric flask (i.e., a 250-milliliter flask for 
about 2.5 grams of residue) and adjust to volume with additional 
heptane. Pipette out an aliquot (about 50 milliliters) calculated to 
contain 0.1-0.5 gram of the chloroform-soluble extract residue and 
analyze chromatographically as described in paragraph 
(d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the 
dried residue from the heptane eluate must be multiplied by the dilution 
factor to obtain the weight of wax, petrolatum, and mineral oil residue 
to be subtracted from the weight of chloroform-soluble extractives 
residue (e') to obtain the wax-, petrolatum-, and mineral oil-corrected 
chloroform-soluble extractives residue (ee'). This ee' is substituted 
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this 
section. (Note: In the case of chloroform-soluble extracts which contain 
high melting waxes (melting point greater than 170 deg. F), it may be 
necessary to dilute the heptane solution further so that a 50-milliliter 
aliquot will contain only 0.1-0.2 gram of the chloroform-soluble extract 
residue.)
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter, except where the 
copolymers are restricted to use in contact with food only of the type 
identified in paragraph (c), Table 1 under Category VIII.

[42 FR 14554, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 176.170, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 176.180   Components of paper and paperboard in contact with dry food.

    The substances listed in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding dry 
food of the type identified in Sec. 176.170(c), Table 1, under Type 
VIII,

[[Page 204]]

subject to the provisions of this section.
    (a) The substances are used in amounts not to exceed that required 
to accomplish their intended physical or technical effect, and are so 
used as to accomplish no effect in food other than that ordinarily 
accomplished by packaging.
    (b) The substances permitted to be used include the following:
    (1) Substances that by Sec. 176.170 and other applicable regulations 
in parts 170 through 189 of this chapter may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard, subject to the provisions of such regulation.
    (2) Substances identified in the following list:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
(2-Alkenyl) succinic anhydrides in       ...............................
 which the alkenyl groups are derived                                   
 from olefins which contain not less                                    
 than 78 percent C30 and higher groups                                  
 (CAS Reg. No. 70983-55-0).                                             
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy)       For use as a polymerization    
 ethoxy]ethyl]disodium sulfosuccinate.    emulsifier and latex emulsion 
                                          stabilizer at levels not to   
                                          exceed 5 percent by weight of 
                                          total emulsion solids.        
Alkyl mono- and disulfonic acids,                                       
 sodium salts (produced from n-alkanes                                  
 in the range of C10-C18 with not less                                  
 than 50 percent C14-C16)..                                             
Aluminum and calcium salts of FD & C     Colorant.                      
 dyes on a substrate of alumina.                                        
Ammonium nitrate.......................  ...............................
Amylose................................  ...............................
Barium metaborate......................  For use as preservative in     
                                          coatings and sizings.         
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative 
 Registry No. 2634-33-5).                 in paper coating compositions 
                                          and limited to use at a level 
                                          not to exceed 0.02 mg/in2     
                                          (0.0031 mg/cm2) of finished   
                                          paper and paperboard.         
N,N'-Bis(hydroxyethyl)lauramide........  ...............................
Bis(trichloromethyl) sulfone C.A.        For use only as a preservative 
 Registry No. 3064-70-8.                  in coatings.                  
Borax..................................  For use as preservative in     
                                          coatings.                     
Boric acid.............................      Do.                        
sec-Butyl alcohol......................  ...............................
Butyl benzyl phthalate.................  ...............................
Candelilla wax.........................  ...............................
Carbon tetrachloride...................  ...............................
Castor oil, polyoxyethylated (42 moles   ...............................
 ethylene oxide).                                                       
Cationic soy protein hydrolyzed          For use only as a coating      
 (hydrolyzed soy protein isolate          adhesive, pigment structuring 
 modified by treatment with 3-chloro-2-   agent, and fiber retention    
 hydroxypropyl-trimethylammonium          aid.                          
 chloride).                                                             
Cationic soy protein (soy protein        For use only as a coating      
 isolate modified by treatment with 3-    adhesive, pigment structuring 
 chloro-2-hydroxypropyltrimethyl-         agent, and fiber retention    
 ammonium chloride).                      aid.                          
Chloral hydrate........................  Polymerization reaction-control
                                          agent.                        
N-Cyclohexyl-p-toluene sulfonamide.....  ...............................
2,5-Di-tert-butyl hydroquinone.........  ...............................
Diethanolamine.........................  ...............................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer  
 No. 120-55-8).                           in polymeric substances.      
Diethylene glycol monobutyl ether......  ...............................
Diethylene glycol monoethyl ether......  ...............................
Diethylenetriamine.....................  ...............................
N,N-Diisopropanolamide of tallow fatty   ...............................
 acids.                                                                 
N-[(dimethylamino)methyl]acrylamide      ...............................
 polymer with acrylamide and styrene.                                   
N,N-Dioleoylethylenediamine, N,N-                                       
 dilinoeoyl-ethylenediamine, and N-                                     
 oleoyl-N-linoleoyl-ethylenediamine                                     
 mixture produced when tall oil fatty                                   
 acids are made to react with                                           
 ethylenediamine such that the finished                                 
 mixture has a melting point of 212                                     
 deg.-228 deg. F, as determined by ASTM                                 
 method D127-60, and an acid value of                                   
 10 maximum. ASTM Method D127-60                                        
 ``Standard Method of Test for Melting                                  
 Point of Petrolatum and                                                
 Microcrystalline Wax'' (Revised 1960)                                  
 is incorporated by reference. Copies                                   
 are available from University                                          
 Microfilms International, 300 N. Zeeb                                  
 Rd., Ann Arbor, MI 48106, or available                                 
 for inspection at the Office of the                                    
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC                                 
 20408.                                                                 
Diphenylamine..........................  ...............................
Dipropylene glycol dibenzoate (CAS Reg.  For use only as plasticizer in 
 No. 27138-31-4).                         polymeric substances.         
Disodium N-octadecylsulfosuccinamate...  ...............................
tert-Dodecyl thioether of polyethylene   ...............................
 glycol.                                                                

[[Page 205]]

                                                                        
Erucamide (erucylamide)................  ...............................
Ethanedial, polymer with tetrahydro-4-   ...............................
 hydroxy-5-methyl-2(1H)pyrimidinone,                                    
 propoxylated.                                                          
Ethylene oxide.........................  Fumigant in sizing.            
Ethylene oxide adduct of mono-(2-        ...............................
 ethylhexyl) o-phosphate.                                               
Fatty acid (C12-C18) diethanolamide....  ...............................
Fish oil fatty acids, hydrogenated,      ...............................
 potassium salt.                                                        
Formaldehyde...........................  ...............................
Glyceryl monocaprate...................  ...............................
Glyceryl tribenzoate (CAS Reg. No. 614-  For use only as a plasticizer  
 33-5).                                   in polymeric coatings.        
Glyoxal................................  ...............................
Glyoxal-urea-formaldehyde condensate     For use as an insolubilizer for
 (CAS Reg. No. 27013-01-0) formed by      starch in coatings.           
 reaction in the molar ratio of                                         
 approximately 47:33:15, respectively.                                  
 The reaction product has a number                                      
 average molecular weight of 27814 as determined by a suitable                                   
 method.                                                                
Glyoxal-urea polymer (CAS Reg. No.       For use as an insolubilizer for
 53037-34-6).                             starch.                       
Hexamethylenetetramine.................  Polymerization crosslinking    
                                          agent for protein, including  
                                          casein. As neutralizing agent 
                                          with myristochromic chloride  
                                          complex and stearato-chromic  
                                          chloride complex.             
Hexylene glycol (2-methyl-2,4-           ...............................
 pentanediol).                                                          
Hydroabietyl alcohol...................  ...............................
5-Hydroxymethoxymethyl-1-aza-3,7-        For use only as an             
 dioxabicyclo[3.3.0] octane, 5-           antibacterial preservative.   
 hydroxymethyl-1-aza-3,7-                                               
 dioxabicyclo[3.3.0]octane, and 5-                                      
 hydroxypoly-[methyleneoxy]methyl-1-aza-                                
 3,7-dioxabicyclo[3.3.0] octane mixture.                                
Isopropanolamine hydrochloride.........  ...............................
Isopropyl m- and p-cresol (thymol        ...............................
 derived).                                                              
Itaconic acid..........................  ...............................
Maleic anhydride-diisobutylene           ...............................
 copolymer, ammonium or sodium salt.                                    
Melamine-formaldehyde modified with:     Basic polymer.                 
  Alcohols (ethyl, butyl, isobutyl,                                     
 propyl, or isopropyl).                                                 
  Diethylenetriamine.                                                   
  Imino-bis-butylamine.                                                 
  Imino-bis-ethyleneimine.                                              
  Imino-bis-propylamine.                                                
  Polyamines made by reacting                                           
 ethylenediamine or trimethylenediamine                                 
 with dichloroethane or                                                 
 dichloropropane.                                                       
  Sulfanilic acid.                                                      
  Tetraethylenepentamine.                                               
  Triethylenetetramine.                                                 
Methyl alcohol.........................                                 
Methyl esters of mono-, di-, and         ...............................
 tripropylene glycol.                                                   
Methyl napthalene sulfonic acid-         ...............................
 formaldehyde condensate, sodium salt.                                  
Methylated poly(N-1,2-dihydroxyethylene- For use only only as an in     
 1,3-imidazolidin-2-one).                 solubilizer for starch        
Modified polyacrylamide resulting from   For use only as a dry strength 
 an epichlorohydrin addition to a         and pigment retention aid     
 condensate of formaldehyde-              agent employed prior to the   
 dicyandiamide-diethylene triamine and    sheetforming operation in the 
 which product is then reacted with       manufacture of paper and      
 polyacrylamide and urea to produce a     paperboard and used at a level
 resin having a nitrogen content of 5.6   not to exceed 1 percent by    
 to 6.3 percent and having a minimum      weight of dry fibers.         
 viscosity in 56 percent-by-weight                                      
 aqueous solution of 200 centipoises at                                 
 25 deg. C, as determined by LVT-series                                 
 Brookfield viscometer using a No. 4                                    
 spindle at 60 r.p.m. (or equivalent                                    
 method).                                                               
Mono- and di(2-alkenyl)succinyl esters   For use only as an emulsifier. 
 of polyethylene glycol containing not                                  
 less than 90 percent of the diester                                    
 product and in which the alkenyl                                       
 groups are derived from olefins that                                   
 contain not less than 95 percent of                                    
 C15-C21 groups.                                                        
Monoglyceride citrate..................  ...............................
Myristo chromic chloride complex.......  ...............................
Napthalene sulfonic acid-formaldehyde    ...............................
 condensate, sodium salt.                                               
Nickel.................................  ...............................
-Nitrostyrene.................  Basic polymer.                 
-cis-9-Octadecenyl-omega-       ...............................
 hydroxypoly (oxyethylene); the                                         
 octadecenyl group is derived from                                      
 oleyl alcohol and the                                                  
 poly(oxyethylene) content averages not                                 
 less than 20 moles.                                                    
-(p-Nonylphenyl)-omega-         ...............................
 hydroxypoly (oxyethylene) sulfate,                                     
 ammonium salt; the nonyl group is a                                    
 propylene trimer isomer and the poly                                   
 (oxyethylene) content averages 9 or 30                                 
 moles.                                                                 
Oleic acid reacted with N-alkyl-(C16-    ...............................
 C18) trimethylenediamine.                                              

[[Page 206]]

                                                                        
Oxidized soy isolate having 50 to 70     For use as a binder adhesive   
 percent of its cystine residues          component of coatings.        
 oxidized to cysteic acid.                                              
Petroleum alicyclic hydrocarbon resins,  For use as modifiers at levels 
 or the hydrogenated product thereof,     up to 30 weight-percent of the
 complying with the identity prescribed   solids content of wax-polymer 
 in Sec.  176.170(b)(2).                  blend coatings.               
Petroleum hydrocarbon resins (produced   ...............................
 by the catalytic polymerization and                                    
 subsequent hydrogenation of styrene,                                   
 vinyltoluene, and indene types from                                    
 distillates of cracked petroleum                                       
 stocks).                                                               
Petroleum hydrocarbons, light and        ...............................
 odorless.                                                              
o-Phthalic acid modified hydrolyzed soy  ...............................
 protein isolate.                                                       
Pine oil...............................  ...............................
Poly(2-aminoethyl acrylate nitrate-co-2- ...............................
 hydroxypropyl acrylate) complying with                                 
 the identity described in Sec.                                         
 176.170(a).                                                            
Polyamide-epichloro hydrin modified      ...............................
 resins resulting from the reaction of                                  
 the initial caprolactam-itaconic acid                                  
 product with diethylenetriamine and                                    
 then condensing this prepolymer with                                   
 epichlorohydrin to form a cationic                                     
 resin having a nitrogen content of 11-                                 
 15 percent and chlorine level of 20-23                                 
 percent on a dry basis.                                                
Polyamide-ethyleneimine-epichlorohydrin  ...............................
 resin (CAS Reg. No. 115340-77-7),                                      
 prepared by reacting equimolar amounts                                 
 of adipic acid and N-(2-aminoethyl)-                                   
 1,2-ethanediamine to form a basic                                      
 polyamidoamine which is modified by                                    
 reaction with ethyleneimine, and                                       
 further reacted with formic acid and                                   
 (chloromethyl)oxirane--hydro-                                 
 -hydroxypoly(oxy-1,2-                                        
 ethanediyl).                                                           
Polybutene, hydrogenated; complying      ...............................
 with the identity prescribed under                                     
 Sec.  178.3740(b) of this chapter.                                     
Poly [2-(diethylamino) ethyl             ...............................
 methacrylate] phosphate.                                               
Polyethylene glycol (200) dilaurate....  ...............................
Polymers: Homopolymers and copolymers    Basic polymer.                 
 of the following monomers:                                             
  Acrylamide.                                                           
  Acrylic acid and its methyl, ethyl,                                   
 butyl, propyl, or octyl esters.                                        
  Acrylonitrile.                                                        
  Butadiene.                                                            
  Crotonic acid.                                                        
  Cyclol acrylate.                                                      
  Decyl acrylate.                                                       
  Diallyl fumarate.                                                     
  Diallyl maleate.                                                      
  Diallyl phthalate.                                                    
  Dibutyl fumarate.                                                     
  Dibutyl itaconate.                                                    
  Dibutyl maleate.                                                      
  Di(2-ethylhexyl) maleate.                                             
  Dioctyl fumarate.                                                     
  Dioctyl maleate.                                                      
  Divinylbenzene.                                                       
  Ethylene.                                                             
  2-Ethylhexyl acrylate.                                                
  Fumaric acid.                                                         
  Glycidyl methacrylate.                                                
  2-Hydroxyethyl acrylate.                                              
  N-(Hydroxymethyl) acrylamide.                                         
  Isobutyl acrylate.                                                    
  Isobutylene.                                                          
  Isoprene.                                                             
  Itaconic acid.                                                        
  Maleic anhydride and its methyl or                                    
 butyl esters.                                                          
  Methacrylic acid and its methyl,                                      
 ethyl, butyl, or propyl esters.                                        
  Methylstyrene.                                                        
  Mono(2-ethylhexyl) maleate.                                           
  Monoethyl maleate.                                                    
  5-Norbornene-2,3-dicarboxylic acid,                                   
 mono-n-butyl ester.                                                    
  Styrene.                                                              
  Vinyl acetate.                                                        
  Vinyl butyrate.                                                       
  Vinyl chloride.                                                       
  Vinyl crotonate.                                                      
  Vinyl hexoate.                                                        
  Vinylidene chloride.                                                  

[[Page 207]]

                                                                        
  Vinyl pelargonate.                                                    
  Vinyl propionate.                                                     
  Vinyl pyrrolidone.                                                    
  Vinyl stearate.                                                       
  Vinyl sulfonic acid.                                                  
Polymer prepared from urea, ethanedial,  For use only as a starch and   
 formaldehyde, and propionaldehyde (CAS   protein reactant in paper and 
 Reg. No. 106569-82-8).                   paperboard coatings.          
Polyoxyethylene (minimum 12 moles)       ...............................
 ester of tall oil (30%-40% rosin                                       
 acids).                                                                
Polyoxypropylene-polyoxyethylene glycol  ...............................
 (minimum molecular weight 1,900).                                      
Polyvinyl alcohol......................  ...............................
Potassium titanate fibers produced by    ...............................
 calcining titanium dioxide, potassium                                  
 chloride, and potassium carbonate,                                     
 such that the finished crystalline                                     
 fibers have a nominal diameter of 0.20-                                
 0.25 micron, a length-to-diameter                                      
 ratio of approximately 25:1 or                                         
 greater, and consist principally of                                    
 K2Ti4 O9 and K2Ti 6O13.                                                
Sodium diisobutylphenoxy diethoxyethyl   ...............................
 sulfonate.                                                             
Sodium diisobutylphenoxy monoethoxy      ...............................
 ethylsulfonate.                                                        
Sodium n-dodecylpolyethoxy (50 moles)    ...............................
 sulfate.                                                               
Sodium isododecylphenoxypolyethoxy (40   ...............................
 moles) sulfate.                                                        
Sodium N-methyl-N-oleyl taurate........  ...............................
Sodium methyl siliconate...............  ...............................
Sodium nitrite.........................  ...............................
Sodium polyacrylate....................  ...............................
Sodium bis-tridecylsulfosuccinate......  ...............................
Sodium xylene sulfonate................  ...............................
Stearato chromic chloride complex......  ...............................
Styrene-allyl alcohol copolymers.......  ...............................
Styrene-methacrylic acid copolymer,      ...............................
 potassium salt.                                                        
Tetraethylenepentamine.................  Polymerization cross-linking   
                                          agent.                        
-[p-(1,1,3,3-                   ...............................
 Tetramethylbutyl)phenyl]-omega                                         
 hydroxypoly(oxyethylene) mixture of                                    
 dihydrogen phosphate and monohydrogen                                  
 phosphate esters and their sodium,                                     
 potassium, and ammonium salts having a                                 
 poly(oxyethylene) content averaging 6-                                 
 9 or 40 moles.                                                         
-[p-(1,1,3,3-                   ...............................
 Tetramethylbutyl)phenyl or p-                                          
 nonylphenyl]-omega-hydroxypoly                                         
 (oxyethylene) where nonyl group is a                                   
 propylene trimer isomer.                                               
Tetrasodium N-(1,2-dicarboxyethyl)-N-    ...............................
 octadecyl sulfosuccinamate.                                            
Toluene................................  ...............................
Triethanolamine........................  ...............................
Triethylenetetramine...................  Polymerization cross-linking   
                                          agent.                        
Triethylenetetramine monoacetate,        ...............................
 partially stearoylated.                                                
Urea-formaldehyde chemically modified                                   
 with:                                                                  
  Alcohol (methyl, ethyl, butyl,                                        
 isobutyl, propyl, or isopropyl).                                       
  Aminomethylsulfonic acid.                                             
  Diaminobutane.                                                        
  Diaminopropane.                                                       
  Diethylenetriamine.                                                   
  N,N'-Dioleoylethylenediamine.                                         
  Diphenylamine.                                                        
  N,N'-Distearoylethylenediamine.                                       
  Ethylenediamine.                                                      
  Guanidine.                                                            
  Imino-bis-butylamine.                                                 
  Imino-bis-ethylamine.                                                 
  Imino-bis-propylamine.                                                
  N-Oleoyl-N'-stearoylethylenediamine.                                  
  Polyamines made by reacting                                           
 ethylenediamine or triethylenediamine                                  
 with dichloroethane or                                                 
 dichloropropane.                                                       
  Tetraethylenepentamine.                                               
  Triethylenetetramine.                                                 
Xylene.................................  ...............................
Xylene sulfonic acid-formaldehyde        ...............................
 condensate, sodium salt.                                               
Zinc stearate..........................  ...............................
------------------------------------------------------------------------

[42 FR 14554, Mar. 15, 1977]


[[Page 208]]


    Editorial Note: For additional Federal Register citations affecting 
Sec. 176.180, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 176.200   Defoaming agents used in coatings.

    The defoaming agents described in this section may be safely used as 
components of articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food, subject to the provisions of this section.
    (a) The defoaming agents are prepared as mixtures of substances 
described in paragraph (d) of this section.
    (b) The quantity of any substance employed in the formulation of 
defoaming agents does not exceed the amount reasonably required to 
accomplish the intended physical or technical effect in the defoaming 
agents or any limitation further provided.
    (c) Any substance employed in the production of defoaming agents and 
which is the subject of a regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter conforms with any specification in such 
regulation.
    (d) Substances employed in the formulation of defoaming agents 
include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for use in 
defoaming agents and used in accordance with such sanction or approval.
    (3) Substances identified in this paragraph (d)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
n-Butyl alcohol........................                                 
tert-Butyl alcohol.....................                                 
Butyl stearate.........................                                 
Castor oil, sulfated, ammonium,                                         
 potassium, or sodium salt.                                             
Cetyl alcohol..........................                                 
Cyclohexane............................                                 
Cyclohexanol...........................                                 
Diethylene glycol monolaurate..........                                 
Diethylene glycol monostearate.........                                 
Dimers and trimers of unsaturated C18    For use only at levels not to  
 fatty acids derived from:                exceed 0.1% by weight of total
                                          coating solids.               
  Animal and vegetable fats and oils.                                   
  Tall oil.                                                             
Dimethylpolysiloxane...................                                 
Dipropylene glycol.....................                                 
Ethyl alcohol..........................                                 
Fats and oils derived from animal,                                      
 marine, or vegetable sources:                                          
Fatty acids derived from animal,                                        
 marine, or vegetable fats and oils,                                    
 and salts of such acids, single or                                     
 mixed, as follows:                                                     
  Aluminum.                                                             
  Ammonium.                                                             
  Calcium.                                                              
  Magnesium.                                                            
  Potassium.                                                            
  Sodium.                                                               
  Zinc.                                                                 
Formaldehyde...........................  For use as preservative of     
                                          defoamer only.                
Glyceryl mono-12-hydroxystearate.......                                 
Glyceryl monostearate..................                                 
Hexane.................................                                 
Hexylene glycol (2-methyl-2,4-                                          
 pentanediol).                                                          
Isobutyl alcohol.......................                                 
Isopropyl alcohol......................                                 
Kerosene...............................                                 
Lecithin hydroxylated..................                                 
Methyl alcohol.........................                                 
Methylcellulose........................                                 
Methyl esters of fatty acids derived                                    
 from animal, marine, or vegetable fats                                 
 and oils.                                                              
Methyl oleate..........................                                 
Methyl palmitate.......................                                 
Mineral oil............................                                 
Mustardseed oil, sulfated, ammonium,                                    
 potassium, or sodium salt.                                             
Myristyl alcohol.......................                                 

[[Page 209]]

                                                                        
Naphtha................................                                 
-Naphthol.....................  For use as preservative of     
                                          defoamer only.                
Nonylphenol............................                                 
Odorless light petroleum hydrocarbons..  As defined in Sec.  178.3650 of
                                          this chapter.                 
Oleic acid, sulfated, ammonium,                                         
 potassium, or sodium salt.                                             
Parachlorometacresol...................  For use as preservative of     
                                          defoamer only.                
Peanut oil, sulfated, ammonium,                                         
 potassium, or sodium salt.                                             
Petrolatum.............................                                 
Pine oil...............................                                 
Polyacrylic acid, sodium salt..........  As a stabilizer and thickener  
                                          in defoaming agents containing
                                          dimethylpolysiloxane.         
Polyethylene...........................                                 
Polyethylene, oxidized.................                                 
Polyethylene glycol (200) dilaurate....                                 
Polyethylene glycol (400) dioleate.....                                 
Polyethylene glycol (600) dioleate.....                                 
Polyethylene glycol (400) esters of                                     
 coconut oil fatty acids.                                               
Polyethylene glycol (400) monooleate...                                 
Polyethylene glycol (600) monooleate...                                 
Polyethylene glycol (600)                                               
 monoricinoleate.                                                       
Polyethylene glycol (400) monostearate.                                 
Polyoxybutylene-polyoxypropylene-                                       
 polyoxyethylene glycol (min. mol. wt.                                  
 3,700).                                                                
Polyoxyethylated (min. 3 mols) cetyl                                    
 alcohol.                                                               
Polyoxyethylated (min. 5 mols) oleyl                                    
 alcohol.                                                               
Polyoxyethylated (min. 1.5 mols)                                        
 tridecyl alcohol.                                                      
Polyoxyethylene (min. 15 mols) ester of                                 
 rosin.                                                                 
Polyoxyethylene (min. 8 mols)                                           
 monooleate.                                                            
Polyoxyethylene (40) stearate..........                                 
Polyoxypropylated (min. 20 mols) butyl                                  
 alcohol.                                                               
Polyoxypropylene glycol (min. mol. wt.                                  
 200).                                                                  
Polyoxypropylene (min. 20 mols) oleate                                  
 butyl ether.                                                           
Polyoxypropylene-polyoxyethylene glycol                                 
 (min. mol. wt. 1,900).                                                 
Polyoxypropylene (min. 40 mols)                                         
 stearate butyl ether.                                                  
Potassium pentachlorophenate...........  For use as preservative of     
                                          defoamer only.                
Potassium trichlorophenate.............      Do.                        
Propylene glycol monoester of soybean                                   
 oil fatty acids.                                                       
Propylene glycol monoester of tallow                                    
 fatty acids.                                                           
Ricebran oil, sulfated, ammonium,                                       
 potassium, or sodium salt.                                             
Rosins and rosin derivatives...........  As provided in Sec.  178.3870  
                                          of this chapter.              
Silica.................................                                 
Sodium 2-mercaptobenzothiazole.........  For use as preservative of     
                                          defoamer only.                
Sodium pentachlorophenate..............      Do.                        
Sodium trichlorophenate................      Do.                        
Sperm oil, sulfated, ammonium,                                          
 potassium, or sodium salt.                                             
Stearyl alcohol........................                                 
Tall oil fatty acids...................                                 
Tallow fatty acids, hydrogenated or                                     
 sulfated.                                                              
Tallow, sulfated, ammonium, potassium,                                  
 or sodium salt.                                                        
Triethanolamine........................                                 
Triisopropanolamine....................                                 
Waxes, petroleum.......................                                 
------------------------------------------------------------------------

    (e) The defoaming agents are used as follows:
    (1) The quantity of defoaming agent or agents used shall not exceed 
the amount reasonably required to accomplish the intended effect, which 
is to prevent or control the formation of foam.
    (2) The defoaming agents are used in the preparation and application 
of coatings for paper and paperboard.



Sec. 176.210   Defoaming agents used in the manufacture of paper and paperboard.

    Defoaming agents may be safely used in the manufacture of paper and 
paperboard intended for use in packaging, transporting, or holding food 
in accordance with the following prescribed conditions:
    (a) The defoaming agents are prepared from one or more of the 
substances named in paragraph (d) of this section, subject to any 
prescribed limitations.

[[Page 210]]

    (b) The defoaming agents are used to prevent or control the 
formation of foam during the manufacture of paper and paperboard prior 
to and during the sheet-forming process.
    (c) The quantity of defoaming agent or agents added during the 
manufacturing process shall not exceed the amount necessary to 
accomplish the intended technical effect.
    (d) Substances permitted to be used in the formulation of defoaming 
agents include substances subject to prior sanctions or approval for 
such use and employed subject to the conditions of such sanctions or 
approvals, substances generally recognized as safe for use in food, 
substances generally recognized as safe for use in paper and paperboard, 
and substances listed in this paragraph, subject to the limitations, if 
any, prescribed.
    (1) Fatty triglycerides, and the fatty acids, alcohols, and dimers 
derived therefrom:

Beef tallow.
Castor oil.
Coconut oil.
Corn oil.
Cottonseed oil.
Fish oil.
Lard oil.
Linseed oil.
Mustardseed oil.
Palm oil.
Peanut oil.
Rapeseed oil.
Ricebran oil.
Soybean oil.
Sperm oil.
Tall oil.

    (2) Fatty triglycerides, and marine oils, and the fatty acids and 
alcohols derived therefrom (paragraph (d)(1) of this section) reacted 
with one or more of the following, with or without dehydration, to form 
chemicals of the category indicated in parentheses:

Aluminum hydroxide (soaps).
Ammonia (amides).
Butanol (esters).
Butoxy-polyoxypropylene, molecular weight 1,000-2,500 (esters).
Butylene glycol (esters).
Calcium hydroxide (soaps).
Diethanolamine (amides).
Diethylene glycol (esters).
Ethylene glycol (esters).
Ethylene oxide (esters and ethers).
Glycerin (mono- and diglycerides).
Hydrogen (hydrogenated compounds).
Hydrogen (amines).
Isobutanol (esters).
Isopropanol (esters).
Magnesium hydroxide (soaps).
Methanol (esters).
Morpholine (soaps).
Oxygen (air-blown oils).
Pentaerythritol (esters).
Polyoxyethylene, molecular weights 200, 300, 400, 600, 700, 1,000, 
1,540, 1,580, 1,760, 4,600 (esters).
Polyoxypropylene, molecular weight 200-2,000 (esters).
Potassium hydroxide (soaps).
Propanol (esters).
Propylene glycol (esters).
Propylene oxide (esters).
Sodium hydroxide (soaps).
Sorbitol (esters).
Sulfuric acid (sulfated and sulfonated compounds).
Triethanolamine (amides and soaps).
Triisopropanolamine (amides and soaps).
Trimethylolethane (esters).
Zinc hydroxide (soaps).

    (3) Miscellaneous:

Alcohols and ketone alcohols mixture (still-bottom product from 
C12-C18 alcohol manufacturing process).
Amyl alcohol.
Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.
Butoxy-polyoxypropylene molecular weight 1,000-2,500.
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Calcium lignin sulfonate.
Capryl alcohol.
p-Chlorometacresol.
Cyclohexanol.
Diacetyltartaric acid ester of tallow mono-glyceride.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691-65-7), for use as a 
preservative at a level not to exceed 0.05 weight-percent of the 
defoaming agent.
Diethanolamine.
Diethylene triamine.
Di-(2-ethylhexyl) phthalate.
2,6-Dimethyl heptanol-4 (nonyl alcohol).
Dimethylpolysiloxane.
Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Ethanol.
2-Ethylhexanol.
Ethylenediamine tetraacetic acid tetrasodium salt.
Formaldehyde.
Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol 
manufacture, of approximate composition: Octyl alcohol 5 percent nonyl 
alcohol 10 percent, decyl and higher alcohols 35 percent, esters 45 
percent, and soaps 5 percent).
2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-oxazoline.

[[Page 211]]

Hexylene glycol (2-methyl-2-4-pentanediol).
12-Hydroxystearic acid.
Isobutanol.
Isopropanol.
Isopropylamine salt of dodecylbenzene sulfonic acid.
Kerosine.
Lanolin.
Methanol.
Methyl 12-hydroxystearate.
Methyl taurine-oleic acid condensate, molecular weight 486.
a,a'-[Methylenebis[4-(1,1,3,3-tetramethylbu-tyl)-o-phenylene]]bis[omega-
hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per 
hydroxyl group.
Mineral oil.
Mono-, di-, and triisopropanolamine.
Mono- and diisopropanolamine stearate.
Monobutyl ether of ethylene glycol.
Monoethanolamine.
Morpholine.
Myristyl alcohol.
Naphtha.
-Naphthol.
Nonylphenol.
Odorless light petroleum hydrocarbons.
Oleyl alcohol.
Petrolatum.
o-Phenylphenol.
Pine oil.
Polybutene, hydrogenated; complying with the identity prescribed under 
Sec. 178.3740(b) of this chapter.
Polyethylene.
Polyethylene, oxidized (air-blown).
Polymer derived from N-vinyl pyrrolidone and copolymers derived from the 
mixed alkyl (C12-C15, C16, C18, C20, and 
C22) methacrylate esters, butyl methacrylate (CAS Reg. No. 97-88-
1), isobutyl methacrylate (CAS Reg. No. 97-86-9) and methyl methacrylate 
(CAS Reg. No. 80-62-6); the combined polymer contains no more than 5 
weight percent of polymer units derived from N-vinyl pyrrolidone and is 
present at a level not to exceed 7 parts per million by weight of the 
finished dry paper and paperboard fibers.
Polyoxyethylene (4 mols) decyl phosphate.
Polyoxyethylene (4 mols) di(2-ethyl hexanoate).
Polyoxyethylene (15 mols) ester of rosin.
Polyoxyethylene (3-15 mols) tridecyl alcohol.
Polyoxypropylene, molecular weight 200-2,000.
Polyoxypropylene-polyoxethylene condensate, minimum molecular weight 
950.
Polyoxypropylene-ethylene oxide condensate of ethylene diamine, 
molecular weight 1,700-3,800.
Polyvinyl pyrrolidone, molecular weight 40,000.
Potassium distearyl phosphate.
Potassium pentachlorophenate.
Potassium trichlorophenate.
Rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this 
chapter.
Silica.
Siloxanes and silicones, dimethyl, methylhydrogen, reaction products 
with polyethylene-polypropylene glycol monoallyl ether (CAS Reg. No. 
71965-38-3).
Sodium alkyl (C9-C15) benzene-sulfonate.
Sodium dioctyl sulfosuccinate.
Sodium distearyl phosphate.
Sodium lauryl sulfate.
Sodium lignin sulfonate.
Sodium 2-mercaptobenzothiazole.
Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde (2 
mols).
Sodium orthophenylphenate.
Sodium pentachlorophenate.
Sodium petroleum sulfonate, molecular weight 440-450.
Sodium trichlorophenate.
Stearyl alcohol.
-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-nonylphenyl-, or p-
dodecylphenyl]-omega-hydroxypoly(oxyethylene) produced by the 
condensation of 1 mole of p-alkylphenol (alkyl group is 1,1,3,3-
tetramethylbutyl, a propylene trimer isomer, or a propylene tetramer 
isomer) with an average of 1.5-15 moles of ethylene oxide.
Tetrahydrofurfuryl alcohol.
Tributoxyethyl phosphate.
Tributyl phosphate.
Tridecyl alcohol.
Triethanolamine.
Triethylene glycol di(2-ethyl hexanoate).
Tri-(2-ethylhexyl) phosphate.
Tristearyl phosphate.
Wax, petroleum, Type I and Type II.
Wax, petroleum (oxidized).
Wax (montan).

[42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27, 1982; 
47 FR 46495, Oct. 19, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, 
June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR 14246, Apr. 1, 1996]



Sec. 176.230   3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.

    3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-2-thione may safely be 
used as a preservative in the manufacture and coating of paper and 
paperboard intended for use in contact with food in accordance with the 
following prescribed conditions:
    (a) It is used as follows:
    (1) In the manufacture of paper and paperboard as a preservative for 
substances added to the pulp suspension prior to the sheet-forming 
operation provided that the preservative is volatilized by heat in the 
drying and finishing of the paper and paperboard.

[[Page 212]]

    (2) As a preservative for coatings for paper and paperboard, 
Provided, That the preservative is volatilized by heat in the drying and 
finishing of the coated paper or paperboard.
    (b) The quantity used shall not exceed the least amount reasonably 
required to accomplish the intended technical effect and shall not be 
intended to nor, in fact, accomplish any physical or technical effect in 
the food itself.
    (c) The use of a preservative in any substance or article subject to 
any regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter must comply with any specifications and limitations prescribed 
by such regulation for the substance or article.



Sec. 176.250   Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.

    Poly-1,4,7,10,13-pentaaza-15-hydrox-yhexadecane may be safely used 
as a retention aid employed prior to the sheet-forming operation in the 
manufacture of paper and paperboard intended for use in contact with 
food in an amount not to exceed that necessary to accomplish the 
intended physical or technical effect and not to exceed 6 pounds per ton 
of finished paper or paperboard.



Sec. 176.260   Pulp from reclaimed fiber.

    (a) Pulp from reclaimed fiber may be safely used as a component of 
articles used in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of paragraph (b) of this section.
    (b) Pulp from reclaimed fiber is prepared from the paper and 
paperboard products described in paragraphs (b) (1) and (2) of this 
section, by repulping with water to recover the fiber with the least 
possible amount of nonfibrous substances.
    (1) Industrial waste from the manufacture of paper and paperboard 
products excluding that which bears or contains any poisonous or 
deleterious substance which is retained in the recovered pulp and that 
migrates to the food, except as provided in regulations promulgated 
under sections 406 and 409 of the Federal Food, Drug, and Cosmetic Act.
    (2) Salvage from used paper and paperboard excluding that which (i) 
bears or contains any poisonous or deleterious substance which is 
retained in the recovered pulp and that migrates to the food, except as 
provided in regulations promulgated under sections 406 and 409 of the 
act or (ii) has been used for shipping or handling any such substance.



Sec. 176.300   Slimicides.

    (a) Slimicides may be safely used in the manufacture of paper and 
paperboard that contact food, in accordance with the following 
prescribed conditions:
    (1) Slimicides are used as antimicrobial agents to control slime in 
the manufacture of paper and paperboard.
    (2) Subject to any prescribed limitations, slimicides are prepared 
from one or more of the slime-control substances named in paragraph (c) 
of this section to which may be added optional adjuvant substances as 
provided for under paragraph (d) of this section.
    (3) Slimicides are added to the process water used in the production 
of paper or paperboard, and the quantity added shall not exceed the 
amount necessary to accomplish the intended technical effect.
    (b) To insure safe usage, the label or labeling of slimicides shall 
bear adequate directions for use.
    (c) Slime-control substances permitted for use in the preparation of 
slimicides include substances subject to prior sanction or approval for 
such use and the following:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Acrolein...............................                                 
Alkenyl (C16-C18) dimethylethyl-                                        
 ammonium bromide.                                                      
n-Alkyl (C12-C18) dimethyl benzyl                                       
 ammonium chloride.                                                     
1,2-Benzisothiazolin-3-one.............  At a level of 0.06 pound per   
                                          ton of dry weight fiber.      
Bis(1,4-bromoacetoxy)-2-butene.........                                 
5,5-Bis(bromoacetoxymethyl) m-dioxane..                                 
2,6-Bis(dimethylaminomethyl)                                            
 cyclohexanone.                                                         
1,2-Bis(monobromoacetoxy) ethane [CA     At a maximum level of 0.10     
 Reg. No. 3785-34-0].                     pound per ton of dry weight   
                                          fiber.                        

[[Page 213]]

                                                                        
Bis(trichloromethyl)sulfone............                                 
4-Bromoacetoxymethyl-m-dioxolane.......                                 
2-Bromo-4'-hydroxyacetophenone.........                                 
2-Bromo-2-nitropropane-1,3-diol (CAS     At a maximum level of 0.6 pound
 Reg. No. 52-51-7).                       per ton of dry weight fiber.  
                                                                        
-Bromo--nitrostyrene.  At a maximum level of 1 pound  
                                          per ton of dry weight fiber.  
Chloroethylenebisthiocyanate...........                                 
5-Chloro-2 - methyl - 4 - isothiazolin-  At a level of 2.5 pounds per   
 3-one calcium chloride and 2-methyl-4-   ton of dry weight fiber.      
 isothiazolin-3-one calcium chloride                                    
 mixture at a ratio of 3 parts to 1                                     
 part.                                                                  
Chlorinated levulinic acids............                                 
Chloromethyl butanethiolsulfonate......                                 
Cupric nitrate.........................                                 
n-Dialkyl (C12-C18)                                                     
 benzylmethylammonium chloride.                                         
1,2-Dibromo-2,4-dicyanobutane (CAS Reg.  At a maximum level of 0.005% of
 No. 35691-65-7).                         dry weight fiber.             
2,2-Dibromo-3-nitrilopropionamide......  At a maximum level of 0.1 lb/  
                                          ton of dry weight fiber.      
2,3-Dibromopropionaldehyde.............                                 
3,5-Dimethyl 1,3,5,2H-                                                  
 tetrahydrothiadiazine-2-thione.                                        
Dipotassium and disodium                                                
 ethylenebis(dithiocarba-mate).                                         
Disodium cyanodithioimidocarbonate.....                                 
n-Dodecylguanidine hydrochloride.......  At a maximum level of 0.20     
                                          pound per ton of dry weight   
                                          fiber.                        
Glutaraldehyde (CAS Reg. No. 111-30-8).  ...............................
2-(p-hydroxyphenyl) glyoxylohydroximoyl  At a level of 0.02 pound per   
 chloride (CAS Registry No. 34911-46-1).  ton of dry weight fiber.      
2-Hydroxypropyl methanethiol sulfonate.                                 
2-Mercaptobenzothiazole................                                 
Methylenebisbutanethiolsulfonate.......                                 
Methylenebisthiocyanate................                                 
2-Nitrobutyl bromoacetate [CA Reg. No.   At a maximum level of 0.15     
 32815-96-6].                             pound per ton of dry weight   
                                          fiber.                        
N-[-(Nitroethyl)benzyl]                                        
 ethylenediamine.                                                       
Potassium 2-mercaptobenzothiazole......                                 
Potassium N-hydroxymethyl-N-                                            
 methyldithiocarba-mate.                                                
Potassium N-methyldithiocarbamate......                                 
Potassium pentachlorophenate...........                                 
Potassium trichlorophenate.............                                 
Silver fluoride........................  Limit of addition to process   
                                          water not to exceed 0.024     
                                          pound, calculated as silver   
                                          fluoride, per ton of paper    
                                          produced.                     
Silver nitrate.........................                                 
Sodium dimethyldithiocarbamate.........                                 
Sodium 2-mercaptobenzothiazole.........                                 
Sodium pentachlorophenate..............                                 
Sodium trichlorophenate................                                 
1,3,6,8-Tetraazatricyclo[6.2.1.13,6]                                    
 dodecane.                                                              
3,3,4,4-Tetrachlorotetrahydrothiophene-                                 
 1,1-dioxide.                                                           
2-(Thiocyanomethylthio) benzothiazole..                                 
Vinylene bisthiocyanate................                                 
------------------------------------------------------------------------

    (d) Adjuvant substances permitted to be used in the preparation of 
slimicides include substances generally recognized as safe for use in 
food, substances generally recognized as safe for use in paper and 
paperboard, substances permitted to be used in paper and paperboard by 
other regulations in this chapter, and the following:

Acetone.
Butlylene oxide.
Dibutyl phthalate.
Didecyl phthalate.
N,N-Dimethylformamide.
Dodecyl phthalate.
Ethanolamine.
Ethylene glycol.
Ethylenediamine.
N-methyl-2-pyrrolidone (CAS Reg. No. 872-50-4).
a,a'-[Methylenebis[4-(1,1,3,3-tetramethylbutyl)-o-phenylene]] bis[omega-
hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per 
hydroxyl group.
Monomethyl ethers of mono-, di-, and tripropylene glycol.
Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide.
Octylphenol reaction product with 25 molecules of propylene oxide and 40 
molecules of ethylene oxide.

[42 FR 14554, Mar. 15, 1977, as amended at 42 FR 41854, Aug. 19, 1977; 
44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Feb. 
15, 1984; 51 FR 19059, May 27, 1986; 51 FR 43734, Dec. 4, 1986; 54 FR 
18103, Apr. 27, 1989; 55 FR 31825, Aug. 6, 1990]

[[Page 214]]



Sec. 176.320   Sodium nitrate-urea complex.

    Sodium nitrate-urea complex may be safely used as a component of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section.
    (a) Sodium nitrate-urea complex is a clathrate of approximately two 
parts urea and one part sodium nitrate.
    (b) Sodium nitrate-urea complex conforming to the limitations 
prescribed in paragraph (b)(1) of this section is used as provided in 
paragraph (b)(2) of this section.
    (1) Limitations. (i) It is used as a plasticizer in glassine and 
greaseproof paper.
    (ii) The amount used does not exceed that required to accomplish its 
intended technical effect or exceed 15 percent by weight of the finished 
paper.
    (2) Conditions of use. The glassine and greaseproof papers are used 
for packaging dry food or as the food-contact surface for dry food.



Sec. 176.350   Tamarind seed kernel powder.

    Tamarind seed kernel powder may be safely used as a component of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section.
    (a) Tamarind seed kernel powder is the ground kernel of tamarind 
seed (Tamarindus indica L.) after removal of the seed coat.
    (b) It is used in the manufacture of paper and paperboard.



PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents




                          Subpart A [Reserved]

Subpart B--Substances for Use as Basic Components of Single and Repeated 
                        Use Food Contact Surfaces

Sec.
177.1010  Acrylic and modified acrylic plastics, semirigid and rigid.
177.1020  Acrylonitrile/butadiene/styrene co-polymer.
177.1030  Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.
177.1040  Acrylonitrile/styrene copolymer.
177.1050  Acrylonitrile/styrene copolymer modified with butadiene/
          styrene elastomer.
177.1060  n-Alkylglutarimide/acrylic copolymers.
177.1200  Cellophane.
177.1210  Closures with sealing gaskets for food containers.
177.1240  1,4-Cyclohexylene dimethylene terephthalate and 1,4-
          cyclohexylene dimethylene isophthalate copolymer.
177.1310  Ethylene-acrylic acid copolymers.
177.1312  Ethylene-carbon monoxide copolymers.
177.1315  Ethylene-1,4-cyclohexylene dimethylene terephthalate 
          copolymers.
177.1320  Ethylene-ethyl acrylate copolymers.
177.1330  Ionomeric resins.
177.1340  Ethylene-methyl acrylate copolymer resins.
177.1345  Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate 
          copolymer.
177.1350  Ethylene-vinyl acetate copolymers.
177.1360  Ethylene-vinyl acetate-vinyl alcohol copolymers.
177.1380  Fluorocarbon resins.
177.1390  Laminate structures for use at temperatures of 250 deg. F and 
          above.
177.1395  Laminate structures for use at temperatures between 120  deg.F 
          and 250  deg.F.
177.1400  Hydroxyethyl cellulose film, water-insoluble.
177.1420  Isobutylene polymers.
177.1430  Isobutylene-butene copolymers.
177.1440  4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum 
          molecular weight 10,000.
177.1460  Melamine-formaldehyde resins in molded articles.
177.1480  Nitrile rubber modified acrylonitrile-methyl acrylate 
          copolymers.
177.1500  Nylon resins.
177.1520  Olefin polymers.
177.1550  Perfluorocarbon resins.
177.1555  Polyarylate resins.
177.1560  Polyarylsulfone resins.
177.1570  Poly-1-butene resins and butene/ethylene copolymers.
177.1580  Polycarbonate resins.
177.1585  Polyestercarbonate resins.
177.1590  Polyester elastomers.
177.1595  Polyetherimide resin.
177.1600  Polyethylene resins, carboxyl modified.
177.1610  Polyethylene, chlorinated.
177.1615  Polyethylene, fluorinated.
177.1620  Polyethylene, oxidized.
177.1630  Polyethylene phthalate polymers.
177.1632  Poly (phenyleneterephthalamide) resins.
177.1635  Poly(p-methylstyrene) and rubber-modified poly(p-
          methylstyrene).
177.1640  Polystyrene and rubber-modified polystyrene.

[[Page 215]]

177.1650  Polysulfide polymer-polyepoxy resins.
177.1655  Polysulfone resins.
177.1660  Poly (tetramethylene terephthalate).
177.1670  Polyvinyl alcohol film.
177.1680  Polyurethane resins.
177.1810  Styrene block polymers.
177.1820  Styrene-maleic anhydride copolymers.
177.1830  Styrene-methyl methacrylate copolymers.
177.1850  Textryls.
177.1900  Urea-formaldehyde resins in molded articles.
177.1950  Vinyl chloride-ethylene copolymers.
177.1960  Vinyl chloride-hexene-1 copolymers.
177.1970  Vinyl chloride-lauryl vinyl ether copolymers.
177.1980  Vinyl chloride-propylene copolymers.
177.1990  Vinylidene chloride/methyl acrylate copolymers.
177.2000  Vinylidene chloride/methyl acrylate/methyl methacrylate 
          polymers.

 Subpart C--Substances for Use Only as Components of Articles Intended 
                            for Repeated Use

177.2210  Ethylene polymer, chlorosulfonated.
177.2250  Filters, microporous polymeric.
177.2260  Filters, resin-bonded.
177.2280  4,4'-Isopropylidenediphenol-epichlorohydrin thermosetting 
          epoxy resins.
177.2355  Mineral reinforced nylon resins.
177.2400  Perfluorocarbon cured elastomers.
177.2410  Phenolic resins in molded articles.
177.2420  Polyester resins, cross-linked.
177.2430  Polyether resins, chlorinated.
177.2440  Polyethersulfone resins.
177.2450  Polyamide-imide resins.
177.2460  Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
177.2465  Polymethyl methacrylate/poly(tri methoxysilylpropyl) 
          methacrylate copolymers.
177.2470  Polyoxymethylene copolymer.
177.2480  Polyoxymethylene homopolymer.
177.2490  Polyphenylene sulfide resins.
177.2510  Polyvinylidene fluoride resins.
177.2550  Reverse osmosis membranes.
177.2600  Rubber articles intended for repeated use.
177.2710  Styrene-divinylbenzene resins, cross-linked.
177.2800  Textiles and textile fibers.
177.2910  Ultra-filtration membranes.

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    Source: 42 FR 14572, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 177 appear at 61 FR 
14482, Apr. 2, 1996.



                          Subpart A [Reserved]



Subpart B--Substances for Use as Basic Components of Single and Repeated 
                        Use Food Contact Surfaces



Sec. 177.1010  Acrylic and modified acrylic plastics, semirigid and rigid.

    Semirigid and rigid acrylic and modified acrylic plastics may be 
safely used as articles intended for use in contact with food, in 
accordance with the following prescribed conditions. The acrylic and 
modified acrylic polymers or plastics described in this section also may 
be safely used as components of articles intended for use in contact 
with food.
    (a) The optional substances that may be used in the formulation of 
the semirigid and rigid acrylic and modified acrylic plastics, or in the 
formulation of acrylic and modified acrylic components of articles, 
include substances generally recognized as safe in food, substances used 
in accordance with a prior sanction or approval, substances permitted 
for use in such plastics by regulations in parts 170 through 189 of this 
chapter, and substances identified in this paragraph. At least 50 
weight-percent of the polymer content of the acrylic and modified 
acrylic materials used as finished articles or as components of articles 
shall consist of polymer units derived from one or more of the acrylic 
or methacrylic monomers listed in paragraph (a)(1) of this section.
    (1) Homopolymers and copolymers of the following monomers:

n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
2-Ethylhexyl acrylate.
Ethyl methacrylate.
Methyl acrylate.
Methyl methacrylate.

    (2) Copolymers produced by copolymerizing one or more of the 
monomers listed in paragraph (a)(1) of

[[Page 216]]

this section with one or more of the following monomers:

Acrylonitrile.
Methacrylonitrile.
-Methylstyrene.
Styrene.
Vinyl chloride.
Vinylidene chloride.

    (3) Polymers identified in paragraphs (a)(1) and (2) of this section 
containing no more than 5 weight-percent of total polymer units derived 
by copolymerization with one or more of the monomers listed in paragraph 
(a)(3)(i) and (ii) of this section. Monomers listed in paragraph 
(a)(3)(ii) of this section are limited to use only in plastic articles 
intended for repeated use in contact with food.
    (i) List of minor monomers:

Acrylamide.
Acrylic acid
1,3-Butylene glycol dimethacrylate.
1,4-Butylene glycol dimethacrylate.
Diethylene glycol dimethacrylate.
Diproplylene glycol dimethacrylate.
Divinylbenzene.
Ethylene glycol dimethacrylate.
Itaconic acid.
Methacrylic acid.
N-Methylolacrylamide.
N-Methylolmethacrylamide.
4-Methyl-1,4-pentanediol dimethacrylate.
Propylene glycol dimethacrylate.
Trivinylbenzene.

    (ii) List of minor monomers limited to use only in plastic articles 
intended for repeated use in contact with food:

Allyl methacrylate [Chemical Abstracts Service Registry No. 96-05-9]
tert-Butyl acrylate.
tert-Butylaminoethyl methacrylate.
sec-Butyl methacrylate.
tert-Butyl methacrylate.
Cyclohexyl methacrylate.
Dimethylaminoethyl methacrylate.
2-Ethylhexyl methacrylate.
Hydroxyethyl methacrylate.
Hydroxyethyl vinyl sulfide.
Hydroxypropyl methacrylate.
Isobornyl methacrylate.
Isobutyl methacrylate.
Isopropyl acrylate.
Isopropyl methacrylate.
Methacrylamide.
Methacrylamidoethylene urea.
Methacryloxyacetamidoethylethylene urea.
Methacryloxyacetic acid.
n-Propyl methacrylate.
3,5,5-Trimethylcyclohexyl methacrylate.

    (4) Polymers identified in paragraphs (a)(1), (2), and (3) of this 
section are mixed together and/or with the following polymers, provided 
that no chemical reactions, other than addition reactions, occur when 
they are mixed:

Butadiene-acrylonitrile copolymers.
Butadiene-acrylonitrile-styrene copolymers.
Butadiene-acrylonitrile-styrene-methyl methacrylic copolymers.
Butadiene-styrene copolymers.
Butyl rubber.
Natural rubber.
Polybutadiene.
Poly (3-chloro-1,3-butadiene).
Polyester identified in Sec. 175.300(b)(3)(vii) of this chapter.
Polyvinyl chloride.
Vinyl chloride copolymers complying with Sec. 177.1980.
Vinyl chloride-vinyl acetate copolymers.

    (5) Antioxidants and stabilizers identified in 
Sec. 175.300(b)(3)(xxx) of this chapter and the following:

Di-tert-butyl-p-cresol.
2-Hydroxy-4-methoxybenzophenone.
2-Hydroxy-4-methoxy-2-carboxybenzophenone.
3-Hydroxyphenyl benzoate.
p-Methoxyphenol.
Methyl salicylate.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-
79-3): For use only: (1) At levels not exceeding 0.2 percent by weight 
in semirigid and rigid acrylic and modified acrylic plastics, where the 
finished articles contact foods containing not more than 15 percent 
alcohol; and (2) at levels not exceeding 0.01 percent by weight in 
semirigid and rigid acrylic and modified acrylic plastics intended for 
repeated food-contact use where the finished article may be used for 
foods containing more than 15 percent alcohol.
Phenyl salicylate.

    (6) Release agents: Fatty acids derived from animal and vegetable 
fats and oils, and fatty alcohols derived from such acids.
    (7) Surface active agent: Sodium dodecylbenzenesulfonate.
    (8) Miscellaneous materials:

Di(2-ethylhexyl) phthalate, for use only as a flow promoter at a level 
not to exceed 3 weight-percent based on the monomers.
Dimethyl phthalate.
Oxalic acid, for use only as a polymerization catalyst aid.
Tetraethylenepentamine, for use only as a catalyst activator at a level 
not to exceed 0.5 weight-percent based on the monomers.

[[Page 217]]

Toluene.
Xylene.

    (b) The semirigid and rigid acrylic and modified acrylic plastics, 
in the finished form in which they are to contact food, when extracted 
with the solvent or solvents characterizing the type of food and under 
the conditions of time and temperature as determined from Tables 1 and 2 
of Sec. 176.170(c) of this chapter, shall yield extractives not to 
exceed the following, when tested by the methods prescribed in paragraph 
(c) of this section. The acrylic and modified acrylic polymers or 
plastics intended to be used as components of articles also shall yield 
extractives not to exceed the following limitations when prepared as 
strips as described in paragraph (c)(2) of this section:
    (1) Total nonvolatile extractives not to exceed 0.3 milligram per 
square inch of surface tested.
    (2) Potassium permanganate oxidizable distilled water and 8 and 50 
percent alcohol extractives not to exceed an absorbance of 0.15.
    (3) Ultraviolet-absorbing distilled water and 8 and 50 percent 
alcohol extractives not to exceed an absorbance of 0.30.
    (4) Ultraviolet-absorbing n-heptane extractives not to exceed an 
absorbance of 0.10.
    (c) Analytical methods--(1) Selection of extractability conditions. 
These are to be chosen as provided in Sec. 176.170(c) of this chapter.
    (2) Preparation of samples. Sufficient samples to allow duplicates 
of all applicable tests shall be cut from the articles or formed from 
the plastic composition under tests, as strips about 2.5 inches by about 
0.85-inch wide by about 0.125-inch thick. The total exposed surface 
should be 5 square inches plus-minus0.5-square inch. The samples, 
after preparation, shall be washed with a clean brush under hot 
tapwater, rinsed under running hot tapwater (140 deg. F minimum), rinsed 
with distilled water, and air-dried in a dust-free area or in a 
desiccator.
    (3) Preparation of solvents. The water used shall be double-
distilled water, prepared in a still using a block tin condenser. The 8 
and 50 percent (by volume) alcohol solvents shall be prepared from ethyl 
alcohol meeting the specifications of the United States Pharmacopeia XX 
and diluted with double-distilled water that has been prepared in a 
still using a tin block condenser. The n-heptane shall be 
spectrophotometric grade. Adequate precautions must be taken to keep all 
solvents dust-free.
    (4) Blank values on solvents. (i) Duplicate determinations of 
residual solids shall be run on samples of each solvent that have been 
exposed to the temperature-time conditions of the extraction test 
without the plastic sample. Sixty milliliters of exposed solvent is 
pipetted into a clean, weighed platinum dish, evaporated to 2-5 
milliliters on a nonsparking, low-temperature hot plate and dried in 
212 deg. F oven for 30 minutes. The residue for each solvent shall be 
determined by weight and the average residue weight used as the blank 
value in the total solids determination set out in paragraph (c)(6) of 
this section. The residue for an acceptable solvent sample shall not 
exceed 0.5 milligram per 60 milliliters.
    (ii) For acceptability in the ultraviolet absorbers test, a sample 
of each solvent shall be scanned in an ultraviolet spectrophotometer in 
5-centimeter silica spectrophotometric absorption cells. The absorbance 
of the distilled water when measured versus air in the reference cell 
shall not exceed 0.03 at any point in the wavelength region of 245 to 
310 m. The absorbance of the 8 percent alcohol when measured 
versus distilled water in the reference cell shall not exceed 0.01 at 
any point in the wavelength region of 245 to 310 m. The 
absorbance of the 50 percent alcohol when measured versus distilled 
water in the reference cell shall not exceed 0.05 at any point in the 
wavelength region of 245 to 310 m. The absorbance of the 
heptane when measured versus distilled water in the reference cell shall 
not exceed 0.15 at 245, 0.09 at 260, 0.04 at 270, and 0.02 at any point 
in the wavelength region of 280 to 310 m.
    (iii) Duplicate ultraviolet blank determinations shall be run on 
samples of each solvent that has been exposed to the temperature-time 
conditions of the extraction test without the plastic sample. An aliquot 
of the exposed solvent shall be measured versus the unexposed solvent in 
the reference cell.

[[Page 218]]

The average difference in the absorbances at any wavelength in the 
region of 245 to 310 m shall be used as a blank correction for 
the ultraviolet absorbers measured at the same wavelength according to 
paragraph (c)(8)(ii) of this section.
    (iv) The acceptability of the solvents for use in the permanganate 
test shall be determined by preparing duplicate permanganate test blanks 
according to paragraph (c)(7)(iv) of this section. For this test, the 
directions referring to the sample extract shall be disregarded. The 
blanks shall be scanned in 5-centimeter silica spectrophotometric cells 
in the spectrophotometer versus the appropriate solvent as reference. 
The absorbance in distilled water in the wavelength region of 544 to 552 
m should be 1.16 but must not be less than 1.05 nor more than 
1.25. The absorbance in the 8 and 50 percent alcohol must not be less 
than 0.85 nor more than 1.15.
    (v) Duplicate permanganate test determinations shall be run on 
samples of distilled water and 8 and 50 percent alcohol solvents that 
have been exposed to the temperature-time conditions of the extraction 
test without the plastic sample. The procedure shall be as described in 
paragraph (c)(7)(iv) of this section, except that the appropriate 
exposed solvent shall be substituted where the directions call for 
sample extract. The average difference in the absorbances in the region 
of 544 to 552 m shall be used as a blank correction for the 
determination of permanganate oxidizable extractives according to 
paragraph (c)(7)(iv) of this section.
    (5) Extraction procedure. For each extraction, place a plastic 
sample in a clean 25 millimeters  x  200 millimeters hard-glass test 
tube and add solvent equal to 10 milliliters of solvent per square inch 
of plastic surface. This amount will be between 45 milliliters and 55 
milliliters. The solvent must be preequilibrated to the temperature of 
the extraction test. Close the test tube with a ground-glass stopper and 
expose to the specified temperature for the specified time. Cool the 
tube and contents to room temperature if necessary.
    (6) Determination of total nonvolatile extractives. Remove the 
plastic strip from the solvent with a pair of clean forceps and wash the 
strip with 5 milliliters of the appropriate solvent, adding the washings 
to the contents of the test tube. Pour the contents of the test tube 
into a clean, weighed platinum dish. Wash the tube with 5 milliliters of 
the appropriate solvent and add the solvent to the platinum dish. 
Evaporate the solvent to 2-5 milliliters on a nonsparking, low-
temperature hotplate. Complete the evaporation in a 212 deg. F oven for 
30 minutes. Cool the dish in a desiccator for 30 minutes and weigh to 
the nearest 0.1 milligram. Calculate the total nonvolatile extractives 
as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.392

[GRAPHIC] [TIFF OMITTED] TR01JA93.393

where:
e=Total increase in weight of the dish, in milligrams.
b=Blank value of the solvent in milligrams, as determined in paragraph 
(c)(4)(i) of this section.
s=Total surface of the plastic sample in square inches.

    (7) Determination of potassium permanganate oxidizable extractives. 
(i) Pipette 25 milliliters of distilled water into a clean 125-
milliliter Erlenmeyer flask that has been rinsed several times with 
aliquots of distilled water. This is the blank. Prepare a distilled 
water solution containing 1.0 part per million of p-methoxyphenol 
(melting point 54-56 deg. C, Eastman grade or equivalent). Pipette 25 
milliliters of this p-methoxyphenol solution into a rinsed Erlenmeyer 
flask. Pipette exactly 3.0 milliliters of 154 parts per million aqueous 
potassium permanganate solution into the p-methoxyphenol and exactly 3.0 
milliliters into the blank, in that order. Swirl both flasks to mix the 
contents and then transfer aliquots from each flask into matched 5-
centimeter spectrophotometric absorption cells. The cells are placed in 
the spectrophotometer cell compartment with the p-methoxyphenol solution 
in the reference beam. Spectrophotometric measurement is conducted as in 
paragraph (c)(7)(iv) of

[[Page 219]]

this section. The absorbance reading in the region 544-552 m 
should be 0.24 but must be not less than 0.12 nor more than 0.36. This 
test shall be run in duplicate. For the purpose of ascertaining 
compliance with the limitations in paragraph (b)(2) of this section, the 
absorbance measurements obtained on the distilled water extracts 
according to paragraph (c)(7)(iv) of this section shall be multiplied by 
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.394

    (ii) The procedure in paragraph (c)(7)(i) of this section is 
repeated except that, in this instance, the solvent shall be 8 percent 
alcohol. The absorbance in the region 544-552 m should be 0.26 
but must be not less than 0.13 nor more than 0.39. This test shall be 
run in duplicate. For the purpose of ascertaining compliance with the 
limitations prescribed in paragraph (b)(2) of this section, the 
absorbance measurements obtained on the 8 percent alcohol extracts 
according to paragraph (c)(7)(iv) of this section shall be multiplied by 
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.395

=Correction factor for aqueous 8 percent alcohol extracts.
    (iii) The procedure in paragraph (c)(7)(i) of this section is 
repeated except that, in this instance, the solvent shall be 50 percent 
alcohol. The absorbance in the region 544-552 m should be 0.25 
but must be not less than 0.12 nor more than 0.38. This test shall be 
run in duplicate. For the purpose of ascertaining compliance with the 
limitations prescribed in paragraph (b)(2) of this section, the 
absorbance measurements obtained on the 50 percent alcohol extracts 
according to paragraph (c)(7)(iv) of this section shall be multiplied by 
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.396

    (iv) Water and 8 and 50 percent alcohol extracts. Pipette 25 
milliliters of the appropriate solvent into a clean, 125-milliliter 
Erlenmeyer flask that has been rinsed several times with aliquots of the 
same solvent. This is the blank. Into another similarly rinsed flask, 
pipette 25 milliliters of the sample extract that has been exposed under 
the conditions specified in paragraph (c)(5) of this section. Pipette 
exactly 3.0 milliliters of 154 parts per million aqueous potassium 
permanganate solution into the sample and exactly 3.0 milliliters

[[Page 220]]

into the blank, in that order. Before use, the potassium permanganate 
solution shall be checked as in paragraph (c)(7)(i) of this section. 
Both flasks are swirled to mix the contents, and then aliquots from each 
flask are transferred to matched 5-centimeter spectrophotometric 
absorption cells. Both cells are placed in the spectrophotometer cell 
compartment with the sample solution in the reference beam. The 
spectrophotometer is adjusted for 0 and 100 percent transmittance at 700 
m. The spectrum is scanned on the absorbance scale from 700 
m to 500 m in such a way that the region 544 
m to 552 m is scanned within 5 minutes to 10 minutes 
of the time that permanganate was added to the solutions. The height of 
the absorbance peak shall be measured, corrected for the blank as 
determined in paragraph (c)(4)(v) of this section, and multiplied by the 
appropriate correction factor determined according to paragraph (c)(7) 
(i), (ii), and (iii) of this section. This test shall be run in 
duplicate and the two results averaged.
    (8) Determination of ultraviolet-absorbing extractives. (i) A 
distilled water solution containing 1.0 part per million of p-
methoxyphenol (melting point 54 deg. C-56 deg. C. Eastman grade or 
equivalent) shall be scanned in the region 360 to 220 m in 5-
centimeter silica spectrophotometric absorption cells versus a distilled 
water reference. The absorbance at the wavelength of maximum absorbance 
(should be about 285 m) is about 0.11 but must be not less than 
0.08 nor more than 0.14. This test shall be run in duplicate. For the 
purpose of ascertaining compliance with the limitations prescribed in 
paragraph (b) (3) and (4) of this section, the absorbance obtained on 
the extracts according to paragraph (c)(8)(ii) of this section shall be 
multiplied by a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.397

    (ii) An aliquot of the extract that has been exposed under the 
conditions specified in paragraph (c)(5) of this section is scanned in 
the wavelength region 360 to 220 m versus the appropriate 
solvent reference in matched 5-centimeter silica spectrophotometric 
absorption cells. The height of any absorption peak shall be measured, 
corrected for the blank as determined in paragraph (c)(4)(iii) of this 
section, and multiplied by the correction factor determined according to 
paragraph (c)(8)(i) of this section.
    (d) In accordance with current good manufacturing practice, finished 
semirigid and rigid acrylic and modified acrylic plastics, and articles 
containing these polymers, intended for repeated use in contact with 
food shall be thoroughly cleansed prior to their first use in contact 
with food.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.
    (f) The acrylic and modified acrylic polymers identified in and 
complying with this section, when used as components of the food-contact 
surface of an article that is the subject of a regulation in this part 
and in parts 174, 175, 176, and 178 of this chapter, shall comply with 
any specifications and limitations prescribed by such regulation for the 
article in the finished form in which it is to contact food.

[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
43 FR 54927, Nov. 24, 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, 
Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR 13139, Apr. 3, 1984; 
50 FR 31045, July 24, 1985]



Sec. 177.1020   Acrylonitrile/butadiene/styrene co-polymer.

    Acrylonitrile/butadiene/styrene copolymer identified in this section 
may

[[Page 221]]

be safely used as an article or component of articles intended for use 
with all foods, except those containing alcohol, under conditions of use 
E, F, and G described in Table 2 of Sec. 176.170(c) of this chapter.
    (a) Identity. For the purpose of this section, the acrylonitrile/
butadiene/styrene copolymer consists of:
    (1) Eighty-four to eighty-nine parts by weight of a matrix polymer 
containing 73 to 78 parts by weight of acrylonitrile and 22 to 27 parts 
by weight of styrene; and
    (2) Eleven to sixteen parts by weight of a grafted rubber consisting 
of (i) 8 to 13 parts of butadiene/styrene elastomer containing 72 to 77 
parts by weight of butadiene and 23 to 28 parts by weight of styrene and 
(ii) 3 to 8 parts by weight of a graft polymer having the same 
composition range as the matrix polymer.
    (b) Adjuvants. The copolymer identified in paragraph (a) of this 
section may contain adjuvant substances required in its production. Such 
adjuvants may include substances generally recognized as safe in food, 
substances used in accordance with prior sanction, substances permitted 
in this part, and the following:

------------------------------------------------------------------------
                 Substance                           Limitations        
------------------------------------------------------------------------
2-Mercapto- ethanol.......................  The finished copolymer shall
                                             contain not more than 100  
                                             ppm 2-mercaptoethanol      
                                             acrylonitrile adduct as    
                                             determined by a method     
                                             titled ``Analysis of       
                                             Cycopac Resin for Residual 
                                             -(2-              
                                             Hydroxyethylmercapto)      
                                             propionitrile,'' which is  
                                             incorporated by reference. 
                                             Copies are available from  
                                             the Bureau of Foods (HFS-  
                                             200), Food and Drug        
                                             Administration, 200 C St.  
                                             SW., Washington, DC 20204, 
                                             or available for inspection
                                             at the Office of the       
                                             Federal Register, 800 North
                                             Capitol Street, NW., suite 
                                             700, Washington, DC 20408. 
------------------------------------------------------------------------

    (c) Specifications. (1) Nitrogen content of the copolymer is in the 
range of 16 to 18.5 percent as determined by Micro-Kjeldahl analysis.
    (2) Residual acrylonitrile monomer content of the finished copolymer 
articles is not more than 11 parts per million as determined by a gas 
chromatographic method titled ``Determination of Residual Acrylonitrile 
and Styrene Monomers-Gas Chromatographic Internal Standard Method,'' 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (d) Extractive limitations. (1) Total nonvolatile extractives not to 
exceed 0.0005 milligram per square inch surface area when the finished 
food contact article is exposed to distilled water, 3 percent acetic 
acid, or n-heptane for 8 days at 120 deg. F.
    (2) The finished food-contact article shall yield not more than 
0.0015 milligram per square inch of acrylonitrile monomer when exposed 
to distilled water and 3 percent acetic acid at 150 deg. F for 15 days 
when analyzed by a polarographic method titled ``Extracted Acrylonitrile 
by Differential Pulse Polarography,'' which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.
    (f) Acrylonitrile copolymers identified in this section are not 
authorized to be used to fabricate beverage containers.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 
47 FR 11841, Mar. 19, 1982; 54 FR 24897, June 12, 1989]



Sec. 177.1030   Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.

    Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer 
identified in this section may be safely used as an article or component 
of articles intended for use with food identified in Table 1 of 
Sec. 176.170(c) of this

[[Page 222]]

chapter as Type I, II, III, IVA, IVB, V, VIB, (except bottles intended 
to hold carbonated beverages), VIIA, VIIB, VIII and IX, under conditions 
of use C, D, E, F, and G described in Table 2 of Sec. 176.170(c) of this 
chapter with a high temperature limitation of 190 deg. F.
    (a) Identity. For the purpose of this section, acrylonitrile/
butadiene/styrene/methyl methacrylate copolymer consists of: (1) 73 to 
79 parts by weight of a matrix polymer containing 64 to 69 parts by 
weight of acrylonitrile, 25 to 30 parts by weight of styrene and 4 to 6 
parts by weight of methyl methacrylate; and (2) 21 to 27 parts by weight 
of a grafted rubber consisting of (i) 16 to 20 parts of butadiene/
styrene/elastomer containing 72 to 77 parts by weight of butadiene and 
23 to 28 parts by weight of styrene and (ii) 5 to 10 parts by weight of 
a graft polymer having the same composition range as the matrix polymer.
    (b) Adjuvants. The copolymer identified in paragraph (a) of this 
section may contain adjuvant substances required in its production. Such 
adjuvants may include substances generally recognized as safe in food, 
substances used in accordance with prior sanction, substances permitted 
under applicable regulations in this part, and the following:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
2-Mercaptoethanol.........................  The finished copolymer shall
                                             contain not more than 800  
                                             ppm 2-mercaptoethanol      
                                             acrylonitrile adduct as    
                                             determined by a method     
                                             titled ``Analysis of       
                                             Cycopac Resin for Residual 
                                             -(2-Hydroxyethylme
                                             rcapto) propionitrile,''   
                                             which is incorporated by   
                                             reference. Copies are      
                                             available from the Bureau  
                                             of Foods (HFS-200), Food   
                                             and Drug Administration,   
                                             200 C St. SW., Washington, 
                                             DC 20204, or available for 
                                             inspection at the Office of
                                             the Federal Register, 800  
                                             North Capitol Street, NW., 
                                             suite 700, Washington, DC  
                                             20408.                     
------------------------------------------------------------------------

    (c) Specifications. (1) Nitrogen content of the copolymer is in the 
range of 13.0 to 16.0 percent as determined by Micro-Kjeldahl analysis.
    (2) Residual acrylonitrile monomer content of the finished copolymer 
articles is not more than 11 parts per million as determined by a gas 
chromatographic method titled ``Determination of Residual Acrylonitrile 
and Styrene Monomers-Gas Chromatographic Internal Standard Method,'' 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (d) Extractive limitations. (1) Total nonvolatile extractives not to 
exceed 0.0005 milligram per square inch surface area of the food-contact 
article when exposed to distilled water, 3 percent acetic acid, 50 
percent ethanol, and n-heptane for 10 days at 120 deg. F.
    (2) The finished food-contact article shall yield not more than 
0.0025 milligram per square inch of acrylonitrile monomer when exposed 
to distilled water, 3 percent acetic acid and n-heptane at 190 deg. F 
for 2 hours, cooled to 120 deg. F (80 to 90 minutes) and maintained at 
120 deg. F for 10 days when analyzed by a polarographic method titled 
``Extracted Acrylonitrile by Differential Pulse Polarography,'' which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.
    (f) Acrylonitrile copolymers identified in this section are not 
authorized to be used to fabricate beverage containers.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 
47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

[[Page 223]]



Sec. 177.1040   Acrylonitrile/styrene copoly-mer.

    Acrylonitrile/styrene copolymers identified in this section may be 
safely used as a component of packaging materials subject to the 
provisions of this section.
    (a) Identity. For the purposes of this section acrylonitrile/styrene 
copoly-mers are basic copolymers meeting the specifications prescribed 
in paragraph (c) of this section.
    (b) Adjuvants. (1) The copolymers identified in paragraph (c) of 
this section may contain adjuvant substances required in their 
production, with the exception that they shall not contain mercaptans or 
other substances which form reversible complexes with acryl-onitrile 
monomer. Permissible adjuvants may include substances generally 
recognized as safe in food, substances used in accordance with prior 
sanction, substances permitted under applicable regulations in this 
part, and those authorized in paragraph (b)(2) of this section.
    (2) The optional adjuvants for the acrylonitrile/styrene copolymer 
identified in paragraphs (c) (1) and (3) of this section are as follows:

------------------------------------------------------------------------
                Substances                           Limitation         
------------------------------------------------------------------------
Condensation polymer of toluene             0.15 pct maximum.           
 sulfonamide and formaldehyde.                                          
------------------------------------------------------------------------

    (c) Specifications.

----------------------------------------------------------------------------------------------------------------
                                                                           Maximum                              
                                  Maximum residual                       extractable                            
                                    acrylonitrile       Nitrogen        fractions at         Conformance with   
Acrylonitrile/styrene copolymers   monomer content     content of         specified       certain specifications
                                     of finished       copolymer      temperatures and                          
                                       article                              times                               
----------------------------------------------------------------------------------------------------------------
1. Acrylonitrile/styrene          80 ppm\1\.......  17.4 to 19 pct.  Total nonvolatile   Minimum number average 
 copolymer consisting of the                                          extractives not     molecular weight is   
 copolymer produced by                                                to exceed 0.01 mg/  30,000.\1\            
 polymerization of 66-72 parts                                        in \2\ surface                            
 by weight of acrylonitrile and                                       area of the food                          
 28-34 parts by weight of                                             contact article                           
 styrene; for use with food of                                        when exposed to                           
 Type VI-B identified in Table 1                                      distilled water                           
 of Sec.  176.170(c) of this                                          and 3 pct acetic                          
 chapter under conditions of use                                      acid for 10 d at                          
 C, D, E, F, G described in                                           66 C (150 F).                             
 Table 2 of Sec.  176.170(c) of                                      The extracted                              
 this chapter.                                                        copolymer shall                           
                                                                      not exceed 0.001                          
                                                                      mg/in \2\ surface                         
                                                                      area of the food                          
                                                                      contact article                           
                                                                      when exposed to                           
                                                                      distilled water                           
                                                                      and 3 pct acetic                          
                                                                      acid for 10 d at                          
                                                                      66 C (150 F) \1\                          
2. Acrylonitrile/styrene          50 ppm\1\.......  12.2 to 17.2     Extracted           Minimum 10 pct solution
 copolymer consisting of the                         pct.             copolymer not to    viscosity at 25 C (77 
 copolymer produced by                                                exceed 2.0 ppm in   F) is 10cP.\1\        
 polymerization of 45-65 parts                                        aqueous extract                           
 by weight of acrylonitrile and                                       or n-heptane                              
 35-55 parts by weigth of                                             extract obtained                          
 styrene; for use with food of                                        when 100 g sample                         
 Types, I, II, III, IV, V, VI                                         of the basic                              
 (except bottles), VII, VIII,                                         copolymer in the                          
 and IX identified in Table 1 of                                      form of particles                         
 Sec.  176.170(c) of this                                             of a size that                            
 chapter under conditions B (not                                      will pass through                         
 to exceed 93 C (200 F)), C, D,                                       a U.S. Standard                           
 E, F, G described in Table 2 of                                      Sieve No. 6 and                           
 Sec.  176.170(c) of this                                             that will be held                         
 chapter.                                                             on a U.S.                                 
                                                                      Standard Sieve                            
                                                                      No. 10 is                                 
                                                                      extracted with                            
                                                                      250 mil of                                
                                                                      deionized water                           
                                                                      or reagent grade                          
                                                                      n-heptane at                              
                                                                      reflux                                    
                                                                      temperature for 2                         
                                                                      h.\1\                                     
3. Acrylonitrile/styrene          0.10 ppm          17.4 to 19 pct.  Total nonvolatile   Maximum carbon dioxide 
 copolymer consisting of the       (calculated on                     extractives not     permeability at 23 C  
 copolymer produced by             the basis of                       to exceed 0.01 mg/  (73 F) for the        
 polymerization of 66-72 parts     the weight of                      in \2\ surface      finished article is   
 by weight of acrylonitrile and    the                                area of the food    0.04 barrer.\3\       
 28-34 parts by weight of          acrylonitrile                      contact article                           
 styrene; for use with food of     copolymer resin                    when exposed to                           
 Types VI-A and VI-B identified    in the finished                    distilled water                           
 in Table 1 of Sec.  176.170(c)    articles).\2\                      and 3 pct acetic                          
 of this chapter under                                                acid for 10 d at                          
 conditions of use C, D, E, F, G                                      66 C (150 F).                             
 described in Table 2 of Sec.                                        The extracted                              
 176.170(c) of this chapter.                                          copolymer shall                           
                                                                      not exceed 0.001                          
                                                                      mg/in \2\ surface                         
                                                                      area of the food                          
                                                                      contact article                           
                                                                      when exposed to                           
                                                                      distilled water                           
                                                                      and 3 pct acetic                          
                                                                      acid for 10 d at                          
                                                                      66 C (150  F).\1\                         
----------------------------------------------------------------------------------------------------------------
\1\ Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction,      
  number average molecular weight, and solution viscosity, titled: ``Determination of Residual Acrylonitrile and
  Styrene Monomers-Gas Chromatographic Internal Standard Method''; ``Infrared Spectrophotometric Determination  
  of Polymer Extracted from Barex 210 Resin Pellets''; ``Procedure for the Determination of Molecular Weights of
  Acrylonitrile/Styrene Copolymers,'' and ``Analytical Method for 10% Solution Viscosity of Tyril,'' which are  
  incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-   
  200), 200 C Street SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800   
  North Capitol Street, NW., suite 700, Washington, DC 20408.                                                   

[[Page 224]]

                                                                                                                
\2\ As determined by the method titled ``Headspace Sampling and Gas-Solid Chromatographic Determination of      
  Residual Acrylonitrile in Acrylonitrile Copolyemr Solutions,'' which is incorporated by reference. Copies are 
  available from the Center for Food Safety and Applied Nutrition (HFS-200), 200 C Street SW., Washington, DC   
  20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700,    
  Washington, DC 20408.                                                                                         
\3\ As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a     
  multilayer construction by ASTM method D-1434-82, ``Standard Method for Determining Gas Permeability          
  Characteristics of Plastic Film and Sheeting,'' which is incorporated by reference. Copies are available from 
  the Center for Food Safety and Applied Nutrition (HFS-200), 200 C Street SW., Washington, DC 20204, and the   
  American Society for Testing Materials, 1916 Race Street, Philadelphia, PA 19103, or may be examined at the   
  Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.               

    (d) Interim listing. Acrylonitrile copolymers identified in this 
section shall comply with the provisions of Sec. 180.22 of this chapter.
    (e) Acrylonitrile copolymer identified in this section may be used 
to fabricate beverage containers only if they comply with the 
specifications of item 3 in paragraph (c) of this section.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 
47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 
Sept. 8, 1987]



Sec. 177.1050   Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer.

    Acrylonitrile/styrene copolymer modified with butadiene/styrene 
elastomer identified in this section may be safely used as a component 
of bottles intended for use with foods identified in Table I of 
Sec. 176.170(c) of this chapter as Type VI-B under conditions for use E, 
F, or G described in Table 2 of Sec. 176.170(c) of this chapter.
    (a) Identity. For the purpose of this section, acrylonitrile/styrene 
copoly- mer modified with butadiene/styrene elastomer consists of a 
blend of:
    (1) 82-88 parts by weight of a matrix copolymer produced by 
polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts 
of styrene; and
    (2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12 
parts of butadiene/styrene elastomer containing 77-82 parts by weight of 
butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by 
weight of a graft copolymer consisting of 70-77 parts by weight of 
acrylonitrile and 23-30 parts by weight of styrene.
    (b) Adjuvants. The modified copoly-mer identified in paragraph (a) 
of this section may contain adjuvant substances required in its 
production. Such adjuvants may include substances generally recognized 
as safe in food, substances used in accordance with prior sanction, 
substances permitted under applicable regulations in this part, and the 
following:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
n-Dodecylmercaptan........................  The finished copolymer shall
                                             contain not more than 500  
                                             parts per million (ppm)    
                                             dodecylmercaptan as        
                                             dodecylmercapto-           
                                             propionitrile as determined
                                             by the method titled,      
                                             ``Determination of -Dodecyl-                
                                             mercaptopropionitrile in NR-
                                             16 Polymer,'' which is     
                                             incorporated by reference. 
                                             Copies are available from  
                                             the Center for Food Safety 
                                             and Applied Nutrition (HFS-
                                             200), Food and Drug        
                                             Administration, 200 C St., 
                                             SW., Washington, DC 20204, 
                                             or available for inspection
                                             at the Office of the       
                                             Federal Register, 800 North
                                             Capitol Street, NW., suite 
                                             700, Washington, DC 20408. 
------------------------------------------------------------------------

    (c) Specifications. (1) Nitrogen content of the modified copolymer 
is in the range of 17.7-19.8 percent.
    (2) Intrinsic viscosity of the matrix copolymer in butyrolactone is 
not less than 0.5 deciliter/gram at 35 deg. C, as determined by the 
method titled ``Molecular Weight of Matrix Copolymer by Solution 
Viscosity,'' which is incorporated by reference. Copies are available 
from

[[Page 225]]

the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (3) Residual acrylonitrile monomer content of the modified copolymer 
articles is not more than 11 ppm as determined by a gas chromatographic 
method titled ``Determination of Residual Acrylonitrile and Styrene 
Monomers-Gas Chromatographic Internal Standard Method,'' which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (d) Extractives limitations. The following extractives limitations 
are determined by an infrared spectrophotometric method titled 
``Infrared Spectrophotometric Determination of Polymer Extracted from 
Borex 210 Resin Pellets,'' which is incorporated by reference. 
Copies are available from the Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408, and are applicable to the modified copolymers in the form of 
particles of a size that will pass through a U.S. Standard Sieve No. 6 
and that will be held on a U.S. Standard Sieve No. 10:
    (1) The extracted copolymer shall not exceed 2.0 ppm in aqueous 
extract obtained when a 100-gram sample of copolymer is extracted with 
250 milliliters of freshly distilled water at reflux temperature for 2 
hours.
    (2) The extracted copolymer shall not exceed 0.5 ppm in n-heptane 
when a 100-gram sample of the basic copol-ymer is extracted with 250 
milliliters spectral grade n-heptane at reflux temperature for 2 hours.
    (e) Accelerated extraction end test. The modified copolymer shall 
yield acrylonitrile monomer not in excess of 0.4 ppm when tested as 
follows:
    (1) The modified copolymer shall be in the form of eight strips \1/
2\ inch by 4 inches by .03 inch.
    (2) The modified copolymer strips shall be immersed in 225 
milliliters of 3 percent acetic acid in a Pyrex glass pressure bottle.
    (3) The pyrex glass pressure bottle is then sealed and heated to 
150 deg. F in either a circulating air oven or a thermostat controlled 
bath for a period of 8 days.
    (4) The Pyrex glass pressure bottle is then removed from the oven or 
bath and cooled to room temperature. A sample of the extracting solvent 
is then withdrawn and analyzed for acrylonitrile monomer by a gas 
chromatographic method titled ``Gas-Solid Chromatographic Procedure for 
Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers 
and Food Simulating Solvents,'' which is incorporated by reference. 
Copies, are available from the Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (f) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.
    (g) Acrylonitrile copolymers identified in this section are not 
authorized to be used to fabricate beverage containers.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977; 
47 FR 11841, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, 
June 12, 1989]



Sec. 177.1060  n-Alkylglutarimide/acrylic copolymers.

    n-Alkylglutarimide/acrylic copolymers identified in this section may 
be safely used as articles or components of articles intended for use in 
contact with food subject to provisions of this section and part 174 of 
this chapter.
    (a) Identity. For the purpose of this section, n-alkylglutarimide/
acrylic copolymers are copolymers obtained by reaction of substances 
permitted by Sec. 177.1010(a) (1), (2), and (3) with the following 
substance: Monomethylamine (CAS Reg. No. 74-89-5), to form n-
methylglutarimide/acrylic copolymers.
    (b) Adjuvants. The copolymers identified in paragraph (a) of this 
section may contain adjuvant substances required in their production. 
The optional adjuvant substances required in the production of the basic 
polymer may include substances permitted for such use by applicable 
regulations, as set forth in part 174 of this chapter.
    (c) Specifications. Maximum nitrogen content of the copolymer 
determined by micro-Kjeldahl analysis, shall not exceed 8 percent.

[[Page 226]]

    (d) Limitations. (1) The n-alkylglutarimide/acrylic copolymers in 
the finished form in which they shall contact food, when extracted with 
the solvent or solvents characterizing the type of food and under the 
conditions of time and temperature described in Tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall yield extractives not to exceed 
the limitations of Sec. 177.1010(b) of this chapter, when prepared as 
strips, as described in Sec. 177.1010(c)(2) of this chapter.
    (2) The n-alkylglutarimide/acrylic copolymers shall not be used as 
polymer modifiers in vinyl chloride homo- or copolymers.
    (e) Conditions of use. The n-alkylglutarimide/acrylic copolymers are 
used as articles or components of articles (other than articles composed 
of vinyl chloride homo- or copolymers) intended for use in contact with 
all foods except beverages containing more than 8 percent alcohol under 
conditions of use D, E, F, and G as described in Table 2 of 
Sec. 176.170(c) of this chapter.

[54 FR 20382, May 11, 1989, as amended at 58 FR 17098, Apr. 1, 1993]



Sec. 177.1200   Cellophane.

    Cellophane may be safely used for packaging food in accordance with 
the following prescribed conditions:
    (a) Cellophane consists of a base sheet made from regenerated 
cellulose to which have been added certain optional substances of a 
grade of purity suitable for use in food packaging as constituents of 
the base sheet or as coatings applied to impart desired technological 
properties.
    (b) Subject to any limitations prescribed in this part, the optional 
substances used in the base sheet and coating may include:
    (1) Substances generally recognized as safe in food.
    (2) Substances for which prior approval or sanctions permit their 
use in cellophane, under conditions specified in such sanctions and 
substances listed in Sec. 181.22 of this chapter.
    (3) Substances that by any regulation promulgated under section 409 
of the act may be safely used as components of cellophane.
    (4) Substances named in this section and further identified as 
required.
    (c) List of substances:

------------------------------------------------------------------------
                                         Limitations (residue and limits
                                             of addition expressed as   
           List of substances             percent by weight of finished 
                                              packaging cellophane)     
------------------------------------------------------------------------
Acrylonitrile-butadiene copolymer        As the basic polymer.          
 resins.                                                                
Acrylonitrile-butadiene-styrene              Do.                        
 copolymer resins.                                                      
Acrylonitrile-styrene copolymer resins.      Do.                        
Acrylonitrile-vinyl chloride copolymer       Do.                        
 resins.                                                                
N-Acyl sarcosines where the acyl group   For use only as release agents 
 is lauroyl or stearoyl..                 in coatings at levels not to  
                                          exceed a total of 0.3 percent 
                                          by weight of the finished     
                                          packaging cellophane.         
Alkyl ketene dimers identified in Sec.                                  
 176.120 of this chapter.                                               
Aluminum hydroxide.....................                                 
Aluminum silicate......................                                 
Ammonium persulfate....................                                 
Ammonium sulfate.......................                                 
Behenamide.............................                                 
Butadiene-styrene copolymer............  As the basic polymer.          
1,3-Butanediol.........................                                 
n-Butyl acetate........................  0.1 percent.                   
n-Butyl alcohol........................      Do.                        
Calcium ethyl acetoacetate.............                                 
Calcium stearoyl-2-lactylate identified  Not to exceed 0.5 percent      
 in Sec.  172.844 of this chapter.        weight of cellophane.         
Carboxymethyl hydroxyethylcellulose                                     
 polymer.                                                               
Castor oil, hydrogenated...............                                 
Castor oil phthalate with adipic acid    As the basic polymer.          
 and fumaric acid-diethylene glycol                                     
 polyester.                                                             
Castor oil phthalate, hydrogenated.....  Alone or in combination with   
                                          other phthalates where total  
                                          phthalates do not exceed 5    
                                          percent.                      
Castor oil, sulfonated, sodium salt....                                 
Cellulose acetate butyrate.............                                 
Cellulose acetate propionate...........                                 
Cetyl alcohol..........................                                 
Clay, natural..........................                                 

[[Page 227]]

                                                                        
Coconut oil fatty acid (C12-C18)         For use only as an adjuvant    
 diethanolamide, coconut oil fatty acid   employed during the processing
 (C12-C18) diethanolamine soap, and       of cellulose pulp used in the 
 diethanolamine mixture having total      manufacture of cellophane base
 alkali (calculated as potassium          sheet.                        
 hydroxide) of 16-18% and having an                                     
 acid number of 25-35.                                                  
Copal resin, heat processed............  As basic resin.                
Damar resin............................                                 
Defoaming agents identified in Sec.                                     
 176.200 of this chapter.                                               
Dialkyl ketones where the alkyl groups   Not to exceed a total of 0.35  
 are lauryl or stearyl.                   percent.                      
Dibutylphthalate.......................  Alone or in combination with   
                                          other phthalates where total  
                                          phthalates do not exceed 5    
                                          percent.                      
Dicyclohexyl phthalate.................      Do.                        
Diethylene glycol ester of the adduct                                   
 of terpene and maleic anhydride.                                       
Di(2-ethylhexyl) adipate...............                                 
Di(2-ethylhexyl) phthalate.............  Alone or in combination with   
                                          other phthalates where total  
                                          phthalates do not exceed 5    
                                          percent.                      
Diisobutyl phthalate...................      Do.                        
Dimethylcyclohexyl phthalate...........      Do.                        
Dimethyldialkyl (C8-C18) ammonium        0.005 percent for use only as a
 chloride.                                flocculant for slip agents.   
Di-n-ocyltin bis (2-ethylhexyl maleate)  For use only as a stabilizer at
                                          a level not to exceed 0.55    
                                          percent by weight of the      
                                          coating solids in vinylidene  
                                          chloride copolymer waterproof 
                                          coatings prepared from        
                                          vinylidene chloride copolymers
                                          identified in this paragraph, 
                                          provided that such vinylidene 
                                          chloride copolymers contain   
                                          not less than 90 percent by   
                                          weight of polymer units       
                                          derived from vinylidene       
                                          chloride.                     
N,N'-Dioleoyethylenediamine, N,N'-       0.5 percent.                   
 dilinoleoylethylene-diamine and N-                                     
 oleoyl-N'linoleoylethylene-diamine                                     
 mixture produced when tall oil fatty                                   
 acids are made to react with                                           
 ethylenediamine such that the finished                                 
 mixture has a melting point of 212                                     
 deg.-228 deg. F., as determined by                                     
 ASTM method D127-60 (``Standard Method                                 
 of Test for Melting Point of                                           
 Petrolatum and Microcrystalline Wax''                                  
 (Revised 1960), which is incorporated                                  
 by reference; copies are available                                     
 from University Microfilms                                             
 International, 300 N. Zeeb Rd., Ann                                    
 Arbor, MI 48106, or available for                                      
 inspection at the Office of the                                        
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC                                 
 20408), and an acid value of 10                                        
 maximum.                                                               
N,N'-Dioleoylethylenediamine (N,N'-                                     
 ethylenebisoleamide).                                                  
Disodium EDTA..........................                                 
Distearic acid ester of                  0.06 percent.                  
 di(hydroxyethyl) diethylenetriamine                                    
 monoacetate.                                                           
N,N'-Distearoylethylenediamine (N,N'-                                   
 ethylenebis stearamide).                                               
Epoxidized polybutadiene...............  For use only as a primer       
                                          subcoat to anchor surface     
                                          coatings to the base sheet.   
Erucamide..............................                                 
Ethyl acetate..........................                                 
Ethylene-vinyl acetate copolymers                                       
 complying with Sec.  177.1350.                                         
2-Ethylhexyl alcohol...................  0.1 percent for use only as    
                                          lubricant.                    
Fatty acids derived from animal and                                     
 vegetable fats and oils, and the                                       
 following salts of such acids, single                                  
 or mixed: Aluminum, ammonium, calcium,                                 
 magnesium, potassium, sodium.                                          
Ferrous ammonium sulfate...............                                 
Fumaric acid...........................                                 
Glycerin-maleic anhydride..............  As the basic polymer.          
Glycerol diacetate.....................                                 
Glycerol monoacetate...................                                 
Hydroxyethyl cellulose, water-insoluble                                 
Hydroxypropyl cellulose identified in                                   
 Sec.  172.870 of this chapter.                                         
Isopropyl acetate......................  Residue limit 0.1 percent      
Isopropyl alcohol......................      Do.                        
Itaconic acid..........................                                 
Lanolin................................                                 
Lauryl alcohol.........................                                 
Lauryl sulfate salts: ammonium,                                         
 magnesium, potassium, sodium.                                          
Maleic acid............................  1 percent.                     
Maleic acid adduct of butadienestyrene                                  
 copolymer.                                                             
Melamine formaldehyde..................  As the basic polymer.          

[[Page 228]]

                                                                        
Melamine-formaldehyde modified with one  As the basic polymer, and used 
 or more of the following: Butyl          as a resin to anchor coatings 
 alcohol, diaminopropane,                 to substrate.                 
 diethylenetriamine, ethyl alcohol,                                     
 guanidine, imino-bis-butylamine, imino-                                
 bis-ethylamine, imino-bis-propylamine,                                 
 methyl alcohol, polyamines made by                                     
 reacting ethylenediamine or                                            
 trimethylenediamine with                                               
 dichloroethane or dichloropropane,                                     
 sulfanilic acid,                                                       
 tetraethylenepentamine,                                                
 triethanolamine, triethylenetetra-mine.                                
Methyl ethyl ketone....................  Residue limit 0.1 percent      
Methyl hydrogen siloxane...............  0.1 percent as the basic       
                                          polymer.                      
-Methylstyrene-vinyltoluene                                    
 copolymer resins (molar ratio 1 -methylstyrene to 3 vinyltoluene).                                   
Mineral oil, white.....................                                 
Naphthalenesulfonic acid-formaldehyde    0.1 percent, for use only as an
 condensate, sodium salt.                 emulsifier.                   
Nitrocellulose, 10.9 percent-12.2                                       
 percent nitrogen.                                                      
Nylon resins complying with Sec.                                        
 177.1500.                                                              
n-Octyl alcohol........................  For use only as a defoaming    
                                          agent in the manufacture of   
                                          cellophane base sheet.        
Olefin copolymers complying with Sec.                                   
 177.1520.                                                              
Oleic acid reacted with N-alkyl                                         
 trimethylenediamine (alkyl C16 to C18).                                
Oleic acid, sulfonated, sodium salt....                                 
Oleyl palmitamide......................                                 
N,N'-Oleoyl-stearylethylenediamine (N-                                  
 (2-stearoyl-aminoethyl)oleamide).                                      
Paraffin, synthetic, complying with                                     
 Sec.  175.250 of this chapter.                                         
Pentaerythritol tetrastearate..........  0.1 percent.                   
Polyamide resins derived from dimerized  For use only in cellophane     
 vegetable oil acids (containing not      coatings that contact food at 
 more than 20 percent of monomer acids)   temperatures not to exceed    
 and ethylenediamine as the basic resin.  room temperature.             
Polyamide resins having a maximum acid   As the basic resin, for use    
 value of 5 and a maximum amine value     only in coatings that contact 
 of 8.5 derived from dimerized            food at temperatures not to   
 vegetable oil acids (containing not      exceed room temperature       
 more than 10 percent monomer acids),     provided that the             
 ethylenediamine, and 4,4-bis(4-          concentration of the polyamido
 hydroxyphenyl)pentanoic acid (in an      resins in the finished food-  
 amount not to exceed 10 percent by       contact coating does not      
 weight of said polyamide resins).        exceed 5 milligrams per square
                                          inch of food-contact surface. 
Polybutadiene resin (molecular weight    For use only as an adjuvant in 
 range 2,000-10,200; bromine number       vinylidene chloride copolymer 
 range 210-320).                          coatings.                     
Polycarbonate resins complying with                                     
 Sec.  177.1580.                                                        
Polyester resin formed by the reaction                                  
 of the methyl ester of rosin, phthalic                                 
 anhydride, maleic anhydride, and                                       
 ethylene glycol, such that the                                         
 polyester resin has an acid number of                                  
 4 to 11, a drop-softening point of 70                                  
 deg. C-92 deg. C, and a color of K or                                  
 paler.                                                                 
Polyethylene...........................                                 
Polyethyleneaminostearamide ethyl        0.1 percent.                   
 sulfate produced when stearic acid is                                  
 made to react with equal parts of                                      
 diethylenetriamine and                                                 
 triethylenetetramine and the reaction                                  
 product is quaternized with diethyl                                    
 sulfate.                                                               
Polyethylene glycol (400) monolaurate..                                 
Polyethylene glycol (600) monolaurate..                                 
Polyethylene glycol (400) monooleate...                                 
Polyethylene glycol (600) monooleate...                                 
Polyethylene glycol (400) monostearate.                                 
Polyethylene glycol (600) monostearate.                                 
Polyethylene, oxidized: complying with                                  
 the identity prescribed in Sec.                                        
 177.1620(a).                                                           
Polyethylenimine.......................  As the basic polymer, for use  
                                          as a resin to anchor coatings 
                                          to the substrate and for use  
                                          as an impregnant in the food- 
                                          contact surface of regenerated
                                          cellulose sheet in an amount  
                                          not to exceed that required to
                                          improve heat-sealable bonding 
                                          between coated and uncoated   
                                          sides of cellophane.          
Polyisobutylene complying with Sec.                                     
 177.1420.                                                              
Polyoxypropylene-polyoxyethylene block   For use as an adjuvant employed
 polymers (molecular weight 1,900-        during the processing of      
 9,000).                                  cellulose pulp used in the    
                                          manufacture of cellophane base
                                          sheet.                        
Polypropylene complying with Sec.                                       
 177.1520.                                                              
Polystyrene............................  As the basic polymer.          
Polyvinyl acetate......................      Do.                        
Polyvinyl alcohol (minimum viscosity of                                 
 4 percent aqueous solution at 20 deg.                                  
 C of 4 centipoises).                                                   
Polyvinyl chloride.....................  As the basic polymer.          

[[Page 229]]

                                                                        
Polyvinyl stearate.....................      Do.                        
n-Propyl acetate.......................  Residue limit 0.1 percent.     
n-Propyl alcohol.......................      Do.                        
Rapeseed oil, blown....................                                 
Rosins and rosin derivatives as                                         
 provided in Sec.  178.3870 of this                                     
 chapter.                                                               
Rubber, natural (natural latex solids).                                 
Silica.................................                                 
Silicic acid...........................                                 
Sodium m-bisulfite.....................                                 
Sodium dioctyl sulfosuccinate..........                                 
Sodium dodecylbenzenesulfonate.........                                 
Sodium lauroyl sarcosinate.............  0.35 percent; for use only in  
                                          vinylidene chloride copolymer 
                                          coatings.                     
Sodium oleyl sulfate-sodium cetyl        For use only as an emulsifier  
 sulfate mixture.                         for coatings; limit 0.005     
                                          percent where coating is      
                                          applied to one side only and  
                                          0.01 percent where coating is 
                                          applied to both sides.        
Sodium silicate........................                                 
Sodium stearoyl-2-lactylate identified   Not to exceed 0.5 percent      
 in Sec.  172.846 of this chapter.        weight of cellophane.         
Sodium sulfate.........................                                 
Sodium sulfite.........................                                 
Spermaceti wax.........................                                 
Stannous oleate........................                                 
2-Stearamido-ethyl stearate............                                 
Stearyl alcohol........................                                 
Styrene-maleic anhydride resins........  As the basic polymer.          
Terpene resins identified in Sec.                                       
 172.615 of this chapter.                                               
Tetrahydrofuran........................  Residue limit of 0.1 percent.  
Titanium dioxide.......................                                 
Toluene................................  Residue limit of 0.1 percent.  
Toluene sulfonamide formaldehyde.......  0.6 percent as the basic       
                                          polymer.                      
Triethylene glycol.....................                                 
Triethylene glycol diacetate, prepared                                  
 from triethylene glycol containing not                                 
 more than 0.1 percent of diethylene                                    
 glycol.                                                                
2,2,4-Trimethyl-1,3 pentanediol          For use only in cellophane     
 diisobutyrate.                           coatings and limited to use at
                                          a level not to exceed 10      
                                          percent by weight of the      
                                          coating solids except when    
                                          used as provided in Sec.      
                                          178.3740 of this chapter      
Urea (carbamide).......................                                 
Urea formaldehyde......................  As the basic polymer.          
Urea formaldehyde modified with          As the basic polymer, and used 
 methanol, ethanol, butanol               as a resin to anchor coatings 
 diethylenetriamine,                      to the substrate.             
 triethylenetetramine,                                                  
 tetraethylenepenta-mine, guanidine,                                    
 sodium sulfite, sulfanilic acid, imino-                                
 bis-ethylamine, imino-bis-propylamine,                                 
 imino-bis-butylamine, diaminopropane,                                  
 diaminobutane, aminomethylsulfonic                                     
 acid, polyamines made by reacting                                      
 ethylenediamine or trimethylenediamine                                 
 with dichlorethane or dichloropropane.                                 
Vinyl acetate-vinyl chloride copolymer   As the basic polymer.          
 resins.                                                                
Vinyl acetate-vinyl chloride-maleic          Do.                        
 acid copolymer resins.                                                 
Vinylidene chloride copolymerized with       Do.                        
 one or more of the following: Acrylic                                  
 acid, acrylonitrile, butyl acrylate,                                   
 butyl methacrylate, ethyl acrylate, 2-                                 
 ethylhexyl acrylate, 2-ethylhexyl                                      
 methacrylate, ethyl methacrylate,                                      
 itaconic acid, methacrylic acid,                                       
 methyl acrylate, methyl methacrylate,                                  
 propyl acrylate, propyl methacrylate,                                  
 vinyl chloride.                                                        
Vinylidene chloride-methacrylate             Do.                        
 decyloctyl copolymer.                                                  
Wax, petroleum, complying with Sec.                                     
 178.3710 of this chapter.                                              
------------------------------------------------------------------------

    (d) Any optional component listed in this section covered by a 
specific food additive regulation must meet any specifications in that 
regulation.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982]

[[Page 230]]



Sec. 177.1210   Closures with sealing gaskets for food containers.

    Closures with sealing gaskets may be safely used on containers 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food in 
accordance with the following prescribed conditions:
    (a) Closures for food containers are manufactured from substances 
generally recognized as safe for contact with food; substances that are 
subject to the provisions of prior sanctions; substances authorized by 
regulations in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter; and closure-sealing gaskets, as further prescribed in this 
section.
    (b) Closure-sealing gaskets and overall discs are formulated from 
substances identified in Sec. 175.300(b) of this chapter, with the 
exception of paragraph (b)(3) (v), (xxxi), and (xxxii) of that section, 
and from other optional substances, including the following:
    (1) Substances generally recognized as safe in food.
    (2) Substances used in accordance with the provisions of a prior 
sanction or approval within the meaning of section 201(s) of the act.
    (3) Substances that are the subject of regulations in parts 174, 
175, 176, 177, 178 and Sec. 179.45 of this chapter and used in 
accordance with the conditions prescribed.
    (4) Substances identified in paragraph (b)(5) of this section, used 
in amounts not to exceed those required to accomplish the intended 
physical or technical effect and in conformance with any limitation 
provided; and further provided that any substance employed in the 
production of closure-sealing gasket compositions that is the subject of 
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter conforms with the identity or specifications prescribed.
    (5) Substances that may be employed in the manufacture of closure-
sealing gaskets include:

                                 Table 1                                
------------------------------------------------------------------------
                                            Limitations (expressed as   
           List of substances             percent by weight of closure- 
                                           sealing gasket composition)  
------------------------------------------------------------------------
Arachidy-l-behenyl amide (C20-C22fatty   5 percent.                     
 acid amides).                                                          
Azodicarbonamide.......................  1. 2 percent.                  
                                         2. 5 percent; for use only in  
                                          the manufacture of            
                                          polyethylene complying with   
                                          item 2.1 in Sec.  177.1520(c) 
                                          of this chapter.              
Balata rubber..........................                                 
Benzyl alcohol.........................  1 percent.                     
Brominated isobutylene-isoprene                                         
 copolymers, produced when isobutylene-                                 
 isoprene copolymers complying with                                     
 Sec.  177.1420(a)(2) are modified by                                   
 bromination with not more than 2.3                                     
 weight-percent of bromine and having a                                 
 Mooney Viscosity (ML 1+8 (125  deg.C))                                 
 of 27 or higher. The viscosity is                                      
 determined by the American Society for                                 
 Testing and Materials (ASTM) method D                                  
 1646-81, ``Standard Test Method for                                    
 Rubber--Viscosity and Vulcanization                                    
 Characteristics (Mooney Viscometer),''                                 
 which is incorporated by reference in                                  
 accordance with 5 U.S.C. 522(a) and 1                                  
 CFR part 51. Copies are available from                                 
 the Association of Official Analytical                                 
 Chemists International, 481 North                                      
 Frederick Ave., suite 500,                                             
 Gaithersberg, MD 20877-2054 and the                                    
 Center for Food Safety and Applied                                     
 Nutrition (HFS-200), Food and Drug                                     
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or available for                                 
 inspection at the Office of the                                        
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC.                                
1,3-Butanediol.........................                                 
Calcium tin stearate...................  2 percent.                     
Calcium zinc stearate..................      Do.                        
Carbon, activated......................  1 percent.                     
Castor oil, hydrogenated...............  2 percent.                     
Chlorinated isobutylene-isoprene                                        
 copolymers complying with Sec.                                         
 177.1420.                                                              
Coco amide (coconut oil fatty acids      2 percent.                     
 amides).                                                               
Cork (cleaned, granulated).............                                 
Diebenzamide phenyl disulfide..........  1 percent; for use only in     
                                          vulcanized natural or         
                                          synthetic rubber gasket       
                                          compositions.                 

[[Page 231]]

                                                                        
Di(C7, C9-alkyl) adipate...............  Complying with Sec.  178.3740  
                                          of this chapter; except that, 
                                          there is no limitation on     
                                          polymer thickness.            
Di-2-ethylhexyl adipate................                                 
Di-2-ethylhexyl sebacate...............  2 percent.                     
Dihexyl ester of sodium sulfosuccinate.  1 percent.                     
Diisodecyl phthalate...................  No limitation on amount used   
                                          but for use only in closure-  
                                          sealing gasket compositions   
                                          used in contact with non-fatty
                                          foods containing no more than 
                                          8 percent of alcohol.         
Di--naphthyl-p-                 1 percent.                     
 phenylenediamine.                                                      
Dipentamethylenethiurametetrasulfide...  0.4 percent; for use only in   
                                          vulcanized natural or         
                                          synthetic rubber gasket       
                                          compositions.                 
Eicosane (technical grade) (water-white                                 
 mixture of predominantly straight-                                     
 chain paraffin hydrocarbons averaging                                  
 20 carbon atoms per molecule).                                         
Epoxidized linseed oil.................                                 
Epoxidized linseed oil modified with                                    
 trimellitic anhydride.                                                 
Epoxidized safflower oil...............                                 
Epoxidized safflower oil modified with                                  
 trimellitic anhydride.                                                 
Epoxidized soybean oil modified with                                    
 trimellitic anhydride.                                                 
Erucylamide............................  5 percent.                     
Ethylene-propylene copolymer...........                                 
Ethylene-propylene modified copolymer                                   
 elastomers produced when ethylene and                                  
 propylene are copolymerized with 5-                                    
 methylene-2-norbornene and/or 5-                                       
 ethylidine-2-norbornene. The finished                                  
 copolymer elastomers so produced shall                                 
 contain not more than 5 weight-percent                                 
 of total polymer units derived from 5-                                 
 methylene-2-norbornene and/or 5-                                       
 ethylidine-2-norbornene, and shall                                     
 have a minimum viscosity average                                       
 molecular weight of 120,000 as                                         
 determined by the method described in                                  
 Sec.  177.1520(d)(5), and a minimum                                    
 Mooney viscosity of 35 as determined                                   
 by the method described in Sec.                                        
 177.1520(d)(6).                                                        
Ethylene-vinyl acetate copolymer.......                                 
Glyceryl mono-12-hydroxystearate         2 percent.                     
 (hydrogenated glyceryl ricinoleate).                                   
Gutta-percha...........................                                 
Hexamethylenetetramine.................  1 percent.                     
Hexylene glycol........................  0.5 percent.                   
Isobutylene-isoprene copolymers                                         
 complying with Sec.  177.1420.                                         
Maleic anhydride-polyethylene copolymer  5 percent.                     
Maleic anhydride-styrene copolymer.....      Do.                        
2,2'-Methylenebis[6-(1-                  1 percent.                     
 methylcylcohexyl)-p-cresol].                                           
Mixed octylated diphenylamine (CAS Reg.  0.1 percent in isobutylene-    
 No. 68411-46-1).                         isoprene and chlorinated      
                                          isobutylene-isoprene          
                                          copolymers complying with Sec.
                                           177.1420, and brominated     
                                          isobutylene-isoprene          
                                          copolymers complying with this
                                          section.                      
Napthalene sulfonic acid-formaldehyde    0.2 percent.                   
 condensate, sodium salt.                                               
Natural rubber (crepe, latex,                                           
 mechanical dispersions).                                               
-cis-9-Octadecenyl-omega-       0.5 percent.                   
 hydroxypoly (oxyethylene); the                                         
 octadecenyl group is derived from                                      
 oleyl alcohol and the poly                                             
 (oxyethylene) content averages 20                                      
 moles.                                                                 
Oleyl alcohol..........................  1 percent.                     
4,4'-Oxybis (benzene sulfonyl            0.5 percent.                   
 hydrazide).                                                            
Paraformaldehyde.......................  1 percent.                     
Polybutadiene..........................                                 
Poly-p-dinitroso benzene (activator for  1 percent; for use only in     
 butyl rubber).                           vulcanized natural or         
                                          synthetic rubber gasket       
                                          compositions.                 
Polyethylene glycol 400 esters of fatty  1 percent.                     
 acids derived from animal and                                          
 vegetable fats and oils..                                              
Polyisobutylene complying with Sec.                                     
 177.1420.                                                              
Polyoxypropylene-polyoxyethylene         0.05 percent.                  
 condensate, average mol. wt. 2750-3000.                                
Potassium benzoate.....................  1 percent.                     
Potassium perchlorate..................      Do.                        
Potassium propionate...................  2 percent.                     
Potassium and sodium persulfate........  1 percent.                     
Resorcinol.............................  0.24 percent; for use only as a
                                          reactive adjuvant substance   
                                          employed in the production of 
                                          gelatin-bonded cord           
                                          compositions for use in lining
                                          crown closures. The gelatin so
                                          used shall be technical grade 
                                          or better.                    

[[Page 232]]

                                                                        
Rosins and rosin derivatives as defined                                 
 in Sec.  175.300(b)(3)(v) of this                                      
 chapter for use only in resinous and                                   
 polymeric coatings on metal                                            
 substrates; for all other uses as                                      
 defined in Sec.  178.3870 of this                                      
 chapter.                                                               
Sodium cetyl sulfate...................  1 percent.                     
Sodium decylbenzenesulfonate...........      Do.                        
Sodium decyl sulfate...................      Do.                        
Sodium formaldehyde sulfoxylate........  0.05 percent.                  
Sodium lauryl sulfate..................  1 percent.                     
Sodium lignin sulfonate................  0.2 percent.                   
Sodium myristyl sulfate (sodium          0.6 percent.                   
 tetradecyl sulfate).                                                   
Sodium nitrite.........................  0.2 percent; for use only in   
                                          annular ring gaskets applied  
                                          in aqueous dispersions to     
                                          closures for containers having
                                          a capacity of not less than 5 
                                          gallons.                      
Sodium o-phenylphenate.................  0.05 percent.                  
Sodium polyacrylate....................  5 percent.                     
Sodium and potassium pentachlorophenate  0.05 percent.                  
Sodium salt of trisopropyl               0.2 percent.                   
 napthalenesulfonic acid.                                               
Sodium tridecylsulfate.................  0.6 percent.                   
Stearic acid amide.....................  5 percent.                     
Sulfur.................................  For use only as a vulcanizing  
                                          agent in vulcanized natural or
                                          synthetic rubber gasket       
                                          compositions at a level not to
                                          exceed 4 percent by weight of 
                                          the elastomer content of the  
                                          rubber gasket composition.    
Tallow, sulfated.......................  1 percent.                     
Tin-zinc stearate......................  2 percent.                     
Tri(mixed mono- and dinonylphenyl)       1 percent.                     
 phosphite.                                                             
Vinyl chloride-vinyl stearate copolymer                                 
Zinc dibutyldithiocarbamate............  0.8 percent; for use only in   
                                          vulcanized natural or         
                                          synthetic rubber gasket       
                                          compositions.                 
------------------------------------------------------------------------


                 Table 2--Maximum Extractives Tolerances                
                         [In parts per million]                         
------------------------------------------------------------------------
                                    Chloroform   Chloroform   Chloroform
  Type of closure-sealing gasket   fraction of  fraction of  fraction of
           composition                water       heptane      alcohol  
                                   extractives  extractives  extractives
------------------------------------------------------------------------
1. Plasticized polymers,                                                
 including unvulcanized or                                              
 vulcanized or otherwise cured                                          
 natural and synthetic rubber                                           
 formed in place as overall discs                                       
 or annular rings from a hot                                            
 melt, solution, plastisol,                                             
 organisol, mechanical                                                  
 dispersion, or latex............          50          500           50 
2. Preformed overall discs or                                           
 annular rings of plasticized                                           
 polymers, including unvulcanized                                       
 natural or synthetic rubber.....          50          250           50 
3. Preformed overall discs or                                           
 annular rings of vulcanized                                            
 plasticized polymers, including                                        
 natural or synthetic rubber.....          50           50           50 
4. Preformed overall discs or                                           
 annular rings of polymeric or                                          
 resinous-coated paper,                                                 
 paperboard, plastic, or metal                                          
 foil substrates.................          50          250           50 
5. Closures with sealing gaskets                                        
 or sealing compositions as                                             
 described in 1, 2, 3, and 4, and                                       
 including paper, paperboard, and                                       
 glassine used for dry foods only       (\1\)        (\1\)        (\1\) 
------------------------------------------------------------------------
\1\Extractability tests not applicable.                                 

    (c) The closure assembly to include the sealing gasket or sealing 
compound, together with any polymeric or resinous coating, film, foil, 
natural cork, or glass that forms a part of the food-contact surface of 
the assembly, when extracted on a suitable glass container with a 
solvent or solvents characterizing the type of foods, and under 
conditions of time and temperature characterizing the conditions of its 
use as determined from Tables 3 and 4 shall yield net chloroform-soluble 
extractives (corrected for zinc as

[[Page 233]]

zinc oleate) not to exceed the tolerances specified in Table 2, 
calculated on the basis of the water capacity of the container on which 
the closure is to be used. Employ the analytical method described in 
Sec. 175.300 of this chapter, adapting the procedural details to make 
the method applicable to closures; such as, for example, placing the 
closed glass container on its side to assure contact of the closure's 
food-contacting surface with the solvent.

                         Table 3--Types of Food                         
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar  
 or both, and including oil-in-water emulsions of low- or high-fat      
 content.                                                               
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or     
 sugar or both, and including oil-in-water emulsions of low- or high-fat
 content.                                                               
III. Aqueous, acid or nonacid products containing free oil or fat; may  
 contain salt, and including water-in-oil emulsions of low- or high-fat 
 content.                                                               
IV. Dairy products and modifications:                                   
  A. Water-in-oil emulsions, high- or low-fat.                          
  B. Oil-in-water emulsions, high- or low-fat.                          
V. Low-moisture fats and oils.                                          
VI. Beverages:                                                          
  A. Containing alcohol.                                                
  B. Nonalcoholic.                                                      
VII. Bakery products.                                                   
VIII. Dry solids (no end-test required).                                
                                                                        


  Table 4--Test Procedures With Time-Temperature Conditions for Determining Amount of Extractives From Closure- 
                     Sealing Gaskets, Using Solvents Simulating Types of Foods and Beverages                    
----------------------------------------------------------------------------------------------------------------
                                                                              Extractant                        
                                  Types of food (see -----------------------------------------------------------
        Conditions of use              Table 3)                                                    8 percent    
                                                           Water\2\          Heptane\1\\2\        alcohol\2\    
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-         I, IV-B...........  250 deg. F, 2 hr..  ..................                    
 sterilized (e.g., over 212 deg.  III, IV-A, VII....  ......do..........  150 deg. F, 2 hr..                    
 F).                                                                                                            
----------------------------------------------------------------------------------------------------------------
B. Boiling water-sterilized.....  II................  212 deg. F, 30 min  ..................                    
                                  III, VII..........  ......do..........  120 deg. F, 30 min                    
----------------------------------------------------------------------------------------------------------------
C. Hot filled or pasteurized      II, IV-B..........  Fill boiling, cool  ..................                    
 above 150 deg. F.                                     to 100 deg. F.                                           
                                  III, IV-A.........  ......do..........  120 deg. F, 15 min                    
                                  V.................  ..................  ......do..........                    
----------------------------------------------------------------------------------------------------------------
D. Hot filled or pasteurized      II, IV-B, VI-B....  150 deg. F, 2 hr..  ..................                    
 below 150 deg. F.                III, IV-A.........  ......do..........  100 deg. F, 30 min                    
                                  V.................  ..................  .......do.........                    
                                  VI-A..............  ..................  ..................  150 deg. F, 2 hr. 
----------------------------------------------------------------------------------------------------------------
E. Temperature filled and stored  II, IV-B, VI-B....  120 deg. F, 24 hr.  ..................  ..................
 (no thermal treatment in the     III, IV-A.........  ......do..........  70 deg. F, 30 min.  ..................
 container).                      V.................  ..................  ......do..........  ..................
                                  VI-A..............    ................    ................  120 deg. F, 24 hr.
----------------------------------------------------------------------------------------------------------------
F. Refrigerated storage (no       I, II, III, IV-A,   70 deg. F, 48 hr..  70 deg. F, 30 min.                    
 thermal treatment).               IV-B, VI-B, VII.                                                             
                                  VI-A..............  ..................  ..................  70 deg. F, 48 hr. 
----------------------------------------------------------------------------------------------------------------
G. Frozen storage (no thermal     I, II, III, IV-B,   70 deg. F, 24 hr..  ..................                    
 treatment in the container).      VII.                                                                         
----------------------------------------------------------------------------------------------------------------
\1\Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.                            
\2\Time and temperature.                                                                                        

[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 
23, 1990; 61 FR 14480, Apr. 2, 1996]



Sec. 177.1240   1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer.

    Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-
cyclohexylene dimethylene isophthalate may be safely used as an article 
or component of articles used in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section:
    (a) The copolymer is a basic polyester produced by the catalytic 
condensation of dimethyl terephthalate and dimethyl isophthalate with 
1,4-

[[Page 234]]

cyclohexanedimethanol, to which may have been added certain optional 
substances required in its production or added to impart desired 
physical and technical properties.
    (b) The quantity of any optional substance employed in the 
production of the copolymer does not exceed the amount reasonably 
required to accomplish the intended physical or technical effect or any 
limitation further provided.
    (c) Any substance employed in the production of the copolymer that 
is the subject of a regulation in parts 174, 175, 176, 177, 178 and 
Sec. 179.45 of this chapter conforms with any specification in such 
regulation.
    (d) Substances employed in the production of the copolymer include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for use in the 
copoly-mer and used in accordance with such sanction or approval.
    (3) Substances which by regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter may be safely used as components of 
resinous or polymeric coatings and film used as food-contact surfaces, 
subject to the provisions of such regulation.
    (e) The copolymer conforms with the following specifications:
    (1) The copolymer, when extracted with distilled water at reflux 
temperature for 2 hours, yields total extractives not to exceed 0.05 
percent.
    (2) The copolymer, when extracted with ethyl acetate at reflux 
temperature for 2 hours, yields total extractives not to exceed 0.7 
percent.
    (3) The copolymer, when extracted with n-hexane at reflux 
temperature for 2 hours, yields total extractives not to exceed 0.05 
percent.

[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984, as amended at 55 
FR 34555, Aug. 23, 1990]



Sec. 177.1310   Ethylene-acrylic acid copolymers.

    The ethylene-acrylic acid copolymers identified in paragraph (a) of 
this section may be safely used as components of articles intended for 
use in contact with food subject to the provisions of this section.
    (a) The ethylene-acrylic acid copolymers consist of basic copolymers 
produced by the copolymerization of ethylene and acrylic acid such that 
the finished basic copolymers contain no more than:
    (1) 10 weight-percent of total polymer units derived from acrylic 
acid when used in accordance with paragraph (b) of this section; and
    (2) 25 weight-percent of total polymer units derived from acrylic 
acid when used in accordance with paragraph (c) of this section.
    (b) The finished food-contact articles made with no more than 10 
percent total polymer units derived from acrylic acid, when extracted 
with the solvent or solvents characterizing the type of food and under 
the conditions of its intended use as determined from tables 1 and 2 of 
Sec. 176.170(c) of this chapter, yield net acidified chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of food-contact 
surface when tested by the methods prescribed in Sec. 177.1330(e)(1), 
(3)(i) through (iv), (4), (5), and (6), except that
    (1) The total residue method using 3 percent acetic acid, as 
prescribed in Sec. 177.1330(e)(6)(i)(a), does not apply, and
    (2) The net acidified chloroform-soluble extractives from paper and 
paperboard complying with Sec. 176.170 of this chapter may be corrected 
for wax, petrolatum, and mineral oil as provided in 
Sec. 176.170(d)(5)(iii)(b) of this chapter.

If the finished food-contact article is itself the subject of a 
regulation in parts 174, 175, 176, 177, 178, and Sec. 179.45 of this 
chapter, it shall also comply with any specifications and limitations 
prescribed for it by that regulation.
    (c) The finished food-contact layer made with basic copolymers 
containing more than 10 weight-percent but no more than 25 weight-
percent of total polymer units derived from acrylic acid and with a 
maximum thickness of 0.0025 inch (2.5 mils) may be used in contact with 
food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table 1 of 
Sec. 176.170(c) of the chapter under conditions of use B through H as 
described in table 2 of Sec. 176.170(c) of this chapter, and in contact 
with food types III, IVA, V, VIIA, and IX identified in table 1 of 
Sec. 176.170(c) of this chapter

[[Page 235]]

under conditions of use E through G as described in table 2 of 
Sec. 176.170(c) of this chapter.
    (d) The provisions of this section are not applicable to ethylene-
acrylic acid copolymers used in food-packaging adhesives complying with 
Sec. 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986; 53 
FR 44009, Nov. 1, 1988]



Sec. 177.1312  Ethylene-carbon monoxide copolymers.

    The ethylene-carbon monoxide copolymers identified in paragraph (a) 
of this section may be safely used as components of articles intended 
for use in contact with food subject to the provisions of this section.
    (a) Identity. For the purposes of this section, ethylene-carbon 
monoxide copolymers (CAS Reg. No. 25052-62-4) consist of the basic 
polymers produced by the copolymerization of ethylene and carbon 
monoxide such that the copolymers contain not more than 30 weight-
percent of polymer units derived from carbon monoxide.
    (b) Conditions of use. (1) The polymers may be safely used as 
components of the food-contact or interior core layer of multilaminate 
food-contact articles.
    (2) The polymers may be safely used as food-contact materials at 
temperatures not to exceed 121  deg.C (250  deg.F).
    (c) Specifications. (1) Food-contact layers formed from the basic 
copolymer identified in paragraph (a) of this section shall be limited 
to a thickness of not more than 0.01 centimeter (0.004 inch).
    (2) The copolymers identified in paragraph (a) of this section shall 
have a melt index not greater than 500 as determined by ASTM method 
D1238-82, condition E ``Standard Test Method for Flow Rates of 
Thermoplastics by Extrusion Plastometer,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (3) The basic copolymer identified in paragraph (a) of this section, 
when extracted with the solvent or solvents characterizing the type of 
food and under the conditions of time and temperature characterizing the 
conditions of its intended use, as determined from Tables 1 and 2 of 
Sec. 176.170(c) of this chapter, yields net chloroform-soluble 
extractives in each extracting solvent not to exceed 0.5 milligram per 
square inch of food-contact surface when tested by methods described in 
Sec. 176.170(d) of this chapter.
    (4) The provisions of this section are not applicable to ethylene-
carbon monoxide copolymers complying with Sec. 175.105 of this chapter.

[57 FR 32422, July 22, 1992]



Sec. 177.1315  Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.

    Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may 
be safely used as articles or components of articles intended for use in 
contact with food subject to provisions of this section and of part 174 
of this chapter.
    (a) Identity. For the purposes of this section, ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymers (1,4-benzene 
dicarboxylic acid, dimethyl ester, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or 
(1,4-benzenedicarboxylic acid, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are 
basic copolymers meeting the specifications prescribed in paragraph (b) 
of this section, to which may have been added certain optional 
substances required in their production or added to impart desired 
physical or technical properties.
    (b) Specifications:

[[Page 236]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                            Maximum                                             
                                                          extractable                                           
                                                       fractions of the                                         
                                                       copolymer in the                                         
                                                       finished form at                                         
   Ethylene-1,4-cyclohexylene                              specified                                            
    dimethylene terephthalate     Inherent viscosity   temperatures and        Test for        Conditions of use
           copolymers                                  times (expressed      orientability                      
                                                       in micrograms of                                         
                                                       the terephthaloyl                                        
                                                        moletles/square                                         
                                                      centimeter of food-                                       
                                                       contact surface)                                         
----------------------------------------------------------------------------------------------------------------
1. Non-oriented ethylene-1,4-     Inherent viscosity  (1) 0.23 microgram  No test required..  In contact with   
 cyclohexylene dimethylene         of a 0.50 percent   per square                              foods, including 
 terephthalate copolymer is the    solution of the     centimeter (1.5                         foods containing 
 reaction product of dimethyl      copolymer in        micrograms per                          not more than 25 
 terephthalate or terephthalic     phenol-tet          square inch) of                         percent (by      
 acid with a mixture containing    rachloroethane      food-contact                            volume) aqueous  
 99 to 66 mole percent of          (60:40 ratio wt/    surface when                            alcohol,         
 ethylene glycol and 1 to 34       wt) solvent is      extracted with                          excluding        
 mole percent of 1,4-cyclo-        not less than       water added at                          carbonated       
 hexanedimethanol (70 percent      0.669 as            82.2 C (180 F)                          beverages and    
 trans isomer, 30 percent cls      determined by       and allowed to                          beer. Conditions 
 isomer).                          using a Wagner      cool to 48.9 C                          of hot fill not  
                                   viscometer (or      (120F) in contact                       to exceed 82.2 C 
                                   equivalent) and     with the food-                          (180 F), storage 
                                   calculated from     contact article.                        at temperatures  
                                   the following                                               not in excess of 
                                   equation:                                                   48.9 C (120 F).  
                                   Inherent                                                    No thermal       
                                   viscosity=(Natura                                           treatment in the 
                                   l logarithm of                                              container.       
                                   (Nr)/(c) where:                                                              
                                   Nr=Ratio of flow                                                             
                                   time of the                                                                  
                                   polymer solution                                                             
                                   to that of the                                                               
                                   solvent, and                                                                 
                                   c=concentration                                                              
                                   of the test                                                                  
                                   solution                                                                     
                                   expressed in                                                                 
                                   grams per 100                                                                
                                   milliliters.                                                                 
                                  ......do..........  (2) 0.23 microgram  ......do..........      Do.           
                                                       per square                                               
                                                       centimeter (1.5                                          
                                                       micrograms per                                           
                                                       square inch) of                                          
                                                       food-contact                                             
                                                       surface when                                             
                                                       extracted with 3                                         
                                                       percent (by                                              
                                                       volume) aqueous                                          
                                                       acetic acid added                                        
                                                       at 82.2 C (180 F)                                        
                                                       and allowed to                                           
                                                       cool to 48.9 C                                           
                                                       (120 F) in                                               
                                                       contact with the                                         
                                                       food-contact                                             
                                                       article.                                                 
                                  ......do..........  (3) 0.08 microgram  ......do..........      Do.           
                                                       per square                                               
                                                       centimeter (0.5                                          
                                                       microgram per                                            
                                                       square inch) of                                          
                                                       food-contact                                             
                                                       surface when                                             
                                                       extracted for 2                                          
                                                       hours with n-                                            
                                                       heptane at 48.9 C                                        
                                                       (120 F). The                                             
                                                       heptane                                                  
                                                       extractable                                              
                                                       results are to be                                        
                                                       divided by a                                             
                                                       factor of 5.                                             
                                  ......do..........  (4) 0.16 microgram  ......do..........      Do.           
                                                       per square                                               
                                                       centimeter (1.0                                          
                                                       microgram per                                            
                                                       square inch) of                                          
                                                       food-contact                                             
                                                       surface when                                             
                                                       extracted for 24                                         
                                                       hours with 25                                            
                                                       percent (by                                              
                                                       volume) aqueous                                          
                                                       ethanol at 48.9 C                                        
                                                       (120 F).                                                 

[[Page 237]]

                                                                                                                
2. Oriented ethylene-1,4-         ......do..........  (1) 0.23 microgram  When extracted      In contact with   
 cyclohexylene dimethylene                             per square          with heptane at     nonalcoholic     
 terephthalate copolymer is the                        centimeter (1.5     65.6 C (150 F)      foods including  
 reaction product of dimethyl                          micrograms per      for 2 hours:        carbonated       
 terephthalate or terephthalic                         square inch) of     terephthaloyl       beverages.       
 acid with a mixture containing                        food-contact        moieties do not     Conditions of hot
 99 to 85 mole percent ethylene                        surface of the      exceed 0.09         fill not         
 glycol and 1 to 15 mole percent                       oriented            microgram per       exceeding 87.8 C 
 of 1,4-cyclohexane-di-methanol                        copolymer when      square centimeter   (190 F), storage 
 (70 percent trans isomer, 30                          extracted with      (0.60 microgram     at temperatures  
 percent cls isomer).                                  water added at      per square inch)    not in excess of 
                                                       87.8 C (190 F)      of food-contact     48.9 C (120 F).  
                                                       and allowed to      surface.            No thermal       
                                                       cool to 48.9 C                          treatment in the 
                                                       (120 F) in                              container.       
                                                       contact with the                                         
                                                       food-contact                                             
                                                       article.                                                 
                                  ......do..........  (2) 0.23 microgram  ......do..........      Do.           
                                                       per square                                               
                                                       centimeter (1.5                                          
                                                       micrograms per                                           
                                                       square inch) of                                          
                                                       food-contact                                             
                                                       surface of                                               
                                                       oriented                                                 
                                                       copolymer when                                           
                                                       extracted with 3                                         
                                                       percent (by                                              
                                                       volume) aqueous                                          
                                                       acetic acid added                                        
                                                       at 87.8 C (190 F)                                        
                                                       and allowed to                                           
                                                       cool to 48.9 C                                           
                                                       (120 F) in                                               
                                                       contact with the                                         
                                                       food-contact                                             
                                                       article..                                                
                                  ......do..........  (3) 0.08 microgram  ......do..........      Do.           
                                                       per square                                               
                                                       centimeter (0.5                                          
                                                       microgram per                                            
                                                       square inch) of                                          
                                                       food-contact                                             
                                                       surface of                                               
                                                       oriented                                                 
                                                       copolymer when                                           
                                                       extracted for 2                                          
                                                       hours with n-                                            
                                                       heptane at 48.9 C                                        
                                                       (120 F). The                                             
                                                       heptane                                                  
                                                       extractable                                              
                                                       results are to be                                        
                                                       divided by a                                             
                                                       factor of 5.                                             
                                  ......do..........  (4) 0.23 microgram  ......do..........  In contact with   
                                                       per square                              foods and        
                                                       centimeter (1.5                         beverages        
                                                       micrograms per                          containing up to 
                                                       square inch) of                         20 percent (by   
                                                       food-contact                            volume) alcohol. 
                                                       surface of                              Conditions of    
                                                       oriented                                thermal treatment
                                                       copolymer when                          in the container 
                                                       extracted with 20                       not exceeding    
                                                       percent (by                             65.6 C (150 F)   
                                                       volume) aqueous                         for 20 minutes.  
                                                       ethanol heated to                       Storage at       
                                                       65.6 C (150 F)                          temperatures not 
                                                       for 20 minutes                          in excess of 48.9
                                                       and allowed to                          C (120 F).       
                                                       cool to 48.9 C                                           
                                                       (120 F) in                                               
                                                       contact with the                                         
                                                       food-contact                                             
                                                       article.                                                 
                                  ......do..........  (5) 0.23 microgram  ......do..........  In contact with   
                                                       per square                              foods and        
                                                       centimeter (1.5                         beverages        
                                                       micrograms per                          containing up to 
                                                       square inch) of                         50 percent (by   
                                                       food-contact                            volume) alcohol. 
                                                       surface of                              Conditions of    
                                                       oriented                                fill and storage 
                                                       copolymer when                          not exceeding    
                                                       extracted with 50                       48.9 C (120 F).  
                                                       percent (by                             No thermal       
                                                       volume) aqueous                         treatment in the 
                                                       ethanol at 48.9 C                       container.       
                                                       (120 F) for 24                                           
                                                       hours.                                                   

[[Page 238]]

                                                                                                                
3. Ethylene-1,4-cyclohexylene     No test required..  For each            No test required..  For each          
 dimethylene terephthalate                             corresponding                           corresponding    
 copolymer is the reaction                             condition of use,                       specification,   
 product of dimethyl                                   must meet                               may be used as a 
 terephthalate or terephthalic                         specifications                          base sheet and   
 acid with a mixture containing                        described in Sec.                       base polymer in  
 99 to 95 mole percent of                               177.1630(f),                           accordance with  
 ethylene glycol and 1 to 5 mole                       (g), (h), or (j).                       conditions of use
 percent of 1,4-                                                                               described in Sec.
 cyclohexanedimethanol (70                                                                      177.1630(f),    
 percent trans isomer, 30                                                                      (g), (h), or (j).
 percent cis isomer)..                                                                                          
----------------------------------------------------------------------------------------------------------------


[[Page 239]]



    (c) Analytical method for determination of extractability. The total 
extracted terephthaloyl moieties can be determined in the extracts, 
without evaporation of the solvent, by measuring the ultraviolet (UV) 
absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or 
equivalent) is zeroed with a sample of the solvent taken from the same 
lot used in the extraction tests. The concentration of the total 
terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent 
aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by 
reference to standards prepared in the appropriate solvent. 
Concentration of the terephthaloyl moieties in heptane is calculated as 
cyclic trimer (C6H4CO2C2H4CO2)3, by 
reference to standards prepared in 95:5 percent (v/v) heptane: 
tetrahydrofuran.

[45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49 
FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov. 
24, 1995]



Sec. 177.1320   Ethylene-ethyl acrylate copolymers.

    Ethylene-ethyl acrylate copolymers may be safely used to produce 
packaging materials, containers, and equipment intended for use in 
producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding food, in accordance with the 
following prescribed conditions:
    (a) Ethylene-ethyl acrylate copolymers consist of basic resins 
produced by the catalytic copolymerization of ethylene and ethyl 
acrylate, to which may have been added certain optional substances to 
impart desired technological properties to the resin. Subject to any 
limitations prescribed in this section, the optional substances may 
include:
    (1) Substances generally recognized as safe in food and food 
packaging.
    (2) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, prior sanction, or 
approvals.
    (b) The ethyl acrylate content of the copolymer does not exceed 8 
percent by weight unless it is blended with polyethylene or with one or 
more olefin copolymers complying with Sec. 177.1520 or with a mixture of 
polyethylene and one or more olefin copolymers, in such proportions that 
the ethyl acrylate content of the blend does not exceed 8 percent by 
weight, or unless it is used in a coating complying with Sec. 175.300 or 
Sec. 176.170 of this chapter, in such proportions that the ethyl 
acrylate content does not exceed 8 percent by weight of the finished 
coating.
    (c) Ethylene-ethyl acrylate copolymers or the blend shall conform to 
the specifications prescribed in paragraph (c)(1) of this section and 
shall meet the ethyl acrylate content limits prescribed in paragraph (b) 
of this section, and the extractability limits prescribed in paragraph 
(c)(2) of this section, when tested by the methods prescribed for 
polyethylene in Sec. 177.1520.
    (1) Specifications--(i) Infrared identification. Ethylene-ethyl 
acrylate copolymers can be identified by their characteristic infrared 
spectra.
    (ii) Quantitative determination of ethyl acrylate content. The ethyl 
acrylate can be determined by the infrared spectra. Prepare a scan from 
10.5 microns to 12.5 microns. Obtain a baseline absorbance at 11.6 
microns and divide by the plaque thickness to obtain absorbance per mil. 
From a previously prepared calibration curve, obtain the amount of ethyl 
acrylate present.
    (iii) Specific gravity. Ethylene-ethyl acrylate copolymers have a 
specific gravity of not less than 0.920 nor more than 0.935, as 
determined by ASTM method D1505-68 (Reapproved 1979), ``Standard Test 
Method for Density of Plastics by the Density-Gradient Technique,'' 
which is incorporated by reference. Copies may be obtained from the 
American Society for Testing Materials, 1916 Race St., Philadelphia, PA 
19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may 
be used in contact with food except as a component of articles used for 
packaging or holding food during cooking provided they meet the 
following extractability limits:
    (i) Maximum soluble fraction of 11.3 percent in xylene after 
refluxing and subsequent cooling to 25 deg. C.

[[Page 240]]

    (ii) Maximum extractable fraction of 5.5 percent when extracted with 
n-hexane at 50 deg. C.
    (d) The provisions of paragraphs (b) and (c)(2) of this section are 
not applicable to ethylene-ethyl acrylate copolymers used in the 
formulation of adhesives complying with Sec. 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19, 1984]



Sec. 177.1330  Ionomeric resins.

    Ionomeric resins manufactured from either ethylene-methacrylic acid 
copolymers (and/or their ammonium, calcium, magnesium, potassium, 
sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl 
acetate copolymers (and/or their ammonium, calcium, magnesium, 
potassium, sodium, and/or zinc partial salts,), or methacrylic acid 
polymers with ethylene and isobutyl acrylate (and/or their potassium, 
sodium and/or zinc partial salts) may be safely used as articles or 
components of articles intended for use in contact with food, in 
accordance with the following prescribed conditions:
    (a) For the purpose of this section, the ethylene-methacrylic acid 
copolymers consist of basic copolymers produced by the copolymerization 
of ethylene and methacrylic acid such that the copolymers contain no 
more than 20 weight percent of polymer units derived from methacrylic 
acid, and the ethylene-methacrylic acid-vinyl acetate copolymers consist 
of basic copolymers produced by the copolymerization of ethylene, 
methacrylic acid, and vinyl acetate such that the copolymers contain no 
more than 15 weight percent of polymer units derived from methacrylic 
acid.
    (b) For the purpose of this section, the methacrylic acid copolymers 
with ethylene and isobutyl acrylate consist of basic copolymers produced 
by the copolymerization of methacrylic acid, ethylene, and isobutyl 
acrylate such that the copolymers contain no less than 70 weight percent 
of polymer units derived from ethylene, no more than 15 weight percent 
of polymer units derived from methacrylic acid, and no more than 20 
weight percent of polymer units derived from isobutyl acrylate. From 20 
percent to 70 percent of the carboxylic acid groups may optionally be 
neutralized to form sodium or zinc salts.
    (c) The finished food-contact article described in paragraph (a) of 
this section, when extracted with the solvent or solvents characterizing 
the type of food and under the conditions of time and temperature 
characterizing the conditions of its intended use as determined from 
Tables 1 and 2 of Sec. 176.170(c) of this chapter, yields net acidified 
chloroform-soluble extractives in each extracting solvent not to exceed 
0.5 milligram per square inch of food-contact surface when tested by the 
methods described in paragraph (e)(1) of this section, and if the 
finished food-contact article is itself the subject of a regulation in 
parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, it shall 
also comply with any specifications and limitations prescribed for it by 
that regulation.

    Note: In testing the finished food-contact article, use a separate 
test sample for each required extracting solvent.

    (d) The finished food-contact article described in paragraph (b) of 
this section, when extracted according to the methods listed in 
paragraph (e)(2) of this section and referenced in this paragraph (d), 
using the solvent or solvents characterizing the type of food as 
determined from Table I of paragraph (f) of this section, shall yield 
net acidified chloroform-soluble extractives as follows:
    (1) For fatty food use. (i) For films of 2 mil (0.002 inches) 
thickness or less, extractives shall not exceed 0.70 milligram/square 
inch1 (0.109 milligram/square centimeter) of food-contact surface 
(n-heptane extractions) when extracted by the abbreviated method cited 
in paragraph (e)(2)(i) of this section.
---------------------------------------------------------------------------

    1 Average of four separate values, no single value of which 
differs from the average of those values by more then plus-minus10 
percent.
---------------------------------------------------------------------------

    (ii) For films of greater than 2 mils (0.002 inch) thickness, 
extractives shall not exceed 0.40 milligram/square inch 1 (0.062 
milligram/square centimeter) of food-contact surface (n-heptane 
extractions) when extracted by the

[[Page 241]]

abbreviated method cited in paragraph (e)(2)(i) of this section, or
    (iii) Alternatively, for films of greater than 2 mils thickness, 
extractives shall not exceed 0.70 milligram/square inch 1 (0.109 
milligram/square centimeter) of food-contact surface (n-heptane 
extractions) when extracted by the equilibrium method cited in paragraph 
(e)(2)(ii) of this section.
    (2) For aqueous foods. (i) The net acidified chloroform-soluble 
extractives shall not exceed 0.02 milligram/square inch 2 (0.003 
milligram/square centimeter) of food-contact surface (water, acetic 
acid, or ethanol/water extractions) when extracted by the abbreviated 
method cited in paragraph (e)(2)(i) of this section.
---------------------------------------------------------------------------

    2 Average of four separate values, no single value of which 
differs from the average of those values by more than plus-minus50 
percent.
---------------------------------------------------------------------------

    (ii) Alternatively, the net acidified chloroform-soluble extractives 
shall not exceed 0.05 milligram/square inch 2 (0.078 mg/square 
centimeter) of food-contact surface (water, acetic acid, or ethanol/
water extractions) when extracted by the equilibrium method cited in 
paragraph (e)(2)(ii) of this section. If when exposed to n-heptane, a 
particular film splits along die lines, thus permitting exposure of both 
sides of the film to the extracting solvent, the results for that film 
sample are invalid and the test must be repeated for that sample until 
no splitting by the solvent occurs. If the finished food-contact article 
is itself the subject of a regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter, it shall also comply with any 
specifications and limitations prescribed for it by that regulation.

    Note: In testing the finished food-contact article, use a separate 
test sample for each required extracting solvent.

    (e) Analytical methods--(1) Selection of extractability conditions 
for ionomeric resins. First ascertain the type of food (Table 1 of 
Sec. 176.170(c) of this chapter) that is being packed or used in contact 
with the finished food-contact article described in paragraph (a) of 
this section, and also ascertain the normal conditions of thermal 
treatment used in packaging or contacting the type of food involved. 
Using Table 2 of Sec. 176.170 (c) of this chapter, select the food-
simulating solvent or solvents and the time-temperature test conditions 
that correspond to the intended use of the finished food-contact 
article. Having selected the appropriate food-simulating solvent or 
solvents and time-temperature exaggeration over normal use, follow the 
applicable extraction procedure. 
---------------------------------------------------------------------------

    \3\ See footnote 2 to paragraph (d)(2)(i) of this section.
---------------------------------------------------------------------------

    (2) Selection of extractability conditions for ionomeric resins. 
Using Table I of paragraph (f) of this section ascertain the type of 
food that is being packed or used in contact with the finished food-
contact article described in paragraph (b) of this section, and also 
ascertain the food-simulating solvent or solvents that correspond to the 
intended use of the finished food-contact article.
    (i) Abbreviated test. For intended use involving food contact at or 
below 120 deg. F (49 deg. C), the appropriate food-simulating solvent is 
to contact the food-contact film for the time and temperatures as 
follows:

------------------------------------------------------------------------
               Solvent                   Time          Temperature      
------------------------------------------------------------------------
n-Heptane............................     \1\2  120 deg. F (49 deg. C). 
Water, 3% acetic acid, or 8%/50%         \1\48  120 deg. F (49 deg. C). 
 ethanol.                                                               
------------------------------------------------------------------------
\1\Hours                                                                

    (ii) Equilibrium test. For intended use involving food contact at or 
below 120 deg. F (49 deg. C), the appropriate food-simulating solvent is 
to contact the food-contact film at a temperature of 120 deg. F until 
equilibrium is demonstrated.

------------------------------------------------------------------------
                                                                Minimum 
                                                              extraction
                           Solvent                               times  
                                                                (hours) 
------------------------------------------------------------------------
n-Heptane...................................................   8, 10, 12
Water, 3% acetic acid, or 8%/50% ethanol....................     72, 96,
                                                                     120
------------------------------------------------------------------------

The results from a series of extraction times demonstrate equilibrium 
when the net chloroform-soluble extractives are unchanging within 
experimental error appropriate to the method as described in paragraphs 
(d) (1)(i) and (2)(i) of this section. Should equilibrium not be 
demonstrated over the above time series, extraction times must be 
extended until three successive

[[Page 242]]

unchanging values for extractives are obtained. In the case where 
intended uses involve temporary food contact above 120 deg. F, the food-
simulating solvent is to be contacted with the food-contact article 
under conditions of time and temperature that duplicate the actual 
conditions in the intended use. Subsequently the extraction is to be 
continued for the time period and under the conditions specified in the 
above table.
    (3) Reagents--(i) Water. All water used in extraction procedures 
should be freshly demineralized (deionized) distilled water.
    (ii) n-Heptane. Reagent grade, freshly redistilled before use, using 
only material boiling at 208 deg. F (97.8 deg. C).
    (iii) Alcohol. 8 or 50 percent (by volume), prepared from 
undenatured 95 percent ethyl alcohol diluted with demineralized 
(deionized), distilled water.
    (iv) Chloroform. Reagent grade, freshly redistilled before use, or a 
grade having an established, consistently low blank.
    (v) Acetic acid. 3 percent (by weight), prepared from glacial acetic 
acid diluted with demineralized (deionized), distilled water.
    (4) Selection of test method. The finished food-contact articles 
shall be tested either by the extraction cell described in the Journal 
of the Association of Official Agricultural Chemists, Vol. 47, No. 1, p. 
177-179 (February 1964), also described in ASTM method F34-76 
(Reapproved 1980), ``Standard Test Method for Liquid Extraction of 
Flexible Barrier Materials,'' which are incorporated by reference, or by 
adapting the in-container methods described in Sec. 175.300(e) of this 
chapter. Copies of the material incorporated by reference are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, and the 
American Society for Testing Materials, 1916 Race St., Philadelphia, PA 
19103, respectively, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (5) Selection of samples. Quadruplicate samples should be tested, 
using for each replicate sample the number of finished articles with a 
food-contact surface nearest to 100 square inches.
    (6) Determination of amount of extractives--(i) Total residues. At 
the end of the exposure period, remove the test container or test cell 
from the oven, if any, and combine the solvent for each replicate in a 
clean Pyrex (or equivalent) flask or beaker, being sure to rinse the 
test container or cell with a small quantity of clean solvent. Evaporate 
the food-simulating solvents to about 100 milliliters in the flask, and 
transfer to a clean, tared evaporating dish (platinum or Pyrex), washing 
the flask three times with small portions of solvent used in the 
extraction procedure, and evaporate to a few milliliters on a 
nonsparking, low-temperature hotplate. The last few milliliters should 
be evaporated in an oven maintained at a temperature of 221 deg. F 
(105 deg. C). Cool the evaporating dish in a desiccator for 30 minutes 
and weigh the residues to the nearest 0.1 milligram, e. Calculate the 
extractives in milligrams per square inch of the container or material 
surface.
    (a) Water, 3 percent acetic acid, and 8 percent and 50 percent 
alcohol. Milligrams extractives per square inch=e/s.
    (b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)

Where:

    e=Milligrams extractives per sample tested.
    s=Surface area tested, in square inches.
    F=Five, the ratio of the amount of extractives removed by heptane 
under exaggerated time-temperature test conditions compared to the 
amount extracted by a fat or oil under exaggerated conditions of thermal 
sterilization and use.
    e'=Acidified chloroform-soluble extractives residue. e' is 
substituted for e in the above equations when necessary (See paragraph 
(e)(6)(ii) of this section for method to obtain e').

If when calculated by the equations in paragraphs (e)(6)(i) (a) and (b) 
of this section, the extractives in milligrams per square inch exceed 
the limitations prescribed in paragraphs (c) or (d) of this section, 
proceed to paragraph (e)(6)(ii) of this section (method for determining 
the amount of acidified chloroform-soluble extractives residue).

[[Page 243]]

    (ii) Acidified chloroform-soluble extractives residue. Add 3 
milliliters of 37 percent ACS reagent grade hydrochloric acid and 3 
milliliters of distilled water to the evaporating dish containing the 
dried and weighed residue, e, obtained in paragraph (e)(6)(i) of this 
section. Mix well so every portion of the residue is wetted with the 
hydrochloric acid solution. Then add 50 milliliters of chloroform. Warm 
carefully, and filter through Whatman No. 41 filter paper (or 
equivalent) in a Pyrex (or equivalent) funnel, collecting the filtrate 
in a clean separatory funnel. Shake for 1 minute, then draw off the 
chloroform layer into a clean tared evaporating dish (platinum or 
Pyrex). Repeat the chloroform extraction, washing the dish, the filter 
paper, and the separatory funnel with this second portion of chloroform. 
Add this filtrate to the original filtrate and evaporate the total down 
to a few milliliters on a low-temperature hotplate. The last few 
milliliters should be evaporated in an oven maintained at 221 deg. F. 
Cool the evaporating dish in a desiccator for 30 minutes and weigh to 
the nearest 0.1 milligram to get the acidified chloroform-soluble 
extractives residue, e'. This e' is substituted for e in the equations 
in paragraphs (e)(6)(i) (a) and (b) of this section.
    (f) The types of food and appropriate solvents are as follows:

                                 Table 1                                
------------------------------------------------------------------------
             Types of food                     Appropriate solvent      
------------------------------------------------------------------------
1. Nonacid (pH above 5.0), aqueous      Water, n-heptane.               
 products; may contain salt or sugar                                    
 or both, and including oil-in-water                                    
 emulsions of low- or high-fat content.                                 
2. Acidic (pH 5.0 or below), aqueous    n-heptane, water, 3% acetic     
 products; may contain salt or sugar     acid.                          
 or both, and including oil-in-water                                    
 emulsions of low- or high-fat content.                                 
3. Aqueous, acid or nonacid products    Water, n-heptane, 3% acetic     
 containing free oil or fat; may         acid.                          
 contain salt, and including water-in-                                  
 oil emulsions of low- or high-fat                                      
 content.                                                               
4. Dairy products and modifications:                                    
  Water, n-heptane....................                                  
  i. Water-in-oil emulsions, high or                                    
   low fat.                                                             
  ii. Oil-in-water emulsions, high or                                   
   low fat.                                                             
5. Low moisture fats and oils.........  n-heptane.                      
6. Beverages:                                                           
  i. Containing up to 8% alcohol......  8% ethanol/water.               
  ii. Nonalcoholic....................  3% acetic acid.                 
  iii. Containing more than 8% alcohol  50% ethanol/water.              
7. Bakery products....................  Water, n-heptane.               
8. Dry solids (without free fat or      No extraction test required.    
 oil).                                                                  
9. Dry solids (with free fat or oil)..  n-heptane.                      
------------------------------------------------------------------------

    (g) The provisions of paragraphs (c) and (d) of this section are not 
applicable to the ionomeric resins that are used in food-packaging 
adhesives complying with Sec. 175.105 of this chapter.

[45 FR 22916, Apr. 4, 1980, as amended at 49 FR 10108, Mar. 19, 1984; 49 
FR 37747, Sept. 26, 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, June 
12, 1989]



Sec. 177.1340   Ethylene-methyl acrylate copolymer resins.

    Ethylene-methyl acrylate copolymer resins may be safely used as 
articles or components of articles intended for use in contact with 
food, in accordance with the following prescribed conditions:
    (a) For the purpose of this section, the ethylene-methyl acrylate 
copolymer resins consist of basic copolymers produced by the 
copolymerization of ethylene and methyl acrylate such that the 
copolymers contain no more than 25 weight percent of polymer units 
derived from methyl acrylate.
    (b) The finished food-contact article, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields net chloroform-soluble extractives (corrected for 
zinc extractives as zinc oleate) in each extracting solvent not to 
exceed 0.5 milligram per square inch of food-contact surface when tested 
by the methods described in Sec. 176.170(d) of this chapter. If the 
finished food-contact article is itself the subject of a regulation in 
parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, it shall 
also comply with any specifications and limitations prescribed for it by 
that regulation.

    Note: In testing the finished food-contact article, use a separate 
test sample for each required extracting solvent.


[[Page 244]]


    (c) The provisions of this section are not applicable to ethylene-
methyl acrylate copolymer resins used in food-packaging adhesives 
complying with Sec. 175.105 of this chapter.



Sec. 177.1345  Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer.

    Ethylene/1, 3-phenylene oxyethylene isophthalate/terephthalate 
copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this 
section may be safely used, subject to the provisions of this section, 
as the non-food-contact layer of laminate structures subject to the 
provisions of Sec. 177.1395, and in blends with polyethylene 
terephthalate polymers complying with Sec. 177.1630.
    (a) Identity. For the purpose of this section, ethylene/1,3-
phenylene oxyethylene isophthalate/terephthalate copolymer consists of 
the basic copolymer produced by the catalytic polycondensation of 
isophthalic acid and terephthalic acid with ethylene glycol and 1,3-
bis(2-hydroxyethoxy)benzene such that the finished resin contains 
between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8 
mole-percent of terephthalic moieties, and not more than 10 mole-percent 
of 1,3-bis(2-hydroxyethoxy)benzene moieties.
    (b) Specifications--(1) Density. Ethylene/1,3-phenylene oxyethylene 
isophthalate/terephthalate copolymer identified in paragraph (a) of this 
section has a density of 1.33  0.02 grams per cubic 
centimeter measured by ASTM Method D 1505-85 (Reapproved 1990), 
``Standard Test Method for Density of Plastics by the Density-Gradient 
Technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the 
American Society for Testing and Materials, 1916 Race St., Philadelphia, 
PA 19103, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, and the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (2) Softening point. Ethylene/1,3-phenylene oxyethylene 
isophthalate/terephthalate copolymer identified in paragraph (a) of this 
section has a softening point of 63  5  deg.C as measured by 
ASTM Method D 1525-87, ``Standard Test Method for VICAT Softening 
Temperature of Plastics,'' which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
this material is provided in paragraph (b)(1) of this section.
    (c) Optional adjuvant substances. Ethylene/1,3-phenylene oxyethylene 
isophthalate/terephthalate copolymer, identified in paragraph (a) of 
this section, may contain optional adjuvant substances required in their 
production. The optional adjuvants may include substances used in 
accordance with Sec. 174.5 of this chapter.
    (d) Limitations. Copolymer blends described above shall not exceed 
30 percent by weight of ethylene/1, 3-phenylene oxyethylene 
isophthalate/terephthalate copolymer. The finished blend may be used in 
contact with food only under conditions of use C through G, as described 
in Table 2 of Sec. 176.170(c) of this chapter, except that with food 
identified as Type III, IV-A, V, VIII-A, and IX in Sec. 176.170(c), 
Table 1, the copolymer may be used under condition of use C at 
temperatures not to exceed 160  deg.F (71  deg.C).

[57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994; 
61 FR 14481, Apr. 2, 1996]



Sec. 177.1350   Ethylene-vinyl acetate copolymers.

    Ethylene-vinyl acetate copolymers may be safely used as articles or 
components of articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food in accordance with the following prescribed conditions:
    (a) Ethylene-vinyl acetate copolymers consist of basic resins 
produced by the catalytic copolymerization of ethylene and vinyl acetate 
to which may have been added certain optional substances to impart 
desired technological or physical properties to the resin. Subject to 
any limitations prescribed in this section, the optional substances may 
include:
    (1) Substances generally recognized as safe in food and food 
packaging.

[[Page 245]]

    (2) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, prior sanction, or 
approvals.
    (3) Substances identified in Sec. 175.300(b)(3) (xxv), (xxvii), 
(xxx), and (xxxiii) of this chapter, and colorants used in accordance 
with Sec. 178.3297 of this chapter.
    (4) Erucamide as identified in Sec. 178.3860 of this chapter.
    (5) Xanthan gum as identified in Sec. 172.695 for use as a 
thickening agent at a level not to exceed 1 percent by weight of coating 
solids in aqueous dispersions of ethylene-vinyl acetate copolymers, 
where such copolymers are used only as coatings or a component of 
coatings.
    (6) The copolymer of vinylidene fluoride and hexafluoropropene (CAS 
Reg. No. 9011-17-0), containing 65 to 71 percent fluorine and having a 
Mooney Viscosity of at least 28, for use as a processing aid at a level 
not to exceed 0.2 percent by weight of ethylene-vinyl acetate 
copolymers.
    (b) Ethylene-vinyl acetate copolymers, with or without the optional 
substances described in paragraph (a) of this section, when extracted 
with the solvent or solvents characterizing the type of food, and under 
conditions of time and temperature characterizing the conditions of 
their intended use as determined from Tables 1 and 2 of Sec. 176.170(c) 
of this chapter, shall yield net chloroform-soluble extractives 
corrected for zinc as zinc oleate not to exceed 0.5 milligram per square 
inch of an appropriate sample.
    (c) The provisions of paragraph (b) of this section are not 
applicable to ethylene-vinyl acetate copolymers used in food-packaging 
adhesives complying with Sec. 175.105 of this chapter.
    (d) Ethylene-vinyl acetate copolymers may be irradiated under the 
following conditions to produce molecular crosslinking of the polymers 
to impart desired properties such as increased strength and increased 
ability to shrink when exposed to heat:
    (1) Electron beam source of ionizing radiation at a maximum energy 
of 3 million electron volts: Maximum absorbed dose not to exceed 150 
kiloGray (15 megarads).
    (2) The finished food-contact film shall meet the extractives 
limitations prescribed in paragraph (e)(2) of this section.
    (3) The ethylene-vinyl acetate copolymer films may be further 
irradiated in accordance with the provisions of paragraph (e)(1) of this 
section: Provided, That the total accumulated radiation dose from both 
electron beam and gamma ray radiation does not exceed 150 kiloGray (15 
megarads).
    (e) Ethylene-vinyl acetate copolymer films intended for contact with 
food may be irradiated to control the growth of microorganisms under the 
following conditions:
    (1) Gamma photons emitted from a cobalt-60 sealed source in the dose 
range of 5-50 kiloGray (0.5-5.0 megarads).
    (2) The irradiated ethylene-vinyl acetate copolymer films, when 
extracted with reagent grade n-heptane (freshly redistilled before use) 
according to methods described under Sec. 176.170(d)(3) of this chapter, 
at 75 deg. F for 30 minutes shall yield total extractives not to exceed 
4.5 percent by weight of the film.

[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54 
FR 35874, Aug. 30, 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30, 
1991]



Sec. 177.1360  Ethylene-vinyl acetate-vinyl alcohol copolymers.

    Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221-
27-2) may be safely used as articles or components of articles intended 
for use in contact with food, in accordance with the following 
prescribed conditions:
    (a) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by 
the partial or complete alcoholysis or hydrolysis of those ethylene-
vinyl acetate copolymers complying with Sec. 177.1350.
    (1) Those copolymers containing a minimum of 55 percent ethylene and 
a maximum of 30 percent vinyl alcohol units by weight may be used in 
contact with foods as described in paragraph (b) of this section.
    (2) Those copolymers containing a minimum of 55 percent ethylene and 
a maximum of 15 percent vinyl alcohol units by weight may be used in 
contact with foods as described in paragraph (c) of this section.

[[Page 246]]

    (3) Those copolymers containing 20 to 40 percent ethylene and 60 to 
80 percent vinyl alcohol units by weight may be used in contact with 
foods as described in paragraph (d) of this section.
    (b) The finished food-contact article shall not exceed 0.013 
centimeter (0.005 inch) thickness and shall contact foods only of the 
types identified in Table 1 of Sec. 176.170(c) of this chapter in 
Categories I, II, IV-B, VI, VII-B, and VIII under conditions of use D 
through G described in Table 2 of Sec. 176.170(c) of this chapter. Film 
samples of 0.013 centimeter (0.005) inch thickness representing the 
finished article shall meet the following extractive limitation when 
tested by ASTM method F34-76 (Reapproved 1980), ``Standard Test Method 
for Liquid Extraction of Flexible Barrier Materials,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (1) The film when extracted with distilled water at 21 deg. C 
(70 deg. F) for 48 hours yields total extractives not to exceed 0.0047 
milligram per square centimeter (0.03 milligram per square inch) of 
food-contact surface.
    (2) The film when extracted with 50 percent ethyl alcohol at 21 deg. 
C (70 deg. F) for 48 hours yields total extractives not to exceed 0.0062 
milligram per square centimeter (0.04 milligram per square inch) of 
food-contact surface.
    (c) The finished food-contact article shall not exceed 0.0076 
centimeter (0.003 inch) thickness and shall contact foods only of the 
types identified in Table 1 of Sec. 176.170(c) of this chapter in 
Categories III, IV-A, VII-A, and IX under conditions of use F and G 
described in Table 2 of Sec. 176.170(c) of this chapter. Film samples of 
0.0076 centimeter (0.003 inch) thickness representing the finished 
articles shall meet the following extractive limitation when tested by 
ASTM method F34-76 (Reapproved 1980), ``Standard Test Method for Liquid 
Extraction of Flexible Barrier Materials,'' which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (b) of this section. The film when extracted with n-heptane 
at 38 deg. C (100 deg. F) for 30 minutes yields total extractives not to 
exceed 0.0078 milligram per square centimeter (0.05 milligram per square 
inch) of food-contact surface, after correcting the total extractives by 
dividing by a factor of five.
    (d) The finished food-contact article shall not exceed 0.018 
centimeter (0.007 inch) thickness and may contact all foods except those 
containing more than 8 percent alcohol under conditions of use B through 
H described in Table 2 of Sec. 176.170(c) of this chapter. Film samples 
of 0.018 centimeter (0.007 inch) thickness representing the finished 
articles shall meet the following extractive limitation when tested by 
ASTM method F34-76 (Reapproved 1980), ``Standard Test Method for Liquid 
Extraction of Flexible Barrier Materials,'' which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (b) of this section. The film when extracted with distilled 
water at 100 deg. C (212 deg. F) for 30 minutes yields total extractives 
not to exceed 0.023 milligram per square centimeter (0.15 milligram per 
square inch) of food-contact surface.
    (e) The provisions of this section are not applicable to ethylene-
vinyl acetate-vinyl alcohol copolymers used in the food-packaging 
adhesives complying with Sec. 175.105 of this chapter.

[47 FR 41531, Sept. 21, 1982, as amended at 49 FR 10108, Mar. 19, 1984]



Sec. 177.1380   Fluorocarbon resins.

    Fluorocarbon resins may be safely used as articles or components of 
articles intended for use in contact with food, in accordance with the 
following prescribed conditions:
    (a) For the purpose of this section, fluorocarbon resins consist of 
basic resins produced as follows:
    (1) Chlorotrifluoroethylene resins produced by the 
homopolymerization of chlorotrifluoroethylene.
    (2) Chlorotrifluoroethylene-1,1-difluoroethylene copolymer resins 
produced by copolymerization of chlorotrifluoroethylene and 1,1-
difluoroethylene.
    (3) Chlorotrifluoroethylene-1,1-difluoroethylene-tetrafluoroethylene 
co-polymer resins produced by copolymerization of

[[Page 247]]

chlorotrifluoroethylene, 1,1-difluoroethylene, and tetrafluoroethylene.
    (4) Ethylene-chlorotrifluoroethylene copolymer resins produced by 
copolymerization of nominally 50 mole percent of ethylene and 50 mole 
percent of chlorotrifluoroethylene. The copolymer shall have a melting 
point of 239 to 243 deg.C and a melt index of less than or equal to 20 
as determined by ASTM Method D 3275-89 ``Standard Specification for E-
CTFE-Fluoroplastic Molding, Extrusion, and Coating Materials,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
Part 51. Copies may be obtained from the American Society for Testing 
and Materials, 1916 Race St., Philadelphia, PA 19013, or may be examined 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.
    (b) Fluorocarbon resins that are identified in paragraph (a) of this 
section and that comply with extractive limitations prescribed in 
paragraph (c) of this section may be used as articles or components of 
articles intended for use in contact with food as follows:
    (1) Fluorocarbon resins that are identified in paragraphs (a)(1), 
(a)(2), and (a)(3) of this section and that comply only with the 
extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of 
this section may be used when such use is limited to articles or 
components of articles that are intended for repeated use in contact 
with food or that are intended for one-time use in contact with foods 
only of the types identified in Sec. 176.170(c) of this chapter, Table 
1, under Types I, II, VI, VII-B, and VIII.
    (2) Fluorocarbon resins that are identified in paragraph (a)(4) of 
this section and that comply with the extractive limitations prescribed 
in paragraphs (c)(1) and (c)(2) of this section may be used only when 
such use is limited to articles or components of articles that are 
intended for repeated use in contact with food.
    (3) In accordance with current good manufacturing practice, those 
food-contact articles intended for repeated use shall be thoroughly 
cleansed prior to their first use in contact with food.
    (c) Extractives limitations are applicable to the basic resins in 
the form of pellets that have been ground or cut into small particles 
that will pass through a U.S. Standard Sieve No. 6 and that will be held 
on a U.S. Standard Sieve No. 10.
    (1) A 100-gram sample of the resin pellets, when extracted with 100 
milliliters of distilled water at reflux temperature for 8 hours, shall 
yield total extractives not to exceed 0.003 percent by weight of the 
resins.
    (2) A 100-gram sample of the resin pellets, when extracted with 100 
milliliters of 50 percent (by volume) ethyl alcohol in distilled water 
at reflux temperature for 8 hours, shall yield total extractives not to 
exceed 0.003 percent by weight of the resins.
    (3) A 100-gram sample of the resin pellets, when extracted with 100 
milliliters of n-heptane at reflux temperature for 8 hours, shall yield 
total extractives not to exceed 0.01 percent by weight of the resins.

[42 FR 14572, Mar. 15, 1977, as amended at 57 FR 185, Jan. 3, 1992]



Sec. 177.1390  Laminate structures for use at temperatures of 250 deg. F and above.

    (a) The high-temperature laminates identified in this section may be 
safely used for food contact at temperatures not exceeding 135 deg. C 
(275 deg. F) unless otherwise specified. These articles are layered 
constructions that are optionally bonded with adhesives. The interior 
(food-contact) layer(s) may be separated from the exterior layer(s) by a 
functional barrier, such as aluminum foil. Upon review of the physical 
properties of a particular construction, the Food and Drug 
Administration may consider other layers to serve as functional 
barriers. This regulation is not intended to limit these constructions 
as to shape, degree of flexibility, thickness, or number of layers. 
These layers may be laminated, extruded, coextruded, or fused.
    (b) When containers subject to this regulation undergo heat 
sterilization to produce shelf-stable foods, certain control measures 
(in addition to the food additive requirements in paragraphs (c) and (d) 
of this section) are

[[Page 248]]

necessary to ensure proper food sterilization and package integrity. 
Refer to parts 108, 110, 113, and 114 of this chapter for details.
    (c) Subject to the provisions of this paragraph, food-contact 
articles produced from high-temperature laminates may be safely used to 
package all food types except those containing more than 8 percent ethyl 
alcohol.
    (1) Polymeric films/layers. Films or layers not separated from food 
by a functional barrier must meet the following requirements:
    (i) Films/layers may consist of the following:
    (a) Polyolefin resins complying with item 2.2 or 3.2 of the table in 
Sec. 177.1520(c).
    (b) Polymeric resin blends formulated from a base polymer complying 
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no 
more than 10 percent by weight of a copolymer of ethylene and vinyl 
acetate complying with Sec. 177.1350.
    (c) Polymeric resin blends formulated from a base polymer complying 
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no 
more than 38 percent by weight of a homopolymer of isobutylene complying 
with Sec. 177.1420(a)(1).
    (d) Polyethylene phthalate resins complying with Sec. 177.1630(e)(4) 
(i) and (ii).
    (e) Polymeric resins that comply with an applicable regulation in 
this chapter which permits food type and time/temperature conditions to 
which the container will be exposed, including sterilization processing.
    (ii) Adjuvants used in these layers must comply with an applicable 
regulation that permits food type and time/temperature conditions to 
which the container will be exposed, including sterilization processing.
    (2) Adhesives. The use of adhesives in these containers is optional. 
Adhesives may be formulated from the following substances, subject to 
the prescribed limitations:
    (i) Any substance suitable for use in formulating adhesives that 
complies with an applicable regulation of this chapter which permits 
food type and time/temperature conditions to which the container will be 
exposed, including sterilization processing.
    (ii) Substances complying with Sec. 175.105 of this chapter may be 
used in these constructions, provided they are separated from the 
interior (food-contact) layer(s) by a functional barrier as discussed 
under paragraph (a) of this section.
    (iii) Maleic anhydride adduct of polypropylene complying with 
Sec. 175.300 of this chapter.
    (iv) Polyester-urethane adhesive for use at temperatures not 
exceeding 121 deg. C (250 deg. F) and formulated from the following:
    (a) Polyester-urethanediol resin prepared by the reaction of a 
mixture of polybasic acids and polyhydric alcohols listed in 
Sec. 175.300(b)(3)(vii) of this chapter, 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) and optional 
trimethoxysilane coupling agents containing amino, epoxy, ether, and/or 
mercapto groups not to exceed 3 percent by weight of the cured adhesive.
    (b) Urethane cross-linking agent comprising not more than 25 percent 
by weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) adduct of 
trimethylol propane (Cas Reg. No. 77-99-6) and/or 1,3-
bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4) adduct of 
trimethylol propane.
    (v) Polyester-epoxy-urethane adhesives formulated from the 
following:
    (a) Polyester resin formed by the reaction of polybasic acids and 
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter. 
Azelaic acid may also be used as a polybasic acid.
    (b) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this 
chapter and comprising no more than 30 percent by weight of the cured 
adhesive.
    (c) Urethane cross-linking agent comprising no more than 14 percent 
weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-
0).
    (vi) Polyurethane-polyester resin-epoxy adhesives formulated from 
the following mixture:

[[Page 249]]

    (a)(1) Polyester-polyurethanediol resins prepared by the reaction of 
a mixture of polybasic acids and polyhydric alcohols listed in 
Sec. 175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9).
    (2) Polyester resin formed by the reaction of polybasic acids and 
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter. 
Additionally, azelaic acid and 1,6-hexanediol may also be used as 
reactants in lieu of a polyhydric alcohol.
    (3) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this 
chapter and comprising not more than 5 percent by weight of the cured 
adhesive.
    (4) Optional trimethoxy silane curing agents, containing amino, 
epoxy, ether, or mercapto groups not in excess of 3 percent of the cured 
adhesive.
    (b) Urethane cross-linking agent, comprising not more than 20 
percent by weight of the cured adhesive, and formulated from trimethylol 
propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4).
    (3) Test specifications. These specifications apply only to 
materials on the food-contact side of a functional barrier, if present. 
All tests must be performed on containers made under production 
conditions. Laminated structures submitted to extraction procedures must 
maintain complete structural integrity (particularly with regard to 
delamination) throughout the test.
    (i) Nonvolatile extractives. (a) For use at temperatures not to 
exceed 121 deg. C (250 deg. F): The container interior (food-contact 
side) shall be extracted with deionized distilled water at 121 deg. C 
(250 deg. F) for 2 hours.
    (1) The chloroform-soluble fraction of the total nonvolatile 
extractives for containers using adhesives listed in paragraphs (c)(2) 
(i), (ii), (iii), and (iv) of this section shall not exceed 0.0016 
milligram per square centimeter (0.01 milligram per square inch) as 
determined by a method titled ``Determination of Non-volatile Chloroform 
Soluble Residues in Retort Pouch Water Extracts,'' which is incorporated 
by reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20404, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (2) The chloroform-soluble fraction of the total nonvolatile 
extractives for containers using adhesives listed in paragraph (c)(2)(v) 
of this section shall not exceed 0.016 milligram per square centimeter 
(0.10 milligram per square inch) as determined by a method titled 
``Determination of Non-volatile Chloroform Soluble Residues in Retort 
Pouch Water Extracts,'' which is incorporated by reference in paragraph 
(c)(3)(i)(a)(1) of this section.
    (b) For use at temperatures not to exceed 135 deg. C (275 deg. F): 
The container interior (food-contact side) shall be extracted with 
deionized distilled water at 135 deg. C (275 deg. F) for 1 hour.
    (1) The chloroform-soluble fraction of the total nonvolatile 
extractives for containers using no adhesive, or adhesives listed in 
paragraphs (c)(2) (i), (ii), and (iii) of this section shall not exceed 
0.0020 milligram per square centimeter (0.013 milligram per square inch) 
as determined by a method titled ``Determination of Non-volatile 
Chloroform Soluble Residues in Retort Pouch Water Extracts,'' which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (c)(3)(i)(a)(1) of this section.
    (2) The chloroform-soluble fraction of the total nonvolatile 
extractives for containers using adhesives listed in paragraph (c)(2)(v) 
of this section shall not exceed 0.016 milligram per square centimeter 
(0.10 milligram per square inch) as determined by a method titled 
``Determination of Non-volatile Chloroform Soluble Residues in Retort 
Pouch Water Extracts,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(3)(i)(a)(1) of this section.
    (3) The chloroform-soluble fraction of the total nonvolatile 
extractives for containers using adhesives listed in paragraph 
(c)(2)(vi) of this section shall

[[Page 250]]

not exceed 0.008 milligram per square centimeter (0.05 milligram per 
square inch) as determined by a method enti-tled, ``Determination of 
Non-volatile Chloroform Soluble Residues in Retort Pouch Water 
Extracts,'' which is incorporated by reference in paragraph 
(c)(3)(i)(a)(1) of this section.
    (ii) Volatiles. Volatile substances employed in the manufacture of 
high-temperature laminates must be removed to the greatest extent 
possible in keeping with good manufacturing practice prescribed in 
Sec. 174.5(a) of this chapter.
    (d) Nylon 12/aluminum foil high-temperature laminates: Subject to 
the provisions of this paragraph, containers constructed of nylon 12 
laminated to aluminum foil may be safely used at temperatures no greater 
than 250 deg. F (121 deg. C) in contact with all food types except those 
containing more than 8 percent alcohol.
    (1) The container is constructed of aluminum foil to which nylon 12 
film is fused. Prior to fusing the nylon 12, the aluminum foil may be 
optionally precoated with a coating complying with Sec. 175.300 of this 
chapter.
    (2) Nylon 12 resin complying with Sec. 177.1500 and having an 
average thickness not to exceed 0.0016 inch (41 microns) may be used as 
the food-contact surface of the container.
    (3) Container test specifications. On exposure to distilled water at 
250 deg. F (121 deg. C) for 2 hours, extractives from the food-contact 
side of the nylon 12 multilayered construction shall not exceed 0.05 
milligram per square inch (0.0078 milligram per square centimeter) as 
total nonvolatile extractives.

[45 FR 2843, Jan. 15, 1980, as amended at 47 FR 49639, Nov. 2, 1982; 48 
FR 236, Jan. 4, 1983; 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, 
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084, 
Oct. 5, 1988; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]



Sec. 177.1395  Laminate structures for use at temperatures between 120  deg.F and 250  deg.F.

    (a) The laminates identified in this section may be safely used at 
the specified temperatures. These articles are layered structures that 
are optionally bonded with adhesives. In these articles, the food-
contact layer does not function as a barrier to migration of components 
from non-food-contact layers. The layers may be laminated, extruded, 
coextruded, or fused.
    (b) Laminate structures may be manufactured from:
    (1) Polymers and adjuvants complying with Sec. 177.1390 of this 
chapter.
    (2) Any polymeric resin listed in these regulations so long as the 
use of the resin in the structure complies with the conditions of use 
(food type and time/temperature) specified in the regulation for that 
resin.
    (3) Optional adjuvant substances used in accordance with Sec. 174.5 
of this chapter.
    (4) The following substances in non-food-contact layers only:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Ethylene/1,3-phenylene oxyethylene          For use only with           
 isophthalate/terephthalate copolynmer       polyethylene terephthalate 
 (CAS Reg. No. 87365-98-8) complying with    as the food-contact layer, 
 Sec.  177.1345.                             complying with Sec.        
                                             177.1630 under conditions  
                                             of use C through G         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter. Laminate          
                                             structures, when extracted 
                                             with 8 percent ethanol at  
                                             150  deg.F for 2 hours     
                                             shall not yield m-pheny    
                                             lenedioxy-O,O'-diethyl     
                                             isophthalate or cyclic     
                                             bis(ethylene isophthalate) 
                                             in excess of 7.8 micrograms/
                                             square decimeter (0.5      
                                             microgram/square inch) of  
                                             food-contact surface.      
Nylon 6/12 resins complying with Sec.       For use with nonalcoholic   
 177.1500(b), item 13.2, of this chapter     foods at temperatures not  
 (CAS Reg. No. 25191-04-2).                  to exceed 100 C (212 F).   
                                             Laminate structures with   
                                             authorized food-contact    
                                             materials yield no more    
                                             than 0.15 milligram of     
                                             epsilon-caprolactam and    
                                             0.04 milligram of omega-   
                                             laurolactam per square inch
                                             when extracted with water  
                                             at 100 C (212 F) for 5     
                                             hours.                     
Nylon 6/66 resins complying with Sec.       For use with nonalcoholic   
 177.1500(b), item 4.2, of this chapter      foods at temperatures not  
 (CAS Reg. No. 24993-04-2).                  to exceed 82.2 C (180 F).  
                                             Laminate structures with   
                                             authorized food-contact    
                                             materials yield no more    
                                             than 0.15 milligram of     
                                             epsilon-caprolactam per    
                                             square inch when extracted 
                                             with water at 82.2 C (180  
                                             F) for 5 hours.            

[[Page 251]]

                                                                        
Nylon 6/69 resins complying with Sec.       For use with nonalcoholic   
 177.1500(b), item 14, of this chapter       foods under conditions of  
 (CAS Reg. No. 51995-62-1).                  use B, C, D, E, F, G, and H
                                             described in Table 2 of    
                                             Sec.  176.170 of this      
                                             chapter. Laminate          
                                             structures with authorized 
                                             food-contact materials may 
                                             contain nylon 6/69 resins  
                                             provided that the nitrogen 
                                             content of aqueous extracts
                                             of a representative        
                                             laminate (obtained at 100 C
                                             (212 F) for 8 hours) does  
                                             not exceed 15 micrograms   
                                             per square centimeter (100 
                                             micrograms per square      
                                             inch).                     
------------------------------------------------------------------------


[52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988; 57 
FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993]



Sec. 177.1400   Hydroxyethyl cellulose film, water-insoluble.

    Water-insoluble hydroxyethyl cellulose film may be safely used for 
packaging food in accordance with the following prescribed conditions:
    (a) Water-insoluble hydroxyethyl cellulose film consists of a base 
sheet manufactured by the ethoxylation of cellulose under controlled 
conditions, to which may be added certain optional substances of a grade 
of purity suitable for use in food packaging as constituents of the base 
sheet or as coatings applied to impart desired technological properties.
    (b) Subject to any limitations prescribed in parts 170 through 189 
of this chapter, the optional substances used in the base sheet and 
coating may include:
    (1) Substances generally recognized as safe in food.
    (2) Substances permitted to be used in water-insoluble hydroxyethyl 
cellulose film by prior sanction or approval and under conditions 
specified in such sanctions or approval, and substances listed in part 
181, Subpart B of this chapter.
    (3) Substances that by any regulation promulgated under section 409 
of the act may be safely used as components of water-insoluble 
hydroxyethyl cellulose film.
    (4) Substances identified in and used in compliance with 
Sec. 177.1200(c).
    (c) Any substance employed in the production of the water-insoluble 
hydroxyethyl cellulose film described in this section that is the 
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 
of this chapter conforms with any specification in such regulation.



Sec. 177.1420   Isobutylene polymers.

    Isobutylene polymers may be safely used as components of articles 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, in 
accordance with the following prescribed conditions:
    (a) For the purpose of this section, isobutylene polymers are those 
produced as follows:
    (1) Polyisobutylene produced by the homopolymerization of 
isobutylene such that the finished polymers have a molecular weight of 
750,000 (Flory) or higher.
    (2) Isobutylene-isoprene copolymers produced by the copolymerization 
of isobutylene with not more than 3 molar percent of isoprene such that 
the finished polymers have a molecular weight of 300,000 (Flory) or 
higher.
    (3) Chlorinated isobutylene-isoprene copolymers produced when 
isobutylene-isoprene copolymers (molecular weight 300,000 (Flory) or 
higher) are modified by chlorination with not more than 1.3 weight-
percent of chlorine.
    (b) The polymers identified in paragraph (a) of this section may 
contain optional adjuvant substances required in the production of the 
polymers. The optional adjuvant substances required in the production of 
the polymers may include substances generally recognized as safe in 
food, substances used in accordance with a prior sanction or approval, 
and aluminum chloride.
    (c) The provisions of this section are not applicable to 
polyisobutylene used in food-packaging adhesives complying with 
Sec. 175.105 of this chapter.



Sec. 177.1430  Isobutylene-butene copolymers.

    Isobutylene-butene copolymers identified in paragraph (a) of this 
section may be safely used as components of articles intended for use in 
contact

[[Page 252]]

with food, subject to the provisions of this section.
    (a) For the purpose of this section, isobutylene-butene copolymers 
consist of basic copolymers produced by the copolymerization of 
isobutylene with mixtures of n-butenes such that the finished basic 
copolymers contain not less than 45 weight percent of polymer units 
derived from isobutylene and meet the specifications prescribed in 
paragraph (b) of this section when tested by the methods described in 
paragraph (c) of this section.
    (b) Specifications:

----------------------------------------------------------------------------------------------------------------
                                                                                                        Maximum 
     Isobutylene-butene copolymers      Molecular weight (range)           Viscosity (range)            bromine 
                                                                                                         value  
----------------------------------------------------------------------------------------------------------------
1. Used as release agents in petroleum  300 to 5,000............  40 to 20,000 seconds Saybolt at 200         40
 wax complying with Sec.  178.3710 of                               deg.F.                                      
 this chapter.                                                                                                  
2. Used as plasticizers in              300 to 5,000............  40 to 20,000 seconds Saybolt at 200         40
 polyethylene complying with Sec.                                   deg.F.                                      
 177.1520 and in polystyrene complying                                                                          
 with Sec.  177.1640 of this chapter.                                                                           
3. Used as components of nonfood        300 to 5,000............  40 to 20,000 seconds Saybolt at 200         40
 articles complying with Secs.                                      deg.F.                                      
 175.300, 176.170, 176.210,                                                                                     
 177.2260(d)(2), 177.2800, and                                                                                  
 178.3570 (provided that addition to                                                                            
 food does not exceed 10 parts per                                                                              
 million), or Sec.  176.180 of this                                                                             
 chapter.                                                                                                       
4. Used as production aids in the       150 to 5,000............  Less than 20,000 seconds Saybolt at        90.
 manufacture of expanded (foamed)                                  200  deg.F.                                  
 polystyrene articles complying with                                                                            
 Sec.  177.1640 of this chapter.                                                                                
5. Used in release coatings on          150 to 5,000............  Less than 20,000 seconds Saybolt at         90
 backings or linings for pressure-                                 200  deg.F.                                  
 sensitive adhesive labels complying                                                                            
 with Sec.  175.125 of this chapter.                                                                            
----------------------------------------------------------------------------------------------------------------

    (c) The analytical methods for determining whether isobutylene-
butene copolymers conform to the specifications in paragraph (b) are as 
follows:
    (1) Molecular weight. Molecular weight shall be determined by 
American Society for Testing and Materials (ASTM) method D2503-82, 
``Standard Test Method for Molecular Weight (Relative Molecular Mass) of 
Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Viscosity. Viscosity shall be determined by ASTM method D445-74, 
``Test for Kinematic Viscosity of Transparent and Opaque Liquids,'' 
which is incorporated by reference. The availability of this 
incorporation by reference is given in paragraph (c)(1) of this section.
    (3) Maximum bromine value. Maximum bromine value shall be determined 
by ASTM method D1492-78, ``Standard Test Method for Bromine Index of 
Aromatic Hydrocarbons by Coulometric Titration,'' which is incorporated 
by reference. The availability of this incorporation by reference is 
given in paragraph (c)(1) of this section.
    (d) The provisions of this section are not applicable to 
isobutylene-butene copolymers used as provided under Sec. 175.105 of 
this chapter.

[52 FR 11641, Apr. 10, 1987]



Sec. 177.1440   4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins minimum molecular weight 10,000.

    4,4'-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum 
molecular weight of 10,000 may be safely used as articles or components 
of articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food in accordance with the following prescribed conditions:
    (a) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins consist of 
basic resins produced by the condensation of equimolar amounts of 4,4'-
isopropylidenediphenol and epichlorohydrin terminated with phenol, to 
which may have been added certain optional adjuvant substances required 
in the production of the resins.
    (b) The optional adjuvant substances required in the production of 
the resins may include substances generally recognized as safe in food, 
substances used in accordance with a prior sanction or approval, and the 
following:

[[Page 253]]



------------------------------------------------------------------------
            List of substances                      Limitations         
------------------------------------------------------------------------
Butyl alcohol............................  Not to exceed 300 p.p.m. as  
                                            residual solvent in finished
                                            resin.                      
Ethyl alcohol............................                               
Toluene..................................  Not to exceed 1,000 p.p.m. as
                                            residual solvent in finished
                                            resin.                      
------------------------------------------------------------------------

    (c) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet 
the following nonvolatile extractives limitations:
    (1) Maximum extractable nonvolatile fraction of 2 parts per million 
when extracted with distilled water at 70 deg. C for 2 hours, using a 
volume-to-surface ratio of 2 milliliters per square inch.
    (2) Maximum extractable nonvolatile fraction of 3 parts per million 
when extracted with n-heptane at 70 deg. C for 2 hours, using a volume-
to-surface ratio of 2 milliliters per square inch.
    (3) Maximum extractable nonvolatile fraction of 6 parts per million 
when extracted with 10 percent (by volume) ethyl alcohol in distilled 
water at 70 deg. C for 2 hours, using a volume-to-surface ratio of 2 
milliliters per square inch.
    (d) The provisions of this section are not applicable to 4,4'-
isopropylidene-diphenol-epichlorohydrin resins listed in other sections 
of Subchapter B of this chapter.



Sec. 177.1460   Melamine-formaldehyde resins in molded articles.

    Melamine-formaldehyde resins may be safely used as the food-contact 
surface of molded articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food in accordance with the following prescribed conditions:
    (a) For the purpose of this section, melamine-formaldehyde resins 
are those produced when 1 mole of melamine is made to react with not 
more than 3 moles of formaldehyde in water solution.
    (b) The resins may be mixed with refined woodpulp and the mixture 
may contain other optional adjuvant substances which may include the 
following:

------------------------------------------------------------------------
            List of substances                      Limitations         
------------------------------------------------------------------------
Colorants used in accordance with Sec.                                  
 178.3297 of this chapter.                                              
Dioctyl phthalate........................  For use as lubricant.        
Hexamethylenetetramine...................  For use only as              
                                            polymerization reaction     
                                            control agent.              
Phthalic acid anhydride..................      Do.                      
Zinc stearate............................  For use as lubricant.        
------------------------------------------------------------------------

    (c) The molded melamine-formaldehyde articles in the finished form 
in which they are to contact food, when extracted with the solvent or 
solvents characterizing the type of food and under the conditions of 
time and temperature as determined from Tables 1 and 2 of 
Sec. 175.300(d) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of food-contact 
surface.

[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]



Sec. 177.1480   Nitrile rubber modified acrylonitrile-methyl acrylate copolymers.

    Nitrile rubber modified acrylonitrile-methyl acrylate copolymers 
identified in this section may be safely used as components of articles 
intended for food-contact use under conditions of use D, E, F, or G 
described in table 2 of Sec. 176.170(c) of this chapter, subject to the 
provisions of this section.
    (a) For the purpose of this section, nitrile rubber modified 
acrylonitrile-methyl acrylate copolymers consist of basic copolymers 
produced by the graft copolymerization of 73-77 parts by weight of 
acrylonitrile and 23-27 parts by weight of methyl acrylate in the 
presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers 
containing approximately 70 percent by weight of polymer units derived 
from butadiene.
    (b) The nitrile rubber modified acrylonitrile-methyl acrylate basic 
copolymers meet the following specifications and extractives 
limitations:
    (1) Specifications. (i) Nitrogen content is in the range 16.5-19 
percent as determined by Kjeldahl analysis.
    (ii) Intrinsic viscosity in acetonitrile at 25 deg. C is not less 
than 0.29 deciliter per gram as determined by ASTM method D1243-79, 
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St.,

[[Page 254]]

Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (iii) Residual acrylonitrile monomer content is not more than 11 
parts per million as determined by gas chromatography.
    (iv) Acetonitrile-soluble fraction after refluxing the base polymer 
in acetonitrile for 1 hour is not greater than 95 percent by weight of 
the basic copolymers.
    (2) Extractives limitations. The following extractive limitations 
are determined by an infrared spectrophotometric method titled, 
``Infrared Spectrophotometric Determination of Polymer Extracted from 
Borex  210 Resin Pellets,'' which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408, and are applicable to the basic copolymers in the 
form of particles of a size that will pass through a U.S. standard sieve 
No. 6 and that will be held on a U.S. standard sieve No. 10:
    (i) Extracted copolymer not to exceed 2.0 parts per million in 
aqueous extract obtained when a 100-gram sample of the basic copolymers 
is extracted with 250 milliliters of demineralized (deionized) water at 
reflux temperature for 2 hours.
    (ii) Extracted copolymer not to exceed 0.5 part per million in n-
heptane extract obtained when a 100-gram sample of the basic copolymers 
is extracted with 250 milliliters of reagent grade n-heptane at reflux 
temperature for 2 hours.
    (c) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.
    (d) Acrylonitrile copolymers identified in this section are not 
authorized to be used to fabricate beverage containers.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977; 
47 FR 11843, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, 
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]



Sec. 177.1500   Nylon resins.

    The nylon resins listed in paragraph (a) of this section may be 
safely used to produce articles intended for use in processing, 
handling, and packaging food, subject to the provisions of this section:
    (a) The nylon resins are manufactured as described in this paragraph 
so as to meet the specifications prescribed in paragraph (b) of this 
section when tested by the methods described in paragraph (c) of this 
section.
    (1) Nylon 66 resins are manufactured by the condensation of 
hexamethylene-diamine and adipic acid.
    (2) Nylon 610 resins are manufactured by the condensation of 
hexamethylene-diamine and sebacic acid.
    (3) Nylon 66/610 resins are manufactured by the condensation of 
equal-weight mixtures of nylon 66 salts and nylon 610 salts.
    (4) Nylon 6/66 resins manufactured by the condensation and 
polymerization of Nylon 66 salts and epsilon-caprolactam.
    (5) Nylon 11 resins are manufactured by the condensation of 11-
aminoundecanoic acid.
    (6) Nylon 6 resins are manufactured by the polymerization of 
epsilon-caprolactam.
    (7) Nylon 66T resins are manufactured by the condensation of 
hexamethyl-enediamine, adipic acid, and terephthalic acid such that 
composition in terms of ingredients is 43.1plus-minus0.2 weight 
percent hexamethyl-enediamine, 35.3plus-minus1.2 weight percent 
adipic acid, and 21.6plus-minus1.2 weight percent terephthalic 
acid.
    (8) Nylon 612 resins are manufactured by the condensation of 
hexamethylenediamine and dodecanedioic acid.
    (9) Nylon 12 resins are manufactured by the condensation of omega-
laurolactam.

[[Page 255]]

    (10)(i) Impact modified Nylon MXD-6 resins (CAS Reg. No. 59655-05-9) 
manufactured by the condensation of adipic acid, 1,3-
benzenedimethanamine, and T3alpha-(3-aminopropyl)-omega-(3-amino-
propoxy)poly- oxyethylene under such conditions that the alpha-(3-amino-
propyl)-omega-(3-aminopropoxy) polyoxyethylene monomer content does not 
exceed 7 percent by weight of the finished resin.
    (ii) Nylon MXD-6 resins (CAS Reg. No. 25718-70-1) manufactured by 
the condensation of adipic acid and 1,3-benzenedimethanamine.
    (11) Nylon 12T resins are manufactured by the condensation of omega-
laurolactam (CAS Reg. No. 0947-04-6), isophthalic acid (CAS Reg. No. 
0121-91-5), and bis(4-amino-3-methylcycl-ohexyl)methane (CAS Reg. No. 
6864-37-5) such that the composition in terms of ingredients is 34.4 
 1.5 weight percent omega-laurolactam, 26.8  0.4 
weight percent isophthalic acid, and 38.8  0.5 weight 
percent bis(4-amino-3-methylcyclohexyl)-methane.
    (12) Nylon 6I/6T resins (CAS Reg. No. 25750-23-6) are manufactured 
by the condensation of hexamethylenediamine, terephthalic acid, and 
isophthalic acid such that 65 to 80 percent of the polymer units are 
derived from hexamethylene isophthalamide.
    (13)(i) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured 
by the copolymerization of a 1 to 1 ratio by weight of epsilon-
caprolactam and omega-laurolactam.
    (ii) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured by 
the copolymerization of a ratio of at least 80 weight percent of 
epsilon-caprolactam and no more than 20 weight percent of omega-
laurolactam.
    (14) Nylon 6/69 resins (CAS Reg. No. 51995-62-1) are manufactured by 
the condensation of 49.5+0.5 weight percent epsilon-caprolactam, 
19.4+0.2 weight percent hexamethylenediamine and 31.2+0.3 weight percent 
azelaic acid.
    (b) Specifications:

[[Page 256]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Maximum extractable fraction in selected solvents
                                                     Melting                                               (expressed in percent by weight of resin)    
                                                      point       Solubility in    Viscosity No. (mL/---------------------------------------------------
          Nylon resins           Specific gravity    (degrees    boiling 4.2N HC1          g)                       95 percent                          
                                                   Fahrenheit)                                           Water        ethyl        Ethyl       Benzene  
                                                                                                                     alcohol      acetate               
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Nylon 66 resins.............  1.14plus-minus.0      475-495  Dissolves in 1 h.  .................          1.5          1.5          0.2          0.2
                                               15                                                                                                       
2. Nylon 610 resins............  1.09plus-minus.0      405-425  Insoluble after 1  .................          1.0          2.0          1.0          1.0
                                               15                h.                                                                                     
3.1 Nylon 66/610 resins........  1.10plus-minus.0      375-395  Dissolves in 1 h.  .................          1.5          2.0          1.0          1.0
                                               15                                                                                                       
4.1  Nylon 6/66 resins, epsilon- 1.13      440-460  ......do.........  .................          2.0          2.0          1.5          1.5
 caprolactam monomer content                 .015                                                                                                       
 not to exceed 0.7 percent by                                                                                                                           
 weight.                                                                                                                                                
4.2  Nylon 6/66 resins with      1.14      380-400  ......do.........  .................          0.8          1.0          0.5          0.5
 combined caprolactam content                .015                                                                                                       
 greater than 60 percent and                                                                                                                            
 residual epsilon-caprolactam                                                                                                                           
 monomer content not to exceed                                                                                                                          
 0.4 percent by weight. For use                                                                                                                         
 only as specified in Sec.                                                                                                                              
 177.1395 of this chapter (CAS                                                                                                                          
 Reg. No. 24993-04-2).                                                                                                                                  
5.1 Nylon 11 resins for use in   1.04plus-minus.0      355-375  Insoluble after 1  .................          .30          .35          .25           .3
 articles intended for 1-time                  15                h.                                                                                     
 use or repeated use in contact                                                                                                                         
 with food.                                                                                                                                             
5.2 Nylon 11 resins for use      1.04plus-minus.0      355-375  ......do.........  .................          .35         1.60          .35          .40
 only:                                         15                                                                                                       
  a. In articles intended for                                                                                                                           
   repeated use in contact with                                                                                                                         
   food.                                                                                                                                                
  b. In side-seam cements for                                                                                                                           
   articles intended for 1-time                                                                                                                         
   use in contact with food and                                                                                                                         
   which are in compliance with                                                                                                                         
   Sec.  175.300 of this                                                                                                                                
   chapter.                                                                                                                                             
6.1 Nylon 6 resins.............  1.15plus-minus.0      392-446  Dissolves in 1 h.  .................          1.0          2.0          1.0          1.0
                                               15                                                                                                       
6.2 Nylon 6 resins for use only  1.15plus-minus.0      392-446  ......do.........  .................          1.5          2.0          1.0          1.0
 in food-contact films having                  15                                                                                                       
 an average thickness not to                                                                                                                            
 exceed 0.001 in.                                                                                                                                       
7. Nylon 66T resins for use      1.16plus-minus.0      482-518  Insoluble after 1  .................          1.0          1.0          .25          .25
 only in food-contact films                    15                h.                                                                                     
 having an average thickness                                                                                                                            
 not to exceed 0.001 in.                                                                                                                                
8. Nylon 612 resins for use      1.06plus-minus.0      406-420  ......do.........  .................          .50         1.50          .50          .50
 only in articles intended for                 15                                                                                                       
 repeated use in contact with                                                                                                                           
 food at temperatures not to                                                                                                                            
 exceed 212 deg. F..                                                                                                                                    
9. Nylon 12 resins for use       1.01plus-minus.0      335-355  ......do.........  .................          1.0          2.0         1.50         1.50
 only:.                                        15                                                                                                       
a. In food-contact films having  ................                                                                                                       
 an average thickness not to                                                                                                                            
 exceed 0.0016 inch intended                                                                                                                            
 for use in contact with                                                                                                                                
 nonalcoholic food under the                                                                                                                            
 conditions of use A                                                                                                                                    
 (sterilization not to exceed                                                                                                                           
 30 minutes at a temperature                                                                                                                            
 not to exceed 250 F), and B                                                                                                                            
 through H of Table 2 of Sec.                                                                                                                           
 176.170(c) of this chapter,                                                                                                                            
 except as provided in Sec.                                                                                                                             
 177.1390(d).                                                                                                                                           

[[Page 257]]

                                                                                                                                                        
b. In coatings intended for                                                                                                                             
 repeated use in contact with                                                                                                                           
 all food types described in                                                                                                                            
 Table 1 of Sec.  176.170(c) of                                                                                                                         
 this chapter, except those                                                                                                                             
 containing more than 8 percent                                                                                                                         
 alcohol, under conditions of                                                                                                                           
 use B through H described in                                                                                                                           
 Table 2 of Sec.  176.170(c) of                                                                                                                         
 this chapter.                                                                                                                                          
10.1 Nylon MXD-6 and impact      1.21      437-491  Dissolves in 1h..  .................          2.0          2.5          1.0          1.0
 modified Nylon MXD-6 film                   0.02                                                                                                       
 having an average thickness                                                                                                                            
 not to exceed 40 microns                                                                                                                               
 (0.0016 inch) for use in                                                                                                                               
 processing, handling, and                                                                                                                              
 packaging of food of types V                                                                                                                           
 and IX listed in table 1 of                                                                                                                            
 Sec.  176.170(c) of this                                                                                                                               
 chapter under conditions of                                                                                                                            
 use C, D, E, F, G, and H in                                                                                                                            
 table 2 of Sec.  176.170(C) of                                                                                                                         
 this chapter.                                                                                                                                          
10.2 Impact modified Nylon MXD-  1.21      437-491  do...............  .................          2.0          2.5          1.0          1.0
 6 resins for use as polymer                 0.02                                                                                                       
 use as polymer modifiers in                                                                                                                            
 Nylon 6 resin films complying                                                                                                                          
 with paragraph (a)(6) of this                                                                                                                          
 section, at levels not to                                                                                                                              
 exceed 13 percent by weight of                                                                                                                         
 films whose average thickness                                                                                                                          
 will not exceed 15 microns                                                                                                                             
 (0.6 mils). The finished film                                                                                                                          
 is used for packaging,                                                                                                                                 
 transporting, or holding food,                                                                                                                         
 excluding beverages containing                                                                                                                         
 more than 8 percent alcohol                                                                                                                            
 (by volume) at temperatures                                                                                                                            
 not to exceed 49 C (120 F)                                                                                                                             
 (conditions of use E, F, and G                                                                                                                         
 in table 2 of Sec.  176.170(c)                                                                                                                         
 of this chapter).                                                                                                                                      
11. Nylon 12T resins for use in  1.06plus-minus0.      290-310  Insoluble after 1  .................          0.1  ...........          0.5          0.5
 contact with all types of food               015                hour.                                                                                  
 except those containing more                                                                                                                           
 than 8 percent alcohol.                                                                                                                                
12. Nylon 6I/6T resins for use   1.2070.1                hour.                                                                                  
 food except alcoholic                                                                                                                                  
 beverages containing more than                                                                                                                         
 8 percent alcohol.                                                                                                                                     
                                                                                                                                                        
13.1 Nylon 6/12 resins for use   1.06      260-285  Dissolves in 1     Greater than 140.          2.0  ...........          1.5          1.5
 only in food-contact films                 0.015                hour.                                                                                  
 having an average thickness                                                                                                                            
 not to exceed 51 microns                                                                                                                               
 (0.002 inch). The finished                                                                                                                             
 film is intended to contact                                                                                                                            
 all foods except those                                                                                                                                 
 containing more than 8 percent                                                                                                                         
 ethanol under conditions of                                                                                                                            
 use B, C, D, E, F, G, and H                                                                                                                            
 listed in table 2 of Sec.                                                                                                                              
 176.170(c) of this chapter.                                                                                                                            
13.2 Nylon 6/12 resins with      1.10      380-400  Dissolves in 1 h.  Greater than 160.          0.8          1.0          0.5          0.5
 residual epsilon-caprolactam                0.15                                                                                                       
 not to exceed 0.5 percent by                                                                                                                           
 weight and residual omega-                                                                                                                             
 laurolactam not to exceed 0.1                                                                                                                          
 percent by weight. For use                                                                                                                             
 only as specified in Sec.                                                                                                                              
 177.1395 of this chapter.                                                                                                                              
14. Nylon 6/69 resins for use         1.09 140 using the             3.0  ...........  ...........  ...........
 only as specified in 21 CFR          minus> 0.02                                   method described                                                    
 177.1395 of this chapter.                                                          in Sec.                                                             
                                                                                    177.1500(c)(5)(i                                                    
                                                                                    i) of this                                                          
                                                                                    chapter.                                                            
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 258]]



    (c) Analytical methods--(1) Specific gravity. Specific gravity shall 
be determined by weighing a 1-gram to 5-gram sample first in air and 
then in freshly boiled distilled water at 23 deg. Cplus-minus2 deg. 
C.
    (2) Melting point. The melting point shall be determined as follows: 
Use a hot-stage apparatus. The use of crossed nicol prisms with a 
microscope hot stage and reading of the thermometer when the 
birefringence disappears increases the accuracy. If the crossed nicol 
apparatus is not available, use the lowest temperature at which the 
sample becomes transparent or the sharp edges or corners of the sample 
become rounded as the melting point. In case of doubt as to the onset of 
melting, the sample is prodded with a sharp instrument. If it sticks to 
the heating block, it is considered to have melted. If the melting point 
is low, dry the sample in an oven at 85 deg. C for 24 hours in a 
nitrogen atmosphere then repeat the test.
    (3) Solubility in boiling 4.2N HCl. The test shall be run on a 
sample approximately the size of a \1/8\-inch cube in at least 25 
milliliters of 4.2 normal hydrochloric acid.
    (4) Maximum extractable fraction in selected solvents. The procedure 
for determining the maximum extractable fraction of the nylon resins in 
selected solvents is as follows:
    (i) Film should be cut with ordinary scissors into pieces of a 
convenient size such as \1/4\-inch squares, for the extraction tests 
described in this section. The granules of nylon molding powders are in 
the proper form for the extraction tests. Samples of fabricated articles 
such as pipe, fittings, and other similar articles must be cut to 
approximately the size of the molding powder. This can be done 
conveniently by using a small-scale commercial plastics granulator and 
cutting the sample through a screen having \1/4\-inch mesh. Fine 
particles should be separated from the cut resin by screening through a 
20-mesh screen. The material retained on the screen is suitable for the 
extraction tests.
    (ii) The organic solvents must be of American Chemical Society 
analytical reagent grade; distilled water is used. Approximately 30 
grams of the prepared sample is weighed to the nearest milligram. The 
weighed resin is transferred to a 500-milliliter round-bottom flask 
equipped with a reflux condenser. Approximately 300-milliliters of 
solvent is added to the flask and the contents refluxed gently for 8 
hours with a heating mantle. The solvent is then filtered off 
immediately while still hot, using a Buchner funnel approximately 5 
inches in diameter, a suction flask, and a hardened filter paper 
(Whatman No. 50 or equivalent). The paper is wet with the solvent and a 
slight suction applied just before starting the filtration. The resin is 
washed twice with approximately 100-milliliter portions of solvent and 
the combined filtrate and washings are reduced to approximately 25 
milliliters by evaporation at reduced pressure (50 millimeters to 100 
millimeters of mercury, absolute), heating as necessary. The contents of 
the flask are transferred to an evaporation dish (which has been held in 
a vacuum desiccator over anhydrous calcium sulfate until constant weight 
has been attained) and carefully evaporated to dryness. The weight of 
the solid residue is determined by difference after holding in a vacuum 
desiccator over anhydrous calcium sulfate until constant weight has been 
attained. The percent of solids extracted is calculated by dividing the 
weight of the solid residue by the weight of the sample and multiplying 
by 100.
    (5) Viscosity number (VN). (i) The viscosity number (VN) for Nylon 
6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin 
per milliliter) shall be determined at 25  deg.C (77  deg.F) by method 
ISO 307-1984(E), ``Plastics-Polyamides-Determination of Viscosity 
Number,'' which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (ii) The viscosity number (VN) for Nylon 6/69 resin in a 99 percent 
cresol solution (5 milligrams resin per milliliter) shall be determined 
at 25  deg.C (77  deg.F) by method ISO 307-1984(E), ``Plastics-
Polyamides-Determination of Viscosity Number,'' which is incorporated

[[Page 259]]

by reference. The availability of this incorporation by reference is 
given in paragraph (c)(5)(i) of this section.

[42 FR 14572, Mar. 15, 1977, as amended at 45 FR 2844, Jan. 15, 1980; 48 
FR 30361, July 1, 1983; 48 FR 33478, July 22, 1983; 48 FR 36099, Aug. 9, 
1983; 51 FR 33250, Sept. 19, 1986; 52 FR 26667, July 16, 1987; 52 FR 
33575, Sept. 4, 1987; 52 FR 39635, Oct. 23, 1987; 52 FR 42760, Nov. 6, 
1987; 53 FR 19773, May 31, 1988; 54 FR 29019, July 11, 1989; 58 FR 2977, 
Jan. 7, 1993; 58 FR 32610, June 11, 1993; 61 FR 14481, Apr. 2, 1996]



Sec. 177.1520   Olefin polymers.

    The olefin polymers listed in paragraph (a) of this section may be 
safely used as articles or components of articles intended for use in 
contact with food, subject to the provisions of this section.
    (a) For the purpose of this section, olefin polymers are basic 
polymers manufactured as described in this paragraph, so as to meet the 
specifications prescribed in paragraph (c) of this section, when tested 
by the methods described in paragraph (d) of this section.
    (1) Polypropylene consists of basic polymers manufactured by the 
catalytic polymerization of propylene.
    (2) Polyethylene consists of basic polymers manufactured by the 
catalytic polymerization of ethylene.
    (3) Olefin basic copolymers consist of basic copolymers manufactured 
by the catalytic copolymerization of:
    (i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such 
olefin basic copolymers contain not less than 96 weight-percent of 
polymer units derived from ethylene and/or propylene, except that:
    (a)(1) Olefin basic copolymers manufactured by the catalytic 
copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall 
contain not less than 90 weight-percent of polymer units derived from 
ethylene;
     (2) Olefin basic copolymers manufactured by the catalytic 
copolymerization of ethylene and hexene-1 shall contain not less than 80 
but not more than 90 weight percent of polymer units derived from 
ethylene.
    (b) Olefin basic copolymers manufactured by the catalytic 
copolymerization of ethylene and 4-methylpentene-1 shall contain not 
less than 89 weight-percent of polymer units derived from ethylene;
    (c)(1) Olefin basic copolymers manufactured by the catalytic 
copolymerization of two or more of the monomers ethylene, propylene, 
butene-1, 2-methylpropene-1, and 2,4,4-trimethylpentene-1 shall contain 
not less than 85 weight-percent of polymer units derived from ethylene 
and/or propylene;
    (2) Olefin basic copolymers manufactured by the catalytic 
copolymerization of propylene and butene-1 shall contain greater than 15 
but not greater than 35 weight percent of polymer units derived from 
butene-1 with the remainder being propylene.
    (d) Olefin basic terpolymers manufactured by the catalytic 
copolymerization of ethylene, hexene-1, and either propylene or butene-
1, shall contain not less than 85 weight percent polymer units derived 
from ethylene.
    (e) Olefin basic copolymers manufactured by the catalytic 
polymerization of ethylene and octene-1, or ethylene, octene-1, and 
either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall contain 
not less than 80 weight percent of polymer units derived from ethylene.
    (ii) 4-Methylpentene-1 and 1-alkenes having 6 to 10 carbon atoms. 
Such olefin basic copolymers shall contain not less than 95 molar 
percent of polymer units derived from 4-methylpentene-1; or
    (iii) Ethylene and propylene that may contain as modifiers not more 
than 5 weight-percent of total polymer units derived by copolymerization 
with one or more of the following monomers:

5-Ethylidine-2-norbornene.
5-Methylene-2-norbornene.

    (iv) Ethylene and propylene that may contain as a modifier not more 
than 4.5 weight percent of total polymer units derived by 
copolymerization with 1,4-hexadiene.
    (v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087-34-7) that 
shall contain not less than 80 weight percent of polymer units derived 
from ethylene.
    (4) Poly(methylpentene) consists of basic polymers manufactured by 
the catalytic polymerization of 4-methylpentene-1.

[[Page 260]]

    (5) Polyethylene graft copolymers consist of polyethylene complying 
with item 2.2 of paragraph (c) of this section which subsequently has 
3a,4,7,7a-tetrahydromethyl-4,7-methanoisobenzofuran-1,3-dione grafted 
onto it at a level not to exceed 1.7 percent by weight of the finished 
copolymer.
    (6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2) 
containing no more than 2 percent by weight of copolymer units derived 
from maleic anhydride.
    (b) The basic olefin polymers identified in paragraph (a) of this 
section may contain optional adjuvant substances required in the 
production of such basic olefin polymers. The optional adjuvant 
substances required in the production of the basic olefin polymers or 
finished food-contact articles may include substances permitted for such 
use by applicable regulations in parts 170 through 189 of this chapter, 
substances generally recognized as safe in food and food packaging, 
substances used in accordance with a prior sanction or approval, and the 
following:

------------------------------------------------------------------------
               Substance                           Limitations          
------------------------------------------------------------------------
Aromatic petroleum hydrocarbon resin,    For use only as an adjuvant at 
 hydrogenated (CAS Reg. No. 88526-47-     levels not to exceed 25       
 0), produced by the catalytic            percent by weight in blends   
 polymerization of aromatic-substituted   with polypropylene complying  
 olefins from distillates of cracked      with paragraph (c), item 1.1  
 petroleum stocks with a boiling point    of this section. The finished 
 no greater than 220 C (428 F), and the   polymer may be used in contact
 subsequent catalytic hydrogenation of    with food Types I, II, IV-B,  
 the resulting aromatic petroleum         VI-A through VI-C, VII-B, and 
 hydrocarbon resin, having a minimum      VIII identified in Table 1 of 
 softening point of 110 C (230 F), as     Sec.  176.170(c) of this      
 determined by ASTM Method E 28-67        chapter and under conditions  
 (Reapproved 1982), ``Standard Test       of use B through H described  
 Method for Softening Point by Ring-and-  in Table 2 of Sec.  176.170(c)
 Ball Apparatus,'' and a minimum          of this chapter; and with food
 aniline point of 107 C (225 F), as       Types III, IV-A, V, VII-A, and
 determined by ASTM Method D 611-82,      IX identified in Table 1 of   
 ``Standard Test Methods for Aniline      Sec.  176.170(c) of this      
 Point and Mixed Aniline Point of         chapter and under conditions  
 Petroleum Products and Hydrocarbon       of use D through G described  
 Solvents,'' both of which are            in Table 2 of Sec.  176.170(c)
 incorporated by reference in             of this chapter.              
 accordance with 5 U.S.C. 552(a) and 1                                  
 CFR part 51. Copies are available from                                 
 the American Society for Testing and                                   
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or from the                                    
 Center for Food Safety and Applied                                     
 Nutrition (HFS-200), Food and Drug                                     
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Office of the Federal                                  
 Register, 800 North Capitol St. NW.,                                   
 suite 700, Washington, DC.                                             
Colorants used in accordance with Sec.   ...............................
 178.3297 of this chapter.                                              
2,5-Dimethyl-2,5-di(tert-                For use as an initiator in the 
 butylperoxy)hexane (CAS Reg. No. 78-63-  production of propylene       
 7).                                      homopolymer complying with    
                                          Sec.  177.1520(c), item 1.1   
                                          and olefin copolymers         
                                          complying with Sec.           
                                          177.1520(c), items 3.1 and 3.2
                                          and containing not less than  
                                          75 weight percent of polymer  
                                          units derived from propylene, 
                                          provided that the maximum     
                                          concentration of tert-butyl   
                                          alcohol in the polymer does   
                                          not exceed 100 parts per      
                                          million, as determined by a   
                                          method titled ``Determination 
                                          of tert-Butyl Alcohol in      
                                          Polypropylene,'' which is     
                                          incorporated by reference.    
                                          Copies are available from the 
                                          Center for Food Safety and    
                                          Applied Nutrition (HFS-200),  
                                          Food and Drug Administration, 
                                          200 C St. SW., Washington, DC 
                                          20204, or available for       
                                          inspection at the Office of   
                                          the Federal Register, 800     
                                          North Capitol Street, NW.,    
                                          suite 700, Washington, DC     
                                          20408.                        

[[Page 261]]

                                                                        
Petroleum hydrocarbon resins             For use only as an adjuvant at 
 (cyclopentadiene-type), hydrogenated     levels not to exceed 30       
 (CAS Reg. No. 68132-00-3) produced by    percent by weight in blends   
 the thermal polymerization of            with: (1) Polypropylene       
 dicyclopentadiene and cyclodiene         complying with paragraph (c), 
 codimers (consisting of a mixture of     item 1.1 of this section, or  
 cyclopentadiene, methyl                  (2) a copolymer of propylene  
 cyclopentadiene, and C4-C5 acyclic       and ethylene containing not   
 dienes), followed by hydrogenation and   less than 94 weight percent   
 having a ring-and-ball softening point   propylene and complying with  
 of 119 C minimum as determined by ASTM   paragraph (c), item 3.2 of    
 Method E 28-67 (Reapproved 1982),        this section. The average     
 ``Standard Test Method for Softening     thickness of the food-contact 
 Point by Ring-and-Ball Apparatus,''      film is not to exceed 0.1     
 and a minimum viscosity of 3,000         millimeter (0.004 inch). The  
 centipoise, measured at 160 C, as        finished polymer may be used  
 determined by ASTM Method D 3236-88,     in contact with food types I, 
 ``Standard Test Method for Apparent      II, IV-B, VI-A, VI-B, VII-B,  
 Viscosity of Hot Melt Adhesives and      and VIII identified in Table 1
 Coating Materials,'' both of which are   of Sec.  176.170(c) of this   
 incorporated by reference in             chapter and under conditions  
 accordance with 5 U.S.C. 552(a) and 1    of use C through G described  
 CFR part 51. Copies are available from   in Table 2 of Sec.  176.170(c)
 the American Society for Testing and     of this chapter.              
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or from the                                    
 Center For Food Safety and Applied                                     
 Nutrition (HFS-200), Food and Drug                                     
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Office of the Federal                                  
 Register, 800 North Capitol St. NW.,                                   
 suite 700, Washington, DC.                                             
Poly(vinylidene fluoride) homopolymer    For use only as a processing   
 (CAS Reg. No. 24937-79-9), having a      aid in the production of      
 melt viscosity of 6 to 37 kilopoise at   olefin polymers complying with
 a shear rate of 100-1 seconds at 232     paragraph (c) of this section 
 deg.C as determined by ASTM Method D     at levels not to exceed 1.0   
 3835-79 (Reapproved 1983), ``Standard    percent by weight of the      
 Test Method for Rheological Properties   polymer. The finished polymers
 of Thermoplastics with a Capillary       may be used only under the    
 Rheometer'' using a capillary of 15:1    conditions described in Sec.  
 L/D, which is incorporated by            176.170(c) of this chapter,   
 reference in accordance with 5 U.S.C.    Table 2, under conditions of  
 552(a) and 1 CFR part 51. Copies are     use B though H.               
 available from the Center for Food                                     
 Safety and Applied Nutrition (HFS-                                     
 200), Food and Drug Administration,                                    
 200 C St. SW., Washington, DC 20204,                                   
 or may be examined at the Office of                                    
 the Federal Register, 800 North                                        
 Capitol Street, NW., suite 700,                                        
 Washington, DC.                                                        
Polyoxyethylene-grafted                  For use as an extrusion aid in 
 polydimethylsiloxane (CAS Reg. No.       the production of extruded    
 68937-54-2).                             olefin polymers that comply   
                                          with Sec.  177.1520(c) at     
                                          levels not to exceed 0.3      
                                          percent by weight of the      
                                          polymer. The finished polymer 
                                          is used in contact with foods 
                                          under conditions of use B     
                                          through H described in Table 2
                                          of Sec.  176.170 of this      
                                          chapter.                      
Triisopropanolamine (CAS Reg. No. 122-   For use as a Zeigler-Natta-type
 20-3).                                   catalyst deactivator and      
                                          antioxidant in the production 
                                          of olefin polymers complying  
                                          with Sec.  177.1520(c), items 
                                          2.1, 2.2, and 2.3, and having 
                                          a minimum density of 0.94     
                                          grams per cubic centimeter,   
                                          and copolymers complying with 
                                          Sec.  177.1520(c), items 3.1  
                                          and 3.2, for use in contact   
                                          with all foods under the      
                                          following conditions of use:  
                                          (a) films with a maximum      
                                          thickness of 0.102 millimeter 
                                          (0.004 inch) may be used under
                                          conditions A through H defined
                                          in Table 2 of Sec.  176.170(c)
                                          of this chapter; and (b)      
                                          articles with thickness       
                                          greater than 0.102 millimeter 
                                          (0.004 inch) may be used under
                                          conditions C through G defined
                                          in Table 2 of Sec.  176.170(c)
                                          of this chapter.              
Trimethylpyridine and dimethylpyridine   For use only as an adjuvant    
 mixture having percent by weight         substance in the production of
 composition as follows: 2,4,6-           propylene homopolymers        
 trimethylpyridine (CAS Reg. No. 108-75-  complying with items 1.1, 1.2,
 8), not less than 60 percent; 2,3,6-     and 1.3, and propylene        
 trimethylpyridine (CAS Reg. No. 1462-    copolymers complying with     
 84-6), not more than 27 percent; 3,5-    items 3.1, and 3.2 of         
 dimethylpyridine (CAS Reg. No. 591-22-   paragraph (c) of this section 
 0), not more than 12 percent; and        provided that the adjuvant is 
 other dimethylpyridines, not more than   used at a level not to exceed 
 6 percent.                               20 parts per million by weight
                                          of the olefin polymers.       
Vinylidene fluoride-hexafluoropropene    For use only as an extrusion   
 copolymer (CAS Reg. No. 9011-17-0)       aid in the production of      
 having a fluorine content of 65 to 71    extruded olefin polymers at   
 percent and a Mooney viscosity of at     levels not to exceed 0.2      
 least 28, as determined by a method      percent by weight of the      
 entitled ``Mooney Viscosity,'' which     polymer. The finished polymers
 is incorporated by reference in          may be used only under the    
 accordance with 5 U.S.C. 552(a).         conditions described in Sec.  
 Copies are available from the Center     176.170(c) of this chapter,   
 for Food Safety and Applied Nutrition    Table 2, under conditions of  
 (HFS-200), Food and Drug                 use B through H.              
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Office of the Federal                                  
 Register, 800 North Capitol Street,                                    
 NW., suite 700, Washington, DC.                                        

[[Page 262]]

                                                                        
Vinylidene fluoride-hexafluoropropene    For use only as a processing   
 copolymer (CAS Reg. No. 9011-17-0),      aid in the production of      
 having a vinylidene fluoride content     olefin polymers complying with
 of not less than 87 percent but less     paragraph (c) of this section 
 than 100 percent by weight and a melt    at levels not to exceed 1.0   
 viscosity of 12 to 27 kilopoise at a     percent by weight of the      
 shear rate of 100-1 seconds at 232       polymer. The finished polymers
 deg.C as determined by ASTM Method D     may be used only under the    
 3835-79 (Reapproved 1983), ``Standard    conditions described in Sec.  
 Test Method for Rheological Properties   176.170(c) of this chapter,   
 of Thermoplastics with a Capillary       Table 2, under conditions of  
 Rheometer'' using a capillary of 15:1    use B though H.               
 L/D, which is incorporated by                                          
 reference in accordance with 5 U.S.C.                                  
 552(a) and 1 CFR part 51. Copies are                                   
 available from the Center for Food                                     
 Safety and Applied Nutrition (HFS-                                     
 200), Food and Drug Administration,                                    
 200 C St. SW., Washington, DC 20204,                                   
 or may be examined at the Office of                                    
 the Federal Register, 800 North                                        
 Capitol Street, NW., suite 700,                                        
 Washington, DC 20408.                                                  
------------------------------------------------------------------------


[[Page 263]]



----------------------------------------------------------------------------------------------------------------
                                                                     Maximum extractable      Maximum soluble   
                                                                     fraction (expressed    fraction (expressed 
                                             Melting point (MP) or   as percent by weight   as percent by weight
        Olefin polymers           Density     softening point (SP)    of polymer) in N-    of polymer) in xylene
                                              (Degrees Centigrade)   hexane at specified        at specified    
                                                                         temperatures           temperatures    
----------------------------------------------------------------------------------------------------------------
1.1 Polypropylene.............  0.880-0.913  MP:160 deg.-180 deg.   6.4 pct at reflux      9.8 pct at 25 deg. C.
                                              C.                     temperature.                               
1.2 Polypropylene,                0.80-0.88  .....................  .....................  .....................
 noncrystalline; for use only                                                                                   
 to plasticize polyethylene                                                                                     
 described under items 2.1 and                                                                                  
 2.2 of this table, provided                                                                                    
 that such plasticized                                                                                          
 polymers meet the maximum                                                                                      
 extractable fraction and                                                                                       
 maximum soluble fraction                                                                                       
 specifications prescribed for                                                                                  
 such basic polyethylene.                                                                                       
1.3 Polypropylene,                0.80-0.88  SP:115 deg.-138 deg.   .....................  .....................
 noncrystalline, for use only:                C.                                                                
 To plasticize polypropylene                                                                                    
 described by item 1.1 of this                                                                                  
 table, provided that such                                                                                      
 plasticized polymers meet the                                                                                  
 maximum extractable fraction                                                                                   
 and maximum soluble fraction                                                                                   
 specifications prescribed for                                                                                  
 such basic polypropylene, and                                                                                  
 further provided that such                                                                                     
 plasticized polypropylene                                                                                      
 contacts food only of the                                                                                      
 types identified in Sec.                                                                                       
 176.170(c) of this chapter,                                                                                    
 Table 1, under Types I, II,                                                                                    
 IV-B, VI-B, VII-B, and VIII;                                                                                   
 and for use at levels not to                                                                                   
 exceed 50 pct by weight of                                                                                     
 any mixture employed as a                                                                                      
 food-contact coating provided                                                                                  
 such coatings contact food                                                                                     
 only of the types identified                                                                                   
 in Sec.  176.170(c) of this                                                                                    
 chapter, Table 1, under Types                                                                                  
 I, II, IV-B, VI-B, VII-B, and                                                                                  
 VIII.                                                                                                          
2.1 Polyethylene for use in       0.85-1.00  .....................  5.5 pct at 50 deg. C.  11.3 pct at 25 deg.  
 articles that contact food                                                                 C.                  
 except for articles used for                                                                                   
 packing or holding food                                                                                        
 during cooking.                                                                                                
2.2 Polyethylene for use in       0.85-1.00  .....................  2.6 pct at 50 deg. C.      Do.              
 articles used for packing or                                                                                   
 holding food during cooking.                                                                                   
2.3 Polyethylene for use only     0.85-1.00  .....................  53 pct at 50 deg. C..  75 pct at 25 deg. C. 
 as component of food-contact                                                                                   
 coatings at levels up to and                                                                                   
 including 50 percent by                                                                                        
 weight of any mixture                                                                                          
 employed as a food-contact                                                                                     
 coating.                                                                                                       
3.1a Olefin copolymers            0.85-1.00  .....................  5.5 pct at 50 C......  30 pct at 25 C       
 described in paragraph                                                                                         
 (a)(3)(i) of this section for                                                                                  
 use in articles that contact                                                                                   
 food except for articles used                                                                                  
 for packing or holding food                                                                                    
 during cooking; except olefin                                                                                  
 copolymers described in                                                                                        
 paragraph (a)(3)(i)(e) of                                                                                      
 this section and listed in                                                                                     
 item 3.1b of this table.                                                                                       
3.1b Olefin copolymers             0.9-1.00  .....................  Do...................  Do.                  
 described in paragraph                                                                                         
 (a)(3)(i)(e) of this section                                                                                   
 for use in contact with food                                                                                   
 only under conditions of use                                                                                   
 D, E, F, G, and H described                                                                                    
 in Sec.  176.170(c) of this                                                                                    
 chapter, Table 2.                                                                                              
3.2a Olefin copolymers            0.85-1.00  .....................  2.6 percent at 50 C..  Do.                  
 described in paragraph                                                                                         
 (a)(3)(i) of this section for                                                                                  
 use in articles used for                                                                                       
 packing or holding food                                                                                        
 during cooking; except olefin                                                                                  
 copolymers described in                                                                                        
 paragraph (a)(3)(i)(c)(2) of                                                                                   
 this section and listed in                                                                                     
 item 3.2b of this table;                                                                                       
 except that olefin copolymers                                                                                  
 containing 89 to 95 percent                                                                                    
 ethylene with the remainder                                                                                    
 being 4-methyl-pentene-1                                                                                       
 contacting food Types III,                                                                                     
 IVA, V, VIIA, and IX                                                                                           
 identified in Sec.                                                                                             
 176.170(c) of this chapter,                                                                                    
 Table 1, shall not exceed                                                                                      
 0.051 millimeter (mm) (0.002                                                                                   
 inch (in)) in thickness when                                                                                   
 used under conditions of use                                                                                   
 A and shall not exceed 0.102                                                                                   
 mm (0.004 in) in thickness                                                                                     
 when used under conditions of                                                                                  
 use B, C, D, E, and H                                                                                          
 described in Sec.  176.170(c)                                                                                  
 of this chapter, Table 2.                                                                                      
 Additionally, olefin                                                                                           
 copolymers described in                                                                                        
 (a)(3)(i)(a)(2) of this                                                                                        
 section may be used only                                                                                       
 under conditions of use B, C,                                                                                  
 D, E, F, G, and H described                                                                                    
 in Sec.  176.170(c) of this                                                                                    
 chapter, Table 2, in contact                                                                                   
 with all food types                                                                                            
 identified in Sec.                                                                                             
 176.170(c) of this chapter,                                                                                    
 Table 1.                                                                                                       
3.2b Olefin copolymers                  Do.  .....................  .....................  .                    
 described in paragraph                                                                                         
 (a)(3)(i)(c)(2) of this                                                                                        
 section have a melt flow                                                                                       
 index no greater than 10                                                                                       
 grams per 10 minutes as                                                                                        
 determined by the method                                                                                       
 described in paragraph (d)(7)                                                                                  
 of this section, and the                                                                                       
 thickness of the finished                                                                                      
 polymer contacting food shall                                                                                  
 not exceed 0.025 mm (0.001                                                                                     
 in). Additionally, optional                                                                                    
 adjuvants permitted for use                                                                                    
 in olefin copolymers                                                                                           
 complying with item 3.2a of                                                                                    
 this table may be used in the                                                                                  
 production of this copolymer.                                                                                  
3.3a Olefin polymers described    0.82-0.85  MP: 235-250  deg.C...  6.6 pct at reflux....  7.5 pct at 25  deg.C.
 in paragraph (a)(3)(ii) of                                                                                     
 this section..                                                                                                 

[[Page 264]]

                                                                                                                
3.3b Olefin copolymers            0.82-0.85                                                                     
 described in paragraph                                                                                         
 (a)(3)(ii) of this section,                                                                                    
 provided that such olefin                                                                                      
 polymers have a melt                                                                                           
 temperature of 220  deg.C to                                                                                   
 250  deg.C (428  deg.F to 482                                                                                  
  deg.F) as determined by the                                                                                   
 method described in paragraph                                                                                  
 (d)(8) of this section and                                                                                     
 minimum intrinsic viscosity                                                                                    
 of 1.0 as determined in                                                                                        
 paragraph (d)(9) of this                                                                                       
 section.                                                                                                       
3.4 Olefin copolymers,            0.85-0.90  .....................  .....................  .....................
 primarily non-crystalline,                                                                                     
 described in par. (a)(3)                                                                                       
 (iii) of this section                                                                                          
 provided that such olefin                                                                                      
 polymers have a minimum                                                                                        
 viscosity average molecular                                                                                    
 weight of 120,000 as                                                                                           
 determined by the method                                                                                       
 described in par. (d)(5) of                                                                                    
 this section and a minimum                                                                                     
 Mooney viscosity of 35 as                                                                                      
 determined by the method                                                                                       
 described in par. (d)(6) of                                                                                    
 this section, and further                                                                                      
 provided that such olefin                                                                                      
 copolymers contact food only                                                                                   
 of the types identified in                                                                                     
 Sec.  176.170(c) of this                                                                                       
 chapter, Table 1, under Types                                                                                  
 I, II, III, IV-B, VI, VII,                                                                                     
 VIII, and IX.                                                                                                  
3.5 Olefin copolymers,            0.85-0.90  .....................  .....................  .....................
 primarily non-crystalline,                                                                                     
 described in paragraph                                                                                         
 (a)(3)(iv) of this section,                                                                                    
 provided that such olefin                                                                                      
 polymers have a minimum                                                                                        
 viscosity average molecular                                                                                    
 weight of 95,600 as                                                                                            
 determined by the method                                                                                       
 described in paragraph (d)(5)                                                                                  
 of this section, and further                                                                                   
 provided that such olefin                                                                                      
 polymers are used only in                                                                                      
 blends with olefin polymers                                                                                    
 described under items 1.1,                                                                                     
 2.1, and 2.2 of this table at                                                                                  
 a maximum level of 25 pct by                                                                                   
 weight, and provided that                                                                                      
 such olefin copolymers                                                                                         
 contact food only of the                                                                                       
 types identified in Sec.                                                                                       
 176.170 (c) of this chapter,                                                                                   
 Table 1, under Types I, II,                                                                                    
 IV-B, VI, VII-B, and VIII at                                                                                   
 temperatures not exceeding                                                                                     
 190 deg. F.                                                                                                    
3.6  Olefin copolymers             Not less  .....................                                              
 described in paragraph           than 0.88                                                                     
 (a)(3)(v) of this section for                                                                                  
 use in blends with olefin                                                                                      
 polymer resins have a melt                                                                                     
 flow index no greater than 5                                                                                   
 grams/10 minutes as                                                                                            
 determined by the method                                                                                       
 described in paragraph (d)(7)                                                                                  
 of this section and the                                                                                        
 thickness of the finished                                                                                      
 blends shall not exceed 0.1                                                                                    
 millimeter (0.004 inch). The                                                                                   
 ethylene/butene-1 copolymer                                                                                    
 may be used subject to the                                                                                     
 following conditions: (1) For                                                                                  
 use at a level not to exceed                                                                                   
 20 weight percent in                                                                                           
 polypropylene as described                                                                                     
 under item 1.1 of this table.                                                                                  
 (2) For use at a level not to                                                                                  
 exceed 40 weight percent in                                                                                    
 polyethylene as described                                                                                      
 under items 2.1 and 2.2 of                                                                                     
 this table. (3) For use at a                                                                                   
 level not to exceed 40 weight                                                                                  
 percent in olefin copolymers                                                                                   
 as described under items 3.1                                                                                   
 and 3.2 of this table.                                                                                         
4. Poly(methylpentene)........    0.82-0.85  MP: 235 deg.-250 deg.  6.6 pct at reflux      7.5 pct at 25 deg. C.
                                              C..                    temperature.                               
5. Polyethylene copolymer          Not less    ...................  0.45 pct at 15  deg.C  1.8 pct at 25  deg.C.
 described in paragraph (a)(5)    than 0.94                                                                     
 of this section and having a                                                                                   
 melt index not to exceed 2,                                                                                    
 for use, either alone or in                                                                                    
 blends with other olefin                                                                                       
 polymers, subject to the                                                                                       
 limitation that when                                                                                           
 contacting foods of types                                                                                      
 III, IV-A, V, VI-C, VII-A,                                                                                     
 VIII, and IX identified in                                                                                     
 Sec.  176.170(c) of this                                                                                       
 chapter, Table 1, the                                                                                          
 thickness of the film (in                                                                                      
 mils) containing the                                                                                           
 polyethylene graft copolymer                                                                                   
 times the concentration of                                                                                     
 the polyethylene graft                                                                                         
 copolymer shall not exceed a                                                                                   
 value of 2.                                                                                                    
6. Ethylene-maleic anhydride      0.92-0.94  .....................  1.36 pct at 50 C.....  2.28 pct at 25 C.    
 copolymers described in          .........                                                                     
 paragraph (a)(6) of this                                                                                       
 section for use as the                                                                                         
 adhesive component in                                                                                          
 multilaminate structures, or                                                                                   
 as the sealant layer in                                                                                        
 flexible packaging, in                                                                                         
 contact with food at                                                                                           
 temperatures not exceeding 49                                                                                  
 C (120 F).                                                                                                     
----------------------------------------------------------------------------------------------------------------


[[Page 265]]


    (d) The analytical methods for determining whether olefin polymers 
conform to the specifications prescribed in this section are as follows, 
and are applicable to the basic polymer in film form not exceeding 4 
mils in thickness. The film to be tested shall be cut into approximately 
1-inch squares by any convenient method that avoids contamination by 
dust, dirt, or grease (Note: Do not touch samples with bare fingers--use 
forceps to hold or transfer samples).
    (1) Density. Density shall be determined by ASTM method D1505-68 
(Reapproved 1979), ``Standard Test Method for Density of Plastics by the 
Density-Gradient Technique,'' which is incorporated by reference. Copies 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (2) Melting point or softening point--(i) Melting point. The melting 
point shall be determined by ASTM method D2117-82, ``Standard Test 
Method for Melting Point of Semicrystalline Polymers by the Hot Stage 
Microscopy Method,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(d)(1) of this section.
    (ii) Softening point. The softening point shall be determined by 
ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for 
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (d)(1) of this section.
    (3) Maximum extractable fraction in n-hexane--(i) Olefin copolymers 
described in paragraph (a)(3)(ii) of this section, polypropylene, and 
poly(methylpentene). A sample is refluxed in the solvent for 2 hours and 
filtered at the boiling point. The filtrate is evaporated and the total 
residue weighed as a measure of the solvent extractable fraction.
    (a) Apparatus. (1) Erlenmeyer flasks, 250-milliliter, with ground 
joint.
    (2) Condensers, Allihn, 400-millimeter jacket, with ground joint.
    (3) Funnels, ribbed 75-millimeter diameter, stem cut to 40 
millimeters.
    (4) Funnels, Buchner type, with coarse-porosity fritted disc, 60-
millimeter diameter.
    (5) Bell jar for vacuum filtration into beaker.
    (b) Reagent. n-Hexane, commercial grade, specific gravity 0.663-
0.667 (20 deg. C/20 deg. C), boiling range 66 deg. C-69 deg. C, or 
equivalent.
    (c) Procedure. Weigh 1 gram of sample accurately and place in a 250-
milliliter Erlenmeyer flask containing two or three boiling stones. Add 
100 milliliters of solvent, attach the flask to the condenser (use no 
grease), and reflux the mixture for 2 hours. Remove the flask from the 
heat, disconnect the condenser, and filter rapidly, while still hot, 
through a small wad of glass wool packed in a short-stem funnel into a 
tared 150-millimeter beaker. Rinse the flask and filter with two 10-
milliliter portions of the hot solvent, and add the rinsings to the 
filtrate. Evaporate the filtrate on a stream bath with the aid of a 
stream of nitrogen. Dry the residue in a vacuum oven at 110 deg. C for 2 
hours, cool in a desiccator, and weigh to the nearest 0.0001 gram. 
Determine the blank on 120 milliliters of solvent evaporated in a tared 
150-milliliter beaker. Correct the sample residue for this blank if 
significant. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.398

    (ii) Olefin copolymers described in paragraph (a)(3)(i) of this 
section and polyethylene. A preweighed sample is extracted at 50  deg.C 
for 2 hours and filtered. The filtrate is evaporated and the total 
residue weighed as a measure of the solvent extractable fraction. 
Alternatively, the sample is reweighed after the extraction period to 
give a measure of the solvent extractable

[[Page 266]]

fraction. The maximum n-hexane-extractable fraction may be determined by 
the methods set forth in paragraphs (d)(3)(ii)(a) through (d)(3)(ii)(i) 
of this section.
    (a) Extraction apparatus. Two-liter, straight-walled, Pyrex (or 
equivalent) resin kettles, fitted with three-hole ground-glass covers 
are most convenient for this purpose. The cover is fitted with a 
thermometer, a gas-tight stirrer driven by an air motor or explosion-
proof electric motor, and a reflux condenser. The kettle is fitted with 
an electric heating mantle of appropriate size and shape, which is 
controlled by a variable-voltage transformer.
    (b) Evaporating apparatus. Rapid evaporation of large volumes of 
solvent requires special precautions to prevent contamination by dust. 
This is facilitated by a special ``gas'' cover consisting of an inverted 
flat Pyrex crystallizing dish of an appropriate size (190 millimeters x 
100 millimeters) to fit a 1-liter beaker. Through the center of the dish 
are sealed an inlet tube for preheated, oxygen-free nitrogen, and an 
outlet tube located 1 inch off center. Nitrogen is fed from the supply 
source through a coil of \1/4\-inch stainless steel tubing immersed in 
the same steam bath used to supply heat for solvent evaporation. All 
connections are made with flexible tetrafluoroethylene tubing.
    (c) Reagents--(1) n-Hexane. Spectrograde n-hexane.
    (2) Nitrogen. High-purity dry nitrogen containing less than 10 parts 
per million of oxygen.
    (d) Procedure. Transfer 2.5 grams (accurately weighed to nearest 
0.001 gram) of the polymer to the resin kettle. Add 1 liter of solvent 
and clamp top in position. Start water flowing through jacket of the 
reflux condenser and apply air pressure to the stirring motor to produce 
vigorous agitation. Turn on heating jacket with transformer set at a 
predetermined voltage to bring the temperature of the contents to 
50 deg. C within 20-25 minutes. As the thermometer reading approaches 
45 deg. C-47 deg. C, reduce the voltage to the predetermined setting 
that will just maintain the temperature at 50 deg. C. Do not overshoot 
the prescribed temperature. Should this occur discard the test and start 
afresh. Exactly 2 hours after the solvent temperature has reached 
50 deg. C, disconnect the heater, remove the resin kettle from the 
heating jacket, and decant the solvent, while still warm, through a 
coarse filter paper placed on top of a fritted-glass funnel, collecting 
the filtrate in a tared, glass-stoppered Erlenmeyer flask of 1-liter 
capacity. Determine the weight of the filtrate recovered to the nearest 
gram. Recovery should be at least 90 percent of the original solvent. 
Losses due to evaporation during heating and filtering have been found 
not to exceed 10 percent. Transfer about half of the solvent filtrate to 
a 1-liter beaker placed on an opening in the steam bath and immediately 
cover with the special ``gas'' cover, the inlet tube of which has been 
attached with flexible tetrafluoroethylene tubing to a source of high-
purity nitrogen in series with a stainless steel heating coil immersed 
directly in the body of the steam bath. Maintain a positive flow of warm 
nitrogen gas throughout the evaporation of the solvent, adding the 
remainder of the filtrate from the Erlenmeyer flask as the evaporation 
proceeds. When the volume of the solvent has been reduced to about 50 
milliliters, transfer the concentrated liquid to a previously tared 
weighing dish of suitable size. Wash the beaker twice with 20-30 
milliliter portions of warm solvent, adding the washings to the weighing 
dish while continuing to evaporate the remainder of the solvent under 
the gas cover with its flow of warm nitrogen directed toward the center 
of the dish. In the event that an insoluble residue that cannot be 
removed with warm solvent remains in the beaker, it may be necessary to 
heat with a small amount of a higher boiling solvent such as benzene or 
toluene, transferring these washings to the weighing dish before final 
evaporation to dryness. Transfer the weighing dish with its residue to a 
vacuum desiccator, and allow it to remain overnight (at least 12 hours), 
after which the net weight of the dry residue is determined to the 
nearest 0.0001 gram. Correct the result for any solvent blank equivalent 
to the nonvolatile matter determined to be contained in the amount of 
solvents used in the test.

[[Page 267]]

    (e) Extraction apparatus for alternate method. Two-liter extraction 
vessel, such as a resin kettle or round bottom flask, fitted with an 
Allihn condenser (size C), a 45/50 male joint with a Teflon sleeve, and 
a Teflon coated stir bar. Water bath maintained at 49.5  deg.C 
0.5  deg.C containing a submersible magnetic stirrer motor 
with power supply. Other suitable means of maintaining temperature 
control, such as electric heating mantles, may be used provided that the 
temperature range can be strictly maintained.
    (f) Sample basket (Optional). A perforated stainless steel 
cylindrical basket that is approximately 1.5 inches in diameter, 1.6 
inches high, and has perforations of 0.125 inches in diameter for 33 
holes/in2, or 40 percent open area. The basket should pass freely 
through the 45/50 female joint of the extraction flask. A No. 6-32 
stainless steel eye-bolt is attached to the lid for positioning the 
basket in the extraction vessel. The positioning rod, approximately 18 
inches long and made from 1/16 inch outside diameter 316 stainless steel 
welding rod or equivalent and hooked at both ends, is used to position 
the basket in the extraction apparatus.
    (g) Vacuum oven. Capable of maintaining 80  deg.C 5 
deg.C and a minimum of 635 millimeters of mercury pressure.
    (h) Reagents. n-Hexane, reagent or spectrograde, aromatic free (less 
than 1 milligram per liter), minimum 85 percent n-hexane. This reagent 
may be reused until it contains a maximum of 1.5 grams polyolefin 
extractables or has been used for 12 determinations.
    (i) Procedure. Assemble the extraction vessel, condenser, and 
magnetic stir bar. Add n-hexane (1 liter) to the extraction vessel and 
clamp the assembly into a water bath set at 49.5  deg.C 0.5 
deg.C. Start the water flowing through the jacket of the reflux 
condenser. Adjust the air flow through the stirring motor to give a 
smooth and uniform stir rate. Allow the n-hexane to preheat for 1 hour 
to bring the temperature to 49.5  deg.C0.5  deg.C. 
Temperature is a critical factor in this analysis and it must not vary 
more than 1  deg.C. If the temperature exceeds these limits, the test 
must be discontinued and restarted. Blown, compression molded, or 
extrusion cast films can be tested. Ideally, the film should be prepared 
by the same process as will be used with the production resin. Using 
gloves and metal tweezers to avoid sample contamination, cut about 2.7 
grams of the prepared film (4 mils or less in thickness) into about 1-
inch squares using clean sharp scissors. Proceed with Option 1 or 2.
    Option 1. Using tweezers and noting the number of film pieces, 
transfer 2.5 grams (accurately weighed to 0.1 milligram) of polymer to 
the extraction vessel. Extract the film sample for 2 hours. Allow the 
vessel to cool and filter the contents through a fritted porcelain 
funnel. Wash the film pieces with fresh n-hexane, aspirate to dryness, 
and transfer, using tweezers, to a beaker. Recount the film pieces to 
verify that none were lost during the transfer. Place the beaker in the 
vacuum oven for 2 hours at 80  deg.C5  deg.C. After 2 hours, 
remove and place in a desiccator to cool to room temperature (about 1 
hour). After cooling, reweigh the film pieces to the nearest 0.1 
milligram. Calculate the percent hexane-extractables content from the 
weight loss of the original sample. Multiply the result by 0.935 and 
compare with extraction limits in paragraph (c) of this section. Repeat 
the above procedure for successive samples.
    Option 2. Transfer 2.50.05 grams of the prepared 1-inch 
film sections into a tared sample basket and accurately weigh to the 
nearest 0.1 milligram. Carefully raise the condenser until the hook on 
the positioning rod is above the neck of the 2-liter extraction vessel. 
The basket should be totally below the level of n-hexane solvent. 
Extract the sample resin film for 2 hours and then raise the basket 
above the solvent level to drain momentarily. Remove the basket and 
rinse the contents by immersing several times in fresh n-hexane. Allow 
the basket to dry between rinsings. Remove the excess solvent by briefly 
blowing the basket with a stream of nitrogen or dry air. Place the 
basket in the vacuum oven for 2 hours at 80  deg.C5  deg.C. 
After 2 hours, remove and place in a desiccator to cool to room 
temperature (about 1 hour). After cooling, reweigh the basket to the 
nearest 0.1 milligram. Calculate

[[Page 268]]

the percent hexane extractables content from the weight loss of the 
original sample. Multiply the result by 0.935 and compare with 
extraction limits in paragraph (c) of this section. Repeat the above 
procedure for successive samples. The same solvent charge should remain 
clear and can be used for at least 12 determinations. Applications of 
solvent reuse should be confirmed for each resin type before use.
    (4) Maximum soluble fraction in xylene--(i) Olefin copolymers 
described in paragraph (a)(3)(ii) of this section, polypropylene, and 
poly(methylpen-tene). A sample is dissolved completely in xylene by 
heating and stirring in a bottle with little free space. The solution is 
allowed to cool without stirring, whereupon the insoluble portion 
precipitates and is filtered off; the total solids content of the 
filtrate is then determined as a measure of the soluble fraction.
    (a) Apparatus. (1) Pyrex (or equivalent) reagent bottle, 125-
milliliter, glass-stoppered.
    (2) Heating mantle of size for 150-milliliter beaker (or suitable 
aluminum block to fit the 125-milliter bottle described in paragraph 
(d)(4)(i)(a)(1) of this section.
    (3) Magnetic stirrer for use under the heating mantle (combination 
magnetic stirrer and hotplate may be used if aluminum block is used in 
place of heating mantle).
    (4) Variable-voltage transformer, 7.5 amperes.
    (5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.
    (6) Constant temperature water bath maintained at 25 deg. 
Cplus-minus0.5 deg. C.
    (7) Aluminum dishes, 18 millimeters x 60 millimeters, disposable.
    (8) Funnel, Buchner type, with coarse-porosity fritted disc, 30-60 
millimeter diameter.
    (b) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of phenyl-
- naphthylamine in 1 liter of industrial grade xylene having 
specific gravity 0.856-0.867 (20 deg. C/20 deg. C) and boiling range 
123 deg. C-160 deg. C.
    (c) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001 
gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-
inch long tetrafluoroethylene-resin-coated stirring bar. Add 100 
milliliters of solvent, set the stopper in lightly, and place the bottle 
in the heating mantle or aluminum block maintained at a temperature of 
120 deg. C, and stir with a magnetic stirrer until the sample is 
completely dissolved. Remove the bottle from the heat and allow it to 
cool 1 hour in the air, without stirring. Then place the bottle in a 
water bath maintained at 25 deg. Cplus-minus0.5 deg. C, and allow 
to stand 1 hour without stirring. Next, remove the bottle from the water 
bath, shake, and pour part of the contents into the coarse-porosity 
fritted-glass funnel. Apply suction, and draw 30-40 milliliters of 
filtrate through, adding more slurry to the funnel, and catching the 
filtrate in a large test tube. (If the slurry is hard to filter, add 10 
grams of diatomaceous earth filter aid to the bottle and shake 
vigorously just prior to the filtration.) Pipet a suitable aliquot 
(preferably 20 milliliters) of the filtrate into a tared aluminum 
disposable dish. Place the dish on a steam bath covered with a fresh 
sheet of aluminum foil and invert a short-stemmed 4-inch funnel over the 
dish. Pass nitrogen (heated if desired) down through the funnel at a 
rate sufficient to just ripple the surface of the solvent. When the 
liquid has evaporated, place the dish in a vacuum oven at 140 deg. C and 
less than 50 millimeters mercury pressure for 2 hours. Cool in a 
desiccator and weigh. (Note: If the residue value seems high, redry in 
the vacuum oven for one-half hour to ensure complete removal of all 
xylene solvent.) Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.399


[[Page 269]]


    (ii) Olefin copolymers described in paragraph (a)(3)(i) of this 
section and polyethylene. A sample is extracted in xylene at reflux 
temperature for 2 hours and filtered. The filtrate is evaporated and the 
total residue weighed as a measure of soluble fraction.
    (a) Apparatus--(1) Extraction apparatus. Two-liter, straight-walled 
Pyrex (or equivalent) resin kettles, fitted with ground-glass covers, 
are most convenient for this purpose. The cover is equipped with a 
thermometer and an efficient reflux condenser. The kettle is fitted with 
an electric heating mantle of appropriate size and shape which is 
controlled by a variable-voltage transformer.
    (2) Constant temperature water bath. It must be large enough to 
permit immersion of the extraction kettle and set to maintain 25 deg. 
Cplus-minus0.1 deg. C.
    (3) Evaporating apparatus. Gas cover consisting of a flat Pyrex 
crystallizing dish (190 millimeters x 100 millimeters) inverted to fit 
over a 1-liter beaker with 8-millimeter gas inlet tube sealed through 
center and an outlet tube 1 inch off center. The beaker with gas cover 
is inserted in an electric heating mantle equipped with a variable-
voltage transformer. The outlet tube is attached to an efficient 
condenser mounted on a receiving flask for solvent recovery and having 
an outlet for connection to an aspirator pump. The heating mantle (with 
the beaker) is mounted on a magnetic stirring device. An infrared heat 
lamp is mounted vertically 3-4 inches above the gas cover to prevent 
condensation of the solvent inside the cover. Make all connections with 
flexible tetrafluoroethylene tubing.
    (b) Reagents--(1) Xylene. American Chemical Society reagent grade 
that has been redistilled through a fractionating column to reduce the 
nonvolatile residue.
    (2) Nitrogen. High-purity dry nitrogen containing less than 104 
parts per million oxygen.
    (c) Procedure. Transfer 5 grams plus-minus0.001 gram of sample 
to the resin kettle, add 1,000 milliliters (840 grams) of xylene, and 
clamp top in position after inserting a piece of glass rod to prevent 
bumping during reflux. Start water flowing through the jacket of the 
reflux condenser and apply full voltage (115 volts) to the heating 
mantle. When the xylene starts to boil, reduce the voltage to a level 
just sufficient to maintain reflux. After refluxing for at least 2 
hours, disconnect the power source to the mantle, remove the kettle, and 
allow to cool in air until the temperature of the contents drops to 
50 deg. C, after which the kettle may be rapidly cooled to 25 deg. C-
30 deg. C by immersing in a cold water bath. Transfer the kettle to a 
constant temperature bath set to maintain 25 deg. C 
plus-minus0.1 deg. C, and allow to equilibrate for a least 1 hour 
(may be left overnight if convenient). Break up any precipitated 
polymers that may have formed, and decant the xylene solution 
successively through a fast filter paper and then through a fritted-
glass filter into a tared 1-liter Erlenmeyer flask, collecting only the 
first 450 milliliters--500 milliliters of filtrate (any attempt to 
collect more of the xylene solution usually results in clogging the 
filter and risking losses). Reweigh the Erlenmeyer flask and calculate 
the weight of the filtrate obtained to the nearest 0.1 gram. Transfer 
the filtrate, quantitatively, from the Erlenmeyer flask to the 1-liter 
beaker, insert the beaker in its heating mantle, add a glass-coated 
magnetic stirring bar, and mount the gas cover in place, connecting the 
inlet tube to the nitrogen source and the outlet to the condenser of the 
receiving flask. Start a flow of nitrogen (2 to 3 liters per minute) 
into the gas cover and connect an aspirator to the receiver using a 
free-flow rate equivalent to 6-7 liters of air per minute. With the 
infrared lamp on, adjust the voltage to the heating mantle to give a 
distillation rate of 12-13 milliliters per minute when the magnetic 
stirrer is revolving just fast enough to promote good boiling. When the 
volume of solvent in the beaker has been reduced to 30-50 milliliters, 
transfer the concentrated extractive to a suitable weighing dish that 
has been previously tared (dry). Rinse the beaker twice with 10-20 
milliliter portions of fresh xylene, adding the rinsings to the weighing 
dish. Evaporate the remainder of the xylene on an electric hotplate set 
at low heat under the gas cover with a stream of nitrogen directed 
toward the center of the dish.

[[Page 270]]

Avoid any charring of the residue. Transfer the weighing dish to a 
vacuum desiccator at room temperature and allow to remain under reduced 
pressure for at least 12 hours (overnight), after which determine the 
net weight of the residue to the nearest 0.0001 gram. Correct the result 
for nonvolatile solvent blank obtained by evaporating the equivalent 
amount of xylene under identical conditions. Calculate the weight of 
residue originally present in the total weight of solvent (840 grams), 
using the appropriate factor based on the weight of filtrate evaporated.
    (5) Viscosity average molecular weight olefin copolymers described 
in paragraphs (a)(3) (iii) and (iv) of this section. The viscosity 
average molecular weight shall be determined from the kinematic 
viscosity (using ASTM method D445-74, ``Test for Kinematic Viscosity of 
Transparent and Opaque Liquids'' (Revised 1974), which is incorporated 
by reference; copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) of solutions of the 
copolymers in solvents and at temperatures as follows:
    (i) Olefin polymers described in paragraph (a)(3)(iii) of this 
section in decahydronaphthalene at 135 deg. C.
    (ii) Olefin polymers described in paragraph (a)(3)(iv) of this 
section in tetrachloroethylene at 30 deg. C.
    (6) Mooney viscosity--olefin copolymers described in paragraph 
(a)(3)(iii) of this section. Mooney viscosity is determined by ASTM 
method D1646-81, ``Standard Test Method for Rubber--Viscosity and 
Vulcanization Characteristics (Mooney Viscometer),'' which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (d)(1) of this section), using the large 
rotor at a temperature of 100 deg. C, except that a temperature of 
127 deg. C shall be used for those copolymers whose Mooney viscosity 
cannot be determined at 100 deg. C. The apparatus containing the sample 
is warmed for 1 minute, run for 8 minutes, and viscosity measurements 
are then made.
    (7) Melt flow index. The melt flow index of olefin polymers 
described below shall be determined by ASTM method D-1238-82, ``Standard 
Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a). 
The availability of this incorporation by reference is given in 
paragraph (d)(1) of this section. The olefin polymers and test 
conditions and procedures are as follows:

------------------------------------------------------------------------
            List of polymers                  Conditions/procedures     
------------------------------------------------------------------------
Olefin copolymers described in           Condition L, procedure A.      
 paragraph (a)(3)(i)(c)(2) of this                                      
 section.                                                               
Olefin copolymers described in           Condition E, procedure A.      
 paragraph (a)(3)(v) of this section.                                   
------------------------------------------------------------------------

    (8) Melting peak temperature. The melt temperature of the olefin 
polymers described in paragraph (a)(3)(ii) of this section shall be 
determined by ASTM method D 3418-82, ``Standard Test Method for 
Transition Temperatures of Polymers by Thermal Analysis,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a). The 
availability of this incorporation by reference is given in paragraph 
(d)(1) of this section.
    (9) Intrinsic viscosity. The intrinsic viscosity of the olefin 
polymers described in paragraph (a)(3)(ii) of this section shall be 
determined by ASTM method D 1601-78, ``Standard Test Method for Dilute 
Solution Viscosity of Ethylene Polymers,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a). The availability of this 
incorporation by reference is given in paragraph (d)(1) of this section.
    (e) Olefin copolymers described in paragraph (a)(3) (i) of this 
section and polyethylene, alone or in combination, may be subjected to 
irradiation bombardment from a source not to exceed 2.3 million volts 
intensity to cause molecular crosslinking of the polymers to impart 
desired properties, such as increased strength and increased ability to 
shrink when exposed to heat.
    (f) The olefin polymers identified in and complying with this 
section, when used as components of the food-contact surface of any 
article that is the subject of a regulation in parts 174, 175, 176, 177, 
178, and Sec. 179.45 of this chapter, shall comply with any 
specifications

[[Page 271]]

and limitations prescribed by such regulation for the article in the 
finished form in which it is to contact food.
    (g) The provisions of this section are not applicable to olefin 
polymers identified in Sec. 175.105(c) (5) of this chapter and used in 
food-packaging adhesives complying with Sec. 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 177.1520, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 177.1550  Perfluorocarbon resins.

    Perfluorocarbon resins identified in this section may be safely used 
as articles or components of articles intended to contact food, subject 
to the provisions of this section:
    (a) Identity. For the purpose of this section, perfluorocarbon 
resins are those produced by: (1) The homopolymerization and/or 
copolymerization of hexafluoropropylene and tetrafluoroethylene, and (2) 
the copolymerization of perfluoropropylvinylether and 
tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the 
extractives limitations in paragraph (d) of this section.
    (b) Optional components. The perfluorocarbon resins identified in 
paragraph (a) of this section as well as articles or coating made from 
these resins may include the following optional components except that 
the resin identified in paragraph (a)(2) of this section may not be used 
with the optional component, lithium polysilicate, mentioned in 
paragraph (b)(4) of this section.
    (1) Substances generally recognized as safe (GRAS) in food or food 
packaging subject to any limitations cited on their use.
    (2) Substances used in accordance with a prior sanction or approval, 
subject to any limitations cited in the prior sanction or approval.
    (3) Substances authorized under applicable regulations in this part 
and in parts 175 and 178 of this chapter and subject to any limitations 
prescribed therein.
    (4) The following substances, subject to any limitations prescribed:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Lithium polysilicate containing not more    For use only as a component 
 than 20 weight percent silica, not more     of repeated-use coatings   
 than 2.1 percent lithium oxide and having   not exceeding 0.030        
 a maximum mole ratio of Si02/Li20 of 8.5    millimeter (0.0012 inch) in
 to 1.                                       thickness where the        
                                             coatings are thermally     
                                             cured at minimum sintering 
                                             temperatures of 371 C (700 
                                             F). Lithium extractives    
                                             shall not exceed 1.55      
                                             milligrams per square      
                                             decimeter (0.1 milligram   
                                             per square inch) of coating
                                             surface when tested in     
                                             accordance with paragraph  
                                             (e)(2) of this section.    
Naphthalene sulfonic acid formaldehyde      For use only:               
 condensate, sodium salt.                   1. As a component of        
                                             repeated-use coatings,     
                                             based on the               
                                             perfluorocarbon resin      
                                             identified in paragraph    
                                             (a)(1) of this section, not
                                             to exceed 0.030 millimeter 
                                             (0.0012 inch) in thickness,
                                             and at a level not to      
                                             exceed 0.4 weight percent  
                                             of the coating.            
                                            2. As a component of        
                                             repeated-use coatings,     
                                             based on the               
                                             perfluorocarbon resin      
                                             identified in paragraph    
                                             (a)(2) of this section, not
                                             to exceed 0.10 millimeter  
                                             (0.004 inch) in thickness, 
                                             and at a level not to      
                                             exceed 0.4 weight percent  
                                             of the coating.            
------------------------------------------------------------------------

    (c) Optional processing. Poly- tetrafluoroethylene resins may be 
irradiated by either a cobalt-60 sealed source, at a maximum dose of 
gamma radiation not to exceed 7.5 megarads, or an electron beam at 
energy levels not to exceed 2.5 million electron volts with a maximum 
dosage of 7.5 megarads, to produce lubricant powders having a particle 
diameter of not more than 20 microns for use only as components of 
articles intended for repeated use in contact with food.
    (d) Specifications--(1) Infrared identification. Perfluorocarbon 
resins can be identified by their characteristic infrared spectra.
    (2) Melt-viscosity. (i) The perfluorocarbon resins identified in 
paragraph (a)(1) of this section shall have a melt viscosity of not less 
than 104 poises at 380 deg. C (716 deg. F) as determined by ASTM 
method D1238-82, ``Standard Test Method for Flow Rates

[[Page 272]]

of Thermoplastics by Extrusion Plastometer,'' which is incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408. The melt viscosity of the perfluorocarbon 
resins identified in paragraph (a)(1) of this section shall not vary 
more than 50 percent within one-half hour at 380 deg. C (716 deg. F).
    (ii) Perfluorocarbon resins identified in paragraph (a)(2) of this 
section shall have a melt viscosity of not less than 104 poises at 
372 deg. C (702 deg. F) as determined by a more detailed method titled 
``Determination of Melt Viscosity, Molecular Weight Distribution Index 
and Viscosity Stability,'' which is incorporated by reference. Copies 
are available from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (3) Thermal instability index. The thermal instability index of the 
tetrafluoroethylene homopolymer shall not exceed 50 as determined by 
ASTM method D1457-56T, ``Test for Thermal Instablility index of 
Tetrafluoroethylene Homopolymer'' (Revised 1956), which is incorporated 
by reference. Copies are available from University Microfilms 
International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408. The requirements of this 
paragraph do not apply to polytetrafluoroethylene resin lubricant 
powders described in paragraph (c) of this section.
    (e) Limitations. \1\ (1) Perfluorocarbon-molded articles having a 
surface area of 6.45 square decimeters (100 square inches) or more and 
at least 1.27 millimeters (0.05 inch) thick shall be extracted at reflux 
temperatures for 2 hours separately with distilled water, 50 percent 
ethanol, n-heptane, and ethyl acetate.
---------------------------------------------------------------------------

    \1\ A more detailed procedure of extraction conditions is entitled, 
``Preparation of Extracts,'' which is incorporated by reference. Copies 
are available from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

    (2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) 
of this section and intended for use as coatings or components of 
coatings shall meet extractability limits prescribed in paragraph (e)(3) 
of this section when the resins in the form of coatings described in 
paragraphs (e)(2) (i) and (ii) of this section are extracted at reflux 
temperatures for 2 hours separately with distilled water, 8 percent 
ethanol, and n-heptane:
    (i) Perfluorocarbon resin coatings based on resins identified in 
paragraph (a)(1) of this section shall be applied to both sides of a 
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of 
0.025 millimeter (0.001 inch) after thermal curing at 399 deg. C 
(750 deg. F) for 10 minutes. If a primer is used, the total thickness of 
the primer plus topcoat shall equal 0.025 millimeter (0.001 inch) after 
heat curing.
    (ii) Perfluorocarbon resin coatings based on resins identified in 
paragraph (a)(2) of this section shall be applied to both sides of a 
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of 0.10 
millimeter (0.004 inch) after thermal curing at 427 deg. C (800 deg. F) 
for 10 minutes. If a primer is used, the total thickness of the primer 
plus topcoat shall equal 0.10 millimeter (0.004 inch) after heat curing.
    (3) The extracted surfaces shall meet the following extractability 
limits:
    (i) Total extractives not to exceed 3.1 milligrams per square 
decimeter (0.2 milligram per square inch).
    (ii) Fluoride extractives calculated as fluorine not to exceed 0.46 
milligram per square decimeter (0.03 milligram per square inch).
    (f) Conditions of use. Perfluorocarbon resins identified in 
paragraph (a)(2) of

[[Page 273]]

this section are limited to use as coatings or components of coatings 
for articles intended for repeated food-contact use.

[43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19, 1982; 
47 FR 14699, Apr. 6, 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, Jan. 
11, 1985; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]



Sec. 177.1555  Polyarylate resins.

    Polyarylate resins (CAS Reg. No. 51706-10-6) may be safely used as 
articles or components of articles intended for use in contact with food 
in accordance with the following prescribed conditions:
    (a) Identity. Polyarylate resins (1, 3-benzenedicarboxylic acid, 
diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4'-
(1-methylethylidine) bis(phenol)) are formed by melt polycondensation of 
bisphenol-A with diphenylisophthalate and diphenylterephthalate.
    (b) Specifications. (1) The finished copolymers shall contain from 
70 to 80 weight percent of polymer units derived from 
diphenylisophthalate and 20 to 30 weight percent of polymer units 
derived from diphenylterephthalate.
    (2) Polyarylate resins shall have a minimum weight average molecular 
weight of 20,000.
    (3) Polyarylate resins may be identified by their characteristic 
infrared spectra.
    (c) Extractive limitations. The finished polyarylate resins in sheet 
form at least 0.5 millimeter (0.020 inch) thick, when extracted with 
water at 121  deg.C (250  deg.F) for 2 hours, shall yield total 
nonvolatile extractives not to exceed 2.33 micrograms per square 
centimeter (15 micrograms per square inch) of the exposed resin surface.
    (d) Limitations. Polyarylate resin articles may be used in contact 
with all foods except beverages containing more than 8 volume percent 
ethanol under conditions of use A through H, described in Table 2 of 
Sec. 176.170(c) of this chapter.

[52 FR 35540, Sept. 22, 1987]



Sec. 177.1560  Polyarylsulfone resins.

    Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used 
as articles or components of articles intended for use in contact with 
food, at temperatures up to and including normal baking temperatures, in 
accordance with the following prescribed conditions:
    (a) Identity. Polyarylsulfone resins are copolymers containing not 
more than 25 percent of oxy-p-phenylene-oxy-p-phenylenesulfonyl-p-
phenylene polymer units and not less than 75 percent of oxy-p-
phenylenesulfonyl-p-phenylene-oxy-p-phenylenesulfonyl-p-phenylene 
polymer units. The copolymers have a minimum reduced viscosity of 0.40 
deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM 
method D2857-70 (Reapproved 1977), ``Standard Test Method for Dilute 
Solution Viscosity of Polymers,'' which is incorporated by reference. 
Copies may be obtained from the American Society for Testing and 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (b) Optional adjuvant substances. The basic polyarylsulfone resins 
identified in paragraph (a) of this section may contain optional 
adjuvant substances required in the production of such basic copolymers. 
These optional adjuvant substances may include substances permitted for 
such use by regulations in parts 170 through 179 of this chapter, 
substances generally recognized as safe in food, substances used in 
accordance with a prior sanction of approval, and substances named in 
this paragraph and further identified as required:

------------------------------------------------------------------------
            Substances                           Limitations            
------------------------------------------------------------------------
Sulfolane.........................  Not to exceed 0.15 percent as       
                                     residual solvent in the finished   
                                     basic resin.                       
------------------------------------------------------------------------

    (c) Extractive limitations. The finished polyarylsulfone resin when 
extracted for 2 hours with the following solvents at the specified 
temperatures yields total extractives in each extracting solvent not to 
exceed 0.008 milligram per square centimeter of food-contact surface: 
distilled water at 121  deg.C (250  deg.F), 50 percent (by volume) ethyl 
alcohol in distilled water at 71.1  deg.C (160  deg.F), 3 percent acetic 
acid in distilled water

[[Page 274]]

at 100  deg.C (212  deg.F), and n-heptane at 65.6  deg.C (150  deg.F).

    Note: In testing the finished polyarylsulfone resin use a separate 
test sample for each required extracting solvent.

[50 FR 31046, July 24, 1985]



Sec. 177.1570   Poly-1-butene resins and butene/ethylene copolymers.

    The poly-1-butene resins and butene/ethylene copolymers identified 
in this section may be safely used as articles or components of articles 
intended for use in contact with food subject to the provisions of this 
section.
    (a) Identity. Poly-1-butene resins are produced by the catalytic 
polymerization of 1-butene liquid monomer. Butene/ethylene copolymers 
are produced by the catalytic polymerization of 1-butene liquid monomer 
in the presence of small amounts of ethylene monomer so as to yield no 
higher than a 6-weight percent concentration of polymer units derived 
from ethylene in the copolymer.
    (b) Specifications and limitations. Poly-1-butene resins and butene/
ethylene copolymers shall conform to the specifications prescribed in 
paragraph (b)(1) of this section, and shall meet the extractability 
limits prescribed in paragraph (b)(2) of this section.
    (1) Specifications--(i) Infrared identification. Poly-1-butene 
resins and butene/ethylene copolymers can be identified by their 
characteristic infrared spectra.
    (ii) Viscosity. Poly-1-butene resins and the butene/ethylene 
copolymers have an intrinsic viscosity 1.0 to 3.2 as determined by ASTM 
method D1601-78, ``Standard Test Method for Dilute Solution Viscosity of 
Ethylene Polymers,'' which is incorporated by reference. Copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (iii) Density. Poly-1-butene resins have a density of 0.904 to 0.920 
gms/cm3, and butene/ethylene copolymers have a density of 0.890 to 
0.916 gms/cm3 as determined by ASTM method D1505-68 (Reapproved 
1979), ``Standard Test Method for Density of Plastics by the Density-
Gradient Technique,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(b)(1)(ii) of this section.
    (iv) Melt index. Poly-1-butene resins have a melt index of 0.1 to 24 
and the butene/ethylene copolymers have a melt index of 0.1 to 20 as 
determined by ASTM method D1238-82, condition E, ``Standard Test Method 
for Flow Rates of Thermoplastics by Extrusion Plastometer,'' which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (b)(1)(ii) of this section.
    (2) Limitations. Poly-1-butene resins and butene/ethylene copolymers 
for use in articles that contact food, and for articles used for packing 
or holding food during cooking shall yield no more than the following 
extractables:
    (i) Poly-1-butene resins may be used as articles or components of 
articles intended for use in contact with food, provided that the 
maximum extractables do not exceed 2.5 percent by weight of the

[[Page 275]]

polymer when film or molded samples are tested for 2 hours at 50  deg.C 
(122  deg.F) in n-heptane.
    (ii) Butene/ethylene copolymers containing no more than 6 percent by 
weight of polymer units derived from ethylene may be used as articles or 
components of articles intended for contact with food under conditions 
of use B, C, D, E, F, G, or H described in Table 2 of Sec. 176.170(c) of 
this chapter, subject to the provisions of this section and provided 
that the maximum extractables from test films 0.1 to 0.2 millimeter 
(0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by weight 
of the polymer when extracted in a soxhlet extractor for 6 hours with 
refluxing 95 percent ethanol.
    (iii) Poly-1-butene resins may be used as articles or components of 
articles intended for packaging or holding food during cooking, provided 
that the thickness of such polymers in the form in which they contact 
food shall not exceed 0.1 millimeter (0.004 inch) and yield maximum 
extractables of not more than 2.5 percent by weight of the polymer when 
films are extracted for 2 hours at 50  deg.C (122  deg.F) in n-heptane.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984; 
50 FR 31349, Aug. 2, 1985]



Sec. 177.1580  Polycarbonate resins.

    Polycarbonate resins may be safely used as articles or components of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, in accordance with the following prescribed conditions:
    (a) Polycarbonate resins are polyesters produced by:
    (1) The condensation of 4,4'-iso-propylidenediphenol and carbonyl 
chloride to which may have been added certain optional adjuvant 
substances required in the production of the resins; or by
    (2) The reaction of molten 4,4'-iso-propylidenediphenol with molten 
diphenyl carbonate in the presence of the disodium salt of 4,4'-
isopropylidenediphenol.
    (3) The condensation of 4,4'-isopro- pylidenediphenol, carbonyl 
chloride, and 0.5 percent weight maximum of a2,a6-bis (6-hydroxy-m-
tolyl) mesitol to which may have been added certain optional adjuvant 
substances required in the production of branched polycarbonate resins.
    (b) The optional adjuvant substances required in the production of 
resins produced by the methods described in paragraph (a)(1) and (3) of 
this section may include substances generally recognized as safe in 
food, substances used in accordance with a prior sanction or approval, 
and the following:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
p-tert-Butylphenol........................  ............................
Chloroform................................  ............................
 p-Cumylphenol (CAS Reg. No. 599-64-4)....  For use only as a chain     
                                             terminator at a level not  
                                             to exceed 5 percent by     
                                             weight of the resin.       
Ethylene dichloride.......................  ............................
Heptane...................................  ............................
Methylene chloride........................  ............................
Monochlorobenzene.........................  Not to exceed 500 p.p.m. as 
                                             residual solvent in        
                                             finished resin.            
Pentaerythritol tetrastearate (CAS Reg.     For use only as a mold      
 No. 115-83-3).                              release agent, at a level  
                                             not to exceed 0.5 percent  
                                             by weight of the finished  
                                             resin.                     
Phenol (CAS Reg. No. 108-95-2)............  ............................
Pyridine..................................  ............................
Toluene: (CAS Reg. No. 108-88-3)..........  Not to exceed 800 parts per 
                                             million as residual solvent
                                             in finished resin.         
Triethylamine.............................  ............................
------------------------------------------------------------------------

    (c) Polycarbonate resins shall conform to the specification 
prescribed in paragraph (c)(1) of this section and shall meet the 
extractives limitations prescribed in paragraph (c)(2) of this section.
    (1) Specification. Polycarbonate resins can be identified by their 
characteristic infrared spectrum.
    (2) Extractives limitations. The polycarbonate resins to be tested 
shall be ground or cut into small particles that will pass through a 
U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve 
No. 10.
    (i) Polycarbonate resins, when extracted with distilled water at 
reflux temperature for 6 hours, shall yield total extractives not to 
exceed 0.15 percent by weight of the resins.
    (ii) Polycarbonate resins, when extracted with 50 percent (by 
volume) ethyl alcohol in distilled water at reflux temperature for 6 
hours, shall yield total extractives not to exceed 0.15 percent by 
weight of the resins.
    (iii) Polycarbonate resins, when extracted with n-heptane at reflux 
temperature for 6 hours, shall yield total extractives not to exceed 
0.15 percent by weight of the resins.

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981; 
49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug. 
8, 1988; 59 FR 43731, Aug. 25, 1994]



Sec. 177.1585  Polyestercarbonate resins.

    Polyestercarbonate resins may be safely used as articles or 
components of articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, or holding food, in 
accordance with the following prescribed conditions:
    (a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced 
by the condensation of 4,4'-isopropylidenediphenol, carbonyl chloride, 
terephthaloyl chloride, and isophthaloyl chloride such that the resins 
are composed of 70 to 85 percent

[[Page 276]]

ester, of which up to 10 percent is the terephthaloyl isomer. The resins 
are manufactured using a phthaloyl chloride/carbonyl chloride mole ratio 
of 2.3-4.0/1 and an isophthaloyl chloride/terephthaloyl chloride mole 
ratio of 9.0/1 or greater.
    (b) Optional adjuvants. The optional adjuvant substances required in 
the production of resins identified in paragraph (a) of this section may 
include:
    (1) Substances used in accordance with Sec. 174.5 of this chapter.
    (2) Substances identified in Sec. 177.1580(b).
    (3) Substances regulated in Sec. 178.2010(b) of this chapter for use 
in polycarbonate resins complying with Sec. 177.1580:

Provided, That the substances are used in accordance with any limitation 
on concentration, conditions of use, and food types specified in 
Sec. 178.2010(b) of this chapter.
    (c) Polyestercarbonate resins shall conform to the specifications 
prescribed in paragraph (c)(1) of this section and shall meet the 
extractive limitations prescribed in paragraph (c)(2) of this section.
    (1) Specifications. Polyestercarbonate resins identified in 
paragraph (a) of this section can be identified by their characteristic 
infrared spectrum. The solution intrinsic viscosity of the 
polyestercarbonate resins shall have a range of 0.50 to 0.58 deciliter 
per gram as determined by a method titled, ``Intrinsic Viscosity (IV) of 
Lexan Polycarbonate Resin by a Single Point Method Using 
Dichloromethane as the Solvent,'' developed by the General Electric Co., 
September 20, 1985, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or may be examined 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.
    (2) Extractives limitations. The polyestercarbonate resins to be 
tested shall be ground or cut into small particles that will pass 
through a U.S. standard sieve No. 6 and that will be held on U.S. 
standard sieve No. 10.
    (i) Polyestercarbonate resins, when extracted with distilled water 
at reflux temperature for 6 hours, shall yield total nonvolatile 
extractives not to exceed 0.005 percent by weight of the resins.
    (ii) Polyestercarbonate resins, when extracted with 50 percent (by 
volume) ethyl alcohol in distilled water at reflux temperature for 6 
hours, shall yield total nonvolatile extractives not to exceed 0.005 
percent by weight of the resins.
    (iii) Polyestercarbonate resins, when extracted with n-heptane at 
reflux temperature for 6 hours, shall yield total nonvolatile 
extractives not to exceed 0.002 percent by weight of the resins.
    (3) Residual methylene chloride levels in polyestercarbonate resins. 
Polyestercarbonate resin articles in the finished form shall not contain 
residual methylene chloride in excess of 5 parts per million as 
determined by a method titled ``Analytical Method for Determination of 
Residual Methylene Chloride in Polyestercarbonate Resin,'' developed by 
the General Electric Co., July 23, 1991, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.

[57 FR 3940, Feb. 3, 1992]



Sec. 177.1590   Polyester elastomers.

    The polyester elastomers identified in paragraph (a) of this section 
may be safely used as the food-contact surface of articles intended for 
use in contact with bulk quantities of dry food of the type identified 
in Sec. 176.170(c) of this chapter, Table 1, under Type VIII, in 
accordance with the following prescribed conditions:
    (a) For the purpose of this section, polyester elastomers are those 
produced by the ester exchange reaction when one or more of the 
following phthalates--dimethyl terephthalate, dimethyl orthophthalate, 
and dimethyl isophthalate--is made to react with alpha-hydroomega-
hydroxypoly

[[Page 277]]

(oxytetramethylene) and/or 1,4-butanediol such that the finished 
elastomer has a number average molecular weight between 20,000 and 
30,000.
    (b) Optional adjuvant substances employed in the production of the 
polyester elastomers or added thereto to impart desired technical or 
physical properties may include the following substances:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
4,4' - Bis (alpha, alpha-dimethyl-benzyl)   For use only as an          
 diphenylamine.                              antioxidant.               
Tetrabutyl titanate.......................  For use only as a catalyst. 
------------------------------------------------------------------------

    (c) An appropriate sample of the finished polyester elastomer in the 
form in which it contacts food when subjected to ASTM method D968-81, 
``Standard Test Methods for Abrasion Resistance of Organic Coatings by 
the Falling Abrasive Tester,'' which is incorporated by reference 
(copies may be obtained from the American Society for Testing Materials, 
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408), using No. 50 emery abrasive in lieu of Ottawa 
sand, shall exhibit an abrasion coefficient of not less than 100 liters 
per mil of thickness.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984]



Sec. 177.1595  Polyetherimide resin.

    The polyetherimide resin identified in this section may be safely 
used as an article or component of an article intended for use in 
contact with food, subject to the provisions of this section.
    (a) Identity. For the purpose of this section, the polyetherimide 
resin is 1,3-isobenzofurandione, 5,5'[(1-methyl-ethylidene)bis(4,1-
phenyleneoxy)] bis-polymer with 1,3-benzenediamine (CAS Reg. No. 61128-
46-9), and is derived from the condensation reaction of m-
phenylenediamine and bisphenol A-dianhydride.
    (b) Optional adjuvants. The basic polymer identified in paragraph 
(a) of this section may contain optional adjuvant substances required in 
the production of basic resins or finished food-contact articles. The 
optional adjuvant substances required in the production of the basic 
polymer may include substances permitted for such use by applicable 
regulations as set forth in part 174 of this chapter.
    (c) Specifications and extractives limitations--(1) Specifications. 
Polyetherimide resin identified in paragraph (a) of this section shall 
have an intrinsic viscosity in chloroform at 25  deg.C (77  deg.F) of 
not less than 0.35 deciliter per gram as determined by a method titled 
``Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as the 
Solvent,'' which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Extractive limitations. Extractive limitations are applicable to 
the basic polyetherimide resin in the form of molded discs of thickness 
0.16 centimeter (0.063 inch). The resin discs when extracted with 
distilled water at 121  deg.C (250  deg.F) for 2 hours yield total 
nonvolatile extractives of not more than 12.3 micrograms per square 
centimeter.

[50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. 3, 1985]



Sec. 177.1600   Polyethylene resins, carboxyl modified.

    Carboxyl-modified polyethylene resins may be safely used as the 
food-contact surface of articles intended for use in contact with food 
in accordance with the following prescribed conditions:
    (a) For the purpose of this section, carboxyl-modified polyethylene 
resins consist of basic polymers produced when etylene-methyl acrylate 
basic copolymers, containing no more than 25 weight percent of polymer 
units derived from methyl acrylate, are made to react in an aqueous 
medium with one or more of the following substances:

Ammonium hydroxide.
Calcium carbonate.
Potassium hydroxide.
Sodium hydroxide.


[[Page 278]]


    (b) The finished food-contact article, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields total extractives in each extracting solvent not to 
exceed 0.5 milligram per square inch of food-contact surface as 
determined by the methods described in Sec. 176.170(d) of this chapter; 
and if the finished food-contact article is itself the subject of a 
regulation in parts 174, 175, 176, 177, 178, and Sec. 179.45 of this 
chapter, it shall also comply with any specifications and limitations 
prescribed for it by that regulation. In testing the finished food-
contact articles, a separate test sample is to be used for each required 
extracting solvent.
    (c) The provisions of paragraph (b) of this section are not 
applicable to carboxyl-modified polyethylene resins used in food-
packaging adhesives complying with Sec. 175.105 of this chapter.



Sec. 177.1610   Polyethylene, chlorinated.

    Chlorinated polyethylene identified in this section may be safely 
used as articles or components of articles that contact food, except for 
articles used for packing or holding food during cooking, subject to the 
provisions of this section.
    (a) For the purpose of this section, chlorinated polyethylene 
consists of basic polymers produced by the direct chlorination of 
polyethylene conforming to the density, maximum n-hexane extractable 
fraction, and maximum xylene soluble fraction specifications prescribed 
under item 2.1 of the table in Sec. 177.1520(c). Such chlorinated 
polyethylene contains a maximum of 60 percent by weight of total 
chlorine, as determined by ASTM method D1303-55 (Reapproved 1979), 
``Standard Test Method for Total Chlorine in Vinyl Chloride Polymers and 
Copolymers,'' which is incorporated by reference (copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408), and has a 7.0 percent maximum extractable fraction in n-hexane 
at 50 deg. C, as determined by the method described in 
Sec. 177.1520(d)(3)(ii).
     (b) Chlorinated polyethylene may be used in contact with all types 
of food, except that when used in contact with fatty food of Types III, 
IV-A, V, VII-A, and IX described in Table 1 of Sec. 176.170(c) of this 
chapter, chlorinated polyethylene is limited to use only as a modifier 
admixed at levels not exceeding 15 weight percent in plastic articles 
prepared from polyvinyl chloride and/or from vinyl chloride copolymers 
complying with Sec. 177.1980.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984; 
59 FR 14550, Mar. 29, 1994]



Sec. 177.1615  Polyethylene, fluorinated.

    Fluorinated polyethylene, identified in paragraph (a) of this 
section, may be safely used as food-contact articles in accordance with 
the following prescribed conditions:
    (a) Fluorinated polyethylene food-contact articles are produced by 
modifying the surface of polyethylene articles through action of 
fluorine gas in combination with gaseous nitrogen as an inert diluent. 
Such modification affects only the surface of the polymer, leaving the 
interior unchanged. Fluorinated polyethylene articles are manufactured 
from basic resins containing not less than 85 weight-percent of polymer 
units derived from ethylene and identified in Sec. 177.1520 (a)(2) and 
(3)(i).
    (b) Fluorinated polyethylene articles conform to the specifications 
and use limitations of Sec. 177.1520(c), items 2.1 and 3.1.
    (c) The finished food-contact article, when extracted with the 
solvent or solvents characterizing the type of food and under conditions 
of time and temperature characterizing the conditions of its intended 
use as determined from Tables 1 and 2 of Sec. 176.170(c) of this 
chapter, yields fluoride ion not to exceed 5 parts per million 
calculated on the basis of the volume of food held by the food-contact 
article.

[48 FR 39057, Aug. 29, 1983]

[[Page 279]]



Sec. 177.1620   Polyethylene, oxidized.

    Oxidized polyethylene identified in paragraph (a) of this section 
may be safely used as a component of food-contact articles, in 
accordance with the following prescribed conditions:
    (a) Oxidized polyethylene is the basic resin produced by the mild 
air oxidation of polyethylene conforming to the density, maximum n-
hexane extractable fraction, and maximum xylene soluble fraction 
specifications prescribed under item 2.3 of the table in 
Sec. 177.1520(c). Such oxidized polyethylene has a minimum number 
average molecular weight of 1,200, as determined by high temperature 
vapor pressure osmometry, contains a maximum of 5 percent by weight of 
total oxygen, and has an acid value of 9 to 19.
    (b) The finished food-contact article, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields net acidified chloroform-soluble extractives not to 
exceed 0.5 milligram per square inch of food-contact surface when tested 
by the methods described in Sec. 177.1330(c), except that net acidified 
chloroform-soluble extractives from paper and paperboard complying with 
Sec. 176.170 of this chapter may be corrected for wax, petrolatum, and 
mineral oil as provided in Sec. 176.170(d) (5)(iii)(b) of this chapter. 
If the finished food-contact article is itself the subject of a 
regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter, it shall also comply with any specifications and limitations 
prescribed for it by such regulations. (Note: In testing the finished 
food-contact article, use a separate test sample for each extracting 
solvent.)
    (c) The provisions of this section are not applicable to oxidized 
polyethylene used as provided in Secs. 175.105 and 176.210 of this 
chapter, and Sec. 177.2800. The provisions of paragraph (b) of this 
section are not applicable to oxidized polyethylene used as provided in 
Secs. 175.125 and 176.170(a)(5) of this chapter and Sec. 177.1200.



Sec. 177.1630   Polyethylene phthalate polymers.

    Polyethylene phthalate polymers identified in this section may be 
safely used as, or components of plastics (films, articles, or fabric) 
intended for use in contact with food in accordance with the following 
prescribed conditions:
     (a) Polyethylene phthalate films consist of a base sheet of 
ethylene terephthalate polymer, ethylene terephthalate-isophthalate 
copolymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate 
copolyesters described in Sec. 177.1315(b)(3), to which have been added 
optional substances, either as constituents of the base sheet or as 
constituents of coatings applied to the base sheet.
    (b) Polyethylene phthalate articles consist of a base polymer of 
ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene 
dimethylene terephthalate copolyesters described in Sec. 177.1315(b)(3), 
to which have been added optional substances, either as constituents of 
the base polymer or as constituents of coatings applied to the base 
polymer.
    (c)(1) Polyethylene phthalate spunbonded nonwoven fabric consist of 
continuous filaments of ethylene terephthalate polymer and ethylene 
terephthalate-isophthalate copolymer to which may have been added 
optional adjuvant substances required in their preparation and 
finishing.
    (2) The ethylene terephthalate-isophthalate copolymer component of 
the fabric shall not exceed 25 percent by weight. The filaments may be 
blended with other fibers regulated for the specific use and the 
spunbonded fabric may be further bonded by application of heat and/or 
pressure.
    (3) The fabric shall be used only in accordance with paragraph (i) 
of this section.
    (d) The quantity of any optional substance employed in the 
production of polyethylene phthalate plastics does not exceed the amount 
reasonably required to accomplish the intended physical or technical 
effect or any limitations further provided. Any substance employed in 
the production of polyethylene phthalate plastics that is the subject of 
a regulation in parts 174,

[[Page 280]]

175, 176, 177, 178 and 179 of this chapter conforms with any 
specification in such regulation.
    (e) Substances employed in the production of polyethylene phthalate 
plastics include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for use in 
polyethylene phthalate plastics and used in accordance with such 
sanction or approval.
    (3) Substances which by regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter may be safely used as components of 
resinous or polymeric food-contact surfaces subject to the provisions of 
such regulation.
    (4) Substances identified in this paragraph (e)(4) subject to the 
limitations prescribed:

                   List of Substances and Limitations

    (i) Base sheet:
Ethylene terephthalate copolymers: Prepared by the condensation of 
dimethyl terephthalate or terephthalic acid with ethylene glycol, 
modified with one or more of the following: Azelaic acid, dimethyl 
azelate, dimethyl sebacate, sebacic acid.
Ethylene terephthalate copolymers: Prepared by the condensation of 
dimethyl terephthalate or terephthalic acid with ethylene glycol, 
modified with one or more of the following: Azelaic acid, dimethyl 
azelate, dimethyl sebacate, sebacic acid, pyromellitic dianhydride. The 
level of pyromellitic dianhydride shall not exceed 0.5 percent by weight 
of the finished copolymer which may be used under conditions of use E 
through H as described in Table 2 of Sec. 176.170(c) of this chapter.
Ethylene terephthalate-isophthalate copolymers: Prepared by the 
condensation of dimethyl terephthalate or terephthalic acid and dimethyl 
isophthalate or isophthalic acid with ethylene glycol. The finished 
copolymers contain either:
    (a) 77 to 83 weight percent or
    (b) At least 97 weight percent of polymer units derived from 
ethylene terephthalate.

    (ii) Base sheet and base polymer:

Ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters 
described in Sec. 177.1315(b)(3).
Ethylene terephthalate polymer: Prepared by the condensation of dimethyl 
terephthalate and ethylene glycol.
Ethylene terephthalate polymer: Prepared by the condensation of 
terephthalic acid and ethylene glycol.

    (iii) Coatings:
Ethylene azelate-terephthalate copolymer: The copolymer, dissolved in 
1,1,2-trichloroethane and/or methylene chloride, may be used as a heat-
activated sealant on polyethylene terephthalate film intended for 
sealing polyethylene terephthalate pouches that are used as containers 
of either nonalcoholic beverages or alcoholic beverages containing not 
more than 15 percent ethyl alcohol. The copolymer has a terephthalate/
azelate molecular ratio of 1.25/1.00 and a relative viscosity of not 
less than 1.5 as determined by a method title ``General Procedure of 
Determining the Relative Viscosity of Resin Polymers,'' which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFF-330), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection, at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408. Total residual copolymer solvent (1,1,2-
trichloroethane and/or methylene chloride) shall not exceed 0.13 
milligram per square inch of film, and food contact of the film shall be 
limited to not more than 1 square inch per 250 grams of beverage.
2-Ethylhexyl acrylate copolymerized with one or more of the following:
    Acrylonitrile.
    Methacrylonitrile.
    Methyl acrylate.
    Methyl methacrylate.
    Itaconic acid.
Vinylidene chloride copolymerized with one or more of the following:
    Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl 
esters.
    Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters.
    Acrylonitrile.
    Methacrylonitrile.
    Vinyl chloride.
    Itaconic acid.
Styrene-maleic anhydride resin, partial 2-butoxyethyl ester, ammonium 
salt (CAS Reg. No. 68890-80-2). For use only as a coating for 
polyethylene phthalate films complying with paragraph (a) of this 
section, at levels not to exceed 0.025 gram per square meter (0.016 
milligram per square inch) of the film, in contact with food of types 
VIII and IX in Table 1 of Sec. 176.170(c) of this chapter, under use 
conditions E, F, and G in Table 2 of Sec. 176.170(c) of this chapter.

    (iv) Emulsifiers:
Sodium dodecylbenzenesulfonate: As an adjuvant in the application of 
coatings to the base sheet or base polymer.
Sodium lauryl sulfate: As an adjuvant in the application of coatings to 
the base sheet or base polymer.

[[Page 281]]

2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For use 
only in copolymer coatings on polyethylene phthalate film under 
conditions of use E, F, and G described in table 2 of Sec. 175.300(d) of 
this chapter, and limited to use at a level not to exceed 2.0 percent by 
weight of the dry copolymer coating.

    (v) Modifier:
1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-
butanediol and -hydro-omega-hydroxypoly(oxy-1,4-butanediyl) CAS 
Reg. No. 9078-71-1) meeting the following specifications:

    Melting point: 200 deg. to 215 deg. C as determined by ASTM method 
D2117-82, ``Standard Test Method for Melting Point of Semicrystalline 
Polymers by the Hot Stage Microscopy Method,'' which is incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    Density: 1.15 to 1.20 as determined by ASTM method D1505-68 
(Reapproved 1979), ``Standard Test Method for Density of Plastics by the 
Density-Gradient Technique,'' which is incorporated by reference. Copies 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    The modifier is used at a level not to exceed 5 percent by weight of 
polyethylene terephthalate film. The average thickness of the finished 
film shall not exceed 0.016 millimeter (0.0006 inch).
Hexanedioic acid polymer with 1,3-benzenedimethanamine (CAS Reg. No. 
25718-70-1) meeting the specifications in Sec. 177.1500(b), item 10, 
when tested by the methods given in Sec. 177.1500(c). The modifier is 
used in polyethylene terephthalate at a level not to exceed 30 percent 
by weight of the polyethylene terephthalate.

    Chloroform-soluble extractives shall not exceed 0.08 milligram/
centimeter 2 (0.5 milligram/inch 2) of food-contact surface of 
the modified polyethylene terephthalate article when exposed to the 
following solvents at temperatures and times indicated:
    (a) Distilled water at 49  deg.C (120  deg.F) for 24 hours;
    (b) n-Heptane at 49  deg.C (120  deg.F) for 24 hours;
    (c) 8 percent ethyl alcohol at 49  deg.C (120  deg.F) for 24 hours.
    For use in contact with all types of foods except (a) those 
containing more than 8 percent alcohol, or (b) those at temperatures 
over 49  deg.C (120  deg.F).

    (f) Polyethylene phthalate plastics conforming with the 
specifications prescribed in paragraph (f)(1) of this section are used 
as provided in paragraph (f)(2) of this section:
    (1) Specifications. (i) The food contact surface, when exposed to 
distilled water at 250 deg. F for 2 hours, yields chloroform-soluble 
extractives not to exceed 0.5 mg/in2 of food contact surface 
exposed to the solvent; and
    (ii) The food contact surface, when exposed to n-heptane at 
150 deg.F for 2

[[Page 282]]

hours, yields chloroform-soluble extractives not to exceed 0.5 mg/
in2 of food contact surface exposed to the solvent.
    (2) Conditions of use. The plastics are used for packaging, 
transporting, or holding food, excluding alcoholic beverages, at 
temperatures not to exceed 250 deg. F.
    (g) Polyethylene phthalate plastics conforming with the 
specifications prescribed in paragraph (g)(1) of this section are used 
as provided in paragraph (g)(2) of this section.
    (1) Specifications. (i) The food contact surface meets the 
specifications in paragraph (f)(1) of this section; and
    (ii) The food contact surface when exposed to 50 percent ethyl 
alcohol at 120 deg. F for 24 hours, yields chloroform-soluble 
extractives not to exceed 0.5 mg/in2 of food contact surface 
exposed to the solvent.
    (2) Conditions of use. The plastics are used for packaging, 
transporting, or holding alcoholic beverages that do not exceed 50 
percent alcohol by volume.
    (h) Uncoated polyethylene phthalate plastics consisting of a base 
sheet or base polymer prepared as prescribed from substances identified 
in paragraphs (e)(4)(i) and (ii) of this section and conforming with the 
specifications prescribed in paragraph (h)(1) of this section are used 
as provided in paragraph (h)(2) of this section:
    (1) Specifications. (i) The food contact surface, when exposed to 
distilled water at 250 deg. F for 2 hours yields chloroform-soluble 
extractives not to exceed 0.02 milligram/inch2 of food contact 
surface exposed to the solvent; and
    (ii) The food contact surface, when exposed to n-heptane at 150 deg. 
F for 2 hours, yields chloroform-soluble extractives not to exceed 0.02 
milligram/inch2 of food contact surface exposed to the solvent.
    (2) Conditions of use. The plastics are used to contain foods during 
oven baking or oven cooking at temperatures above 250 deg. F.
    (i) Polyethylene phthalate fabric, identified in paragraph (c) of 
this section and conforming with the specifications prescribed in 
paragraph (i)(1) of this section, is used only as provided in paragraph 
(i)(2) of this section.
    (1) Specifications. Chloroform-soluble extractives shall not exceed 
0.2 milligram/inch2 of food-contact surface when exposed to the 
following solvents at temperatures and times indicated:
    (i) Distilled water at 212 deg. F for 2 hours.
    (ii) n-Heptane at 150 deg. F for 2 hours.
    (iii) 50 percent ethyl alcohol at 120 deg. F for 24 hours.
    (2) Conditions of use. The plastics are intended for:
    (i) Dry food contact.
    (ii) Bulk food (excluding alcoholic beverages) repeated use 
applications, including filtration, at temperatures not exceeding 
212 deg. F.
    (iii) Filtration of bulk alcoholic beverages, not exceeding 50 
percent alcohol by volume, at temperatures not exceeding 120 deg. F.
     (j) Polyethylene phthalate plastics, composed of ethylene 
terephthalate-isophthalate containing a minimum of 98 weight percent of 
polymer units derived from ethylene terephthalate, or ethylene-1,4-
cyclohexylene dimethylene terephthalate copolyesters described in 
Sec. 177.1315(b)(3), conforming with the specifications prescribed in 
paragraph (j)(1) of this section, are used as provided in paragraph 
(j)(2) of this section.
    (1) Specifications. (i) The food contact surface meets the 
specifications in paragraph (f)(1) of this section and
    (ii)(a) Containers with greater than 500 mL capacity. The food-
contact surface when exposed to 95 percent ethanol at 120 deg. F for 24 
hours should not yield chloroform-soluble extractives in excess of 0.005 
mg/in2.
    (b) Containers with less than or equal to 500 mL capacity. The food 
contact surface when exposed to 95 percent ethanol at 120 deg.F for 24 
hours should not yield chloroform-soluble extractives in excess of 0.05 
mg/in2.
    (2) Conditions of use. The plastics are used for packaging, 
transporting, or holding alcoholic foods that do not exceed 95 percent 
alcohol by volume.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 18611, Apr. 8, 1977; 44 
FR 40886, July 13, 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, Mar. 
19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 30361, July 1, 1983; 49 FR 
10110, Mar. 19, 1984; 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, 
1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, Apr. 19, 1989; 54 FR 
24898, June 12, 1989; 60 FR 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 
1995]



Sec. 177.1632  Poly (phenyleneterephthalamide) resins.

    Poly(phenyleneterephthalamide) resins identified in paragraph (a) of 
this section may be safely used as articles or components of articles 
intended for repeated contact with food.
    (a) Identity. For the purpose of this section, the poly(phenylene- 
terephthalamide) resins (CAS Reg. No. 26125-61-1) are produced by the 
polymerization of terephthalolyl chloride with p-phenylenediamine. The 
poly(phenyleneterephthalamide) resin fibers and yarns may contain 
optional adjuvant substances required in their preparation and 
finishing.
    (b) Optional adjuvant substances. The poly(phenyleneterephthalamide) 
resins identified in paragraph (a) of this section may contain the 
following optional adjuvant substances, subject to any limitation on 
their use:
    (1) Optional adjuvant substances authorized for this use in 
accordance with Sec. 174.5 of this chapter.
    (2) Optional finish components, total weight not to exceed 1 percent 
by weight of the base polymer, as follows:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Diundecylphthalate (CAS Reg. No. 3648-20-                               
 2).                                                                    
Mono- and dipotassium salts of lauryl                                   
 phosphate (CAS Reg. No. 39322-78-6).                                   
o-Phenylphenol (CAS Reg. No. 90-43-7).....  For use as a fungicide for  
                                             finish coating materials.  
                                             Not to exceed 0.01 percent 
                                             by weight of the base      
                                             polymer.                   

[[Page 283]]

                                                                        
Poly(oxyethylene/                                                       
 oxypropylene)monobutylether (CAS Reg. No.                              
 9038-95-3).                                                            
Poly(oxyethylene) mono(nonylphenyl)ether                                
 (CAS Reg. No. 9019-45-9).                                              
Polyvinyl methylether (CAS Reg. No. 9003-                               
 09-2).                                                                 
Poly(oxyethylene) sorbitol monolaurate                                  
 tetraoleate (CAS Reg. No. 71243-28-2).                                 
Poly(oxyethylene) sorbitol hexaoleate (CAS                              
 Reg. No. 57171-56-9).                                                  
4,4'-Butylidenebis (6-tert-butyl-m-cresol)  For use only as an oxidation
 (CAS Reg. No. 85-60-9).                     inhibitor for finish       
                                             coating materials. Not to  
                                             exceed 0.01 percent by     
                                             weight of the base polymer.
------------------------------------------------------------------------

    (c) Specifications. (1) Poly(phenyleneterephthalamide) resins in the 
form of continuous filament yarns or fibers that have been scoured in 
accordance with paragraph (d)(1) of this section, when refluxed in a 50 
percent ethanol/water mixture for 24 hours, yields total extractables 
not exceeding 0.5 percent by weight of the sample.
    (2) Poly(phenyleneterephthalamide) resins in the form of pulp, when 
refluxed in a 50 percent ethanol/water mixture for 24 hours, yields 
total extractables not exceeding 0.65 percent by weight of the sample.
    (d) Conditions of use. (1) Poly(phenyleneterephthalamide) resins in 
the form of continuous filament yarns and fibers may be used as 
components of articles intended for repeated use in contact with food at 
temperatures not to exceed 260  deg.C (500  deg.F). All items are 
scoured prior to use by agitation in a water bath containing 0.5 gram/
liter of tetrasodium pyrophosphate and 0.5 percent detergent. The items 
are agitated at 80  deg.C (180  deg.F) for 20 minutes, and then 
subjected to a cold water rinse.
    (2) Poly(phenyleneterephthalamide) resins in the form of pulp may be 
used as gaskets and packing for food processing equipment at 
temperatures not to exceed 260  deg.C (500  deg.F).

[57 FR 3125, Jan. 28, 1992]



Sec. 177.1635  Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).

    Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) 
identified in this section may be safely used as components of articles 
intended for use in contact with food, subject to the provisions of this 
section:
    (a) Identity. For the purposes of this section, poly(p-
methylstyrene) and rubber-modified poly(p-methylstyrene) are basic 
polymers, manufactured as described in this paragraph, meeting the 
specifications prescribed in paragraph (c) of this section.
    (1) Poly(p-methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced 
by the polymerization of p-methylstyrene.
    (2) Rubber-modified poly(p-methylstyrene) (CAS Reg. No. 33520-88-6) 
polymer produced by combining styrene-butadiene copolymer and/or 
polybutadiene with poly(p-methylstyrene), either during or after 
polymerization of the poly(p-methylstyrene), such that the finished 
polymers contain not less than 75 weight percent of total polymer units 
derived from p-methylstyrene) monomer.
    (b) Optional adjuvants. The basic polymers identified in paragraph 
(a) of this section may contain optional adjuvant substances required in 
the production of such basic polymers. Such optional adjuvant substances 
may include substances permitted for such use by applicable regulations 
in this chapter, substances generally recognized as safe in food, 
substances generally recognized as safe in indirect additives, and 
substances used in accordance with prior sanction or approval.
    (c) Specifications. (1) Poly(p-methylstyrene) basic polymers 
identified in paragraph (a)(1) of this section shall contain not more 
than 1 weight percent of total residual p-methystyrene monomer, as 
determined by a gas chromatographic method titled, ``Gas Chromatographic 
Determination of PMS and PET in PPMS Basic Polymers,'' which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug

[[Page 284]]

Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Rubber-modified poly(p-methylstyrene) basic polymers identified 
in paragraph (a)(2) of this section shall contain not more than 0.5 
weight percent of total residual p-methylstyrene monomer, as determined 
by the method identified in paragraph (c)(1) of this section
    (d) Other specifications and limitations. The poly(p-methylstyrene) 
and rubber-modified poly(p-methylstyrene) identified in and complying 
with this section, when used as components of the food-contact surface 
of any article that is the subject of a regulation in parts 175, 176, 
177, 178 and Sec. 179.45 of this chapter, shall comply with any 
specifications and limitations prescribed by such regulation for the 
article in the finished form in which it is to contact food.
    (e) Conditions of use. Poly(p-methylstyrene) basic polymers and 
rubber-modified poly(p-methylstyrene) basic polymers identified in 
paragraphs (a)(1) and (a)(2), respectively, of this section shall be 
used in contact with food only under conditions of use B through H set 
forth in Table 2 of Sec. 176.170(c) of this chapter.

[48 FR 31384, July 8, 1983, as amended at 54 FR 24898, June 12, 1989; 55 
FR 52989, Dec. 26, 1990]



Sec. 177.1640   Polystyrene and rubber-modified polystyrene.

    Polystyrene and rubber-modified polystyrene identified in this 
section may be safely used as components of articles intended for use in 
contact with food, subject to the provisions of this section.
    (a) Identity. For the purposes of this section, polystyrene and 
rubber-modified polystyrene are basic polymers manufactured as described 
in this paragraph so as to meet the specifications prescribed in 
paragraph (c) of this section when tested by the method described in 
paragraph (d) of this section.
    (1) Polystyrene consists of basic polymers produced by the 
polymerization of styrene.
    (2) Rubber-modified polystyrene consists of basic polymers produced 
by combining styrene-butadiene copolymers and/or polybutadiene with 
polystyrene, either during or after polymerization of the polystyrene, 
such that the finished basic polymers contain not less than 75 weight 
percent of total polymer units derived from styrene monomer.
    (b) Optional adjuvants. The basic polymers identified in paragraph 
(a) of this section may contain optional adjuvant substances required in 
the production of such basic polymers. Such optional adjuvant substances 
may include substances permitted for such use by regulations in parts 
170 through 189 of this chapter, substances generally recognized as safe 
in food, and substances used in accordance with a prior sanction or 
approval.
    (c) Specifications. (1) Polystyrene basic polymers identified in 
paragraph (a)(1) of this section shall contain not more than 1 weight 
percent of total residual styrene monomer, as determined by the method 
described in paragraph (d) of this section, except that when used in 
contact with fatty foods of Types III, IV-A, V, VII-A, and IX described 
in Table 1 of Sec. 176.170(c) of this chapter, such polystyrene basic 
polymers shall contain not more than 0.5 weight percent of total 
residual styrene monomer.
    (2) Rubber-modified polystyrene basic polymers identified in 
paragraph (a)(2) of this section shall contain not more than 0.5 weight 
percent of total residual styrene monomer, as determined by the method 
described in paragraph (d) of this section.
    (d) Analytical method for determination of total residual styrene 
monomer content--(1) Scope. This method is suitable for the 
determination of residual styrene monomer in all types of styrene 
polymers.
    (2) Principle. The sample is dissolved in methylene chloride. An 
aliquot of the solution is injected into a gas chromatograph. The amount 
of styrene monomer present is determined from the area of the resulting 
peak.
    (3) Apparatus--(i) Gas chromatograph. Beckman GC-2A gas 
chromatograph with hydrogen flame detector or apparatus of equivalent 
sensitivity.

[[Page 285]]

    (ii) Chromatograph column. One-quarter inch outside diameter 
stainless steel tubing (0.028 inch wall thickness), 4 feet in length, 
packed with 20 percent polyethylene glycol (20,000 molecular weight) on 
alkaline treated 60-80 mesh firebrick.
    (iii) Recorder. Millivolt range of 0-1, chart speed of 30 inches per 
hour.
    (4) Reagents. Compressed air, purified; helium gas; hydrogen gas; 
methylene chloride, redistilled; and styrene monomer, redistilled.
    (5) Operating conditions for the gas chromatograph. (i) The column 
is operated at a temperature of 100 deg. C with a helium flow rate of 82 
milliliters per minute.
    (ii) The hydrogen burner is operated with 15 pounds per square inch 
of air pressure and 7 pounds per square inch of hydrogen pressure.
    (iii) The attenuation of the hydrogen flame detector is set at 
2 x 102.
    (6) Standardization. (i) Prepare a standard solution by weighing 
accurately 15 to 20 milligrams of styrene monomer into a 2-ounce bottle 
containing 25.0 milliliters of methylene chloride. Cap the bottle 
tightly and shake to thoroughly mix the solution.
    (ii) By means of a microliter syringe, inject 1 microliter of the 
standard solution into the gas chromatograph. Measure the area of the 
styrene monomer peak which emerges after approximately 12 minutes.
    (7) Procedure. (i) Transfer 1 gram of sample (accurately weighed to 
the nearest 0.001 gram to a 2-ounce bottle and add several glass beads. 
Pipette 25.0 milliliters of methylene chloride into the bottle. Cap the 
bottle tightly and place on a mechanical shaker. Shake until the polymer 
is completely dissolved. If any insoluble residue remains, allow the 
bottle to stand (or centrifuge at a low speed) until a clear supernatant 
layer appears.
    (ii) By means of a microliter syringe, inject 3 microliters of the 
clear supernatant liquid into the gas chromatograph.
    (iii) Measure the area of the resulting styrene monomer peak. 
Compare the sample peak area with the area produced by the standard 
styrene monomer solution. Calculation:
Percent residual styrene monomer=Milligrams monomer in standard x peak 
area of sample/Peak area of monomer standard x sample weight in 
grams x 30
    (e) Other specifications and limitations. The polystyrene and 
rubber-modified polystyrene identified in and complying with this 
section, when used as components of the food-contact surface of any 
article that is the subject of a regulation in parts 174, 175, 176, 177, 
178 and Sec. 179.45 of this chapter, shall comply with any 
specifications and limitations prescribed by such regulation for the 
article in the finished form in which it is to contact food.
    (f) Nonapplicability. The provisions of this section are not 
applicable to polystyrene and rubber-modified polystyrene used in food-
packaging adhesives complying with Sec. 175.105 of this chapter.



Sec. 177.1650   Polysulfide polymer-polyepoxy resins.

    Polysulfide polymer-polyepoxy res- ins may be safely used as the 
food-contact surface of articles intended for packaging, transporting, 
holding, or otherwise contacting dry food, in accordance with the 
following prescribed conditions:
    (a) Polysulfide polymer-polyepoxy resins are the reaction products 
of liquid polysulfide polymers and polyfunctional epoxide resins, cured 
with the aid of tri(dimethylaminomethyl) phenol, to which have been 
added certain optional substances to impart desired technological 
properties to the resins. Subject to any limitations prescribed in this 
section, the optional substances may include:
    (1) Substances generally recognized as safe in food and food 
packaging.
    (2) Substances the use of which is permitted under applicable 
regulations in this part, prior sanctions, or approvals.
    (3) Substances named in this subparagraph and further identified as 
required:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Bis(2-chloroethyl) formal..............                                 

[[Page 286]]

                                                                        
Bis(dichloropropyl) formal.............  Cross-linking agent.           
Butyl alcohol..........................  Solvent.                       
Carbon black (channel process).........                                 
Chlorinated paraffins..................  Cross-linking agent.           
Epoxidized linseed oil.................                                 
Epoxidized soybean oil.................                                 
Epoxy resins (as listed in Sec.                                         
 175.300(b)(3)(viii)(a) of this                                         
 chapter)..                                                             
Ethylene glycol monobutyl ether........  Solvent.                       
Magnesium chloride.....................                                 
Methyl isobutyl ketone.................  Solvent.                       
Naphthalene sulfonic acid-formaldehyde                                  
 condensate, sodium salt.                                               
Sodium dibutyl naphthalene sulfonate...  Wetting agent.                 
Sodium hydrosulfide....................                                 
Sodium polysulfide.....................                                 
,',,'-Tetrachloro normal propyl ether.                                    
Titanium dioxide.......................                                 
Toluene................................  Solvent.                       
Trichloroethane........................  Cross-linking agent.           
1,2,3-Trichloropropane.................      Do.                        
Urea-formaldehyde resins...............                                 
Xylene.................................  Solvent.                       
------------------------------------------------------------------------

    (b) The resins are used as the food-contact surface for dry food.
    (c) An appropriate sample of the finished resin in the form in which 
it contacts food, when subjected to ASTM method D968-81, ``Standard Test 
Methods for Abrasion Resistance of Organic Coatings by the Falling 
Abrasive Tester,'' which is incorporated by reference (copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408), using No. 50 Emery abrasive in lieu of Ottawa sand, shall 
exhibit and abrasion coefficient of not less than 20 liters per mil of 
film thickness.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]



Sec. 177.1655  Polysulfone resins.

    Polysulfone resins identified in paragraph (a) of this section may 
be safely used as articles or components of articles intended for use in 
contact with food, in accordance with the following prescribed 
conditions:
    (a) For the purpose of this section, polysulfone resins (poly(oxy-p-
phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenyl-
ene)resins) (CAS Reg. No. 25154-01-2) consist of basic resins produced 
when the disodium salt of 4,4'-isopropylidenediphenol is made to react 
with 4,4' dichlorodiphenyl sulfone in such a way that the finished 
resins have a minimum number average molecular weight of 15,000, as 
determined by osmotic pressure in monochlorobenzene.
    (b) The basic polysulfone resins identified in paragraph (a) of this 
section may contain optional adjuvant substances required in the 
production of such basic resins. The optional adjuvant substances 
required in the production of the basic polysulfone resins may include 
substances described in Sec. 174.5(d) of this chapter and the following:

------------------------------------------------------------------------
        List of substances                      Limitations             
------------------------------------------------------------------------
Dimethyl sulfoxide...............  Not to exceed 50 parts per million as
                                    residual solvent in finished basic  
                                    resin.                              
Monochlorobenzene................  Not to exceed 500 parts per million  
                                    as residual solvent in finished     
                                    basic resin.                        
------------------------------------------------------------------------

    (c) Polysulfone resins, when extracted at reflux temperatures for 6 
hours with the solvents--distilled water, 50 percent (by volume) ethyl 
alcohol in distilled water, 3 percent acetic acid in distilled water, 
and n-heptane, yield total extractives in each extracting solvent not to 
exceed 0.0078 milligram per square centimeter (0.05 milligram per square 
inch) of resin surface. Note: In testing the finished polysulfone 
resins, use a separate resin test sample for each required extracting 
solvent.
    (d) Polysulfone resins intended for repeated use in contact with 
food may be used under conditions of use A through H in Table 2 of 
Sec. 176.170(c) of this chapter. The resins intended for single-service 
food-contact use may be used only under condition of use H described in 
Table 2 of Sec. 176.170(c) of this chapter.

[51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 1986]



Sec. 177.1660   Poly (tetramethylene terephthalate).

    Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter-
ephthaloyl)) [Chemical Abstracts Service Registry No. 24968-12-5] 
identified in this section may be safely used as articles or components 
of articles intended to contact food, in accordance

[[Page 287]]

with the following prescribed conditions:
    (a) Identity. For the purpose of this section, poly (tetramethylene 
terephthalate) is the reaction product of dimethyl terephthalate with 
1,4-butanediol to which may have been added certain optional substances 
to impart desired technological properties to the polymer.
    (b) Optional adjuvant substances. Poly(tetramethylene terephthalate) 
identified in paragraph (a) of this section may contain optional 
adjuvant substances. The quantity of any optional adjuvant substance 
employed in the production of the polymer does not exceed the amount 
reasonably required to accomplish the intended technical or physical 
effect. Such adjuvants may include substances generally recognized as 
safe in food, substances used in accordance with prior sanction, and 
substances permitted under applicable regulations in this part.
    (c) Specifications. (1) Inherent viscosity of a 0.50 percent 
solution of the polymer in phenol/tetrachloroethane (60/40 weight ratio) 
solvent is not less than 0.6 as determined using a Wagner viscometer (or 
equivalent) and calculated from the following equation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.400

where:
    Nr=Ratio of flow time of the polymer solution to that of the 
solvent and c=polymer concentration of the test solution in grams per 
100 milliliters.

    (2) Poly(tetramethylene terephthalate) in the finished form in which 
it is to contact food shall yield total extractives as follows:
    (i) Not to exceed 0.08 milligram per square inch of food contact 
surface when extracted for 2 hours at 250 deg. F with distilled water.
    (ii) Not to exceed 0.02 milligram per square inch of food contact 
surface when extracted for 2 hours at 150 deg. F with n-heptane.
    (iii) Not to exceed 0.04 milligram per square inch of food contact 
surface when extracted for 2 hours at 212 deg. F with 3 percent aqueous 
acetic acid.
    (iv) Not to exceed 0.02 milligram per square inch of food contact 
surface when extracted for 2 hours at 65.6  deg.C (150  deg.F) with 50 
percent ethanol.

[42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52 
FR 20069, May 29, 1987]



Sec. 177.1670   Polyvinyl alcohol film.

    Polyvinyl alcohol film may be safely used in contact with food of 
the types identified in Sec. 176.170(c) of this chapter, Table 1, under 
Types V, VIII, and IX, in accordance with the following prescribed 
conditions:
    (a) The polyvinyl alcohol film is produced from polyvinyl alcohol 
having a minimum viscosity of 4 centipoises when a 4-percent aqueous 
solution is tested at 20 deg. C.
    (b) The finished food-contact film for use in contact with Food 
Types V or IX, when extracted with the solvent characterizing the type 
of food and under the conditions of time and temperature characterizing 
its intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields total extractives not to exceed 0.078 milligram per 
square centimeter (0.5 milligram per square inch) of food-contact 
surface when tested by ASTM method F34-76 (Reapproved 1980), ``Standard 
Test Method for Liquid Extraction of Flexible Barrier Materials,'' which 
is incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) The finished food-contact film shall not be used as a component 
of food containers intended for use in contact with water.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]



Sec. 177.1680  Polyurethane resins.

    The polyurethane resins identified in paragraph (a) of this section 
may be safely used as the food-contact surface of articles intended for 
use in contact with bulk quantities of dry food of the type identified 
in Sec. 176.170(c) of this chapter, Table 1, under Type VIII, in 
accordance with the following prescribed conditions:

[[Page 288]]

    (a) For the purpose of this section, polyurethane resins are those 
produced when one or more of the isocyanates listed in paragraph (a)(1) 
of this section is made to react with one or more of the substances 
listed in paragraph (a) (2) of this section:
    (1) Isocyanates:

Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4).
Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2).
4,4'-Diisocyanato-3,3'-dimethylbiphenyl (bi-tolylene diisocyanate).
Diphenylmethane diisocyanate.
Hexamethylene diisocyanate.
3-Isocyanatomethyl - 3,5,5 - trimethylcyclohexyl isocyanate.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate.

    (2) List of substances:

Adipic acid.
1,4-Butanediol.
1,3-Butylene glycol.
1,4-Cyclohexane dimethanol (CAS Reg. No. 105-08-8).
2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6-Hexanediol (CAS Reg. No. 629-11-8).-Hydro--
hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1).
-Hydro-omega-hydroxypoly (oxytetramethylene).
,'- (Isopropylidenedi - p - phenylene)bis [omega -
hydroxypoly (oxypropylene)(3-4 moles)], average molecular weight 675.
Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS Reg. No. 9003-11-6).
Methyl oxirane polymer with oxirane, ether with 1,2,3-propanetriol (CAS 
Reg. No. 9082-00-2).
,','','''-Neopentanetetrayltetrakis 
[omega- hydroxypoly (oxypropylene) (1-2 moles)], average molecular 
weight 400.
Pentaerythritol-linseed oil alcoholysis product.
Phthalic anhydride.
Polybutylene glycol.
Polyethyleneadipate modified with ethanolamine with the molar ratio of 
the amine to the adipic acid less than 0.1 to 1.
Poly(oxycarbonylpentamethylene).
Polyoxypropylene ethers of 4.4'-isopropyl-idenediphenol (containing an 
average of 2-4 moles of propylene oxide).
Polypropylene glycol.
,',''-1,2,3-Propanetriyltris [omega-
hydroxypoly (oxypropylene) (15-18 moles)], average molecular weight 
3,000.
Propylene glycol.
,',''-[Propylidynetris (methylene)] tris 
[omega-hydroxypoly (oxypropylene) (minimum 1.5 moles)], minimum 
molecular weight 400.
-[(1,1,3,3-Tetramethylbutyl) - phenyl]-omega - 
hydroxypoly(oxyethylene) (5 moles), average molecular weight 425.
Trimethylol propane.

    (b) Optional adjuvant substances employed in the production of the 
polyurethane resins or added thereto to impart desired technical or 
physical properties may include the following substances:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
1-[(2-Aminoethyl)amino]2-propanol......  As a curing agent.             
1-(3-Chloroallyl)-3,5,7-triaza-1-        As a preservative.             
 azoniaadamantane chloride.                                             
Colorants used in accordance with Sec.   ...............................
 178.3297 of this chapter..                                             
Dibutyltin diacetate...................  As a catalyst.                 
Dibutyltin dichloride..................      Do.                        
Dibutyltin dilaurate...................      Do.                        
N,N-Dimethyldodecylamine...............      Do.                        
N-Dodecylmorpholine....................      Do.                        
a,a'-[Isopropylidenebis[p-               As a stabilizer.               
 phenyleneoxy(2-hydroxytrimethylene)                                    
 ]]bis[omega-hydroxypoly-(oxyethylene)                                  
 (136-170 moles)], average molecular                                    
 weight 15,000.                                                         
4,4'-Methylenedianiline................  As a curing agent.             
1,1',1''-Nitrilotri-2-propanol.........      Do.                        
2,2'-(p-Phenylenedioxy) diethanol......      Do.                        
Polyvinyl isobutyl ether...............                                 
Polyvinyl methyl ether.................                                 
Soyaalkyd resin........................  Conforming in composition with 
                                          Sec.  175.300 of this chapter 
                                          and containing litharge not to
                                          exceed that residual from its 
                                          use as the reaction catalyst  
                                          and creosol not to exceed that
                                          required as an antioxidant.   
Tetrakis [methylene-(2,5-di-tert-butyl-  Stabilizer.                    
 4-hydroxyhydrocinnamate)]methane (CAS                                  
 Reg. No. 6683-19-8).                                                   
N,N,N'N'-Tetrakis (2-                    As a curing agent.             
 hydroxypropyl)ethylenediamine.                                         
Triethanolamine........................      Do.                        
Trimethyleneglycol di (p-aminobenzoate)  As a curing agent.             
 (CAS Reg. No. 57609-64-0).                                             
------------------------------------------------------------------------


[[Page 289]]


    (c) An appropriate sample of the finished resin in the form in which 
it contacts food, when subjected to ASTM method D968-81, ``Standard Test 
Methods for Abrasion Resistance of Organic Coatings by the Falling 
Abrasive Tester,'' which is incorporated by reference (copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408), using No. 50 Emery abrasive in lieu of Ottawa sand, shall 
exhibit an abrasion coefficient of not less than 20 liters per mil of 
film thickness.

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 57033, Nov. 20, 1981; 
49 FR 10110, Mar. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, 
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991]



Sec. 177.1810   Styrene block polymers.

    The styrene block polymers identified in paragraph (a) of this 
section may be safely used as articles or as components of articles 
intended for use in contact with food, subject to provisions of this 
section.
    (a) For the purpose of this section, styrene block polymers are 
basic polymers manufactured as described in this paragraph, so that the 
finished polymers meet the specifications prescribed in paragraph (b) of 
this section, when tested by the methods described in paragraph (c) of 
this section.
    (1) Styrene block polymers with 1,3-butadiene are those produced by 
the catalytic solution polymerization of styrene and 1,3-butadiene.
    (2) Styrene block polymers with 2-methyl-1,3-butadiene are those 
produced by the catalytic solution polymerization of styrene and 2-
methyl-1,3-butadiene.
    (3) Styrene block polymers with 1,3-butadiene, hydrogenated are 
those produced by the catalytic solution polymerization of styrene and 
1,3-butadiene, and subsequently hydrogenated.
    (b) Specifications:

----------------------------------------------------------------------------------------------------------------
                                                                                 Maximum            Maximum     
                                                                               extractable        extractable   
                                                                               fraction in       fraction in 50 
                                  Molecular                      Glass       distilled water    percent ethanol 
     Styrene block polymers        weight      Solubility      transition      at specified       at specified  
                                  (minimum)                      points       temperatures,      temperatures,  
                                                                                times, and         times, and   
                                                                               thicknesses        thicknesses   
----------------------------------------------------------------------------------------------------------------
1. (i) Styrene block polymers        29,000  Completely      -98 C (-144    0.0039 mg/cm\2\    0.002 mg/cm\2\   
 with 1,3-butadiene; for use as               soluble in      F) to -71 C    (0.025 mg/in\2\)   (0.01 mg/in\2\) 
 articles or as components of                 toluene.        (-96 F) and    of surface at      of surface at 66
 articles that contact food of                                86 C (187 F)   reflux             C (150 F) for 2 
 Types I, II, IV-B, VI, VII-B,                                to 122 C       temperature for    hr on a 0.19 cm 
 and VIII identified in Table 1                               (252 F).       30 min on a 0.19   (0.075 in) thick
 in Sec.  176.170(c) of this                                                 cm (0.075 in)      sample.         
 chapter under conditions of                                                 thick sample.                      
 use D, E, F, and G described                                                                                   
 in Table 2 in Sec.  176.170(c)                                                                                 
 of this chapter.                                                                                               
(ii) Styrene block polymers          29,000  ......do......  ......do.....  ......do.........      Do.          
 with 1,3-butadiene; for use as                                                                                 
 components of pressure-                                                                                        
 sensitive adhesives that                                                                                       
 contact food of Types I, II,                                                                                   
 IV-B, VI, VII-B, and VIII                                                                                      
 identified in Table 1 in Sec.                                                                                  
 176.170(c) of this chapter                                                                                     
 under conditions of use C, D,                                                                                  
 E, F and G described in Table                                                                                  
 2 in Sec.  176.170(c) of this                                                                                  
 chapter, provided the pressure-                                                                                
 sensitive adhesives be applied                                                                                 
 only to closure tapes for                                                                                      
 sealing containers having a                                                                                    
 capacity of not less than 160                                                                                  
 cc (5.5 fluid ounces) and that                                                                                 
 the area of the adhesive                                                                                       
 exposed to food shall not                                                                                      
 exceed 4.03 cm\2\ (0.625                                                                                       
 in\2\). The pressure-sensitive                                                                                 
 adhesive may contain terpene                                                                                   
 resins as identified in Sec.                                                                                   
 175.125(b)(2) of this chapter.                                                                                 

[[Page 290]]

                                                                                                                
2. Styrene block polymers with       29,000  ......do......  -65 C (-85 F)  0.002 mg/cm\2\     0.002 mg/cm\2\   
 2-methyl-1,3-butadiene; for                                  to -47 C (-    (0.01 mg/in\2\)    (0.01 mg/in\2\) 
 use as articles or as                                        53 F) and 86   of surface at      of surface at 66
 components of articles that                                  C (187 F) to   reflux             C (150 F) for 2 
 contact food of Types I, II,                                 122 C (252     temperature for    hr on a 0.071 cm
 IV-B, VI, VII-B, and VIII                                    F).            2 hr on a 0.071    (0.028 in) thick
 identified in Table 1 in Sec.                                               cm (0.028 in)      sample.         
 176.170(c) of this chapter.                                                 thick sample.      (Optionally,    
                                                                             (Optionally,       maximum net     
                                                                             maximum net        residue soluble 
                                                                             residue soluble    in chloroform   
                                                                             in chloroform      shall not exceed
                                                                             shall not exceed   0.00040 mg/cm\2\
                                                                             0.00020 mg/cm\2\   (0.0025 mg/     
                                                                             (0.0013 mg/        in\2\) of       
                                                                             in\2\) of          surface.)       
                                                                             surface.).                         
3. (i) Styrene block polymers        16,000  do............  -50 C (-58 F)  0.002 mg/cm2       0.002 mg/cm2     
 with 1,3-butadiene,                                          to -30 C (-    (0.01 mg/in2) of   (0.01 mg/in2) of
 hydrogenated (CAS Reg. No.                                   22 F) and 92   surface at         surface at 66 C 
 66070-58-4): for use as                                      C (198 F) to   reflux             (150 F) for 2 hr
 articles or as components of                                 98 C (208 F).  temperature for    on a 0.071 cm   
 articles that contact food of                                               2 hr on a 0.071    (0.028 in) thick
 Types I, II, IV-B, VI, VII-B,                                               cm (0.028 in)      sample.         
 and VIII identified in Table 1                                              thick sample.                      
 in Sec.  176.170(c) of this                                                                                    
 chapter.                                                                                                       
(ii) Styrene block polymers          16,000  do............  do...........  do...............  Do.              
 with 1,3-butadiene,                                                                                            
 hydrogenated (CAS Reg. No.                                                                                     
 66070-58-4): for use at levels                                                                                 
 not to exceed 42.4 percent by                                                                                  
 weight as a component of                                                                                       
 closures with sealing gaskets                                                                                  
 that would contact food of                                                                                     
 Types III, IV-A, V, VII-A,                                                                                     
 VIII, and IX identified in                                                                                     
 Table 1 in Sec.  176.170(c) of                                                                                 
 this chapter, and in condition                                                                                 
 of use D as described under                                                                                    
 Table 2 in Sec.  176.170(c) of                                                                                 
 this chapter.                                                                                                  
----------------------------------------------------------------------------------------------------------------

    (c) The analytical methods for determining whether styrene block 
polymers conform to the specifications prescribed in this section are as 
follows and are applicable to the finished polymer.
    (1) Molecular weight. Molecular weight shall be determined by 
intrinsic viscosity (or other suitable method).
    (2) Glass transition points. The glass transition points shall be 
determined by either of the following methods:
    (i) ASTM method D2236-70 (``Standard Method of Test for Dynamic 
Mechanical Properties of Plastics by Means of Torsional Pendulum,'' 
which is incorporated by reference; copies are available from American 
Society for Testing and Materials (ASTM), 1916 Race Street, 
Philadelphia, PA 19103, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408) modified by using a forced resonant vibration instead of a 
fixed vibration and by using frequencies of 25 to 40 cycles per second 
instead of 0.1 to 10 cycles per second.
    (ii) Direct reading viscoelastometric method titled ``Direct Reading 
Viscoelastrometric Method for Determining Glass Transition Points of 
Styrene Block Polymers'' (which is incorporated by reference; copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408), by which 
the glass transition points are determined in the tensile mode of 
deformation at a frequency of 35 hertz using a Rheovibron Model DDV-II 
(or equivalent) Direct Reading Viscoelastometer. Take maxima in the out-
of-phase component of the complex modulus as the glass transition 
points. For block polymers of low styrene content or for simple block 
polymers, the polymer may be treated with 0.3 part

[[Page 291]]

per hundred dicumyl peroxide and cured for 30 minutes at 153 deg. C to 
accentuate the upper transition point.
    (3) Maximum extractable fractions in distilled water and 50 percent 
ethanol and the maximum net residue solubles in chloroform. The maximum 
extractable fractions in distilled water and 50 percent ethanol, and the 
maximum net residue solubles in chloroform, shall be determined in 
accordance with Sec. 176.170(d)(3) of this chapter using a sandwich form 
of the finished copolymer of the specified thickness and for the time 
and temperature specified in paragraph (b) of this section.
    (d) The provisions of this section are not applicable to butadiene-
styrene copolymers listed in other sections of this subpart.
    (e) The provisions of this section are not applicable to styrene 
block polymers with 1,3-butadiene listed in Sec. 175.105 of this 
chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 43621, Aug. 30, 1977; 
47 FR 11844, Mar. 19, 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, June 
12, 1989; 58 FR 65546, Dec. 15, 1993]



Sec. 177.1820   Styrene-maleic anhydride copolymers.

    Styrene-maleic anhydride copolymers identified in paragraph (a) of 
this section may be safely used as articles or components of articles 
intended for use in contact with food, subject to provisions of this 
section.
    (a) For the purpose of this section, styrene-maleic anhydride 
copolymers are those produced by the polymerization of styrene and 
maleic anhydride so that the finished polymers meet the specifications 
prescribed in paragraph (b) of this section, when tested by the methods 
described in paragraph (c) of this section.
    (b) Specifications:

----------------------------------------------------------------------------------------------------------------
                                                                                 Maximum            Maximum     
                                                                               extractable        extractable   
                                  Molecular                     Residual       fraction in       fraction in n- 
                                   weight       Residual         maleic      distilled water       heptane at   
   Styrene-maleic copolymers      (minimum       styrene       anhydride       at specified        specified    
                                   number        monomer        monomer       temperatures,      temperatures,  
                                  average)                                      times, and         times, and   
                                                                              particle size      particle size  
----------------------------------------------------------------------------------------------------------------
1. Styrene-maleic anhydride          70,000  0.3 weight      0.1 weight     0.006 weight       0.02 weight      
 copolymers containing not more               percent.        percent.       percent at         percent at 73   
 than 15 pct maleic anhydride                                                reflux             deg. F for 2 hr 
 units by weight; for use as                                                 temperature for    utilizing       
 articles or as components of                                                1 hr utilizing     particles of a  
 articles that contact food of                                               particles of a     size that will  
 Types I, II, III, IV-A, IV-B,                                               size that will     pass through a  
 V, VI-B (except carbonated                                                  pass through a     U.S. standard   
 beverages), VII-A, VII-B,                                                   U.S. standard      sieve No. 10 and
 VIII, and IX identified in                                                  sieve No. 10 and   will be held on 
 Table 1 in Sec.  176.170(c) of                                              will be held on    a U.S. standard 
 this chapter under conditions                                               a U.S. standard    sieve No. 20.   
 of use B, C, D, E, F, G, and H                                              sieve No. 20.                      
 described in Table 2 in Sec.                                                                                   
 176.170(c) of this chapter.                                                                                    
2. Styrene-maleic anhydride      ..........  0.3...........  0.1..........  0.015 weight       1.0 weight       
 copolymer modified with                                                     percent at         percent at 23   
 butadiene, (CAS Reg. No. 27288-                                             reflux             deg. C (73 deg. 
 99-9) containing not more than                                              temperature for    F) for 2 hours  
 15 percent maleic anhydride                                                 1 hour utilizing   utilizing       
 units by weight and not more                                                particles of a     particles of a  
 than 20 percent styrene-                                                    size that will     size that will  
 butadiene and/or butadiene                                                  pass through a     pass through a  
 rubber units by weight; for                                                 U.S. standard      U.S. standard   
 use (except carbonated                                                      sieve No. 10 and   sieve No. 10 and
 beverage bottles) as articles                                               will be held on    will be held on 
 or as components of articles                                                a U.S. standard    a U.S. standard 
 that contact food of Types I,                                               sieve No. 20.      sieve No. 20.   
 II, III, IV-A, IV-B, V, VI,                                                                                    
 VII-A, VII-B, VIII, and IX                                                                                     
 identified in Table I in Sec.                                                                                  
 176.170(c) of this chapter                                                                                     
 under conditions of use B, C,                                                                                  
 D, E, F, G, and H described in                                                                                 
 Table 2 in Sec.  176.170(c) of                                                                                 
 this chapter.                                                                                                  
----------------------------------------------------------------------------------------------------------------

    (c) The analytical methods for determining conformance with 
specifications for styrene-maleic anhydride copolymers prescribed in 
this section are as follows:

[[Page 292]]

    (1) Molecular weight. Molecular weight shall be determined by 
membrane osmometry.
    (2) Residual styrene monomer content. Residual styrene monomer 
content shall be determined by the method described in Sec. 177.1640(d).
    (3) Residual maleic anhydride monomer content. Residual maleic 
anhydride monomer content shall be determined by a gas chromatographic 
method titled ``Determination of Residual Maleic Anhydride in Polymers 
by Gas Chromatography,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
or available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (d) The provisions of this section are not applicable to styrene-
maleic anhydride copolymers listed in other sections of this subpart.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982; 
47 FR 14698, Apr. 6, 1982; 54 FR 24898, June 12, 1989]



Sec. 177.1830   Styrene-methyl methacrylate copolymers.

    Styrene-methyl methacrylate copolymers identified in this section 
may be safely used as components of plastic articles intended for use in 
contact with food, subject to the provisions of this section.
    (a) For the purpose of this section, styrene-methyl methacrylate 
copolymers consist of basic copolymers produced by the copolymerization 
of styrene and methyl methacrylate such that the finished basic 
copolymers contain more than 50 weight percent of polymer units derived 
from styrene.
    (b) The finished plastic food-contact article, when extracted with 
the solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of 
intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields extractives not to exceed the following when tested 
by the methods prescribed in Sec. 177.1010(c);
    (1) Total nonvolatile extractives not to exceed 0.3 milligram per 
square inch of surface tested.
    (2) Potassium permanganate oxidizable distilled water and 8 and 50 
percent alcohol extractives not to exceed an absorbance of 0.15.
    (3) Ultraviolet-absorbing distilled water and 8 and 50 percent 
alcohol extractives not to exceed an absorbance of 0.30.
    (4) Ultraviolet-absorbing n-heptane extractives not to exceed an 
absorbance of 0.40.



Sec. 177.1850   Textryls.

    Textryls identified in this section may be safely used as articles 
or components of articles, intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting or 
holding food, subject to the provisions of this section.
    (a) Textryls are nonwoven sheets prepared from natural or synthetic 
fibers, bonded with fibryl (Fibryl consists of a polymeric resin in 
fibrous form commingled with fiber to facilitate sheet formation and 
subsequently heat cured to fuse the fibryl and effect bonding).
    (b) Textryls are prepared from the fibers, fibryls, and adjuvants 
identified in paragraph (c) of this section, and subject to limitations 
prescribed in that paragraph, provided that any substance that is the 
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 
of this chapter conforms with any specifications in such regulation for 
that substance as a component of polymeric resins used as food contact 
surfaces.
    (c) The fibers, fibryls, and adjuvants permitted are as follows:

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
(1) Fibers prepared from polyethylene    Conforming with Sec.  177.1630.
 terephthalate resins.                                                  
(2) Fibryls prepared from vinyl          As the basic polymer.          
 chloride-vinyl acetate copolymer.                                      
(3) Adjuvant substance,                  As a solvent in the preparation
 dimethylformamide.                       of fibryl.                    
------------------------------------------------------------------------


[[Page 293]]


    (d) Textryls meeting the conditions of test prescribed in paragraph 
(d)(1) of this section are used as prescribed in paragraph (d)(2) of 
this section.
    (1) Conditions of test. Textryls, when extracted with distilled 
water at reflux temperature for 1 hour, yield total extractives not to 
exceed 1 percent.
    (2) Uses. Textryls are used for packaging or holding food at 
ordinary temperatures and in the brewing of hot beverages.



Sec. 177.1900   Urea-formaldehyde resins in molded articles.

    Urea-formaldehyde resins may be safely used as the food-contact 
surface of molded articles intended for use in contact with food, in 
accordance with the following prescribed conditions:
    (a) For the purpose of this section, urea-formaldehyde resins are 
those produced when 1 mole of urea is made to react with not more than 2 
moles of formaldehyde in water solution.
    (b) The resins may be mixed with refined wood pulp and the mixture 
may contain other optional adjuvant substances which may include the 
following:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Hexamethylenetetramine....................  For use only as             
                                             polymerization-control     
                                             agent.                     
Tetrachlorophthalic acid anhydride........      Do.                     
Zinc stearate.............................  For use as lubricant.       
------------------------------------------------------------------------

    (c) The finished food-contact article, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of Sec. 175.300(d) of 
this chapter, yields total extractives in each extracting solvent not to 
exceed 0.5 milligram per square inch of food-contact surface as 
determined by the methods described in Sec. 175.300(e) of this chapter.

    Note: In testing the finished food-contact article, use a separate 
test sample for each required extracting solvent.



Sec. 177.1950   Vinyl chloride-ethylene copolymers.

    The vinyl chloride-ethylene copolymers identified in paragraph (a) 
of this section may be safely used as components of articles intended 
for contact with food, under conditions of use D, E, F, or G described 
in Table 2 of Sec. 176.170 (c) of this chapter, subject to the 
provisions of this section.
    (a) For the purpose of this section, vinyl chloride-ethylene 
copolymers consist of basic copolymers produced by the copolymerization 
of vinyl chloride and ethylene such that the finished basic copolymers 
meet the specifications and extractives limitations prescribed in 
paragraph (c) of this section, when tested by the methods described in 
paragraph (d) of this section.
    (b) The basic vinyl chloride-ethylene copolymers identified in 
paragraph (a) of this section may contain optional adjuvant substances 
required in the production of such basic copolymers. The optional 
adjuvant substances required in the production of the basic vinyl 
chloride-ethylene copolymers may include substances permitted for such 
use by regulations in parts 170 through 189 of this chapter, substances 
generally recognized as safe in food, and substances used in accordance 
with a prior sanction or approval.
    (c) The vinyl chloride-ethylene basic copolymers meet the following 
specifications and extractives limitations:
    (1) Specifications. (i) Total chlorine content is in the range of 53 
to 56 percent as determined by any suitable analytical procedure of 
generally accepted applicability.
    (ii) Intrinsic viscosity in cyclohexanone at 30 deg. C is not less 
than 0.50 deciliter per gram as determined by ASTM method D1243-79, 
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Extractives limitations. The following extractives limitations 
are determined by the methods described in paragraph (d) of this 
section:
    (i) Total extractives do not exceed 0.10 weight-percent when 
extracted with n-heptane at 150 deg. F for 2 hours.

[[Page 294]]

    (ii) Total extractives do not exceed 0.03 weight-percent when 
extracted with water at 150 deg. F for 2 hours.
    (iii) Total extractives obtained by extracting with water at 
150 deg. F for 2 hours contain no more than 0.5 milligram of vinyl 
chloride-ethylene copol-ymer per 100 grams of sample tested as 
determined from the organic chlorine content. The organic chlorine 
content is determined as described in paragraph (d)(3) of this section.
    (d) Analytical methods: The analytical methods for determining 
whether vinyl chloride-ethylene basic copolymers conform to the 
extractives limitations prescribed in paragraph (c) of this section are 
as follows and are applicable to the basic copolymers in powder form 
having a particle size such that 100 percent will pass through a U.S. 
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard 
Sieve No. 80:
    (1) Reagents--(i) Water. All water used in these procedures shall be 
demineralized (deionized), freshly distilled water.
    (ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be 
used.
    (2) Determination of total amount of extractives. All determinations 
shall be done in duplicate using duplicate blanks. Approximately 400 
grams of sample (accurately weighed) shall be placed in a 2-liter 
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask 
with aluminum foil. The covered flask and contents are suspended in a 
thermostated bath and are kept, with continual shaking at 150 deg. F for 
2 hours. The solution is then filtered through a No. 42 Whatman filter 
paper, and the filtrate is collected in a graduated cylinder. The total 
amount of filtrate (without washing) is measured and called A 
milliliters. The filtrate is transferred to a Pyrex (or equivalent) 
beaker and evaporated on a steam bath under a stream of nitrogen to a 
small volume (approximately 50-60 milliliters). The concentrated 
filtrate is then quantitatively transferred to a tared 100-milliliter 
Pyrex beaker using small, fresh portions of solvent and a rubber 
policeman to effect the transfer. The concentrated filtrate is 
evaporated almost to dryness on a hotplate under nitrogen, and is then 
transferred to a drying oven at 230 deg. F in the case of the aqueous 
extract or to a vacuum oven at 150 deg. F in the case of the heptane 
extract. In the case of the aqueous extract, the evaporation to constant 
weight is completed in 15 minutes at 230 deg. F; and in the case of 
heptane extract, it is overnight under vacuum at 150 deg. F. The residue 
is weighed and corrected for the solvent blank. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.401

    (3) Vinyl chloride-ethylene copolymer content of aqueous extract--
(i) Principle. The vinyl chloride-ethylene copolymer content of the 
aqueous extract can be determined by determining the organic chlorine 
content and calculating the amount of copolymer equivalent to the 
organic chlorine content.
    (ii) Total organic chlorine content. A weighed sample of 
approximately 400 grams is extracted with 1,200 milliliters of water at 
150 deg. F for 2 hours, filtered, and the volume of filtrate is measured 
(A milliliters) as described in paragraph (d)(2) of this section.
    (a) A slurry of Amberlite IRA-400, or equivalent, is made with 
distilled water in a 150-milliliter beaker. The slurry is added to a 
chromatographic column until it is filled to about half its length. This 
should give a volume of resin of 15-25 milliliters. The liquid must not 
be allowed to drain below the top of the packed column.
    (b) The column is regenerated to the basic (OH) form by slowly 
passing through it (10-15 milliliters per minute) 10 grams of sodium 
hydroxide dissolved in 200 milliliters of water. The column is washed 
with distilled water until the

[[Page 295]]

effluent is neutral to phenolphthalein. One drop of methyl red indicator 
is added to the A milliliters of filtered aqueous extract and, if on the 
basic side (yellow), nitric acid is added drop by drop until the 
solution turns pink.
    (c) The extract is deionized by passing it through the exchange 
column at a rate of 10-15 milliliters per minute. The column is washed 
with 200 milliliters of distilled water. The deionized extract and 
washings are collected in a 1,500-milliliter beaker. The solution is 
evaporated carefully on a steam plate to a volume of approximately 50 
milliliters and then transferred quantitatively, a little at a time, to 
a clean 22-milliliter Parr cup, also on the steam plate. The solution is 
evaporated to dryness. Next 0.25 gram of sucrose and 0.5 gram of benzoic 
acid are added to the cup. One scoop (approximately 15 grams) of sodium 
peroxide is then added to the cup. The bomb is assembled and ignition is 
conducted in the usual fashion.
    (d) After the bomb has cooled, it is rinsed thoroughly with 
distilled water and disassembled. The top of the bomb is rinsed into a 
250-milliliter beaker with distilled water. The beaker is placed on the 
steam plate. The bomb cup is placed in the beaker and carefully tipped 
over to allow the water to leach out the combustion mixture. After the 
bubbling has stopped, the cup is removed from the beaker and rinsed 
thoroughly. The solution is cooled to room temperature and cautiously 
neutralized with concentrated nitric acid by slowly pouring the acid 
down a stirring rod until the bubbling ceases. The solution is cooled 
and an equal volume of acetone is added.
    (e) The solution is titrated with 0.005 N silver nitrate using 
standard potentiometric titration techniques with a silver electrode as 
indicator and a potassium nitrate modified calomel electrode as a 
reference electrode. An expanded scale recording titrimeter. Metrohm 
Potentiograph 2336 or equivalent, should be used; a complete blank must 
be run in duplicate.
    (iii) Calculations.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.402
    
where:
T=Milliliters of silver nitrate (sample minus blank) x normality of 
silver nitrate.
F=1,200/A (as defined above)
    (e) The vinyl chloride-ethylene copolymers identified in and 
complying with this section, when used as components of the food-contact 
surface of any article that is the subject of a regulation in parts 174, 
175, 176, 177, 178 and Sec. 179.45 of this chapter, shall comply with 
any specifications and limitations prescribed by such regulation for the 
article in the finished form in which it is to contact food.
    (f) The provisions of this section are not applicable to vinyl 
chloride-ethylene copolymers used as provided in Secs. 175.105 and 
176.180 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]



Sec. 177.1960   Vinyl chloride-hexene-1 copolymers.

    The vinyl chloride-hexene-1 copolymers identified in paragraph (a) 
of this section or as components of articles intended for use in contact 
with food, under conditions of use D, E, F, or G described in Table 2 of 
Sec. 176.170(c) of this chapter, subject to the provisions of this 
section.
    (a) Identity. For the purposes of this section vinyl chloride-
hexene-1 copolymers consist of basic copolymers produced by the 
copolymerization of vinyl chloride and hexene-1 such that the finished 
copolymers contain not more than 3 mole-percent of polymer units derived 
from hexene-1 and meet the specifications and extractives limitations 
prescribed in paragraph (b) of this section. The copolymers may 
optionally contain hydroxypropyl methylcellulose and trichloroethylene

[[Page 296]]

used as a suspending agent and chain transfer agent, respectively, in 
their production.
    (b) Specifications and limitations. The vinyl chloride-hexene-1 
basic copolymers meet the following specifications and extractives 
limitations:
    (1) Specifications. (i) Total chlorine content is 53 to 56 percent 
as determined by any suitable analytical procedure of generally accepted 
applicability.
    (ii) Inherent viscosity in cyclohexanone at 30 deg. C is not less 
than 0.59 deciliters per gram as determined by ASTM method D1243-79, 
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Extractives limitations. The following extractives limitations 
are determined by the methods prescribed in Sec. 177.1970(d).
    (i) Total extractives do not exceed 0.01 weight percent when 
extracted with water at 150 deg. F for 2 hours.
    (ii) Total extractives do not exceed 0.30 weight percent when 
extracted with n-heptane at 150 deg. F for 2 hours.
    (c) Other specifications and limitations. The vinyl chloride-hexene-
1 copolymers identified in and complying with this section, when used as 
components of the food-contact surface of any article that is subject to 
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter, shall comply with any specifications and limitations prescribed 
by such regulation for the article in the finished form in which it is 
to contact food.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]



Sec. 177.1970   Vinyl chloride-lauryl vinyl ether copolymers.

    The vinyl chloride-lauryl vinyl ether copolymers identified in 
paragraph (a) of this section may be used as an article or as a 
component of an article intended for use in contact with food subject to 
the provisions of this section.
    (a) Identity. For the purposes of this section vinyl chloride-lauryl 
vinyl ether copolymers consist of basic copolymers produced by the 
copolymerization of vinyl chloride and lauryl vinyl ether such that the 
finished copolymers contain not more than 3 weight-percent of polymer 
units derived from lauryl vinyl ether and meet the specifications and 
extractives limitations prescribed in paragraph (c) of this section.
    (b) Optional adjuvant substances. The basic vinyl chloride-lauryl 
vinyl ether copolymers identified in paragraph (a) of this section may 
contain optional adjuvant substances required in the production of such 
basic copolymers. These optional adjuvant substances may include 
substances permitted for such use by regulations in parts 170 through 
189 of this chapter, substances generally recognized as safe in food, 
and substances used in accordance with a prior sanction or approval.
    (c) Specifications and limitations. The vinyl chloride-lauryl vinyl 
ether basic copolymers meet the following specifications and extractives 
limitations:
    (1) Specifications. (i) Total chlorine content is 53 to 56 percent 
as determined by any suitable analytical procedure of generally accepted 
applicability.
    (ii) Inherent viscosity in cylcohexanone at 30 deg. C is not less 
than 0.60 deciliter per gram as determined by ASTM method D1243-79, 
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Extractives limitations. The following extractives limitations 
are determined by the method described in paragraph (d) of this section:
    (i) Total extractives do not exceed 0.03 weight-percent when 
extracted with water at 150 deg. F for 2 hours.
    (ii) Total extractives do not exceed 0.60 weight-percent when 
extracted with n-heptane at 150 deg. F for 2 hours.

[[Page 297]]

    (d) Analytical methods. The analytical methods for determining total 
extractives are applicable to the basic copolymers in powder form having 
a particle size such that 100 percent will pass through a U.S. Standard 
Sieve No. 40 and such that not more than 10 percent will pass through a 
U.S. Standard Sieve No. 200.
    (1) Reagents--(i) Water. All water used in these procedures shall be 
demineralized (deionized), freshly distilled water.
    (ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be 
used.
    (2) Determination of total amount of extractives. Place an 
accurately weighed sample of suitable size in a clean borosilicate 
flask, and for each gram of sample add 3 milliliters of solvent 
previously heated to 150 deg.F. Maintain the temperature of the contents 
of the flask at 150 deg. F for 2 hours using a hot plate while also 
maintaining gentle mechanical agitation. Filter the contents of the 
flask rapidly through No. 42 Whatman filter paper with the aid of 
suction. Transfer the filtrate to flat glass dishes that are warmed on a 
hot plate and evaporate the solvent with the aid of a stream of filtered 
air. When the volume of the filtrate has been reduced to 10 to 15 
milliliters, transfer the filtrate to tared 50-milliliter borosilicate 
glass beakers and complete evaporation to a constant weight in a 
140 deg. F vacuum oven. Carry out a corresponding blank determination 
with each solvent. Determine the weight of the residue corrected for the 
solvent blank and calculate the result as percent of the initial weight 
of the resin sample taken for analysis.
    (e) Other specifications and limitations. The vinyl chloride-lauryl 
vinyl ether copolymers identified in and complying with this section, 
when used as components of the food-contact surface of any article that 
is subject to a regulation in parts 174, 175, 176, 177, 178 and 
Sec. 179.45 of this chapter, shall comply with any specifications and 
limitations prescribed by such regulation for the article in the 
finished form in which it is to contact food.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]



Sec. 177.1980   Vinyl chloride-propylene copolymers.

    The vinyl chloride-propylene copolymers identified in paragraph (a) 
of this section may be safely used as components of articles intended 
for contact with food, subject to the provisions of this section.
    (a) For the purpose of this section, vinyl chloride-propylene 
copolymers consist of basic copolymers produced by the copolymezation of 
vinyl chloride and propylene such that the finished basic copolymers 
meet the specifications and extractives limitations prescribed in 
paragraph (c) of this section, when tested by the methods described in 
paragraph (d) of this section.
    (b) The basic vinyl chloride-propylene copolymers identified in 
paragraph (a) of this section may contain optional adjuvant substances 
required in the production of such basic copolymers. The optional 
adjuvant substances required in the production of the basic vinyl 
chloride-propylene copolymers may include substances permitted for such 
use by regulations in parts 170 through 189 of this chapter, substances 
generally recognized as safe in food, and substances used in accordance 
with a prior sanction or approval.
    (c) The vinyl chloride-propylene basic copolymers meet the following 
specifications and extractives limitations:
    (1) Specifications. (i) Total chlorine content is in the range of 53 
to 56 percent as determined by any suitable analytical procedure of 
generally accepted applicability.
    (ii) Intrinsic viscosity in cyclohexanone at 30 deg. C is not less 
than 0.50 deciliter per gram as determined by ASTM method D1243-79, 
``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.

[[Page 298]]

    (2) Extractives limitations. The following extractives limitations 
are determined by the methods described in paragraph (d) of this 
section:
    (i) Total extractives do not exceed 0.10 weight-percent when 
extracted with n-heptane at 150 deg. F for 2 hours.
    (ii) Total extractives do not exceed 0.03 weight-percent when 
extracted with water at 150 deg. F for 2 hours.
    (iii) Total extractives obtained by extracting with water at 
150 deg. F for 2 hours contain no more than 0.17 milligram of vinyl 
chloride-propylene copolymer per 100 grams of sample tested as 
determined from the organic chlorine content. For the purpose of this 
section, the organic chlorine content is the difference between the 
total chlorine and ionic chlorine contents determined as described in 
paragraph (d) of this section.
    (d) Analytical methods: The analytical methods for determining 
whether vinyl chloride-propylene basic copolymers conform to the 
extractives limitations prescribed in paragraph (c) of this section are 
as follows and are applicable to the basic copolymers in powder form 
having a particle size such that 100 percent will pass through a U.S. 
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard 
Sieve No. 80:
    (1) Reagents--(i) Water. All water used in these procedures shall be 
demineralized (deionized), freshly distilled water.
    (ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be 
used.
    (2) Determination of total amount of extractives. All determinations 
shall be done in duplicate using duplicate blanks. Approximately 400 
grams of sample (accurately weighed) shall be placed in a 2-liter 
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask 
with aluminum foil. The covered flask and contents are suspended in a 
thermostated bath and are kept, with continual shaking, at 150 deg. F 
for 2 hours. The solution is then filtered through a No. 42 Whatman 
filter paper, and the filtrate is collected in a graduated cylinder. The 
total amount of filtrate (without washing) is measured and called A 
milliliters. The filtrate is transferred to a Pyrex (or equivalent) 
beaker and evaporated on a steam bath under a stream of nitrogen to a 
small volume (approximately 50-60 milliliters). The concentrated 
filtrate is then quantitatively transferred to a tared 100-milliliter 
Pyrex beaker using small, fresh portions of solvent and a rubber 
policeman to effect the transfer. The concentrated filtrate is 
evaporated almost to dryness on a hotplate under nitrogen, and is then 
transferred to a drying oven at 230 deg. F in the case of the aqueous 
extract or to a vacuum oven at 150 deg. F in the case of the heptane 
extract. In the case of the aqueous extract the evaporation to constant 
weight is completed in 15 minutes at 230 deg. F; and in the case of 
heptane extract, it is overnight under vacuum at 150 deg. F. The residue 
is weighed and corrected for the solvent blank. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.403

    (3) Vinyl chloride-propylene copolymer content of aqueous extract--
(i) Principle. The vinyl chloride-propylene copolymer content of the 
aqueous extract can be determined by determining the organic chlorine 
content and calculating the amount of copolymer equivalent to the 
organic chlorine content. The organic chlorine content is the difference 
between the total chlorine content and the ionic chlorine content.
    (ii) Total chlorine content. A weighed sample is extracted with 
water at 150 deg. F for 2 hours, filtered, and the volume of filtrate is 
measured (A milliliters) as described in paragraph (d)(2) of this 
section. Two drops of 50 percent by weight sodium hydroxide solution are 
added to prevent loss of chloride from

[[Page 299]]

ammonium chloride, if present, and the solution is evaporated to 
approximately 15 milliliters. The concentrated filtrate is 
quantitatively transferred to a 22-milliliter Parr bomb fusion cup and 
gently evaporated to dryness. To the contents of the cup are added 3.5 
grams of granular sodium peroxide, 0.1 gram of powdered starch, and 0.02 
gram potassium nitrate; and the contents are mixed thoroughly. The bomb 
is assembled, water is added to the recess at the top of the bomb and 
ignition is conducted in the usual fashion using a Meeker burner. The 
heating is continued for 1 minute after the water at the top has 
evaporated. The bomb is quenched in water, rinsed with distilled water, 
and placed in a 400-milliliter beaker. The bomb cover is rinsed with 
water, catching the washings in the same 400-milliliter beaker. The bomb 
is covered with distilled water and a watch glass and heated until the 
melt has dissolved. The bomb is removed, rinsed, catching the rinsings 
in the beaker, and the solution is acidified with concentrated nitric 
acid using methyl purple as an indicator. The beaker is covered with a 
watch glass, and the contents are boiled gently for 10-15 minutes. After 
cooling to room temperature the solution is made slightly alkaline with 
50 percent by weight sodium hydroxide solution, then acidified with 
dilute (1:5) nitric acid. Then 1.5 milliliters of 2 N nitric acid per 
100 milliliters of solution is added and the solution is titrated with 
0.005 N silver nitrate to the equivalence potential end point using an 
expanded scale pH meter (Beckman Model 76, or equivalent). A complete 
blank must be run in duplicate. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.404

where:
A=volume of filtrate obtained in extraction.
B=milliliters of silver nitrate solution used in sample 
titration x normality of silver nitrate solution.
C=milliliters of silver nitrate solution used in blank 
titration x normality of silver nitrate solution.

    (iii) Ionic chlorine content. A weighed sample is extracted with 
water at 150 deg. F for 2 hours, filtered, and the volume of filtrate is 
measured (A milliliters) as in paragraph (d)(2) of this section. Two 
drops of 50 percent by weight sodium hydroxide solution are added and 
the solution is evaporated to approximately 150 milliliters. The 
solution is quantitatively transferred to a 250-milliliter beaker, 
methyl purple indicator is added, and the solution is neutralized with 
0.1 N nitric acid. For each 100 milliliters of solution is added 1.5 
milliliters of 2 N nitric acid. The solution is titrated with 0.005 N 
silver nitrate to the equivalence potential end point, using the 
expanded scale pH meter described in paragraph (d)(3)(ii) of this 
section. A complete blank must be run in duplicate. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.405

where:
A=volume of filtrate obtained in extraction.
D=milliliters of silver nitrate solution used in sample 
titration x normality of silver nitrate solution.

[[Page 300]]

E=milliliters of silver nitrate solution used in blank 
titration x normality of silver nitrate solution.

    (iv) Organic chlorine content and vinyl chloride-propylene copolymer 
content of aqueous extract. The organic chlorine content and the vinyl 
chloride propylene copolymer content of the aqueous extract is 
calculated as follows:
    (a) Organic chlorine content. Milliequivalents of organic chlorine 
in aqueous extract of 100 grams of sample equal milliequivalents of 
total chlorine in aqueous extract of 100 grams of sample (as calculated 
in paragraph (d)(3)(ii) of this section) minus milliequivalents of ionic 
chlorine in aqueous extract of 100 grams of sample (as calculated in 
paragraph (d)(3)(iii) of this section).
    (b) Vinyl chloride-propylene copolymer content. Milligrams of vinyl 
chloride-propylene copolymer in aqueous extract of 100 grams of sample 
equal milliequivalents of organic chlorine in aqueous extract of 100 
grams of sample (as calculated in paragraph (d)(3)(iv) (a) of this 
section) multiplied by 84.5.

    Note: The conversion factor, 84.5, is derived from the equivalent 
weight of chlorine divided by the chlorine content of the heptane 
extractable fraction.)

    (e) The vinyl chloride-propylene copolymers identified in and 
complying with this section, when used as components of the food-contact 
surface of any article that is the subject of a regulation in parts 174, 
175, 176, 177, 178 and Sec. 179.45 of this chapter, shall comply with 
any specifications and limitations prescribed by such regulation for the 
article in the finished form in which it is to contact food.
    (f) The provisions of this section are not applicable to vinyl 
chloride-propylene copolymers used in food-packaging adhesives complying 
with Sec. 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984]



Sec. 177.1990  Vinylidene chloride/methyl acrylate copolymers.

    The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No. 
25038-72-6) identified in paragraph (a) of this section may be safely 
used as an article or as a component of an article intended for use in 
contact with food subject to the provisions of this section.
    (a) Identity. For the purposes of this section vinylidene chloride/
methyl acrylate copolymers consist of basic copolymers produced by the 
copolymerization of vinylidene chloride and methyl acrylate such that 
the copolymers contain not more than 15 weight-percent of polymer units 
derived from methyl acrylate.
    (b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate copolymers identified in paragraph (a) of this section 
may contain optional adjuvant substances required in the production of 
such basic copolymers. These optional adjuvant substances may include 
substances permitted for such use by regulations in parts 170 through 
179 of this chapter, substances generally recognized as safe in food, 
and substances used in accordance with a prior sanction or approval.
    (c) Specifications. (1) The methyl acrylate content is determined by 
an infrared spectrophotometric method titled ``Determination of 
Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate Copolymers,'' 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) The weight average molecular weight of the copolymer is not less 
than 50,000 when determined by gel permeation chromatography using 
tetrahydrofuran as the solvent. The gel permeation chromatograph is 
calibrated with polystyrene standards. The basic gel permeation 
chromatographic method is described in ANSI/ASTM D3536-76, ``Standard 
Test Method for Molecular Weight Averages and Molecular Weight 
Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel 
Permeation Chromatography-GPC),'' which is incorporated by reference. 
Copies are available from University Microfilms International, 300 North 
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office 
of the Federal Register, 800 North Capitol

[[Page 301]]

Street, NW., suite 700, Washington, DC 20408.
    (3) Residual vinylidene chloride and residual methyl acrylate in the 
copolymer in the form in which it will contact food (unsupported film, 
barrier layer, or as a copolymer for blending) will not exceed 10 parts 
per million and 5 parts per million, respectively, as determined by 
either a gas chromatographic method titled ``Determination of Residual 
Vinylidene Chloride and Methyl Acrylate in Vinylidene Chloride/Methyl 
Acrylate Copolymer Resins and Films,'' or, alternatively, ``Residual 
Methyl Acrylate and Vinylidene Chloride Monomers in Saran MA/VDC Resins 
and Pellets by Headspace Gas Chromatography,'' dated March 3, 1986, 
which are incorporated by reference in accordance with 5 U.S.C. 552(a). 
Copies are available from the Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (d) Extractives limitations. The basic copolymer resin in the form 
of granules that will pass through a U.S. Standard Sieve No. 45 (350 
microns) shall meet the following extractives limitations:
    (1) 10-gram samples of the resin, when extracted separately with 100 
milliliters of distilled water at 121 deg. C (250 deg. F) for 2 hours, 
and 100 milliliters of n-heptane at 66 deg. C (150 deg. F) for 2 hours, 
shall yield total nonvolatile extractives not to exceed 0.5 percent by 
weight of the resin.
    (2) The basic copolymer in the form of film when extracted 
separately with distilled water at 121 deg. C (250 deg. F) for 2 hours 
shall yield total nonvolatile extractives not to exceed 0.047 milligram 
per square centimeter (0.3 milligram per square inch).
    (e) Conditions of use. The copolymers may be safely used as articles 
or components of articles intended for use in producing, manufacturing, 
processing, preparing, treating, packaging, transporting, or holding 
food, including processing of packaged food at temperatures not to 
exceed 135  deg.C (275  deg.F).
    (f) Other specifications and limitations. The vinylidene chloride-
methyl acrylate copolymers identified in and complying with this 
section, when used as components of the food contact surface of any 
article that is subject to a regulation in parts 174 through 178 and 
Sec. 179.45 of this chapter, shall comply with any specifications and 
limitations prescribed by such regulation for the article in the 
finished form in which it is to contact food.

[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended at 
53 FR 47185, Nov. 22, 1988; 54 FR 24898, June 12, 1989]



Sec. 177.2000  Vinylidene chloride/methyl acrylate/methyl methacrylate polymers.

    The vinylidene chloride/methyl acrylate/methyl methacrylate polymers 
(CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section 
may be safely used as articles or as a component of articles intended 
for use in contact with food subject to the provisions of this section.
    (a) Identity. For the purpose of this section, vinylidene chloride/
methyl acrylate/methyl methacrylate polymers consist of basic polymers 
produced by the copolymerization of vinylidene chloride/methyl acrylate/
methyl methacrylate such that the basic polymers or the finished food-
contact articles meet the specifications prescribed in paragraph (d) of 
this section.
    (b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate/methyl methacrylate polymers identified in paragraph (a) 
of this section may contain optional adjuvant substances required in the 
production of such basic polymers. These optional adjuvant substances 
may include substances permitted for such use by regulations in parts 
170 through 179 of this chapter, substances generally recognized as safe 
in food, and substances used in accordance with a prior sanction of 
approval.
    (c) Conditions of use. The polymers may be safely used as articles 
or as components of articles intended for use in producing, 
manufacturing, processing, preparing, treating, packaging, transporting, 
or holding food, including processing of packaged food at temperatures 
up to 121 deg. C (250 deg. F).
    (d) Specifications and limitations. The vinylidene chloride/methyl 
acrylate/

[[Page 302]]

methyl methacrylate basic polymers and/or finished food-contact articles 
meet the following specifications and limitations:
    (1)(i) The basic vinylidene chloride/methyl acrylate/methyl 
methacrylate polymers contain not more than 2 weight percent of polymer 
units derived from methyl acrylate monomer and not more than 6 weight 
percent of polymer units derived from methyl methacrylate monomer.
    (ii) The basic polymers are limited to a thickness of not more than 
0.005 centimeter (0.002 inches).
    (2) The weight average molecular weight of the basic polymer is not 
less than 100,000 when determined by gel permeation chromatography using 
tetrahydrofuran as the solvent. The gel permeation chromatography is 
calibrated with polystyrene standards. The basic gel permeation 
chromatographic method is described in ANSI/ASTM D3536-76, which is 
incorporated by reference. Copies are available from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (3) The basic polymer or food-contact article described in paragraph 
(a) of this section, when extracted with the solvent or solvents 
characterizing the type of food and under the conditions of time and 
temperature characterizing the conditions of its intended use as 
determined from Tables 1 and 2 of Sec. 176.170(c) of this chapter, 
yields net chloroform-soluble extractives in each extracting solvent not 
to exceed .08 milligram per square centimeter (0.5 milligram per square 
inch) of food-contact surface when tested by the methods described in 
Sec. 176.170(d). If the finished food-contact article is itself the 
subject of a regulation in parts 174 through 178 and Sec. 179.45 of this 
chapter, it shall also comply with any specifications and limitations 
prescribed for it by the regulation.

[49 FR 29578, July 23, 1984]



 Subpart C--Substances for Use Only as Components of Articles Intended 
                            for Repeated Use



Sec. 177.2210   Ethylene polymer, chlorosulfonated.

    Ethylene polymer, chlorosulfonated as identified in this section may 
be safely used as an article or component of articles intended for use 
in contact with food, subject to the provisions of this section.
    (a) Ethylene polymer, chlorosulfonated is produced by 
chlorosulfonation of a carbon tetrachloride solution of polyethylene 
with chlorine and sulfuryl chloride.
    (b) Ethylene polymer, chlorosulfonated shall meet the following 
specifications:
    (1) Chlorine not to exceed 25 percent by weight.
    (2) Sulfur not to exceed 1.15 percent by weight.
    (3) Molecular weight is in the range of 95,000 to 125,000.

Methods for the specifications in this paragraph (b), titled ``Chlorine 
and Bromine--Coulometric Titration Method by Aminco Chloridometer,'' 
``Hypolon Synthetic Rubber--Determination of Sulfur by Parr 
Bomb,'' and ASTM method D2857-70 (Reapproved 1977), ``Standard Test 
Method for Dilute Solution Viscosity of Polymers,'' are incorporated by 
reference. Copies of the ASTM method may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103. 
Copies of the other two methods are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204. Copies of all three methods may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) The additive is used as the article, or a component of articles, 
intended for use as liners and covers for reservoirs intended for the 
storage of water for drinking purposes.
    (d) Substances permitted by Sec. 177.2600 may be employed in the 
preparation of

[[Page 303]]

ethylene polymers, chlorosulfonated, subject to any limitations 
prescribed therein.
    (e) The finished ethylene copolymers, chlorosulfonated shall conform 
to Sec. 177.2600(e) and (g).

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 
54 FR 24898, June 12, 1989]



Sec. 177.2250   Filters, microporous polymeric.

    Microporous polymeric filters identified in paragraph (a) of this 
section may be safely used, subject to the provisions of this section, 
to remove particles of insoluble matter in producing, manufacturing, 
processing, and preparing bulk quantities of liquid food.
    (a) Microporous polymeric filters consist of a suitably permeable, 
continuous, polymeric matrix of polyvinyl chloride, vinyl chloride-
propylene, or vinyl chloride-vinyl acetate, in which finely divided 
silicon dioxide is embedded. Cyclohexanone may be used as a solvent in 
the production of the filters.
    (b) Any substance employed in the production of microporous 
polymeric filters that is the subject of a regulation in parts 170 
through 189 of this chapter must conform with any specification in such 
regulation.
    (c) Cyclohexanone when used as a solvent in the production of the 
filters shall not exceed 0.35 percent by weight of the microporous 
polymeric filters.
    (d) The microporous polymeric filters may be colored with colorants 
used in accordance with Sec. 178.3297 of this chapter.
    (e) The temperature of food being processed through the microporous 
polymeric filters shall not exceed 180 deg. F.
    (f) The microporous polymeric filters shall be maintained in a 
sanitary manner in accordance with good manufacturing practice so as to 
prevent potential microbial adulteration of the food.
    (g) To assure safe use of the microporous polymeric filters, the 
label or labeling shall include adequate directions for a pre-use 
treatment, consisting of washing with a minimum of 2 gallons of potable 
water at a temperature of 180 deg. F for each square foot of filter, 
prior to the filter's first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]



Sec. 177.2260   Filters, resin-bonded.

    Resin-bonded filters may be safely used in producing, manufacturing, 
processing, and preparing food, subject to the provisions of this 
section.
    (a) Resin-bonded filters are prepared from natural or synthetic 
fibers to which have been added substances required in their preparation 
and finishing, and which are bonded with resins prepared by condensation 
or polymerization of resin-forming materials, together with adjuvant 
substances required in their preparation, application, and curing.
    (b) The quantity of any substance employed in the production of the 
resin-bonded filter does not exceed the amount reasonably required to 
accomplish the intended physical or technical effect or any limitation 
further provided.
    (c) Any substance employed in the production of resin-bonded filters 
that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 
Sec. 179.45 of this chapter conforms with any specification in such 
regulation.
    (d) Substances employed in the production of resin-bonded filters 
include the following, subject to any limitations provided:

                   List of Substances and Limitations

(1) Fibers:
    Cellulose pulp.
    Cotton.
    Nylon. (From nylon resins complying with the provisions of 
applicable regulations in Subchapter B of this chapter.
    Polyethylene terephthalate complying in composition with the 
provisions of Sec. 177.1630; for use in inline filtration only as 
provided for in paragraphs (e) and (f) of this section.
    Rayon (viscose).
(2) Substances employed in fiber finishing: 
    BHT.
    Butyl (or isobutyl) palmitate or stearate.
    2,5-Di-tert-butyl hydroquinone for use only in lubricant 
formulations for rayon fiber finishing and at a usage level not to 
exceed 0.1 percent by weight of the lubricant formulations.

[[Page 304]]

    Dimethylpolysiloxane.
    4-Ethyl-4-hexadecyl morpholinium ethyl sulfate for use only as a 
lubricant in the manufacture of polyethylene terephthalate fibers 
specified in paragraph (d)(1) of this section at a level not to exceed 
0.03 percent by weight of the finished fibers.
    Fatty acid (C10-C18) diethanolamide condensates.
    Fatty acids derived from animal or vegetable fats and oils, and 
salts of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Triethanolamine.
    Fatty acid (C10-C18) mono- and diesters of polyoxyethylene 
glycol (molecular weight 400-3,000).
    Methyl esters of fatty acids (C10-C18).
    Mineral oil.
    Polybutene, hydrogenated; complying with the identity prescribed 
under Sec. 178.3740 (b) of this chapter.
    Polyoxyethylene (4 mols) ethylenediamine monolauramide for use only 
in lubricant formulations for rayon fiber finishing and at a usage level 
not to exceed 10 percent by weight of the lubricant formulations.
    Ricebran oil.
    Titanium dioxide.
(3) Resins:
    Acrylic polymers produced by polymerizing ethyl acrylate alone or 
with one or more of the monomers: Acrylic acid, acrylonitrile, N-
methylolacrylamide, and styrene. The finished copolymers shall contain 
at least 70 weight percent of polymer units derived from ethyl acrylate, 
no more than 2 weight percent of total polymer units derived from 
acrylic acid, no more than 10 weight percent of total polymer units 
derived from acrylonitrile, no more than 2 weight percent of total 
polymer units derived from N-methylolacrylamide, and no more than 25 
weight percent of total polymer units derived from styrene. For use only 
as provided in paragraph (m) of this section.
    Melamine-formaldehyde.
    Melamine-formaldehyde chemically modified with one or more of the 
amine catalysts identified in Sec. 175.300(b)(3)(xiii) of this chapter.
    Melamine-formaldehyde chemically modified with methyl alcohol.
    Melamine-formaldehyde chemically modified with urea; for use only as 
provided for in paragraphs (e), (f), (g), (h), and (i) of this section.
    Phenol-formaldehyde resins.
    Polyvinyl alcohol.
    Polyvinyl alcohol with the copolymer of acrylic acid-allyl sucrose.
    Polyvinyl alcohol with melamine formaldehyde.
    Polyvinyl acetate with melamine formaldehyde.
    p--Toluenesulfonamide-formaldehyde chemically modified with one 
or more of the amine catalysts identified in Sec. 175.300 (b)(3)(xiii) 
of this chapter.
(4) Adjuvant substances:
    Dimethyl polysiloxane with methylcellulose and sorbic acid (as an 
antifoaming agent).
    Phosphoric acid.
(5) Colorants: Colorants used in accordance with Sec. 178.3297 of this 
chapter.

    (e) Resin-bonded filters conforming with the specifications of 
paragraph (e) (1) of this section are used as provided in paragraph 
(e)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 
distilled water at 100 deg.F for 2 hours, yields total extractives not 
to exceed 2.8 percent by weight of the filter.
    (2) Conditions of use. It is used to filter milk or potable water at 
operating temperatures not to exceed 100 deg.F.
    (f) Resin-bonded filters conforming with the specifications of 
paragraph (f) (1) of this section are used as provided in paragraph 
(e)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 
distilled water at 145 deg.F for 2 hours, yields total extractives not 
to exceed 4 percent by weight of the filter.
    (2) Conditions of use. It is used to filter milk or potable water at 
operating temperatures not to exceed 145 deg.F.
    (g) Resin-bonded filters conforming with the specifications of 
paragraph (g) (1) of this section are used as provided in paragraph 
(g)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to n-hexane 
at reflux temperature for 2 hours, yields total extractives not to 
exceed 0.5 percent by weight of the filter.
    (2) Conditions of use. It is used to filter edible oils.
    (h) Resin-bonded filters conforming with the specifications of 
paragraph (h) (1) of this section are used as provided in paragraph 
(h)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 
distilled water at

[[Page 305]]

212 deg.F for 2 hours, yields total extractives not to exceed 4 percent 
by weight of the filter.
    (2) Conditions of use. It is used to filter milk, coffee, tea, and 
potable water at temperatures not to exceed 212 deg.F.
    (i) Resin-bonded filters conforming with the specifications of 
paragraph (i) (1) of this section are used as provided in paragraph 
(i)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 
distilled water for 2 hours at a temperature equivalent to, or higher 
than, the filtration temperature of the aqueous food, yields total 
extractives not to exceed 4 percent, by weight, of the filter.
    (2) Conditions of use. It is used in commercial filtration of bulk 
quantities of nonalcoholic, aqueous foods having a pH above 5.0.
    (j) Resin-bonded filters conforming with the specifications of 
paragraph (j) (1) of this section are used as provided in paragraph 
(j)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 5 
percent (by weight) acetic acid for 2 hours at a temperature equivalent 
to, or higher than, the filtration temperature of the aqueous food, 
yields total extractives not to exceed 4 percent, by weight, of the 
filter.
    (2) Conditions of use. It is used in commercial filtration of bulk 
quantities of nonalcoholic, aqueous foods having a pH of 5.0 or below.
    (k) Resin-bonded filters conforming with the specifications of 
paragraph (k) (1) of this section are used as provided in paragraph 
(k)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 8 
percent (by volume) ethyl alcohol in distilled water for 2 hours at a 
temperature equivalent to, or higher than, the filtration temperature of 
the alcoholic beverage, yields total extractives not to exceed 4 
percent, by weight, of the filter.
    (2) Conditions of use. It is used in commercial filtration of bulk 
quantities of alcoholic beverages containing not more than 8 percent 
alcohol.
    (l) Resin-bonded filters conforming with the specifications of 
paragraph (l) (1) of this section are used as provided in paragraph 
(l)(2) of this section:
    (1) Total extractives. The finished filter, when exposed to 50 
percent (by volume) ethyl alcohol in distilled water for 2 hours at a 
temperature equivalent to, or higher than, the filtration temperature of 
the alcoholic beverage, yields total extractives not to exceed 4 
percent, by weight, of the filter.
    (2) Conditions of use. It is used in commercial filtration of bulk 
quantities of alcoholic beverages containing more than 8 percent 
alcohol.
    (m) Resin-bonded filters fabricated from acrylic polymers as 
provided in paragraph (d)(3) of this section together with other 
substances as provided in paragraph (d), (1), (2), and (4) of this 
section may be used as follows:
    (1) The finished filter may be used to filter milk or potable water 
at operating temperatures not to exceed 100 deg.F, provided that the 
finished filter when exposed to distilled water at 100 deg.F for 2 hours 
yields total extractives not to exceed 1 percent by weight of the 
filter.
    (2) The finished filter may be used to filter milk or potable water 
at operating temperatures not to exceed 145 deg.F, provided that the 
finished filter when exposed to distilled water at 145 deg.F for 2 hours 
yields total extractives not to exceed 1.2 percent by weight of the 
filter.
    (n) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]



Sec. 177.2280   4,4'-Isopropylidenediphenolepi-chlorohydrin thermosetting epoxy resins.

    4,4'-Isopropylidenediphenol-epichlo-rohydrin thermosetting epoxy 
resins may be safely used as articles or components of articles intended 
for repeated use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, in 
accordance with the following prescribed conditions:
    (a) The basic thermosetting epoxy resin is made by reacting 4,4'-
isopropylidenediphenol with epichlorohydrin.
    (b) The resin may contain one or more of the following optional 
substances provided the quantity used

[[Page 306]]

does not exceed that reasonably required to accomplish the intended 
effect:

Allyl glycidyl ether...................  As curing system additive.     
Di- and tri-glycidyl ester mixture       As modifier at levels not to   
 resulting from the reaction of           exceed equal parts by weight  
 epichlorohydrin with mixed dimers and    of the 4,4'-                  
 trimers of unsaturated C18 monobasic     isopropylidenediphenol-       
 fatty acids derived from animal and      epichlorohydrin basic resin   
 vegetable fats and oils.                 and limited to use in contact 
                                          with alcoholic beverages      
                                          containing not more than 8    
                                          percent of alcohol.           
1,2-Epoxy-3-phenoxypropane.............  As curing system additive.     
Glyoxal................................      Do.                        
4,4'-Isopropylidenediphenol............      Do.                        
4,4'-Methylenedianiline................      Do.                        
m-Phenylenediamine.....................      Do.                        
Tetrahydrophthalic anhydride...........      Do.                        
------------------------------------------------------------------------

    (c) In accordance with good manufacturing practice, finished 
articles containing the resins shall be thoroughly cleansed prior to 
their first use in contact with food.
    (d) The provisions of this section are not applicable to 4,4'-
isopropylidenedi-phenol-epichlorohydrin resins listed in other sections 
of parts 174, 175, 176, 177, 178 and 179 of this chapter.

[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984]



Sec. 177.2355  Mineral reinforced nylon resins.

    Mineral reinforced nylon resins identified in paragraph (a) of this 
section may be safely used as articles or components of articles 
intended for repeated use in contact with nonacidic food (pH above 5.0) 
and at use temperatures not exceeding 212 deg. F. in accordance with the 
following prescribed conditions:
    (a) For the purpose of this section the mineral reinforced nylon 
resins consist of nylon 66, as identified in and complying with the 
specifications of Sec. 177.1500, reinforced with up to 40 weight percent 
of calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl) 
propylamine (Chemical Abstracts Service Registry No. 000919302) based on 
the weight of the calcium silicate.
    (b) The mineral reinforced nylon resins may contain up to 0.2 
percent by weight of titanium dioxide as an optional adjuvant substance.
    (c) The mineral reinforced nylon resins with or without the optional 
substance described in paragraph (b) of this section, and in the form of 
\1/8\-inch molded test bars, when extracted with the solvents, i.e., 
distilled water and 50 percent (by volume) ethyl alcohol in distilled 
water, at reflux temperature for 24 hours using a volume-to-surface 
ratio of 2 milliliters of solvent per square inch of surface tested, 
shall meet the following extractives limitations:
    (1) Total extractives not to exceed 5.0 milligrams per square inch 
of food-contact surface tested for each solvent.
    (2) The ash after ignition of the extractives described in paragraph 
(c)(1) of this section, not to exceed 0.5 milligram per square inch of 
food-contact surface tested.
    (d) In accordance with good manufacturing practice, finished 
articles containing the mineral reinforced nylon resins shall be 
thoroughly cleansed prior to their first use in contact with food.

[42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]



Sec. 177.2400  Perfluorocarbon cured elastomers. 

    Perfluorocarbon cured elastomers identified in paragraph (a) of this 
section may be safely used as articles or components of articles 
intended for repeated use in contact with nonacid food (pH above 5.0), 
subject to the provisions of this section.
    (a) Identity. (1) For the purpose of this section, perfluorocarbon 
cured elastomers are produced by terpolymerizing tetrafluorethylene (CAS 
Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-
5), and perfluoro-2-phenoxypropyl vinyl ether (CAS Reg. No. 24520-19-2) 
and subsequent curing of the terpolymer (CAS Reg. No. 26658-70-

[[Page 307]]

8) using the crosslinking agent, phenol, 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl) ethylidene] bis-,dipotassium salt (CAS Reg. No. 25088-
69-1) and accelerator, 1,4,7,10,13,16-hexaoxacyclooctadecane (CAS Reg. 
No. 17455-13-9).
    (2) The perfluorocarbon base polymer shall contain no less than 40 
weight-percent of polymer units derived from tetrafluoroethylene, no 
less than 40 weight-percent of polymer units derived from 
perfluoromethyl vinyl ether and no more than 5 weight-percent polymer 
units derived from perfluoro-2-phenoxy-propyl vinyl ether.
    (3) The composition limitations of the cured elastomer, calculated 
as parts per 100 parts of terpolymer, are as follows: Phenol, 4,4'-
[2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene] bis-,dipotassium salt--
not to exceed 5 parts. 1,4,7,10,13,16-Hexaoxacyclo-octadecane--not to 
exceed 5 parts.
    (b) Optional adjuvant substances. The perfluorocarbon cured 
elastomer identified in paragraph (a) of this section may contain the 
following optional adjuvant substances, subject to any limitations cited 
on their use:
    (1) Substances generally recognized as safe (GRAS) in food or food 
packaging.
    (2) Substances used in accordance with a prior sanction.
    (3) Substances authorized under applicable regulations in this part 
and in parts 175 and 178 of this chapter and subject to any limitations 
prescribed therein.
    (4) Substances identified in this paragraph (b)(4) subject to such 
limitations as are provided:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Carbon black (channel process of furnace    Not to exceed 15 parts per  
 combustion process) (CAS Reg. No. 1333-86-  100 parts of the           
 4).                                         terpolymer.                
Magnesium oxide (CAS Reg. No. 1309-48-4)..  Not to exceed 5 parts per   
                                             100 parts of the           
                                             terpolymer.                
------------------------------------------------------------------------

    (c) Specifications--(1) Infrared identification. Perfluorocarbon 
cured elastomers may be identified by the characteristic infrared 
spectra of the pyrolysate breakdown product that is obtained by heating 
and decomposing the elastomer using the method entitled ``Qualitative 
Identification of Kalrez by Infrared Examination of 
Pyrolysate.'' This method is incorporated by reference. Copies of the 
method are available from the Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (2) Thermogravimetry. Perfluorocarbon cured elastomers have a major 
decomposition peak occurring at 490  deg.15  deg.C (914 
deg.F). Less than 1.5 percent of the elastomers will volatilize below 
400  deg.C (752  deg.F) when run under nitrogen at a 10  deg.C or 18 
deg.F per minute heating rate using a Du Pont Thermal Analyzer Model 
1099 with Model 951 TGA unit or the equivalent.
    (d) Extractive limitations. Articles fabricated from perfluorocarbon 
cured elastomers having a thickness of at least 1.0 millimeter (0.039 
inch) when extracted at reflux temperatures for 2 hours separately with 
distilled water, 50 percent ethanol, and n-heptane, shall meet the 
following extractability limits:
    (1) Total extractives not to exceed 3.1 milligrams per square 
decimeter (0.2 milligrams per square inch).
    (2) Fluoride extractives calculated as fluorine not to exceed 0.47 
milligram per square decimeter (0.03 milligram per square inch).
    (e) Conditions of use. In accordance with current good manufacturing 
practice, finished food contact articles containing the perfluorocarbon 
cured elastomers shall be thoroughly cleaned prior to their first use in 
contact with food.

[49 FR 43050, Oct. 26, 1984]



Sec. 177.2410   Phenolic resins in molded articles.

    Phenolic resins identified in this section may be safely used as the 
food-contact surface of molded articles intended for repeated use in 
contact with nonacid food (pH above 5.0), in accordance with the 
following prescribed conditions:
    (a) For the purpose of this section, the phenolic resins are those 
produced when one or more of the phenols listed in paragraph (a)(1) of 
this section are made to react with one or more of the

[[Page 308]]

aldehydes listed in paragraph (a)(2) of this section, with or without 
aniline and/or anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-
s-triazine):
    (1) Phenols:

p-tert-Amylphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Octylphenol.
Phenol.
o- and p-Phenylethylphenol mixture produced when phenol is made to react 
with styrene in the presence of sulfuric acid catalyst.

    (2) Aldehydes:

Acetaldehyde.
Formaldehyde.
Paraldehyde.

    (b) Optional adjuvant substances employed in the production of the 
phenolic resins or added thereto to impart desired technical or physical 
properties include the following:

                                                                        
                                                                        
                                                                        
Asbestos fiber.                                                         
Barium           For use as catalyst.                                   
 hydroxide.                                                             
Calcium          For use as lubricant.                                  
 stearate.                                                              
Carbon black                                                            
 (channel                                                               
 process).                                                              
Diatomaceous                                                            
 earth.                                                                 
Glass fiber....                                                         
Hexamethylenete  For use as curing agent.                               
 tramine.                                                               
Mica...........                                                         
Oxalic acid....  For use as catalyst.                                   
Zinc stearate..  For use as lubricant.                                  
------------------------------------------------------------------------

    (c) The finished food-contact article, when extracted with distilled 
water at reflux temperature for 2 hours, using a volume-to-surface ratio 
of 2 milliliters of distilled water per square inch of surface tested, 
shall meet the following extractives limitations:
    (1) Total extractives not to exceed 0.15 milligram per square inch 
of food-contact surface.
    (2) Extracted phenol not to exceed 0.005 milligram per square inch 
of food-contact surface.
    (3) No extracted aniline when tested by a spectrophotometric method 
sensitive to 0.006 milligram of aniline per-square inch of food-contact 
surface.
    (d) In accordance with good manufacturing practice, finished molded 
articles containing the phenolic resins shall be thoroughly cleansed 
prior to their first use in contact with food.



Sec. 177.2420   Polyester resins, cross-linked.

    Cross-linked polyester resins may be safely used as articles or 
components of articles intended for repeated use in contact with food, 
in accordance with the following prescribed conditions:
    (a) The cross-linked polyester resins are produced by the 
condensation of one or more of the acids listed in paragraph (a)(1) of 
this section with one or more of the alcohols or epoxides listed in 
paragraph (a)(2) of this section, followed by copolymerization with one 
or more of the cross-linking agents listed in paragraph (a)(3) of this 
section:
    (1) Acids:

Adipic.
Fatty acids, and dimers thereof, from natural sources.
Fumaric.
Isophthalic.
Maleic.
Methacrylic.
Orthophthalic.
Sebacic.
Terephthalic.
Trimellitic.

    (2) Polyols and polyepoxides:

Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
4,4' - Isopropylidenediphenol - epichlorohydrin.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Polyoxypropylene ethers of 4,4'-isopropylide-nediphenol (containing an 
average of 2-7.5 moles of propylene oxide).
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
2,2,4-Trimethyl-1,3-pentanediol.

    (3) Cross-linking agents:

Butyl acrylate.
Butyl methacrylate.
Ethyl acrylate.
Ethylhexyl acrylate.
Methyl acrylate.
Methyl methacrylate.
Styrene.
Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in 
coatings contacting bulk quantities of dry food of the type identified 
in Sec. 176.170(c) of this chapter, Table 1, under type VIII.

[[Page 309]]

Vinyl toluene.

    (b) Optional adjuvant substances employed to facilitate the 
production of the resins or added thereto to impart desired technical or 
physical properties include the following, provided that the quantity 
used does not exceed that reasonably required to accomplish the intended 
physical or technical effect and does not exceed any limitations 
prescribed in this section:

------------------------------------------------------------------------
                                         Limitations (limits of addition
           List of substances             expressed as percent by weight
                                                of finished resin)      
------------------------------------------------------------------------
1. Inhibitors:                           Total not to exceed 0.08       
                                          percent.                      
  Benzoquinone.........................  0.01 percent.                  
  tert-Butyl catechol..................                                 
  TBHQ.................................                                 
  Di-tert-butyl hydroquinone...........                                 
  Hydroquinone.........................                                 
2. Accelerators:                         Total not to exceed 1.5        
                                          percent.                      
  Benzyl trimethyl ammonium chloride...  0.05 percent.                  
  Calcium naphthenate..................                                 
  Cobalt naphthenate...................                                 
  Copper naphthenate...................                                 
  N, N-Diethylaniline..................  0.4 percent.                   
  N, N-Dimethylaniline.................      Do.                        
  Ethylene guanidine hydrochloride.....  0.05 percent.                  
3. Catalysts:                            Total not to exceed 1.5        
                                          percent, except that methyl   
                                          ethyl ketone peroxide may be  
                                          used as the sole catalyst at  
                                          levels not to exceed 2        
                                          percent.                      
  Azo-bis-isobutyronitrile.............                                 
  Benzoyl peroxide.....................                                 
  tert-Butyl perbenzoate...............                                 
  Chlorbenzoyl peroxide................                                 
  Cumene hydroperoxide.................                                 
  Dibutyltin oxide (CAS Reg. No. 818-08- For use in the polycondensation
   6).                                    reaction at levels not to     
                                          exceed 0.2 percent of the     
                                          polyester resin.              
                                                                        
  Dicumyl peroxide.....................                                 
  Hydroxybutyltin oxide (CAS Reg. No.    For use in the polycondensation
   2273-43-0).                            reaction at levels not to     
                                          exceed 0.2 percent of the     
                                          polyester resin.              
                                                                        
  Lauroyl peroxide.....................                                 
  p-Menthane hydroperoxide.............                                 
  Methyl ethyl ketone peroxide.........                                 
  Monobutyltin tris(2-ethylhexoate)      For use in the polycondensation
   (CAS Reg. No. 23850-94-4).             reaction at levels not to     
                                          exceed 0.2 percent of the     
                                          polyester resin.              
                                                                        
4. Solvents for inhibitors,                                             
 accelerators, and catalysts:                                           
  Butyl benzyl phthalate (containing                                    
   not more than 1.0 percent by weight                                  
   of dibenzyl phthalate).                                              
  Dibutyl phthalate....................                                 
  Diethylene glycol....................  As a solvent for benzyl        
                                          trimethyl ammonium chloride or
                                          ethylene guanidine            
                                          hydrochloride only.           
  Dimethyl phthalate...................                                 
  Methyl alcohol.......................                                 
  Styrene..............................                                 
  Triphenyl phosphate..................                                 
5. Reinforcements:                                                      
  Asbestos.............................                                 
  Glass fiber..........................                                 
  Polyester fiber produced by the                                       
   condensation of one or more of the                                   
   acids listed in paragraph (a)(1) of                                  
   this section with one or more of the                                 
   alcohols listed in paragraph (a)(2)                                  
   of this section.                                                     
6. Miscellaneous materials:                                             
  Castor oil, hydrogenated.............                                 
  -Methylstyrene..............                                 
  Polyethylene glycol 6000.............                                 
  Silicon dioxide......................                                 
  Wax, petroleum.......................  Complying with Sec.  178.3710  
                                          of this chapter.              
------------------------------------------------------------------------

    (c) The cross-linked polyester resins, with or without the optional 
substances described in paragraph (b) of this section, and in the 
finished form in which they are to contact food, when extracted with the 
solvent or solvents characterizing the type of food and

[[Page 310]]

under the conditions of time and temperature characterizing the 
conditions of their intended use, as determined from Tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall meet the following extractives 
limitations:
    (1) Net chloroform-soluble extractives not to exceed 0.1 milligram 
per square inch of food-contact surface tested when the prescribed food-
simulating solvent is water or 8 or 50 percent alcohol.
    (2) Total nonvolatile extractives not to exceed 0.1 milligram per 
square inch of food-contact surface tested when the prescribed food-
simulating solvent is heptane.
    (d) In accordance with good manufacturing practice, finished 
articles containing the cross-linked polyester resins shall be 
thoroughly cleansed prior to their first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 
54 FR 48858, Nov. 28, 1989]



Sec. 177.2430   Polyether resins, chlorinated.

    Chlorinated polyether resins may be safely used as articles or 
components of articles intended for repeated use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The chlorinated polyether resins are produced by the catalytic 
polymerization of 3,3-bis(chloromethyl)-oxetane, and shall contain not 
more than 2 percent residual monomer.
    (b) In accordance with good manufacturing practice, finished 
articles containing the chlorinated polyether resins shall be thoroughly 
cleansed prior to their first use in contact with food.



Sec. 177.2440  Polyethersulfone resins.

    Polyethersulfone resins identified in paragraph (a) of this section 
may be safely used as articles or components of articles intended for 
repeated use in contact with food in accordance with the following 
prescribed conditions:
    (a) For the purpose of this section, polyethersulfone resins are:
    (1) Poly(oxy-p-phenylenesulfonyl-p-phenylene) resins (CAS Reg. No. 
25667-42-9), which have a minimum number average molecular weight of 
16,000.
    (2) 1,1'-sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (maximum 8 percent) and 4,4'-
sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0), 
which have a minimum number average molecular weight of 26,000.
    (3) In paragraphs (a)(1) and (a)(2) of this section, the minimum 
number average molecular weight is determined by reduced viscosity in 
dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved 
1977), ``Standard Test Method for Dilute Solution Viscosity of 
Polymers,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Division of Petition 
Control (HFS-215), Center for Food Safety and Applied Nutrition, 1110 
Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (b) The basic resins identified in paragraphs (a)(1) and (a)(2) of 
this section may contain optional adjuvant substances described in 
Sec. 174.5(d) of this chapter and the following:


                                                                        
------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Diphenylsulfone...........................  Not to exceed 0.2 percent as
                                             residual solvent in the    
                                             finished basic resin       
                                             described in paragraph     
                                             (a)(1) of this section.    
Dimethyl sulfoxide........................   Not to exceed 0.01 percent 
                                             as residual solvent in the 
                                             finished basic resin       
                                             described in paragraph     
                                             (a)(1) of this section.    
N-methyl-2-pyrrolidone....................  Not to exceed 0.01 percent  
                                             as residual solvent in the 
                                             finished basic resin       
                                             described in paragraph     
                                             (a)(2) of this section.    
------------------------------------------------------------------------

    (c) The finished food-contact article, when extracted at reflux 
temperatures for 2 hours with the following four solvents, yields net 
chloroform-soluble extractives in each extracting solvent not to exceed 
0.02 milligram per square inch of food-contact surface: distilled water, 
50 percent (by volume) ethyl alcohol in distilled water, 3 percent 
acetic acid in distilled water, and n-heptane. (Note: In testing the 
finished food-contact article, use a separate

[[Page 311]]

test sample for each required extracting solvent.)
    (d) In accordance with good manufacturing practice, finished food-
contact articles containing the polyethersulfone resins shall be 
thoroughly cleansed before their first use in contact with food.

[44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 
49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, 
Sept. 20, 1995]



Sec. 177.2450   Polyamide-imide resins.

    Polyamide-imide resins identified in paragraph (a) of this section 
may be safely used as components of articles intended for repeated use 
in contact with food, in accordance with the following prescribed 
conditions:
    (a) Identity. (1) For the purpose of this section the polyamide-
imide resins are derived from the condensation reaction of substantially 
equimolar parts of trimellitic anhydride and p,p'-diphenylmethane 
diisocyanate.
    (2) The polyamide-imide resins (CAS Reg. No. 31957-38-7) derived 
from the condensation reaction of equimolar parts of benzoyl chloride-
3,4-dicarboxylic anhydride and 4,4'-diphenylmethanediamine.
    (b) Specifications. (1) Polyamide-imide resins identified in 
paragraph (a)(1) of this section shall have a nitrogen content of not 
less than 7.8 weight percent and not more than 8.2 weight percent. 
Polyamide-imide resins identified in paragraph (a)(2) of this section 
shall have a nitrogen content of not less than 7.5 weight percent and 
not more than 7.8 weight percent. Nitrogen content is determined by the 
Dumas Nitrogen Determination as set forth in the ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 13th Ed. 
(1980), sections 7.016-7.020, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies may be obtained from the 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (2) Polyamide-imide resins identified in paragraph (a)(1) of this 
section shall have a solution viscosity of not less than 1.200. 
Polyamide-imide resins identified in paragraph (a)(2) of this section 
shall have a solution viscosity of not less than 1.190. Solution 
viscosity shall be determined by a method titled ``Solution Viscosity'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a). 
Copies are available from the Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (3) The polyamide-imide resins identified in paragraph (a)(1) of 
this section are heat cured at 600  deg.F for 15 minutes when prepared 
for extraction tests and the residual monomers: p,p-diphenylmethane 
diisocyanate should not be present at greater than 100 parts per million 
and trimellitic anhydride should not be present at greater than 500 
parts per million. Residual monomers are determined by gas 
chromatography (the gas chromatography method titled ``Amide-Imide 
Polymer Analysis--Analysis of Monomer Content,'' is incorporated by 
reference in accordance with 5 U.S.C. 552(a). Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC).
    (c) Extractive limitations are applicable to the polyamide-imide 
resins identified in paragraphs (a) (1) and (2) of this section in the 
form of films of 1 mil uniform thickness after coating and heat curing 
at 600  deg.F for 15 minutes on stainless steel plates, each having such 
resin-coated surface area of 100 square inches. The cured-resin film 
coatings shall be extracted in accordance with the method described in 
Sec. 176.170(d)(3) of this chapter, using a plurality of spaced, coated 
stainless steel plates, exposed to the respective food simulating 
solvents. The resin shall meet the following extractive limitations 
under the corresponding extraction conditions:

[[Page 312]]

    (1) Distilled water at 250 deg. F for 2 hours: Not to exceed 0.01 
milligram per square inch.
    (2) Three percent acetic acid at 212 deg. F for 2 hours: Not to 
exceed 0.05 milligram per square inch.
    (3) Fifty percent ethyl alcohol at 160 deg. F for 2 hours: Not to 
exceed 0.03 milligram per square inch.
    (4) n-Heptane at 150 deg. F for 2 hours: Not to exceed 0.05 
milligram per square inch.
    (d) In accordance with good manufacturing practice, those food 
contact articles, having as components the polyamide-imide resins 
identified in paragraph (a) of this section and intended for repeated 
use shall be thoroughly cleansed prior to their first use in contact 
with food.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11845, Mar. 19, 1982; 
49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, 
Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996]



Sec. 177.2460   Poly(2,6-dimethyl-1,4-phenylene) oxide resins.

    The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in 
paragraph (a) of this section may be used as an article or as a 
component of an article intended for use in contact with food subject to 
the provisions of this section.
    (a) Identity. For the purposes of this section, poly(2,6-dimethyl-
1,4-phenylene) oxide resins consist of basic resins produced by the 
oxidative coupling of 2,6-xylenol such that the finished basic resins 
meet the specifications and extractives limitations prescribed in 
paragraph (c) of this section.
    (b) Optional adjuvant substances. The basic poly(2,6-dimethyl-1,4-
phenylene) oxide resins identified in paragraph (a) of this section may 
contain optional adjuvant substances required in the production of such 
basic resins. The optional adjuvant substances required in the 
production of the basic poly(2,6-dimethyl-1,4-phenylene) oxide resins 
may include substances permitted for such use by regulations in parts 
170 through 189 of this chapter, substances generally recognized as safe 
in food, substances used in accordance with a prior sanction or 
approval, and the following:

------------------------------------------------------------------------
                                            Limitations (expressed as   
           List of substances             percent by weight of finished 
                                                   basic resin)         
------------------------------------------------------------------------
Diethylamine...........................  Not to exceed 0.16 percent as  
                                          residual catalyst.            
Methyl alcohol.........................  Not to exceed 0.02 percent as  
                                          residual solvent.             
Toluene................................  Not to exceed 0.2 percent as   
                                          residual solvent.             
------------------------------------------------------------------------

    (c) Specifications and extractives limitations. The poly(2,6-
dimethyl-1,4-phenylene) oxide basic resins meet the following:
    (1) Specifications. Intrinsic viscosity is not less then 0.40 
deciliter per gram as determined by ASTM method D1243-79, ``Standard 
Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,'' 
which is incorporated by reference, modified as follows. Copies of the 
incorporation by reference may be obtained from the American Society for 
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (i) Solvent: Chloroform, reagent grade containing 0.01 percent tert-
butylcatechol.
    (ii) Resin sample: Powdered resin obtained from production prior to 
molding or extrusion.
    (iii) Viscometer: Cannno-Ubbelohde series 25 dilution viscometer (or 
equivalent).
    (iv) Calculation: The calculation method used is that described in 
Appendix X.1.3 (ASTM method D1243-79, cited and incorporated by 
reference in paragraph (c)(1) of this section) with the reduced 
viscosity determined for three concentration levels (0.4, 0.2, and 0.1 
gram per deciliter) and extrapolated to zero concentration for 
intrinisic viscosity. The following formula is used for determining 
reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.406

Where:

[[Page 313]]

t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.

    (2) Extractives limitations. Total resin extracted not to exceed 
0.02 weight-percent when extracted with n-heptane at 160 deg.F for 2 
hours as determined using 200 milliliters of reagent grade n-heptane 
which has been freshly distilled before use and 25 grams of poly (2,-6-
dimethyl-1,4-phenylene) oxide resin. The resin as tested is in pellet 
form having a particle size such that 100 percent of the pellets will 
pass through a U.S. Standard Sieve No. 6 and 100 percent of the pellets 
will be held on a U.S. Standard Sieve No. 10.
    (d) Other limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide 
resins identified in and complying with this section, when used as 
components of the food-contact surface of any article that is the 
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 
of this chapter, shall comply with any specifications and limitations 
prescribed by such regulation for the article in the finished form in 
which it is to contact food.
    (e) Uses. The poly(2,6-dimethyl-1,4-phenylene) oxide resins 
identified in and complying with the limitations in this section may be 
used as articles or components of articles intended for repeated food-
contact use or as articles or components of articles intended for 
single-service food-contact use only under the conditions described in 
Sec. 176.170(c) of this chapter, Table 2, conditions of use H.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984]



Sec. 177.2465  Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers.

    Polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate 
copolymers (CAS Reg. No. 26936-30-1) may be safely used as components of 
surface primers used in conjunction with silicone polymers intended for 
repeated use and complying with Sec. 175.300 of this chapter and 
Sec. 177.2600, in accordance with the following prescribed conditions.
    (a) Identity. For the purpose of this section, 
polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate 
copolymers are produced by the polymerization of methylmethacrylate and 
trimethoxysilylpropylmethacrylate.
    (b) Conditions of use. (1) The polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymers are used at levels 
not to exceed 6.0 percent by weight of the primer formulation.
    (2) The copolymers may be used in food contact applications with all 
food types under conditions of use B through H as described in Table 2 
of Sec. 176.170(c) of this chapter.

[59 FR 5948, Feb. 9, 1994]



Sec. 177.2470   Polyoxymethylene copolymer.

    Polyoxymethylene copolymer identified in this section may be safely 
used as an article or component of articles intended for food-contact 
use in accordance with the following prescribed conditions:
    (a) Identity. For the purpose of this section, polyoxymethylene 
copolymers are identified as the following: The reaction product of 
trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg. 
No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of 
formaldehyde) and a maximum of 5 percent by weight of butanediol formal 
(CAS Reg. No. 25214 85-1). Both copolymers may have certain optional 
substances added to impart desired technological properties to the 
copolymer.
    (b) Optional adjuvant substances. The polyoxymethylene copolymer 
identified in paragraph (a) of this section may contain optional 
adjuvant substances required in its production. The quantity of any 
optional adjuvant substance employed in the production of the copolymer 
does not exceed the amount reasonably required to accomplish the 
intended technical or physical effect. Such adjuvants may include 
substances generally recognized as safe in food, substances used in 
accordance with prior sanction, substances permitted under applicable 
regulations in parts 170 through 189 of this chapter, and the following:
    (1) Stabilizers (total amount of stabilizers not to exceed 2.0 
percent and

[[Page 314]]

amount of any one stabilizer not to exceed 1.0 percent of polymer by 
weight)

Calcium ricinoleate.
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) (CAS Reg. 
No. 35074-77-2).
Melamine-formaldehyde resin.
2,2'-Methylenebis(4-methyl-6-tert- butylphenol).
Nylon 6/66, weight ratio 2/3.
Tetrakis [methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] 
methane.

    (2) Lubricant: N,N'Distearoylethyl-enediamine.
    (c) Specifications. (1) Polyoxymethylene copolymer can be identified 
by its characteristic infrared spectrum.
    (2) Minimum number average molecular weight of the copolymer is 
15,000 as determined by a method titled ``Number Average Molecular 
Weight,'' which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (d) Extractive limitations. (1) Polyoxymethylene copolymer in the 
finished form in which it is to contact food, when extracted with the 
solvent or solvents characterizing the type of food and under conditions 
of time and temperature as determined from Tables 1 and 2 of 
Sec. 175.300(d) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of food-contact 
surface.
    (2) Polyoxymethylene copolymer with or without the optional 
substances described in paragraph (b) of this section, when ground or 
cut into particles that pass through a U.S.A. Standard Sieve No. 6 and 
that are retained on a U.S.A. Standard Sieve No. 10, shall yield total 
extractives as follows:
    (i) Not to exceed 0.20 percent by weight of the copolymer when 
extracted for 6 hours with distilled water at reflux temperature.
    (ii) Not to exceed 0.15 percent by weight of the copolymer when 
extracted for 6 hours with n-heptane at reflux temperature.
    (e) Conditions of use. (1) The polyoxymethylene copolymer is for use 
as articles or components of articles intended for repeated use.
    (2) Use temperature shall not exceed 250 deg.F.
    (3) In accordance with good manufacturing practice, finished 
articles containing polyoxymethylene copolymer shall be thoroughly 
cleansed before their first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20, 1983; 
49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, May 
17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR 24898, June 12, 1989]



Sec. 177.2480  Polyoxymethylene homopoly-mer.

    Polyoxymethylene homopolymer identified in this section may be 
safely used as articles or components of articles intended for food-
contact use in accordance with the following prescribed conditions:
    (a) Identity. For the purpose of this section, polyoxymethylene 
homopolymer is polymerized formaldehyde [Chemical Abstracts Service 
Registry No. 9002-81-7]. Certain optional adjuvant substances, described 
in paragraph (b) of this section, may be added to impart desired 
technological properties to the homopolymer.
    (b) Optional adjuvant substances. The polyoxymethylene homopolymer 
identified in paragraph (a) of this section may contain optional 
adjuvant substances in its production. The quantity of any optional 
adjuvant substance employed in the production of the homopolymer does 
not exceed the amount reasonably required to accomplish the intended 
effect. Such adjuvants may include substances generally recognized as 
safe in food, substances used in accordance with prior sanction, 
substances permitted under applicable regulations in this part, and the 
following:
    (1) Stabilizers. The homopolymer may contain one or more of the 
following stabilizers. The total amount of stabilizers shall not exceed 
1.9 percent of homopolymer by weight, and the quantity of individual 
stabilizer used shall not exceed the limitations set forth below:

[[Page 315]]



                                                                        
------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Hexamethylenebis(3,5-di-tert-butyl-4-       At a maximum level of 1     
 hydroxy-hydrocinnamate) (CAS Reg. No.       percent by weight of homo- 
 35074-77-2).                                polymer. The finished      
                                             articles shall not be used 
                                             for foods containing more  
                                             than 8 percent alcohol.    
2,2'-Methylenebis(4-methyl-6-tert-          At a maximum level of 0.5   
 butylphenol).                               percent by weight of       
                                             homopolymer.               
Nylon 66/610/6 terpolymer, respective       At a maximum level of 1.5   
 proportions of nylon polymers by weight     percent by weight of       
 are: 3/2/4.                                 homopolymer.               
Nylon 612/6 copolymer (CAS Reg. No. 51733-      Do.                     
 10-9), weight ratio 6/1.                                               
Tetrakis[methylene(3,5-di-tert-butyl-4-     At a maximum level of 0.5   
 hydroxy-hydrocinnamate)] methane.           percent by weight of       
                                             homopolymer.               
------------------------------------------------------------------------

    (2) Lubricant. N,N'-Distearoylethyl-enediamine.
    (3) Molding assistant. Polyethylene glycol 6,000.
    (c) Specifications. (1) Polyoxymethylene homopolymer can be 
identified by its characteristic infrared spectrum.
    (2) Minimum number average molecular weight of the homopolymer is 
25,000.
    (3) Density of the homopolymer is between 1.39 and 1.44 as 
determined by ASTM method D1505-68 (Reapproved 1979), ``Standard Test 
Method for Density of Plastics by the Density-Gradient Technique,'' 
which is incorporated by reference. Copies may be obtained from the 
American Society for Testing Materials, 1916 Race St., Philadelphia, PA 
19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (4) Melting point is between 172 deg. C and 184 deg. C as determined 
by ASTM method D2133-66, ``Specifications for Acetal Resin Injection 
Molding and Extrusion Materials'' (Revised 1966), which is incorporated 
by reference. Copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (d) Extractive limitations. (1) Polyoxymethylene homopolymer, in the 
finished form which is to contact food, when extracted with the solvent 
or solvents characterizing the type of food and under conditions of time 
and temperature characterizing the conditions of intended use under 
paragraphs (c)(3) and (d) of Sec. 175.300 of this chapter and as limited 
by paragraph (e) of this section, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of food-contact 
surface.
    (2) Polyoxymethylene homopolymer, with or without the optional 
adjuvant substances described in paragraph (b) of this section, when 
ground or cut into particles that pass through a U.S.A. Standard Sieve 
No. 6 and that are retained on a U.S.A. Standard Sieve No. 10, shall 
yield extractives as follows:
    (i) Formaldehyde not to exceed 0.0050 percent by weight of 
homopolymer as determined by a method titled ``Formaldehyde Release and 
Formaldehyde Analysis,'' which is incorporated by reference. Copies are 
available from Center for Food Safety and Applied Nutrition (HFS-200) 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (ii) Total extractives not to exceed 0.20 percent by weight of 
homopolymer when extracted for 6 hours with distilled water at reflux 
temperature and 0.15 percent by weight of homopolymer when extracted for 
6 hours with n-heptane at reflux temperature.
    (e) Conditions of use. (1) Polyoxymethylene homopolymer is for use 
as articles or components of articles intended for repeated use.
    (2) Use temperature shall not exceed 250 deg. F.
    (3) In accordance with good manufacturing practice, finished 
articles containing polyoxymethylene homopolymer shall be thoroughly 
cleansed prior to first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978; 
47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, 
Mar. 19, 1984; 54 FR 24898, June 12, 1989]



Sec. 177.2490   Polyphenylene sulfide resins.

    Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins) 
may

[[Page 316]]

be safely used as coatings or components of coatings of articles 
intended for repeated use in contact with food, in accordance with the 
following prescribed conditions.
    (a) Polyphenylene sulfide resins consist of basic resins produced by 
the reaction of equimolar parts of p-dichlorobenzene and sodium sulfide, 
such that the finished resins meet the following specifications as 
determined by methods titled ``Oxygen Flask Combustion-Gravimetric 
Method for Determination of Sulfur in Organic Compounds,'' 
``Determination of the Inherent Viscosity of Polyphenylene Sulfide,'' 
and ``Analysis for Dichlorobenzene in Ryton Polyphenylene Sulfide,'' 
which are incorporated by reference. Copies are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (1) Sulfur content: 28.2-29.1 percent by weight of finished resin.
    (2) Minimum inherent viscosity: 0.13 deciliters per gram.
    (3) Maximum residual p-dichlorobenzene: 0.8 ppm.
    (b) Subject to any limitations prescribed in parts 170 through 189 
of this chapter, the following optional substances may be added to the 
polyphenylene sulfide basic resins in an amount not to exceed that 
reasonably required to accomplish the intended physical or technical 
effect.
    (1) Substances generally recognized as safe in food.
    (2) Substances used in accordance with prior sanction or approval.
    (3) Substances the use of which is permitted in coatings under 
regulations in parts 170 through 189 of this chapter.
    (c) The finished coatings are thermally cured at temperatures of 
700 deg. F and above.
    (d) Polyphenylene sulfide resin coatings may be used in contact with 
food at temperatures not to exceed the boiling point of water; provided 
that the finished cured coating, when extracted at reflux temperatures 
for 8 hours separately with distilled water, 50 percent ethanol in 
water, and 3 percent acetic acid, yields total extractives in each 
extracting solvent not to exceed 0.02 milligram per square inch of 
surface and when extracted at reflux temperature for 8 hours with 
heptane yields total extractives not to exceed 0.1 milligram per square 
inch of surface.
    (e) Polyphenylene sulfide resin coatings containing perfluorocarbon 
resins complying with Sec. 177.1550 may be used in contact with food at 
temperatures up to and including normal baking and frying temperatures; 
provided that the finished cured coating, when extracted at reflux 
temperatures for 2 hours separately with distilled water, 50 percent 
ethanol in water, 3 percent acetic acid and heptane, yields total 
extractives in each extracting solvent not to exceed 0.2 milligram per 
square inch of surface and when extracted at reflux temperature for 1 
hour with diphenyl ether yields total extractives not to exceed 4.5 
milligrams per square inch of surface.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11846, Mar. 19, 1982; 
54 FR 24898, June 12, 1989]



Sec. 177.2510   Polyvinylidene fluoride resins.

    Polyvinylidene fluoride resins may be safely used as articles or 
components of articles intended for repeated use in contact with food, 
in accordance with the following prescribed conditions:
    (a) For the purpose of this section, the polyvinylidene fluoride 
resins consist of basic resins produced by the polymerization of 
vinylidene fluoride.
    (b) The finished food-contact article, when extracted at reflux 
temperatures for 2 hours with the solvents distilled water, 50 percent 
(by volume) ethyl alcohol in distilled water, and n-heptane, yields 
total extractives in each extracting solvent not to exceed 0.01 
milligram per square inch of food-contact surface tested; and if the 
finished food-contact article is itself the subject of a regulation in 
parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, it shall 
also comply with any specifications and limitations prescribed for it by 
that

[[Page 317]]

regulation. (Note: In testing the finished food-contact article, use a 
separate test sample for each required extracting solvent.)
    (c) In accordance with good manufacturing practice, finished food-
contact articles containing the polyvinylidene fluoride resins shall be 
thoroughly cleansed prior to their first use in contact with food.



Sec. 177.2550  Reverse osmosis membranes.

    Substances identified in paragraph (a) of this section may be safely 
used as reverse osmosis membranes intended for use in processing bulk 
quantities of liquid food to separate permeate from food concentrate or 
in purifying water for food manufacturing under the following prescribed 
conditions:
    (a) Identity. For the purpose of this section, reverse osmosis 
membranes may consist of either of the following formulations:
    (1) A cross-linked high molecular weight polyamide reaction product 
of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS 
Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The membrane 
is on the food-contact surface, and its maximum weight is 62 milligrams 
per square decimeter (4 milligrams per square inch) as a thin film 
composite on a suitable support.
    (2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6), 
identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and 
1,2-dichloroethane, whose surface is the reaction product of this 
copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final 
polymer is 99811-80-0) for use as the food-contact surface of reverse 
osmosis membranes used in processing liquid food. The composite membrane 
is on the food-contact surface and its maximum weight is 4.7 milligrams 
per square decimeter (0.3 milligrams per square inch) as a thin film 
composite on a suitable support. The maximum weight of the 2,4-
toluenediisocyanate component of the thin film composite is 0.47 
milligrams per square decimeter (0.03 milligrams per square inch).
    (3) For the purpose of this section, the reverse osmosis membrane 
consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid, 
calcium salt (2:1) polymer with 1,3-benzenediamine, 1,3-
benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride (CAS 
Reg. No. 39443-76-0). The membrane is the food contact surface and may 
be applied as a film on a suitable support. Its maximum weight is 512 
milligrams per square decimeter (33 milligrams per square inch).
    (4) A cross-linked high molecular weight polyamide reaction product 
of poly(N-vinyl-N-methylamine) (CAS Reg. No. 31245-56-4), N,N'-bis(3-
aminopropyl)ethylenediamine (CAS Reg. No. 10563-26-5), 1,3-
benzenedicarbonyl dichloride (CAS Reg. No. 99-63-8) and 1,3,5-
benzenetricarbonyl trichloride (CAS Reg. No. 4422-95-1). The membrane is 
the food-contact surface. Its maximum weight is 20 milligrams per square 
decimeter (1.3 milligrams per square inch) as a thin film composite on a 
suitable support.
     (5) A polyamide reaction product of 1,3,5-benzenetricarbonyl 
trichloride polymer (CAS Reg. No. 4422-95-1) with piperazine (CAS Reg. 
No. 110-85-0) and 1,2-diaminoethane (CAS Reg. No. 107-15-3). The 
membrane is the food-contact layer and may be applied as a film on a 
suitable support. Its maximum weight is 15 milligrams per square 
decimeter (1 milligram per square inch).
    (b) Optional adjuvant substances. The basic polymer identified in 
paragraph (a) of this section may contain optional adjuvant substances 
required in the production of such basic polymer. These optional 
adjuvant substances may include substances permitted for such use by 
regulations in parts 170 through 186 of this chapter, substances 
generally recognized as safe in food, and substances used in accordance 
with a prior sanction or approval.
    (c) Supports. Suitable supports for reverse osmosis membranes are 
materials permitted for such use by regulations in parts 170 through 186 
of this chapter, substances generally recognized as safe in food, and 
substances used in accordance with a prior sanction or approval.
     (d) Conditions of use--(1) Reverse osmosis membranes described in 
paragraphs (a)(1), (a)(2), (a)(3), and (a)(5) of this section may be 
used in contact

[[Page 318]]

with all types of liquid food at temperatures up to 80  deg.C (176 
deg.F).
    (2) Reverse osmosis membranes described in paragraph (a)(4) of this 
section may be used in contact wit all types of liquid food, except food 
containing more than 8 percent alcohol, at temperatures up to 80  deg.C 
(176  deg.F).
    (3) Reverse osmosis membranes shall be maintained in a sanitary 
manner in accordance with current good manufacturing practice so as to 
prevent microbial adulteration of food.
    (4) To assure their safe use, reverse osmosis membranes and their 
supports shall be thoroughly cleaned prior to their first use in 
accordance with current good manufacturing practice.

[49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11, 1987; 
53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Mar. 
7, 1990; 59 FR 9925, Mar. 2, 1994]



Sec. 177.2600   Rubber articles intended for repeated use.

    Rubber articles intended for repeated use may be safely used in 
producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding food, subject to the provisions of 
this section.
    (a) The rubber articles are prepared from natural and/or synthetic 
polymers and adjuvant substances as described in paragraph (c) of this 
section.
    (b) The quantity of any substance employed in the production of 
rubber articles intended for repeated use shall not exceed the amount 
reasonably required to accomplish the intended effect in the rubber 
article and shall not be intended to accomplish any effect in food.
    (c) Substances employed in the preparation of rubber articles 
include the following, subject to any limitations prescribed:
    (1) Substances generally recognized as safe for use in food or food 
packaging.
    (2) Substances used in accordance with the provisions of a prior 
sanction or approval.
    (3) Substances that by regulation in parts 170 through 189 of this 
chapter may be safely used in rubber articles, subject to the provisions 
of such regulation.
    (4) Substances identified in this paragraph (c)(4), provided that 
any substance that is the subject of a regulation in parts 174, 175, 
176, 177, 178 and Sec. 179.45 of this chapter conforms with any 
specification in such regulation.
    (i) Elastomers.

Acrylonitrile-butadiene copolymer.
Brominated isobutylene-isoprene copolymers complying with Sec. 177.1210.
Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers 
containing not more than 5 weight percent of polymer units derived from 
ethylene glycol dimethacrylate.
Butadiene-acrylonitrile-methacrylic acid copolymer.
Butadiene-styrene-methacrylic acid copolymer.
Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride copolymer.
Ethylene-propylene copolymer elastomers which may contain not more than 
5 weight-percent of total polymer units derived from 5-methylene-2-
norbornene and/or 5-ethylidine-2-norbornene.
Ethylene-propylene-dicyclopentadiene copolymer.
Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 
weight percent of total polymer units derived from 1,4-hexadiene.
Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No. 88254-10-
8) produced when acrylonitrile/butadiene copolymers are modified by 
hydrogenation of the olefinic unsaturation to leave not more than 10 
percent trans olefinic unsaturation and no ,-olefinic 
unsaturation as determined by a method entitled ``Determination of 
Residual ,-Olefinic and Trans Olefinic Unsaturation 
Levels in HNBR,'' developed October 1, 1991, by Polysar Rubber Corp., 
1256 South Vidal St., Sarnia, Ontario, Canada N7T 7MI, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or may be examined at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
Isobutylene-isoprene copolymer.
Polybutadiene.
Polyester elastomers derived from the reaction of dimethyl 
terephthalate, 1,4-butanediol, and -hydro--
hydroxypoly (oxytetramethylene). Additionally, trimethyl trimellitate 
may be used as a reactant. The polyester elastomers may be used only in 
contact with foods containing

[[Page 319]]

not more than 8 percent alcohol and limited to use in contact with food 
at temperatures not exceeding 150  deg.F.
Polyisoprene.
Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from 
the reaction of diphenylmethane diisocyanate with 1,4-butanediol and 
polytetramethylene ether glycol.
Polyurethane resins derived from reactions of diphenylmethane 
diisocyanate with adipic acid and 1,4-butanediol.
Rubber, natural.
Silicone basic polymer as described in ASTM method D1418-81, ``Standard 
Practice for Rubber and Rubber Latices--Nomenclature,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    Silicone (Si) elastomers containing methyl groups.
    Silicone (Psi) elastomers containing methyl and phenyl groups.
    Silicone (Vsi) elastomers containing methyl and vinyl groups.
    Silicone (Fsi) elastomers containing methyl and fluorine groups.
    Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl 
groups.
Styrene-butadiene copolymer.
Vinylidene fluoride-hexafluoropropylene copolymers (minimum number 
average molecular weight 70,000 as determined by osmotic pressure in 
methyl ethyl ketone).
Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymers 
(minimum number average molecular weight 100,000 as determined by 
osmotic pressure in methyl ethyl ketone).

    (ii) Vulcanization materials--(a) Vulcanizing agents.

4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking 
agent in the vulcanization of vinylidene fluoridehexafluoropropylene 
copolymer and vinylidene fluoride-hexafluoropropylene-
tetrafluoroethylene copolymer elastomers identified under paragraph 
(c)(4)(i) of this section and limited to use at levels not to exceed 2.4 
percent by weight of such copolymers.
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use 
as a cross linking agent in the vulcanization of natural rubber, 
styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and 
ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of 
this section and limited to use at levels not to exceed 2.4 percent by 
weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in 
the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer 
and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene 
copolymer elastomers identified under paragraph (c)(4)(i) of this 
section and limited to use at levels not to exceed 1.5 percent by weight 
of such copolymers.
Sulfur, ground.

    (b) Accelerators (total not to exceed 1.5 percent by weight of 
rubber product).

2-Benzothiazyl-N,N-diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert-Butyl-2-benzothiazole sulfenamide.
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N-Cyclohexyl-2-benzothiazole sulfenamide.
Dibenzoyl-p-quinone dioxime.
Dibenzylamine.
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis[benzothiazole].
4,4'-Dithiodimorpholine.
N,N'-Di-o-tolylguanidine.
Di-o-tolylguanidine salt of pyrocatecholborate.
Ethylenediamine carbamate.
Heptaldehyde-aniline resin (iodine number 430-445).
Hexamethylenetetramine.
2-Mercaptobenzothiazole.
2-Mercaptothiazoline.
N-Oxydiethylene-benzothiazole-2-sulfenamide.
Piperidinium pentamethylenedithiocarba-mate.
Potassium pentamethylenedithiocarbamate.
p-Quinone dioxime.

[[Page 320]]

Sodium dibutyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Stannous oleate for use only as an accelerator for silicone elastomers.
Tetrabutylthiuram monosulfide.
Tetraethylthiuram disulfide.
(1,1,4,4-Tetramethyltetramethylene)bis [tert-butyl peroxide].
Tetramethylthiuram monosulfide.
Thiram (tetramethylthiuram disulfide).
Triallyl cyanurate.
Triethylenetetramine.
1,3,5-Triethyl-hexahydro-s-triaxine (triethyltrimethylenetriamine).
Triphenylguanidine.
Zinc butyl xanathate.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc 2-mercaptobenzothiazole.
Ziram (zinc dimethyldithiocarbamate).

    (c) Retarders (total not to exceed 10 percent of weight of rubber 
product). 

Cyanoguanidine.
Phthalic anhydride.
Salicylic acid.

    (d) Activators (total not to exceed 5 percent by weight of rubber 
product except magnesium oxide may be used at higher levels).

Diethylamine.
Fatty acid amines, mixed.
Fatty acids.
Magnesium carbonate.
Magnesium oxide, light and heavy.
Oleic acid, dibutylamine salt (dibutylammonium oleate).
Stannous chloride.
Tall oil fatty acids.
Tetrachloro-p-benzoquinone.
Triethanolamine.
Zinc salts of fatty acids.

    (iii) Antioxidants and antiozonants (total not to exceed 5 percent 
by weight of rubber product).

Aldol-a-naphthylamine.
Alkylated (C4 and/or C8) phenols.
BHT (butylated hydroxytoluene).
4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-butylphenol 
(CAS Reg. No. 991-84-4) for use only as a stabilizer at levels not to 
exceed 0.5 percent by weight of the finished rubber product.
Butylated reaction product of p-cresol and dicyclopentadiene as 
identified in Sec. 178.2010(b) of this chapter.
Butylated, styrenated cresols identified in Sec. 178.2010(b) of this 
chapter.
4,4'-Butylidinebis(6-tert-butyl-m-cresol).
N-Cyclohexyl-N'-phenylphenylenediamine.
p,p'-Diaminodiphenylmethane.
2,5-Di-tert-amylhydroquinone.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or 
xylyl.
2,6-Di-tert-butyl-p-phenylphenol.
1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline.
4,4'-Dimethoxydiphenylamine.
4,6-Dinonyl-o-cresol.
N,N'-Dioctyl-p-phenylenediamine.
Diphenylamine-acetone resin.
Diphenylamine-acetone-formaldehyde resin.
N,N'-Diphenylethylenediamine.
N,N'-Disalicylalpropylenediamine.
N,N'-Di-o-tolylethylenediamine.
Hydroquinone monobenzyl ether.
Isopropoxydiphenylamine.
N-Isopropyl-N'-phenyl-p-phenylenediamine.
2,2'-Methylenebis(6-tert-butyl-4-ethylphenol).
2,2'-Methylenebis(4-methyl-6-tert- butylphenol).
2,2'-Methylenebis(4-methyl-6-nonylphenol).
2,2'-Methylenebis(4-methyl-6-tert- octylphenol).
Monooctyl- and dioctyldiphenylamine.
N,N'-Di--naphthyl-p-phenylenediamine.
Phenyl-a-naphthylamine.
Phenyl--naphthylamine.
Phenyl--naphthylamine-acetone aromatic amine resin (average 
molecular weight 600; nitrogen content 5.3 percent).
o- and p-Phenylphenol.
Polybutylated (mixture) 4,4'-isopropylidenediphenol.
Sodium pentachlorophenate.
Styrenated cresols produced when 2 moles of styrene are made to react 
with 1 mole of a mixture of phenol and o-, m-, and p- cresols so that 
the final product has a Brookfield viscosity at 25 deg. C of 1400 to 
1700 centipoises.
Styrenated phenol.
4,4'-Thiobis (6-tert-butyl-m-cresol).
Toluene-2,4-diamine.
N-o-Tolyl-N'-phenyl-p-phenylenediamine.
p(p-Tolylsufanilamide) diphenylamine.
Tri(mixed mono- and dinonylphenyl) phosphite.
Tri(nonylphenyl) phosphite-formaldehyde resins produced when 1 mole of 
tri(nonylphenyl) phosphite is made to react with 1.4 moles of 
formaldehyde or produced when 1 mole of nonylphenol is made to react 
with 0.36 mole of formaldehyde and the reaction product is then further 
reacted with 0.33 mole of phosphorus trichloride. The finished resins 
have a minimum viscosity of 20,000 centipoises at 25 deg. C, as 
determined by LV-series Brookfield viscometer (or equivalent) using a 
No. 4 spindle at 12 r.p.m., and have an organic phosphorus content of 
4.05 to 4.15 percent by weight.


[[Page 321]]


    (iv) Plasticizers (total not to exceed 30 percent by weight of 
rubber product unless otherwise specified).

n-Amyl n-decyl phthalate.
Butylacetyl ricinoleate.
n-Butyl ester of tall oil fatty acids.
Butyl laurate.
Butyl oleate.
Butyl stearate.
Calcium stearate.
Castor oil.
Coumarone-indene resins.
2,2'-Dibenzamidodiphenyl disulfide.
Dibenzyl adipate.
Dibutoxyethoxyethyl adipate.
Dibutyl phthalate.
Dibutyl sebacate.
Didecyl adipate.
Didecyl phthalate.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisooctyl adipate.
Diisooctyl sebacate.
Dioctyl adipate.
Dioctyl phthalate.
Dioctyl sebacate.
Dipentene resin.
Diphenyl ketone.
Fatty acids.
Fatty acids, hydrogenated.
Isooctyl ester of tall oil fatty acids.
Lanolin.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a-
methylstyrene to 3 vinyltoluene).
Mineral oil; (1) In rubber articles complying with this section, not to 
exceed 30 percent by weight; (2) Alone or in combination with waxes, 
petroleum, total not to exceed 45 percent by weight of rubber articles 
that contain at least 20 percent by weight of ethylene-propylene 
copolymer elastomer complying with paragraph (c)(4)(i) of this section, 
in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX 
idenified in Table 1 of Sec. 176.170(c) of this chapter.
Montan wax.
n-Octyl n-decyl adipate.
n-Octyl n-decyl phthalate.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the homo- and copolymerization 
of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid 
arylalkene types from distillates of cracked petroleum stocks).
Petroleum hydrocarbon resin (produced by the catalytic polymerization 
and subsequent hydrogenation of styrene, vinyltoluene, and indene types 
from distillates of cracked petroleum stocks).
Petroleum oil, sulfonated.
Phenol-formaldehyde resin.
Pine tar.
Polybutene.
Polystyrene.
Propylene glycol.
n-Propyl ester of tall oil fatty acids.
Rapeseed oil vulcanized with rubber maker's sulfur.
Rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this 
chapter.
Soybean oil vulcanized with rubber maker's sulfur.
Styrene-acrylonitrile copolymer.
Terpene resins.
Triethylene glycol dicaprate.
Triethylene glycol dicaprylate.
Waxes, petroleum.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zinc 2-benzamidothiophenate.

    (v) Fillers.

Aluminum hydroxide.
Aluminum silicate.
Asbestos fiber, chrysotile or crocidolite.
Barium sulfate.
Carbon black (channel process or furnace combustion process; total 
carbon black not to exceed 50 percent by weight of rubber product; 
furnace combustion black content not to exceed 10 percent by weight of 
rubber products intended for use in contact with milk or edible oils).
Cork.
Cotton (floc, fibers, fabric).
Mica.
Nylon (floc, fibers, fabric).
Silica.
Titanium dioxide.
Zinc carbonate.
Zinc sulfide.

    (vi) Colorants. Colorants used in accordance with Sec. 178.3297 of 
this chapter.
    (vii) Lubricants (total not to exceed 2 percent by weight of rubber 
product).

Polyethylene.
Sodium stearate.

    (viii) Emulsifiers.

Fatty acid salts, sodium or potassium.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
Rosins and rosin-derivatives identified in Sec. 175.105(c)(5) of this 
chapter.
Sodium decylbenzenesulfonate
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
Tall oil mixed soap (calcium, potassium, and sodium).

    (ix) Miscellaneous (total not to exceed 5 percent by weight of 
rubber product).

Animal glue as described in Sec. 178.3120 of this chapter.
Azodicarbonamide as chemical blowing agent.
2-Anthraquinone sulfonic acid sodium salt for use only as polymerization 
inhibitor in

[[Page 322]]

chloroprene polymers and not to exceed 0.03 percent by weight of the 
chloroprene polymers.
n-Butyllithium for use only as polymerization catalyst for 
polybutadiene.
4-tert-Butyl-o-thiocresol as peptizing agent.
tert-Butyl peracetate.
p-tert-Butylpyrocatechol.
Dialkyl (C8-C18) dimethylammonium chloride for use only as a 
flocculating agent in the manufacture of silica.
Di- and triethanolamine.
Diethyl xanthogen disulfide.
4-(Diiodomethylsulfonyl) toluene, Chemical Abstracts Service Registry 
No. 20018-09-01, for use as an antifungal preservative at levels not to 
exceed 0.3 percent by weight of the sealants and caulking materials.
Dodecyl mercaptan isomers, single or mixed.
2-Ethoxyethanol.
Iodoform.
p-Menthane hydroperoxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen 
phosphate and monohydrogen phosphate esters, barium salt; the nonyl 
group is a propylene trimer isomer and the poly (oxyethylene) content 
averages 9 moles; for use only as residual polymerization emulsifier at 
levels not to exceed 0.7 percent by weight of ethylene-propylene-1,4-
hexadiene copolymers identified under paragraph (c)(4)(i) of this 
section.
4,4'-Oxybis (benzenesulfonhydrazide) as chemical blowing agent.
Phenothiazine.
Potassium persulfate.
Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
Sodium nitrite.
Sodium salt of ethylenediamine tetraacetic acid and glycine.
Sodium sulfide.
Styrene monomer.
Tall oil.
Thioxylenois as peptizing agents.
Tridecyl mercaptan.
Zinc 4-tert-butylthiophenate as peptizing agent.

    (d) Rubber articles intended for use with dry food are so formulated 
and cured under conditions of good manufacturing practice as to be 
suitable for repeated use.
    (e) Rubber articles intended for repeated use in contact with 
aqueous food shall meet the following specifications: The food-contact 
surface of the rubber article in the finished form in which it is to 
contact food, when extracted with distilled water at reflux temperature, 
shall yield total extractives not to exceed 20 milligrams per square 
inch during the first 7 hours of extraction, nor to exceed 1 milligram 
per square inch during the succeeding 2 hours of extraction.
    (f) Rubber articles intended for repeated use in contact with fatty 
foods shall meet the following specifications: The food-contact surface 
of the rubber article in the finished form in which it is to contact 
food, when extracted with n-hexane at reflux temperature, shall yield 
total extractives not to exceed 175 milligrams per square inch during 
the first 7 hours of extraction, nor to exceed 4 milligrams per square 
inch during the succeeding 2 hours of extraction.
    (g) In accordance with good manufacturing practice finished rubber 
articles intended for repeated use in contact with food shall be 
thoroughly cleansed prior to their first use in contact with food.
    (h) The provisions of this section are not applicable to rubber 
nursing-bottle nipples.
    (i) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 16972, Apr. 21, 1978; 
44 FR 52189, Sept. 7, 1979; 45 FR 67321, Oct. 10, 1980; 46 FR 46796, 
Sept. 22, 1981; 49 FR 4073, Feb. 2, 1984; 49 FR 10111, Mar. 19, 1984; 52 
FR 35910, Sept. 24, 1987; 54 FR 35638, Aug. 29, 1989; 54 FR 38969, Sept. 
22, 1989; 55 FR 34555, Aug. 23, 1990; 56 FR 42933, Aug. 30, 1991; 57 FR 
3128, Jan. 28, 1992; 58 FR 60554, Nov. 17, 1993; 59 FR 46171, Sept. 7, 
1994; 60 FR 39648, Aug. 3, 1995; 61 FR 14246, Apr. 1, 1996]



Sec. 177.2710   Styrene-divinylbenzene resins, cross-linked.

    Styrene-divinylbenzene cross-linked copolymer resins may be safely 
used as articles or components of articles intended for repeated use in 
producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding food, in accordance with the 
following prescribed conditions:
    (a) The resins are produced by the copolymerization of styrene with 
divinylbenzene.
    (b) The resins meet the extractives limitations prescribed in this 
paragraph:
    (1) The resins to be tested are ground or cut into small particles 
that will pass through a U.S. standard sieve No.

[[Page 323]]

3 and that will be held on a U.S. standard sieve No. 20.
    (2) A 100-gram sample of the resins, when extracted with 100 
milliliters of ethyl acetate at reflux temperature for 1 hour, yields 
total extractives not to exceed 1 percent by weight of the resins.
    (c) In accordance with good manufacturing practice, finished 
articles containing the resins shall be thoroughly cleansed prior to 
their first use in contact with food.



Sec. 177.2800   Textiles and textile fibers.

    Textiles and textile fibers may safely be used as articles or 
components of articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food, subject to the provisions of this section.
    (a) The textiles and textile fibers are prepared from one or more of 
the fibers identified in paragraph (d) of this section and from certain 
other adjuvant substances required in the production of the textiles or 
textile fibers or added to impart desired properties.
    (b) The quantity of any adjuvant substance employed in the 
production of textiles or textile fibers does not exceed the amount 
reasonably required to accomplish the intended physical or technical 
effect or any limitation further provided.
    (c) Any substance employed in the production of textiles or textile 
fibers that is the subject of a regulation in parts 174, 175, 176, 177, 
178 and Sec. 179.45 of this chapter conforms with any specification in 
such regulation.
    (d) Substances employed in the production of or added to textiles 
and textile fibers may include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for use in 
textiles and textile fibers and used in accordance with such sanction or 
approval.
    (3) Substances generally recognized as safe for use in cotton and 
cotton fabrics used in dry-food packaging.
    (4) Substances that by regulation in this part may safely be used in 
the production of or as a component of textiles or textile fibers and 
subject to provisions of such regulation.
    (5) Substances identified in this paragraph (d)(5), subject to such 
limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
(i) Fibers:                                                             
  Cotton...............................                                 
  Polyethylene terephthalate complying   For use only in the manufacture
   in composition with the provisions     of items for repeated use.    
   of Sec.  177.1630(e)(4)(ii)..                                        
  Rayon................................                                 
(ii) Adjuvant substances:                                               
  Aluminum stearate....................                                 
  Borax................................  For use as preservative only.  
Butyl-acetyl ricinoleate...............                                 
Colorants used in accordance with Sec.                                  
 178.3297 of this chapter..                                             
Di-tert-butyl hydroquinone.............                                 
Dimethylpolysiloxane...................                                 
Ethylenediaminetetraacetic acid, sodium                                 
 salt.                                                                  
4-Ethyl-4-hexadecyl morpholinium ethyl   For use only as a lubricant in 
 sulfate.                                 the manufacture of            
                                          polyethylene terephthalate    
                                          fibers specified in paragraph 
                                          (d)(5)(i) of this section at a
                                          level not to exceed 0.03      
                                          percent by weight of the      
                                          finished fibers.              
Eugenol................................                                 
Fats, oils, fatty acids, and fatty                                      
 alcohols derived from castor, coconut,                                 
 cottonseed, fish, mustardseed, palm,                                   
 peanut, rapeseed, ricebran, soybean,                                   
 sperm, and tall oils and tallow.                                       
Fats, oils, fatty acids, and fatty                                      
 alcohols described in the preceding                                    
 item reacted with one or more of the                                   
 following substances:                                                  
  n-Butyl and isobutyl alcohol.........                                 
  Diethylene glycol....................                                 
  Diethanolamine.......................                                 
  Glycerol.............................                                 
  Hexylene glycol (2-methyl-2,4-                                        
   pentanediol).                                                        
  Hydrogen.............................                                 
  Isopropyl alcohol....................                                 
  Methyl alcohol.......................                                 
  Oxygen...............................                                 

[[Page 324]]

                                                                        
  Polyethylene glycol (molecular weight                                 
   400-3,000).                                                          
  Potassium hydroxide..................                                 
  Propylene glycol.....................                                 
  Sodium hydroxide.....................                                 
  Sulfuric acid........................                                 
Formaldehyde...........................  For use as preservative only.  
Glyceryl mono-12-hydroxystearate.......                                 
2-(9-Heptadecenyl)-1-[2-(10-                                            
 octadecenamido)ethyl-2-imidazolinium                                   
 ethyl sulfate.                                                         
Hexylene glycol (2-methyl,-2,4-                                         
 pentanediol).                                                          
Isobutyl alcohol.......................                                 
Isopropyl alcohol......................                                 
Kerosene...............................                                 
Methyl ester of sulfated ricebran oil..                                 
Mineral oil............................  For use only at a level not to 
                                          exceed 0.15 percent by weight 
                                          of finished fibers.           
Mono- and diisopropylated m- and p-                                     
 cresols (isothymol derivative).                                        
N-Oleyl, N'-acetyl, N'--                                       
 hydroxy-ethylenediamine.                                               
Petrolatum.............................                                 
Petroleum sulfonate....................                                 
Pine oil...............................                                 
Polybutene, hydrogenated; complying                                     
 with the identity prescribed under 21                                  
 CFR 178.3740(b) of this chapter.                                       
Polyethylene, oxidized (air blown).....                                 
Polyvinyl acetate......................                                 
Polyvinyl alcohol......................                                 
Potassium soap of a saponified sulfated                                 
 castor oil.                                                            
Sodium bis(2,6-dimethylheptyl-4)                                        
 sulfosuccinate.                                                        
Sodium dioctyl sulfosuccinate..........                                 
Sodium dodecyl benzenesulfonate........                                 
Sodium fluoride........................  For use as preservative only.  
Sodium hydrosulfite....................                                 
Sodium hypochlorite....................                                 
Sodium lauryl sulfate..................                                 
Sodium 2-mercaptobenzothiazole.........      Do.                        
Sodium pentachlorophenate..............      Do.                        
Styrene-butadiene copolymer............                                 
Sulfated butyl, isobutyl and propyl                                     
 oleate.                                                                
Tallow.................................                                 
Tallow, sulfonated.....................                                 
Titanium dioxide.......................                                 
Triethanolamine........................                                 
Ultramarine blue.......................                                 
Waxes, petroleum.......................                                 
Zinc hydrosulfite......................                                 
------------------------------------------------------------------------

    (e) Textile and textile fibers are used as articles or components of 
articles that contact dry food only.
    (f) The provisions of this section are not applicable to jute fibers 
used as prescribed by Sec. 178.3620(d)(2) of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981; 
49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 
30, 1991]



Sec. 177.2910  Ultra-filtration membranes.

    Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), 
(a)(3), and (a)(4) of this section may be safely used in the processing 
of food, under the following prescribed conditions;
    (a)(1) Ultra-filtration membranes that consist of paper impregnated 
with cured phenol-formaldehyde resin, which is used as a support and is 
coated with a vinyl chloride-acrylonitrile copolymer.
    (2) Ultra-filtration membranes that consist of a sintered carbon 
support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) 
containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9).
    (3) Ultra-filtration membranes that consist of an aluminum oxide 
support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) 
containing up to 5 percent yttrium oxide (CAS Reg. No. 1314-36-9).

[[Page 325]]

    (4) Ultrafiltration membranes that consist of a microporous 
poly(vinylidene fluoride) membrane with a hydrophilic surface modifier 
consisting of hydroxypropyl acrylate/tetraethylene glycol diacrylate 
copolymer.
    (b) Any substance employed in the production of ultra-filtration 
membranes that is the subject of a regulation in parts 174, 175, 176, 
177, 178 and Sec. 179.45 of this chapter conforms with the 
specifications of such regulation.
    (c) Ultra-filtration membranes are used in the physical separation 
of dissolved or colloidally suspended varying molecular size components 
of liquids during the commercial processing of bulk quantities of food.
    (d) Ultra-filtration membranes shall be maintained in a sanitary 
manner in accordance with good manufacturing practice so as to prevent 
potential microbial adulteration of the food.
    (e) Ultrafiltration membranes identified in paragraph (a)(4) may be 
used to filter aqueous or acidic foods containing up to 13 percent of 
alcohol at temperatures not to exceed 21 deg.C (70 deg.F).
    (f) To assure safe use of the ultra-filtration membranes, the label 
or labeling shall include adequate directions for a pre-use treatment, 
consisting of conditioning and washing with a minimum of 8 gallons of 
potable water prior to their first use in contact with food.
    (g) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 53 FR 17925, May 19, 1988; 58 
FR 48599, Sept. 17, 1993; 60 FR 54426, Oct. 24, 1995]



PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents




                          Subpart A--[Reserved]

 Subpart B--Substances Utilized To Control the Growth of Microorganisms

Sec.
178.1005  Hydrogen peroxide solution.
178.1010  Sanitizing solutions.

                 Subpart C--Antioxidants and Stabilizers

178.2010  Antioxidants and/or stabilizers for polymers.
178.2550  4-Hydroxymethyl-2,6-di-tert- butylphenol.
178.2650  Organotin stabilizers in vinyl chloride plastics.

            Subpart D--Certain Adjuvants and Production Aids

178.3010  Adjuvant substances used in the manufacture of foamed 
          plastics.
178.3120  Animal glue.
178.3125  Anticorrosive agents.
178.3130  Antistatic and/or antifogging agents in food-packaging 
          materials.
178.3280  Castor oil, hydrogenated.
178.3290  Chromic chloride complexes.
178.3295  Clarifying agents for polymers.
178.3297  Colorants for polymers.
178.3300  Corrosion inhibitors used for steel or tinplate.
178.3400  Emulsifiers and/or surface-active agents.
178.3450  Esters of stearic and palmitic acids.
178.3480  Fatty alcohols, synthetic.
178.3500  Glycerin, synthetic.
178.3505  Glyceryl tri-(12-acetoxystearate).
178.3520  Industrial starch-modified.
178.3530  Isoparaffinic petroleum hydrocarbons, synthetic.
178.3570  Lubricants with incidental food contact.
178.3600  Methyl glucoside-coconut oil ester.
178.3610  a-Methylstyrene-vinyltoluene resins, hydrogenated.
178.3620  Mineral oil.
178.3650  Odorless light petroleum hydrocarbons.
178.3690  Pentaerythritol adipate-stearate.
178.3700  Petrolatum.
178.3710  Petroleum wax.
178.3720  Petroleum wax, synthetic.
178.3730  Piperonyl butoxide and pyrethrins as components of bags.
178.3740  Plasticizers in polymeric substances.
178.3750  Polyethylene glycol (mean molecular weight 200-9,500).
178.3760  Polyethylene glycol (400) monolaurate.
178.3770  Polyhydric alcohol esters of oxidatively refined (Gersthofen 
          process) montan wax acids.
178.3780  Polyhydric alcohol esters of long chain monobasic acids.
178.3790  Polymer modifiers in semirigid and rigid vinyl chloride 
          plastics.
178.3800  Preservatives for wood.
178.3850  Reinforced wax.
178.3860  Release agents.
178.3870  Rosins and rosin derivatives.
178.3900  Sodium pentachlorophenate.
178.3910  Surface lubricants used in the manufacture of metallic 
          articles.

[[Page 326]]

178.3930  Terpene resins.
178.3940  Tetraethylene glycol di-(2-ethyl-hexoate).
178.3950  Tetrahydrofuran.

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    Source: 42 FR 14609, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 178 appear at 61 FR 
14482, Apr. 2, 1996.



                          Subpart A--[Reserved]



 Subpart B--Substances Utilized To Control the Growth of Microorganisms



Sec. 178.1005  Hydrogen peroxide solution.

    Hydrogen peroxide solution identified in this section may be safely 
used to sterilize polymeric food-contact surfaces identified in 
paragraph (e)(1) of this section.
    (a) Identity. For the purpose of this section, hydrogen peroxide 
solution is an aqueous solution containing not more than 35 percent 
hydrogen peroxide (CAS Reg. No. 7722-84-1) by weight, meeting the 
specifications prescribed in paragraph (c) of this section.
    (b) Optional adjuvant substances. Hydrogen peroxide solution 
identified in paragraph (a) of this section may contain substances 
generally recognized as safe in or on food, substances generally 
recognized for their intended use in food packaging, substances used in 
accordance with a prior sanction or approval, and substances permitted 
by applicable regulations in parts 174 through 179 of this chapter.
    (c) Specifications. Hydrogen peroxide solution shall meet the 
specifications of the ``Food Chemicals Codex,'' 3d Ed. (1981), pp. 146-
147, which is incorporated by reference (copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408), and the 
United States Pharmacopeia XX (1980), except that hydrogen peroxide may 
exceed the concentration specified therein.
    (d) Limitations. No use of hydrogen peroxide solution in the 
sterilization of food packaging material shall be considered to be in 
compliance if more than 0.5 part per million of hydrogen peroxide can be 
determined in distilled water packaged under production conditions 
(assay to be performed immediately after packaging).
    (e) Conditions of use. (1) Hydrogen peroxide solution identified in 
and complying with the specifications in this section may be used by 
itself or in combination with other processes to treat food-contact 
surfaces to attain commercial sterility at least equivalent to that 
attainable by thermal processing for metal containers as provided for in 
part 113 of this chapter. Food-contact surfaces include the following:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Ethylene-acrylic acid copolymers..........  Complying with Sec.         
                                             177.1310 of this chapter.  
Ethylene-carbon monoxide copolymers.......  Complying with Sec.         
                                             177.1312 of this chapter.  
Ethylene-methyl acrylate copolymer resins.  Complying with Sec.         
                                             177.1340 of this chapter.  
Ethylene-vinyl acetate copolymers.........  Complying with Sec.         
                                             177.1350 of this chapter.  
Ionomeric resins..........................  Complying with Sec.         
                                             177.1330 of this chapter.  
Isobutylene polymers......................  Complying with Sec.         
                                             177.1420 (a)(1) and (a)(2) 
                                             of this chapter.           
Olefin polymers...........................  Complying with Sec.         
                                             177.1520 of this chapter.  
Polycarbonate resins......................  Complying with Sec.         
                                             177.1580 of this chapter.  
Polyethylene-terephthalate polymers.......  Complying with Sec.         
                                             177.1630 of this chapter   
                                             (excluding polymers        
                                             described in Sec.          
                                             177.1630(c)) of this       
                                             chapter.                   
Poly-l-butene resins and butene/ethylene    Complying with Sec.         
 copolymers.                                 177.1570 of this chapter.  
Polystryrene and rubber-modified            Complying with Sec.         
 polystyrene polymers.                       177.1640 of this chapter.  
Vinylidene chloride/methyl acrylate         Complying with Sec.         
 copolymers.                                 177.1990 of this chapter.  
------------------------------------------------------------------------

    (2) The packaging materials identified in paragraph (e)(1) of this 
section may be used for packaging all commercially sterile foods except 
that the olefin polymers may be used in articles for packaging foods 
only of the types identified in Sec. 176.170(c) of this chapter, Table 
1, under Categories I, II, III, IV-B, V, and VI.
    (3) Processed foods packaged in the materials identified in 
paragraph (e)(1) of this section shall conform with parts

[[Page 327]]

108, 110, 113, and 114 of this chapter as applicable.

[46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49 
FR 32345, Aug. 14, 1984; 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. 
23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, Nov. 22, 1988; 54 FR 
5604, Feb. 6, 1989; 54 FR 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 
55 FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, 1992]



Sec. 178.1010   Sanitizing solutions.

    Sanitizing solutions may be safely used on food-processing equipment 
and utensils, and on other food-contact articles as specified in this 
section, within the following prescribed conditions:
    (a) Such sanitizing solutions are used, followed by adequate 
draining, before contact with food.
    (b) The solutions consist of one of the following, to which may be 
added components generally recognized as safe and components which are 
permitted by prior sanction or approval.
    (1) An aqueous solution containing potassium, sodium, or calcium 
hypochlorite, with or without the bromides of potassium, sodium, or 
calcium.
    (2) An aqueous solution containing dichloroisocyanuric acid, 
trichloroisocyanuric acid, or the sodium or potassium salts of these 
acids, with or without the bromides of potassium, sodium, or calcium.
    (3) An aqueous solution containing potassium iodide, sodium p-
toluenesulfonchloroamide, and sodium lauryl sulfate.
    (4) An aqueous solution containing iodine, butoxy monoether of mixed 
(ethylene-propylene) polyalkylene glycol having a cloudpoint of 90 deg.-
100 deg. C in 0.5 percent aqueous solution and an average molecular 
weight of 3,300, and ethylene glycol monobutyl ether. Additionally, the 
aqueous solution may contain diethylene glycol monoethyl ether as an 
optional ingredient.
    (5) An aqueous solution containing elemental iodine, hydriodic acid, 
a-(p-nonylphenyl)-omega-hydroxypoly-(oxyethylene) (complying with the 
identity prescribed in Sec. 178.3400(c) and having a maximum average 
molecular weight of 748) and/or polyoxyethylene-polyoxypropylene block 
polymers (having a minimum average molecular weight of 1,900). 
Additionally, the aqueous solution may contain isopropyl alcohol as an 
optional ingredient.
    (6) An aqueous solution containing elemental iodine, sodium iodide, 
sodium dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block 
polymers (having a minimum average molecular weight of 1,900).
    (7) An aqueous solution containing dodecylbenzenesulfonic acid and 
either isopropyl alcohol or polyoxyethylene-polyoxypropylene block 
polymers (having a minimum average molecular weight of 2,800). In 
addition to use on food-processing equipment and utensils, this solution 
may be used on glass bottles and other glass containers intended for 
holding milk.
    (8) An aqueous solution containing elemental iodine, butoxy 
monoether of mixed (ethylene-propylene) polyalkylene glycol having a 
minimum average molecular weight of 2,400 and -lauroyl-omega-
hydroxypoly (oxyethylene) with an average 8-9 moles of ethylene oxide 
and an average molecular weight of 400. In addition to use on food-
processing equipment and utensils, this solution may be used on beverage 
containers, including milk containers or equipment. Rinse water treated 
with this solution can be recirculated as a preliminary rinse. It is not 
to be used as final rinse.
    (9) An aqueous solution containing n-alkyl (C12-C18) 
benzyldimethylam-monium chloride compounds having average molecular 
weights of 351 to 380. The alkyl groups consist principally of groups 
with 12 to 16 carbon atoms and contain not more than 1 percent each of 
groups with 8 and 10 carbon atoms. Additionally, the aqueous solution 
may contain either ethyl alcohol or isopropyl alcohol as an optional 
ingredient.
    (10) An aqueous solution containing trichloromelamine and either 
sodium lauryl sulfate or dodecyl- benzenesulfonic acid. In addition to 
use on food-processing equipment and utensils and other food-contact 
articles, this solution may be used on beverage containers except milk 
containers or equipment.
    (11) An aqueous solution containing equal amounts of n-alkyl 
(C12-C18) benzyl dimethyl ammonium chloride and n- alkyl 
(C12-C18) dimethyl

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ethylbenzyl ammonium chloride (having an average molecular weight of 
384). In addition to use on food-processing equipment and utensils, this 
solution may be used on food-contact surfaces in public eating places.
    (12) An aqueous solution containing the sodium salt of sulfonated 
oleic acid, polyoxyethylene-polyoxypropylene block polymers (having an 
average molecular weight of 2,000 and 27 to 31 moles of 
polyoxypropylene). In addition to use on food-processing equipment and 
utensils, this solution may be used on glass bottles and other glass 
containers intended for holding milk. All equipment, utensils, glass 
bottles, and other glass containers treated with this sanitizing 
solution shall have a drainage period of 15 minutes prior to use in 
contact with food.
    (13) An aqueous solution containing elemental iodine and alkyl 
(C12-C15) monoether of mixed (ethylene-propylene) polyalkylene 
glycol, having a cloud-point of 70 deg.-77 deg.C in 1 percent aqueous 
solution and an average molecular weight of 807.
    (14) An aqueous solution containing iodine, butoxy monoether of 
mixed (ethylene-propylene) polyalkylene glycol, having a cloud-point of 
90 deg.-100 deg.C in 0.5 percent aqueous solution and an average 
molecular weight of 3,300, and polyoxyethylene-polyoxypropylene block 
polymers (having a minimum average molecular weight of 2,000).
    (15) An aqueous solution containing lithium hypochlorite.
    (16) An aqueous solution containing equal amounts of n-alkyl 
(C12-C18) benzyl dimethyl ammonium chloride and n- alkyl 
(C12-C14) dimethyl ethylbenzyl ammonium chloride (having 
average molecular weights of 377 to 384), with the optional adjuvant 
substances tetrasodium ethylenediaminetetraacetate and/or alpha-(p-
nonylphenol)-omega-hydroxy poly (oxyethylene) having an average poly- 
(oxyethylene) content of 11 moles. Alpha-hydro-omega-hydroxypoly-
(oxyethylene) poly(oxypropoylene) (15 to 18 mole minimum) poly 
(oxyethylene) block copolymer, having a minimum molecular weight of 
1,900 (CAS Registry No. 9003-11-6) may be used in lieu of alpha- (p-
nonylphenol)-omega-hydroxy- poly(oxyethylene) having an average 
poly(oxyethylene) content of 11 moles. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
    (17) An aqueous solution containing di-n-alkyl(C8-
C10)dimethyl ammonium chlorides having average molecular weights of 
332-361 and either ethyl alcohol or isopropyl alcohol. In addition to 
use on food-processing equipment and utensils, this solution may be used 
on food-contact surfaces in public eating places.
    (18) An aqueous solution containing n-alkyl(C12-C18) 
benzyldimethylammo-nium chloride, sodium metaborate, alpha-terpineol and 
alpha[p-(1,1,3,3-tetramethylbutyl)phenyl] -omega-hydroxy-poly 
(oxyethylene) produced with one mole of the phenol and 4 to 14 moles 
ethylene oxide.
    (19) An aqueous solution containing sodium dichloroisocyanurate and 
tetrasodium ethylenediaminetetraace- tate. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
    (20) An aqueous solution containing ortho-phenylphenol, ortho-
benzyl-para-chlorophenol, para-tertiaryamylphenol, sodium -alpha-
alkyl(C12-C15)-omega-hydroxypoly (oxyethylene) sulfate with 
the poly(oxyethylene) content averaging one mole, potassium salts of 
coconut oil fatty acids, and isopropyl alcohol or hexylene glycol.
    (21) An aqueous solution containing sodium dodecylbenzenesulfonate. 
In addition to use on food-processing equipment and utensils, this 
solution may be used on glass bottles and other glass containers 
intended for holding milk.
    (22) An aqueous solution containing (1) di-n-alkyl(C8-C10) 
dimethylammonium chloride compounds having average molecular weights of 
332-361, (2) n-alkyl (C12-C18) benzyldimethylammonium chloride 
compounds having average molecular weights of 351-380 and consisting 
principally of alkyl groups with 12 to 16 carbon atoms with or without 
not over 1 percent each of groups with 8 and 10 carbon atoms, and (3) 
ethyl alcohol.

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The ratio of compound (1) to compound (2) is 60 to 40.
    (23) An aqueous solution containing n-alkyl (C12-C16) 
benzyl-dimethylammonium chloride and didecyldimethylammonium chloride.
    (24) An aqueous solution containing elemental iodine (CAS Reg. No. 
7553-56-2), alpha-[p-(1,1,3,3-tetramethylbutyl)-phenyl]-omega-
hydroxypoly-(oxyethylene) produced with one mole of the phenol and 4 to 
14 moles ethylene oxide, and alpha-alkyl(C12-C15)-omega-
hydroxy[poly(oxyethylene) poly(oxypropylene)] (having an average 
molecular weight of 965).
    (25) An aqueous solution containing elemental iodine (CAS Reg. No. 
7553-56-2), potassium iodide (CAS Reg. No. 7681-11-0), and isopropanol 
(CAS Reg. No. 67-63-0). In addition to use on food processing equipment 
and utensils, this solution may be used on beverage containers, 
including milk containers and equipment and on food-contact surfaces in 
public eating places.
    (26) [Reserved]
    (27) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), octanoic acid (CAS Reg. No. 124-07-2), and sodium 1-
octanesulfonate (CAS Reg. No. 5324-84-5). Additionally, the aqueous 
solution may contain isopropyl alcohol (CAS Reg. No. 67-63-0) as an 
optional ingredient.
    (28) An aqueous solution containing sulfonated 9-octadecenoic acid 
(CAS Reg. No. 68988-76-1) and sodium xylenesulfonate (CAS Reg. No. 1300-
72-7).
    (29) An aqueous solution containing dodecyldiphenyloxidedisulfonic 
acid (CAS Reg. No. 30260-73-2), sulfonated tall oil fatty acid (CAS Reg. 
No. 68309-27-3), and neo-decanoic acid (CAS Reg. No. 26896-20-8). In 
addition to use on food-processing equipment and utensils, this solution 
may be used on glass bottles and other glass containers intended for 
holding milk.
    (30) An aqueous solution containing hydrogen peroxide (CAS Reg. No. 
7722-84-1), peracetic acid (CAS Reg. No. 79-21-0), acetic acid (CAS Reg. 
No. 64-19-7), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. 
No. 2809-21-4).
    (31) An aqueous solution containing elemental iodine, alpha-
alkyl(C10-C14)-omega-hydroxypoly(oxyethylene)poly-
(oxypropylene) of average molecular weight between 768 and 837, and 
alpha-alkyl(C12-C18)-omega-hydroxypoly(oxyethylene) 
poly(oxypropylene) of average molecular weight between 950 and 1,120. In 
addition to use on food-processing equipment and utensils, this solution 
may be used on food-contact surfaces in public eating places.
    (32) An aqueous solution containing (i) di-n-alkyl(C8-
C10)dimethyl- ammonium chloride compounds having average molecular 
weights of 332 to 361, (ii) n-alkyl(C12-C18)benzyldimethyl- 
ammonium chloride compounds having average molecular weights of 351 to 
380 and consisting principally of alkyl groups with 12 to 16 carbon 
atoms with no more than 1 percent of groups with 8 and 10, (iii) ethyl 
alcohol, and (iv) alpha-(p-nonylphenyl)-omega-hydroxypoly(oxyethylene) 
produced by the condensation of 1 mole of p-nonylphenol with 9 to 12 
moles of ethylene oxide. The ratio of compound (i) to compound (ii) is 3 
to 2.
    (33) An aqueous solution containing (i) di-n-alkyl-(C8-
C10)-dimethylammonium chloride compounds having average molecular 
weights of 332 to 361; (ii) n-alkyl(C12-C18) -
benzyldimethylammonium chloride compounds having molecular weights of 
351 to 380 and consisting principally of alkyl groups with 12 to 16 
carbon atoms with no more than 1 percent of the groups with 8 to 10; and 
(iii) tetrasodium ethylenediamine tetraacetate. Additionally, the 
aqueous solution contains either alpha-(p-nonylphenyl)-omega-
hydroxypoly-(oxyethylene) or alpha-alkyl(C11-C15)-omega-
hydroxypoly-(oxyethylene), each produced with 9 to 13 moles of ethylene 
oxide. The ratio of compound (i) to compound (ii) is 3 to 2.
    (34) An aqueous solution of an equilibrium mixture of oxychloro 
species (predominantly chlorite, chlorate, and chlorine dioxide) 
generated either (i) by directly metering a concentrated chlorine 
dioxide solution, prepared just prior to use, into potable water to 
provide the concentration of available chlorine dioxide stated in 
paragraph (c)(29) of this section, or (ii) by acidification of an 
aqueous alkaline solution

[[Page 330]]

of oxychloro species (predominantly chlorite and chlorate) followed by 
dilution with potable water to provide the concentration of available 
chlorine dioxide described in paragraph (c)(29) of this section.
    (35) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), octanoic acid (CAS Reg. No. 124-07-2), lactic acid (CAS Reg. No. 
050-21-5), phosphoric acid (CAS Reg. No. 7664-38-2) and a mixture of the 
sodium salt of naphthalenesulfonic acid (CAS Reg. No. 1321-69-3); the 
methyl, dimethyl, and trimethyl dervatives of the sodium salt of 
naphthalenesulfonic acid; and a mixture of the sodium salt of 
naphthalenesulfonic acid, and the methyl, dimethyl, and trimethyl 
derivatives of the sodium salt of naphthalenesulfonic acid alkylated at 
3 percent by weight with C6-C9 linear olefins, as components 
of a sanitizing solution to be used on food-processing equipment and 
utensils. The methyl and dimethyl substituted derivatives (described 
within this paragraph (b)(35)) constitute no less than 70 percent by 
weight of the mixture of naphthalenesulfonates.
    (36) The sanitizing solution contains decanoic acid (CAS Reg. No. 
334-48-5); octanoic acid (CAS Reg. No. 124-07-2); lactic acid (CAS Reg. 
No. 050-21-5); phosphoric acid (CAS Reg. No. 7664-38-2); a mixture of 1-
octanesulfonic acid (CAS Reg. No. 3944-72-7), and 1-octanesulfonic-2-
sulfinic acid (CAS Reg. No. 113652-56-5) or 1,2-octanedisulfonic acid 
(CAS Reg. No. 1934210); the condensate of four moles of 
poly(oxyethylene)poly(oxypropylene) block copolymers with one mole of 
ethylenediamine (CAS Reg. No. 11111-34-5); and the optional ingredient 
FD&C Yellow No. 5 (CAS Reg. No. 001934210). In addition to use on food-
processing equipment and utensils, this solution may be used on dairy-
processing equipment.
    (37) The sanitizing solution contains sodium hypochlorite (CAS Reg. 
No. 7681-52-9), trisodium phosphate (CAS Reg. No. 7601-54-9), sodium 
lauryl sulfate (CAS Reg. No. 151-21-3), and potassium permanganate (CAS 
Reg. No. 7722-64-7). Magnesium oxide (CAS Reg. No. 1309-48-4) and 
potassium bromide (CAS Reg. No. 7758-02-3) may be added as optional 
ingredients to this sanitizing solution. In addition to use on food-
processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
    (38) An aqueous solution containing hydrogen peroxide (CAS Reg. No. 
7722-84-1); peroxyacetic acid (CAS Reg. No. 79-21-0); acetic acid (CAS 
Reg. No. 64-19-7); sulfuric acid (CAS Reg. No. 7664-93-9); and 2,6-
pyridinedicarboxylic acid (CAS Reg. No. 499-83-2). In addition to use on 
food-processing equipment and utensils, this solution may be used on 
dairy-processing equipment.
    (39) An aqueous solution containing phosphoric acid (CAS Reg. No. 
7664-38-2); octenyl succinic acid (CAS Reg. No. 28805-58-5); N,N-
dimethyloctanamine (CAS Reg. No. 7378-99-6); and a mixture of n-
carboxylic acids (C6-C12, consisting of not less than 56 
percent octanoic acid and not less than 40 percent decanoic acid). This 
solution may be used on food-processing equipment and utensils, 
including dairy-processing equipment.
    (40) An aqueous solution prepared by combining elemental iodine (CAS 
Reg. No. 7553-56-2); hydriodic acid (CAS Reg. No. 10034-85-2); sodium N-
cyclohexyl-N-palmitoyl taurate (CAS Reg. No. 132-43-4); chloroacetic 
acid, sodium salt reaction products with 4,5-dihydro-2-undecyl-1H-
imidazole-1-ethanol and sodium hydroxide (CAS Reg. No. 68608-66-2); 
dodecylbenzene sulfonic acid (CAS Reg. No. 27176-87-0); phosphoric acid 
(CAS Reg. No. 7664-38-2); isopropyl alcohol (CAS Reg. No. 67-63-0); and 
calcium chloride (CAS Reg. No. 10043-52-4). In addition to use on food-
processing equipment and utensils, this solution may be used on dairy-
processing equipment.
    (41) An aqueous solution containing n-alkyl(C12-
C16)benzyldimethylammonium chloride, having average molecular 
weights ranging from 351 to 380 wherein the alkyl groups contain 
principally 12 to 16 carbons and not more than 1 percent each of the 
groups with 8 and 10 carbon atoms; ammonium chloride (CAS Reg. No. 
12125-02-9); calcium stearate (CAS Reg. No. 1592-23-0); sodium 
bicarbonate (CAS Reg. No. 144-55-8); starch or dextrin, or both starch 
and dextrin

[[Page 331]]

(CAS Reg. No. 9004-53-9); and the optional ingredient methylene blue 
(CAS Reg. No. 61-73-4). In addition to use on food-processing equipment 
and utensils, this solution may be used on food-contact surfaces in 
public eating places.
    (42) An aqueous solution containing decanoic acid (CAS Reg. No. 334-
48-5), nonanoic acid (CAS Reg. No. 112-05-0), phosphoric acid (CAS Reg. 
No. 7664-38-2), propionic acid (CAS Reg No. 79-09-04), and sodium 1-
octanesulfonate (CAS Reg. No. 5324-84-5). Sulfuric acid (CAS Reg. No. 
7664-93-9) may be added as an optional ingredient. In addition to use on 
food-processing equipment and utensils, this solution may be used on 
dairy-processing equipment.
    (43) An aqueous solution of iodine and hypochlorous acid generated 
by the dilution of an aqueous acidic (21.5 percent nitric acid) solution 
of iodine monochloride. In addition to use on food-processing equipment 
and utensils, this solution may be used on dairy-processing equipment.
    (44) An aqueous solution of citric acid, disodium 
ethylenediaminetetraacetate, sodium lauryl sulfate, and monosodium 
phosphate. In addition to use on food-processing equipment and utensils, 
this solution may be used on dairy-processing equipment.
    (c) The solutions identified in paragraph (b) of this section will 
not exceed the following concentrations:
    (1) Solutions identified in paragraph (b)(1) of this section will 
provide not more than 200 parts per million of available halogen 
determined as available chlorine.
    (2) Solutions identified in paragraph (b)(2) of this section will 
provide not more than 100 parts per million of available halogen 
determined as available chlorine.
    (3) Solution identified in paragraph (b)(3) of this section will 
provide not more than 25 parts per million of titratable iodine. The 
solutions will contain the components potassium iodide, sodium p-
toluenesulfonchloramide and sodium lauryl sulfate at a level not in 
excess of the minimum required to produce their intended functional 
effect.
    (4) Solutions identified in paragraph (b)(4), (5), (6), (8), (13), 
and (14) of this section will contain iodine to provide not more than 25 
parts per million of titratable iodine. The adjuvants used with the 
iodine will not be in excess of the minimum amounts required to 
accomplish the intended technical effect.
    (5) Solutions identified in paragraph (b)(7) of this section will 
provide not more than 400 parts per million dodecylbenzenesulfonic acid 
and not more than 80 parts per million of polyoxyethylene-
polyoxypropylene block polymers (having a minimum average molecular 
weight of 2,800) or not more than 40 parts per million of isopropyl 
alcohol.
    (6) Solutions identified in paragraph (b)(9) of this section shall 
provide when ready to use no more than 200 parts per million of the 
active quaternary compound.
    (7) Solutions identified in paragraph (b)(10) of this section shall 
provide not more than sufficient trichloromelamine to produce 200 parts 
per million of available chlorine and either sodium lauryl sulfate at a 
level not in excess of the minimum required to produce its intended 
functional effect or not more than 400 parts per million of 
dodecylbenzenesulfonic acid.
    (8) Solutions identified in paragraph (b)(11) of this section shall 
provide, when ready to use, not more than 200 parts per million of 
active quaternary compound.
    (9) The solution identified in paragraph (b)(12) of this section 
shall provide not more than 200 parts per million of sulfonated oleic 
acid, sodium salt.
    (10) Solutions identified in paragraph (b)(15) of this section will 
provide not more than 200 parts per million of available chlorine and 
not more than 30 ppm lithium.
    (11) Solutions identified in paragraph (b)(16) of this section shall 
provide not more than 200 parts per million of active quaternary 
compound.
    (12) Solutions identified in paragraph (b)(17) of this section shall 
provide, when ready to use, a level of 150 parts per million of the 
active quaternary compound.
    (13) Solutions identified in paragraph (b)(18) of this section shall 
provide not

[[Page 332]]

more than 200 parts per million of active quaternary compound and not 
more than 66 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl) 
phenyl]-omega-hydroxypoly (oxyethylene).
    (14) Solutions identified in paragraph (b)(19) of this section shall 
provide, when ready to use, a level of 100 parts per million of 
available chlorine.
    (15) Solutions identified in paragraph (b)(20) of this section are 
for single use applications only and shall provide, when ready to use, a 
level of 800 parts per million of total active phenols consisting of 400 
parts per million ortho-phenylphenol, 320 parts per million ortho-
benzyl-para-chlorophenol and 80 parts per million para-
tertiaryamylphenol.
    (16) Solution identified in paragraph (b)(21) of this section shall 
provide not more than 430 parts per million and not less than 25 parts 
per million of sodium dodecylbenzenesulfonate.
    (17) Solutions identified in paragraph (b)(22) of this section shall 
provide, when ready to use, at least 150 parts per million and not more 
than 400 parts per million of active quaternary compound.
    (18) Solutions identified in paragraph (b)(23) of this section shall 
provide at least 150 parts per million and not more than 200 parts per 
million of the active quaternary compound.
    (19) Solutions identified in paragraphs (b)(24), (b)(25), and 
(b)(43) of this section shall provide at least 12.5 parts per million 
and not more than 25 parts per million of titratable iodine. The 
adjuvants used with the iodine shall not be in excess of the minimum 
amounts required to accomplish the intended technical effect.
    (20)-(21) [Reserved]
    (22) Solutions identified in paragraph (b)(27) of this section shall 
provide, when ready to use, at least 109 parts per million and not more 
than 218 parts per million of total active fatty acids and at least 156 
parts per million and not more than 312 parts per million of the sodium 
1-octanesulfonate.
    (23) Solutions identified in paragraph (b)(28) of this section shall 
provide, when ready to use, at least 156 parts per million and not more 
than 312 parts per million of sulfonated 9-octadecenoic acid, at least 
31 parts per million and not more then 62 parts per million of sodium 
xylenesulfonate.
    (24) Solutions identified in paragraph (b)(29) of this section will 
provide at least 237 parts per million and not more than 474 parts per 
million dodecyldiphenyloxidedisulfonic acid, at least 33 parts per 
million and not more than 66 parts per million sulfonated tall oil fatty 
acid, and at least 87 parts per million and not more than 174 parts per 
million neo-decanoic acid.
    (25) Solutions identified in paragraph (b)(30) of this section shall 
provide, when ready to use, not less than 550 parts per million and not 
more than 1,100 parts per million hydrogen peroxide, not less than 100 
parts per million and not more than 200 parts per million peracetic 
acid, not less than 150 parts per million and not more than 300 parts 
per million acetic acid, and not less than 15 parts per million and not 
more than 30 parts per million 1-hydroxyethylidene-1,1-diphosphonic 
acid.
    (26) The solution identified in paragraph (b)(31) of this section 
shall provide, when ready to use, at least 12.5 parts per million and 
not more than 25 parts per million of titratable iodine. The adjuvants 
used with the iodine will not be in excess of the minimum amounts 
required to accomplish the intended technical effect.
    (27) Solutions identified in paragraph (b)(32) of this section shall 
provide, when ready to use, at least 150 parts per million and no more 
than 400 parts per million of active quarternary compounds in solutions 
containing no more than 600 parts per million water hardness. The 
adjuvants used with the quarternary compounds will not exceed the 
amounts required to accomplish the intended technical effect.
    (28) Solutions identified in paragraph (b)(33) of this section shall 
provide, when ready to use, at least 150 parts per million and not more 
than 400 parts per million of active quaternary compounds. The adjuvants 
used with the quaternary compounds shall not exceed the amounts required 
to accomplish the intended technical effect. Tetrasodium ethylenediamine 
tetraacetate shall be added at a minimum level of 60 parts per million. 
Use

[[Page 333]]

of these sanitizing solutions shall be limited to conditions of water 
hardness not in excess of 300 parts per million.
    (29) Solutions identified in paragraph (b)(34) of this section 
should provide, when ready to use, at least 100 parts per million and 
not more than 200 parts per million available chlorine dioxide as 
determined by the method titled ``Iodometric Method for the 
Determination of Available Chlorine Dioxide (50-250 ppm available 
ClO2),'' which is incorporated by reference. Copies are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (30) Solutions identified in paragraph (b)(35) of this section shall 
provide, when ready for use, at least 117 parts per million and not more 
than 234 parts per million of total fatty acids and at least 166 parts 
per million and not more than 332 parts per million of a mixture of 
naphthalenesulfonates. The adjuvants phosphoric acid and lactic acid, 
used with decanoic acid, octanoic acid, and sodium naphthalenesulfonate 
and its alkylated derivatives, will not be in excess of the minimum 
amounts required to accomplish the intended technical effects.
    (31) Solutions identified in paragraph (b)(36) of this section shall 
provide, when ready for use, at least 29 parts per million and not more 
than 58 parts per million decanoic acid; at least 88 parts per million 
and not more than 176 parts per million of octanoic acid; at least 69 
parts per million and not more than 138 parts per million of lactic 
acid; at least 256 parts per million and not more than 512 parts per 
million of phosphoric acid; at least 86 parts per million and not more 
than 172 parts per million of 1-octanesulfonic acid; at least 51 parts 
per million and not more than 102 parts per million of 1-octanesulfonic-
2-sulfinic acid or 1,2-octanedisulfonic acid; and at least 10 parts per 
million and not more than 20 parts per million of the condensate of four 
moles of poly(oxyethylene)poly(oxypropylene) block copolymers with one 
mole of ethylenediamine. The colorant adjuvant FD&C Yellow No. 5 shall 
not be used in excess of the minimum amount required to accomplish the 
intended technical effect.
    (32)(i) The solution identified in paragraph (b)(37) of this section 
without potassium bromide shall provide, when ready to use, at least 100 
parts per million and not more than 200 parts per million of available 
halogen determined as available chlorine; at least 2,958 parts per 
million and not more than 5,916 parts per million of trisodium 
phosphate; at least 1 part per million and not more than 3 parts per 
million of sodium lauryl sulfate; and at least 0.3 part per million and 
not more than 0.7 part per million on potassium permanganate.
    (ii) The solution identified in paragraph (b)(37) of this section 
with potassium bromide shall provide, when ready to use, at least 25 
parts per million and not more than 200 parts per million of available 
halogen determined as available chlorine; at least 15 parts per million 
and not more than 46 parts per million of potassium bromide; at least 
690 parts per million and not more than 2,072 parts per million of 
trisodium phosphate; at least 0.3 part per million and not more than 1 
part per million of sodium lauryl sulfate; and at least 0.1 part per 
million and not more than 0.3 part per million of potassium 
permanganate.
    (iii) Magnesium oxide when used in paragraph (c)(32) (i) or (ii) of 
this section shall not be used in excess of the minimum amount required 
to accomplish its intended technical effect.
    (33) Solutions identified in paragraph (b)(38) of this section shall 
provide when ready for use not less than 300 parts per million and not 
more than 465 parts per million of hydrogen peroxide; not less than 200 
parts per million and not more than 315 parts per million of 
peroxyacetic acid; not less than 200 parts per million and not more than 
340 parts per million of acetic acid; not less than 10 parts per million 
and not more than 20 parts per million of sulfuric acid; and not less 
than 0.75 parts per million and not more than 1.2 parts per million of 
2,6-pyridinedicarboxylic acid.
    (34) Solutions identified in paragraph (b)(39) of this section shall 
provide

[[Page 334]]

when ready for use not less than 460 parts per million and not more than 
625 parts per million of phosphoric acid, and all components shall be 
present in the following proportions: 1 part phosphoric acid to 0.25 
octenyl succinic acid to 0.18 part N,N-dimethyloctanamine to 0.062 part 
of a mixture of n-carboxylic acids (C6-C12, consisting of not 
less than 56 percent octanoic acid and not less than 40 percent decanoic 
acid).
    (35) Solutions identified in paragraph (b)(40) of this section shall 
provide when ready for use not less than 12.5 parts per million and not 
more than 25.0 parts per million of titratable iodine; and not less than 
2.7 parts per million and not more than 5.5 parts per million of 
dodecylbenzene sulfonic acid. All components shall be present in the 
following proportions: 1.0 part dodecylbenzene sulfonic acid to 43 parts 
sodium N-cyclohexyl-N-palmitoyl taurate to 7.7 parts chloroacetic acid, 
sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-
1-ethanol and sodium hydroxide to 114 parts phosphoric acid to 57 parts 
isopropyl alcohol to 3.0 parts calcium chloride.
    (36) Solutions identified in paragraph (b)(41) of this section shall 
provide, when ready for use, not less than 150 parts per million and not 
more than 200 parts per million of n-alkyl(C12-
C16)benzyldimethylammonium chloride; and not more than 0.4 part per 
million of the colorant methylene blue. Components shall be present in 
the product used to prepare the solution in the following proportions: 1 
part n-alkyl(C12-C16)benzyldimethylammonium chloride to 0.24 
part ammonium chloride to 0.08 part calcium stearate to 0.60 part sodium 
bicarbonate to 0.08 part starch or dextrin, or a combination of starch 
and dextrin.
    (37)(i) The solution identified in paragraph (b)(42) of this section 
not containing sulfuric acid shall provide when ready for use not less 
than 45 parts per million and not more than 90 parts per million of 
decanoic acid; and all components shall be present in the following 
proportions (weight/weight (w/w)): 1 part decanoic acid to 1 part 
nonanoic acid to 9.5 parts phosphoric acid to 3.3 parts propionic acid 
to 3.3 parts sodium 1-octanesulfonate.

    (ii) The solution identified in paragraph (b)(42) of this section 
containing sulfuric acid shall provide when ready for use not less than 
45 parts per million and not more than 90 parts per million of decanoic 
acid; and all components shall be present in the following proportions 
(w/w): 1 part decanoic acid to 1 part nonanoic acid to 2.8 parts 
phosphoric acid to 3.3 parts propionic acid to 3.3 parts sodium 1-
octanesulfonate to 3.2 parts sulfuric acid.
    (38) The solution identified in paragraph (b)(44) of this section 
shall provide, when ready for use, at least 16,450 parts per million and 
not more than 32,900 parts per million of citric acid; at least 700 
parts per million and not more than 1,400 parts per million of disodium 
ethylenediaminetetraacetate; at least 175 parts per million and not more 
than 350 parts per million of sodium lauryl sulfate; and at least 175 
parts per million and not more than 350 parts per million of monosodium 
phosphate.
    (d) Sanitizing agents for use in accordance with this section will 
bear labeling meeting the requirements of the Federal Insecticide, 
Fungicide, and Rodenticide Act.

[42 FR 14609, Mar. 16, 1977]

    Editorial Note: For Federal Register  citations affecting 
Sec. 178.1010, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



                 Subpart C--Antioxidants and Stabilizers



Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

    The substances listed in paragraph (b) of this section may be safely 
used as antioxidants and/or stabilizers in polymers used in the 
manufacture of articles or components of articles intended for use in 
producing, manufacturing, packing, processing, preparing, treating, 
packaging, transporting, or holding food, subject to the provisions of 
this section:
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect.
    (b) List of substances:

[[Page 335]]



------------------------------------------------------------------------
           Substances                           Limitations             
------------------------------------------------------------------------
N-n-Alkyl-N'-(carboxymethyl)-     For use only:                         
 N,N'-trimethylenediglycine; the  1. As component of nonfood articles   
 alkyl group is even numbered in   complying with Secs.  175.105 and    
 the range C14-C18 and the         177.2600 of this chapter.            
 nitrogen content is in the       2. At levels not to exceed 1.35       
 range 5.4-5.6 weight percent.     percent by weight of natural rubber, 
                                   butadiene-acrylonitrile, butadiene-  
                                   acrylonitrile-styrene, and butadiene-
                                   styrene polymers that are used in    
                                   contact with nonalcoholic food at    
                                   temperatures not to exceed room      
                                   temperature and that are employed in 
                                   closure-sealing gaskets complying    
                                   with Sec.  177.1210 of this chapter  
                                   or in coatings complying with Sec.   
                                   175.300, Sec.  176.170, or Sec.      
                                   175.320 of this chapter. The average 
                                   thickness of such coatings and       
                                   closure-sealing gaskets shall not    
                                   exceed 0.004 inch.                   
p-tert-Amylphenolformaldehyde     For use only at levels not to exceed  
 resins produced when one mole     2.1 percent by weight of polyamide   
 of p-tert-amylphenol is made to   resins that are:                     
 react under acid conditions      1. Derived from dimerized vegetable   
 with one mole of formaldehyde.    oil acids (containing not more than  
                                   20 percent of monomer acids) and     
                                   ethylenediamine.                     
                                  2. Used in compliance with regulations
                                   in parts 174, 175, 176, 177, 178 and 
                                   Sec.  179.45 of this chapter.        
1,4-Benzenedicarboxylic acid,     For use only at levels not to exceed  
 bis[2-(1,1-dimethylethyl)-6-[[3-  0.075 percent by weight of olefin    
 (1,1-dimethylethyl)-2-hydroxy-5-  polymers complying with Sec.         
 methylphenyl]methyl]-4-methyl-    177.1520 of this chapter.            
 phenyl]ester (CAS Reg. No.                                             
 57569-40-1).                                                           
2-(2H-Benzotriazol-2-yl)-4,6-     For use only:                         
 bis(1-methyl-1-                    1. At levels not to exceed 0.5      
 phenylethyl)phenol (CAS Reg.      percent by weight of polyethylene    
 No. 70321-86-7).                  phthalate polymers complying with    
                                   Sec.  177.1630 of this chapter.      
                                    2. At levels not to exceed 3.0      
                                   percent by weight of polycarbonate   
                                   resins complying with Sec.  177.1580 
                                   of this chapter.                     
2-(2H-Benzotriazol-2-yl)-4-(1,    For use only at levels not to exceed  
 1, 3, 3-tetramethylbutyl)         0.5 percent by weight of             
 phenol (CAS Reg. No. 3147-75-9).  polycarbonate resins complying with  
                                   Sec.  177.1580 of this chapter:      
                                   Provided, That the finished resins   
                                   contact food only under conditions of
                                   use E, F, and G described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
 , 3(or 4)-              For use only:                         
 Bis(octadecylthio)cyclohexyleth                                        
 ane (CAS Reg. No. 37625-75-5);                                         
 CAS synonym: 1-[(beta-                                                 
 (octadecylthio)ethyl]-3(or 4)-                                         
 (octadecylthio)cyclohexane.                                            
                                  1. At levels not to exceed 0.3 percent
                                   by weight of all polymers for use in 
                                   contact with foods of Types I, II, IV-
                                   B, VI, VII-B, and VIII under         
                                   conditions of use B through H as     
                                   described in Tables 1 and 2 of Sec.  
                                   176.170(c) of this chapter.          
                                  2. At levels not to exceed 0.3 percent
                                   by weight of polyolefins complying   
                                   with Sec.  177.1520 of this chapter, 
                                   for use in contact with food of types
                                   III, IV-A, V, VII-A, and IX under    
                                   conditions of use C through G as     
                                   described in Tables 1 and 2 of Sec.  
                                   176.170(c) of this chapter.          
1,2-Bis(3,5-di-tert-butyl-4-      For use only:                         
 hydroxyhydrocinnamoyl)-          1. As provided in Sec.  175.105 of    
 hydrazine (CAS Reg. No. 32687-    this chapter.                        
 78-8).                           2. At levels not exceeding 0.1 percent
                                   by weight of acrylonitrile-butadiene-
                                   styrene copolymers used in accordance
                                   with parts 175, 176, 177, and 181 of 
                                   this chapter.                        
                                  3. At levels not exceeding 0.1 percent
                                   by weight of polyoxymethylene        
                                   copolymers complying with Sec.       
                                   177.2470 of this chapter and of      
                                   polyoxymethylene homopolymers        
                                   complying with Sec.  177.2480 of this
                                   chapter.                             
2,6-Bis(1-methylheptadecyl)-p-    For use only at levels not exceeding  
 cresol.                           0.3 percent by weight of olefin      
                                   polymers complying with Sec.         
                                   177.1520(c) of this chapter, items   
                                   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
                                   3.2, 3.3, or 4. The average thickness
                                   of such polymers in the form in which
                                   they contact fatty food or food      
                                   containing more than 8 percent of    
                                   alcohol shall not exceed 0.004 inch. 
3,9-Bis[2-{3-(3-tert-butyl-4-     For use only:                         
 hydroxy-5-                                                             
 methylphenyl)propionyloxy}-1,1-                                        
 dimethylethyl]-2,4,8,10-                                               
 tetraoxaspiro[5.5]undecane (CAS                                        
 Reg. No. 90498-90-1)..                                                 

[[Page 336]]

                                                                        
                                   1. At levels not to exceed 0.2       
                                   percent by weight of polypropylene   
                                   complying with Sec.  177.1520(c),    
                                   item 1.1 of this chapter. The        
                                   finished polymer is to be used in    
                                   contact with food only under         
                                   conditions of use D through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                   2. At levels not to exceed 0.3       
                                   percent by weight of polyethylene    
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.1, provided that
                                   the polymer has a minimum density of 
                                   0.94 grams per cubic centimeter and  
                                   is used in contact with food only    
                                   under conditions of use D through G  
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
4-[[4,6-Bis(octylthio)-s-triazin- For use only:                         
 2-yl]amino]-2,6-di-tert-           1. At levels not to exceed 0.5      
 butylphenol (CAS Reg. No. 991-      percent by weight: in styrene block
 84-4).                              copolymers complying with Sec.     
                                     177.1810 of this chapter; in rosins
                                     and rosin derivatives complying    
                                     with Sec.  175.300(b)(3)(v) of this
                                     chapter; in can end cement         
                                     formulations complying with Sec.   
                                     175.300(b)(3)(xxxi) of this        
                                     chapter; in side seam cement       
                                     formulations complying with Sec.   
                                     175.300(b)(3)(xxxii) of this       
                                     chapter; in petroleum alicyclic    
                                     hydrocarbon resins and terpene     
                                     resins complying with Sec.         
                                     175.320(b)(3) of this chapter; in  
                                     rosin and rosin derivatives        
                                     complying with Sec.  176.170(a)(5) 
                                     of this chapter; in petroleum      
                                     alicyclic hydrocarbon resins or    
                                     their hydrogenated products        
                                     complying with Sec.  176.170(b)(2) 
                                     of this chapter; in terpene resins 
                                     complying with Sec.                
                                     175.300(b)(2)(xi) of this chapter, 
                                     when such terpene resins are used  
                                     in accordance with Sec.            
                                     176.170(b)(1) of this chapter; in  
                                     resins and polymers complying with 
                                     Sec.  176.180(b) of this chapter;  
                                     in closures with sealing gaskets   
                                     complying with Sec.  177.1210 of   
                                     this chapter; in petroleum         
                                     hydrocarbon resin and rosins and   
                                     rosin derivatives complying with   
                                     Sec.  178.3800(b) of this chapter; 
                                     and in reinforced wax complying    
                                     with Sec.  178.3850 of this        
                                     chapter.                           
                                    2. At levels not to exceed 0.2      
                                     percent by weight of the finished  
                                     cellophane complying with Sec.     
                                     177.1200 of this chapter.          
                                    3. At levels not to exceed 0.1      
                                     percent by weight in polystyrene   
                                     and rubber-modified polystyrene    
                                     complying with Sec.  177.1640 of   
                                     this chapter: Provided, That the   
                                     finished polystyrene and rubber-   
                                     modified polystyrene polymer       
                                     contact food only under conditions 
                                     of use B through G described in    
                                     Table 2 of Sec.  176.170(c) of this
                                     chapter.                           
                                    4. In adhesives complying with Sec. 
                                     175.105 of this chapter; in        
                                     pressure-sensitive adhesives       
                                     complying with Sec.  175.125 of    
                                     this chapter; and as provided in   
                                     Sec.  177.2600 of this chapter.    
4,4-Bis(,-      For use at levels not to exceed 0.3   
 dimethylbenzyl)diphenylamine      percent by weight of polypropylene   
 (CAS Reg. No. 10081-67-1).        complying with Sec.  177.1520(c) of  
                                   this chapter. The polypropylene      
                                   articles are limited to use in       
                                   contact with non-fatty foods only.   
Boric acid (CAS Reg. No. 10043-   For use only at levels not to exceed  
 35-3)..                           0.16 percent by weight of ethylene-  
                                   vinyl acetate-vinyl alcohol          
                                   copolymers complying with Sec.       
                                   177.1360(a)(3) and (d) of this       
                                   chapter.                             
1,3-Butanediol..................  ......................................
Butylated reaction product of p-  For use only as components of nonfood 
 cresol and dicyclopentadiene      articles complying with Secs.        
 produced by reacting p-cresol     175.105 and 177.2600(c)(4)(iii) of   
 and dicyclopentadiene in an       this chapter.                        
 approximate mole ratio of 1.5                                          
 to 1, respectively, followed by                                        
 alkylation with isobutylene so                                         
 that the butyl content of the                                          
 final product is not less than                                         
 18 percent.                                                            

[[Page 337]]

                                                                        
Butylated, styrenated cresols     For use only:                         
 produced when equal moles of     1. As provided in Secs.  175.105 and  
 isobutylene, styrene, and a       177.2600 of this chapter.            
 metacresol-paracresol mixture    2. At levels not to exceed 0.5 percent
 having a no more than 3 C         by weight of polystyrene, rubber-    
 distillation range including      modified polystyrene, or olefin      
 202 C are made to react so that   polymers complying with Sec.         
 the final product meets the       177.1520 (c) of this chapter, items  
 following specifications: Not     1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
 less than 95 percent by weight    3.2, 3.3, or 4, or complying with    
 of total alkylated phenols        other sections in parts 174, 175,    
 consisting of 13-25 percent by    176, 177, 178 and Sec.  179.45 of    
 weight of butylated m- and p-     this chapter, used in articles that  
 cresols, 26-38 percent by         contact food only unded the          
 weight of styrenated m- and p-    conditions described in Sec.         
 cresols, 37-49 percent by         176.170(c) of this chapter, Table 2, 
 weight of butylated styrenated    under conditions of use C through G. 
 m- and p-cresols, and not more                                         
 than 10 percent by weight total                                        
 of alkylated xylenols,                                                 
 alkylated o-cresol, alkylated                                          
 phenol, and alkylated                                                  
 ethylphenol; acidity not more                                          
 than 0.003 percent; and                                                
 refractive index at 25 C of                                            
 1.5550-1.5650, as determined by                                        
 ASTM method D1218-82,                                                  
 ``Standard Test Method for                                             
 Refractive Index and Refractive                                        
 Dispersion of Hydrocarbon                                              
 Liquids,'' which is                                                    
 incorporated by reference.                                             
 Copies may be obtained from the                                        
 American Society for Testing                                           
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or may                                         
 be examined at the Office of                                           
 the Federal Register, 800 North                                        
 Capitol Street, NW., suite 700,                                        
 Washington, DC 20408.                                                  
2-tert-Butyl-a(3-tert-butyl-4-    For use only:                         
 hydroxyphenyl)-p-cumenyl bis(p-  1. As components of nonfood articles  
 nonylphenyl) phosphite; the       complying with Secs.  175.105 and    
 nonyl group is a propylene        177.2600 of this chapter.            
 trimer isomer and the            2. At levels not to exceed 1.35       
 phosphorus content is in the      percent by weight of natural rubber, 
 range 3.8-4.0 weight percent.     butadiene-acrylonitrile, butadiene-  
                                   acrylonitrile-styrene, and butadiene-
                                   styrene polymers that are used in    
                                   contact with nonalcoholic food at    
                                   temperatures not to exceed room      
                                   temperature and that are employed in 
                                   closure-sealing gaskets complying    
                                   with Sec.  177.1210 of this chapter  
                                   or in coatings complying with Sec.   
                                   175.300, Sec.  175.320, or Sec.      
                                   176.170 of this chapter. The average 
                                   thickness of such coatings and       
                                   closure-sealing gaskets shall not    
                                   exceed 0.004 inch.                   
2-(3'-tert-Butyl-2'-hydroxy-5'-   For use only at levels not to exceed  
 methyl-phenyl)-5-                 0.5 percent by weight of olefin      
 chlorobenzotriazole with a        polymers complying with Sec.         
 melting point of 137-141 deg.C.   177.1520(c) of this chapter, provided
                                   that the finished polymer contacts   
                                   foods only of the types identified in
                                   Categories I, II, IV-B, VI-A and B,  
                                   VII-B, and VIII in Table 1, Sec.     
                                   176.170 of this chapter.             
4,4'-Butylidenebis(6-tert-butyl-  For use only.                         
 m-cresol).                                                             
                                  1. As provided in Secs.  175.105 and  
                                   177.2600 of this chapter.            
                                  2. At levels not to exceed 0.5 percent
                                   by weight of polypropylene complying 
                                   with Sec.  177.1520 of this chapter  
                                   and for use at levels not to exceed  
                                   0.3 percent by weight of polyethylene
                                   complying with Sec.  177.1520 of this
                                   chapter, provided that the finished  
                                   polypropylene and polyethylene       
                                   contact food only of the types       
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories I, II, VI-B, and VIII.    
Butyric acid, 3,3-bis(3-tert-     For use only: 1. At levels not to     
 butyl-4-hydroxyphenyl)ethylene    exceed 0.5 percent by weight of      
 ester (CAS Reg. No. 32509-66-3).  olefin copolymers complying with Sec.
                                    177.1520(c) of this chapter, items  
                                   3.1 and 3.2 except that when used in 
                                   contact with foods described as types
                                   III, IV-A, V, VII-A, and IX in Table 
                                   1 of Sec.  176.170(c) of this        
                                   chapter, the olefin copolymers may   
                                   only be used under conditions of use 
                                   E, F, and G set forth in Table 2 of  
                                   Sec.  176.170(c) of this chapter.    
                                  2. At levels not to exceed 0.5 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 1.1, 3.1, or 3.2  
                                   (where the copolymers complying with 
                                   items 3.1 and 3.2 contain not less   
                                   than 85 weight-percent of polymer    
                                   units derived from propylene).       
                                  3. At levels not to exceed 0.2 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 3.1,   
                                   and 3.2.                             
Calcium benzoate................                                        
Calcium bis[monoethyl(3,5-di-     For use only:                         
 tert-butyl-4-hydroxy-            1. At levels not to exceed 0.25       
 benzyl)phosphonate] (CAS Reg.     percent by weight of polypropylene   
 No. 65140-91-2).                  that complies with Sec.  177.1520(c) 
                                   of this chapter, items 1.1, 1.2, and 
                                   1.3.                                 
                                  2. At levels not to exceed 0.2 percent
                                   by weight of polyethylene and olefin 
                                   copolymers that comply with Sec.     
                                   177.1520(c) of this chapter, items   
                                   2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4,   
                                   3.5, and 3.6. Finished polymers      
                                   having a density less than 0.94 gram 
                                   per cubic centimeter shall be used in
                                   contact with food only under         
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  3. In adhesives complying with Sec.   
                                   175.105 of this chapter.             
                                  4. At levels not to exceed 0.5 percent
                                   by weight of pressure-sensitive      
                                   adhesives complying with Sec.        
                                   175.125 of this chapter.             

[[Page 338]]

                                                                        
                                  5. At levels not to exceed 0.5 percent
                                   by weight of rosins and rosin        
                                   derivatives complying with Sec.      
                                   175.300(b)(3)(v) of this chapter.    
                                  6. At levels not to exceed 0.5 percent
                                   by weight of can end cement          
                                   formulations complying with Sec.     
                                   175.300(b)(3)(xxxi) of this chapter. 
                                  7. At levels not to exceed 0.5 percent
                                   by weight of side seam cement        
                                   formulations complying with Sec.     
                                   175.300(b)(3)(xxxii) of this chapter.
                                  8. At levels not to exceed 0.5 percent
                                   by weight of petroleum alicyclic     
                                   hydrocarbon resins complying with    
                                   Sec.  175.320(b)(3) of this chapter. 
                                  9. At levels not to exceed 0.5 percent
                                   by weight of rosin and rosin         
                                   derivatives complying with Sec.      
                                   176.170(a)(5) of this chapter; and   
                                   petroleum alicyclic hydrocarbon      
                                   resins, or the hydrogenated product  
                                   thereof, complying with Sec.         
                                   176.170(b)(2) of this chapter.       
                                  10. At levels not to exceed 0.5       
                                   percent by weight of resins and      
                                   polymers used as components of paper 
                                   and paperboard in contact with dry   
                                   food in compliance with Sec.  176.180
                                   of this chapter.                     
                                  11. At levels not to exceed 0.5       
                                   percent by weight of closures with   
                                   sealing gaskets complying with Sec.  
                                   177.1210 of this chapter.            
                                  12. At levels not to exceed 0.5       
                                   percent by weight of the finished    
                                   rubber article complying with Sec.   
                                   177.2600 of this chapter.            
                                  13. At levels not to exceed 0.5       
                                   percent by weight of petroleum       
                                   hydrocarbon resin and rosins and     
                                   rosin derivatives complying with Sec.
                                    178.3800(b).                        
                                  14. At levels not to exceed 0.5       
                                   percent by weight of reinforced wax  
                                   complying with Sec.  178.3850.       
Calcium myristate...............                                        
Calcium ricinoleate.............  For use only at levels not to exceed 1
                                   percent by weight of polyoxymethylene
                                   copolymer as provided in Sec.        
                                   177.2470(b)(1) of this chapter.      
Calcium stearate................                                        
Carbethoxymethyl diethyl          At levels not to exceed 0.07 percent  
 phosphonate (CAS Reg. No. 867-    by weight of polyethylene phthalate  
 13-0).                            polymers complying with Sec.         
                                   177.1630 of this chapter.            
Cerium stereate (CAS Reg. No.     For use only at levels not to exceed  
 10119-53-6).                      0.5 percent by weight in rigid and   
                                   semirigid vinyl chloride homo- and   
                                   copolymer articles modified in       
                                   accordance with Sec.  178.3790(b)(1) 
                                   of this chapter that contact food    
                                   under conditions of use B through H  
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
Cupric acetate and lithium        For use at levels not exceeding 0.025 
 iodide.                           percent cupric acetate and 0.065     
                                   percent lithium iodide by weight of  
                                   nylon 66 resins complying with Sec.  
                                   177.1500 of this chapter; the        
                                   finished resins are used or are      
                                   intended to be used to contain foods 
                                   during oven baking or oven cooking at
                                   temperatures above 250 deg.F. The    
                                   average thickness of such resins in  
                                   the form in which they contact food  
                                   shall not exceed 0.0012 inch.        
Cuprous iodide..................  For use at levels not exceeding 0.01  
                                   percent cuprous iodide by weight of  
                                   nylon 66T resins complying with Sec. 
                                   177.1500 of this chapter; the        
                                   finished resins are used or are      
                                   intended to be used to contain foods 
                                   during oven baking or oven cooking at
                                   temperatures above 250 deg.F. The    
                                   average thickness of such resins in  
                                   the form in which they contact food  
                                   shall not exceed 0.001 inch.         
Cuprous iodide and cuprous        For use at levels not exceeding 0.0025
 bromide.                          percent cuprous iodide and 0.0175    
                                   percent cuprous bromide by weight of 
                                   nylon 66 resins complying with Sec.  
                                   177.1500 of this chapter; the        
                                   finished resins are used or are      
                                   intended to be used to contain foods 
                                   during oven baking or oven cooking at
                                   temperatures above 250 deg.F. The    
                                   average thickness of such resins in  
                                   the form in which they contact food  
                                   shall not exceed 0.0015 inch.        
Cyanoguanidine..................  For use only at levels not to exceed 1
                                   percent by weight of polyoxymethylene
                                   copolymer as provided in Sec.        
                                   177.2470(b)(1) of this chapter.      
Cyclic neopentanetetrayl          For use only at levels not to exceed  
 bis(octadecyl phosphite) (CAS     0.1 percent by weight of ethylene-   
 Reg. No. 3806-34-6); the          vinyl acetate copolymers complying   
 phosphorus content is in the      with Sec.  177.1350 of this chapter  
 range of 7.8 to 8.2 weight        that contact food under conditions of
 percent.                          use E, F, and G described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
Cyclic neopentanetetrayl          For use only:                         
 bis(octadecyl phosphite) (CAS    1. At levels not to exceed 0.25       
 Reg. No. 3806-34-6) (which may    percent by weight of olefin polymers 
 contain not more than 1 percent   complying with Sec.  177.1520(c) of  
 by weight of                      this chapter, items 1.1, 2.1, and    
 triisopropanolamine (CAS Reg.     3.1.                                 
 No. 122-20-3)); the phosphorus   2. At levels not to exceed 0.25       
 content is in the range of 7.8    percent by weight of olefin polymers 
 to 8.2 weight percent.            complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.2, that contact 
                                   food Types I, II, VI-A, VII-B, and   
                                   VIII described in Table 1 of Sec.    
                                   176.170(c) of this chapter under     
                                   conditions of use B (for boil-in-bag 
                                   applications), C, D, E, F, G, and H  
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  3. At levels not to exceed 0.15       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520, items 
                                   1.1 and 3.2, that contact food Types 
                                   I, II, VI-A, VII-B, and VIII         
                                   described in Table 1 of Sec.         
                                   176.170(c) of this chapter under     
                                   conditions of use B (for boil-in-bag 
                                   applications), C, D, E, F, G, and H  
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          

[[Page 339]]

                                                                        
                                  4. At levels not to exceed 0.20       
                                   percent by weight of polystyrene and/
                                   or rubber modified polystyrene       
                                   complying with Sec.  177.1640 of this
                                   chapter that contact food under      
                                   conditions of use E, F, and G        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
4,4'-Cyclohexylidenebis(2-        For use only at levels not to exceed  
 cyclohexylphenol).                0.1 percent by weight of olefin      
                                   polymers complying with Sec.         
                                   177.1520(c) of this chapter, items   
                                   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
                                   3.2, 3.3, or 4: Provided, That the   
                                   finished polymers contact food only  
                                   of the types identified in Sec.      
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, IV-B, VI, VII-
                                   B, and VIII.                         
Dicetyl thiodipropionate having   The concentration of this additive and
 a melting point of 59 -62 C as    any other permitted antioxidants in  
 determined by ASTM method E324-   the finished food-contact article    
 79, ``Standard Test Method for    shall not exceed a total of 0.5      
 Relative Initial and Final        milligram per square inch of food-   
 Melting Points and the Melting    contact surface.                     
 Range of Organic Chemicals,''                                          
 and a saponification value in                                          
 the range 176-183 as determined                                        
 by ASTM method D1962-67                                                
 (Reapproved 1979), ``Standard                                          
 Test Method for Saponification                                         
 Value of Drying Oils, Fatty                                            
 Acids, and Polymerized Fatty                                           
 Acids,'' which are incorporated                                        
 by reference. Copies may be                                            
 obtained from the American                                             
 Society for Testing Materials,                                         
 1916 Race St., Philadelphia, PA                                        
 19103, or may be examined at                                           
 the Office of the Federal                                              
 Register, 800 North Capitol                                            
 Street, NW., suite 700,                                                
 Washington, DC 20408.                                                  
Didodecyl- 1,4-dihydro-2,6-       For use only at levels not to exceed  
 dimethyl-3,5-pyridinedicarboxyl   0.3 percenmt by weight in rigid      
 aate (CAS Reg. No. 36265-41-5).   polymer articles modified in         
                                   accordance with Sec.  178.3790 that  
                                   contact food, under conditions of use
                                   E, F, and G described in Table 2 of  
                                   Sec.  176.170 of this chapter.       
2,6-Di(-methyl benzyl)-  For use only at levels not to exceed  
 4-methyl phenol [Chemical         0.2 percent by weight of olefin      
 Abstracts Service Registry No.    polymers complying with item 3.4 in  
 1817-68-1].                       Sec.  177.1520(c) of this chapter,   
                                   provided that such olefin polymers   
                                   are limited to use at a level not to 
                                   exceed 25 percent by weight in other 
                                   olefin polymers complying with Sec.  
                                   177.1520 of this chapter; and the    
                                   total amount in such finished olefin 
                                   polymers not to exceed 0.05 percent  
                                   by weight, including the level that  
                                   may be contributed by its presence at
                                   6 percent in the item ``butylated,   
                                   styrenated cresols * * * '' listed in
                                   this paragraph; and further provided 
                                   that the finished olefin polymers are
                                   intended for contact with foods,     
                                   except those containing more than 8  
                                   percent alcohol.                     
Dimethyl succinate polymer with   For use only:                         
 4-hydroxy-2,2,6,6-tetramethyl-1- 1. At levels not to exceed 0.3 percent
 piperidineethanol (CAS Reg. No.   by weight of olefin polymers         
 65447-77-0).                      complying with Sec.  177.1520 of this
                                   chapter and under conditions of use B
                                   through H described in Table 2 of    
                                   Sec.  176.170(c) of this chapter.    
                                  2. At levels not to exceed 0.3 percent
                                   by weight of ethylene-vinyl acetate  
                                   copolymers complying with Sec.       
                                   177.1350 of this chapter and under   
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
Dimethyltin/monomethyltin         For use only at levels not to exceed 2
 isooctylmercaptoacetates          percent by weight:                   
 consisting of 5 to 90 percent    1. In rigid polyvinyl chloride used in
 by weight of monomethyltin tris   the manufacture of pipes intended for
 (isooctylmercaptoacetate) (CAS    contact with water in food-processing
 Reg. No. 54849-38-6) or           plants, and                          
 monomethyltin tris(2-            2. In rigid polyvinyl chloride and in 
 ethylhexylmercaptoacetate) (CAS   rigid vinyl chloride copolymers      
 Reg. No. 57583-34-3) and 10 to    complying with Sec.  177.1950 of this
 95 percent by weight of           chapter or Sec.  177.1980 of this    
 dimethyltin bis                   chapter for use in contact with food 
 (isooctylmercaptoacetate) (CAS    of Types I, II, III, IV (except      
 Reg. No. 26636-01-1) or           liquid milk), V, VI, VII, VIII, and  
 dimethyltin bis(2-                IX described in Table 1 of Sec.      
 ethylhexylmercaptoacetate) (CAS   176.170(c) of this chapter under     
 Reg. No. 57583-35-43), and no     conditions of use C through G        
 more than 0.4 percent by weight   described in Table 2 of Sec.         
 of trimethyltin compounds, and    176.170(c) of this chapter at        
 having the following              temperatures not to exceed 88 C (190 
 specifications: Tin content (as   F).                                  
 Sn) in the range of 15 to 21                                           
 percent and mercaptosulfur                                             
 content in the range of 11 to                                          
 13.5 percent. Other alkyltin                                           
 compounds are not to exceed 20                                         
 ppm.                                                                   

[[Page 340]]

                                                                        
Dimyristyl thiodipropionate       Finished food-contact articles        
 having a melting point of 48 -    containing this additive shall meet  
 52 C as determined by ASTM        the extractives limitations          
 method E324-79, ``Standard Test   prescribed in Sec.  176.170(c) of    
 Method for Relative Initial and   this chapter.                        
 Final Melting Points and the                                           
 Melting Range of Organic                                               
 Chemicals,'' and a                                                     
 saponification equivalent in                                           
 the range 280-290 as determined                                        
 by ASTM method D1962-67                                                
 (Reapproved 1979), ``Standard                                          
 Test Method for Saponification                                         
 Value of Drying Oils, Fatty                                            
 Acids, and Polymerized Fatty                                           
 Acids,'' which are incorporated                                        
 by reference. Copies may be                                            
 obtained from the American                                             
 Society for Testing Materials,                                         
 1916 Race St., Philadelphia PA                                         
 19103, or may be examined at                                           
 the Office of the Federal                                              
 Register, 800 North Capitol                                            
 Street, NW., suite 700,                                                
 Washington, DC 20408.                                                  
Di(n-octyl)tin bis(2-ethylhexyl   For use only at levels not to exceed  
 maleate) [CAS Reg. No. 10039-33-  0.5 percent by weight of             
 5] having 12.5 to 15.0 percent    acrylonitrile copolymers complying   
 by weight of tin (Sn) and         with Secs.  177.1020 and 177.1030 of 
 having a saponification number    this chapter and used in contact with
 of 260 to 280. The additive is    all food types under conditions of   
 made from di(n-octyl)tin oxide    use C through G described in Table 2 
 meeting the specifications of     of Sec.  176.170(c) of this chapter. 
 Sec.  178.2650(a)(1).                                                  
N,N'-Diphenylthiourea...........  For use only:                         
                                  1. At levels not to exceed 0.5 percent
                                   by weight of polyvinyl chloride and/ 
                                   or vinyl chloride copolymers         
                                   complying with Sec.  177.1980 of this
                                   chapter.                             
                                  2. At levels not to exceed 0.5 percent
                                   by weight of vinyl chloride-vinyl    
                                   acetate copolymers containing not    
                                   more than 20 molar percent of vinyl  
                                   acetate.                             
2,6-Di-tert-butyl-4-ethylphenol.  For use only in contact with          
                                   nonalcoholic foods:                  
                                  1. At levels not exceeding 0.04 mg/   
                                   in\2\ of food contact surface and not
                                   exceeding 0.1 percent by weight in   
                                   ethylene polymers and copolymers     
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 2.3,   
                                   3.1, 3.2, and 3.3; Sec.  177.1340;   
                                   and Sec.  177.1350 of this chapter.  
                                   The average thickness of such        
                                   polymers and copolymers in the form  
                                   in which they contact food shall not 
                                   exceed 0.0025 in.                    
                                  2. At levels not exceeding 0.04 mg/   
                                   in\2\ of food contact surface in     
                                   ethylene polymers and copolymers     
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 2.3,   
                                   3.1, 3.2, and 3.3; Sec.  177.1340;   
                                   and Sec.  177.1350 of this chapter.  
                                   The average thickness of such        
                                   polymers and copolymers in the form  
                                   in which they contact food shall be  
                                   greater than 0.0025 in but shall not 
                                   exceed 0.025 in.                     
3,5-Di-tert-butyl-4-              For use only:                         
 hydroxyhydrocinnamic acid        1.  At levels not to exceed 0.5       
 triester with 1,3,5-tris(2-       percent by weight of polypropylene   
 hydroxyethyl)-s-triazine-2,4,6-   complying with Sec.  177.1520 of this
 (1H,3H,5H)-trione (CAS Reg. No.   chapter in articles that contact food
 34137-09-2).                      not in excess of high temperature    
                                   heat-sterilized condition of use A   
                                   described in Sec.  176.170(c) of this
                                   chapter, Table 2.                    
                                  2. At levels not to exceed 0.5 percent
                                   by weight of polyethylene complying  
                                   with Sec.  177.1520 of this chapter  
                                   in articles that contact food not in 
                                   excess of high temperature heat-     
                                   sterilized condition of use A        
                                   described in 176.170(c) of this      
                                   chapter, Table 2.                    
                                  3. In adhesives complying with Sec.   
                                   175.105 of this chapter.             
                                  4. At levels not to exceed 0.25       
                                   percent by weight of olefin          
                                   copolymers complying with Sec.       
                                   177.1520(c) of this chapter, items   
                                   3.1, 3.2, 3.3, 3.4, 3.5, and 4.0.    
                                  5. At levels not to exceed 2 percent  
                                   by weight of polyester elastomers,   
                                   complying with Sec.  177.1590 of this
                                   chapter, in contact with dry food    
                                   only, and finished rubber articles   
                                   for repeated use, complying with Sec.
                                    177.2600 of this chapter, in contact
                                   with all foods, at temperatures not  
                                   to exceed 150 F.                     
Di-tert-butylphenyl phosphonite   For use only:                         
 condensation product with        1. At levels not to exceed 0.1 percent
 biphenyl (CAS Reg. No. 38613-77-  by weight of olefin polymers         
 3) produced by the condensation   complying with Sec.  177.1520(c) of  
 of 2,4-di-tert-butylphenol with   this chapter, items 1.1, 2.1, 2.2,   
 the Friedel-Crafts addition       3.1, 3.2, or 3.3.                    
 product (phosphorus trichloride  2. At levels not to exceed 0.1 percent
 and biphenyl) so that the food    by weight of polycarbonate resins    
 additive has a minimum            complying with Sec.  177.1580 of this
 phosphorus content of 5.4         chapter.                             
 percent, an acid value not       3. At levels not to exceed 0.2 percent
 exceeding 10 mg KOH/gm, and a     by weight of polystyrene and 0.3     
 melting range of 85 C to 110 C    percent by weight of rubber-modified 
 (185 F to 230 F).                 polystyrene complying with Sec.      
                                   177.1640 of this chapter.            
                                  4. At levels not to exceed 0.15       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.1, 2.2, 3.1, or 
                                   3.2, where the polyethylene component
                                   has a density less than 0.94 gram per
                                   cubic centimeter.                    

[[Page 341]]

                                                                        
2,4-Di-tert-butylphenyl-3,5-di-   For use only:                         
 tert-butyl-4-hydroxy-benzoate    1. At levels not to exceed 0.6 percent
 (CAS Reg. No. 4221-80-1).         by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 1.1: (1) when used
                                   in single-use articles that contact  
                                   food of types I, II, IV-B, VI-A, VI- 
                                   B, VII-B, and VIII, identified in    
                                   table 1 of Sec.  176.170(c) of this  
                                   chapter; and (2) when used in        
                                   repeated-use articles that contact   
                                   food of types I, II, III, IV, V, VI, 
                                   VII, VIII, and IX identified in table
                                   1 of Sec.  176.170(c) of this        
                                   chapter. The additive is used under  
                                   conditions of use B through H        
                                   described in table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  2. At levels not to exceed 0.25       
                                   percent by weight of olefin polymers 
                                   having a density of not less than    
                                   0.94 gram per cubic centimeter and   
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 3.1,   
                                   and 3.2: (1) when used in single-use 
                                   articles that contact food of types  
                                   I, II, IV-B, VI-A, VI-B, VII-B, and  
                                   VIII, identified in table 1 of Sec.  
                                   176.170(c) of this chapter; and (2)  
                                   when used in repeated-use articles   
                                   that contact food of types I, II,    
                                   III, IV, V, VI, VII, VIII, and IX    
                                   identified in table 1 of Sec.        
                                   176.170(c) of this chapter. The      
                                   additive is used under conditions of 
                                   use B through H described in table 2 
                                   of Sec.  176.170(c) of this chapter. 
2,4-Di-tert-pentyl-6-[1-(3,5-di-  For use only:                         
 tert-pentyl-2-                                                         
 hydroxyphenyl)ethyl]phenyl                                             
 acrylate (CAS Reg. No. 123968-                                         
 25-2)..                                                                
                                  1. At levels not to exceed 0.2 percent
                                   by weight of polypropylene complying 
                                   with Sec.  177.1520 of this chapter. 
                                   The additive is used under conditions
                                   of use D through G described in Table
                                   2 of Sec.  176.170(c) of this        
                                   chapter.                             
                                  2. At levels not to exceed 0.5 percent
                                   by weight of styrene block polymers  
                                   complying with Sec.  177.1810 of this
                                   chapter. The additive is used under  
                                   conditions of use D through G        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  3.  At levels not to exceed 0.5       
                                   percent by weight of polystyrene and 
                                   rubber-modified polystyrene complying
                                   with Sec.  177.1640 of this chapter  
                                   in contact with all food types under 
                                   conditions of use D through G as     
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
Ethylenebis(oxyethylene)-bis-(3-  1. At levels not to exceed 0.3 percent
 tert-butyl-4-hydroxy-5-           by weight of polystyrene and/or      
 methylhydrocinnamate) (CAS Reg.   rubber modified polystyrene polymers 
 No. 36443-68-2).                  complying with Sec.  177.1640 of this
                                   chapter.                             
                                  2. At levels not to exceed 0.3 percent
                                   by weight of acrylonitrile-butadiene-
                                   styrene copolymers used in accordance
                                   with applicable regulations in parts 
                                   175, 176, 177, and 181 of this       
                                   chapter.                             
                                  3. At levels not to exceed 0.75       
                                   percent by weight of polyoxymethylene
                                   copolymers used in accordance with   
                                   Sec.  177.2470 of this chapter. The  
                                   finished articles shall not be used  
                                   for foods containing more than 15    
                                   percent alcohol.                     
                                  4. At levels not to exceed 0.25       
                                   percent by weight of polyoxymethylene
                                   homopolymers used in accordance with 
                                   Sec.  177.2480 of this chapter. The  
                                   finished articles shall not be used  
                                   for foods containing more than 15    
                                   percent alcohol.                     
                                  5. At levels not to exceed 0.2 percent
                                   by weight of rigid vinyl chloride    
                                   plastics prepared from vinyl chloride
                                   homopolymers and/or vinly chloride   
                                   copolymers used in accordance with a 
                                   prior sanction or applicable         
                                   regulations in parts 175, 176, and   
                                   177 of this chapter. The vinyl       
                                   chloride copolymers shall contain not
                                   less than 50 weight percent of total 
                                   polymer units derived from vinyl     
                                   chloride.                            
                                  6. At levels not to exceed 0.1 percent
                                   by weight of vinylidene chloride     
                                   homopolymers and/or vinylidene       
                                   chloride copolymers used in          
                                   accordance with a prior sanction or  
                                   applicable regulations in parts 175, 
                                   176, and 177 of this chapter. The    
                                   vinylidene chloride copolymers shall 
                                   contain not less than 50 weight      
                                   percent of total polymer units       
                                   derived from vinylidene chloride.    
                                  7. In adhesives used in accordance    
                                   with Sec.  175.105 of this chapter.  
2,2'-Ethylidenebis(4,6-di-tert-   For use only:                         
 butylphenol) (CAS Reg. No.       1. At levels not to exceed 0.1 percent
 35958-30-6).                      by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 1.1, 1.2, 1.3,    
                                   3.1, or 3.2 (where the polymers      
                                   complying with items 3.1 and 3.2     
                                   contain primarily polymer units      
                                   derived from propylene).             
                                  2. At levels not to exceed 0.05       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.1, 2.2, or 2.3. 
                                   The finished polymers are to be used 
                                   only under conditions of use B       
                                   through H described in Table 2 of    
                                   Sec.  176.170(c) of this chapter.    
                                  3. At levels not to exceed 0.075      
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.1, 2.2, or 2.3  
                                   (where the density of each of these  
                                   polymers is not less than 0.94 g/cc) 
                                   and item 3.1 or 3.2 (where each of   
                                   these polymers contains primarily    
                                   polymer units derived from ethylene).

[[Page 342]]

                                                                        
                                  4. At levels not to exceed 0.05       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 3.3, 3.4, 3.5, or 
                                   4.                                   
                                  5. At levels not to exceed 0.1 percent
                                   by weight of ethylene vinyl acetate  
                                   copolymers complying with Sec.       
                                   177.1350 of this chapter and under   
                                   conditions of use C through G        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  6. At levels not to exceed 0.1 percent
                                   by weight of rigid or semirigid      
                                   polyvinyl chloride and under         
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  7. At levels not to exceed 0.2 percent
                                   by weight of acrylonitrile-butadiene-
                                   styrene copolymers containing less   
                                   than 30 percent by weight of         
                                   acrylonitrile and under conditions of
                                   use D through G described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
                                  8. At levels not to exceed 0.1 percent
                                   by weight of polystyrene complying   
                                   with Sec.  177.1640 of this chapter  
                                   and under conditions of use D through
                                   G described in table 2 of Sec.       
                                   176.170(c) of this chapter.          
                                  9. At levels not to exceed 0.2 percent
                                   by weight of rubber-modified         
                                   polystyrene complying with Sec.      
                                   177.1640 of this chapter.            
                                  10. In adhesives complying with Sec.  
                                   175.105 of this chapter.             
Hexadecyl 3,5-di-tert-butyl-4-    For use only at levels not to exceed  
 hydroxybenzoate (CAS Reg. No.     0.5 percent by weight of olefin      
 67845-93-6).                      polymers complying with Sec.         
                                   177.1520 of this chapter.            
Hexamethylenebis (3,5-di-tert-    For use only:                         
 butyl-4-hydroxyhydrocinnamate)   1. As provided in Sec.  177.2470(b)(1)
 (CAS Reg. No. 35074-77-2).        and Sec.  177.2480(b)(1) of this     
                                   chapter.                             
                                  2. In adhesives complying with Sec.   
                                   175.105 of this chapter.             
                                  3. At levels not to exceed 1 percent  
                                   by weight in pressure-sensitive      
                                   adhesives complying with Sec.        
                                   175.125 of this chapter.             
                                  4. At levels not to exceed 1 percent  
                                   by weight in can end cement          
                                   formulations complying with Sec.     
                                   175.300(b)(3)(xxxi) of this chapter. 
                                  5. At levels not to exceed 1 percent  
                                   by weight in side seam cement        
                                   formulations complying with Sec.     
                                   175.300(b)(3)(xxxii) of this chapter.
                                  6. At levels not to exceed 1 percent  
                                   by weight in petroleum alicyclic     
                                   hydrocarbon resins, polyamide resins,
                                   and terpene resins complying with    
                                   Sec.  175.320 of this chapter.       
                                  7. At levels not to exceed 1 percent  
                                   by weight in rosin and rosin         
                                   derivatives when used in accordance  
                                   with Sec.  176.170(a)(5) of this     
                                   chapter.                             
                                  8. At levels not to exceed 1 percent  
                                   by weight in petroleum alicyclic     
                                   hydrocarbon resins or their          
                                   hydrogenated products complying with 
                                   Sec.  176.170(b)(2) of this chapter. 
                                  9. At levels not to exceed 1 percent  
                                   by weight in terpene resins complying
                                   with Sec.  175.300(b)(3)(xi) of this 
                                   chapter, when such terpene resins are
                                   used in accordance with Sec.         
                                   176.170(b)(1) of this chapter.       
                                  10. At levels not to exceed 1 percent 
                                   by weight in resins and polymers     
                                   authorized for use in accordance with
                                   Sec.  176.180 of this chapter.       
                                  11. At levels not to exceed 1 percent 
                                   by weight in closures with sealing   
                                   gaskets complying with Sec.  177.1210
                                   of this chapter.                     
                                  12. At levels not to exceed 1 percent 
                                   by weight in rubber articles intended
                                   for repeated use complying with Sec. 
                                   177.2600 of this chapter.            
                                  13. At levels not to exceed 1 percent 
                                   by weight in petroleum hydrocarbon   
                                   resin and rosins and rosin           
                                   derivatives used in accordance with  
                                   Sec.  178.3800 of this chapter.      
                                  14. At levels not to exceed 1 percent 
                                   by weight in reinforced wax complying
                                   with Sec.  178.3850 of this chapter. 
N,N'-Hexamethylenebis (3,5-di-    For use only:                         
 tert-butyl-4-                    1. At levels not to exceed 1 percent  
 hydroxyhydrocinnamamide) (CAS     by weight of nylon resins complying  
 Reg. No. 23128-74-7).             with Sec.  177.1500(b) of this       
                                   chapter, items 1 through 8, that     
                                   contact food only of the types       
                                   identified in categories in Sec.     
                                   176.170(c) of this chapter, Table 1  
                                   except VI-A and VI-C.                
                                  2. At levels not to exceed 0.75       
                                   percent by weight of nylon 12 resins 
                                   complying with Sec.  177.1500(b) of  
                                   this chapter, item 9, that contact   
                                   food only of the types identified in 
                                   categories in Sec.  176.170(c) of    
                                   this chapter, Table 1, except VI-A   
                                   and VI-C.                            
                                  3. At levels not to exceed 0.6 percent
                                   by weight of polyester resins        
                                   complying with Sec.                  
                                   175.300(b)(3)(vii) of this chapter.  
                                  4.  At levels not to exceed 0.6       
                                   percent by weight of closures with   
                                   sealing gaskets complying with Sec.  
                                   177.1210 of this chapter.            
                                  5. At levels not to exceed 0.6 percent
                                   by weight of repeated use rubber     
                                   articles complying with Sec.         
                                   177.2600 of this chapter.            
                                  6.  At levels not to exceed 0.5       
                                   percent by weight of polyoxymethylene
                                   copolymer complying with Sec.        
                                   177.2470 of this chapter.            
                                  7.  At levels not to exceed 0.5       
                                   percent by weight of polyoxymethylene
                                   homopolymer complying with Sec.      
                                   177.2480 of this chapter.            

[[Page 343]]

                                                                        
2-Hydroxy-4-isooctoxy-            For use only at levels not to exceed  
 benzophenone. Chemical            0.5 percent by weight of olefin      
 Abstracts (CA) name: Methanone,   copolymers complying with Sec.       
 [2-hydroxy-4-(isooctyloxy)        177.1520(c) of this chapter: Items   
 phenyl]phenyl; CA Registry No.    1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
 330:59-05-1.                      3.2, 3.3 or 4: Provided, That the    
                                   finished polymer contacts food only  
                                   of the types identified in Sec.      
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, VII-B and VIII   
                                   under conditions of use E, F, and G  
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
2(2-Hydroxy-5-                    For use only:                         
 methylphenyl)benzotriazole       1. As component of nonfood articles   
 meeting the following             complying with Sec.  177.1010 of this
 specification: melting point      chapter.                             
 126-132 C (258.8-269.6 F) (CAS   2. At levels not to exceed 0.25       
 Reg. No. 2440-22-4).              percent by weight of rigid polyvinyl 
                                   chloride and/or rigid vinyl chloride 
                                   copolymers complying with Sec.       
                                   177.1980 of this chapter.            
                                  3. In polystyrene that complies with  
                                   Sec.  177.1640 of this chapter and   
                                   that is limited to use in contact    
                                   with dry food of Type VIII described 
                                   in Table 1 of Sec.  176.170(c) of    
                                   this chapter.                        
                                  4. At levels not to exceed 0.25       
                                   percent by weight of polystyrene and/
                                   or rubber-modified polystyrene       
                                   polymers complying with Sec.         
                                   177.1640 of this chapter intended to 
                                   contact nonalcoholic food: Provided, 
                                   That the finished basic rubber-      
                                   modified polystyrene polymers in     
                                   contact with fatty foods shall       
                                   contain not less than 90 weight      
                                   percent of total polymer units       
                                   derived from styrene monomer.        
                                  5. At levels not to exceed 0.5 percent
                                   by weight of polycarbonate resins    
                                   complying with Sec.  177.1580 of this
                                   chapter. Provided, That the finished 
                                   polycarbonate resins contact food    
                                   only of Types I, II, III, IV, V, VI- 
                                   A, VI-B, VII, VIII, and IX identified
                                   in Table 1 of Sec.  176.170(c) of    
                                   this chapter and under conditions of 
                                   use E, F, and G described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
                                  6. At levels not to exceed 0.5 percent
                                   by weight of ethylene-1,4-           
                                   cyclohexylene dimethylene            
                                   terephthalate copolymers complying   
                                   with Sec.  177.1315 of this chapter  
                                   and of ethylene phthalate polymers   
                                   complying with Sec.  177.1630 of this
                                   chapter and that contact food only   
                                   under conditions of use D through G  
                                   described in Table 2, Sec.           
                                   176.170(c) of this chapter.          
2-Hydroxy-4-n-octoxy-             For use only at levels not to exceed  
 benzophenone.                     0.5 percent by weight of olefin      
                                   polymers complying with Sec.         
                                   177.1520(c) of this chapter, items   
                                   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
                                   3.2, 3.3, or 4: Provided, That the   
                                   finished polymer contacts food only  
                                   of the types identified in Sec.      
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, IV-B, VII-B, and 
                                   VIII , and under the conditions of   
                                   use B through H described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
4,4'-Isopropylidenediphenol       For use only at levels not exceeding  
 alkyl(1C12-C15) phosphites; the   1.0 percent by weight in rigid       
 phosphorus content is in the      polyvinyl chloride and/or rigid vinyl
 range of 5.2-5.6 weight percent.  chloride copolymers complying with   
                                   Secs.  177.1950, 177.1970 or 177.1980
                                   of this chapter, and used in contact 
                                   with food, except milk, only under   
                                   the conditions described in Sec.     
                                   176.170(c) of this chapter, Table 2, 
                                   under conditions of use D through G. 
Magnesium salicylate............  For use only in rigid polyvinyl       
                                   chloride and/or in rigid vinyl       
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter:      
                                   Provided, That total salicylates     
                                   (calculated as the acid) do not      
                                   exceed 0.3 percent by weight of such 
                                   polymers.                            
2-methyl-4,6-bis-                 For use only:                         
 [(octylthio)methyl] phenol (CAS  1. In adhesives complying with Sec.   
 Reg. No. 110553-27-0)             175.105 of this chapter.             
                                  2. At levels not to exceed 0.5 percent
                                   by weight of can-end cements and side-
                                   seam cements complying with Sec.     
                                   175.300(b)(3)(xxxi) and (xxxii) of   
                                   this chapter.                        
                                  3. At levels not to exceed 1 percent  
                                   by weight of pressure-sensitive      
                                   adhesives complying with Sec.        
                                   175.125 of this chapter, petroleum   
                                   alicyclic hydrocarbon resins         
                                   complying with Sec.  176.170 of this 
                                   chapter, resins and polymers         
                                   complying with Sec.  176.180 of this 
                                   chapter, and closures with sealing   
                                   gaskets complying with Sec.  177.1210
                                   of this chapter.                     
                                  4. At levels not to exceed 0.5 percent
                                   by weight of finished rubber products
                                   complying with Sec.  177.2600 of this
                                   chapter.                             
                                  5. At levels not to exceed 0.1 percent
                                   by weight of petroleum alicyclic     
                                   0hydrocarbon resins complying with   
                                   Sec.  175.320 of this chapter; rubber-
                                   modified polystyrene complying with  
                                   Sec.  177.1640 of this chapter that  
                                   contact food only under conditions of
                                   use B through H described in Table 2,
                                   Sec.  176.170(c) of this chapter; and
                                   petroleum hydrocarbon resins and     
                                   rosins and rosin derivatives         
                                   complying with Sec.  178.3800 of this
                                   chapter.                             
                                  6. At levels not to exceed 0.2 percent
                                   by weight of styrene block polymers  
                                   complying with Sec.  177.1810 of this
                                   chapter that contact food of Types I,
                                   II, IV-B, VI, VII-B, and VIII        
                                   described in Table 1, Sec.           
                                   176.170(c) of this chapter, only     
                                   under conditions of use C through H  
                                   described in Table 2, Sec.           
                                   176.170(c) of this chapter.          

[[Page 344]]

                                                                        
2,2'-Methylenebis(4,6-di-tert-    For use only at levels not to exceed  
 butylphenyl)2-ethylhexyl          0.25 percent by weight of            
 phosphite (CAS Reg. No. 126050-   polypropylene complying with Sec.    
 54-2).                            177.1520 of this chapter. The        
                                   finished polymers may only be used in
                                   contact with food of the types       
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories I, II, IV-B, VI-B, VII-B, 
                                   and VIII under conditions of use B   
                                   through H described in Table 2, Sec. 
                                   176.170(c) of this chapter, and with 
                                   food of the types identified in Sec. 
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories III, IV-A, V, VI-A, 
                                   VI-C, VII-A, and IX under conditions 
                                   of use C through G described in Table
                                   2, Sec.  176.170(c) of this chapter. 
2,2'-Methylenebis (6-tert-butyl-  For use only:                         
 4-ethylphenol).                  1. In acrylonitrile-butadiene-styrene 
                                   copolymers at levels not to exceed   
                                   0.6 percent by weight of the         
                                   copolymer.                           
                                  2. In semirigid and rigid acrylic and 
                                   modified acrylic plastics complying  
                                   with Sec.  177.1010 of this chapter  
                                   at levels not to exceed 0.1 percent  
                                   by weight of the plastic.            
4,4'-Methylenebis (2,6-di-tert-   For use only:                         
 butyl-phenol).                                                         
                                  1. As provided in Sec.  175.105 of    
                                   this chapter.                        
                                  2. At levels not to exceed 0.25       
                                   percent by weight of petroleum       
                                   hydrocarbon resins used in compliance
                                   with regulations in parts 174, 175,  
                                   176, 177, 178 and Sec.  179.45 of    
                                   this chapter.                        
                                  3. At levels not to exceed 0.25       
                                   percent by weight of terpene resins  
                                   used in compliance with regulations  
                                   in parts 174, 175, 176, 177, 178 and 
                                   Sec.  179.45 of this chapter.        
                                  4. At levels not to exceed 0.5 percent
                                   by weight of polyethylene complying  
                                   with Sec.  177.1520 of this chapter: 
                                   Provided, That the polyethylene end  
                                   product contacts foods only of the   
                                   types identified in Categories I, II,
                                   IV-B, VI, VII-B, and VIII in Table 1,
                                   Sec.  176.170(c) of this chapter.    
                                  5. At levels not to exceed 0.5 percent
                                   by weight of polybutadiene used in   
                                   rubber articles complying with Sec.  
                                   177.2600 of this chapter: Provided,  
                                   That the rubber end product contacts 
                                   foods only of the types identified in
                                   Categories I, II, IV-B, VI, VII-B,   
                                   and VIII in Table 1, Sec.  176.170(c)
                                   of this chapter.                     
2,2'-Methylenebis(4-methyl-6-     For use only:                         
 tert-butylphenol).                                                     
                                  1. At levels not to exceed 0.1 percent
                                   by weight of olefin polymers         
                                   complying with sec. 177.1520(c) of   
                                   this chapter, items 1.1, 1.2, 1.3,   
                                   2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4   
                                   used in articles that contact food of
                                   the types identified in sec.         
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, IV-B, VI, VII-
                                   B, and VIII.                         
                                  2. At levels not to exceed 1 percent  
                                   by weight of polyoxymethylene        
                                   copolymer as provided in sec.        
                                   177.2470(b)(1) of this chapter.      
                                  3. At levels not to exceed 0.5 percent
                                   by weight of polyoxymethylene        
                                   homopolymer as provided in Sec.      
                                   177.2480(b)(1) of this chapter.      
2,2-Methylenebis(4-methyl-6-tert- For use only:                         
 butylphenol) monoacrylate (CAS   1. At levels not to exceed 0.5 percent
 Reg. No. 61167-58-6).             by weight of polystyrene and rubber- 
                                   modified polystyrene complying with  
                                   Sec.  177.1640 of this chapter.      
                                  2. At levels not to exceed 0.5 percent
                                   by weight of styrene block ploymers  
                                   complying with Sec.  177.1810 of this
                                   chapter.                             
                                  3. At levels not to exceed 1 percent  
                                   by weight of adhesives complying with
                                   Sec.  175.105 of this chapter and    
                                   pressure sensitive adhesives         
                                   complying with Sec.  175.125 of this 
                                   chapter.                             
                                  4. At levels not to exceed 0.5 percent
                                   by weight of acrylonitrile-butadiene-
                                   styrene copolymers that comply with  
                                   Sec.  177.1020 of this chapter when  
                                   used in articles that contact food   
                                   only under conditions of use E, F,   
                                   and G as described in Table 2, Sec.  
                                   176.170 (c) of this chapter.         
2,2'-Methylenebis[6-(1-           For use only:                         
 methylcyclo-hexyl)-p-cresol].                                          
                                  1. As provided in Sec.  177.1210 of   
                                   this chapter.                        
                                  2. At levels not to exceed 0.2 percent
                                   by weight of polyethylene complying  
                                   with Sec.  177.1520 of this chapter: 
                                   Provided, That the finished          
                                   polyethylene contacts foods only of  
                                   the type identified in Sec.          
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, VI-B, and    
                                   VIII.                                
                                  3. In polyethylene complying with Sec.
                                    177.1520 of this chapter: Provided, 
                                   That the finished polyethylene       
                                   contacts foods only of the types     
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories III, IV, V, VI-A, VII, and
                                   IX, and only at temperatures not to  
                                   exceed room temperature: And further 
                                   provided, That percentage            
                                   concentration of the antioxidant in  
                                   the polyethylene, when multiplied by 
                                   the thickness in inches of the       
                                   finished polyethylene, shall not be  
                                   greater than 0.0005.                 
2,2'-Methylenebis(4-methyl-6-     For use only in acrylonitrile-        
 nonylphenol) and 2,6-bis(2-       butadiene-styrene copolymers used in 
 hydroxy-3-nonyl-5-methyl-         contact with nonalcoholic foods.     
 benzyl)-p-cresol mixtures                                              
 (varying proportions).                                                 
Nylon 66/610/6 terpolymer (see    For use only at levels not to exceed  
 Sec.  177.1500 of this chapter    1.5 percent by weight of             
 for identification).              polyoxymethylene homopolymer as      
                                   provided in Sec.  177.2480 (b)(1) of 
                                   this chapter.                        

[[Page 345]]

                                                                        
Nylon 612/6 copolymer. (CAS Reg.  For use only at levels not to exceed  
 No. 51733-10-9), weight ratio 6/  1.5 percent by weight of             
 1.                                polyoxymethylene homopolymer as      
                                   provided in Sec.  177.2480(b)(1).    
Octadecyl 3,5-di-tert-butyl-4-    For use only:                         
 hydroxyhydrocinnamate (CAS Reg.  1. At levels not exceeding 0.25       
 No. 2082-79-3).                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 1.1, 1.2, 1.3,    
                                   2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4.  
                                  2. As provided in Secs.  175.105 and  
                                   177.1010(a)(5) of this chapter.      
                                  3. At levels not exceeding 0.25       
                                   percent by weight of polystyrene and/
                                   or rubber-modified polystyrene       
                                   polymers complying with Sec.         
                                   177.1640 of this chapter, except that
                                   the finished basic rubber-modified   
                                   polystyrene polymers in contact with 
                                   fatty foods shall contain not less   
                                   than 85 weight percent of total      
                                   polymer units derived from styrene   
                                   monomer.                             
                                  4. At levels not to exceed 0.5 percent
                                   by weight of acrylonitrile-butadiene-
                                   styrene copolymers used in accordance
                                   with prior sanction or regulations in
                                   parts 174, 175, 176, 177, 178 and    
                                   Sec.  179.45 of this chapter.        
                                  5. At levels not exceeding 0.25       
                                   percent by weight of olefin          
                                   copolymers complying with Sec.       
                                   177.1520(c) of this chapter, items   
                                   3.4 and 3.5 as follows: (a) item 3.4,
                                   Provided, That the finished copolymer
                                   contacts foods only of types         
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories I, II, III, IV-B, VI, VII,
                                   VIII, and IX; (b) item 3.5, Provided,
                                   That the finished copolymer contacts 
                                   non-fatty foods only of types        
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories I, II, IV-B, VI, VII-B,   
                                   and VIII.                            
                                  6. At levels not exceeding 0.05       
                                   percent by weight of modified semi-  
                                   rigid and rigid vinyl chloride       
                                   plastics modified with methacrylate- 
                                   butadiene-styrene copolymers in      
                                   accordance with Sec.  178.3790.      
                                  7. At levels not exceeding 0.2 percent
                                   by weight of rigid polyvinyl         
                                   chloride.                            
                                  8. At levels not to exceed 0.3 percent
                                   by weight of polycarbonate resins    
                                   that comply with Sec.  177.1580 and  
                                   that contact food only under         
                                   conditions of use E, F, and G        
                                   described in Table 2, Sec.           
                                   176.170(c) of this chapter.          
                                  9. At levels not exceeding 0.1 percent
                                   by weight of ethylene-vinyl acetate  
                                   copolymers complying with Sec.       
                                   177.1350 of this chapter.            
                                  10. At levels not to exceed 0.2       
                                   percent by weight of nitrile rubber- 
                                   modified acrylonitrile-methyl        
                                   acrylate copolymers that comply with 
                                   Sec.  177.1480 of this chapter when  
                                   used in articles that contact food   
                                   only under conditions of use D, E, F,
                                   and G described in Table 2, Sec.     
                                   176.170(c) of this chapter.          
                                  11. At levels not exceeding 0.3       
                                   percent by weight of styrene block   
                                   polymers complying with Sec.         
                                   177.1810 of this chapter when used in
                                   articles that contact food only of   
                                   the types identified in Sec.         
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, IV-B, VI, VII-
                                   B, and VIII, and under conditions of 
                                   use D, E, F, and G described in Table
                                   2 of Sec.  176.170(c) of this        
                                   chapter.                             
                                  12. At levels not exceeding 0.2       
                                   percent by weight of vinylidene      
                                   chloride homopolymers and/or         
                                   vinylidene chloride copolymers       
                                   complying with applicable regulations
                                   in parts 175, 176, 177, 179, and 181 
                                   of this chapter. The vinylidene      
                                   chloride copolymers shall contain not
                                   less than 50 weight percent of total 
                                   polymer units derived from vinylidene
                                   chloride.                            
                                  13. At levels not exceeding 0.025     
                                   percent by weight of chlorinated     
                                   isobutylene-isoprene copolymers      
                                   complying with Sec.  177.1420(a)(3)  
                                   of this chapter.                     
                                  14. At levels not exceeding 0.5       
                                   percent by weight of the finished    
                                   rubber article complying with Sec.   
                                   177.2600 of this chapter.            
Oxidized bis(hydrogenated tallow  For use only at levels not to exceed  
 alkyl)amines.                     0.05 percent by weight of olefin     
                                   polymers complying with Sec.         
                                   177.1520(c) of this chapter, item    
                                   1.1, 1.2, or 1.3: The finished       
                                   polymers may be used in contact with 
                                   food types I, II, IV-B, VII-B, and   
                                   VIII described in Table 1 of Sec.    
                                   176.170(c) of this chapter, under    
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter, and with 
                                   food types III, IV-A, V, VI, VII-A,  
                                   and IX described in Table 1 of Sec.  
                                   176.170(c) of this chapter, under    
                                   conditions of use D through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
2,2'-Oxamidobis[ethyl 3-(3,5-di-  For use only:                         
 tert-butyl-4-                    1. At levels not to exceed 0.5 percent
 hydroxyphenyl)propionate] (CAS    by weight of polystyrene and rubber- 
 Reg. No. 70331-94-1).             modified polystyrene complying with  
                                   Sec.  177.1640 of this chapter.      
                                  2. At levels not to exceed 0.5 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 1.1, 1.2, and    
                                   1.3.                                 
                                  3. At levels not to exceed 0.5 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 2.3,   
                                   3.1, 3.2, 3.3, 3.4, 3.5, and 4.0 that
                                   contact food Types I, II, IV-B, VI,  
                                   VII-B and VIII described in Table 1  
                                   of Sec.  176.170(c) of this chapter. 

[[Page 346]]

                                                                        
                                  4. At levels not to exceed 0.1 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.2, 2.3,   
                                   3.1, 3.2, 3.3, and 4.0 that contact  
                                   food Types III, IV-A, V, VII-A, and  
                                   IX described in Table 1 of Sec.      
                                   176.170(c) of this chapter; except   
                                   that olefin copolymers complying with
                                   items 3.1 and 3.2 where the majority 
                                   of polymer units are derived from    
                                   propylene may contain the additive at
                                   levels not to exceed 0.5 percent by  
                                   weight.                              
                                  5. At levels not to exceed 0.1 percent
                                   by weight of olefin polymers         
                                   complying with item 3.4 of Sec.      
                                   177.1520(c) of this chapter, that    
                                   contact food Types III, VII-A, and IX
                                   described in Table 1 of Sec.         
                                   176.170(c) of this chapter; except   
                                   that olefin copolymers complying with
                                   item 3.4 where the majority of the   
                                   polymer units are derived from       
                                   propylene may contain the additive at
                                   levels not to exceed 0.5 percent by  
                                   weight.                              
Pentaerythritol and its stearate  For use only in rigid polyvinyl       
 ester.                            chloride and/or in rigid vinyl       
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter:      
                                   Provided, That the total amount of   
                                   pentaerythritol and/or               
                                   pentaerythritol stearate (calculated 
                                   as free pentaerythritol) does not    
                                   exceed 0.4 percent by weight of such 
                                   polymers.                            
N-Phenylbenzenamine reaction      For use at levels not to exceed 0.5   
 products with 2,4,4-              percent by weight of pressure-       
 trimethylpentenes (CAS Reg. No.   sensitive adhesives complying with   
 68411-46-1).                      Sec.  175.125 of this chapter.       
Phosphoric acid triesters with    At levels not to exceed 0.1 percent by
 triethylene glycol (CAS Reg.      weight of polyethylene phthalate     
 No. 64502-13-2).                  polymers complying with Sec.         
                                   177.1630 of this chapter, such that  
                                   the polymers contact foods only of   
                                   Type VI-B described in Table 1 of    
                                   Sec.  176.170(c) of this chapter.    
Phosphorous acid, cyclic          For use only at levels not to exceed  
 butylethyl propanediol, 2,4,6-    0.2 percent by weight of olefin      
 tri-tert-butylphenyl ester (CAS   polymers complying with Sec.         
 Reg. No. 161717-32-4).            177.1520(c) of this chapter, items   
                                   1.1, 1.2, or 1.3, and items 2.1, 2.2,
                                   or 2.3 (where the density of these   
                                   polymers is not less than 0.94 gram  
                                   per cubic centimeter), and items 3.1 
                                   or 3.2, provide that the finished    
                                   polymer contacts food only of types  
                                   I, II, and VI-B as described in Table
                                   1 of Sec.  176.170(c) of this chapter
                                   only under conditions of use B, C, D,
                                   E, F, G, and H as described in Table 
                                   2 of Sec.  176.170(c) of this        
                                   chapter.                             
Phosphorous acid, cyclic          For use only at levels not to exceed  
 neopentanetetrayl bis(2,4-di-     0.10 percent by weight of olefin     
 tert-butylphenyl) ester (CAS      polymers complying with Sec.         
 Reg. No. 26741-53-7) which may    177.1520(c) of this chapter, item    
 contain not more than 1 percent   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, or
 by weight of                      3.2, and limited to use in contact   
 triisopropanolamine (CAS Reg.     with food only under conditions of   
 No. 122-20-3).                    use B, C, D, E, F, G, and H described
                                   in Table 2 of Sec.  176.170(c) of    
                                   this chapter. Olefin polymers that   
                                   contain more than 50 weight-percent  
                                   of polymer units derived from        
                                   ethylene shall have a density equal  
                                   to or greater than 0.94 gram per     
                                   cubic centimeter.                    
Phosphorous acid, cyclic          For use only at levels not to exceed  
 neopentanetetrayl bis (2,6-di-    0.25 percent by weight of            
 tert-butyl-4-methylphenyl)ester   polypropylene complying with Sec.    
 (CAS Reg. No. 80693-00-1)..       177.1520 of this chapter. The        
                                   finished polymer may only be used in 
                                   contact with food of the types       
                                   identified in Sec.  176.170(c) of    
                                   this chapter, Table 1, under         
                                   Categories I, II, III, and VI-B under
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter, and with 
                                   food of the types under Categories V,
                                   VI-A, and VI-C under conditions of   
                                   use C through G.                     
Phosphorous acid, cyclic          For use only:                         
 neopentanetetrayl bis(2,4-di-    1. At levels not to exceed 0.86       
 tert-butylphenyl)ester (CAS       percent by weight in polyvinyl       
 Reg. No. 26741-53-7).             chloride and/or vinyl chloride       
                                   copolymers that comply with Secs.    
                                   177.1950, 177.1960, 177.1970, or     
                                   177.1980 of this chapter for use with
                                   all food types described in Table 1  
                                   of Sec.  176.170(c) of this chapter, 
                                   except those containing more than 15 
                                   percent alcohol, under conditions of 
                                   use B, C, D, E, F, G, and H described
                                   in Table 2 of Sec.  176.170(c) of    
                                   this chapter.                        
                                  2. At levels not to exceed 0.25       
                                   percent by weight of polycarbonate   
                                   resins that comply with Sec.         
                                   177.1580 of this chapter for use with
                                   all food types described in Table 1  
                                   of Sec.  176.170(c) of this chapter, 
                                   except those containing more than 15 
                                   percent alcohol, under conditions of 
                                   use B, C, D, E, F, G, and H described
                                   in Table 2 of Sec.  176.170(c) of    
                                   this chapter.                        
                                  3. At levels not to exceed 0.05       
                                   percent by weight in olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 3.1, that contain 
                                   more than 50 weight percent of       
                                   polymer units derived from ethylene  
                                   and whose density is less than 0.94  
                                   gram per cubic centimeter. The       
                                   average thickness of such polymers   
                                   intended for use in contact with food
                                   types V and VII-A described in Table 
                                   1 of Sec.  176.170(c) of this chapter
                                   shall not exceed 80 micrometers      
                                   (0.003 inch).                        

[[Page 347]]

                                                                        
Poly(1,4-                         For use only:                         
 cyclohexylenedimethylene-3,3'-   1. In polypropylene complying with    
 thiodipropionate) partially       Sec.  177.1520(c) of this chapter,   
 terminated with stearyl alcohol   item 1.1, and used in contact with   
 and produced when approximately   nonfatty, nonalcoholic food.         
 equal moles of 1,4-              2. At levels not to exceed 0.5 percent
 cyclohexanedimethanol and 3,3'-   by weight of polypropylene complying 
 thiodipropionic acid are made     with Sec.  177.1520(c) of this       
 to react in the presence of       chapter, item 1.1, and used in       
 stearyl alcohol so that the       contact with fatty, nonalcoholic     
 final product has an average      food. The average thickness of such  
 molecular weight in the range     polymers in the form in which they   
 of 1,800-2,200, as determined     contact fatty nonalcoholic food shall
 by vapor pressure osmometry,      not exceed 0.005 inch.               
 and has a maximum acid value of                                        
 2.5.                                                                   
Poly[(1,3-                        For use only at levels not to exceed  
 dibutyldistannthianediylidene)-   0.2 by percent weight in polyvinyl   
 1,3-dithio] having the formula    chloride resin where such resin      
 [C8H18Sn2S3]n (where n averages   constitutes not less than 98.7       
 1.5-2) and produced so as to      percent of a finished semirigid or   
 meet the following                rigid polyvinyl chloride food-contact
 specifications: Softening         surface, provided that the finished  
 point, 130-145 deg. C; volatile   food-contact article is employed only
 components at 150 deg. C, less    to package meat, cheese, and food    
 than 1.0 percent; sulphur         Types I, VIII, and IX as described in
 (sulfide) content in the range    Table 1 of Sec.  176.170(c) of this  
 20.5-22.0 percent; tin content    chapter. The finished food-contact   
 in the range 52.0-53.2 percent.   article containing this stabilizer,  
                                   when extracted with refined          
                                   cottonseed oil at 120 deg. F for 48  
                                   hours, using a volume-to-surface     
                                   ratio of 2 milliliters per square    
                                   inch of surface tested, shall yield  
                                   tin (Sn) not to exceed 0.0005        
                                   milligram per square inch of food-   
                                   contact surface.                     
Poly[(6-morpholino-s-triazine-    For use only:                         
 2,4-diyl)[(2,2,6,6-tetramethyl-  1. At levels not to exceed 0.3 percent
 4-piperidyl)imino]hexamethylene   by weight of polypropylene complying 
 [(2,2,6,6-tetramethyl-4-          with Sec.  177.1520(c) of this       
 piperidyl)imino]] (CAS Reg. No.   chapter, items 1.1,1.2, and 1.3, and 
 82451-48-7).                      of ethylene polymers complying with  
                                   Sec.  177.1520(c) of this chapter,   
                                   items 2.1, 2.3, and 3.1, whose       
                                   specific gravity is not less than    
                                   0.94. The finished polymers are to   
                                   contact food only under conditions of
                                   use D, E, F, and G described in Table
                                   2 of Sec.  176.170(c) of this        
                                   chapter.                             
                                  2. At levels not to exceed 0.3 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, items 2.1, 2.3, and    
                                   3.1, whose specific gravity is less  
                                   than 0.94, and of olefin polymers    
                                   complying with items 3.3., 3.4, 3.5, 
                                   and 4.0. The finished polymers are to
                                   contact food in articles having a    
                                   volume of at least 18.9 liters (5    
                                   gallons) only under conditions of use
                                   D, E, F, and G described in Table 2  
                                   of Sec.  176.170(c) of this chapter. 
Poly[[6-[(1,1,3,3-                For use only:                         
 tetramethybutyl) amino]-s-       1. At levels not to exceed 0.3 percent
 triazine-2,4-diyl][2,2,6,6-       by weight of polypropylene complying 
 tetramethyl-4-                    with Sec.  177.1520 of this chapter. 
 piperidyl)imino]hexamethylene[(  2. At levels not to exceed 0.2 percent
 2,2,6,6-tetramethyl-4-            by weight of polyethylene complying  
 piperidyl)imino]] (CAS Reg. No.   with Sec.  177.1520 of this chapter, 
 70624-18-9).                      that has a density equal to or       
                                   greater than 0.94 gram per cubic     
                                   centimeter.                          
                                  3. At levels not to exceed 0.3 percent
                                   by weight of polyethylene that has a 
                                   density less than 0.94 gram per cubic
                                   centimeter complying with Sec.       
                                   177.1520 of this chapter, items 2.1, 
                                   2.2, and 2.3, and of olefin polymers 
                                   and copolymers complying with items  
                                   3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4. 
                                   The finished polymers are to contact 
                                   food only under conditions of use B  
                                   through H described in Table 2 of    
                                   Sec.  176.170(c) of this chapter, and
                                   when contacting fatty foods of Types 
                                   III, IV-A, V, VII-A, and IX described
                                   in Table 1 of Sec.  176.170(c) of    
                                   this chapter, the finished articles  
                                   are to have a volume of at least 18.9
                                   liters (5 gallons).                  
Potassium bromide and either      For use at levels not exceeding 0.18  
 cupric acetate or cupric          percent potassium bromide and 0.005  
 carbonate.                        percent copper as cupric acetate or  
                                   cupric carbonate by weight of nylon  
                                   66 resins complying with Sec.        
                                   177.1500 of this chapter; the        
                                   finished resins are used or are      
                                   intended to be used to contain foods 
                                   during oven baking or oven cooking at
                                   temperatures above 250 deg. F. The   
                                   average thickness of such resins in  
                                   the form in which they contact food  
                                   shall not exceed 0.0015 inch.        
N,N'-1,3-Propanediylbis (3,5-di-  For use only at levels not to exceed  
 tert-butyl-4-                     0.6 percent by weight of rubber      
 hydroxyhydrocinnamamide) (CAS     articles for repeated use complying  
 Reg. No. 69851-61-2).             with Sec.  177.2600 of this chapter. 
Stearoylbenzoylmethane (CAS Reg.  For use only at levels not to exceed  
 No. 58446-52-9) consisting of a   0.5 percent by weight of vinyl       
 mixture of -diketones    chloride homopolymers modified in    
 produced by the condensation of   accordance with Sec.  178.3790(b)(1).
 acetophenone and technical        The finished polymers may be used in 
 methyl stearate..                 contact with food containing up to 50
                                   percent alcohol under conditions of  
                                   use B through H described in Table 2 
                                   of Sec.  176.170(c) of this chapter. 
Styrenated diphenylamine (CAS     For use only in adhesives complying   
 Reg. No. 68442-68-2).             with Sec.  175.105 of this chapter   
                                   and in rubber articles intended for  
                                   repeated use complying with Sec.     
                                   177.2600 of this chapter.            

[[Page 348]]

                                                                        
2-[[2,4,8,10-Tetrakis(1,1-        For use only:                         
 dimethylethyl)dibenzo[d,f][1,3,  1. At levels not to exceed 0.075      
 2]-dioxaphosphepin-6-yl]oxy]-     percent by weight of olefin          
 N,N-bis[2-[[2,4,8,10-             copolymers complying with Sec.       
 tetrakis(1,1-                     177.1520(c) of this chapter, item    
 dimethylethyl)dibenzo[d,f][1,3,   3.1a or 3.2a (where the density of   
 2]dioxaphosphepin-6-              each of these polymers is not less   
 yl]oxy]ethyl]ethanamine (CAS      than 0.94 gram per cubic centimeter),
 Reg. No. 80410-33-9).             and under conditions of use B through
                                   H described in Table 2 of Sec.       
                                   176.170(c) of this chapter.          
Tetrakis [methylene(3,5- di-tert- For use only:                         
 butyl-4- hydroxyhydro-           1. At levels not to exceed 0.5 percent
 cinnamate)] methane (CAS Reg.     by weight of all polymers used as    
 No. 6683-19-8).                   indirect additives in food packaging,
                                   except as specified below.           
                                  2. At levels not to exceed 0.1 percent
                                   by weight of petroleum wax or        
                                   synthetic petroleum wax complying    
                                   with Sec.  176.170(a)(5) of this     
                                   chapter.                             
                                  3. At levels not to exceed 1.0 percent
                                   by weight of:                        
                                  (a) Pressure sensitive adhesives      
                                   complying with Sec.  175.125 of this 
                                   chapter.                             
                                  (b) Can end cement formulations       
                                   complying with Sec.                  
                                   175.300(b)(3)(xxxi) of this chapter. 
                                  (c) Petroleum alicyclic hydrocarbon   
                                   resins complying with Sec.           
                                   175.320(b)(3) of this chapter, Sec.  
                                   176.170(b)(2) of this chapter, or    
                                   their hydrogenated products complying
                                   with Sec.  176.170(b)(2) of this     
                                   chapter.                             
                                  (d) Rosin and rosin derivatives used  
                                   in accordance with parts 175 through 
                                   178 of this chapter.                 
                                  (e) Terpene resins complying with Sec.
                                    175.300(b)(2)(xi) of this chapter   
                                   when such terpene resins are used in 
                                   accordance with Sec.  176.170(b) of  
                                   this chapter.                        
                                  (f) Resins and polymers complying with
                                   Sec.  176.180 of this chapter.       
                                  (g) Closures with sealing gaskets     
                                   complying with Sec.  177.1210 of this
                                   chapter.                             
                                  (h) Polyoxymethylene copolymer as     
                                   provided in Sec.  177.2470(b)(1) of  
                                   this chapter.                        
                                  (i) Petroleum hydrocarbon resin       
                                   complying with Sec.  178.3800.       
                                  (j) Reinforced wax complying with Sec.
                                    178.3850.                           
4,4-Thiobis(6-tert-butyl-m-       For use only:                         
 cresol).                                                               
                                  1. As provided in Secs.  175.105 and  
                                   177.2600 of this chapter.            
                                  2. At levels not to exceed 0.25       
                                   percent by weight of polyethylene    
                                   complying with Sec.  177.1520 of this
                                   chapter: Provided, That the specific 
                                   gravity of the polyethylene is not   
                                   less than 0.926: And further         
                                   provided, That the finished          
                                   polyethylene contacts food only of   
                                   the types identified in Sec.         
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, VI-B, and    
                                   VIII.                                
Thiodiethylene bis(3,5-di-tert-   For use only:                         
 butyl-4-hydroxyhydrocinnamate)   1. In adhesives complying with Sec.   
 (CAS Reg. No. 41484-35-9).        175.105 of this chapter.             
                                  2. At levels not to exceed 0.5 percent
                                   by weight of pressure-sensitive      
                                   adhesives complying with Sec.        
                                   175.125 of this chapter, petroleum   
                                   alicyclic hydrocarbon resins         
                                   complying with Sec.  176.170 of this 
                                   chapter, resins and polymers         
                                   complying with Sec.  176.180 of this 
                                   chapter, closures with sealing       
                                   gaskets complying with Sec.  177.1210
                                   of this chapter, and finished rubber 
                                   products complying with Sec.         
                                   177.2600 of this chapter.            
Thiodipropionic acid............  ......................................
1,3,5-Trimethyl-2,4,6-tris(3,5-   For use only:                         
 di-tert-butyl-4-hydroxybenzyl)   1. At levels not to exceed 0.5 percent
 benzene(CAS Reg. No. 1709-70-2).  by weight of polymers except nylon   
                                   resins identified in Sec.  177.1500  
                                   of this chapter.                     
                                  2. At levels not to exceed 1 percent  
                                   by weight of nylon resins identified 
                                   in Sec.  177.1500 of this chapter.   
Tri(mixed mono-and                                                      
 dinonylphenyl) phosphite (which                                        
 may contain not more than 1                                            
 percent by weight of                                                   
 triisopropanolamine).                                                  
1,3,5-Tris(3,5-di-tert-butyl-4-   For use only:                         
 hydroxybenzyl)-s-triazine-       1. At levels not to exceed 0.25       
 2,4,6(1H,3H,5H)trione (CAS Reg.   percent by weight of polypropylene   
 No. 27676-62-6).                  complying with Sec.  177.1520 of this
                                   chapter.                             
                                  2. In polyethylene complying with Sec.
                                    177.1520 of this chapter:           
                                  (a) At levels not to exceed 0.1 weight
                                   percent.                             
                                  (b) At levels not to exceed 0.5 weight
                                   percent in contact with nonfatty     
                                   food.                                
                                  3. At levels not to exceed 0.5 percent
                                   by weight of ethylene-propylene-5-   
                                   ethylidine-2-norbornene terpolymers  
                                   complying with Sec.  177.1520 of this
                                   chapter. The maximum thickness of    
                                   such polymers in the form in which   
                                   they contact food shall not exceed   
                                   0.005 inch.                          
                                  4. At levels not exceeding 0.1 percent
                                   by weight of olefin copolymers       
                                   complying with Sec. 177.1520(c) of   
                                   this chapter, items 3.1, 3.2, 3.3,   
                                   3.4, or 3.5.                         
                                  5. At levels not exceeding 0.25       
                                   percent by weight of olefin          
                                   copolymers complying with Sec.       
                                   177.1520(c) of this chapter, items   
                                   3.1 and 3.2, and also containing not 
                                   less than 85 weight percent of       
                                   polymer units derived from propylene.

[[Page 349]]

                                                                        
                                  6. At levels not to exceed 0.2 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c)(4)  
                                   of this chapter. The finished        
                                   polymers may be used in contact with 
                                   food under conditions of use A       
                                   through H described in Table 2 of    
                                   Sec.  176.170(c) of this chapter.    
1,3,5-Tris(3,5-di-tert-butyl-4-   For use only in contact with nonfatty 
 hydro-xyhydrocinnamoyl)           foods:                               
 hexahydro-s-triazine.            1. At levels not to exceed 0.25       
                                   percent by weight of polypropylene   
                                   complying with Sec.  177.1520 of this
                                   chapter.                             
                                  2. At levels not to exceed 0.1 percent
                                   by weight of polyethylene complying  
                                   with Sec.  177.1520 of this chapter. 
                                  3. At levels not to exceed 0.5 percent
                                   by weight of ethylene-propylene-5-   
                                   ethylidine-2-norbornene terpolymers  
                                   complying with Sec.  177.1520 of this
                                   chapter. The maximum thickness of    
                                   such polymers in the form in which   
                                   they contact food shall not exceed   
                                   0.005 inch.                          
1,3,5-Tris(4-tert-butyl-3-        For use only:                         
 hydroxy-2,6-dimethylbenzyl)-     1. At levels not to exceed 0.1 percent
 1,3,5-triazine-2,4,6-(1H,3H,5H)-  by weight of olefin polymers         
 trione. [CAS Reg. No. 40601-76-   complying with Sec.  177.1520 of this
 1].                               chapter, under conditions of use A   
                                   through H described in table 2 of    
                                   Sec.  176.170(c) of this chapter.    
                                  2. At levels not to exceed 0.1 percent
                                   by weight of polystyrene and rubber- 
                                   modified polystyrene that comply with
                                   Sec.  177.1640 of this chapter,      
                                   provided that the finished           
                                   polystyrene and rubber-modified      
                                   polystyrene contact food only under  
                                   the conditions described in Sec.     
                                   176.170(c) of this chapter, Table 2, 
                                   under conditions of use E through G. 
Tris(2,4-di-tert-                 For use only:                         
 butylphenyl)phosphite. (CAS      1. At levels not to exceed 0.5 percent
 Reg. No. 31570-04-4).             by weight of elastomers used in      
                                   rubber articles complying with Sec.  
                                   177.2600 of this chapter.            
                                  2. At levels not to exceed 1 percent  
                                   by weight of nylon resins complying  
                                   with Sec.  177.1500 of this chapter: 
                                   Provided, That the finished polymer  
                                   contacts food only under conditions  
                                   of use E, F, and G described in Table
                                   2 of Sec.  176.170(c) of this        
                                   chapter.                             
                                  3. At levels not to exceed 0.3 percent
                                   by weight of polycarbonate resins    
                                   complying with Sec.  177.1580 of this
                                   chapter.                             
                                  4. At levels not to exceeds 0.2       
                                   percent by weight of polystyrene and 
                                   rubber-modified polystyrene polymers 
                                   complying with Sec.  177.1640 of this
                                   chapter: Provided, that the finished 
                                   polymer contacts food only under     
                                   conditions of use B, C, D, E, F, G,  
                                   and H described in Table 2 of Sec.   
                                   176.170(c) of this chapter.          
                                  5. At levels not to exceed 0.25       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 1.1, 1.2, or 1.3. 
                                  6. At levels not to exceed 0.2.       
                                   percent by weight of olefin polymers 
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 2.1, 2.2, 2.3,    
                                   3.1, or 3.2. The finished polymers   
                                   complying with item 2.1, 2.2, or 2.3 
                                   having a density less than 0.94 gram 
                                   per cubic centimeter and a thickness 
                                   greater than 0.051 millimeter (0.002 
                                   inch), shall contact food only under 
                                   conditions of use E, F, and G        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  7. At levels not to exceed 0.2 percent
                                   by weight of ethylene-vinyl-acetate  
                                   copolymers complying with Sec.       
                                   177.1350 of this chapter, and that   
                                   are limited to use in contact with   
                                   food only under conditions of use E, 
                                   F, and G described in Table 2 of Sec.
                                    176.170(c) of this chapter. The     
                                   average thickness of such polymers in
                                   the form in which they contact fatty 
                                   food shall not exceed 0.1 millimeter 
                                   (0.004 inch).                        
                                  8. At levels not to exceed 0.2 percent
                                   by weight of olefin polymers         
                                   complying with Sec.  177.1520(c) of  
                                   this chapter, item 4. The finished   
                                   polymers having a thickness greater  
                                   than 0.051 millimeter (0.002 inch),  
                                   shall contact food only under        
                                   conditions of use E, F, and G        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  9. At levels not to exceed 0.5 percent
                                   by weight of acrylic and modified    
                                   acrylic plastics, semirigid and      
                                   rigid, complying with Sec.  177.1010 
                                   of this chapter.                     
                                  10. At levels not to exceed 0.1       
                                   percent by weight of isobutylene     
                                   polymers complying with Sec.         
                                   177.1420 of this chapter.            
                                  11. In adhesives complying with Sec.  
                                   175.105 of this chapter.             
                                  12. At levels not to exceed 0.5       
                                   percent by weight of pressure        
                                   sensitive adhesives complying with   
                                   Sec.  175.125 of this chapter.       
                                  13. At levels not to exceed 0.5       
                                   percent by weight of can end cement  
                                   formulations complying with Sec.     
                                   175.300(b)(3) (xxxi) of this chapter.
                                  14. At levels not to exceed 0.5       
                                   percent by weight of side seam cement
                                   formulations complying with Sec.     
                                   175.300(b)(3) (xxxii) of this        
                                   chapter.                             
                                  15. At levels not to exceed 0.5       
                                   percent by weight of petroleum       
                                   alicyclic hydrocarbon resins         
                                   complying with Sec.  175.320(b)(3) of
                                   this chapter.                        
                                  16. At levels not to exceed 0.5       
                                   percent by weight of petroleum       
                                   alicyclic hydrocarbon resins or their
                                   hydrogenated products complying with 
                                   Sec.  176.170(b) (2) of this chapter.

[[Page 350]]

                                                                        
                                  17. At levels not to exceed 0.5       
                                   percent by weight of resins and      
                                   polymers complying with Sec.         
                                   176.180(b) of this chapter.          
                                  18. At levels not to exceed 0.5       
                                   percent by weight of rosins and rosin
                                   derivatives complying with Sec.      
                                   176.210(d)(3) of this chapter.       
                                  19. At levels not to exceed 0.5       
                                   percent by weight of closures with   
                                   sealing gaskets complying with Sec.  
                                   177.1210 of this chapter.            
                                  20. At levels not to exceed 0.5       
                                   percent by weight of petroleum       
                                   hydrocarbon resin, and rosins and    
                                   rosin derivatives complying with Sec.
                                    178.3800(b).                        
                                  21. At levels not to exceed 0.5       
                                   percent by weight of reinforced wax  
                                   complying with Sec.  178.3850.       
                                  22. At levels not to exceed 0.5       
                                   percent by weight of olefin          
                                   copolymers complying with Sec.       
                                   177.1520(c) of this chapter, item    
                                   3.3. The finished polymers may be    
                                   used in contact with food under      
                                   conditions of use A through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
                                  23. At levels not to exceed 0.15      
                                   percent by weight of poly-1-butene   
                                   resins and butene/ethylene copolymers
                                   complying with Sec.  177.1570 of this
                                   chapter: Provided, that the finished 
                                   polymer contacts food only under     
                                   conditions of use B through H        
                                   described in Table 2 of Sec.         
                                   176.170(c) of this chapter.          
Tris(2-methyl-4-hydroxy-5-tert-   For use only:                         
 butylphenyl)butane (CAS Reg.     1. At levels not to exceed 0.25       
 No. 1843-03-4).                   percent by weight of polymers used as
                                   provided in Sec.  176.180 of this    
                                   chapter.                             
                                  2. At levels not to exceed 0.25       
                                   percent by weight of the following   
                                   polymers when used in articles that  
                                   contact food of Types I, II, IV-B, VI-
                                   B, VII-B, and VIII described in Table
                                   1 of Sec.  176.170(c) of this        
                                   chapter: Olefin polymers complying   
                                   with Sec.  177.1520(c) of this       
                                   chapter, items 1.1, 1.2, 1.3, 2.1,   
                                   2.2, 2.3, 3.1, 3.2, 3.3, or 4 or     
                                   complying with other sections in     
                                   parts 174, 175, 176, 177, 178 and    
                                   Sec.  179.45 of this chapter; vinyl  
                                   chloride polymers; and/or vinyl      
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter.      
                                  3. At levels not to exceed 0.1 percent
                                   by weight of the following polymers  
                                   when used in articles that contact   
                                   food of Types III, IV-A, V, VI-A, VI-
                                   C, VII-A, and IX described in Table 1
                                   of Sec.  176.170(c) of this chapter: 
                                   Olefin polymers complying with Sec.  
                                   177.1520(c) of this chapter, items   
                                   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,   
                                   3.2, 3.3, or 4 or complying with     
                                   other sections in parts 174, 175,    
                                   176, 177, 178 and Sec.  179.45 of    
                                   this chapter; vinyl chloride         
                                   polymers; and/or vinyl chloride      
                                   copolymers complying with Sec.       
                                   177.1980 of this chapter.            
                                  4. As provided in Sec.  175.105 of    
                                   this chapter.                        
                                  5. At levels not to exceed 0.2 percent
                                   by weight of polystyrene and/or      
                                   modified polystyrene polymers        
                                   identified in Sec.  177.1640 of this 
                                   chapter.                             
                                  6. At levels not to exceed 0.25       
                                   percent by weight of acrylonitrile-  
                                   butadiene-styrene copolymers used in 
                                   contact with nonalcoholic foods.     
                                  7. At levels not to exceed 1 percent  
                                   by weight of closure-sealing gasket  
                                   compositions complying with Sec.     
                                   177.1210(b) of this chapter.         
Zinc dibutyldithiocarbamate (CAS  For use only:                         
 Reg. No. 136-23-2).              1. At levels not to exceed 0.2 percent
                                   by weight of isobutyleneisoprene     
                                   copolymers complying with Sec.       
                                   177.1420 of this chapter: Provided,  
                                   That the finished copolymers contact 
                                   food only of the types identified in 
                                   Sec.  176.170(c) of this chapter,    
                                   Table 1, under Types V, VII, VIII,   
                                   and IX.                              
                                  2. At levels not to exceed 0.02       
                                   percent by weight of polypropylene   
                                   polymers complying with Sec.         
                                   177.1520(c), item 1.1 of this        
                                   chapter.                             
Zinc palmitate..................                                        
Zinc salicylate.................  For use only in rigid polyvinyl       
                                   chloride and/or in rigid vinyl       
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter:      
                                   Provided, That total salicylates     
                                   (calculated as the acid) do not      
                                   exceed 0.3 percent by weight of such 
                                   polymers.                            
Zinc stearate...................                                        
------------------------------------------------------------------------
\1\ Copies are available from the American Society for Testing and      
  Materials, 1916 Race Street, Philadelphia, Pa. 19103.                 

[42 FR 14609, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 178.2010, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 178.2550  4-Hydroxymethyl-2,6-di-tert-butylphenol.

    4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an 
antioxidant in articles intended for use in contact with food, in 
accordance with the following prescribed conditions:

[[Page 351]]

    (a) The additive has a solidification point of 140 deg.-141 deg.C.
    (b) The concentration of the additive and any other permitted 
antioxidants in the finished food-contact article does not exceed a 
total of 0.5 milligram per square inch of food-contact surface.



Sec. 178.2650  Organotin stabilizers in vinyl chloride plastics.

    The organotin chemicals identified in paragraph (a) of this section 
may be safety used alone or in combination, at levels not to exceed a 
total of 3 parts per hundred of resin, as stabilizers in vinyl chloride 
homopolymers and copolymers complying with the provisions of 
Sec. 177.1950 or Sec. 177.1980 of this chapter and that are identified 
for use in contact with food of types I, II, III, IV (except liquid 
milk), V, VI (except malt beverages and carbonated nonalcoholic 
beverages), VII, VIII, and IX described in table 1 of Sec. 176.170(c) of 
this chapter, except for the organotin chemical identified in paragraph 
(a)(3) of this section, which may be used in contact with food of types 
I through IX at temperatures not exceeding 75  deg.C (167  deg.F), and 
further that the organotin chemicals identified in paragraphs (a) (5) 
and (6) of this section may be used in contact with food of types I 
through IX at temperatures not exceeding 66  deg.C (150  deg.F), 
conditions of use D through G described in table 2 of Sec. 176.170(c) of 
this chapter, and further that dodecyltin chemicals identified in 
paragraph (a)(7) of this section which may be used in contact with food 
of types I, II, III, IV (except liquid milk), V, VI (except malt 
beverages and carbonated nonalcoholic beverages), VII, VIII, and IX 
described in table 1 of Sec. 176.170(c) of this chapter at temperatures 
not exceeding 71  deg.C (160  deg.F), in accordance with the following 
prescribed conditions:
    (a) For the purpose of this section, the organotin chemicals are 
those listed in paragraphs (a) (1), (2), (3), (4), (5), (6), and (7) of 
this section.
    (1) Di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate) is an octyltin 
chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having 
8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di(n-
octyl)tin dichloride or di(n-octyl)tin oxide. The isooctyl radical in 
the mercaptoacetate is derived from oxo process isooctyl alcohol. Di(n-
octyl)tin dichloride has an organotin composition that is not less than 
95 percent by weight of di(n-octyl)tin dichloride and not more than 5 
percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tin oxide has 
an organotin composition that is not less than 95 percent by weight of 
di(n-octyl)tin oxide and not more than 5 percent by weight of bis[tri(n-
octyl)tin] oxide, and/or mono n-octyltin oxide.
    (2) Di(n-octyl) tin maleate polymer is an octyltin chemical having 
the formula [(C8H17)2SnC4H2O4]n 
(where n is between 2 and 4 inclusive), having 25.2 to 26.6 percent by 
weight of tin (Sn) and having a saponification number of 225 to 255. It 
is made from di(n-octyl)tin dichloride or di(n-octyl)tin oxide meeting 
the specifications prescribed for di(n- octyl) tin dichloride or di(n-
octyl) tin oxide in paragraph (a)(1) of this section.
    (3) C10-16-Alkyl mercaptoacetates reaction products with 
dichlorodioctylstannane and trichlorooctylstannane (CAS Reg. No. 83447-
69-2) is an organotin chemical mixture having 10.8 to 11.8 percent by 
weight of tin (Sn) and having 8.0 to 8.6 percent by weight of mercapto 
sulfur. It is made from a mixture of di(n-octyl)tin dichloride and (n-
octyl)tin trichloride which has an organotin composition that is not 
less than 95 percent by weight di(n-octyl)tin dichloride/(n-octyl)tin 
trichloride, and not more than 1.5 percent by weight of tri(n-octyl)tin 
chloride. The alkyl radical in the mercaptoacetate is derived from a 
mixture of saturated n-alcohols which has a composition that is not less 
than 50 percent by weight tetradecyl alcohol, and that is not more than 
50 percent by weight total of decyl alcohol and/or dodecyl alcohol, and/
or hexadecyl alcohol.
    (4) (n-Octyl)tin S,S'S" tris(isooctyl-mercaptoacetate) is an 
octyltin chemical having the formula n-
C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No. 
26401-86-5) having 13.4 to 14.8 percent by weight of tin (Sn) and having 
10.9 to 11.9 percent by weight of mercapto sulfur. It is made from (n-
octyl)tin trichloride. The isooctyl radical in the mercaptoacetate is 
derived from oxo

[[Page 352]]

process isooctyl alcohol. The (n-octyl)tin trichloride has an organotin 
composition that is not less than 95 percent by weight of (n-octyl)tin 
trichloride and not more than 5 percent by weight of tri(n-octyl)tin 
chloride.
    (5) Bis(beta-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) (CAS 
Reg. No. 63397-60-4) is an estertin chemical having 14.0 to 15.0 percent 
by weight of tin (Sn) and having 7.5 to 8.5 percent by weight of 
mercapto sulfur. It is made from bis(beta-carbobutoxyethyl)tin 
dichloride. The isooctyl radical in the mercaptoacetate is derived from 
oxo process primary octyl alcohols. The bis(beta-carbobutoxyethyl)tin 
dichloride has an organotin composition that is not less than 95 percent 
by weight of bis(beta-carbobutoxyethyl)tin dichloride and not more than 
5 percent by weight of bis(beta-carbobutoxyethyltin trichloride. The 
triestertin chloride content of bis(beta-carbobutoxyethyltin) dichloride 
shall not exceed 0.02 percent. p
    (6) Beta-carbobutoxyethyltin tris(isooctylmercaptoacetate) (CAS Reg. 
No. 63438-80-2) is an estertin chemical having 13.0 to 14.0 percent by 
weight of tin (Sn) and having 10.5 to 11.5 percent by weight of mercapto 
sulfur. It is made from beta-carbobutoxyethyltin trichloride. The 
isooctyl radical in the mercaptoacetate is derived from oxo process 
primary octyl alcohol. The beta-carbobutoxyethyltin trichloride has an 
organotin composition that is not less than 95 percent by weight of 
beta-carbobutoxyethyltin trichloride and not more than 5 percent total 
of triestertin chloride and diestertin chloride.
    (7) The dodecyltin stabilizer is a mixture of 50 to 60 percent by 
weight of n-dodecyltin S,S',S''-tris(isooctylmercaptoacetate) (CAS Reg. 
No. 67649-65-4) and 40 to 50 percent by weight of di(n-dodecyl)tin S,S'-
di(isooctylmercaptoacetate) (CAS Reg. No. 84030-61-5) having 13 to 14 
percent by weight of tin (Sn) and having 8 to 9 percent by weight of 
mercapto sulfur. It is made from a mixture of dodecyltin trichloride and 
di(dodecyl)tin dichloride which has not more than 0.2 percent by weight 
of dodecyltin trichloride, not more than 2 percent by weight of 
dodecylbutyltin dichloride and not more than 3 percent by weight of 
tri(dodecyl)tin chloride. The isooctyl radical in the mercaptoacetate is 
derived from oxo process primary octyl alcohols.
    (b) The vinyl chloride plastic containers, film or panels in the 
finished form in which they are to contact food, shall meet the 
following limitations:
    (1) The finished plastics intended for contact with foods of the 
types listed in this section shall be extracted with the solvent or 
solvents characterizing those types of foods as determined from Table 2 
of Sec. 176.170(c) of this chapter at the temperature reflecting the 
conditions of intended use as determined therein. Additionally, 
extraction tests for acidic foods shall be included and simulated by 3-
percent acetic acid at temperatures specified for water in Table 2 of 
Sec. 176.170(c) of this chapter. The extraction tests shall cover at 
least three equilibrium periodic determinations, as follows:
    (i) The exposure time for the first determination shall be at least 
72 hours for aqueous solvents, and at least 6 hours for heptane.
    (ii) Subsequent determinations shall be at a minimum of 24-hour 
intervals for aqueous solvents, and 2-hour intervals for heptane. These 
tests shall yield total octylin stabilizers not to exceed 0.5 parts per 
million as determined by analytical method entitled ``Atomic Absorption 
Spectrometric Determination of Sub-part-per-Million Quantities of Tin in 
Extracts and Biological Materials with Graphite Furnace,'' Analytical 
Chemistry, Vol. 49, p. 1090-1093 (1977), which is incorporated by 
reference.Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St., 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (iii) Subsequent determinations for the dodecyltin mixture described 
in paragraph (a)(7) of this section shall be at a minimum of 24-hour 
intervals for aqueous solvents and 2-hour intervals for heptane. These 
tests shall yield di(n-octyl)tin

[[Page 353]]

S,S'-bis(isooctylmercaptoacetate), or di(n-octyl)tin maleate polymer, or 
(C10-C16)-alkylmercaptoacetate reaction products with 
dichlorodioctylstannane and trichlorooctylstannane, or n-octyltin 
S,S',S''-tris(isooctylmercaptoacetate), tris(isooctylmercaptoacetate) 
and di(n-dodecyl)tin bis(isooctylmercaptoacetate) or any combination 
thereof, not to exceed 0.5 parts per million as determined by an 
analytical method entitled ``Atomic Absorption Spectrophotometric 
Determination of Sub-part-per-Million Quantities of Tin in Extracts and 
Biological Materials with Graphite Furnace,'' Analytical Chemistry, Vol. 
49, pp. 1090-1093 (1977), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). The availability of this incorporation 
by reference is given in paragraph (b)(1)(ii) of this section.
    (2) In lieu of the tests prescribed in paragraph (b) (1) of this 
section, the finished plastics intended for contact with foods only of 
Types II, V, VI-A (except malt beverages), and VI-C may be end-tested 
with food-simulating solvents, under conditions of time and temperature, 
as specified below, whereby such tests shall yield the octyltin residues 
cited in paragraph (b)(1) of this section not in excess of 0.5 ppm:

------------------------------------------------------------------------
                                                             Temperature
                         Food-simulating solvent     Time      (degrees 
                                                    (hours)  Fahrenheit)
------------------------------------------------------------------------
Type II...............  Acetic acid, 3 pct.......        48         135 
Type V................  Heptane..................         2         100 
Type VI-A.............  Ethyl alcohol, 8 pct.....        24         120 
Type VI-C.............  Ethyl alcohol, 50 percent        24         120 
------------------------------------------------------------------------


[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 
48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, 
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2, 1985; 50 FR 
3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 
1985; 54 FR 24898, June 12, 1989]



            Subpart D--Certain Adjuvants and Production Aids



Sec. 178.3010  Adjuvant substances used in the manufacture of foamed plastics.

    The following substances may be safely used as adjuvants in the 
manufacture of foamed plastics intended for use in contact with food, 
subject to any prescribed limitations:

                                                                        
------------------------------------------------------------------------
          List of substances                       Limitations          
------------------------------------------------------------------------
Azodicarbonamide......................  For use as a blowing agent in   
                                         polyethylene complying with    
                                         item 2.1 in Sec.  177.1520(c)  
                                         of this chapter at a level not 
                                         to exceed 5 percent by weight  
                                         of finished foamed             
                                         polyethylene.                  
 1,1-Difluoroethane (CAS Reg. No. 75-    For use as a blowing agent in  
 37-6).                                  polystyrene.                   
Isopentane............................  For use as a blowing agent in   
                                         polystyrene.                   
n-Pentane.............................      Do.                         
1,1,2,2-Tetra-chloroethylene..........  For use only as a blowing agent 
                                         adjuvant in polystyrene at a   
                                         level not to exceed 0.3 percent
                                         by weight of finished foamed   
                                         polystyrene intended for use in
                                         contact with food only of the  
                                         types identified in Sec.       
                                         176.170(c) of this chapter,    
                                         Table 1, under Categories I,   
                                         II, VI, and VIII.              
Toluene...............................  For use only as a blowing agent 
                                         adjuvant in polystyrene at a   
                                         level not to exceed 0.35       
                                         percent by weight of finished  
                                         foamed polystyrene.            
------------------------------------------------------------------------


[47 FR 22090, May 21, 1982, as amended at 58 FR 64895, Dec. 10, 1993]



Sec. 178.3120   Animal glue.

    Animal glue may be safely used as a component of articles intended 
for use in producing, manufacturing, packing, processing, preparing, 
treating, packaging, transporting, or holding food, subject to the 
provisions of this section.
    (a) Animal glue consists of the proteinaceous extractives obtained 
from hides, bones, and other collagen-rich substances of animal origin 
(excluding diseased or rotted animals), to which may be added other 
optional adjuvant substances required in its production or added to 
impart desired properties.
    (b) The quantity of any substance employed in the production of 
animal glue does not exceed the amount reasonably required to accomplish 
the intended physical or technical effect nor any limitation further 
provided.
    (c) Any substance employed in the production of animal glue and 
which is the subject of a regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter conforms with any specification in such 
regulation.
    (d) Optional adjuvant substances employed in the production of 
animal glue include:

[[Page 354]]

    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for use in 
animal glue and used in accordance with such sanction or approval.
    (3) Substances identified in this paragraph (d)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
       List of substances                       Limitations             
------------------------------------------------------------------------
Alum (double sulfate of aluminum                                        
 and ammonium, potassium, or                                            
 sodium).                                                               
4-Chloro-3-methylphenol(p-        For use as preservative only.         
 chlorome-tacresol)..                                                   
Chromium potassium sulfate        For use only in glue used as a        
 (chrome alum).                    colloidal flocculant added to the    
                                   pulp suspension prior to the sheet-  
                                   forming operation in the manufacture 
                                   of paper and paper board.            
3,5-Dimethyl-1,3,5,H-             For use as preservative only.         
 tetrahydrothiadia-zine-2-thione.                                       
Disodium                              Do.                               
 cyanodithioimidocarbonate.                                             
Defoaming agents................  As provided in Sec.  176.210 of this  
                                   chapter.                             
Ethanolamine....................                                        
Ethylenediamine.................                                        
Formaldehyde....................  For use as a preservative only.       
Potassium N-                          Do.                               
 methyldithiocarbamate.                                                 
Potassium pentachlorophenate....      Do.                               
Rosins and rosin derivatives....  As provided in Sec.  178.3870.        
Sodium chlorate.................                                        
Sodium dodecylbenzenesulfonate..                                        
Sodium 2-mercaptobenzothiazole..  For use as preservative only.         
Sodium pentachlorophenate.......      Do.                               
Sodium o-phenylphenate..........      Do.                               
Zinc dimethyldithiocarbamate....      Do.                               
Zinc 2-mercaptobenzothiazole....      Do.                               
------------------------------------------------------------------------

    (e) The conditions of use are as follows:
    (1) The use of animal glue in any substance or article that is the 
subject of a regulation in this subpart conforms with any specifications 
or limitations prescribed by such regulation for the finished form of 
the substance or article.
    (2) It is used as an adhesive or component of an adhesive in 
accordance with the provisions of Sec. 175.105 of this chapter.
    (3) It is used as a colloidal flocculant added to the pulp 
suspension prior to the sheet-forming operation in the manufacture of 
paper and paperboard.
    (4) It is used as a protective colloid in resinous and polymeric 
emulsion coatings.



Sec. 178.3125  Anticorrosive agents.

    The substances listed in this section may be used as anticorrosive 
agents in food-contact materials subject to the provisions of this 
section:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Zinc hydroxy phosphite (CAS Reg. No. 55799- For use only as a component 
 16-1).                                      of resinous and polymeric  
                                             food-contact coatings      
                                             intended for repeated use  
                                             in contact with dry foods. 
------------------------------------------------------------------------


[50 FR 21835, May 29, 1985]



Sec. 178.3130   Antistatic and/or antifogging agents in food-packaging materials.

    The substances listed in paragraph (b) of this section may be safely 
used as antistatic and/or antifogging agents in food-packaging 
materials, subject to the provisions of this section:
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect.
    (b) List of substances:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Alpha-(Carboxymethyl)-omega-             For use only as an antistatic  
 (tetradecyloxy)polyoxyethylene).         and/or antifogging agent at   
                                          levels not to exceed 0.2 pct  
                                          by weight in polyolefin film  
                                          not exceeding 0.001 inch      
                                          thickness.                    

[[Page 355]]

                                                                        
N-Acyl sarcosines where the acyl group   For use only:                  
 is lauroyl, oleoyl, or derived from     1. As antistatic and/or        
 the combined fatty acids of coconut      antifogging agent at levels   
 oil.                                     not to exceed a total of 0.15 
                                          pct by weight of polyolefin   
                                          film used for packaging meat, 
                                          fresh fruits, and fresh       
                                          vegetables. The average       
                                          thickness of such polyolefin  
                                          film shall not exceed 0.003   
                                          inch.                         
                                         2. As antistatic and/or        
                                          antifogging agent at levels   
                                          not to exceed a total of 0.15 
                                          pct by weight of ethylene-    
                                          vinyl acetate copolymer film  
                                          complying with Sec.  177.1350 
                                          of this chapter and used for  
                                          packaging meat, fresh fruits, 
                                          fresh vegetables, and dry food
                                          of Type VIII described in     
                                          Table 1 of Sec.  176.170(c) of
                                          this chapter. The average     
                                          thickness of such ethylene-   
                                          vinyl acetate copolymer film  
                                          shall not exceed 0.003 inch   
                                          when used for packaging meat, 
                                          fresh fruits, and fresh       
                                          vegetables.                   
Alkyl mono- and disulfonic acids,        For use only:                  
 sodium salts (produced from n-alkanes                                  
 in the range of C10-C18 with not less                                  
 than 50 percent C14-C16)..                                             
                                                                        
1. As antistatic agents at levels not                                   
 to exceed 0.1 percent by weight of                                     
 polyolefin films that comply with Sec.                                 
  177.1520 of this chapter: Provided,                                   
 that the finished olefin polymers                                      
 contact foods of Types I, II, III, IV,                                 
 V, VIA, VIB, VII, VIII, and IX                                         
 described in Table 1 of Sec.                                           
 176.170(c) of this chapter, and under                                  
 conditions of use E, F, and G                                          
 described in Table 2 of Sec.                                           
 176.170(c) of this chapter.                                            
                                                                        
2.  As antistatic agents at levels not                                  
 to exceed 3.0 percent by weight of                                     
 polystyrene or rubber-modified                                         
 polystyrene complying with Sec.                                        
 177.1640(c) of this chapter under                                      
 conditions of use B through H                                          
 described in Table 2 of Sec.                                           
 176.170(c) of this chapter.                                            
N,N-Bis(2-hydroxyethyl)alkyl(C12-        For use only as an antistatic  
 C18)amine.                               agent at levels not to exceed 
                                          0.1 pct by weight of          
                                          polyolefin food-contact films.
N,N-Bis(2-hydroxyethyl)alkyl(C13-        For use only as an antistatic  
 C15)amine (CAS Reg. No. 70955-14-5)..    agent at levels not to exceed 
                                          0.2 percent by weight in      
                                          molded or extruded high-      
                                          density polyethylene (having a
                                          density  0.95 g/   
                                          cm3) and polypropylene        
                                          containers that contact food  
                                          only of the types identified  
                                          in Sec.  176.170(c) of this   
                                          chapter, Table 1, under types 
                                          I, VI-B, VII-B, and VIII,     
                                          under the conditions of use E 
                                          through G described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter, provided such foods  
                                          have a pH above 5.0.          
N,N-Bis(2-hydroxyethyl) alkylamine,      For use only:                  
 where the alkyl groups (C14-C18) are    1. As an antistatic agent at   
 derived from tallow.                     levels not to exceed 0.15 pct 
                                          by weight in molded or        
                                          extruded polyethylene         
                                          containers that contact food  
                                          only of the types identified  
                                          in Sec.  176.170(c) of this   
                                          chapter, Table 1, under Types 
                                          I, IV-B, VI-B, VII-B, and     
                                          VIII, under the conditions of 
                                          use E through G described in  
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter provided such    
                                          foods have a pH above 5.0.    
                                         2. As an antistatic agent at   
                                          levels not to exceed 0.10 mg. 
                                          per square inch of food-      
                                          contact surface in vinylidene 
                                          chloride copolymer coatings   
                                          complying with Sec.  175.320, 
                                          Sec.  177.1200, or Sec.       
                                          177.1630 of this chapter,     
                                          provided that such coatings   
                                          contact food only of the types
                                          identified in Sec.  176.170(c)
                                          of this chapter, Table 1,     
                                          under Types I, IV, VII, VIII, 
                                          and IX under the conditions of
                                          use E through G described in  
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter. The finished    
                                          copolymers shall contain at   
                                          least 70 weight pct of polymer
                                          units derived from vinylidene 
                                          chloride; and shall contain   
                                          not more than 5 weight pct of 
                                          total polymer units derived   
                                          from acrylamide, acrylic acid,
                                          fumaric acid, itaconic acid,  
                                          methacrylic acid, octadecyl   
                                          methacrylate, and vinyl       
                                          sulfonic acid.                
N,N-Bis(2-hydroxyethyl) dodecanamide     For use only as an antistatic  
 produced when diethanolamine is made     agent at levels not to exceed 
 to react with methyl laurate such that   0.5 percent by weight of      
 the finished product: Has a minimum      molded or extruded            
 melting point of 36 deg. C; has a        polyethylene containers       
 minimum amide assay of 90 percent;       intended for contact with     
 contains no more than 2 percent by       honey, chocolate syrup, liquid
 weight of free diethanolamine; and       sweeteners, condiments, flavor
 contains no more than 0.5 percent by     extracts and liquid flavor    
 weight of N,N'-bis(2-hydroxyethyl)       concentrates, grated cheese,  
 piperazine, as determined by paper       light and heavy cream, yogurt,
 chromatography method.                   and foods of Type VIII as     
                                          described in Table 1 of Sec.  
                                          176.170(c) of this chapter.   

[[Page 356]]

                                                                        
N,N-Bis(2-hydroxyethyl) octadecylamine,  For use only as an antistatic  
 Chemical Abstracts Service Registry      agent at levels not to exceed 
 No. 10213-78-2, N-(2-hydroxyethyl)-N-    0.45 percent by weight in     
 octadecylglycine (monosodium salt),      polypropylene films complying 
 Chemical Abstracts Service Registry      with Sec.  177.1520 of this   
 No. 66810-88-6, and N,N-Bis(2-           chapter, and used for         
 hydroxyethyl)-N-(carboxymethyl)          packaging food of Types I, II,
 octadecanaminum hydroxide (inner         III, IV, V, VI-B, VII, VIII,  
 salt), Chemical Abstracts Service        and IX described in Table 1 of
 Registry No. 24170-14-7, as the major    Sec.  176.170(c) of this      
 components of a mixture prepared by      chapter, and under conditions 
 reacting ethylene oxide with             of use B through H described  
 octadecylamine and further reacting      in Table 2 of Sec.            
 this product with sodium                 176.170(c). The average       
 monochloroacetate and sodium             thickness of such             
 hydroxide, such that the final product   polypropylene film shall not  
 has: A nitrogen content of 3.3-3.8       exceed 0.002 inch.            
 percent; a melting point of 42 deg.-50                                 
 deg. C; and a pH of 10.0-11.5 in a 1                                   
 percent by weight aqueous solution.                                    
-n-Dodecanol-omega-hydroxypoly  For use only as an antistatic  
 (oxyethylene) produced by the            agent at levels not to exceed 
 condensation of 1 mole of n-dodecanol    0.2 pct by weight in low-     
 with an average of 9.5 moles of          density polyethylene film     
 ethylene oxide to form a condensate      having an average thickness   
 having a hydroxyl content of 2.7 to      not exceeding 0.005 inch.     
 2.9 pct and having a cloud point of 80                                 
 deg. C to 92 deg. C in 1 pct by weight                                 
 aqueous solution.                                                      
Glycerol ester mixtures of ricinoleic    As an antifogging agent at     
 acid, containing not more than 50        levels not exceeding 1.5 pct  
 percent monoricinoleate, 45 pct          by weight of permitted        
 diricinoleate, 10 pct triricinoleate,    plasticized vinyl chloride    
 and 3.3 pct free glycerine.              homo-and/or copolymers.       
N-Methacryloyloxyethyl-N, N-             For use only as an antistatic  
 dimethylammonium--N-methyl      agent at levels not to exceed 
 carboxylate chloride sodium salt,        0.2 percent by weight of      
 octadecyl methacrylate, ethyl            polyolefin films that contact 
 methacrylate, cyclohexyl methacrylate,   foods under the conditions of 
 N-vinyl-2-pyrrolidone copolymer (CAS     use B through H described in  
 Reg. No. 66822-60-4)..                   Table 2 of Sec.  176.170(c) of
                                          this chapter. The average     
                                          thickness of such polyolefin  
                                          film shall not exceed 0.02    
                                          centimeter (0.008 inch).      
Octadecanoic acid 2-[2-hydroxyethyl)     For use only as an antistatic  
 octadecylamino]ethyl ester (CAS Reg.     agent at levels such that the 
 No. 52497-24-2), (octadecylimino)        product of film thickness in  
 diethylene distearate (CAS Reg. No.      microns times the weight      
 94945-28-5), and octadecyl               percent additive does not     
 bis(hydroxyethyl)amine (CAS Reg. No.     exceed 16, in polypropylene   
 10213-78-2), as the major components     films complying with Sec.     
 of a mixture prepared by reacting        177.1520(c)1.1 of this        
 ethylene oxide with octadecylamine and   chapter, and used for         
 further reacting this product with       packaging food (except for    
 octadecanoic acid, such that the final   food containing more than 8   
 product has: a maximum acid value of 5   percent alcohol) under        
 mg KOH/g and total amine value of 86     conditions of use B through H 
 6 mg KOH/g as determined     described in Table 2 of Sec.  
 by a method entitled ``Total Amine       176.170(c) of this chapter.   
 Value,'' which is incorporated by                                      
 reference. Copies of the method are                                    
 available from the Center for Food                                     
 Safety and Applied Nutrition (HFS-                                     
 200), Food and Drug Administration,                                    
 200 C St. SW., Washington, DC 20204,                                   
 or available for inspection at the                                     
 Office of the Federal Register, 800                                    
 North Capitol Street, NW., suite 700,                                  
 Washington, DC 20408..                                                 
------------------------------------------------------------------------

[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 
45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, 
June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 
58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, 
Apr. 11, 1995]



Sec. 178.3280   Castor oil, hydrogenated.

    Hydrogenated castor oil may be safely used in the manufacture of 
articles or components of articles intended for use in contact with food 
subject to the provisions of this section.
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect.
    (b) The additive is used as follows:

------------------------------------------------------------------------
                  Use                              Limitations          
------------------------------------------------------------------------
1. As a lubricant for vinyl chloride     For use only at levels not to  
 polymers used in the manufacture of      exceed 4 pct by weight of     
 articles or components of articles       vinyl chloride polymers.      
 authorized for food-contact use.                                       
2. As a component of cellophane........  Complying with Sec.  177.1200  
                                          of this chapter.              
3. As a component of resinous and        Complying with Sec.  175.300 of
 polymeric coatings.                      this chapter.                 
4. As a component of paper and           Complying with Sec.  176.170 of
 paperboard in contact with aqueous and   this chapter.                 
 fatty food.                                                            
5. As a component of closures with       Complying with Sec.  177.1210  
 sealing gaskets for food containers.     of this chapter.              
6. As a component of cross-linked        Complying with Sec.  177.2420  
 polyester resins.                        of this chapter.              
7. As a component of olefin polymers     For use only at levels not to  
 complying with Sec.  177.1520 of this    exceed 2 percent by weight of 
 chapter.                                 the polymer.                  
------------------------------------------------------------------------



[[Page 357]]

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]



Sec. 178.3290   Chromic chloride complexes.

    Myristo chromic chloride complex and stearato chromic chloride 
complex may be safely used as release agents in the closure area of 
packaging containers intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food, subject to the provisions of this section:
    (a) The quantity used shall not exceed that reasonably required to 
accomplish the intended technical effect nor exceed 7 micrograms of 
chromium per square inch of closure area.
    (b) The packaging container which has its closure area treated with 
the release agent shall have a capacity of not less than 120 grams of 
food per square inch of such treated closure area.



Sec. 178.3295  Clarifying agents for polymers.

    Clarifying agents may be safely used in polymers that are articles 
or components of articles intended for use in contact with food, subject 
to the provisions of this section:

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
Bis(p-ethylbenzylidene) sorbitol (CAS    For use only as a clarifying   
 Reg. No. 79072-96-1).                    agent at a level not to exceed
                                          0.3 percent by weight of      
                                          olefin polymers complying with
                                          Sec.  177.1520(c) of this     
                                          chapter, items 1.1, 3.1, or   
                                          3.2, where the copolymers     
                                          complying with items 3.1 or   
                                          3.2 contain not less than 85- 
                                          weight percent of polymer     
                                          units derived from propylene, 
                                          in contact with all food types
                                          except alcoholic beverages    
                                          containing more than 20       
                                          percent by weight of alcohol; 
                                          under conditions of use B     
                                          through H described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter.                      
                                                                        
Di(p-tolylidene) sorbitol (CAS Reg. No.  For use only as a clarifying   
 54686-97-4).                             agent at a level not to exceed
                                          0.32 percent by weight in     
                                          propylene homopolymer         
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          item 1.1, and in olefin       
                                          copolymers complying with Sec.
                                           177.1520(c) of this chapter, 
                                          item 3.1 (containing at least 
                                          85 weight percent of polymer  
                                          units derived from propylene),
                                          in contact with all food types
                                          under conditions of use C     
                                          through G described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter.                      
Dibenzylidene sorbitol (CAS Reg. No.     For use only as a clarifying   
 32647-67-9) formed by the condensation   agent for olefin polymers     
 of two moles of benzaldehyde with one    complying with Sec.           
 mole of sorbitol, such that the final    177.1520(c) 1.1, 3.1, and 3.2 
 product has a minimum content of 95      of this chapter under         
 percent dibenzylidene sorbitol.          conditions of use C, D, E, F, 
                                          and G, described in Table 2 of
                                          Sec.  176.170(c) of this      
                                          chapter at a level not        
                                          exceeding 0.25 percent by     
                                          weight of the polymer.        
Dimethyldibenzylidene sorbitol (CAS      For use only as a clarifying   
 Reg. No. 135861-56-2).                   agent at a level not to exceed
                                          0.4 percent by weight of      
                                          olefin polymers complying with
                                          Sec.  177.1520(c) of this     
                                          chapter, items 1.1, 3.1, and  
                                          3.2, where the copolymers     
                                          complying with items 3.1 and  
                                          3.2 contain not less than 85  
                                          weight percent of polymer     
                                          units derived from            
                                          polypropylene; in contact with
                                          all food types under          
                                          conditions of use B, C, D, E, 
                                          F, G, and H, described in     
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter.                 
Polyvinylcyclohexane (CAS Reg. No.       For use only as a clarfiying   
 25498-06-0).                             agent for polypropylene       
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          item 1.1., and in propylene   
                                          containing copolymers         
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 3.1 and 3.2, at a level 
                                          not exceeding 0.1 percent by  
                                          weight of the polyolefin.     
Sodium di(p-tert-butylphenyl)phosphate   For use only as a clarifying   
 (CAS Reg. No. 10491-31-3).               agent at a level not exceeding
                                          0.35 parts per hundred of the 
                                          resin in olefin polymers      
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 1.1, 3.1, or 3.2 (where 
                                          the copolymers complying with 
                                          items 3.1 and 3.2 contain not 
                                          less than 85 weight percent of
                                          polymer units derived from    
                                          propylene).                   

[[Page 358]]

                                                                        
Sodium 2,2'- methylenebis(4,6-di-tert-   For use only as a clarifying   
 butylphenyl)phosphate (CAS Reg. No.      agent at a level not exceeding
 85209-91-2)..                            0.30 percent by weight of     
                                          olefin polymers complying with
                                          Sec.  177.1520(c) of this     
                                          chapter, items 1.1, 3.1, or   
                                          3.2 (where the copolymers     
                                          complying with items 3.1 and  
                                          3.2 contain not less than 85  
                                          weight percent of polymer     
                                          units derived from            
                                          polypropylene). The finished  
                                          polymers contact foods only of
                                          types I, II, IV-B, VI-B, VII- 
                                          B, and VIII as identified in  
                                          Table 1 of Sec.  176.170(c) of
                                          this chapter and limited to   
                                          conditions of use B through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter, or
                                          foods of all types, limited to
                                          conditions of use C through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter.   
------------------------------------------------------------------------


[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 
FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 
12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 
13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994]



Sec. 178.3297  Colorants for polymers.

    The substances listed in paragraph (e) of this section may be safely 
used as colorants in the manufacture of articles or components of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions and definitions set forth in this 
section:
    (a) The term colorant means a dye, pigment, or other substance that 
is used to impart color to or to alter the color of a food-contact 
material, but that does not migrate to food in amounts that will 
contribute to that food any color apparent to the naked eye. For the 
purpose of this section, the term ``colorant'' includes substances such 
as optical brighteners and fluorescent whiteners, which may not 
themselves be colored, but whose use is intended to affect the color of 
a food-contact material.
    (b) The colorant must be used in accordance with current good 
manufacturing practice, including use levels which are not in excess of 
those reasonably required to accomplish the intended coloring effect.
    (c) Colorants in this section must conform to the description and 
specifications indicated. If a polymer described in this section is 
itself the subject of a regulation promulgated under section 409 of the 
Federal Food, Drug, and Cosmetic Act, it shall also comply with any 
specifications and limitations prescribed by that regulation. Extraction 
testing guidelines to conduct studies for additional uses of colorants 
under this section are available from the Food and Drug Administration 
free of charge from the Center for Food Safety and Applied Nutrition, 
(HFS-200) Food and Drug Administration, 200 C St. SW., Washington, DC 
20204.
     (d) Color additives and their lakes listed for direct use in foods, 
under the provisions of the color additive regulations in parts 73, 74, 
81, and 82 of this chapter, may also be used as colorants for food-
contact polymers.
    (e) List of substances:

------------------------------------------------------------------------
                Substances                           Limitations        
------------------------------------------------------------------------
Aluminum..................................                              
Aluminum hydrate..........................                              
Aluminum and potassium silicate (mica)....                              
Aluminum mono-, di-, and tristearate......                              
Aluminum silicate (China clay)............                              
4-[[5-[[[4-(Aminocarbonyl) phenyl]          For use at levels not to    
 amino]carbonyl]- 2-methoxyphenyl]azo]-N-    exceed 1 percent by weight 
 (5-chloro-2,4-dimethoxyphenyl)-3-hydroxy-   of polymers. The finished  
 2-naphthalene-carboxamide (C.I. Pigment     articles are to contact    
 Red 187, CAS Reg. No. 59487-23-9).          foods only under conditions
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   

[[Page 359]]

                                                                        
N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-   For use at levels not to    
 dihydro-2-oxo-1H-benzimidazol-5-            exceed 1 percent by weight 
 yl)amino]carbonyl]-2-                       of polymers. The finished  
 oxopropyl]azo]benzamide (C. I. Pigment      articles are to contact    
 Yellow 181, CAS Reg. No. 74441-05-7).       food only under conditions 
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
Barium sulfate............................                              
Bentonite.................................                              
Bentonite, modified with 3-                                             
 dimethyldioctadecylammonium ion.                                       
4,4'-Bis(4-anilino-6-diethanolamine--triazin-2-ylamino)-2,2'-stilbene         fibers specified in Sec.   
 disulfonic acid, disodium salt.             177.2800 of this chapter.  
4,4'-Bis(4-anilino-6-methylethanolamine-        Do.                     
 -triazin-2-ylamino)-2,2'-                                     
 stilbene disulfonic acid, disodium salt.                               
Burnt umber...............................                              
Calcium carbonate.........................                              
Calcium silicate..........................                              
Calcium sulfate...........................                              
Carbon black (channel process, prepared by                              
 the impingement process from stripped                                  
 natural gas).                                                          
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-       For use at levels not to    
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-        exceed 0.3 percent by      
 methylbenzenesulfonic acid,calcium salt     weight of the finished     
 (1:1); (C. I. Pigment Yellow 191, CAS       polymers. The finished     
 Reg. No. 129423-54-7)..                     articles are to contact    
                                             food only under conditions 
                                             of use B through H as      
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
 Chromium oxide green, Cr2 O3 (C.I.          For use only:              
 pigment green 17, C.I. No. 77288).           1. In olefin polymers     
                                             complying with Sec.        
                                             177.1520 of this chapter.  
                                              2. In repeat-use rubber   
                                             articles complying with    
                                             Sec.  177.2600 of this     
                                             chapter; total use is not  
                                             to exceed 10 percent by    
                                             weight of rubber articles. 
Cobalt aluminate..........................  For use only:               
                                              1. In resinous and        
                                             polymeric coatings         
                                             complying with Sec.        
                                             175.300 of this chapter.   
                                              2. Melamine-formaldehyde  
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1460 of this chapter.  
                                              3. Xylene-formaldehyde    
                                             resins condensed with 4-   
                                             4'isopropylidenediphenol-  
                                             epichlorohydrin epoxy      
                                             resins complying with Sec. 
                                             175.380 of this chapter.   
                                              4. Ethylene-vinyl acetate 
                                             copolymers complying with  
                                             Sec.  177.1350 of this     
                                             chapter.                   
                                              5. Urea-formaldehyde      
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1900 of this chapter.  
                                              6. At levels not to exceed
                                             5 percent by weight of all 
                                             polymers except those      
                                             listed under limitations 1 
                                             through 5 of this item. The
                                             finished articles are to   
                                             contact food under         
                                             conditions of use A through
                                             H described in Table 2 of  
                                             Sec.  176.170(c) of this   
                                             chapter.                   
Copper chromite black spinel (C.I. Pigment  For use at levels not to    
 Black 28, CAS Reg. No. 68186-91-4)..        exceed 5 percent by weight 
                                             of polymers. The finished  
                                             articles are to contact    
                                             food only under conditions 
                                             of use A through H as      
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
D&C Red No. 7 and its lakes...............                              
Diatomaceous earth........................                              
4,4'-Diamino-[1,1'-bianthracene]-           For use at levels not to    
 9,9',10,10'-tetrone (CAS Reg. No. 4051-63-  exceed 1 percent by weight 
 2).                                         of polymers. The finished  
                                             articles are to contact    
                                             food only under conditions 
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-          For use at levels not to    
 benzimidazol-5-yl)azo]-2,4,6(1H, 3H, 5H)-   exceed 1 percent by weight 
 pyrimidinetrione (CAS Reg. No. 72102-84-    of polymers. The finished  
 2).                                         articles are to contact    
                                             food only under conditions 
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
3,3'-[(2,5-Dimethyl-1,4-                    For use at levels not to    
 phenylene)bis[imino(1-acetyl-2-oxo-2,1-     exceed 1 percent by weight 
 ethanediyl)azo]]bis[4-chloro-N-(5-chloro-   of polymers. The finished  
 2-methylphenyl)-benzamide] (CAS Reg. No.    articles are to contact    
 5280-80-8).                                 food only under conditions 
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
3,3'-[(2,5-Dimethyl-1,4-                    For use at levels not to    
 phenylene)bis[imino-carbonyl(2-hydroxy-     exceed 1 percent by weight 
 3,1-naphthalenediyl) azo]] bis(4-           of polymers. The finished  
 methylbenzoic acid), bis(2-chloroethyl)     articles are to contact    
 ester (CAS Reg. No. 68259-05-2)..           food only under conditions 
                                             of use B through H         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   

[[Page 360]]

                                                                        
2,2'-[1,2-Ethanediylbis(oxy-2,1-            For use at levels not to    
 phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-1H-  exceed 1.0 percent by      
 benzimidazol-5-yl)]-3-oxo-butanamide        weight of polymers. The    
 (C.I. Pigment Yellow 180, CAS Reg. No.      finished articles are to   
 77804-81-0).                                contact food only under    
                                             conditions of use B through
                                             G described in Table 2 of  
                                             Sec.  176.170(c) of this   
                                             chapter.                   
2,2'-(1,2-Ethenediyldi-4,1-phenylene)       For use as an optical       
 bis(benzoxazole) (CAS Reg. No. 1533-45-5).  brightener for all polymers
                                             at a level not to exceed   
                                             0.025 percent by weight of 
                                             polymer. The finished      
                                             polymer shall contact foods
                                             only of the types          
                                             identified in Table 1 of   
                                             Sec.  176.170(c) of this   
                                             chapter, under categories  
                                             I, II, IV-B, VI-A, VI-B,   
                                             VII-B, and VIII at         
                                             temperatures not to exceed 
                                             275 F.                     
Iron oxides...............................                              
Kaolin-modified, produced by treating       For use only in olefin      
 kaolin with a reaction product of           polymers complying with    
 isopropyl titanate and oleic acid in        Sec.  177.1520 of this     
 which 1 mole of isopropyl titanate is       chapter at levels not to   
 reacted with 1 to 2 moles of oleic acid.    exceed 40 percent by weight
 The reaction product will not exceed 8      of olefin polymer.         
 percent of the modified kaolin. The oleic                              
 acid used shall meet the requirements                                  
 specified in Sec.  172.860 of this                                     
 chapter.                                                               
Magnesium oxide...........................                              
Magnesium silicate (talc).................                              
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-        For use as an optical       
 phenylcoumarin (CAS Reg. No. 3333-62-8)     brightener only in:        
 having a melting point of 250  deg.C to      1. Olefin polymers        
 251  deg.C and a nitrogen content of 10.7   complying with Sec.        
 to 11.2 percent.                            177.1520 of this chapter   
                                             only at levels such that   
                                             the product of             
                                             concentration of the       
                                             optical brightener         
                                             (expressed in parts per    
                                             million by weight of the   
                                             olefin polymer) multiplied 
                                             by the thickness of the    
                                             olefin polymer (expressed  
                                             in thousandths of an inch  
                                             and limited to no more than
                                             0.400 inch) shall not      
                                             exceed 500; provided that  
                                             the level of the brightener
                                             shall not exceed 20 parts  
                                             per million by weight of   
                                             the olefin polymer, and    
                                             further that the olefin    
                                             polymers shall comply with 
                                             specifications for items   
                                             1.1, 2.1, 3.1, 3.3, and 4  
                                             of Sec.  177.1520(c) of    
                                             this chapter. The polymer  
                                             may be used under the      
                                             conditions described in    
                                             Sec.  176.170(c) of this   
                                             chapter, Table 2, under    
                                             conditions of use E, F, and
                                             G.                         
                                              2. Polyethylene           
                                             terephthalate specified in 
                                             Sec.  177.2800(d)(5)(i) of 
                                             this chapter at a level not
                                             to exceed 0.035 percent by 
                                             weight of the finished     
                                             fibers.                    
1,1-[(6-Phenyl-1,3,5-triazine-2,4-          For use at levels not to    
 diyl)diimino]bis-9,10-anthracenedione       exceed 0.25 percent by     
 (CAS Reg. No. 4118-16-5).                   weight of polyethylene     
                                             phthalate polymers that    
                                             comply with Sec.  177.1630 
                                             of this chapter. The       
                                             finished articles are to   
                                             contact food only under    
                                             conditions of use E, F, and
                                             G described in table 2,    
                                             Sec.  176.170(c) of this   
                                             chapter, except, when such 
                                             articles are used with food
                                             types III, IV-A, and V,    
                                             described in table 1, Sec. 
                                             176.170(c) of this chapter,
                                             the finished articles are  
                                             to contact food only under 
                                             conditions of use D, E, F, 
                                             and G.                     
Phthalocyanine blue (C.I. pigment blue 15,                              
 15:1, 15:2, 15:3, and 15:4; C.I. No.                                   
 74160; CAS Reg. No. 147-14-8).                                         
Phthalocyanine green (C.I. pigment green                                
 7, C.I. No. 74260).                                                    
C.I. Pigment red 38 (C.I. No. 21120)......  For use only in rubber      
                                             articles for repeated use  
                                             complying with Sec.        
                                             177.2600 of this chapter;  
                                             total use is not to exceed 
                                             10 percent by weight of    
                                             rubber article.            
Quinacridone red (C.I. Pigment violet 19,                               
 C.I. No. 73900).                                                       
Sienna (raw and burnt)....................                              
Silica....................................                              
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-          For use only at levels not  
 tetrachloro-2,3-dihydro-1,3-dioxo-1H-       to exceed 1 percent by     
 inden-2-yl)-8-quinolinyl]-1H-isoindole-     weight of polymers. The    
 1,3(2H)-dione (C. I. Pigment Yellow 138,    finished articles are to   
 CAS Reg. No.30125-47-4)..                   contact food only under    
                                             conditions of use C through
                                             H, as described in Table 2 
                                             of Sec.  176.170(c) of this
                                             chapter; provided further  
                                             that the finished articles 
                                             shall not be filled at     
                                             temperatures exceeding 158 
                                             F (70 C).                  
2,2'-(2,5-Thiophenediyl)-bis (5-tert-       For use as an optical       
 butylbenzoxazole) (CAS Reg. No. 7128-64-    brightener only:           
 5).                                        1. At levels not to exceed  
                                             0.05 percent by weight of  
                                             the following polymers:    
                                             olefin polymers complying  
                                             with Sec.  177.1520(c) of  
                                             this chapter, item 2.1,    
                                             2.3, 3.1, 3.3, or 4;       
                                             polystyrene and            
                                             rubbermodified polystyrene 
                                             complying with Sec.        
                                             177.1640 of this chapter;  
                                             and polyvinyl chloride. The
                                             finished polymers shall    
                                             contact foods only of the  
                                             types identified in Table  
                                             1, Sec.  176.170(c) of this
                                             chapter, under Categories  
                                             I, II, IV-B, VI-A, VI-B,   
                                             and VIII under conditions  
                                             of use E, F, and G         
                                             described in Table 2 of    
                                             Sec.  176.170(c) of this   
                                             chapter.                   
                                            2. At levels not to exceed  
                                             0.05 percent by weight of  
                                             polypropylene complying    
                                             with Sec.  177.1520(c) of  
                                             this chapter, item 1.1,    
                                             1.2, or 1.3. The finished  
                                             polymer shall contact foods
                                             only of the types          
                                             identified in Table 1, Sec.
                                              176.170(c) of this        
                                             chapter, under Categories  
                                             I, II, IV-B, VI, VII-B, and
                                             VIII under conditions of   
                                             use A through H described  
                                             in Table 2 of Sec.         
                                             176.170(c) of this chapter.

[[Page 361]]

                                                                        
                                            3. At levels not to exceed  
                                             0.01 percent by weight of  
                                             polypropylene complying    
                                             with Sec.  177.1520(c) of  
                                             this chapter, item 1.1,    
                                             1.2, or 1.3. The finished  
                                             polymer shall contact foods
                                             only of the types          
                                             identified in Table 1, Sec.
                                              176.170(c) of this        
                                             chapter, under Categories  
                                             III, IV-A, V, VII-A, and IX
                                             under conditions of use A  
                                             through H described in     
                                             Table 2 of Sec.  176.170(c)
                                             of this chapter.           
                                            4 At levels not to exceed   
                                             0.01 percent by weight of  
                                             polyoxymethylene complying 
                                             with Sec.  177.2480 of this
                                             chapter.                   
                                            5. At levels not to exceed  
                                             0.015 percent by weight of 
                                             polycarbonate resins       
                                             complying with Sec.        
                                             177.1580 of this chapter.  
                                             The finished polymer shall 
                                             contact foods of the types 
                                             identified in Table 1 of   
                                             Sec.  176.170(c) of this   
                                             chapter, under categories, 
                                             I, II, IV-B, VI-B, and VIII
                                             under conditions of use B  
                                             through H described in     
                                             Table 2 of Sec.  176.170(c)
                                             of this chapter.           
Titanium dioxide..........................                              
Titanium dioxide-barium sulfate...........                              
Titanium dioxide-magnesium silicate.......                              
Ultramarines..............................  As identified in Sec.       
                                             73.2725 of this chapter.   
Zinc carbonate............................  For use only:               
                                              1. In resinous and        
                                             polymeric coatings         
                                             complying with Sec.        
                                             175.300 of this chapter.   
                                              2. Melamineformaldehyde   
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1460 of this chapter.  
                                              3. Xylene-formaldehyde    
                                             resins condensed with 4-4'-
                                             isopropylidene diphenol-   
                                             epichlorohydrin epoxy      
                                             resins complying with Sec. 
                                             175.380 of this chapter.   
                                              4. Ethylene-vinyl acetate 
                                             copolymers complying with  
                                             Sec.  177.1350 of this     
                                             chapter.                   
                                              5. Urea-formaldehyde      
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1900 of this chapter.  
Zinc chromate.............................  For use only in rubber      
                                             articles for repeated use  
                                             complying with Sec.        
                                             177.2600 of this chapter;  
                                             total use is not to exceed 
                                             10 percent by weight of    
                                             rubber article.            
Zinc oxide................................  For use only:               
                                              1. In resinous and        
                                             polymeric coatings         
                                             complying with Sec.        
                                             175.300 of this chapter.   
                                              2. Melamine-formaldehyde  
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1460 of this chapter.  
                                              3. Xylene-formaldehyde    
                                             resins condensed with 4-4'-
                                             isopropylidene-diphenol-   
                                             epichlorohydrin epoxy      
                                             resins complying with Sec. 
                                             175.380 of this chapter.   
                                              4. Ethylene-vinyl acetate 
                                             copolymers complying with  
                                             Sec.  177.1350 of this     
                                             chapter.                   
                                              5. Urea-formaldehyde      
                                             resins in molded articles  
                                             complying with Sec.        
                                             177.1900 of this chapter.  
Zinc sulfide..............................  For use at levels not to    
                                             exceed 10 percent by       
                                             weight.                    
------------------------------------------------------------------------

    [48 FR 46774, 46775, Oct. 14, 1983, as amended at 51 FR 7551, Mar. 
5, 1986; 51 FR 19168, May 28, 1986; 51 FR 23535, June 30, 1986; 53 FR 
52132, Dec. 27, 1988; 54 FR 21053, May 16, 1989; 54 FR 24898, June 12, 
1989; 54 FR 35875, Aug. 30, 1989; 55 FR 3585, Feb. 2, 1990; 55 FR 12344, 
Apr. 3, 1990; 55 FR 18721, May 4, 1990; 55 FR 31827, Aug. 6, 1990; 56 FR 
42933, Aug. 30, 1991; 56 FR 65782, Dec. 18, 1991; 58 FR 17514, Apr. 5, 
1993; 58 FR 67323, Dec. 21, 1993; 59 FR 3654, Jan. 26, 1994; 59 FR 5705, 
Feb. 8, 1994; 59 FR 10065, 10066, Mar. 3, 1994; 60 FR 31244, June 14, 
1995; 60 FR 39648, Aug. 3, 1995; 61 FR 2116, Jan. 25, 1996; 61 FR 14246, 
Apr. 1, 1996; 61 FR 14481, Apr. 2, 1996]



Sec. 178.3300   Corrosion inhibitors used for steel or tinplate.

    Corrosion inhibitors may be safely used for steel or tinplate 
intended for use in, or to be fabricated as, food containers or food-
processing or handling equipment, subject to the provisions of this 
section.
    (a) The corrosion inhibitors are prepared from substances identified 
in this section and used subject to the limitations prescribed.
    (b) The following corrosion inhibitors or adjuvants are used in 
amounts not to exceed those reasonably required to accomplish the 
intended physical or technical effect:
    (1) Corrosion inhibitors (active ingredients) used in packaging 
materials for the packaging of steel or tinplate or articles fabricated 
therefrom:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Dicyclohexylamine and its salts of fatty                                
 acids derived from animal or vegetable                                 
 oil.                                                                   
Dicyclohexylamine nitrite.................                              
Morpholine and its salts of fatty acids                                 
 derived from animal or vegetable oils.                                 
------------------------------------------------------------------------

    (2) Adjuvants employed in the application and use of corrosion 
inhibitors:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Propylene glycol..........................                              
------------------------------------------------------------------------


[[Page 362]]





Sec. 178.3400   Emulsifiers and/or surface-active agents.

    The substances listed in paragraph (c) of this section may be safely 
used as emulsifiers and/or surface-active agents in the manufacture of 
articles or components of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, subject to the provisions of this 
section.
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect; and the quantity 
that may become a component of food as a result of such use shall not be 
intended to, nor in fact, accomplish any physical or technical effect in 
the food itself.
    (b) The use as an emulsifier and/or surface-active agent in any 
substance or article that is the subject of a regulation in parts 174, 
175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any 
specifications and limitations prescribed by such regulation for the 
finished form of the substance or article.
    (c) List of substances:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
-Alkyl-, -alkenyl-,    For use only at levels not to  
 and -alkylaryl-omega-           exceed 0.5 pct by weight of   
 hydroxypoly(oxyethylene) mixture         coatings complying with Sec.  
 consisting of 30 weight pct of -(2,4,6-triisobutylphenyl)-omega-      limited to use as an          
 hydroxypoly(oxyethylene) having an       emulsifier for polyhydric     
 average poly(oxyethylene) content of 7   alcohol diesters used as      
 moles and 70 weight pct of a 1:1         provided in Sec.  178.3770(b).
 weight ratio mixture of -(Z)-   The weight of the finished    
 9-octadecenyl-omega-                     coating shall not exceed 2    
 hydroxypoly(oxyethylene) having an       milligrams per square inch of 
 average poly(oxyethylene) content of     food-contact surface.         
 18 moles and -alkyl(C16-C18)-                                 
 omega-hydroxypoly(oxyethylene) having                                  
 an average poly(oxyethylene) content                                   
 of 18 moles.                                                           
n-Alkylbenzenesulfonic acid (alkyl       For use only as emulsifiers and/
 group consisting of not less than 95     or surface active agents as   
 percent C10 to C16) and its ammonium,    components of nonfood articles
 calcium, magnesium, potassium, and       complying with Secs.  175.300,
 sodium salts.                            175.320, 175.365, 175.380,    
                                          176.170, 176.180, 177.1010,   
                                          177.1200, 177.1210, 177.1630, 
                                          177.2600, and 177.2800 of this
                                          chapter and Sec.  178.3120.   
Alkyl mono- and disulfonic acids,        For use only:                  
 sodium salts (produced from n-alkanes                                  
 in the range of C10-C18 with not less                                  
 than 50 percent C14-C16)..                                             
                                         1.  As provided in Sec.        
                                          176.170 of this chapter.      
                                         2.  At levels not to exceed 2  
                                          percent by weight of polyvinyl
                                          chloride and/or vinyl chloride
                                          copolymers complying with Sec.
                                           177.1980 of this chapter.    
                                         3.  As emulsifiers in          
                                          vinylidene chloride copolymer 
                                          or homopolymer coatings at    
                                          levels not to exceed a total  
                                          of 2.6 percent by weight of   
                                          coating solids. The finished  
                                          polymer contacts food only of 
                                          the Types I, II, III, IV, V,  
                                          VIA, VIB, VII, VIII, and IX as
                                          identified in Table 1 of Sec. 
                                          176.170(c) of this chapter,   
                                          and limited to conditions of  
                                          use E, F, and G described in  
                                          Table 2 of Sec.  176.170 of   
                                          this chapter.                 
                                         4.  As emulsifiers and/or      
                                          surface-active agents at      
                                          levels not to exceed 3.0      
                                          percent by weight of          
                                          polystyrene or rubber-modified
                                          polystyrene complying with    
                                          Sec.  177.1640(c) of this     
                                          chapter under conditions of   
                                          use B through H described in  
                                          Table 2 of Sec.  176.170(c) of
                                          this chapter.                 
-Alkyl-omega-                                                  
 hydroxypoly(oxyethylene) produced by                                   
 condensation of 1 mole of C11-C15                                      
 straight-chain randomly substitued                                     
 secondary alcohols with an average of                                  
 7-20 moles of ethylene oxide.                                          

[[Page 363]]

                                                                        
alpha Olefin sulfonate [alkyl group is   For use only:                  
 in the range of C10-C18 with not less   1. In acrylonitrile-butadiene  
 than 50 percent C14-C16], ammonium,      copolymers identified in Sec. 
 calcium, magnesium, potassium, and       177.2600(c)(4)(i) of this     
 sodium salts.                            chapter.                      
                                         2. At levels not to exceed 1   
                                          percent by weight of acrylic  
                                          coatings complying with Sec.  
                                          175.300(b)(3)(xx) of this     
                                          chapter and having a maximum  
                                          thickness of 0.051 millimeter 
                                          (0.002 inch). The finished    
                                          polymers contact food only of 
                                          the Types V, VIII, and IX as  
                                          identified in Table 1 of Sec. 
                                          176.170(c) of this chapter.   
                                         3. At levels not to exceed 2   
                                          percent by weight of vinyl    
                                          chloride copolymer coatings   
                                          having a maximum thickness of 
                                          0.051 millimeter (0.002 inch) 
                                          and complying with Sec.       
                                          175.300(b)(3)(xv) of this     
                                          chapter. The finished polymers
                                          contact food only of the Types
                                          V, VIII, and IX as identified 
                                          in Table 1 of Sec.  176.170(c)
                                          of this chapter.              
                                         4. As provided in Sec.  175.105
                                          of this chapter.              
Alpha-sulfo-omega-                       For use only as an emulsifier  
 (dodecyloxy)poly(oxyethylene) ammonium   at levels not to exceed 0.3   
 salt (CAS Reg. No. 30174-67-5).          percent by weight of styrene- 
                                          butadiene copolymer coatings  
                                          for paper and paperboard      
                                          complying with Sec.  176.170  
                                          of this chapter.              
Ammonium salt of epoxidized oleic acid,  For use only:                  
 produced from epoxidized oleic acid     1. As a polymerization         
 (predominantly dihydroxystearic and      emulsifier at levels not to   
 acetoxyhydroxystearic acids) meeting     exceed 1.5 pct by weight of   
 the following specifications: Acid       vinyl chloride polymers used  
 number 160-180, saponification number    as components of nonfood      
 210-235, iodine number 2-15, and epoxy   articles complying with Secs. 
 groups 0-0.4 percent.                    175.105, 175.300, 176.170,    
                                          176.180, and 177.1210 of this 
                                          chapter. Such vinyl chloride  
                                          polymers are limited to       
                                          polyvinyl chloride and/or     
                                          vinyl chloride copolymers     
                                          complying with Sec.  177.1980 
                                          of this chapter.              
                                         2. As a polymerization         
                                          emulsifier at levels not to   
                                          exceed 1.5 pct by weight of   
                                          vinyl chloride-vinyl acetate  
                                          copolymers used as components 
                                          of nonfood articles complying 
                                          with Secs.  175.105, 175.300, 
                                          176.170, 176.180, and 177.1210
                                          of this chapter.              
-Di-sec-butylphenyl-omega-                                     
 hydroxypoly(oxyethylene) produced by                                   
 the condensation of 1 mole of di-sec-                                  
 butylphenol with an average of 4-14 or                                 
 30-50 moles of ethylene oxide; if a                                    
 blend of products is used, the average                                 
 number of moles of ethylene oxide                                      
 reacted to produce any product that is                                 
 a component of the blend shall be in                                   
 the range 4-14 or 30-50; sec-butyl                                     
 groups are predominantly (90 percent                                   
 or more) o-, p-substituents.                                           
-Dodecyl-omega-hydroxpoly                                      
 (oxyethylene) mixture of dihydrogen                                    
 phosphate and monohydrogen phosphate                                   
 esters that have an acid number (to pH                                 
 5.2) of 103-111 and that are produced                                  
 by the esterification of the                                           
 condensation product of 1 mole of n-                                   
 dodecyl alcohol with 4-4.5 moles of                                    
 ethylene oxide.                                                        
-(p-Dodecylphenyl)-omega-                                      
 hydroxypoly (oxyethylene) produced by                                  
 the condensation of 1 mole of                                          
 dodecylphenol (dodecyl group is a                                      
 propylene tetramer isomer) with an                                     
 average of 4-14 or 30-50 moles of                                      
 ethylene oxide; if a blend of products                                 
 is used, the average number of moles                                   
 of ethylene oxide reacted to produce                                   
 any product that is a component of the                                 
 blend shall be in the range 4-14 or 30-                                
 50.                                                                    
-(p-nonylphenyl)-omega-                                        
 hydroxypoly (oxyethylene) mixture of                                   
 dihydrogen phosphate and monohydrogen                                  
 phosphate esters that have an acid                                     
 number (to pH 5.2) of 49-59 and that                                   
 are produced by the esterification of                                  
 a-(p-nonylphenyl)-omega-hydroxypoly                                    
 (oxyethylene) complying with the                                       
 identity prescribed in Sec.                                            
 178.3400(c) and having an average                                      
 poly(oxyethylene) content of 5.5-6.5                                   
 moles.                                                                 
-(p-Nonylphenyl)-omega-                                        
 hydroxypoly (oxyethylene) mixture of                                   
 dihydrogen phosphate and monohydrogen                                  
 phosphate esters that have an acid                                     
 number (to pH 5.2) of 62-72 and that                                   
 are produced by the esterification of                                  
 - (p-nonylphenyl) omega-                                      
 hydroxypoly (oxyethylene) complying                                    
 with the identity prescribed in Sec.                                   
 178.3400(c) and having an average                                      
 poly(oxyethylene) content of 9-10                                      
 moles.                                                                 

[[Page 364]]

                                                                        
-(p-Nonylphenyl)-omega-                                        
 hydroxypoly (oxyethylene) mixture of                                   
 dihydrogen phosphate and monohydrogen                                  
 phosphate esters that have an acid                                     
 number (to pH 5.2) of 98-110 and that                                  
 are produced by the esterification of                                  
 -(p-nonylphenyl)-omega-                                       
 hydroxypoly (oxyethylene) complying                                    
 with the identity prescribed in Sec.                                   
 178.3400(c) and having an average                                      
 poly(oxyethylene) content of 45-55                                     
 moles.                                                                 
-(p-Nonylphenyl)-omega-                                        
 hydroxypoly (oxyethylene) produced by                                  
 the condensation of 1 mole of                                          
 nonylphenol (nonyl group is a                                          
 propylene trimer isomer) with an                                       
 average of 4-14 or 30-50 moles of                                      
 ethylene oxide: if a blend of products                                 
 is used, the average number of moles                                   
 of ethylene oxide reacted to produce                                   
 any product that is a component of the                                 
 blend shall be in the range 4-14 or 30-                                
 50.                                                                    
-(p-Nonylphenyl)-omega-                                        
 hydroxypoly (oxyethylene) sulfate,                                     
 ammonium or sodium salt: the nonyl                                     
 group is a propylene trimer isomer and                                 
 the poly (oxyethylene) content average                                 
 4 moles.                                                               
Poly[(methylene-p-nonylphenoxy)          For use in coatings at levels  
 poly(oxypropylene)(4-12 moles)           not to exceed 1 mg per square 
 propanol] of minimum molecular weight    foot of food-contact surface. 
 3500.                                                                  
Poly(oxypropylene) (45-48 moles) block   For use only as a surface-     
 polymer with poly(oxyethylene). The      active agent at levels not to 
 finished block polymers meet the         exceed 0.5 percent by weight  
 following specifications: Average        of polyolefin film or         
 molecular weight 11,000-18,000;          polyolefin coatings. Such     
 hydroxyl number 6.2-10.2; cloud point above 100 deg. C.     coatings shall have an average
 for 10 pct solution.                     thickness not to exceed 0.005 
                                          inch and shall be limited to  
                                          use in contact with foods that
                                          have a pH above 5.0 and that  
                                          contain no more than 8 pct of 
                                          alcohol.                      
Polysorbate 20 (polyoxyethylene (20)                                    
 sorbitan monolaurate) meeting the                                      
 following specifications:                                              
 Saponification number 40-50, acid                                      
 number 0-2, hydroxyl number 60-108,                                    
 oxyethylene content 70-74 pct.                                         
Polysorbate 40 (polyoxyethylene (20)                                    
 sorbitan monopalmitate) meeting the                                    
 following specifications:                                              
 Saponification number 41-52,                                           
 oxyethylene content 66-70.5 pct.                                       
Polysorbate 60 conforming to the                                        
 identity prescribed in Sec.  172.836                                   
 of this chapter.                                                       
Polysorbate 65 conforming to the                                        
 identity prescribed in Sec.  172.838                                   
 of this chapter.                                                       
Polysorbate 80 conforming to the                                        
 identity prescribed in Sec.  172.840                                   
 of this chapter.                                                       
Polysorbate 85 (polyoxyethylene (20)                                    
 sorbitan trioleate) meeting the                                        
 following specifications:                                              
 Saponification number 80-95,                                           
 oxyethylene content 46-50 percent.                                     
Sodium 1,4-dicylcohexyl sulfosuccinate.                                 
Sodium 1,4-dihexyl sulfosuccinate......                                 
Sodium 1,4 diisobutyl sulfosuccinate...                                 
Sodium dioctyl sulfosuccinate..........                                 
Sodium 1,4-dipentyl sulfosuccinate.....                                 
Sodium 1,4-ditridecyl sulfosuccinate...                                 
Sodium lauryl sulfate..................                                 
Sodium                                                                  
 monoalkylphenoxybenzenedisulfonate and                                 
 sodium                                                                 
 dialkylphenoxybenzenedisulfonate                                       
 mixtures containing not less than 70                                   
 pct of the monoalkylated product where                                 
 the alkyl group is C8-C16.                                             
Sorbitan monolaurate meeting the                                        
 following specifications.                                              
 Saponification number 153-170; and                                     
 hydroxyl number 330-360.                                               
Sorbitan monooleate meeting the                                         
 following specifications:                                              
 Saponification number 145-160,                                         
 hydroxyl number 193-210.                                               
Sorbitan monopalmitate meeting the                                      
 following specifications:                                              
 Saponification No. 140-150; and                                        
 hydroxyl No. 275-305.                                                  
Sorbitan monostearate conforming to the                                 
 identity prescribed in Sec.  172.842                                   
 of this chapter.                                                       
Sorbitan trioleate meeting the                                          
 following specifications:                                              
 Saponification No. 170-190; and                                        
 hydroxyl No. 55-70.                                                    
Sorbitan tristearate meeting the                                        
 following specifications:                                              
 Saponification No. 176-188; and                                        
 hydroxyl No. 66-80.                                                    

[[Page 365]]

                                                                        
Sulfosuccinic acid 4-ester with          For use only at levels not to  
 polyethylene glycol dodecyl ether,       exceed 5 percent by weight of 
 disodium salt (CAS Reg. No. 39354-45-    total monomers used in the    
 5).                                      emulsion polymerization of    
                                          polyvinyl acetate, acrylic,   
                                          and vinyl/acrylic polymers    
                                          intended for use as coatings  
                                          for paper and paperboard.     
-[p-(1,1,3,3-                                                  
 Tetramethylbutyl)phenyl] omega-                                        
 hydroxypoly(oxyethylene) produced by                                   
 the condensation of 1 mole of p-                                       
 (1,1,3,3-tetramethylbutyl) phenol with                                 
 an average of 4-14 or 30-40 moles of                                   
 ethylene oxide; if a blend of products                                 
 is used, the average number of moles                                   
 of ethylene oxide reacted to produce                                   
 any product that is a component of the                                 
 blend shall be in the range 4-14 or 30-                                
 50.                                                                    
Tetrasodium N-(1,2-dicarboxyethyl)-N-    For use only as a              
 octadecyl-sulfosuccinate.                polymerization emulsifier for 
                                          resins applied to tea-bag     
                                          material.                     
-Tridecyl-omega-hydroxypoly                                    
 (oxyethylene) mixture of dihydrogen                                    
 phosphate and monohydrogen phosphate                                   
 esters that have an acid number (to pH                                 
 5.2) of 75-85 and that are produced by                                 
 the esterification of the condensation                                 
 product of one mole of ``oxo'' process                                 
 tridecyl alcohol with 5.5-6.5 moles of                                 
 ethylene oxide.                                                        
-Tridecyl-omega-hydroxypoly                                    
 (oxyethyl-ene) mixture of dihydrogen                                   
 phosphate and monohydrogen phosphate                                   
 esters that have an acid number (to pH                                 
 5.2) of 58-70 and that are produced by                                 
 the esterification of the condensation                                 
 product of one mole of ``oxo'' process                                 
 tridecyl alcohol with 9-10 moles of                                    
 ethylene oxide.                                                        
------------------------------------------------------------------------

    (d) The provisions of this section are not applicable to emulsifiers 
and/or surface-active agents listed in Sec. 175.105(c)(5) of this 
chapter and used in food-packaging adhesives complying with Sec. 175.105 
of this chapter.

[42 FR 14609, Mar. 15, 1977, as amended at 43 FR 58557, Dec. 15, 1978; 
44 FR 42679, July 20, 1979; 45 FR 67321, Oct. 10, 1980; 48 FR 24870, 
June 3, 1983; 49 FR 5748, Feb. 15, 1984; 51 FR 31763, Sept. 5, 1986; 56 
FR 41457, Aug. 21, 1991; 58 FR 26687, May 5, 1993; 60 FR 18351, Apr. 11, 
1995; 61 FR 14246, Apr. 1, 1996]



Sec. 178.3450   Esters of stearic and palmitic acids.

    The ester stearyl palmitate or palmityl stearate or mixtures thereof 
may be safely used as adjuvants in food-packaging materials when used in 
accordance with the following prescribed conditions:
    (a) They are used or intended for use as plasticizers or lubricants 
in polystyrene intended for use in contact with food.
    (b) They are added to the formulated polymer prior to extrusion.
    (c) The quantity used shall not exceed that required to accomplish 
the intended technical effect.



Sec. 178.3480   Fatty alcohols, synthetic.

    Synthetic fatty alcohols may be safely used as components of 
articles intended for use in contact with food, and in synthesizing food 
additives and other substances permitted for use as components of 
articles intended for use in contact with food in accordance with the 
following prescribed conditions:
    (a) The food additive consists of fatty alcohols meeting the 
specifications and definition prescribed in Sec. 172.864 of this 
chapter, except as provided in paragraph (c) of this section.
    (b) It is used or intended for use as follows:
    (1) As substitutes for the corresponding naturally derived fatty 
alcohols permitted for use as components of articles intended for use in 
contact with food by existing regulations in parts 174, 175, 176, 177, 
178 and Sec. 179.45 of this chapter: Provided, That the use is in 
compliance with any prescribed limitations.
    (2) As substitutes for the corresponding naturally derived fatty 
alcohols used as intermediates in the synthesis of food additives and 
other substances permitted for use as components of food-contact 
articles.
    (c) Synthetic fatty alcohols identified in paragraph (c)(1) of this 
section may contain not more than 0.8 weight percent of total diols as 
determined by a method titled ``Diols in Monohydroxy Alcohol by 
Miniature Thin Layer Chromatography (MTLC),'' which is

[[Page 366]]

incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFF-330), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl, 
myristyl, cetyl, and stearyl alcohols meeting the specifications and 
definition prescribed in Sec. 172.864 of this chapter, except that they 
may contain not more than 0.8 weight percent total diols.
    (ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by 
the process described in Sec. 172.864(a)(2) of this chapter such that 
lauryl and myristyl alcohols meet the specifications in 
Sec. 172.864(a)(1)(i) of this chapter, and cetyl and stearyl alcohols 
meet the specifications in Sec. 172.864(a)(1)(ii) of this chapter.
    (2) Conditions of use. (i) Synthetic fatty alcohols as substitutes 
for the corresponding naturally derived fatty alcohols permitted for use 
in compliance with Sec. 178.3910.
    (ii) Synthetic lauryl alcohol as a substitute for the naturally 
derived lauryl alcohol permitted as an intermediate in the synthesis of 
sodium lauryl sulfate used in compliance with Sec. 178.3400.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 
54 FR 24898, June 12, 1989]



Sec. 178.3500   Glycerin, synthetic.

    Synthetic glycerin may be safely used as a component of articles 
intended for use in packaging materials for food, subject to the 
provisions of this section:
    (a) It is produced by the hydrogenolysis of carbohydrates, and shall 
contain not in excess of 0.2 percent by weight of a mixture of 
butanetriols.
    (b) It is used in a quantity not to exceed that amount reasonably 
required to produce its intended physical or technical effect, and in 
accordance with any limitations prescribed by applicable regulations in 
parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be 
intended to, nor in fact accomplish, any direct physical or technical 
effect in the food itself.



Sec. 178.3505  Glyceryl tri-(12-acetoxystearate).

    Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be 
safely used as a component of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, subject to the provisions of this 
section.
    (a) The additive is applied to the surface of calcium carbonate at a 
level not to exceed 1 weight-percent of the total mixture.
    (b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture 
is used as an adjuvant in polymers in contact with nonfatty foods at a 
level not to exceed 20 weight-percent of the polymer.

[50 FR 1503, Jan. 11, 1985]



Sec. 178.3520   Industrial starch-modified.

    Industrial starch-modified may be safely used as a component of 
articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section.
    (a) Industrial starch-modified is identified as follows:
    (1) A food starch-modified or starch or any combination thereof that 
has been modified by treatment with one of the reactants hereinafter 
specified, in an amount reasonably required to achieve the desired 
functional effect but in no event in excess of any limitation 
prescribed, with or without subsequent treatment as authorized in 
Sec. 172.892 of this chapter.

------------------------------------------------------------------------
           List of reactants                       Limitations          
------------------------------------------------------------------------
Ammonium persulfate, not to exceed 0.3                                  
 pct. or in alkaline starch not to                                      
 exceed 0.6 pct..                                                       
(4-Chlorobutene-2) trimethylammonium     Industrial starch modified by  
 chloride, not to exceed 5 pct.           this treatment shall be used  
                                          only as internal sizing for   
                                          paper and paperboard intended 
                                          for food packaging.           
-Diethylaminoethyl chloride                                    
 hydrochloride, not to exceed 4 pct.                                    

[[Page 367]]

                                                                        
Dimethylaminoethyl methacrylate, not to                                 
 exceed 3 pct.                                                          
Dimethylol ethylene urea, not to exceed  Industrial starch modified by  
 0.375 pct.                               this treatment shall be used  
                                          only as internal sizing for   
                                          paper and paperboard intended 
                                          for food packaging.           
2,3-Epoxypropyltrimethylammonium                                        
 chloride, not to exceed 5 pct.                                         
Ethylene oxide, not to exceed 3 pct of                                  
 reacted ethylene oxide in finished                                     
 product.                                                               
Phosphoric acid, not to exceed 6 pct     Industrial starch modified by  
 and urea, not to exceed 20 pct.          this treatment shall be used  
                                          only as internal sizing for   
                                          paper and paperboard intended 
                                          for food packaging and as     
                                          surface sizing and coating for
                                          paper and paperboard that     
                                          contact food only of Types IV-
                                          A, V, VII, VIII, and IX       
                                          described in Table 1 of Sec.  
                                          176.170(c) of this chapter.   
------------------------------------------------------------------------

    (2) A starch irradiated under one of the following conditions to 
produce free radicals for subsequent graft polymerization with the 
reactants listed in this paragraph (a)(2):
    (i) Radiation from a sealed cobalt 60 source, maximum absorbed dose 
not to exceed 5.0 megarads.
    (ii) An electron beam source at a maximum energy of 7 million 
electron volts of ionizing radiation, maximum absorbed dose not to 
exceed 5.0 megarads.

------------------------------------------------------------------------
           List of reactants                       Limitations          
------------------------------------------------------------------------
Acrylamide and [2-(methacryloyloxy)      For use only as a retention aid
 ethyl]trimethylammonium methyl           and dry strength agent        
 sulfate, such that the finished          employed before the sheet-    
 industrial starch-modified shall         forming operation in the      
 contain:                                 manufacture of paper and      
                                          paperboard intended to contact
                                          food, and used at a level not 
                                          to exceed 0.25 pct by weight  
                                          of the finished dry paper and 
                                          paperboard fibers.            
  1. Not more than 60 weight percent                                    
   vinyl copolymer (of which not more                                   
   than 32 weight percent is [2-                                        
   (methacryloyloxy)ethyl]                                              
   trimethylammonium methyl sulfate).                                   
  2. Not more than 0.20 pct residual                                    
   acrylamide.                                                          
  3. A minimum nitrogen content of 9.0                                  
   pct.                                                                 
------------------------------------------------------------------------

    (b) The following adjuvants may be used as surface-active agents in 
the processing of industrial starch-modified:

Polyethylene glycol (400) dilaurate.
Polyethylene glycol (400) monolaurate.
Polyoxyethylene (4) lauryl ether.

    (c) To insure safe use of the industrial starch-modified, the label 
of the food additive container shall bear the name of the additive 
``industrial starch-modified,'' and in the instance of an industrial 
starch-modified which is limited with respect to conditions of use, the 
label of the food additive container shall contain a statement of such 
limited use.

[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977]



Sec. 178.3530   Isoparaffinic petroleum hydrocarbons, synthetic.

    Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used 
in the production of nonfood articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, subject to the provisions of this 
section.
    (a) The isoparaffinic petroleum hydrocarbons, produced by synthesis 
from petroleum gases consist of a mixture of liquid hydrocarbons meeting 
the following specifications:

    Boiling point 63 deg. -260 deg. C, as determined by ASTM method D86-
82, ``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North

[[Page 368]]

Capitol Street, NW., suite 700, Washington, DC 20408.
    Ultraviolet absorbance:
260-319 millimicrons--1.5 maximum.
320-329 millimicrons--0.08 maximum.
330-350 millimicrons--0.05 maximum.
    Nonvolatile residue 0.002 gram per 100 milliliters maximum.
    Synthetic isoparaffinic petroleum hydrocarbons containing 
antioxidants shall meet the specified ultraviolet absorbance limits 
after correction for any absorbance due to the antioxidants. The 
ultraviolet absorbance shall be determined by the procedure described 
for application to mineral oil under ``Specifications'' on page 66 of 
the ``Journal of the Association of Official Agricultural Chemists,'' 
Vol. 45 (February 1962), which is incorporated by reference, 
disregarding the last sentence of that procedure. For hydrocarbons 
boiling below 121 deg. C, the nonvolatile residue shall be determined by 
ASTM method D1353-78, ``Standard Test Method for Nonvolatile Matter in 
Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related 
Products;'' for those boiling above 121 deg. C, ASTM procedure D381-80, 
``Standard Test Method for Existent Gum in Fuels by Jet Evaporation,'' 
which are incorporated by reference. Copies may be obtained from the 
American Society for Testing Materials, 1916 Race St., Philadelphia, PA 
19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.

    (b) Isoparaffinic petroleum hydrocarbons may contain antioxidants 
authorized for use in food in an amount not to exceed that reasonably 
required to accomplish the intended technical effect.
    (c) Isoparaffinic petroleum hydrocarbons are used in the production 
of nonfood articles. The quantity used shall not exceed the amount 
reasonably required to accomplish the intended technical effect, and the 
residual remaining in the finished article shall be the minimum amount 
reasonably attainable.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 
49 FR 10112, Mar. 19, 1984]



Sec. 178.3570  Lubricants with incidental food contact.

    Lubricants with incidental food contact may be safely used on 
machinery used for producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of this section:
    (a) The lubricants are prepared from one or more of the following 
substances:
    (1) Substances generally recognized as safe for use in food.
    (2) Substances used in accordance with the provisions of a prior 
sanction or approval.
    (3) Substances identified in this paragraph (a)(3).

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
Aluminum stearoyl benzoyl hydroxide....  For use only as a thickening   
                                          agent in mineral oil          
                                          lubricants at a level not to  
                                          exceed 10 pct by weight of the
                                          mineral oil.                  
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-      For use as a copper deactivator
 benzotriazole-1-methanamine (CAS Reg.    at a level not to exceed 0.1  
 No. 94270-86-7)..                        percent by weight of the      
                                          lubricant.                    
BHA....................................                                 
BHT....................................                                 
-Butyl-omega-                   Addition to food not to exceed 
 hydroxypoly(oxyethylene)                 10 parts per million.         
 poly(oxypropylene) produced by random                                  
 condensation of a 1:1 mixture by                                       
 weight of ethylene oxide and propylene                                 
 oxide with butanol; minimum molecular                                  
 weight 1,500; Chemical Abstracts                                       
 Service Registry No. 9038-95-3.                                        
-Butyl-omega-                       Do.                        
 hydroxypoly(oxypropylene); minimum                                     
 molecular weight 1,500; Chemical                                       
 Abstracts Service Registry No. 9003-13-                                
 8.                                                                     
Castor oil.............................      Do.                        
Castor oil, dehydrated.................      Do.                        
Castor oil, partially dehydrated.......      Do.                        
Dialkyldimethylammonium aluminum         For use only as a gelling agent
 silicate (CAS Reg. No. 68953-58-2),      in mineral oil lubricants at a
 which may contain up to 7 percent by     level not to exceed 15 percent
 weight 1,6-hexanediol (CAS Reg. No.      by weight of the mineral oil. 
 629-11-8), where the alkyl groups are                                  
 derived from hydrogenated tallow fatty                                 
 acids (C14-C18) and where the aluminum                                 
 silicate is derived from bentonite.                                    
Dimethylpolysiloxane (viscosity greater  Addition to food not to exceed 
 than 300 centistokes).                   1 part per million.           

[[Page 369]]

                                                                        
Disodium decanedioate (CAS Reg. No.      For use only:                  
 17265-14-4).                            1.  As a corrosion inhibitor or
                                          rust preventative in mineral  
                                          oil-bentonite lubricants at a 
                                          level not to exceed 2 percent 
                                          by weight of the grease.      
                                         2.  As a corrosion inhibitor or
                                          rust preventative only in     
                                          greases at a level not to     
                                          exceed 2 percent by weight of 
                                          the grease.                   
Disodium EDTA (CAS Reg. No. 139-33-3)..  For use only as a chelating    
                                          agent and sequestrant at a    
                                          level not to exceed 0.06      
                                          percent by weight of lubricant
                                          at final use dilution.        
Ethoxylated resin phosphate ester        For use only as a surfactant to
 mixture consisting of the following      improve lubricity in          
 compounds:                               lubricating fluids complying  
                                          with this section at a level  
                                          not to exceed 5 percent by    
                                          weight of the lubricating     
                                          fluid.                        
  1. Poly(methylene-p-tert-butyl-                                       
   phenoxy)poly-(oxyethylene) mixture                                   
   of dihydrogen phosphate and                                          
   monohydrogen phosphate esters (0 to                                  
   40 percent of the mixture). The                                      
   resin is formed by condensation of 1                                 
   mole of p-tert-butylphenol with 2 to                                 
   4 moles of formaldehyde and                                          
   subsequent ethoxylation with 4 to 12                                 
   moles of ethylene oxide;.                                            
  2. Poly(methylene-p-nonylphenoxy)                                     
   poly(oxyethylene) mixture of                                         
   dihydrogen phosphate and                                             
   monohydrogen phosphate esters (0 to                                  
   40 percent of the mixture). The                                      
   resin is formed by condensation of 1                                 
   mole of p-nonylphenol with 2 to 4                                    
   moles of formaldehyde and subsequent                                 
   ethoxylation with 4 to 12 moles of                                   
   ethylene oxide; and.                                                 
  3. n-Tridecyl alcohol mixture of                                      
   dihydrogen phosphate and                                             
   monohydrogen phosphate esters (40 to                                 
   80 percent of the mixture; CAS Reg.                                  
   No. 56831-62-0).                                                     
Fatty acids derived from animal or                                      
 vegetable sources, and the                                             
 hydrogenated forms of such fatty acids.                                
2-(8-Heptadecenyl)-4,5-dihydro-1H-       For use at levels not to exceed
 imidazole-1-ethanol (CAS Reg. No. 95-    0.5 percent by weight of the  
 38-5).                                   lubricant.                    
Hexamethylenebis(3,5-di-tert-butyl-4-    For use as an antioxidant at   
 hydroxyhydrocinnamate) (CAS Reg. No.     levels not to exceed 0.5      
 35074-77-2).                             percent by weight of the      
                                          lubricant.                    
-Hydro-omega-hydroxypoly        Addition to food not to exceed 
 (oxyethylene) poly(oxypropylene)         10 parts per million.         
 produced by random condensation of                                     
 mixtures of ethylene oxide and                                         
 propylene oxide containing 25 to 75                                    
 percent by weight of ethylene oxide;                                   
 minimum molecular weight 1,500;                                        
 Chemical Abstracts Service Registry                                    
 No. 9003-11-6.                                                         
12-Hydroxystearic acid.................                                 
Isopropyl oleate.......................  For use only as an adjuvant (to
                                          improve lubricity) in mineral 
                                          oil lubricants.               
Magnesium ricinoleate..................  For use only as an adjuvant in 
                                          mineral oil lubricants at a   
                                          level not to exceed 10 percent
                                          by weight of the mineral oil. 
Mineral oil............................  Addition to food not to exceed 
                                          10 parts per million.         
N-Methyl-N-(1-oxo-9-                     For use as a corrosion         
 octadecenyl)glycine (CAS Reg. No. 110-   inhibitor at levels not to    
 25-8).                                   exceed 0.5 percent by weight  
                                          of the lubricant.             
N-phenylbenzenamine, reaction products   For use only as an antioxidant 
 with 2,4,4-trimethylpentene (CAS Reg.    at levels not to exceed 0.5   
 No. 68411-46-1).                         percent by weight of the      
                                          lubricant.                    
Petrolatum.............................  Complying with Sec.  178.3700. 
                                          Addition to food not to exceed
                                          10 parts per million.         
Phenyl--and/or phenyl--naphthylamine.                        combination, as antioxidant in
                                          mineral oil lubricants at a   
                                          level not to exceed a total of
                                          1 percent by weight of the    
                                          mineral oil.                  
Phosphoric acid, mono- and dihexyl       For use only as an adjuvant at 
 esters, compounds with                   levels not to exceed 0.5      
 tetramethylnonylamines and C11-14        percent by weight of the      
 alkylamines.                             lubricant.                    
Phosphoric acid, mono- and diisooctyl    For use only as a corrosion    
 esters, reacted with tert-alkyl and      inhibitor or rust preventative
 (C12-C14) primary amines (CAS Reg. No.   inlubricants at a level not to
 68187-67-7).                             exceed 0.5 percent by weight  
                                          of the lubricant.             
Polyurea, having a nitrogen content of   For use only as an adjuvant in 
 9-14 percent based on the dry polyurea   mineral oil lubricants at a   
 weight, produced by reacting tolylene    level not to exceed 10 percent
 diisocyanate with tall oil fatty acid    by weight of the mineral oil. 
 (C16 and C18) amine and ethylene                                       
 diamine in a 2:2:1 molar ratio.                                        
Polybutene (minimum average molecular    Addition to food not to exceed 
 weight 80,000).                          10 parts per million.         
Polybutene, hydrogenated; complying          Do.                        
 with the identity prescribed under                                     
 Sec.  178.3740.                                                        
Polyethylene...........................      Do.                        
Polyisobutylene (average molecular       For use only as a thickening   
 weight 35,000-140,000 (Flory)).          agent in mineral oil          
                                          lubricants.                   
Sodium nitrite.........................  For use only as a rust         
                                          preventive in mineral oil     
                                          lubricants at a level not to  
                                          exceed 3 percent by weight of 
                                          the mineral oil.              
Tetrakis[methylene(3,5-di-tert-butyl-4-  For use only as an antioxidant 
 hydroxyhydro-cinnamate)]methane (CAS     in lubricants at a level not  
 Reg. No. 6683-19-8).                     to exceed 0.5 percent by      
                                          weight of the lubricant.      

[[Page 370]]

                                                                        
Thiodiethylenebis (3,5-di-tert-butyl-4-  For use as an antioxidant at   
 hydroxyhydrocinnamate) (CAS Reg. No.     levels not to exceed 0.5      
 41484-35-9).                             percent by weight of the      
                                          lubricant.                    
Tri[2(or 4)-C9-10-branched               For use only as an extreme     
 alkylphenyl]phosphorothioate (CAS Reg.   pressure-antiwear adjuvant at 
 No. 126019-82-7)..                       levels not to exceed 0.5      
                                          percent by weight of the      
                                          lubricant.                    
Triphenyl phosphorothionate (CAS Reg.    For use as an adjuvant in      
 No. 597-82-0).                           lubricants herein listed at a 
                                          level not to exceed 0.5       
                                          percent by weight of the      
                                          lubricant.                    
Tris(2,4-di-tert-butylphenyl)phosphite   For use only as a stabilizer at
 (CAS Reg. NO. 31570-04-4).               levels not to exceed 0.5      
                                          percent by weight of the      
                                          lubricant.                    
Thiodiethylenebis(3,5-di-tert-butyl-4-   For use as an antioxidant at   
 hydroxy-hydro- cinnamate) (CAS Reg.      levels not to exceed 0.5      
 No. 41484-35-9).                         percent by weight of the      
                                          lubricant.                    
Zinc sulfide...........................  For use at levels not to exceed
                                          10 percent by weight of the   
                                          lubricant.                    
------------------------------------------------------------------------

    (b) The lubricants are used on food-processing equipment as a 
protective antirust film, as a release agent on gaskets or seals of tank 
closures, and as a lubricant for machine parts and equipment in 
locations in which there is exposure of the lubricated part to food. The 
amount used is the minimum required to accomplish the desired technical 
effect on the equipment, and the addition to food of any constituent 
identified in this section does not exceed the limitations prescribed.
    (c) Any substance employed in the production of the lubricants 
described in this section that is the subject of a regulation in parts 
174, 175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with 
any specification in such regulation.

[42 FR 14609, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting 
Sec. 178.3570, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 178.3600   Methyl glucoside-coconut oil ester.

    Methyl glucoside-coconut oil ester identified in Sec. 172.816(a) of 
this chapter may be safely used as a processing aid (filter aid) in the 
manufacture of starch, including industrial starch-modified complying 
with Sec. 178.3520, intended for use as a component of articles that 
contact food.



Sec. 178.3610   a-Methylstyrene-vinyltoluene resins, hydrogenated.

    Hydrogenated -methylstyrene-vinyltoluene copolymer resins 
having a molar ratio of 1 -methylstyrene to 3 vinyltoluene may 
be safely used as components of polyolefin film intended for use in 
contact with food, subject to the following provisions:
    (a) Hydrogenated -methylstyrene-vinyltoluene copolymer 
resins have a drop-softening point of 125 deg. to 165 deg. C and a 
maximum absorptivity of 0.17 liter per gram centimeter at 266 
nanometers, as determined by methods titled ``Determination of Softening 
Point (Drop Method)'' and ``Determination of Unsaturation of Resin 
1977,'' which are incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (b) The polyolefin film is produced from olefin polymers complying 
with Sec. 177.1520 of this chapter, and the average thickness of the 
film in the form in which it contacts food does not exceed 0.002 inch.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 
54 FR 24898, June 12, 1989]



Sec. 178.3620  Mineral oil.

    Mineral oil may be safely used as a component of nonfood articles 
intended for use in contact with food, subject to the provisions of this 
section:
    (a) White mineral oil meeting the specifications prescribed in 
Sec. 172.878 of this chapter may be used as a component of nonfood 
articles provided such use complies with any applicable limitations in 
parts 170 through 189 of this chapter. The use of white mineral oil in 
or on food itself, including the use of white mineral oil as a 
protective coating or release agent for food, is subject

[[Page 371]]

to the provisions of Sec. 172.878 of this chapter.
    (b) Technical white mineral oil identified in paragraph (b)(1) of 
this section may be used as provided in paragraph (b)(2) of this 
section.
    (1) Technical white mineral oil consists of specially refined 
distillates of virgin petroleum or of specially refined distillates that 
are produced synthetically from petroleum gases. Technical white mineral 
oil meets the following specifications:
    (i) Saybolt color 20 minimum as determined by ASTM method D156-82, 
``Standard Test Method for Saybolt Color of Petroleum Products (Saybolt 
Chromometer Method),'' which is incorporated by reference. Copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (ii) Ultraviolet absorbance limits as follows:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                   Wavelength (m)                    centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280 to 289..................................................         4.0
290 to 299..................................................         3.3
300 to 329..................................................         2.3
330 to 350..................................................         0.8
------------------------------------------------------------------------

Technical white mineral oil containing antioxidants shall meet the 
specified ultraviolet absorbance limits after correction for any 
absorbance due to the antioxidants. The ultraviolet absorbance shall be 
determined by the procedure described for application to mineral oil 
under ``Specification'' on page 66 of the ``Journal of the Association 
of Official Agricultural Chemists,'' Volume 45 (February 1962) (which is 
incorporated by reference; copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408), disregarding the last two sentences of that 
procedure and substituting therefor the following: Determine the 
absorbance of the mineral oil extract in a 10-millimeter cell in the 
range from 260-350 m, inclusive, compared to the solvent 
control. If the absorbance so measured exceeds 2.0 at any point in range 
280-350 m, inclusive, dilute the extract and the solvent 
control, respectively, to twice their volume with dimethyl sulfoxide and 
remeasure the absorbance. Multiply the remeasured absorbance values by 2 
to determine the absorbance of the mineral oil extract per centimeter 
optical pathlength.
    (2) Technical white mineral oil may be used wherever mineral oil is 
permitted for use as a component of nonfood articles complying with 
Secs. 175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 of 
this chapter and Secs. 178.3570 and 178.3910.
    (3) Technical white mineral oil may contain any antioxidant 
permitted in food by regulations issued in accordance with section 409 
of the Act, in an amount not greater than that required to produce its 
intended effect.
    (c) Mineral oil identified in paragraph (c)(1) of this section may 
be used as provided in paragraph (c)(2) of this section.
    (1) The mineral oil consists of virgin petroleum distillates refined 
to meet the following specifications:
    (i) Initial boiling point of 450 deg.F minimum.
    (ii) Color 5.5 maximum as determined by ASTM method D1500-82, 
``Standard Test Method for ASTM Color of Petroleum Products (ASTM Color 
Scale),'' which is incorporated by reference. The availability of this 
incorporation by reference is given in paragraph (b)(1)(i) of this 
section.
    (iii) Ultraviolet absorbance limits as follows as determined by the 
analytical method described in paragraph (c)(3) of this section:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                   Wavelength (m)                    centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280 to 289..................................................         0.7
290 to 299..................................................         0.6
300 to 359..................................................         0.4
360 to 400..................................................         .09
------------------------------------------------------------------------

    (2) The mineral oil may be used wherever mineral oil is permitted 
for use as

[[Page 372]]

a component of nonfood articles complying with Secs. 175.105 and 176.210 
of this chapter and Sec. 178.3910 (for use only in rolling of metallic 
foil and sheet stock), Secs. 176.200, 177.2260, 177.2600, and 177.2800 
of this chapter.
    (3) The analytical method for determining ultraviolet absorbance 
limit is as follows:

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware, 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of oil samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Reservoir. 500-milliliter capacity, equipped with a 24/40 standard 
taper male fitting at the bottom and a suitable ball-joint at the top 
for connecting to the nitrogen supply. The male fitting should be 
equipped with glass hooks.
    Chromatographic tube. 180 millimeters in length, inside diameter to 
be 15.7 millimeters plus-minus0.1 millimeter, equipped with a 
coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and 
a female 24/40 standard tapered fitting at the opposite end. (Overall 
length of the column with the female joint is 235 millimeters.) The 
female fitting should be equipped with glass hooks.
    Disc. Tetrafluoroethylene polymer 2-inch diameter disk approximately 
\3/16\-inch thick with a hole bored in the center to closely fit the 
stem of the chromatographic tube.
    Suction flask. 250-milliliter or 500-milliliter filter flask.
    Condenser. 24/40 joints, fitted with a drying tube, length optional.
    Evaporation flask (optional). 250-milliliter or 500-milliliter 
capacity all-glass flask equipped with standard taper stopper having 
inlet and outlet tubes to permit passage of nitrogen across the surface 
of contained liquid to be evaporated.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5,000 centimeter plus-minus0.005 centimeter; also for 
checking spectrophotometer performance only, optical path length in the 
range 1,000 centimeter plus-minus0.005 centimeter. With distilled 
water in the cells, determine any absorbance differences.
    Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons 
with spectral slit width of 2 millimicrons or less; under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Absorbance accuracy \1\ plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    \1\ As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrophotometry, U.S. Department of Commerce (1949). The 
accuracy is to be determined by comparison with the standard values at 
290, 345, and 400 millimicrons. Circular 484 is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
---------------------------------------------------------------------------

    Wavelength accuracy, plus-minus1.0 millimicron.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane, benzene, acetone, and methyl alcohol designated in the list 
following this paragraph shall pass the following test:
    To the specified quantity of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains. (To the residue from benzene 
add a 10-milliliter portion of purified isooctane, reevaporate, and 
repeat once to insure complete removal of benzene.)
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted,

[[Page 373]]

and a stream of nitrogen is fed through the inlet tube while the outlet 
tube is connected to a solvent trap and vacuum line in such a way as to 
prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue (except for methyl 
alcohol) shall not exceed 0.01 per centimeter path length between 280 
and 400 m. For methyl alcohol this absorbance value shall be 
0.00.
    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test 
described in the preceding paragraph. Purify, if necessary, by passage 
through a column of activated silica gel (Grade 12, Davison Chemical 
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in 
length and 5 centimeters to 8 centimeters in diameter.
    Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. 
Purify, if necessary, by distillation or otherwise.
    Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. 
Purify, if necessary, by distillation.
    Eluting mixtures:
    1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 250-milliliter glass-stoppered volumetric flask and adjust to 
volume with isooctane, with mixing.
    2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 250-milliliter glass-stoppered volumetric flask and adjust to 
volume with isooctane, with mixing.
    3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 
milliliters of acetone and 200 milliliters of benzene, and mix.
    n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference point between 
280 m-400 m. The absorbance per centimeter path length 
shall not exceed 0.00 in this range. Purify, if necessary, by 
percolation through activated silica gel or by distillation.
    Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl 
alcohol. Purify, if necessary, by distillation.
    Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach 
Corporation, Camas, Washington, or equivalent). Absorbance (1-centimeter 
cell, distilled water reference, sample completely saturated with 
nitrogen).

------------------------------------------------------------------------
                                                              Absorbance
                         Wavelength                            (maximum)
------------------------------------------------------------------------
261.5.......................................................        1.00
270.........................................................         .20
275.........................................................         .09
280.........................................................         .06
300.........................................................        .015
------------------------------------------------------------------------

    There shall be no irregularities in the absorbance curve within 
these wavelengths.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Sodium borohydride. 98 percent.
    Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco 
Division, distributed by chemical supply firms, or equivalent). Place 
100 grams of the magnesium oxide in a large beaker, add 700 milliliters 
of distilled water to make a thin slurry, and heat on a steam bath for 
30 minutes with intermittent stirring. Stir well initially to insure 
that all the adsorbent is completely wetted. Using a Buchner funnel and 
a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable 
diameter, filter with suction. Continue suction until water no longer 
drips from the funnel. Transfer the adsorbent to a glass trough lined 
with aluminum foil (free from rolling oil). Break up the magnesia with a 
clean spatula and spread out the adsorbent on the aluminum foil in a 
layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 
160 deg. C plus-minus1 deg. C. Pulverize the magnesia with mortar 
and pestle. Sieve the pulverized adsorbent between 60-180 mesh. Use the 
magnesia retained on the 180-mesh sieve.
    Celite 545. Johns Mansville Company, diatomaceous earth, or 
equivalent.
    Magnesium oxide-Celite 545 mixture (2+1) by weight. Place the 
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, 
respectively, by weight in a glass-stoppered flask large enough for 
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture 
to a glass trough lined with aluminum foil (free from rolling oil) and 
spread it out on a layer about 1 centimeter to 2 centimeters thick. 
Reheat the mixture at 160 deg. Cplus-minus1 deg. C for 2 hours, and 
store in a tightly closed flask.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter course, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter path length 
between 280 m and 400 m when tested as prescribed 
under ``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.
    Before proceeding with analysis of a sample, determine the 
absorbance in a 5-centimeter path cell between 250 millimicrons and

[[Page 374]]

400 millimicrons for the reagent blank by carrying out the procedure, 
without an oil sample, recording the spectra after the extraction stage 
and after the complete procedure as prescribed. The absorbance per 
centimeter pathlength following the extraction stage should not exceed 
0.02 in the wavelength range from 280 m to 400 m; the 
absorbance per centimeter pathlength following the complete procedure 
should not exceed 0.02 in the wavelength range from 280 m to 
400 m. If in either spectrum the characteristic benzene peaks 
in the 250 m-260 m region are present, remove the 
benzene by the procedure under ``Organic solvents'' and record 
absorbance again.
    Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory 
funnel and add 75 milliliters of phosphoric acid. Mix the contents of 
the funnel and allow to stand for 10 minutes. (The reaction between the 
sulfoxide and the acid is exothermic. Release pressure after mixing, 
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake 
to pre-equilibrate the solvents. Draw off the individual layers and 
store in glass-stoppered flasks.
    Weigh a 20-gram sample of the oil and transfer to a 500-milliliter 
separatory funnel containing 100 milliliters of pre-equilibrated 
sulfoxide-phosphoric acid mixture. Complete the transfer of the sample 
with small portions of preequilibrated isooctane to give a total volume 
of the oil and solvent of 75 milliliters. Shake the funnel vigorously 
for 2 minutes. Set up three 250-milliliter separatory funnels with each 
containing 30 milliliters of pre-equilibrated isooctane. After 
separation of liquid phases, carefully draw off lower layer into the 
first 250-milliliter separatory funnel and wash in tandem with the 30-
milliliter portions of isooctane contained in the 250-milliliter 
separatory funnels. Shaking time for each wash is 1 minute. Repeat the 
extraction operation with two additional portions of the sulfoxide-acid 
mixture and wash each extractive in tandem through the same three 
portions of isooctane.
    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter) containing 480 milliliters of 
distilled water; mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on 
the steam bath under nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Quantitatively transfer the residue with isooctane to a 200-
milliliter volumetric flask, make to volume, and mix. Determine the 
absorbance of the solution in the 1-centimeter pathlength cells compared 
to isooctane as reference between 280 m-400 m (take 
care to lose none of the solution in filling the sample cell). Correct 
the absorbance values for any absorbance derived from reagents as 
determined by carrying out the procedure without an oil sample. If the 
corrected absorbance does not exceed the limits prescribed in this 
paragraph, the oil meets the ultraviolet absorbance specifications. If 
the corrected absorbance per centimeter pathlength exceeds the limits 
prescribed in this paragraph, proceed as follows: Quantitatively 
transfer the isooctane solution to a 125-milliliter flask equipped with 
24/40 joint, and evaporate the isooctane on the steam bath under a 
stream of nitrogen to a volume of 1 milliliter of hexadecane. Add 10 
milliliters of methyl alcohol and approximately 0.3 gram of sodium 
borohydride. (Minimize exposure of the borohydride to the atmosphere. A 
measuring dipper may be used.) Immediately fit a water-cooled condenser 
equipped with a 24/40 joint and with a drying tube into the flask, mix 
until the borohydride is dissolved, and allow to stand for 30 minutes at 
room temperature, with intermittent swirling. At the end of this period, 
disconnect the flask and evaporate the methyl alcohol on the steam bath 
under nitrogen until the sodium borohydride begins to come out of the 
solution. Then add 10 milliliters of isooctane and evaporate to a volume 
of about 2-3 milliliters. Again, add 10 milliliters of isooctane and 
concentrate to a volume of approximately 5 milliliters. Swirl the flask 
repeatedly to assure adequate washing of the sodium borohydride 
residues.
    Fit the tetrafluoroethylene polymer disc on the upper part of the 
stem of the chromatographic tube, then place the tube with the disc on 
the suction flask and apply the vacuum (approximately 135 millimeters Hg 
pressure). Weigh out 14 grams of the 2:1 magnesium oxide-Celite 545 
mixture and

[[Page 375]]

pour the adsorbent mixture into the chromatographic tube in 
approximately 3-centimeter layers. After the addition of each layer, 
level off the top of the adsorbent with a flat glass rod or metal 
plunger by pressing down firmly until the adsorbent is well packed. 
Loosen the topmost few millimeters of each adsorbent layer with the end 
of a metal rod before the addition of the next layer. Continue packing 
in this manner until all the 14 grams of the adsorbent is added to the 
tube. Level off the top of the adsorbent by pressing down firmly with a 
flat glass rod or metal plunger to make the depth of the adsorbent bed 
approximately 12.5 centimeters in depth. Turn off the vacuum and remove 
the suction flask. Fit the 500-milliliter reservoir onto the top of the 
chromatographic column and prewet the column by passing 100 milliliters 
of isooctane through the column. Adjust the nitrogen pressure so that 
the rate of descent of the isooctane coming off the column is between 2-
3 milliliters per minute. Discontinue pressure just before the last of 
the isooctane reaches the level of the adsorbent. (Caution: Do not allow 
the liquid level to recede below the adsorbent level at any time.) 
Remove the reservoir and decant the 5-milliliter isooctane concentrate 
solution onto the column and with slight pressure again allow the liquid 
level to recede to barely above the adsorbent level. Rapidly complete 
the transfer similarly with two 5-milliliter portions of isooctane, 
swirling the flask repeatedly each time to assure adequate washing of 
the residue. Just before the final 5-milliliter wash reaches the top of 
the adsorbent, add 100 milliliters of isooctane to the reservoir and 
continue the percolation at the 2-3 milliliters per minute rate. Just 
before the last of the isooctane reaches the adsorbent level, add 100 
milliliters of 10 percent benzene in isooctane to the reservoir and 
continue the percolation at the aforementioned rate. Just before the 
solvent mixture reaches adsorbent level, add 25 milliliters of 20 
percent benzene in isooctane to the reservoir and continue the 
percolation at 2-3 milliliters per minute until all this solvent mixture 
has been removed from the column. Discard all the elution solvents 
collected up to this point. Add 300 milliliters of the acetone-benzene-
water mixture to the reservoir and percolate through the column to 
eluate the polynuclear compounds. Collect the eluate in a clean 1-liter 
separatory funnel. Allow the column to drain until most of the solvent 
mixture is removed. Wash the eluate three times with 300-milliliter 
portions of distilled water, shaking well for each wash. (The addition 
of small amounts of sodium chloride facilitates separation.) Discard the 
aqueous layer after each wash. After the final separation, filter the 
residual benzene through anhydrous sodium sulfate pre-washed with 
benzene (see Sodium sulfate under ``Reagents and Materials'' for 
preparation of filter) into a 250-milliliter Erlenmeyer flask (or 
optionally into the evaporation flask). Wash the separatory funnel with 
two additional 20-milliliter portions of benzene which are also filtered 
through the sodium sulfate. Add 1 milliliter of n-hexadecane and 
completely remove the benzene by evaporation under nitrogen, using the 
special procedure to eliminate benzene as previously described under 
``Organic solvents.'' Quantitatively transfer the residue with isooctane 
to a 200-milliliter volumetric flask and adjust to volume. Determine the 
absorbance of the solution in the 1-centimeter pathlength cells compared 
to isooctane as reference between 250 m-400 m. Correct 
for any absorbance derived from the reagents as determined by carrying 
out the procedure without an oil sample. If either spectrum shows the 
characteristic benzene peaks in the 250 m-260 m 
region, evaporate the solution to remove benzene by the procedure under 
``Organic solvents.'' Dissolve the residue, transfer quantitatively, and 
adjust to volume in isooctane in a 200-milliliter volumetric flask. 
Record the absorbance again. If the corrected absorbance does not exceed 
the limits proposed in this paragraph, the oil meets the proposed 
ultraviolet absorbance specifications.

    (d) Mineral oil identified in paragraph (d)(1) of this section may 
be used as provided in paragraph (d)(2) of this section.
    (1) The mineral oil consists of virgin petroleum distillates refined 
to meet the following specifications:
    (i) Distillation endpoint at 760 millimeters pressure not to exceed 
371 deg. C, with a maximum residue not to exceed 2 percent, as 
determined by ASTM method D86-82, ``Standard Method for Distillation of 
Petroleum Products,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(b)(1)(i) of this section.
    (ii) Ultraviolet absorbance limits as follows as determined by the 
method described in paragraph (d)(3) of this section.

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                   Wavelength (m)                    centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280 to 299..................................................         2.3
300 to 319..................................................         1.2
320 to 359..................................................          .8
360 to 400..................................................          .3
------------------------------------------------------------------------

    (iii) Pyrene content not to exceed a maximum of 25 parts per million 
as determined by the method described in paragraph (d)(3) of this 
section.
    (2) The mineral oil may be used only in the processing of jute fiber 
employed in the production of textile bags intended for use in contact 
with the following types of food: Dry grains and dry seeds (for example, 
beans, peas, rice, and lentils); whole root crop vegetables of the types 
identified in 40 CFR 180.34(f); unshelled and shelled nuts (including 
peanuts); and dry animal feed. The finished processed jute fiber shall 
contain no more than 6 percent by weight of residual mineral oil.
    (3) The analytical method for determining ultraviolet absorbance 
limits and pyrene content is as follows:

    I. Apparatus. A. Assorted beakers, separatory funnels fitted with 
tetrafluoroethylene polymer stopcocks, and graduated cylinders.
    B. Volumetric flasks, 200-milliliter.
    C. A chromatographic column made from nominal 1.3 centimeters 
outside diameter x 75 centimeters glass tubing tapered at one end and 
joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The 
opposite end is flanged and joined to a female 24/40 standard taper 
fitting. This provides for accommodating the 500-milliliter reservoir 
described in item I.E below.

[[Page 376]]

    D. A chromatographic column made from nominal 1.7 centimeters 
outside diameter x 115 centimeters glass tubing tapered at one end and 
joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The 
opposite end is flanged and joined to a 2.5 centimeters outside diameter 
x 9.0 centimeters glass tube having a female 24/40 standard taper 
fitting. This provides for accommodating the 500-milliliter reservoir 
described in item I. E below.
    E. A 500-milliliter reservoir having a 24/40 standard taper male 
fitting at bottom and a suitable ball joint at the top for connecting to 
the nitrogen supply. The female fitting of the chromatographic columns 
described in items I. C and D above and the male fitting of the 
reservoir described in this item E should both be equipped with glass 
hooks.

    (Note: Rubber stoppers are not to be used. Stopcock grease is not to 
be used on ground-glass joints in this method.)

    F. A spectrophotometer equipped to automatically record absorbance 
of liquid samples in 1-centimeter pathlength cells in the spectral 
region of 280-400 m with a spectral slit width of 2 m 
or less. At an absorbance level of about 0.4, absorbance measurements 
shall be repeatable within plus-minus0.01 and accurate within 
plus-minus0.05. Wavelength measurements shall be repeatable with 
plus-minus0.2 m and accurate within plus-minus1.0 
m. Instrument operating conditions are selected to realize this 
performance under dynamic (automatic) recording operations. Accuracy of 
absorbance measurements are determined at 290, 345, and 400 m, 
using potassium chromate as the reference standard. (National Bureau of 
Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, 
1949.)
    G. Two fused quartz cells having pathlengths of 
1.00plus-minus0.005 centimeter or better.
    II. Purity of reagents and materials. Reagent-grade chemicals shall 
be used in all tests. It is further specified that each chemical shall 
be tested for purity in accordance with the instruction given under 
``Reagents and Materials'' in III below. In addition, a blank run by the 
procedure shall be made on each purified lot of reagents and materials. 
Unless otherwise indicated, references to water shall be understood to 
mean distilled water.
    III. Reagents and materials--A. Organic solvents. All solvents used 
throughout the procedure shall meet the specifications and tests 
described in this section III. The isooctane, benzene, cyclohexane, 
nitromethane, and n-hexadecane designated shall pass the following test: 
To the specified quantity of solvent in a 150-milliliter beaker, add 1 
milliliter of purified n-hexadecane and evaporate on the steam bath 
under a stream of nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains (to the residue from benzene and 
nitromethane add a 10-milliliter portion of purified isooctane, re-
evaporate, and repeat once to insure complete removal of solvent). 
Dissolve the 1 milliliter of n-hexadecane residue in isooctane and make 
to 10-milliliter volume. Determine the absorbance in 1.0-centimeter 
pathlength cells compared to water as reference. The absorbance of the 
solution of solvent residue shall not exceed 0.05 between 280 and 400 
m.
    1. Isooctane (2,2,4-trimethylpentane). Use 240 milliliters for the 
above test. Purify, if necessary, by passage through a column of 
activated silica gel.
    2. Benzene. Use 200 milliliters for the above test. Purify, if 
necessary, by distillation or otherwise.
    3. Cyclohexane. Use 70 milliliters for the above test. Purify, if 
necessary, by distillation, silica gel percolation, or otherwise.
    4. Nitromethane. Use 125 milliliters for the above test. Purify, if 
necessary, by distillation or otherwise.
    5. n-Hexadecane. Determine the absorbance on this solvent directly. 
Purify, if necessary, by silica gel percolation or otherwise.
    B. Other materials--1. Pyrene standard reference. Pyrene, reagent 
grade, melting point range 150-152 deg. C. (Organic Chemical 3627, 
Eastman Kodak Co., Rochester, N.Y., or equivalent). The standard 
reference absorbance is the absorbance at 334 millimicrons of a standard 
reference solution of pyrene containing a concentration of 1.0 milligram 
per liter in purified isooctane measured against isooctane of the same 
spectral purity in 1.0-centimeter cells. (This absorbance will be 
approximately 0.28.)
    2. Chrysene solution. Prepare a solution at a concentration of 5.0 
milligrams per liter by dissolving 5.0 milligrams of chrysene in 
purified isooctane in a 1-liter volumetric flask. Adjust to volume with 
isooctane.
    3. Nitrogen gas. Water pumped or equivalent purity, cylinder with 
regulator, and valve control flow at 5 p.s.i.
    4. Silica gel. 100-200 mesh (Davison Chemical, Baltimore, Md., Grade 
923, or equivalent), purified and activated by the following procedure: 
Place about 1 kilogram of silica gel in a large column and wash with 
contaminant-free benzene until a 200-milliliter sample of the benzene 
coming off the column will pass the ultraviolet absorption test for 
benzene. This test is performed as stipulated under ``Organic solvents'' 
in A under III above. When the silica gel has been sufficiently cleaned, 
activate the gel before use by placing the 1-kilogram batch in a shallow 
container in a layer no greater than 1 inch in depth and heating in an 
oven (Caution! Explosion Hazard) at 130 deg. C. for 16 hours, and store 
in a vacuum desiccator. Reheating about once a week is necessary if the 
silica gel is repeatedly removed from the desiccator.

[[Page 377]]

    5. Aluminum oxide (Aluminum Co. of America, Grade F-20, or 
equivalent grade). 80-200 mesh, purified and activated by the following 
procedure: Place about 1 kilogram of aluminum oxide in a large column 
and wash with contaminant-free benzene until a 200-milliliter sample of 
the benzene coming off the column will pass the ultraviolet absorption 
test for benzene. This test is performed as stipulated under ``Organic 
solvents'' in A under III above. (Caution! Remove Benzene From Adsorbent 
Under Vacuum To Minimize Explosion Hazard in Subsequent Heating!) When 
the aluminum oxide has been sufficiently cleaned and freed of solvent, 
activate it before use by placing the 1-kilogram batch in a shallow 
container in a layer no greater than 1 inch in depth. Heat in an oven at 
130 deg. C for 16 hours. Upon removal from heat, store at atmospheric 
pressure over 80 percent (by weight) sulfuric acid in a desiccator for 
at least 36 hours before use. This gives aluminum oxide with between 6 
to 9.5 percent volatiles. This is determined by heating a weighed sample 
of the prepared aluminum oxide at 2,000 deg. F for 2 hours and then 
quickly reweighing. To insure the proper adsorptive properties of the 
aluminum oxide, perform the following test:
    a. Weigh 50 grams plus-minus1 gram of the activated aluminum 
oxide and pack into the chromatographic column (1.3 centimeters x 75 
centimeters) described under ``Apparatus'' in C under I above. Use glass 
wool at the column exit to prevent the aluminum oxide from passing 
through the column.
    b. Place a 250-milliliter graduated cylinder under the column to 
measure the amount of eluate coming from the column.
    c. Prewet the aluminum oxide by passing 40 milliliters of isooctane 
through the column. Adjust the nitrogen pressure so that the rate of 
descent of the isooctane coming off the column is between 1.5 to 2.5 
milliliters per minute.
    d. Just prior to the last of the isooctane reaching the top of the 
aluminum oxide bed, add 10 milliliters of the isooctane solution 
containing 5.0 milligrams of chrysene per liter.
    e. Continue percolation until the isooctane is just above the 
aluminum oxide. Then add 200 milliliters of a mixture of benzene and 
isooctane (33\1/3\ percent benzene and 66\2/3\ percent isooctane by 
volume) to the reservoir and continue percolation.
    f. Continue percolation, collecting the eluates (40 milliliters of 
the prewet solution, 10 milliliters of the sample solution, and 200 
milliliters of the gradient solution) in the 250-milliliter graduated 
cylinder until the level of the gradient solution is just above the 
aluminum oxide. Add 200 milliliters of the eluting solution of benzene 
and isooctane (90 percent benzene and 10 percent isooctane by volume) to 
the column and continue collecting until a total of 250 milliliters of 
solution has been obtained. This may be discarded. Now begin to collect 
the final eluate.
    g. Place a 100-milliliter graduated cylinder under the column and 
continue the percolation until a 100-milliliter eluate has been 
obtained.
    h. Measure the amount of chrysene in this 100-milliliter fraction by 
ultraviolet analysis. If the aluminum oxide is satisfactory, more than 
80 percent of the original amount of chrysene should be found in this 
fraction. (Note: If the amount of chrysene recovered is less than 80 
percent, the original batch of aluminum oxide should be sieved between 
100-160 mesh. Activation and testing of this sieved batch should 
indicate a satisfactory aluminum oxide for use.)
    IV. Sampling. Precautions must be taken to insure that an 
uncontaminated sample of the mineral oil is obtained since ultraviolet 
absorption is very sensitive to small amounts of extraneous material 
contaminating the sample through careless handling.
    V. Procedure. A. Blank. Before proceeding with the analysis of a 
sample, determine the absorbance of the solvent residues by carrying out 
the procedure without a sample.
    B. Sample. 1. Weigh out 20.0 grams plus-minus0.1 gram of the 
mineral oil into a beaker and transfer to a 250-milliliter separatory 
funnel fitted with a tetrafluoroethylene polymer stopcock, using enough 
cyclohexane (25 milliliters) to give a final total volume of 50 
milliliters (mineral oil plus cyclohexane).
    2. Add 25 milliliters of nitromethane saturated with cyclohexane and 
shake by hand vigorously for 3 minutes. Recover the lower nitromethane 
layer in a 150-milliliter beaker containing 1 milliliter of n-hexadecane 
and evaporate on the steam bath under nitrogen. Repeat the extraction 
four more times, recovering each extract in the 150-milliliter beaker. 
Exercise care not to fill the beaker to such a capacity that solvent 
losses may occur. Evaporate the combined nitromethane extracts to 1 
milliliter of n-hexadecane residue containing the nitromethane-soluble 
mineral oil extractives. (Note: Complete removal of the nitromethane is 
essential. This can be assured by two successive additions of 5 
milliliters of isooctane and reevaporation.)
    3. Remove the beaker from the steam bath and allow to cool.
    4. Weigh 50 grams plus-minus1 gram of activated aluminum oxide 
and pack into the chromatographic column (1.3 centimeters x 75 
centimeters) described under ``Apparatus'' in C under I above. (Note: A 
small plug of glass wool is placed at the column exit to prevent the 
aluminum oxide from passing through the column. After adding aluminum 
oxide, tap the column lightly to remove air voids. All percolations 
using aluminum oxide are performed under nitrogen pressure. The

[[Page 378]]

500-milliliter reservoir described under ``Apparatus'' in E under I 
above is to be used to hold the elution solvents.)
    5. Prewet the column by adding 40 milliliters of isooctane to the 
column. Adjust nitrogen pressure so that rate of descent of the 
isooctane coming off the column is 2.0 to 3.0 milliliters per minute. Be 
careful to maintain the level of solvent in the reservoir to prevent air 
from entering the aluminum oxide bed. New or additional solvent is added 
just before the last portion of the previous solvent enters the bed. To 
minimize possible photo-oxidation effects, the following procedures 
(steps 6 through 18) shall be carried out in subdued light.
    6. Before the last of the isooctane reaches the top of the aluminum 
oxide bed, release the nitrogen pressure and turn off the stopcock on 
the column. Transfer the n-hexadecane residue from the 150-milliliter 
beaker from procedure step 3 above onto the column, using several washes 
of isooctane (total volume of washes should be no greater than 10-15 
milliliters).
    7. Open the stopcock and continue percolation until the isooctane is 
about 1 centimeter above the top of the aluminum oxide bed. Add 200 
milliliters of isooctane to the reservoir, and continue the percolation 
at the specified rate.
    8. Just before the isooctane surface reaches the top of the aluminum 
oxide bed, add 200 milliliters of a mixture of benzene and isooctane 
(33\1/3\ percent benzene and 66\2/3\ percent isooctane by volume) to the 
reservoir, and continue the percolation.
    9. Just before the surface of this mixture reaches the top of the 
aluminum oxide bed, release the nitrogen pressure, turn off the 
stopcock, and discard all the elution solvents collected up to this 
point.
    10. Add to the reservoir 300 milliliters of a mixture of benzene and 
isooctane (90 percent benzene and 10 percent isooctane by volume), place 
a 25-milliliter graduated cylinder under the column, continue the 
percolation until 20 milliliters of eluate has been collected, and then 
discard the eluate.
    11. At this point, place a clean 250-milliliter Erlenmeyer flask 
under the column. Continue the percolation and collect all the remaining 
eluate.

    (Note: Allow the column to drain completely. An increase in the 
nitrogen pressure may be necessary as the last of the solvent comes off 
the column.)

    12. Place 1 milliliter of n-hexadecane into a 150-milliliter beaker. 
Place this onto a steam bath under a nitrogen stream and transfer in 
small portions the eluate from step 11 above. Wash out the Erlenmeyer 
flask with small amounts of benzene and transfer to the evaporation 
beaker. Evaporate until only 1 milliliter of hexadecane residue remains. 
(Note: Complete removal of the benzene is essential. This can be assured 
by two successive additions of 5 milliliters of isooctane and 
reevaporation.)
    13. Remove the beaker from the steam bath and cool.
    14. Place a sample of 113.5 grams activated 100- 200-mesh silica gel 
in a 500-milliliter glass-stoppered Erlenmeyer flask. Add to the silica 
gel 46.2 grams (41 milliliters) of nitromethane. Stopper and shake the 
flask vigorously until no lumps of silica gel are observed and then 
shake occasionally during a period of 1 hour. The resultant 
nitromethane-treated silica gel is 29 weight-percent nitro-methane and 
71 weight-percent silica gel.
    15. Place a small plug of glass wool in the tapered end of the 1.7 
centimeters outside diameter x 115 centimeters column, described under 
``Apparatus'' in D of I above, adjacent to the stopcock to prevent 
silica gel from passing through the stopcock. Pack the nitromethane-
treated silica gel into the column, tapping lightly. The resultant 
silica gel bed should be about 95 centimeters in depth. Place into a 
flask 170 milliliters of isooctane saturated with nitromethane.
    16. Place a 100-milliliter graduated cylinder under the column and 
transfer the residue from the beaker in procedure step 13 above with 
several washes of the 170 milliliters of isooctane, saturated with 
nitromethane, onto the top of the column. (Total volume of washes should 
be no greater than 10 to 15 milliliters.) Permit isooctane solution to 
enter the silica gel bed until the liquid level is at the top bed level. 
Place the remaining amount of the 170 milliliters of isooctane, 
saturated with nitromethane, in the reservoir above the bed for 
percolation through the silica gel. Apply nitrogen pressure to the top 
of the column, adjusting the pressure so that the isooctane is collected 
at the rate of 2.5 to 3.5 milliliters per minute, and percolate 
isooctane through the bed until a quantity of 75.0 milliliters of eluate 
is collected. Discard the 75 milliliters of eluate. Turn off the 
stopcock and add 250 milliliters of benzene to the reservoir above the 
bed. Use a 400-milliliter beaker to collect the remaining eluate.
    17. Open the stopcock, renew the pressure, and percolate the 
remaining isooctane and benzene through the column eluting the remaining 
aromatics. Transfer the eluate in small portions from the 400 milliliter 
beaker to a 150-milliliter beaker containing 1 milliliter of n-
hexadecane and evaporate on the steam bath under nitrogen. Rinse the 
400-milliliter beaker well with small portions of isooctane to obtain a 
complete transfer.

    (Note: Complete removal of the nitromethane and benzene is 
essential. This can be assured by successive additions of 5 milliliters 
of isooctane and reevaporation.)

    18. Transfer the residue with several washes of isooctane into a 
200-milliliter volumetric flask. Add isooctane to mark.

[[Page 379]]

    19. Record the spectrum of the sample solution in a 1-centimeter 
cell compared to isooctane from 270 to 400 m. After making 
necessary corrections in the spectrum for cell differences and for the 
blank absorbance, record the maximum absorbance in each of the 
wavelength intervals (m), 280-299, 300-319, 320-359, 360-400.
    a. If the spectrum then shows no discernible peak corresponding to 
the absorbance maximum of the pyrene reference standard solution at 334 
m, the maximum absorbances in the respective wavelength 
intervals recorded shall not exceed those prescribed in paragraph 
(d)(1)(ii) of this section.
    b. If such a peak is evident in the spectrum of the sample solution, 
and the spectrum as a whole is not incompatible with that of a pyrene 
contaminant yielding such a peak of the observed absorbance, calculate 
the concentration of pyrene that would yield this peak (334 m) by the 
base-line technique described in ASTM method E169-63 (Reapproved 1981), 
``Standard Recommended Practices for General Techniques of Ultraviolet 
Quantitative Analysis,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(b)(1)(i) of this section. Correct each of the maximum absorbances in 
the respective specified wavelength intervals by subtracting the 
absorbance due to pyrene, determined as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.407

Where:

Cp=Calculated concentration of pyrene in sample solution;
Sp=Concentration of pyrene reference standard solution in same units of 
concentration;
Sa=Absorbance of pyrene reference standard solution at wavelength of 
maximum absorbance of sample solution in the respective specified 
wavelength intervals.

    Also calculate the pyrene content of the oil sample in parts per 
million as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.408

Where:

C=Calculated concentration of pyrene in milligrams per liter of sample 
solution.

    c. The pyrene content so determined shall not exceed 25 p.p.m. The 
maximum absorbances corrected for pyrene content as described in this 
step 19 for each of the specified wavelength intervals shall not exceed 
the limits prescribed in paragraph (d)(1)(ii) of this section.
    d. If the spectrum as a whole of the sample solution is in any 
respect clearly incompatible with the presence of pyrene as the source 
of the peak at 334 m, then the maximum absorbances in the 
respective wavelength intervals without correction for any assumed 
pyrene content shall not exceed the limits prescribed in paragraph 
(d)(1)(ii) of this section.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 
49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989]



Sec. 178.3650   Odorless light petroleum hydrocarbons.

    Odorless light petroleum hydrocarbons may be safely used, as a 
component of nonfood articles intended for use in contact with food, in 
accordance with the following prescribed conditions:
    (a) The additive is a mixture of liquid hydrocarbons derived from 
petroleum or synthesized from petroleum gases. The additive is chiefly 
paraffinic, isoparaffinic, or naphthenic in nature.
    (b) The additive meets the following specifications:
    (1) Odor is faint and not kerosenic.
    (2) Initial boiling point is 300 deg. F minimum.
    (3) Final boiling point is 650 deg. F maximum.
    (4) Ultraviolet absorbance limits determined by method specified in 
Sec. 178.3620(b)(1)(ii), as follows:

------------------------------------------------------------------------
                                                                Maximum 
                                                              absorbance
                                                                  per   
                   Wavelength (M)                    centimeter
                                                                optical 
                                                              pathlength
------------------------------------------------------------------------
280 to 289..................................................         4.0
290 to 299..................................................         3.3
300 to 329..................................................         2.3
330 to 360..................................................          .8
------------------------------------------------------------------------

    (c) The additive is used as follows:

------------------------------------------------------------------------
                  Use                              Limitations          
------------------------------------------------------------------------
As a plasticizer and absorber oil in     In an amount not to exceed that
 the manufacture of polyolefin articles   required to produce intended  
 authorized for food contact use.         effect, consistent with good  
                                          manufacturing practice.       
As a lubricant of fibers of textiles     At a use level not to exceed   
 authorized for food contact use.         0.15 percent by weight of     
                                          finished fibers.              
As a component of adhesives............  Complying with Sec.  175.105 of
                                          this chapter.                 
As a defoamer in the manufacture of      Complying with Sec.  176.210 of
 paper and paperboard.                    this chapter.                 

[[Page 380]]

                                                                        
As a defoamer in coatings..............  Complying with Sec.  176.200 of
                                          this chapter.                 
------------------------------------------------------------------------



Sec. 178.3690  Pentaerythritol adipate-stearate.

    Pentaerythritol adipate-stearate identified in paragraph (a) of this 
section may be safely used as a lubricant in the fabrication of rigid 
and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene 
copolymers complying with Sec. 177.1980 of this chapter used as articles 
or components of articles that contact food, excluding food with alcohol 
content greater than 8 percent under conditions of use of E, F, and G 
described in Table 2 in Sec. 175.300(d) of this chapter, subject to the 
provisions of this section.
    (a) Identity. For the purpose of this section, pentaerythritol 
adipate-stearate is an ester of pentaerythritol with adipic acid and 
stearic acid and its associated fatty acids (chiefly palmitic), with 
adipic acid comprising 14 percent and stearic acid and its associated 
acids (chiefly palmitic) comprising 71 percent of the organic moieties.
    (b) Specifications. Pentaerythritol adipate-stearate has the 
following specifications:
    (1) Melting point (dropping) of 55-58  deg.C as determined by ASTM 
method D566-76 (Reapproved 1982), ``Standard Test Method for Dropping 
Point of Lubricating Grease,'' which is incorporated by reference. 
Copies may be obtained from the American Society for Testing Materials, 
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (2) Acid value not to exceed 15 as determined by ASTM method D1386-
78, ``Standard Test Method for Saponification Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by 
reference. Copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (3) Saponification number of 270-280 as determined by ASTM method 
D1387-78, ``Standard Test Method for Acid Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by 
reference. Copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (4) Iodine number not to exceed 2 as determined by Iodine Absorption 
Number, Hanus Method, of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' sections 28.018-28.019, 
13th Ed. (1980), which is incorporated by reference. Copies may be 
obtained from the Association of Official Analytical Chemists 
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877-2504, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC 20408.
    (c) The total amount of ester (calculated as free pentaerythritol) 
shall not exceed 0.4 percent by weight of the polyvinyl chloride and/or 
the vinyl chloride-propylene copolymers complying with Sec. 177.1980.

[45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 
FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. 
29, 1992]



Sec. 178.3700   Petrolatum.

    Petrolatum may be safety used as a component of nonfood articles in 
contact with food, in accordance with the following conditions:
    (a) Petrolatum complies with the specifications set forth in the 
United States Pharmacopeia XX (1980) for white petrolatum or in the 
National Formulary XV (1980) for yellow petrolatum.
    (b) Petrolatum meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in Sec. 172.886(b) 
of this chapter:

[[Page 381]]

     Ultraviolet absorbance per centimeter pathlength:

------------------------------------------------------------------------
                        Millimicrons                            Maximum 
------------------------------------------------------------------------
280 to 289..................................................        0.25
290 to 299..................................................         .20
300 to 359..................................................         .14
360 to 400..................................................         .04
------------------------------------------------------------------------

    (c) It is used or intended for use as a protective coating of the 
surfaces of metal or wood tanks used in fermentation process, in an 
amount not in excess of that required to produce its intended effect.
    (d) Petrolatum as defined by this section may be used for the 
functions described and within the limitations prescribed by specific 
regulations in parts 175, 176, 177, and 178 of this chapter which 
prescribe uses of petrolatum. For the purpose of cross-reference, such 
specific regulations include: Secs. 175.105, 175.125, 175.300, 176.170, 
176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter.
    (e) Petrolatum may contain any antioxidant permitted in food by 
regulations issued pursuant to section 409 of the act, in an amount not 
greater than that required to produce its intended effect.

[42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 
55 FR 12172, Apr. 2, 1990]



Sec. 178.3710   Petroleum wax.

    Petroleum wax may be safely used as a component of nonfood articles 
in contact with food, in accordance with the following conditions:
    (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in 
nature, derived from petroleum, and refined to meet the specifications 
prescribed in this section.
    (b) The petroleum wax meets the following ultraviolet absorbance 
limits when subjected to the analytical procedure described in 
Sec. 172.886(b) of this chapter.
     Ultraviolet absorbance per centimeter pathlength:

------------------------------------------------------------------------
                        Millimicrons                            Maximum 
------------------------------------------------------------------------
280 to 289..................................................        0.15
290 to 299..................................................         .12
300 to 359..................................................         .08
360 to 400..................................................         .02
------------------------------------------------------------------------

    (c) Petroleum wax may contain any antioxidant permitted in food by 
regulations issued in accordance with section 409 of the act, in an 
amount not greater than that required to produce its intended effect.
    (d) Petroleum wax may contain a total of not more than 1 weight 
percent of residues of the following polymers when such residues result 
from use of the polymers as processing aids (filter aids) in the 
production of the petroleum wax: Homopolymers and/or copolymers derived 
from one or more of the mixed n-alkyl (C12, C14, C16, and 
C18) methacrylate esters where the C12 and C14 alkyl 
groups are derived from coconut oil and the C16 and C18 groups 
are derived from tallow.
    (e) Petroleum wax may contain 2-hydroxy-4-n-octoxybenzophenone as a 
stabilizer at a level not to exceed 0.01 weight percent of the petroleum 
wax.
    (f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No. 
27029-57-8), as described in Sec. 172.886(c)(2) of this chapter, as a 
processing aid in the manufacture of petroleum wax.

[42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986]



Sec. 178.3720   Petroleum wax, synthetic.

    Synthetic petroleum wax may be safely used in applications and under 
the same conditions where naturally derived petroleum wax is permitted 
in Subchapter B of this chapter as a component of articles intended to 
contact food, provided that the synthetic petroleum wax meets the 
definition and specifications prescribed in Sec. 172.888 of this 
chapter.



Sec. 178.3730   Piperonyl butoxide and pyrethrins as components of bags.

    Piperonyl butoxide in combination with pyrethrins may be safely used 
for insect control on bags that are intended for use in contact with 
dried feed in compliance with Secs. 561.310 and 561.340 of this chapter, 
or that are intended for use in contact with dried food in compliance 
with Secs. 193.60 and 193.390 of this chapter.

[[Page 382]]



Sec. 178.3740   Plasticizers in polymeric substances.

    Subject to the provisions of this regulation, the substances listed 
in paragraph (b) of this section may be safely used as plasticizers in 
polymeric substances used in the manufacture of articles or components 
of articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food.
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect.
    (b) List of substances:

------------------------------------------------------------------------
           Substances                           Limitations             
------------------------------------------------------------------------
Butylbenzyl phthalate...........  For use only:                         
                                  1. As provided in Secs.  175.105 and  
                                   176.180 of this chapter.             
                                  2. In polymeric substances used in    
                                   food-contact articles complying with 
                                   Sec.  175.300, Sec.  175.320, or Sec.
                                    176.170 of this chapter: Provided,  
                                   That the butyl benzyl phthalate      
                                   contains not more than 1 percent by  
                                   weight of dibenzyl phthalate.        
                                  3. In polymeric substances used in    
                                   other permitted food-contact         
                                   articles: Provided, That the butyl   
                                   benzyl phthalate contains not more   
                                   than 1 percent by weight of dibenzyl 
                                   phthalate; and Provided further, That
                                   the finished food-contact article,   
                                   when extracted with the solvent or   
                                   solvents characterizing the type of  
                                   food and under the conditions of time
                                   and temperature characterizing the   
                                   conditions of its intended use as    
                                   determined from Tables 1 and 2 of    
                                   Sec.  175.300(d) of this chapter,    
                                   shall yield net chloroform-soluble   
                                   extractives not to exceed 0.5 mg. per
                                   square inch, as determined by the    
                                   methods prescribed in Sec.           
                                   175.300(e) of this chapter.          
1,3-Butylene glycoladipic acid    For use at levels not exceeding 33    
 polyester (1,700-2,200            percent by weight of polyvinyl       
 molecular weight) terminated      chloride homopolymers used in contact
 with a 16 percent by weight       with food (except foods that contain 
 mixture of myristic, palmitic,    more than 8 percent of alcohol) at   
 and stearic acids.                temperatures not to exceed room      
                                   temperature. The average thickness of
                                   such homopolymers in the form in     
                                   which they contact food shall not    
                                   exceed 0.004 inch.                   
Di(C7, C9-alkyl) adipate, in      For use only under the conditions     
 which the C7, C9-alkyl groups     listed below, and excluding use as a 
 are derived from linear alpha     component of resinous and polymeric  
 olefins by the oxo process.       coatings described in Sec.  175.300  
                                   of this chapter.                     
                                  1. At levels not to exceed 24 percent 
                                   by weight of permitted vinyl chloride
                                   homo- and/or copolymers used in      
                                   contact with nonfatty foods. The     
                                   average thickness of such polymers in
                                   the form in which they contact food  
                                   shall not exceed 0.005 inch.         
                                  2. At levels not to exceed 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter, with     
                                   fatty foods having a fat and oil     
                                   content not exceeding a total of 40  
                                   pct by weight. The average thickness 
                                   of such polymers in the form in which
                                   they contact food shall not exceed   
                                   0.005 inch.                          
                                  3. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact with nonfatty foods. The     
                                   average thickness of such polymer in 
                                   the form in which they contact food  
                                   shall not exceed 0.002 inch.         
                                  4. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter with fatty
                                   foods having a fat and oil content   
                                   not exceeding a total of 40 pct by   
                                   weight. The average thickness of such
                                   polymers in the form in which they   
                                   contact food shall not exceed 0.002  
                                   inch.                                
Di-n-alkyl adipate made from C6   For use only:                         
 C8-C10 (predominately C8 and     1. At levels not exceeding 24 pct by  
 C10) or C8-C10 synthetic fatty    weight of permitted vinyl chloride   
 alcohols complying with Sec.      homo- and/or copolymers used in      
 172.864 of this chapter.          contact with nonfatty foods. The     
                                   average thickness of such polymers in
                                   the form in which they contact food  
                                   shall not exceed 0.005 inch.         
                                  2. At levels not exceeding 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter, with     
                                   fatty foods having a fat and oil     
                                   content not exceeding a total of 40  
                                   pct by weight. The average thickness 
                                   of such polymers in the form in which
                                   they contact food shall not exceed   
                                   0.005 inch.                          
                                  3. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact with nonfatty foods. The     
                                   average thickness of such polymers in
                                   the form in which they contact food  
                                   shall not exceed 0.002 inch.         

[[Page 383]]

                                                                        
                                  4. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter, with     
                                   fatty foods having a fat and oil     
                                   content not exceeding a total of 40  
                                   pct by weight. The average thickness 
                                   of such polymers in which they       
                                   contact food shall not exceed 0.002  
                                   inch.                                
Dicyclohexyl phthalate..........  For use only:                         
                                  1. As provided in Secs.  175.105,     
                                   176.170, 176.180, and 177.1200 of    
                                   this chapter.                        
                                  2. Alone or in combination with other 
                                   phthalates, in plastic film or sheet 
                                   prepared from polyvinyl acetate,     
                                   polyvinyl chloride, and/or vinyl     
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter. Such 
                                   plastic film or sheet shall be used  
                                   in contact with food at temperatures 
                                   not to exceed room temperature and   
                                   shall contain no more than 10 pct by 
                                   weight of total phthalates,          
                                   calculated as phthalic acid.         
Di(2-ethylhexyl) adipate........  ......................................
Diisononyl adipate..............  For use only:                         
                                  1. At levels not exceeding 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact with nonfatty, nonalcoholic  
                                   foods. The average thickness of such 
                                   polymers in the form in which they   
                                   contact food shall not exceed 0.005  
                                   inch.                                
                                  2. At levels not exceeding 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact under conditions of use F and
                                   G described in Table 2 of Sec.       
                                   176.170(c) of this chapter with      
                                   fatty, nonalcoholic foods having a   
                                   fat and oil content not exceeding a  
                                   total of 30 pct by weight. The       
                                   average thickness of such polymers in
                                   the form in which they contact food  
                                   shall not exceed 0.005 inch.         
                                  3. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact with nonfatty, nonalcoholic  
                                   foods. The average thickness of such 
                                   polymers in the form in which they   
                                   contact food shall not exceed 0.002  
                                   inch.                                
                                  4. At levels not exceeding 35 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter with      
                                   fatty, nonalcoholic foods having a   
                                   fat and oil content not exceeding a  
                                   total of 40 pct by weight. The       
                                   average thickness of such polymers in
                                   the form in which they contact food  
                                   shall not exceed 0.002 inch.         
Diisononyl phthalate............  For use only at levels not exceeding  
                                   43 pct by weight of permitted vinyl  
                                   chloride homo- and/or copolymers used
                                   in contact with food only of the     
                                   types identified in Sec.  176.170(c) 
                                   of this chapter, Table 1, under      
                                   Categories I, II, IV-B, and VIII, at 
                                   temperatures not exceeding room      
                                   temperature. The average thickness of
                                   such polymers in the form in which   
                                   they contact food shall not exceed   
                                   0.005 inch.                          
Di(2-ethylhexyl) azelate........  For use only:                         
                                  1. At levels not exceeding 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact with nonfatty, nonalcoholic  
                                   food. The average thickness of such  
                                   polymers in the form in which they   
                                   contact food shall not exceed 0.003  
                                   inch.                                
                                  2. At levels not exceeding 24 pct by  
                                   weight of permitted vinyl chloride   
                                   homo- and/or copolymers used in      
                                   contact, under conditions of use F   
                                   and G described in Table 2 of Sec.   
                                   176.170(c) of this chapter, with     
                                   fatty, nonalcoholic food having a fat
                                   and oil content not exceeding a total
                                   of 30 percent by weight. The average 
                                   thickness of such polymers in the    
                                   form in which they contact food shall
                                   not exceed 0.003 inch.               
Di-n-hexylazelate...............  For use only:                         
                                  1. In polymeric substances used in    
                                   contact with nonfatty food.          
                                  2. In polymeric substances used in    
                                   contact with fatty food and limited  
                                   to use at levels not exceeding 15 pct
                                   by weight of such polymeric substance
                                   except as provided under limitation  
                                   3.                                   
                                  3. At levels greater than 15 but not  
                                   exceeding 24 pct by weight of        
                                   permitted vinyl chloride homo- and/or
                                   copolymers used in contact, under    
                                   conditions of use F or G described in
                                   Table 2 of Sec.  176.170(c) of this  
                                   chapter, with fatty food having a fat
                                   and oil content not exceeding a total
                                   of 30 pct by weight. The average     
                                   thickness of such polymers in the    
                                   form in which they contact food shall
                                   not exceed 0.003 inch.               
Dihexyl phthalate...............  For use only:                         
                                  1. As provided in Sec.  175.105 of    
                                   this chapter.                        
                                  2. In articles that contact food only 
                                   of the types identified in Sec.      
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, IV-B, VI-B,  
                                   and VIII.                            
Diphenyl phthalate..............  For use only:                         
                                  1. As provided in Sec.  175.105 of    
                                   this chapter.                        

[[Page 384]]

                                                                        
                                  2. Alone or in combination with other 
                                   phthalates, in plastic film or sheet 
                                   prepared from polyvinyl acetate,     
                                   polyvinyl chloride, and/or vinyl     
                                   chloride copolymers complying with   
                                   Sec.  177.1980 of this chapter. Such 
                                   plastic film or sheet shall be used  
                                   in contact with food at temperatures 
                                   not to exceed room temperature and   
                                   shall contain no more than 10 pct by 
                                   weight of total phthalates,          
                                   calculated as phthalic acid.         
Epoxidized butyl esters of        Iodine number, maximum 5; oxirane     
 linseed oil fatty acids.          oxygen, minimum 7.8 pct.             
Epoxidized linseed oil..........  Iodine number, maximum 5; oxirane     
                                   oxygen, minimum 9-pct.               
Mineral oil, white..............                                        
Polybutene, hydrogenated          For use only:                         
 (minimum viscosity at 99 F, 39   1. In polymeric substances used in    
 Saybolt Universal seconds, as     contact with non-fatty food.         
 determined by ASTM methods D445- 2. In polyethylene complying with Sec.
 82 (``Standard Test Method for     177.1520 of this chapter and used in
 Kinematic Viscosity of            contact with fatty food, provided    
 Transparent and Opaque Liquids    that the hydrogenated polybutene is  
 (and the Calculation of Dynamic   added in an amount not to exceed 0.5 
 Viscosity)'') and D2161-82        pct by weight of the polyethylene,   
 (``Standard Method for            and further provided that such       
 Conversion of Kinematic           plasticized polyethylene shall not be
 Viscosity to Saybolt Universal    used as a component of articles      
 Viscosity or to Saybolt Furol     intended for packing or holding food 
 Viscosity''), and bromine         during cooking.                      
 number of 3 or less, as          3. In polystyrene complying with Sec. 
 determined by ASTM method D1492-  177.1640 of this chapter and used in 
 78 (``Standard Test Method for    contact with fatty food, provided    
 Bromine Index of Aromatic         that the hydrogenated polybutene is  
 Hydrocarbons by Coulometric       added in an amount not to exceed 5   
 Titration''), which are           pct by weight of the polystyrene, and
 incorporated by reference.        further provided that such           
 Copies may be obtained from the   plasticized polystyrene shall not be 
 American Society for Testing      used as a component of articles      
 Materials, 1916 Race St.,         intended for packing or holding food 
 Philadelphia, PA 19103, or may    during cooking.                      
 be examined at the Office of                                           
 the Federal Register, 800 North                                        
 Capitol Street, NW., suite 700,                                        
 Washington, DC 20408.                                                  
Polyisobutylene (mol weight 300-  For use in polyethylene complying with
 5,000).                           Sec.  177.1520 of this chapter,      
                                   provided that the polyisobutylene is 
                                   added in an amount not exceeding 0.5 
                                   pct by weight of the polyethylene,   
                                   and further provided that such       
                                   plasticized polyethylene shall not be
                                   used as a component of articles      
                                   intended for packing or holding food 
                                   during cooking.                      
Polyisobutylene complying with                                          
 Sec.  177.1420 of this chapter.                                        
Polypropylene glycol (CAS         For use only in polystyrene plastics, 
 registry No. 25322-69-4)          identified in Sec.  177.1640(a)(1),  
 (minimum mean molecular weight    in an amount not to exceed 6 pct by  
 1,200).                           weight of the finished food-contact  
                                   article.                             
Propylene glycol azelate          For use only at levels not exceeding  
 (average mol. weight 3,000).      41 pct by weight of permitted        
                                   polyvinyl chloride coatings. Such    
                                   coatings shall be used only as bulk  
                                   food contact surfaces of articles    
                                   intended for repeated use, complying 
                                   with Sec.  177.2600 of this chapter. 
Triethylene glycol..............  Diethylene glycol content not to      
                                   exceed 0.1 pct.                      
2,2,4-Trimethyl-1,3-pentanediol   For use only in cellulosic plastics in
 diisobutyrate.                    an amount not to exceed 15 pct by    
                                   weight of the finished food-contact  
                                   article, provided that the finished  
                                   plastic article contacts food only of
                                   the types identified in Sec.         
                                   176.170(c) of this chapter, Table 1, 
                                   under Categories I, II, VI-B, VII-B, 
                                   and VIII.                            
------------------------------------------------------------------------

    (c) The use of the plasticizers in any polymeric substance or 
article subject to any regulation in parts 174, 175, 176, 177, 178 and 
179 of this chapter must comply with any specifications and limitations 
prescribed by such regulation for the finished form of the substance or 
article.

[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977; 
45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar. 
19, 1984; 51 FR 47011, Dec. 30, 1986]



Sec. 178.3750   Polyethylene glycol (mean molecular weight 200-9,500).

    Polyethylene glycol identified in this section may be safely used as 
a component of articles intended for use in contact with food, in 
accordance with the following prescribed conditions:
    (a) The additive is an addition polymer of ethylene oxide and water 
with a mean molecular weight of 200 to 9,500.
    (b) It contains no more than 0.2 percent total by weight of ethylene 
and diethylene glycols if its mean molecular weight is 350 or higher and 
no more than 0.5 percent total by weight of ethylene and diethylene 
glycols if its mean molecular weight is below 350, when tested by the 
analytical methods prescribed in Sec. 172.820(b) of this chapter.
    (c) The provisions of paragraph (b) of this section are not 
applicable to polyethylene glycols used in food-packaging adhesives 
complying with Sec. 175.105 of this chapter.

[[Page 385]]



Sec. 178.3760   Polyethylene glycol (400) monolaurate.

    Polyethylene glycol (400) monolaurate containing not more than 0.1 
percent by weight of ethylene and/or diethylene glycol may be used at a 
level not to exceed 0.3 percent by weight of twine as a finish on twine 
to be used for tying meat provided the twine fibers are produced from 
nylon resins complying with Sec. 177.1500 of this chapter.



Sec. 178.3770   Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.

    Polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids identified in this section may be safely used 
as components of articles intended for use in contact with food in 
accordance with the following prescribed conditions:
    (a) The polyhydric alcohol esters identified in this paragraph may 
be used as lubricants in the fabrication of vinyl chloride plastic food-
contact articles prepared from polyvinyl chloride and/or from vinyl 
chloride copolymers complying with Sec. 177.1980 of this chapter. Such 
esters meet the following specifications and are produced by partial 
esterification of oxidatively refined (Gersthofen process) montan wax 
acids by either ethylene glycol or 1,3-butanediol with or without 
neutralization of unreacted carboxylic groups with calcium hydroxide:
    (1) Dropping point 76 deg.-105 deg. C, as determined by ASTM method 
D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of 
Lubricating Grease,'' which is incorporated by reference. Copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Acid value 10-20, as determined by ASTM method D1386-78 
(``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978), which is incorporated by reference; 
copies are available from American Society for Testing and Materials 
(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-
ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 
ratio.
    (3) Saponification value 100-160, as determined by ASTM method 
D1387-78 (``Standard Test Method for Saponification Number (Empirical) 
of Synthetic and Natural Waxes'' (Revised 1978), which is incorporated 
by reference; copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol 
in a 2:1 ratio instead of ethyl alcohol in preparation of potassium 
hydroxide solution.
    (4) Ultraviolet absorbance limits as follows, as determined by the 
analytical method described in this subparagraph:

    Ultraviolet absorbance per centimeter pathlength.

------------------------------------------------------------------------
                        Millimicrons                            Maximum 
------------------------------------------------------------------------
280 to 289..................................................        0.07
290 to 299..................................................         .06
300 to 359..................................................         .04
360 to 400..................................................         .01
------------------------------------------------------------------------

                            Analytical Method

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware, 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of wax samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

[[Page 386]]

                                apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard 
taper male fitting at the bottom and a suitable balljoint at the top.
    Chromatographic tube. 1,200 millimeters in length, inside diameter 
to be 16.5 millimeters plus-minus0.5 millimeter, equipped with a 
coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and 
a female 24/40 standard tapered fitting at the opposite end. (Overall 
length of the column with the female joint is 1,255 millimeters.) The 
female fitting should be equipped with glass hooks.
    Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 
\3/16\-inch thick with a hole bored in the center to closely fit the 
stem of the chromatographic tube.
    Heating jackets. Conical, for 500-milliliter and 1,000-milliliter 
separatory funnels. (Used with variable transformer heat control.)
    Suction flask. 250-milliliter or 500-milliliter filter flask.
    Condenser. \24/40\ joints, fitted with a drying tube, length 
optional.
    Evaporation flasks (optional). A 250-milliliter or 500-milliliter 
capacity and a 1-liter capacity all-glass flask equipped with standard 
taper stopper having inlet and outlet tubes to permit passage of 
nitrogen across the surface of contained liquid to be evaporated.
    Vacuum distillation assembly. All glass (for purification of 
dimethyl sulfoxide) 2-liter distillation flask with heating mantle; 
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters 
in length and distilling head with separable cold finger condenser. Use 
of tetrafluoroethylene polymer sleeves on the glass joints will prevent 
freezing. Do not use grease on stopcocks or joints.
    Oil bath. Capable of heating to 90 deg. C.
    Spectrophotometric cells. Fused quartz cells, optical pathlength in 
the range 1.000 centimeter plus-minus0.005 centimeter. With 
distilled water in the cells, determine any absorbance differences.
    Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons 
with spectral slit width of 0.2 millimicron or less; under instrument 
operating conditions for these absorbance measurements. The 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Absorbance accuracy,1plus-minus0.05 at 0.4 absorbance.
    1As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrometry, U.S. Department of Commerce (1949). The 
accuracy is to be determined by comparison with the standard values at 
290, 345, and 400 millimicrons. Circular 484 is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
---------------------------------------------------------------------------

    Wavelength repeatability, plus-minus0.2 millimicron.
    Wavelength accuracy, plus-minus1.0 millimicron.
    Recording time, 50 seconds.
    Time constant, 0.6 second.
    Sensitivity, 30.
    Ordinate scale, 90-100 percent transmission through scale.
    Abscissa scale, 8X.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane and benzene designated in the list following this paragraph 
shall pass the following test:
    To be specified quantity of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains. (To the residue from benzene 
add a 10-milliliter portion of purified isooctane, reevaporate, and 
repeat once to insure complete removal of benzene.)
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted, and a stream of nitrogen is fed through the inlet tube while 
the outlet tube is connected to a solvent trap and vacuum line in such a 
way as to prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make up to 25 milliliters volume. Determine the absorbance in the 1-
centimeter pathlength cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue (except for methyl 
alcohol) shall not exceed 0.01 per centimeter pathlength between 280 
m and 400 m.

[[Page 387]]

    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test 
described in the preceding paragraph. Purify, if necessary, by passage 
through a column of activated silica gel (Grade 12, Davison Chemical 
Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5 
centimeters to 8 centimeters in diameter.
    Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. 
Purify, if necessary, by distillation or otherwise.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 1-centimeter cell compared to isooctane as reference point between 
280 m-400 m. The absorbance per centimeter pathlength 
shall not exceed 0.00 in this range. If necessary, purify by filtering 
through a column containing 100 grams of aluminum oxide (use same grade 
as described below) in the lower half and 100 grams of activated silica 
gel in the upper half keeping the column at 150 deg. C., for a period of 
15 hours or overnight. The first 100 milliliters of eluate are used. 
Purification can also be accomplished by distillation.
    Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18 deg. 
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 
milliliters of distilled water in a 500-milliliter separatory funnel, 
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane 
to the solution and extract by shaking the funnel vigorously for 2 
minutes. Draw off the lower aqueous layer into a second 500-milliliter 
separatory funnel and repeat the extraction with 40 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and materials'' for preparation of filter), into a 250-milliliter 
Erlenmeyer flask, or optionally into the evaporating flask. Wash the 
first separatory funnel with the second 40-milliliter isooctane 
extractive, and pass through the sodium sulfate into the flask. Then 
wash the second and first separatory funnels successively with a 10-
milliliter portion of isooctane, and pass the solvent through the sodium 
sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate 
the isooctane on the steam bath under nitrogen. Discontinue evaporation 
when not over 1 milliliter of residue remains. To the residue, add a 10-
milliliter portion of isooctane and reevaporate to 1 milliliter of 
hexadecane. Again, add 10 milliliters of isooctane to the residue and 
evaporate to 1 milliliter of hexadecane to insure complete removal of 
all volatile materials. Dissolve the 1 milliliter of hexadecane in 
isooctane and make to 25-milliliter volume. Determine the absorbance in 
1-centimeter pathlength cells compared to isooctane as reference. The 
absorbance of the solution should not exceed 0.02 per centimeter 
pathlength in the 280 m-400 m range. (Note: Difficulty 
in meeting this absorbance specification may be due to organic 
impurities in the distilled water. Repetition of the test omitting the 
dimethyl sulfoxide will disclose their presence. If necessary to meet 
the specification, purify the water by redistillation, passage through 
an ion-exchange resin, or otherwise.)
    Purify, if necessary, by the following procedure: To 1,500 
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, 
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A 
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and 
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated 
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide 
through four thicknesses of fluted paper (18.5 centimeters, Schleicher & 
Schuell, No. 597, or equivalent). If the initial filtrate contains 
carbon fines, refilter through the same filter until a clear filtrate is 
obtained. Protect the sulfoxide from air and moisture during this 
operation by covering the solvent in the funnel and collection flask 
with a layer of isooctane. Transfer the filtrate to a 2-liter separatory 
funnel and draw off the dimethyl sulfoxide into the 2-liter distillation 
flask of the vacuum distillation assembly and distill at approximately 
3-millimeter Hg pressure or less. Discard the first 200-milliliter 
fraction of the distillate and replace the distillate collection flask 
with a clean one. Continue the distillation until approximately 1 liter 
of the sulfoxide has been collected.
    At completion of the distillation, the reagent should be stored in 
glass-stoppered bottles since it is very hygroscopic and will react with 
some metal containers in the presence of air.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Aluminum oxide (80-200 mesh Woelm neutral activity grade 1 
[Brockmann], Alupharm Chemicals, New Orleans, La., or equivalent). 
Pipette 1 milliliter of distilled water into a dry 250-milliliter 
Erlenmeyer flask equipped with a ground-glass stopper. Stopper the flask 
and rotate it in such a manner as to completely wet out the inside 
surfaces. When this has been done add 180 grams of the aluminum oxide 
and shake until no lumps or wet spots remain. Allow to stand at room 
temperature for a period of 2 hours. At the end of this time the water 
should be evenly distributed throughout the aluminum oxide powder, and 
it should have the same free flowing properties as the original material 
(flow velocity with water 0.2 milliliter per minute). At this point the 
aluminum oxide has an activity of 1 as expressed in Brockmann degrees, 
and

[[Page 388]]

the amount of added water is 0.5 percent by volume. This product is used 
in toto and as is, without further screening.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter pathlength 
between 280 m and 400 m when tested as prescribed 
under ``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.

                                procedure

    Before proceeding with analysis of a sample, determine the 
absorbance in a 1-centimeter path cell between 250 m and 400 
m for the reagent blank by carrying out the procedure, without 
a wax sample, at room temperature, recording the spectrum after the 
complete procedure as prescribed. The absorbance per centimeter 
pathlength following the complete procedure should not exceed 0.04 in 
the wavelength range from 280 m to 299 m, inclusive, 
nor 0.02 in the wavelength range from 300 m to 400 m. 
If in either spectrum the characteristic benzene peaks in the 250 
m-260 m region are present, remove the benzene by the 
procedure under ``Organic solvents'' and record absorbance again. Place 
300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and 
add 75 milliliters of phosphoric acid. Mix the contents of the funnel 
and allow to stand for 10 minutes. (The reaction between the sulfoxide 
and the acid is exothermic. Release pressure after mixing, then keep 
funnel stoppered.) Add 150 milliliters of isooctane and shake to 
preequilibrate the solvents. Draw off the individual layers and store in 
glass-stoppered flasks.
    In a 1-liter separatory funnel place a representative 25-gram sample 
of wax, add 50 milliliters of isooctane, heat gently, stir until the wax 
is in solution; add 100 milliliters of preequilibrated sulfoxide-
phosphoric acid mixture and shake, making sure it remains in solution. 
If the wax comes out of solution during these operations, let the 
stoppered funnel remain in the jacket until the wax redissolves. (Remove 
stopper from the funnel at intervals to release pressure.) When the wax 
is in solution, remove the funnel from the jacket and shake it 
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels 
with each containing 30 milliliters of preequilibrated isooctane. After 
separation of the liquid phases, allow to cool until the main portion of 
the wax-isooctane solution begins to show a precipitate. Gently swirl 
the funnel when precipitation first occurs on the inside surface of the 
funnel to accelerate this process. Carefully draw off the lower layer, 
filter it slowly through a thin layer of glass wool fitted loosely in a 
filter funnel into the first 250-milliliter separatory funnel, and wash 
in tandem with the 30-milliliter portions of isooctane contained in the 
250-milliliter separatory funnels. Shaking time for each wash is 1 
minute. Repeat the extraction operation with two additional portions of 
the sulfoxide-acid mixture, replacing the funnel in the jacket after 
each extraction to keep the wax in solution and washing each extractive 
in tandem through the same three portions of isooctane.
    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter), containing 480 milliliters of 
distilled water, mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane 
using an aspirator vacuum under nitrogen and in an oil bath temperature 
of approximately 90 deg. C. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Reserve the residue for column chromatography on the aluminum oxide. 
Fit the tetrafluoroethylene polymer disc on the upper part of the stem 
of the chromatographic tube, then place the tube with the disc on the 
suction flask and apply the vacuum (approximately 135 millimeters Hg 
pressure). Weigh out 180 grams of the aluminum oxide and pour the 
adsorbent mixture

[[Page 389]]

into the chromatographic tube in approximately 30-centimeter layers. 
After the addition of each layer, level off the top of the adsorbent 
with a flat glass rod or metal plunger by pressing down firmly until the 
adsorbent is well packed. Loosen the topmost few millimeters of each 
adsorbent layer with the end of a metal rod before the addition of the 
next layer. Continue packing in this manner until all the 180 grams of 
the adsorbent is added to the tube. Level off the top of the adsorbent 
by pressing down firmly with a flat glass rod or metal plunger to make 
the depth of the adsorbent bed approximately 80 centimeters in depth. 
Turn off the vacuum and remove the suction flask. Dissolve the 
hexadecane residue in 10 milliliters of warm benzene and decant the 
solution onto the column and allow the liquid level to recede to barely 
above the adsorbent level. Rapidly complete the transfer similarly with 
two 10-milliliter portions of benzene swirling the flask repeatedly each 
time to assure adequate washing of the residue. Fix the 1,000-milliliter 
reservoir onto the top of the chromatographic column. Just before the 
final 10-milliliter wash reaches the top of the adsorbent, add 670 
milliliters of benzene to the reservoir and continue the percolation at 
the 2-3 milliliter per minute rate until a total of 670 milliliters of 
benzene has been utilized. Collect the eluate in a clean 1-liter 
Erlenmeyer flask (or optionally into a 1-liter evaporation flask). Allow 
the column to drain until most of the solvent mixture is removed. Add 1 
milliliter of n-hexadecane and completely remove the benzene by 
evaporation under nitrogen, using the special procedure to eliminate 
benzene as previously described under ``Organic Solvents.'' 
Quantitatively transfer the residue with isooctane to a 25-milliliter 
volumetric flask and adjust to volume. Determine the absorbance of the 
solution in the 1-centimeter pathlength cells compared to isooctane as 
reference between 250 m-400 m. Correct for any 
absorbance derived from the reagents as determined by carrying out the 
procedure without a wax sample. If either spectrum shows the 
characteristic benzene peaks in the 250 m-260 m 
region, evaporate the solution to remove benzene by the procedure under 
``Organic Solvents.'' Dissolve the residue, transfer quantitatively, and 
adjust to volume in isooctane in a 25-milliliter volumetric flask. 
Record the absorbance again. If the corrected absorbance does not exceed 
the limits prescribed in paragraph (a) of this section, the wax meets 
the ultraviolet absorbance specifications.
    (b) The polyhydric alcohol esters identified in this paragraph may 
be used as release agents in resinous and polymeric coatings for 
polyolefin films complying with Sec. 175.320 of this chapter. Such 
esters meet the following specifications and are produced by partial 
esterification of oxidatively refined (Gersthofen process) montan wax 
acids with equimolar proportions of ethylene glycol and 1,3-butanediol:
    (1) Dropping point 77 deg.-82 deg. C, as determined by ASTM method 
D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of 
Lubricating Grease,'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a)(1) of this section.
    (2) Acid value 25-35, as determined by ASTM method D1386-78 
(``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978), which is incorporated by reference; 
copies are available from American Society for Testing and Materials 
(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-
ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 1:2 
ratio.
    (3) Saponification value 135-150, as determined by ASTM method 
D1387-78 (``Standard Test Method for Saponification Number (Empirical) 
of Synthetic and Natural Waxes'' (Revised 1978), which is incorporated 
by reference; copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol 
in a 2:1 ratio instead of ethyl alcohol in preparation of potassium 
hydroxide solution.
    (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of 
this section, as determined by the analytical method described therein.
    (c) The polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids, identified in paragraph (a) or (b) of this 
section, may also be used as a component of an aqueous dispersion of 
vinylidene chloride copolymers, subject to the conditions described in 
paragraphs (c) (1) and (2) of this section.

[[Page 390]]

    (1) The aqueous dispersion of the additive contains not more that 18 
percent polyhydric alcohol esters of oxidatively refined (Gersthofen 
process) montan wax acids, not more than 2 percent poly(oxyethylene) 
(minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No. 9005-98-
2), and not more than 1 percent poly(oxyethylene) (minimum 3 moles 
ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9).
    (2) The aqueous dispersion described in paragraph (c)(1) of this 
section is used as an additive to aqueous dispersions of vinylidene 
chloride copolymers, regulated in Secs. 175.300, 175.320, 175.360, 
176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed 
1.5 percent (solids basis) in the finished coating.
    (d) The polyhydric alcohol esters identified in this paragraph may 
be used as lubricants in the fabrication of vinyl chloride plastic food 
contact articles prepared from vinyl chloride polymers. Such esters meet 
the following specifications and are produced by partial esterification 
of oxidatively refined (Gersthofen process) montan wax acids with 
glycerol followed by neutralization:
    (1) Dropping point 79 to 85  deg.C, as determined by the American 
Society for Testing and Materials (ASTM), Method D-566-76 (Reapproved 
1982), ``Standard Test Method for Dropping Point of Lubricating 
Grease,'' which is incorporated by reference in accordance with 5 U.S.C. 
552(a). The availability of this incorporation by reference is given in 
paragraph (a)(1) of this section.
    (2) Acid value 20-30, as determined by ASTM Method D-1386-78 
``Standard Test Method for Acid Number (Empirical) of Synthetic and 
Natural Waxes'' (Revised 1978) (which is incorporated by reference in 
accordance with 5 U.S.C. 552(a); the availability of this incorporation 
by reference is given in paragraph (a)(2) of this section), using as a 
solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl 
alcohol in a 2:1 ratio.
    (3) Saponification value 130-160, as determined by ASTM Method D-
1387-78 ``Standard Test Method for Saponification Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), (which is incorporated by 
reference in accordance with 5 U.S.C. 552(a); the availability of this 
incorporation by reference is given in paragraph (a)(3) of this 
section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl 
alcohol in the preparation of potassium hydroxide solution.
    (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of 
this section, as determined by the analytical method described therein.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982; 
49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, 
June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993]



Sec. 178.3780   Polyhydric alcohol esters of long chain monobasic acids.

    Polyhydric alcohol esters of long chain monobasic acids identified 
in this section may be safely used as lubricants in the fabrication of 
polyvinyl chloride and/or polyvinyl chloride copolymer articles 
complying with Sec. 177.1980 of this chapter that contact food of Types 
I, II, IV-B, VI-B, VII-B, and VIII identified in Table 1 in 
Sec. 176.170(c) of this chapter under conditions of use E, F, and G 
described in Table 2 in Sec. 176.170(c) of this chapter, subject to the 
provisions of this section.
    (a) Identity. For the purpose of this section, polyhydric alcohol 
esters of long chain monobasic acids consist of polyhydric alcohol 
esters having number average molecular weights in the range of 1,050 to 
1,700. The esters are produced by the reaction of either ethylene glycol 
or glycerol with long chain monobasic acids containing from 9 to 49 
carbon atoms obtained by the ozonization of long chain alpha-olefins, 
the unreacted carboxylic acids in the formation of the glycerol esters 
being neutralized with calcium hydroxide to produce a composition having 
up to 2 percent by weight calcium. The alpha-olefins, obtained from the 
polymerization of ethylene, have 20 to 50 carbon atoms and contain a 
minimum of 75 percent by weight straight chain alpha-olefins and not 
more than 25 percent vinylidene compounds.
    (b) Specifications. The polyhydric alcohol esters have the following 
specifications:

[[Page 391]]

    (1) Melting point of 60-80 deg. C for the ethylene glycol ester and 
90-105 deg. C for the glycerol ester as determined by the Fisher Johns 
method as described in ``Semimicro Qualitative Organic Analysis--The 
Systematic Identification of Organic Compounds,'' by Cheronis and 
Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (2) Acid value 15-25 for each ester as determined by the A.O.C.S. 
method Trla-64T ``Titer Test,'' which is incorporated by reference. 
Copies are available from American Association of Oil Chemists, 36 East 
Wacker Drive, Chicago, IL 60601, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408. The method is modified to use as the acid 
solvent a 1:1 volume mixture of anhydrous isopropyl alcohol and toluene. 
The solution is titrated with 0.1N methanolic sodium hydroxide.
    (3) Saponification value 120-160 for the ethylene glycol ester and 
90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T 
``Saponification Value,'' which is incorporated by reference. Copies are 
available from American Association of Oil Chemists, 36 East Wacker 
Drive, Chicago, IL 60601, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (4) Ultraviolet absorbance as specified in Sec. 178.3770(a)(4) of 
this chapter when tested by the analytical method described therein.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 
54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996]



Sec. 178.3790   Polymer modifiers in semirigid and rigid vinyl chloride plastics.

    The polymers identified in paragraph (a) of this section may be 
safely admixed, alone or in mixture with other permitted polymers, as 
modifiers in semirigid and rigid vinyl chloride plastic food-contact 
articles prepared from vinyl chloride homopolymers and/or from vinyl 
chloride copolymers complying with Sec. 177.1950, Sec. 177.1970, and/or 
Sec. 177.1980 of this chapter, in accordance with the following 
prescribed conditions:
    (a) For the purpose of this section, the polymer modifiers are 
identified as follows:
    (1) Acrylic polymers identified in this subparagraph provided that 
such polymers contain at least 50 weight-percent of polymer units 
derived from one or more of the monomers listed in paragraph (a)(1)(i) 
of this section.
    (i) Homopolymers and copolymers of the following monomers:

n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
Methyl methacrylate.

    (ii) Copolymers produced by copolymerizing one or more of the 
monomers listed in paragraph (a)(1)(i) of this section with one or more 
of the following monomers:

Acrylonitrile.
Butadiene.
a-Methylstyrene.
Styrene.
Vinylidene chloride.

    (iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this 
section containing no more than 5 weight-percent of total polymer units 
derived by copolymerization with one or more of the following monomers:

Acrylic acid.
1,3-Butylene glycol dimethacrylate.
Divinylbenzene.
Methacrylic acid.

    (iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii), 
and (iii) of this section; provided that no chemical reactions, other 
than addition reactions, occur when they are mixed.
    (2) Polymers identified in paragraph (a)(1) of this section combined 
during their polymerization with butadiene-styrene copolymers; provided 
that no chemical reactions, other than addition reactions, occur when 
they are combined. Such combined polymers may contain 50 weight-percent 
or more of total polymer units derived from the butadiene-styrene 
copolymers.

[[Page 392]]

    (b) The polymer content of the finished plastic food-contact article 
consists of:
    (1) Not less than 80 weight-percent of polymer units derived from 
the vinyl chloride polymers identified in the introduction to this 
section and not more than 5 weight-percent of polymer units derived from 
polymers identified in paragraph (a)(1) of this section and may 
optionally contain up to 15 weight-percent of polymer units derived from 
butadiene-styrene copolymers; or
    (2) Not less than 50 weight-percent of polymer units derived from 
the vinyl chloride polymers identified in the introduction to this 
section, not more than 50 weight-percent of polymer units derived from 
homopolymers and/or copolymers of ethyl acrylate and methyl 
methacrylate, and not more than 30 weight-percent of polymer units 
derived from copolymers of methyl methacrylate, a-methylstyrene and 
acrylonitrile and may optionally contain up to 15 weight-percent of 
polymer units derived from butadiene-styrene copolymers.
    (c) No chemical reactions, other than addition reactions, occur 
among the vinyl chloride polymers and the modifying polymers present in 
the polymer mixture used in the manufacture of the finished plastic 
food-contact article.
    (d) The finished plastic food-contact article, when extracted with 
the solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from Tables 1 and 2 of Sec. 176.170(c) of 
this chapter, yields extractives not to exceed the limits prescribed in 
Sec. 177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by 
the methods prescribed in Sec. 177.1010 (c) of this chapter.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.



Sec. 178.3800   Preservatives for wood.

    Preservatives may be safely used on wooden articles that are used or 
intended for use in packaging, transporting, or holding raw agricultural 
products subject to the provisions of this section:
    (a) The preservatives are prepared from substances identified in 
paragraph (b) of this section and applied in amounts not to exceed those 
necessary to accomplish the technical effect of protecting the wood from 
decay, mildew, and water absorption.
    (b) The substances permitted are as follows:

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Copper-8-quinolinolate.................                                 
Mineral spirits........................                                 
Paraffin wax...........................  Used singly or in combination  
                                          so as to constitute not less  
                                          than 50% of the solids.       
Petroleum hydrocarbon resin, produced        Do.                        
 by the homo- and copolymerization of                                   
 dienes and olefins of the aliphatic,                                   
 alicyclic, and monobenzenoid                                           
 arylalkene type from distillates of                                    
 cracked petroleum stocks.                                              
Pentachlorophenol and its sodium salt..  Not to exceed 50 p.p.m. in the 
                                          treated wood, calculated as   
                                          pentachlorophenol.            
Rosins and rosin derivatives...........  As provided in Sec.  178.3870. 
Zinc salt of sulfonated petroleum......                                 
------------------------------------------------------------------------



Sec. 178.3850   Reinforced wax.

    Reinforced wax may be safely used as an article or component of 
articles intended for use in producing, manufacturing, packing, 
processing, transporting, or holding food subject to the provisions of 
this section.
    (a) Reinforced wax consists of petroleum wax to which have been 
added certain optional substances required in its production, or added 
to impart desired physical or technical properties.
    (b) The quantity of any optional adjuvant substance employed in the 
production of or added to reinforced wax does not exceed the amount 
reasonably required to accomplish the intended physical or technical 
effect or any limitation provided in this section.

[[Page 393]]

    (c) Any substance employed in the production of reinforced wax, 
including any optional substance, that is the subject of a regulation in 
parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, conforms 
with any specification in such regulation.
    (d) The substances and optional adjuvant substances employed in the 
production of or added to reinforced wax include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction for use in reinforced wax 
and used in accordance with such sanction or approval.
    (3) Substances identified in this subparagraph and subject to any 
limitations provided therein:

------------------------------------------------------------------------
            List of substances                       Limitations        
------------------------------------------------------------------------
Copolymer of isobutylene modified with                                  
 isoprene.                                                              
Petroleum wax, Type I and Type II.........                              
Polyethylene..............................                              
Rosins and rosin derivatives as provided                                
 in Sec.  178.3870.                                                     
Synthetic wax polymer as described in Sec.  Not to exceed 5 percent by  
  176.170(a)(5) of this chapter.             weight of the petroleum    
                                             wax.                       
------------------------------------------------------------------------

    (e) Reinforced wax conforming with the specifications in this 
paragraph is used as provided in paragraph (e)(2) of this section.
    (1) The chloroform-soluble portion of the water extract obtained by 
exposing reinforced wax to demineralized water at 70 deg. F for 48 hours 
shall not exceed 0.5 milligram per square inch of food-contact surface.
    (2) It is used as a packaging material or component of packaging 
materials for cheese and cheese products.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982]



Sec. 178.3860   Release agents.

    Substances listed in paragraph (b) of this section may be safely 
used as release agents in petroleum wax complying with Sec. 178.3710 and 
in polymeric resins that contact food, subject to the provisions of this 
section.
    (a) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect or any limitations 
prescribed in this section.
    (b) Release agents:

------------------------------------------------------------------------
       List of substances                       Limitations             
------------------------------------------------------------------------
Erucamide (erucylamide).........                                        
N,N'-Dioleoylethylenediamine....  For use only in polyvinyl chloride    
                                   films in amounts such that the       
                                   concentration of the substance in    
                                   these films in the form in which the 
                                   films contact food shall not exceed  
                                   0.055 milligram of the substance per 
                                   square inch of film.                 
Oleyl palmitamide...............                                        
Polybutene, hydrogenated;         For use only subject to the           
 complying with the identity       limitations prescribed for           
 prescribed under Sec.             hydrogenated polybutene under Sec.   
 178.3740(b).                      178.3740(b).                         
Poly(vinyl acetate/vinyl N-       For use only in application to the    
 octadecylcarbamate) (CAS Reg.     backing of pressuresensitive adhesive
 No. 70892-21-6) produced by the   tapes at levels not to exceed 0.2    
 reaction between                  milligram per square centimeter (1.29
 stoichiometrically equivalent     milligrams per square inch) of       
 amounts of octadecyl isocyanate   backing.                             
 and vinyl alcohol/vinyl acetate                                        
 copolymer; minimum average                                             
 molecular weight is 500,000.                                           
Rice bran wax...................  For use only in plastics intended for 
                                   contact with dry foods identified as 
                                   Type VIII in Table 1 of Sec.         
                                   176.170(c) of this chapter, at levels
                                   not in excess of 1.0 percent by      
                                   weight of the polymer.               
Saturated fatty acid amides                                             
 manufactured from fatty acids                                          
 derived from animal, marine, or                                        
 vegetable fats and oils.                                               
Stearyl erucamide...............                                        
------------------------------------------------------------------------

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 
FR 51902, Oct. 23, 1981]



Sec. 178.3870   Rosins and rosin derivatives.

    The rosins and rosin derivatives identified in paragraph (a) of this 
section may safely be used in the manufacture of articles or components 
of articles intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding 
food, subject to the provisions of this section.

[[Page 394]]

    (a) The rosins and rosin derivatives are identified as follows:
    (1) Rosins:
    (i) Gum rosin, refined to color grade of K or paler.
    (ii) Wood rosin, refined to color grade of K or paler.
    (iii) Tall oil rosin, refined to color grade of K or paler.
    (iv) Dark tall oil rosin, a fraction resulting from the refining of 
tall oil rosin produced by multicolumnar distillation of crude tall oil 
to effect removal of fatty acids and pitch components and having a 
saponification number of from 110-135 and 32 percent-44 percent rosin 
acids.
    (v) Dark wood rosin, all or part of the residue after the volatile 
terpene oils are distilled from the oleoresin extracted from pine wood.
    (2) Modified rosins manufactured from rosins identified in paragraph 
(a)(1) of this section:
    (i) Partially hydrogenated rosin, catalytically hydrogenated to a 
maximum refractive index of 1.5012 at 100 deg. C, and a color of WG or 
paler.
    (ii) Fully hydrogenated rosin, catalytically hydrogenated to a 
maximum dehydroabietic acid content of 2 percent, a minimum drop-
softening point of 79 deg. C, and a color of X or paler.
    (iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst 
to a drop-softening point of 95 deg.-105 deg. C and a color of WG or 
paler.
    (iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and 
from which sufficient nondimerized rosin has been removed by 
distillation to achieve a minimum drop-softening point of 143 deg. C, 
and a color of H or paler.
    (v) Disproportionated rosin, catalytically disproportionated to a 
minimum dehydroabietic acid content of 35 percent, a maximum abietic 
acid content of 1 percent, a maximum content of substituted 
phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler.
    (3) Rosin esters manufactured from rosins and modified rosins 
identified in paragraphs (a)(1) and (2) of this section:
    (i) Glycerol ester of wood rosin purified by steam stripping to have 
an acid number of 3 to 9, a drop-softening point of 88 deg.-96 deg. C, 
and a color of N or paler.
    (ii) Glycerol ester of partially hydrogenated wood rosin, having an 
acid number of 3 to 10, a drop-softening point of 79 deg.-88 deg. C, and 
a color of N or paler.
    (iii) Glycerol ester of partially dimerized rosin, having an acid 
number of 3 to 8, a drop-softening point of 109 deg.-119 deg. C, and a 
color of M or paler.
    (iv) Glycerol ester of fully dimerized rosin, having an acid number 
of 5 to 16, a drop-softening point of 165 deg.-175 deg. C, and a color 
of H or paler.
    (v) Glycerol ester of maleic anhydride-modified wood rosin, having 
an acid number of 30 to 40, a drop-softening point of 138 deg.-146 deg. 
C, a color of M or paler, and a saponification number less than 280.
    (vi) Methyl ester of rosin, partially hydrogenated, purified by 
steam stripping to have an acid number of 4 to 8, a refractive index of 
1.5170 to 1.5205 at 20 deg. C, and a viscosity of 23 to 66 poises at 
25 deg. C.
    (vii) Pentaerythritol ester of wood rosin, having an acid number of 
6 to 16, a drop-softening point of 109 deg.-116 deg. C, and a color of M 
or paler.
    (viii) Pentaerythritol ester of partially hydrogenated wood rosin, 
having an acid number of 7 to 18, a drop-softening point of 102 deg.-
110 deg. C, and a color of K or paler.
    (ix) Pentaerythritol ester of maleic anhydride-modified wood rosin, 
having an acid number of 8 to 16, a drop-softening point of 154 deg.-
162 deg. C, a color of M or paler, and having a saponification number 
less than 280.
    (x) Pentaerythritol ester of maleic anhydride-modified wood rosin, 
having an acid number of 9 to 16, a drop-softening point of 130 deg.-
140 deg. C, a color of N or paler, and having a saponification number 
less than 280.
    (xi) Pentaerythritol ester of maleic anhydride-modified wood rosin, 
having an acid number of 134 to 145, a drop-softening point of 127 deg.-
137 deg. C, a color of M or paler, and having a saponification number 
less than 280.

[[Page 395]]

    (xii) Pentaerythritol ester of maleic anhydride-modified wood rosin, 
having an acid number of 30 to 40, a drop-softening point of 131 deg.-
137 deg. C, a color of N or paler, and having a saponification number 
less than 280.
    (xiii) Pentaerythritol ester of maleic anhydride-modified wood 
rosin, further modified by reaction with 4,4'-isopropyl-idenediphenol-
formaldehyde condensate, having an acid number of 10 to 22, a drop-
softening point of 162 deg.-172 deg. C, a color of K or paler, a 
saponification number less than 280, and a maximum ultraviolet 
absorbance of 0.14 at 296 m (using a 1-centimeter cell and 200 
milligrams of the rosin ester per liter of solvent consisting of ethyl 
alcohol made alkaline by addition of 0.1 percent of potassium 
hydroxide).
    (xiv) Mixed methyl and pentaerythritol ester of maleic anhydride-
modified wood rosin, having an acid number of 73 to 83, a drop-softening 
point of 113 deg.-123 deg. C, a color of M or paler, and a 
saponification number less than 280.
    (xv) Triethylene glycol ester of partially hydrogenated wood rosin, 
having an acid number of 2 to 10, a color of K or paler, and a viscosity 
of 350 to 425 seconds Saybolt at 100 deg. C.
    (xvi) Glycerol ester of maleic anhydride-modified wood rosin, having 
an acid number of 17 to 23, a drop-softening point of 136 deg.-140 deg. 
C, a color of M or paler, and a saponification number less than 280. For 
use only in cellophane complying with Sec. 177.1200 of this chapter.
    (xvii) Citric acid-modified glycerol ester of rosin, having an acid 
number less than 20, a drop-softening point of 105 deg.-115 deg. C, and 
a color of K or paler. For use only as a blending agent in coatings for 
cellophane complying with Sec. 177.1200 of this chapter.
    (xviii) Glycerol ester of tall oil rosin, purified by steam 
stripping to have an acid number of 5-12, a softening point of 80 deg.-
88 deg. C, and a color of N or paler.
    (xix) Glycerol ester of maleic anhydride-modified tall oil rosin, 
having an acid number of 30 to 40, a drop-softening point of 141 deg.-
146 deg. C, a color of N or paler, and a saponification number less than 
280.
    (xx) Glycerol ester of disproportionated tall oil rosin, having an 
acid number of 5 to 10, a drop-softening point of 84 deg.-93 deg. C, a 
color of WG or paler, and a saponification number less than 180.
    (4) Rosin salts and sizes--Ammonium, calcium, potassium, sodium, or 
zinc salts of rosin manufactured by the partial or complete 
saponification of any one of the rosins or modified rosins identified in 
paragraph (a)(1) and (2) of this section, or blends thereof, and with or 
without modification by reaction with one or more of the following:
    (i) Formaldehyde.
    (ii) Fumaric acid.
    (iii) Maleic anhydride.
    (iv) Saligenin.
    (b) The quantity used shall not exceed the amount reasonably 
required to accomplish the intended technical effect.
    (c) The use in any substance or article that is the subject of a 
regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter shall conform with any specifications and limitations prescribed 
by such regulation for the finished form of the substance or article.
    (d) The provisions of this section are not applicable to rosins and 
rosin derivatives identified in Sec. 175.300(b)(3)(v) of this chapter 
and used in resinous and polymeric coatings complying with Sec. 175.300 
of this chapter.
    (e) The provisions of this section are not applicable to rosins and 
rosin derivatives identified in Sec. 175.105(c)(5) of this chapter and 
used in defoaming agents complying with Sec. 176.210 of this chapter, 
food-packaging adhesives complying with Sec. 175.105 of this chapter, 
and rubber articles complying with Sec. 177.2600 of this chapter.
    (f) The analytical methods for determining whether rosins and rosin 
derivatives conform to the specifications prescribed in paragraph (a) of 
this section are as follows:
    (1) Color: Color shall be as determined by ASTM method D509-70 
(Reapproved 1981), ``Standard Methods of Sampling and Grading Rosin,'' 
which is incorporated by reference. Copies may be obtained from the 
American Society for Testing Materials, 1916 Race St., Philadelphia, PA 
19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (2) Refractive index: Refractive index shall be as determined by 
ASTM method D1747-62 (Reapproved 1978), ``Standard Test Method for 
Refractive Index of Viscous Materials,'' which is incorporated by 
reference. The availability

[[Page 396]]

of this incorporation by reference is given in paragraph (f)(1) of this 
section.
    (3) Acid number: Acid number shall be as determined by ASTM method 
D465-82, ``Standard Test Methods for Acid Number of Rosin,'' which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (f)(1) of this section.
    (4) Viscosity: Viscosity in poises shall be as determined by ASTM 
method D1824-66 (Reapproved 1980), ``Standard Test Method for Apparent 
Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield 
Viscometer,'' and in Saybolt seconds by ASTM method D88-81, ``Standard 
Test Method for Saybolt Viscosity,'' which are incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (f)(1) of this section.
    (5) Softening point: Softening point shall be as determined by ASTM 
method E28-67, ``Standard Test Method for Softening Point by Ring and 
Ball Apparatus'' (Reapproved 1977), which is incorporated by reference. 
Copies are available from American Society for Testing and Materials 
(ASTM), 1916 Race St., Philadelphia, PA 19103, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (6) Analytical methods for determining drop-softening point, 
saponification number, and any other specifications not listed under 
paragraphs (f)(1) through (5) of this section, titled: (i) 
``Determination of Abeitic Acid and Dehydroabietic Acid in Rosins''; 
(ii) ``Determination of Softening Point of Solid Resins''; (iii) 
``Determination of Saponification Number of Rosin Esters,'' and (iv) 
``Determination of Phenolic Modification of Rosin Derivatives,'' which 
are incorporated by reference. Copies are available from the Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 
49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989]



Sec. 178.3900   Sodium pentachlorophenate.

    Sodium pentachlorophenate may be safely used as a preservative for 
ammonium alginate employed as a processing aid in the manufacture of 
polyvinyl chloride emulsion polymers intended for use as articles or 
components of articles that contact food at temperatures not to exceed 
room temperature. The quantity of sodium pentachlorophenate used shall 
not exceed 0.5 percent by weight of ammonium alginate solids.



Sec. 178.3910   Surface lubricants used in the manufacture of metallic articles.

    The substances listed in this section may be safely used in surface 
lubricants employed in the manufacture of metallic articles that contact 
food, subject to the provisions of this section.
    (a) The following substances may be used in surface lubricants used 
in the rolling of metallic foil or sheet stock provided that total 
residual lubricant remaining on the metallic article in the form in 
which it contacts food does not exceed 0.015 milligram per square inch 
of metallic food-contact surface:
    (1) Substances identified in paragraphs (b)(1) and (2) of this 
section.
    (2) Substances identified in this paragraph.

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
-Butyl--hydroxypoly                                  
 (oxyethylene)-poly (oxypropylene) (CAS                                 
 Reg. No. 9038-95-3) produced by random                                 
 condensation of a 1:1 mixture by                                       
 weight of ethylene oxide and propylene                                 
 oxide with butanol and having a                                        
 minimum molecular weight of 1,000.                                     
                                                                        
-Butyl--              For use at levels not to exceed
 hydroxypoly(oxypropyl-ene) (CAS Reg.     20 percent by weight of the   
 No. 9003-13-8) having minimum            finished lubricant            
 molecular weight of 1000.                formulation.                  
-Lauroyl--                                           
 hydroxypoly (oxyethylene) (CAS Reg.                                    
 No. 9004-81-3) having a minimum                                        
 molecular weight of 200.                                               
Acetate esters derived from synthetic                                   
 straight chain alcohols (complying                                     
 with Sec.  172.864 of this chapter)                                    
 that have even numbers of carbon atoms                                 
 in the range C8-C18.                                                   
alpha-Alkyl-omega-hydroxypoly-                                          
 (oxyethylene) produced by the                                          
 condensation of 1 mole of C12-C15                                      
 straight chain primary alcohols with                                   
 an average of 3 moles of ethylene                                      
 oxide (CAS Reg. No. 68002-97-1).                                       

[[Page 397]]

                                                                        
Benzotriazole (CAS Reg. No. 95-14-7)...                                 
Bis(hydrogenated tallow alkyl)amine      Not to be used in combination  
 (CAS Reg. No. 61789-79-5).               with sodium nitrite.          
Bis(hydrogenated tallow                                                 
 alkyl)aminoethanol (CAS Reg. No.                                       
 116438-56-3).                                                          
N,N-Bis(2-hydroxyethyl)butylamine (CAS                                  
 Reg. No. 102-79-4).                                                    
Tert-Butyl alcohol.....................                                 
Di(2-ethylhexyl)phthalate..............                                 
Diethyl phthalate......................                                 
Diethylene glycol monobutylether (CAS                                   
 Reg. No. 112-34-5).                                                    
Dimers, trimers, and/or their partial    For use only at a level not to 
 methyl esters; such dimers and trimers   exceed 10 percent by weight of
 are of unsaturated C18 fatty acids       finished lubricant            
 derived from animal and vegetable fats   formulation.                  
 and oils and/or tall oil, and such                                     
 partial methyl esters meet the                                         
 following specifications:                                              
 Saponification value 180-200, acid                                     
 value 70-130, and maximum iodine value                                 
 120.                                                                   
Di-n-octyl sebacate....................                                 
Ethylenediaminetetraacetic acid, sodium                                 
 salts.                                                                 
Isopropyl alcohol......................                                 
Isopropyl oleate.......................                                 
Isotridecyl alcohol, ethoxylated (CAS                                   
 Reg. No. 9043-30-5).                                                   
Methyl esters of coconut oil fatty                                      
 acids.                                                                 
Methyl esters of fatty acids (C16-C18)                                  
 derived from animal and vegetable fats                                 
 and oils.                                                              
Polybutene, hydrogenated: complying                                     
 with the identity prescribed under                                     
 Sec.  178.3740(b).                                                     
Polyethylene glycol (400) monostearate.                                 
Polyisobutylene (minimum molecular                                      
 weight 300).                                                           
Polyoxyethylated (5 moles) tallow amine                                 
 (CAS Reg. No. 61791-26-2).                                             
Polyvinyl alcohol......................                                 
Sodium nitrite.........................  For use only as a rust         
                                          inhibitor in lubricant        
                                          formulations provided the     
                                          total residual sodium nitrite 
                                          on the metallic article in the
                                          form in which it contacts food
                                          does not exceed 0.007         
                                          milligram per square inch of  
                                          metallic food-contact surface.
Sodium petroleum sulfonate, MW 440-450                                  
 (CAS Reg. No. 68608-24-4) derived from                                 
 naphthenic oil having a Saybolt                                        
 viscosity range of 500-600 Saybolt                                     
 Universal Seconds (SUS at 37-8 C (100                                  
 F) as determined by ASTM method D88-                                   
 81, ``Standard Test Method for Saybolt                                 
 Viscosity,'' which is incorporated by                                  
 reference. Copies are available from                                   
 the American Society for Testing                                       
 Materials, 1961 Race St.,                                              
 Philadelphia, PA 19103, or available                                   
 for inspection at the Office of the                                    
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington, DC                                 
 20408.                                                                 
Synthetic alcohol mixture of straight-                                  
 and branched-chain alcohols that have                                  
 even numbers of carbon atoms in the                                    
 range C4-C18 and that are prepared                                     
 from ethylene, aluminum, and hydrogen                                  
 such that the finished synthetic                                       
 alcohol mixture contains not less than                                 
 75 pct of straight-chain primary                                       
 alcohols and contains not less than 85                                 
 pct total C10 and C12 alcohols.                                        
Synthetic primary alcohol mixture of     For use at a level not to      
 straight- and branched-chain alcohols    exceed 8 pct by weight of the 
 that contain at least 99 pct primary     finished lubricant            
 alcohols consisting of the following:    formulation.                  
 not less than 70 pct normal alcohols;                                  
 not less than 96.5 pct C12-C15                                         
 alcohols; and not more than 2.5 pct                                    
 alpha, omega C13-C16 diols. The                                        
 alcohols are prepared from linear                                      
 olefins from a purified kerosene                                       
 fraction, carbon monoxide and hydrogen                                 
 using a modified oxo process, such                                     
 that the finished primary alcohol                                      
 mixture meets the following                                            
 specifications: Molecular weight,                                      
 207plus-minus4; hydroxyl number, 266-                                  
 276.                                                                   
Synthetic primary alcohol mixture of     For use only at a level not to 
 straight- and branched-chain alcohols    exceed 8 pct by weight of the 
 that contain at least 99 pct primary     finished lubricant            
 alcohols consisting of the following:    formulation.                  
 not less than 70 percent normal                                        
 alcohols; not less than 93 pct C12-C13                                 
 alcohols; not more than 5 pct C14-C15                                  
 alcohols; and not more than 2.5 pct                                    
 alpha, omega, C13-C16 diols. The                                       
 alcohols are prepared from linear                                      
 olefins from a purified kerosene                                       
 fraction, carbon monoxide and hydrogen                                 
 using a modified oxo process, such                                     
 that the finished primary alcohol                                      
 mixture meets the following                                            
 specifications:                                                        
  Molecular weight 194plus-minus5;                                      
   hydroxyl number, 283-296.                                            

[[Page 398]]

                                                                        
Tallow, sulfonated.....................                                 
Triethanolamine........................                                 
------------------------------------------------------------------------

    (3) Mineral oil conforming to the identity prescribed in 
Sec. 178.3620(c).
    (4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i) 
of this section: Provided, That the total residual lubricant on the 
metallic article in the form in which it contacts food meets the 
ultraviolet absorbance limits prescribed in paragraph (a) (4) (ii) of 
this section as determined by the analytical method described in 
paragraph (a) (4) (iii) of this section.
    (i) Light petroleum hydrocarbons are derived by distillation from 
virgin petroleum stocks or are synthesized from petroleum gases. They 
are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature, 
and meet the following specifications:
    (a) Initial boiling point is 24  deg.C minimum and final boiling 
point is 288  deg.C maximum, as determined by ASTM method D86-82, 
``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (b) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum, 
as determined by ASTM method D381-80, ``Standard Test Method for 
Existent Gum in Fuels by Jet Evaporation,'' when the final boiling point 
is 121  deg.C or above and by ASTM method D1353-78, ``Standard Test 
Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, 
Varnish, Lacquer, and Related Products,'' when the final boiling point 
is below 121  deg.C. These ASTM methods are incorporated by reference. 
The availability of these incorporations by reference is given in 
paragraph (a)(4)(i)(a) of this section.
    (c) Saybolt color 20 minimum as determined by ASTM method D156-82, 
``Standard Test Method for Saybolt Color of Petroleum Products (Saybolt 
Chromometer Method),'' which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(a)(4)(i)(a) of this section.
    (d) Aromatic component content shall not exceed 32 percent.
    (e) Conforms with ultraviolet absorbance limits prescribed in 
Sec. 178.3620(c) as determined by the analytical method described 
therein.
    (ii) Ultraviolet absorbance limits on residual lubricants are as 
follows:

------------------------------------------------------------------------
                                                               Maximum  
                                                              absorbance
                                                                per 5   
                  Wavelength (m)                    centimeters
                                                               optical  
                                                              pathlength
------------------------------------------------------------------------
280-289....................................................          0.7
290-299....................................................           .6
300-359....................................................           .4
360-400....................................................          .09
------------------------------------------------------------------------

    (iii) The analytical method for determining ultraviolet absorbance 
limits on residual lubricants is as follows:

                          General Instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent, residues, etc. Examine all glassware 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of oil samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                Apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Evaporation flask (optional). 250-milliliter or 500-milliliter 
capacity all-glass flask equipped with standard-taper stopper having

[[Page 399]]

inlet and outlet tubes to permit passage of nitrogen across the surface 
of contained liquid to be evaporated.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5,000 centimeters plus-minus0.005 centimeter; also for 
checking spectrophotometer performance only, optical path length in the 
range 1.000 centimeter plus-minus0.005 centimeter. With distilled 
water in the cells, determine any absorbance differences.
    Spectrophotometer. Special range 250 millicrons-400 millimicrons 
with spectral slit width of 2 millimicrons or less; under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
    Absorbance accuracy,1 plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    1As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrometry, U.S. Department of Commerce (1949), which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408. The accuracy is to be determined by 
comparison with the standard values at 210, 345, and 400 millimicrons.
---------------------------------------------------------------------------

    Wavelength repeatability, plus-minus0.2 millimicron.
    Wavelength accuracy, plus-minus1.0 millimicron.
    Soxhlet apparatus. 60-millimeter diameter body tubes fitted with 
condenser and 500-milliliter round-bottom boiling flask. A supply of 
paper thimbles to fit is required.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         Reagents and Materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane (2,2,4-trimethylpentane) shall pass the following test:
    Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains.
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted, and a stream of nitrogen is fed through the inlet tube while 
the outlet tube is connected to a solvent trap and vacuum line in such a 
way as to prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue shall not exceed 0.01 
per centimeter path length between 280 and 400 m. Purify, if 
necessary, by passage through a column of activated silica gel (Grade 
12, Davison Chemical Co., Baltimore, Maryland, or equivalent) about 90 
centimeters in length and 5 centimeters to 8 centimeters in diameter.
    n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference point between 
280 m-400 m. The absorbance per centimeter path length 
shall not exceed 0.00 in this range. Purify, if necessary, by 
percolation through activated silica gel or by distillation.
    Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach 
Corp., Camas, Washington, or equivalent). Absorbance (1-centimeter cell, 
distilled water reference, sample completely saturated with nitrogen).

------------------------------------------------------------------------
                                                              Absorbance
                         Wavelength                            (maximum)
------------------------------------------------------------------------
261.5.......................................................        1.00
270.........................................................         .20
275.........................................................         .09
280.........................................................         .06
300.........................................................        .015
------------------------------------------------------------------------

    There shall be no irregularities in the absorbance curve within 
these wavelengths.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
milliliter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter path length 
between 280 m and 400 m when tested as prescribed 
under ``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.
    Before proceeding with analysis of a sample, determine the 
absorbance in a 5-centimeter path cell between 250 millimicrons and 400 
millimicrons for the reagent blank by

[[Page 400]]

carrying out the procedure, without a metal sample. The absorbance per 
centimeter path length should not exceed 0.02 in the wavelength range 
from 280 m to 400 m.
    Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory 
funnel and add 75 milliliters of phosphoric acid. Mix the contents of 
the funnel and allow to stand for 10 minutes. (The reaction between the 
sulfoxide and the acid is exothermic. Release pressure after mixing, 
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake 
to pre-equilibrate the solvents. Draw off the individual layers and 
store in glass-stoppered flasks.

                                Procedure

    Sample. Select metal foil or sheet stock for the test which has not 
been previously contaminated by careless handling or exposure to 
atmospheric dust and fumes. A commercial coil in the form supplied for 
spindle mounting in a packaging line or wrapping machine is most 
suitable. Strip off the outside turn of metal and discard. Carefully 
avoid contamination or damage from handling the metal (wear gloves). 
Remove a 16-18-foot length from the coil and place it on a flat surface 
protected by a length of new kraft paper. Cut four 15-foot strips from 
the sample, each 3 inches wide (avoid tearing the edges of the strips). 
Using a piece of suitable glass rod, roll the strips of metal into loose 
coils and insert each into a Soxhlet thimble. Each turn of coil should 
be visibly separated from the adjacent turn.
    Extraction. Fill each of the four Soxhlet tubes with purified 
isooctane (see under heading ``Reagents and Materials,'' above) until 
siphon action occurs and then refill the tube body. Supply heat to the 
boiling flask and allow extraction to continue for at least 8 hours or 
until repeated weighings of the dried and cooled coil show no further 
weight loss.
    Combine the isooctane extracts from the four Soxhlet units in a 
suitable beaker, rinsing each tube and flask into the beaker with fresh 
purified solvent. Evaporate the solvent under an atmosphere of inert gas 
(nitrogen) to residual volume of 50-60 milliliters and transfer this 
solution to a 500-milliliter separatory funnel containing 100 
milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. 
Complete the transfer of the sample with small portions of pre-
equilibrated isooctane to give a total volume of the residue and solvent 
of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up 
three 250-milliliter separatory funnels with each containing 30 
milliliters of pre-equilibrated isooctane. After separation of liquid 
phases, carefully draw off lower layer into the first 250-milliliter 
separatory funnel and wash in tandem with the 30-milliliter portion of 
isooctane contained in the 250-milliliter separatory funnels. Shaking 
time for each wash is 1 minute. Repeat the extraction operation with two 
additional portions of the sulfoxide-acid mixture and wash each 
extractive in tandem through the same three portions of isooctane.
    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter) containing 480 milliliters of 
distilled water; mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliter of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80 
milliliter extractives three times with 100-milliliter portions 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate pre-washed with isooctane (see sodium sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on 
the steam bath under nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the 
absorbance of the solution in 5-centimeter pathlength cells compared to 
isooctane as reference between 280m-400m (take care to 
lose none of the solution in filling the sample cell). Correct the 
absorbance values for any absorbance derived from reagents as determined 
by carrying out the procedure without a metal sample. If the corrected 
absorbance does not exceed the limits prescribed in this paragraph, the 
residue meets the ultraviolet absorbance specifications.

    (b) The following substances may be used in surface lubricants used 
to facilitate the drawing, stamping, or forming of metallic articles 
from rolled foil or sheet stock by further processing provided that the 
total residual lubricant remaining on the metallic article in the form 
in which it contacts food does not exceed 0.2 milligram per square inch 
of food-contact surface:

[[Page 401]]

    (1) Antioxidants used in compliance with regulations in parts 170 
through 189 of this chapter.
    (2) Substances identified in this subparagraph.

------------------------------------------------------------------------
           List of substances                      Limitations          
------------------------------------------------------------------------
Acetyl tributyl citrate................                                 
Acetyl triethyl citrate................                                 
Butyl stearate.........................                                 
Castor oil.............................                                 
Dibutyl sebacate.......................                                 
Di(2-ethylhexyl) azelate...............                                 
Di(2-ethylhexyl) sebacate..............                                 
Diisodecyl phthalate...................                                 
Dimethylpolysiloxane...................  Conforming to the identity     
                                          prescribed in Sec.  181.28 of 
                                          this chapter.                 
Dipropylene glycol.....................                                 
Epoxidized soybean oil.................  Conforming to the identity     
                                          prescribed in Sec.  181.27 of 
                                          this chapter.                 
Fatty acids derived from animal and                                     
 vegetable fats and oils, and salts of                                  
 such acids, single or mixed, as                                        
 follows:                                                               
  Aluminum                                                              
  Magnesium                                                             
  Potassium                                                             
  Sodium                                                                
  Zinc                                                                  
Fatty alcohols, straight-chain with                                     
 even number carbon atoms (C10 or                                       
 greater).                                                              
Isobutyl stearate......................                                 
Lanolin................................                                 
Linoleic acid amide....................                                 
Mineral oil............................  Conforming to the identity     
                                          prescribed in Sec.  178.3620  
                                          (a) or (b).                   
Mono-, di-, and tristearyl citrate.....                                 
Oleic acid amide.......................                                 
Palmitic acid amide....................                                 
Petrolatum.............................  Conforming to the identity     
                                          prescribed in Sec.  178.3700. 
 Phosphoric acid, mono- and dihexyl      For use only at levels not to  
 esters, compounds with                   exceed 0.5 percent by weight  
 tetramethylnonylamines and C11-14-       of the finished surface       
 alkylamines (CAS Reg. No. 80939-62-4).   lubricant formulation.        
Polyethylene glycol (molecular weight    Mono- and diethylene glycol    
 300 or greater).                         content not to exceed a total 
                                          of 0.2 pct.                   
Stannous stearate......................                                 
Stearic acid amide.....................                                 
Stearyl stearate.......................                                 
Tetrakis[methylene (3,5-di-tert-butyl-4- For use at a level not to      
 hydroxyhydrocinnamate)] methane (CAS     exceed 0.5 percent by weight  
 Registry No. 6683-19-8).                 of the finished surface       
                                          lubricant formulation.        
Triethylene glycol.....................  Diethylene glycol content not  
                                          to exceed 0.1 pct.            
Wax, petroleum.........................  Complying with Sec.  178.3710. 
------------------------------------------------------------------------

    (c) The substances identified in paragraph (a)(2) of this section 
may be used in surface lubricants used to facilitate the drawing, 
stamping, and forming of metallic articles from rolled foil and sheet 
stock provided that total residual lubricant remaining on the metallic 
article in the form in which it contacts food does not exceed 0.015 
milligram per square inch of food-contact surface.
    (d) Subject to any prescribed limitations, the quantity of surface 
lubricant used in the manufacture of metallic articles shall not exceed 
the least amount reasonably required to accomplish the intended 
technical effect and shall not be intended to nor, in fact, accomplish 
any technical effect in the food itself.
    (e) The use of the surface lubricants in the manufacture of any 
article that is the subject of a regulation in parts 174, 175, 176, 177, 
178 and Sec. 179.45 of this chapter must comply with any specifications 
prescribed by such regulation for the finished form of the article.
    (f) Any substance that is listed in this section and the subject of 
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter shall comply

[[Page 402]]

with any applicable specifications prescribed by such regulation.

[42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 
FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 
10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 
24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5, 
1992; 58 FR 17513, Apr. 5, 1993]



Sec. 178.3930   Terpene resins.

    The terpene resins identified in paragraph (a) of this section may 
be safely used as components of polypropylene film intended for use in 
contact with food, and the terpene resins identified in paragraph (b) of 
this section may be safely used as components of polyolefin film 
intended for use in contact with food;
    (a) Terpene resins consisting of the hydrogenated polymers of 
terpene hydrocarbons obtainable from sulfate turpentine and meeting the 
following specifications: Drop-softening point of 118 deg.-138 deg. C; 
iodine value less than 20.
    (b) Terpene resins consisting of polymers of beta-pinene and meeting 
the following specifications: Acid value less than 1; saponification 
number less than 1; color less than 4 on the Gardner scale as measured 
in 50 percent mineral spirits solution.



Sec. 178.3940   Tetraethylene glycol di-(2-ethylhexoate).

    Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22 
parts per million ethylene and/or diethylene glycols may be used at a 
level not to exceed 0.7 percent by weight of twine as a finish on twine 
to be used for tying meat provided the twine fibers are produced from 
nylon resins complying with Sec. 177.1500 of this chapter.



Sec. 178.3950   Tetrahydrofuran.

    Tetrahydrofuran may be safely used in the fabrication of articles 
intended for packaging, transporting, or storing foods, subject to the 
provisions of this section.
    (a) It is used as a solvent in the casting of film from a solution 
of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene 
chloride that have been polymerized singly or copolymerized with one 
another in any combination, or it may be used as a solvent in the 
casting of film prepared from vinyl chloride copolymers complying with 
Sec. 177.1980 of this chapter.
    (b) The residual amount of tetrahydrofuran in the film does not 
exceed 1.5 percent by weight of film.



PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD--Table of Contents




                          Subpart A [Reserved]

               Subpart B--Radiation and Radiation Sources

Sec.
179.21  Sources of radiation used for inspection of food, for inspection 
          of packaged food, and for controlling food processing.
179.25  General provisions for food irradiation.
179.26  Ionizing radiation for the treatment of food.
179.30  Radiofrequency radiation for the heating of food, including 
          microwave frequencies.
179.39  Ultraviolet radiation for the processing and treatment of food.

           Subpart C--Packaging Materials for Irradiated Foods

179.45  Packaging materials for use during the irradiation of 
          prepackaged foods.

    Authority: Secs. 201, 402, 403, 409, 703, 704 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373, 374).

    Source: 42 FR 14635, Mar. 15, 1977, unless otherwise noted.



                          Subpart A [Reserved]



               Subpart B--Radiation and Radiation Sources



Sec. 179.21   Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.

    Sources of radiation for the purposes of inspection of foods, for 
inspection of packaged food, and for controlling food processing may be 
safely used under the following conditions:
    (a) The radiation source is one of the following:
    (1) X-ray tubes producing X-radiation from operation of the tube 
source at

[[Page 403]]

energy levels of 300 kilovolt peak or lower.
    (2) Sealed units producing radiations at energy levels of not more 
than 2.2 million electron volts from one of the following isotopes: 
Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-
226, and strontium-90.
    (3) Sealed units producing neutron radiation from the isotope 
Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.
    (b) To assure safe use of these radiation sources:
    (1) The label of the sources shall bear, in addition to the other 
information required by the Act:
    (i) Appropriate and accurate information identifying the source of 
radiation.
    (ii) The maximum energy of radiation emitted by X-ray tube sources.
    (2) The label or accompanying labeling shall bear:
    (i) Adequate directions for installation and use.
    (ii) A statement that no food shall be exposed to radiation sources 
listed in paragraph (a) (1) and (2) of this section so as to receive an 
absorbed dose in excess of 10 grays.
    (iii) A statement that no food shall be exposed to a radiation 
source listed in paragraph (a)(3) of this section so as to receive an 
absorbed dose in excess of 2 milligrays.

[42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 
61 FR 14246, Apr. 1, 1996]



Sec. 179.25  General provisions for food irradiation.

    For the purposes of Sec. 179.26, current good manufacturing practice 
is defined to include the following restrictions:
    (a) Any firm that treats foods with ionizing radiation shall comply 
with the requirements of part 110 of this chapter and other applicable 
regulations.
    (b) Food treated with ionizing radiation shall receive the minimum 
radiation dose reasonably required to accomplish its intended technical 
effect and not more than the maximum dose specified by the applicable 
regulation for that use.
    (c) Packaging materials subjected to irradiation incidental to the 
radiation treatment and processing of prepackaged foods shall comply 
with Sec. 179.45.
    (d) Radiation treatment of food shall conform to a scheduled 
process. A scheduled process for food irradiation is a written procedure 
that ensures that the radiation dose range selected by the food 
irradiation processor is adequate under commercial processing conditions 
(including atmosphere and temperature) for the radiation to achieve its 
intended effect on a specific product and in a specific facility. A food 
irradiation processor shall operate with a scheduled process established 
by qualified persons having expert knowledge in radiation processing 
requirements of food and specific for that food and for that irradiation 
processor's treatment facility.
    (e) A food irradiation processor shall maintain records as specified 
in this section for a period of time that exceeds the shelf life of the 
irradiated food product by 1 year, up to a maximum of 3 years, whichever 
period is shorter, and shall make these records available for inspection 
and copy by authorized employees of the Food and Drug Administration. 
Such records shall include the food treated, lot identification, 
scheduled process, evidence of compliance with the scheduled process, 
ionizing energy source, source calibration, dosimetry, dose distribution 
in the product, and the date of irradiation.

(Approved by the Office of Management and Budget under control number 
0910-0186)

[51 FR 13399, Apr. 18, 1986]



Sec. 179.26  Ionizing radiation for the treatment of food.

    Ionizing radiation for treatment of foods may be safely used under 
the following conditions:
    (a) Energy sources. Ionizing radiation is limited to:
    (1) Gamma rays from sealed units of the radionuclides cobalt-60 or 
cesium-137.
    (2) Electrons generated from machine sources at energies not to 
exceed 10 million electron volts.
    (3) X-rays generated from machine sources at energies not to exceed 
5 million electron volts.

[[Page 404]]

    (b) Limitations.

------------------------------------------------------------------------
                    Use                              Limitations        
------------------------------------------------------------------------
1. For control of Trichinella spiralis in   Minimum dose 0.3 kiloGray   
 pork carcasses or fresh, non-heat-          (kGy) (30 kilorad (krad)); 
 processed cuts of pork carcasses.           maximum dose not to exceed 
                                             1 kGy (100 krad).          
2. For growth and maturation inhibition of  Not to exceed 1 kGy (100    
 fresh foods.                                krad).                     
3. For disinfestation of arthropod pests      Do.                       
 in food.                                                               
4. For microbial disinfection of dry or     Not to exceed 10 kGy (1     
 dehydrated enzyme preparations (including   megarad (Mrad)).           
 immobilized enzymes).                                                  
5. For microbial disinfection of the        Not to exceed 30 kGy (3     
 following dry or dehydrated aromatic        Mrad).                     
 vegetable substances when used as                                      
 ingredients in small amounts solely for                                
 flavoring or aroma: culinary herbs,                                    
 seeds, spices, vegetable seasonings that                               
 are used to impart flavor but that are                                 
 not either represented as, or appear to                                
 be, a vegetable that is eaten for its own                              
 sake, and blends of these aromatic                                     
 vegetable substances. Turmeric and                                     
 paprika may also be irradiated when they                               
 are to be used as color additives. The                                 
 blends may contain sodium chloride and                                 
 minor amounts of dry food ingredients                                  
 ordinarily used in such blends.                                        
6. For control of food-borne pathogens in   Not to exceed 3 kGy (300    
 fresh or frozen, uncooked poultry           krad); any packaging used  
 products that are: (1) Whole carcasses or   shall not exclude oxygen.  
 disjointed portions of such carcasses                                  
 that are ``ready-to-cook poultry'' within                              
 the meaning of 9 CFR 381.1(b)(44), or (2)                              
 mechanically separated poultry product (a                              
 finely comminuted ingredient produced by                               
 the mechanical deboning of poultry                                     
 carcasses or parts of carcasses).                                      
7. For the sterilization of frozen,         Minimum dose 44 kGy (4.4    
 packaged meats used solely in the           Mrad). Packaging materials 
 National Aeronautics and Space              used need not comply with  
 Administration space flight programs.       Sec.  179.25(c) provided   
                                             that their use is otherwise
                                             permitted by applicable    
                                             regulations in parts 174   
                                             through 186 of this        
                                             chapter.                   
------------------------------------------------------------------------

    (c) Labeling. (1) The label and labeling of retail packages of foods 
irradiated in conformance with paragraph (b) of this section shall bear 
the following logo along with either the statement
[GRAPHIC] [TIFF OMITTED] TR01FE93.000

    ``Treated with radiation'' or the statement ``Treated by 
irradiation'' in addition to information required by other regulations. 
The logo shall be placed prominently and conspicuously in conjunction 
with the required statement.
    (2) For irradiated foods not in package form, the required logo and 
phrase ``Treated with radiation'' or ``Treated by irradiation'' shall be 
displayed to the purchaser with either (i) the labeling of the bulk 
container plainly in view or (ii) a counter sign, card, or other 
appropriate device bearing the information that the product has been 
treated with radiation. As an alternative, each item of food may be 
individually labeled. In either case, the information must be 
prominently and conspicuously displayed to purchasers. The labeling 
requirement applies only to a food that has been irradiated, not

[[Page 405]]

to a food that merely contains an irradiated ingredient but that has not 
itself been irradiated.
    (3) For a food, any portion of which is irradiated in conformance 
with paragraph (b) of this section, the label and labeling and invoices 
or bills of lading shall bear either the statement ``Treated with 
radiation--do not irradiate again'' or the statement ``Treated by 
irradiation--do not irradiate again'' when shipped to a food 
manufacturer or processor for further processing, labeling, or packing.

[51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18, 1988; 
53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 
18, 1990; 55 FR 18544, May 2, 1990; 60 FR 12670, Mar. 8, 1995]



Sec. 179.30   Radiofrequency radiation for the heating of food, including microwave frequencies.

    Radiofrequency radiation, including microwave frequencies, may be 
safely used for heating food under the following conditions:
    (a) The radiation source consists of electronic equipment producing 
radio waves with specific frequencies for this purpose authorized by the 
Federal Communications Commission.
    (b) The radiation is used or intended for use in the production of 
heat in food wherever heat is necessary and effective in the treatment 
or processing of food.



Sec. 179.39   Ultraviolet radiation for the processing and treatment of food.

    Ultraviolet radiation for the processing and treatment of food may 
be safely used under the following conditions:
    (a) The radiation sources consist of ultraviolet emission tubes 
designed to emit wavelengths within the range of 2200-3000 Angstrom 
units with 90 percent of the emission being the wavelength 2537 Angstrom 
units.
    (b) The ultraviolet radiation is used or intended for use as 
follows:

----------------------------------------------------------------------------------------------------------------
             Irradiated food                              Limitations                            Use            
----------------------------------------------------------------------------------------------------------------
Food and food products...................  Irradiated with 2,200 to 3,000 A.         Surface microorganism      
                                            emissions, without ozone production:      control.                  
                                            high fat-content food irradiated in                                 
                                            vacuum or in an inert atmosphere;                                   
                                            intensity of radiation, 1 W (of 2,537                               
                                            A. radiation) per 5 to 10 ft.\2\.                                   
Potable water............................  Irradiated with 2,200 to 3,000 A.         Sterilization of water used
                                            emissions, without ozone production;      in food production.       
                                            coefficient of absorption, 0.19 per cm                              
                                            or less; flow rate, 100 gal/h per watt                              
                                            of 2,537 A. radiation; water depth, 1                               
                                            cm or less; lamp-operating temperature,                             
                                            36 deg. to 46 deg. C.                                               
----------------------------------------------------------------------------------------------------------------



           Subpart C--Packaging Materials for Irradiated Foods



Sec. 179.45   Packaging materials for use during the irradiation of prepackaged foods.

    The packaging materials identified in this section may be safely 
subjected to irradiation incidental to the radiation treatment and 
processing of prepackaged foods, subject to the provisions of this 
section and to the requirement that no induced radioactivity is 
detectable in the packaging material itself:
    (a) The radiation of the food itself shall comply with regulations 
in this part.
    (b) The following packaging materials may be subjected to a dose of 
radiation, not to exceed 10 kilograys, unless otherwise indicated, 
incidental to the use of gamma radiation in the radiation treatment of 
prepackaged foods:
    (1) Nitrocellulose-coated or vinylidene chloride copolymer-coated 
cellophane complying with Sec. 177.1200 of this chapter.
    (2) Glassine paper complying with Sec. 176.170 of this chapter.
    (3) Wax-coated paperboard complying with Sec. 176.170 of this 
chapter.
    (4) Polyolefin film prepared from one or more of the basic olefin 
polymers complying with Sec. 177.1520 of this chapter. The finished film 
may contain:
    (i) Adjuvant substances used in compliance with Secs. 178.3740 and 
181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl 
sulfate, polyvinyl chloride, and materials as listed in paragraph 
(d)(2)(i) of this section.

[[Page 406]]

    (ii) Coatings comprising a vinylidene chloride copolymer containing 
a minimum of 85 percent vinylidene chloride with one or more of the 
following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl 
acrylate, and methyl methacrylate.
    (5) Kraft paper prepared from unbleached sulfate pulp to which 
rosin, complying with Sec. 178.3870 of this chapter, and alum may be 
added. The kraft paper is used only as a container for flour and is 
irradiated with a dose not exceeding 500 grays.
    (6) Polyethylene terephthalate film prepared from the basic polymer 
as described in Sec. 177.1630(e)(4)(i) and (ii) of this chapter. The 
finished film may contain:
    (i) Adjuvant substances used in compliance with Secs. 178.3740 and 
181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl 
sulfate, polyvinyl chloride, and materials as listed in paragraph 
(d)(2)(i) of this section.
    (ii) Coatings comprising a vinylidene chloride copolymer containing 
a minimum of 85 percent vinylidene chloride with one or more of the 
following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl 
acrylate, and methyl methacrylate.
    (iii) Coatings consisting of polyethylene conforming to 
Sec. 177.1520 of this chapter.
    (7) Polystyrene film prepared from styrene basic polymer. The 
finished film may contain adjuvant substances used in compliance with 
Secs. 178.3740 and 181.22 through 181.30 of this chapter.
    (8) Rubber hydrochloride film prepared from rubber hydrochloride 
basic polymer having a chlorine content of 30-32 weight percent and 
having a maximum extractable fraction of 2 weight percent when extracted 
with n-hexane at reflux temperature for 2 hours. The finished film may 
contain adjuvant substances used in compliance with Secs. 178.3740 and 
181.22 through 181.30 of this chapter.
    (9) Vinylidene chloride-vinyl chloride copolymer film prepared from 
vinylidene chloride-vinyl chloride basic copolymers containing not less 
than 70 weight percent of vinylidene chloride and having a viscosity of 
0.50-1.50 centipoises as determined by ASTM method D729-81, ``Standard 
Specification for Vinylidene Chloride Molding Compounds,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408. The finished film may 
contain adjuvant substances used in compliance with Secs. 178.3740 and 
181.22 through 181.30 of this chapter.
    (10) Nylon 11 conforming to Sec. 177.1500 of this chapter.
    (c) Ethylene-vinyl acetate copolymers complying with Sec. 177.1350 
of this chapter. The ethylene-vinyl acetate packaging materials may be 
subjected to a dose of radiation, not to exceed 30 kilogray (3 
megarads), incidental to the use of gamma, electron beam, or X-radiation 
in the radiation treatment of packaged foods.
    (d) The following packaging materials may be subjected to a dose of 
radiation, not to exceed 60 kilograys incidental to the use of gamma or 
X-radiation in the radiation processing of prepackaged foods:
    (1) Vegetable parchments, consisting of a cellulose material made 
from waterleaf paper (unsized) treated with concentrated sulfuric acid, 
neutralized, and thoroughly washed with distilled water.
    (2) Films prepared from basic polymers and with or without 
adjuvants, as follows:
    (i) Polyethylene film prepared from the basic polymer as described 
in Sec. 177.1520(a) of this chapter. The finished film may contain one 
or more of the following added substances:

------------------------------------------------------------------------
               Substances                          Limitations          
------------------------------------------------------------------------
Amides of erucic, linoleic, oleic,       Not to exceed 1 pct by weight  
 palmitic, and stearic acid.              of the polymer.               
BHA as described in Sec.  172.110 of         Do.                        
 this chapter.                                                          
BHT as described in Sec.  172.115 of         Do.                        
 this chapter.                                                          
Calcium and sodium propionates.........      Do.                        
Petroleum wax as described in Sec.           Do.                        
 178.3710 of this chapter.                                              
Polypropylene, noncrystalline, as        Not to exceed 2 pct by weight  
 described in Sec.  177.1520(c) of this   of the polymer.               
 chapter.                                                               

[[Page 407]]

                                                                        
Stearates of aluminum, calcium,          Not to exceed 1 pct by weight  
 magnesium, potassium, and sodium as      of the polymer.               
 described in Sec.  172.863(a) of this                                  
 chapter.                                                               
Triethylene glycol as described in Sec.      Do.                        
  178.3740(b) of this chapter.                                          
Mineral oil as described in Sec.             Do.                        
 178.3620 (a) or (b) of this chapter.                                   
------------------------------------------------------------------------

    (ii) Polyethylene terephthalate film prepared from the basic polymer 
as described in Sec. 177.1630(e)(4)(ii) of this chapter. The finished 
film may contain one or more of the added substances listed in paragraph 
(d)(2)(i) of this section.
    (iii) Nylon 6 films prepared from the nylon 6 basic polymer as 
described in Sec. 177.1500(a)(6) of this chapter and meeting the 
specifications of item 6.1 of the table in Sec. 177.1500(b) of this 
chapter. The finished film may contain one or more of the added 
substances listed in paragraph (d)(2)(i) of this section.
    (iv) Vinyl chloride-vinyl acetate copolymer film prepared from the 
basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride 
with 10.0 to 11.5 weight percent of vinyl acetate and having a maximum 
volatility of not over 3.0 percent (1 hour at 105 deg. C) and viscosity 
not less than 0.30 determined by ASTM method D1243-79, ``Standard Test 
Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,'' 
Method A, which is incorporated by reference. The availability of this 
incorporation by reference is given in paragraph (b)(9) of this section. 
The finished film may contain one or more of the added substances listed 
in paragraph (d)(2)(i) of this section.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 
54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, Mar. 
29, 1994; 61 FR 14246, Apr. 1, 1996]



PART 180--FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY--Table of Contents




                      Subpart A--General Provisions

Sec.
180.1  General.

       Subpart B--Specific Requirements for Certain Food Additives

180.22  Acrylonitrile copolymers.
180.25  Mannitol.
180.30  Brominated vegetable oil.
180.37  Saccharin, ammonium saccharin, calcium saccharin, and sodium 
          saccharin.

    Authority: Secs. 201, 402, 403, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 371); sec. 301 of the 
Public Health Service Act (42 U.S.C. 241).

    Editorial Note: Nomenclature changes to part 180 appear at 61 FR 
14482, Apr. 2, 1996.



                      Subpart A--General Provisions



Sec. 180.1   General.

    (a) Substances having a history of use in food for human consumption 
or in food contact surfaces may at any time have their safety or 
functionality brought into question by new information that in itself is 
not conclusive. An interim food additive regulation for the use of any 
such substance may be promulgated in this subpart when new information 
raises a substantial question about the safety or functionality of the 
substance but there is a reasonable certainty that the substance is not 
harmful and that no harm to the public health will result from the 
continued use of the substance for a

[[Page 408]]

limited period of time while the question raised is being resolved by 
further study.
    (b) No interim food additive regulation may be promulgated if the 
new information is conclusive with respect to the question raised or if 
there is a reasonable likelihood that the substance is harmful or that 
continued use of the substance will result in harm to the public health.
    (c) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may propose 
an interim food additive regulation. A final order promulgating an 
interim food additive regulation shall provide that continued use of the 
substance in food is subject to each of the following conditions:
    (1) Use of the substance in food or food contact surfaces must 
comply with whatever limitations the Commissioner deems to be 
appropriate under the circumstances.
    (2) Within 60 days following the effective date of the regulation, 
an interested person shall satisfy the Commissioner in writing that 
studies adequate and appropriate to resolve the questions raised about 
the substance have been undertaken, or the Food and Drug Administration 
may undertake the studies. The Commissioner may extend this 60-day 
period if necessary to review and act on proposed protocols. If no such 
commitment is made, or adequate and appropriate studies are not 
undertaken, an order shall immediately be published in the Federal 
Register revoking the interim food additive regulation effective upon 
publication.
    (3) A progress report shall be filed on the studies every January 1 
and July 1 until completion. If the progress report is inadequate or if 
the Commissioner concludes that the studies are not being pursued 
promptly and diligently or if interim results indicate a reasonable 
likelihood that a health hazard exists, an order will promptly be 
published in the Federal Register revoking the interim food additive 
regulation effective upon publication.
    (4) If nonclinical laboratory studies are involved, studies filed 
with the Commissioner shall include, with respect to each study, either 
a statement that the study has been or will be conducted in compliance 
with the good laboratory practice regulations as set forth in part 58 of 
this chapter, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (5)  [Reserved]
    (6) If clinical investigations involving human subjects are 
involved, such investigations filed with the Commissioner shall include, 
with respect to each investigation, a statement that the investigation 
either was conducted in compliance with the requirements for 
institutional review set forth in part 56 of this chapter, or was not 
subject to such requirements in accordance with Secs. 56.104 or 56.105, 
and that it has been or will be conducted in compliance with the 
requirements for informed consent set forth in part 50 of this chapter.
    (d) Promptly upon completion of the studies undertaken on the 
substance, the Commissioner will review all available data, will 
terminate the interim food additive regulation, and will either issue a 
food additive regulation or will require elimination of the substance 
from the food supply.
    (e) The Commissioner may consult with advisory committees, 
professional organizations, or other experts in the field, in 
evaluating:
    (1) Whether an interim food additive regulation is justified,
    (2) The type of studies necessary and appropriate to resolve 
questions raised about a substance,
    (3) Whether interim results indicate the reasonable likelihood that 
a health hazard exists, or
    (4) Whether the data available at the conclusion of those studies 
justify a food additive regulation.
    (f) Where appropriate, an emergency action level may be issued for a 
substance subject to paragraph (a) of this section that is not an 
approved food additive, pending the issuance of a final interim food 
additive regulation. Such an action level shall be issued pursuant to 
sections 306 and 402(a) of the act to identify, based upon available 
data, a safe level of use for the substance. Such an action level shall 
be issued in a notice published in the Federal

[[Page 409]]

Register and shall be followed as soon as practicable by a proposed 
interim food additive regulation. Where the available data do not permit 
establishing an action level for the safe use of a substance, use of the 
substance may be prohibited. The identification of a prohibited 
substance may be made in part 189 of this chapter when appropriate.

[42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 
42 FR 52821, Sept. 30, 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, 
Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR 39634, Sept. 27, 1989]



       Subpart B--Specific Requirements for Certain Food Additives



Sec. 180.22   Acrylonitrile copolymers.

    Acrylonitrile copolymers may be safely used on an interim basis as 
articles or components of articles intended for use in contact with 
food, in accordance with the following prescribed conditions:
    (a) Limitations for acrylonitrile monomer extraction for finished 
food-contact articles, determined by a method of analysis titled ``Gas-
Solid Chromatographic Procedure for Determining Acrylonitrile Monomer in 
Acrylonitrile-Containing Polymers and Food Simulating Solvents,'' which 
is incorporated by reference. Copies are available from the Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408, are as follows:
    (1) In the case of single-use articles having a volume to surface 
ratio of 10 milliliters or more per square inch of food contact 
surface--0.003 milligram/square inch when extracted to equilibrium at 
120 deg. F with food-simulating solvents appropriate to the intended 
conditions of use.
    (2) In the case of single-use articles having a volume to surface 
ratio of less than 10 milliliters per square inch of food contact 
surface--0.3 part per million calculated on the basis of the volume of 
the container when extracted to equilibrium at 120 deg. F with food-
simulating solvents appropriate to the intended conditions of use.
    (3) In the case of repeated-use articles--0.003 milligram/square 
inch when extracted at a time equivalent to initial batch usage 
utilizing food-simulating solvents and temperatures appropriate to the 
intended conditions of use.

The food-simulating solvents shall include, where applicable, distilled 
water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and 
either n-heptane or an appropriate oil or fat.
    (b) Where necessary, current regulations permitting the use of 
acrylonitrile copolymers shall be revised to specify limitations on 
acrylonitrile/mercaptan complexes utilized in the production of 
acrylonitrile copolymers. Such copolymers, if they contain reversible 
acrylonitrile/mercaptan complexes and are used in other than repeated-
use conditions, shall be tested to determine the identity of the complex 
and the level of the complex present in the food-contact article. Such 
testing shall include determination of the rate of decomposition of the 
complex at temperatures of 100 deg. F, 160 deg. F, and 212 deg. F using 
3 percent acetic acid as the hydrolic agent. Acrylonitrile monomer 
levels, acrylonitrile/mercaptan complex levels, acrylonitrile oligomer 
levels, descriptions of the analytical methods used to determine the 
complex and the acrylonitrile migration, and validation studies of these 
analytical methods shall be submitted by June 9, 1977, to the Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, unless an extension 
is granted by the Food and Drug Administration for good cause shown. 
Analytical methods for the determination of acrylonitrile complexes with 
n-dodecyl-mercaptan, n-octyl mercaptan, and 2-mercaptoethanol, titled 
``Determination of -Dodecyl-mercaptopropionitrile in NR-16R 
Aqueous Extracts'' and ``Measurement of -(2-
Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating Solvent,'' 
are incorporated by reference. Copies are available from the Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of

[[Page 410]]

the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The following data shall be provided for finished food-contact 
articles intended for repeated use:
    (1) Qualitative and quantitative migration values at a time 
equivalent to initial batch usage, utilizing solvents and temperatures 
appropriate to the intended conditions of use.
    (2) Qualitative and quantitative migration values at the time of 
equilibrium extractions, utilizing solvents and temperatures appropriate 
to the intended conditions of use.
    (3) Data on the volume and/or weight of food handled during the 
initial batch time period(s), during the equilibrium test period, and 
over the estimated life of the food-contact surface.
    (d) Where acrylonitrile copolymers represent only a minor component 
of a polymer system, calculations based on 100 percent migration of the 
acrylonitrile component may be submitted in lieu of the requirements of 
paragraphs (a), (b), and (c) of this section in support of the continued 
safe use of acrylonitrile copolymers.
    (e) On or before September 13, 1976, any interested person shall 
satisfy the Commissioner of Food and Drugs that toxicological feeding 
studies adequate and appropriate to establish safe conditions for the 
use of acrylonitrile copolymers have been, or soon will be, undertaken. 
Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime 
feeding studies with a mammalian species, preferably with animals 
exposed in utero to the chemical, (2) studies of multigeneration 
reproduction with oral administration of the test material, (3) 
assessment of teratogenic and mutagenic potentials, (4) subchronic oral 
administration in a nonrodent mammal, (5) tests to determine any 
synergistic toxic effects between acrylonitrile monomer and cyanide ion, 
and (6) a literature search on the effects of chronic ingestion of 
hydrogen cyanide. Data on levels of acrylamide extractable from 
acrylonitrile copolymers shall also be submitted. Protocols of testing 
should be submitted for review to the Center for Food Safety and Applied 
Nutrition (HFS-200, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204.
    (f) Acrylonitrile copolymers may be used in contact with food only 
if authorized in parts 174 through 179 or Sec. 181.32 of this chapter, 
except that other uses of acrylonitrile copolymers in use prior to June 
14, 1976, may continue under the following conditions:
    (1) On or before August 13, 1976, each use of acrylonitrile 
copolymers in a manner not authorized by Sec. 181.32 of this chapter or 
parts 174 through 179 of this chapter shall be the subject of a notice 
to the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 200 C St. SW., Washington, DC 20204. Such notice 
shall be accompanied by a statement of the basis, including any articles 
and correspondence, on which the user in good faith believed the use to 
be prior-sanctioned. The Commissioner of Food and Drugs shall, by notice 
in the Federal Register, identify any use of acrylonitrile copolymers 
not in accordance with this paragraph. Those uses are thereafter 
unapproved food additives and consequently unlawful.
    (2) Any use of acrylonitrile copolymers subject to paragraph (f)(1) 
of this section shall be the subject of a petition submitted on or 
before December 13, 1976, in accordance with Sec. 171.1 of this chapter, 
unless an extension of time is granted by the Food and Drug 
Administration for good cause shown. Any application for extension shall 
be by petition submitted in accordance with the requirements of part 10 
of this chapter. If a petition is denied, in whole or in part, those 
uses subject to the denial are thereafter unapproved food additives and 
consequently unlawful.
    (3) Any use of acrylonitrile copolymers subject to paragraph (f)(1) 
of this section shall meet the acrylonitrile monomer extraction 
limitation set forth in paragraph (a) of this section and shall be 
subject to the requirements of paragraph (b) of this section.
    (g) In addition to the requirements of this section, the use of 
acrylonitrile copolymers shall comply with all

[[Page 411]]

applicable requirements in other regulations in this part.

[42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 
54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996]



Sec. 180.25   Mannitol.

    (a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol 
(C6H14O6) a hexahydric alcohol, differing from sorbitol 
principally by having a different optical rotation. Mannitol is produced 
by one of the following processes:
    (1) The electrolytic reduction or transition metal catalytic 
hydrogenation of sugar solutions containing glucose or fructose.
    (2) The fermentation of sugars or sugar alcohols such as glucose, 
sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 188-190, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an anticaking agent and free-flow 
agent as defined in Sec. 170.3(o)(1) of this chapter, formulation aid as 
defined in Sec. 170.3(o) (14) of this chapter, firming agent as defined 
in Sec. 170.3(o)(10) of this chapter, flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter, lubricant and release 
agent as defined in Sec. 170.3(o)(18) of this chapter, nutritive 
sweetener as defined in Sec. 170.3(o)(21) of this chapter, processing 
aid as defined in Sec. 170.3(o)(24) of this chapter, stabilizer and 
thickener as defined in Sec. 170.3(o)(28) of this chapter, surface-
finishing agent as defined in Sec. 170.3(o)(30) of this chapter, and 
texturizer as defined in Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in food at levels not to exceed 98 
percent in pressed mints and 5 percent in all other hard candy and cough 
drops as defined in Sec. 170.3(n)(25) of this chapter, 31 percent in 
chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 40 percent 
in soft candy as defined in Sec. 170.3(n)(38) of this chapter, 8 percent 
in confections and frostings as defined in Sec. 170.3(n)(9) of this 
chapter, 15 percent in nonstandardized jams and jellies, commercial, as 
defined in Sec. 170.3(n)(28) of this chapter, and at levels less than 
2.5 percent in all other foods.
    (e) The label and labeling of food whose reasonably foreseeable 
consumption may result in a daily ingestion of 20 grams of mannitol 
shall bear the statement ``Excess consumption may have a laxative 
effect''.
    (f) In accordance with Sec. 180.1, adequate and appropriate feeding 
studies have been undertaken for this substance. Continued uses of this 
ingredient are contingent upon timely and adequate progress reports of 
such tests, and no indication of increased risk to public health during 
the test period.
    (g) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 
FR 7991, Mar. 1, 1996]



Sec. 180.30   Brominated vegetable oil.

    The food additive brominated vegetable oil may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive complies with specifications prescribed in the 
``Food Chemicals Codex,'' 3d Ed. (1981), pp. 40-41, which is 
incorporated by reference, except that free fatty acids (as oleic) shall 
not exceed 2.5 percent and iodine value shall not exceed 16. Copies of 
the material incorporated by reference may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20418.
    (b) The additive is used on an interim basis as a stabilizer for 
flavoring oils used in fruit-flavored beverages, for which any 
applicable standards of identity do not preclude such use, in an amount 
not to exceed 15 parts per million in the finished beverage, pending the 
outcome of additional toxicological studies on which periodic reports at 
6-month intervals are to be furnished and final results submitted to the 
Food

[[Page 412]]

and Drug Administration promptly after completion of the studies.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]



Sec. 180.37   Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin.

    The food additives saccharin, ammonium saccharin, calcium saccharin, 
and sodium saccharin may be safely used as sweetening agents in food in 
accordance with the following conditions, if the substitution for 
nutritive sweeteners is for a valid special dietary purpose and is in 
accord with current special dietary food regulations and policies or if 
the use or intended use is for an authorized technological purpose other 
than calorie reduction:
    (a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 - 
dioxide (C7H5NO3S). The named salts of saccharin are 
produced by the additional neutralization of saccharin with the proper 
base to yield the desired salt.
    (b) The food additives meet the specifications of the ``Food 
Chemicals Codex,'' 3d Ed. (1981), pp. 22, 62, 266-267, 297-299, which is 
incorporated by reference. Copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) Authority for such use shall expire when the Commissioner 
receives the final reports on the ongoing studies in Canada and 
publishes an order on the safety of saccharin and its salts based on 
those reports and other available data.
    (d) The additives are used or intended for use as a sweetening agent 
only in special dietary foods, as follows:
    (1) In beverages, fruit juice drinks, and bases or mixes when 
prepared for consumption in accordance with directions, in amounts not 
to exceed 12 milligrams of the additive, calculated as saccharin, per 
fluid ounce.
    (2) As a sugar substitute for cooking or table use, in amounts not 
to exceed 20 milligrams of the additive, calculated as saccharin, for 
each expressed teaspoonful of sugar sweetening equivalency.
    (3) In processed foods, in amounts not to exceed 30 milligrams of 
the additive, calculated as saccharin, per serving of designated size.
    (e) The additives are used or intended for use only for the 
following technological purposes:
    (1) To reduce bulk and enhance flavors in chewable vitamin tablets, 
chewable mineral tablets, or combinations thereof.
    (2) To retain flavor and physical properties of chewing gum.
    (3) To enhance flavor of flavor chips used in nonstandardized bakery 
products.
    (f) To assure safe use of the additives, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate mixes of the 
additive for manufacturing purposes shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive, expressed as 
saccharin, in any intermediate mix.
    (iii) Adequate directions for use to provide a final food product 
that complies with the limitations prescribed in paragraphs (d) and (e) 
of this section.
    (2) The label of any finished food product containing the additive 
shall bear:
    (i) The name of the additive.
    (ii) The amount of the additive, calculated as saccharin, as 
follows:
    (a) For beverages, in milligrams per fluid ounce;
    (b) For cooking or table use products, in milligrams per dispensing 
unit;
    (c) For processed foods, in terms of the weight or size of a serving 
which shall be that quantity of the food containing 30 milligrams or 
less of the additive.
    (iii) When the additive is used for calorie reduction, such other 
labeling as is required by part 105 or Sec. 100.130 of this chapter.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]

[[Page 413]]



PART 181--PRIOR-SANCTIONED FOOD INGREDIENTS--Table of Contents




                      Subpart A--General Provisions

Sec.
181.1  General.
181.5  Prior sanctions.

          Subpart B--Specific Prior-Sanctioned Food Ingredients

181.22  Certain substances employed in the manufacture of food-packaging 
          materials.
181.23  Antimycotics.
181.24  Antioxidants.
181.25  Driers.
181.26  Drying oils as components of finished resins.
181.27  Plasticizers.
181.28  Release agents.
181.29  Stabilizers.
181.30  Substances used in the manufacture of paper and paperboard 
          products used in food packaging.
181.32  Acrylonitrile copolymers and resins.
181.33  Sodium nitrate and potassium nitrate.
181.34  Sodium nitrite and potassium nitrite.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14638, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 181 appear at 61 FR 
14482, Apr. 2, 1996.



                      Subpart A--General Provisions



Sec. 181.1   General.

    (a) An ingredient whose use in food or food packaging is subject to 
a prior sanction or approval within the meaning of section 201(s)(4) of 
the Act is exempt from classification as a food additive. The 
Commissioner will publish in this part all known prior sanctions. Any 
interested person may submit to the Commissioner a request for 
publication of a prior sanction, supported by evidence to show that it 
falls within section 201(s)(4) of the Act.
    (b) Based upon scientific data or information that shows that use of 
a prior-sanctioned food ingredient may be injurious to health, and thus 
in violation of section 402 of the Act, the Commissioner will establish 
or amend an applicable prior sanction regulation to impose whatever 
limitations or conditions are necessary for the safe use of the 
ingredient, or to prohibit use of the ingredient.
    (c) Where appropriate, an emergency action level may be issued for a 
prior-sanctioned substance, pending the issuance of a final regulation 
in accordance with paragraph (b) of this section. Such an action level 
shall be issued pursuant to section 402(a) of the Act to identify, based 
upon available data, conditions of use of the substance that may be 
injurious to health. Such an action level shall be issued in a notice 
published in the Federal Register and shall be followed as soon as 
practicable by a proposed regulation in accordance with paragraph (b) of 
this section. Where the available data demonstrate that the substance 
may be injurious at any level, use of the substance may be prohibited. 
The identification of a prohibited substance may be made in part 189 of 
this chapter when appropriate.

[42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30, 1977; 
54 FR 39635, Sept. 27, 1989]



Sec. 181.5   Prior sanctions.

    (a) A prior sanction shall exist only for a specific use(s) of a 
substance in food, i.e., the level(s), condition(s), product(s), etc., 
for which there was explicit approval by the Food and Drug 
Administration or the United States Department of Agriculture prior to 
September 6, 1958.
    (b) The existence of a prior sanction exempts the sanctioned use(s) 
from the food additive provisions of the Act but not from the other 
adulteration or the misbranding provisions of the Act.
    (c) All known prior sanctions shall be the subject of a regulation 
published in this part. Any such regulation is subject to amendment to 
impose whatever limitation(s) or condition(s) may be necessary for the 
safe use of the ingredient, or revocation to prohibit use of the 
ingredient, in order to prevent the adulteration of food in violation of 
section 402 of the Act.
    (d) In proposing, after a general evaluation of use of an 
ingredient, regulations affirming the GRAS status of substances added 
directly to human food in part 184 of this chapter or substances in 
food-contact surfaces in part 186 of this chapter, or establishing a

[[Page 414]]

food additive regulation for substances added directly to human food in 
parts 172 and 173 of this chapter or food additives in food-contact 
surfaces in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this 
chapter, the Commissioner shall, if he is aware of any prior sanction 
for use of the ingredient under conditions different from those proposed 
in the regulation, concurrently propose a separate regulation covering 
such use of the ingredient under this part. If the Commissioner is 
unaware of any such applicable prior sanction, the proposed regulation 
will so state and will require any person who intends to assert or rely 
on such sanction to submit proof of its existence. Any food additive or 
GRAS regulation promulgated after a general evaluation of use of an 
ingredient constitutes a determination that excluded uses would result 
in adulteration of the food in violation of section 402 of the Act, and 
the failure of any person to come forward with proof of such an 
applicable prior sanction in response to a proposal will constitute a 
waiver of the right to assert or rely on such sanction at any later 
time. The notice will also constitute a proposal to establish a 
regulation under this part, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof of such an applicable prior sanction in response 
to the proposal.



          Subpart B--Specific Prior-Sanctioned Food Ingredients



Sec. 181.22   Certain substances employed in the manufacture of food-packaging materials.

    Prior to the enactment of the food additives amendment to the 
Federal Food, Drug, and Cosmetic Act, sanctions were granted for the 
usage of the substances listed in Secs. 181.23, 181.24, 181.25, 181.26, 
181.27, 181.28, 181.29, and 181.30 in the manufacture of packaging 
materials. So used, these substances are not considered ``food 
additives'' within the meaning of section 201(s) of the Act, provided 
that they are of good commercial grade, are suitable for association 
with food, and are used in accordance with good manufacturing practice. 
For the purpose of this subpart, good manufacturing practice for food-
packaging materials includes the restriction that the quantity of any of 
these substances which becomes a component of food as a result of use in 
food-packaging materials shall not be intended to accomplish any 
physical or technical effect in the food itself, shall be reduced to the 
least amount reasonably possible, and shall not exceed any limit 
specified in this subpart.

[42 FR 56728, Oct. 28, 1977]



Sec. 181.23   Antimycotics.

    Substances classified as antimycotics, when migrating from food-
packaging material shall include:

Calcium propionate.
Methylparaben (methyl p-hydroxybenzoate).
Propylparaben (propyl p-hydroxybenzoate).
Sodium benzoate.
Sodium propionate.
Sorbic acid.

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.24  Antioxidants.

    Substances classified as antioxidants, when migrating from food-
packaging material (limit of addition to food, 0.005 percent) shall 
include:

Butylated hydroxyanisole.
Butylated hydroxytoluene.
Dilauryl thiodipropionate.
Distearyl thiodipropionate.
Gum guaiac.
Nordihydroguairetic acid.
Propyl gallate.
Thiodipropionic acid.
2,4,5-Trihydroxy butyrophenone.

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.25   Driers.

    Substances classified as driers, when migrating from food-packaging 
material shall include:

Cobalt caprylate.
Cobalt linoleate.
Cobalt naphthenate.
Cobalt tallate.
Iron caprylate.
Iron linoleate.
Iron naphthenate.
Iron tallate.
Manganese caprylate.
Manganese linoleate.
Manganese naphthenate.

[[Page 415]]

Manganese tallate.

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.26   Drying oils as components of finished resins.

    Substances classified as drying oils, when migrating from food-
packaging material (as components of finished resins) shall include:

Chinawood oil (tung oil).
Dehydrated castor oil.
Linseed oil.
Tall oil.

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.27   Plasticizers.

    Substances classified as plasticizers, when migrating from food-
packaging material shall include:

Acetyl tributyl citrate.
Acetyl triethyl citrate.
p-tert-Butylphenyl salicylate.
Butyl stearate.
Butylphthalyl butyl glycolate.
Dibutyl sebacate.
Di-(2-ethylhexyl) phthalate (for foods of high water content only).
Diethyl phthalate.
Diisobutyl adipate.
Diisooctyl phthalate (for foods of high water content only).
Diphenyl-2-ethylhexyl phosphate.
Epoxidized soybean oil (iodine number maximum 6; and oxirane oxygen, 
minimum, 6.0 percent).
Ethylphthalyl ethyl glycolate.
Glycerol monooleate.
Monoisopropyl citrate.
Mono, di-, and tristearyl citrate.
Triacetin (glycerol triacetate).
Triethyl citrate.
3-(2-Xenolyl)-1,2-epoxypropane.

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
50 FR 49536, Dec. 3, 1985]



Sec. 181.28   Release agents.

    Substances classified as release agents, when migrating from food-
packaging material shall include:

Dimethylpolysiloxane (substantially free from hydrolyzable chloride and 
alkoxy groups, no more than 18 percent loss in weight after heating 4 
hours at 200 deg. C.; viscosity 300 centisokes, 600 centisokes at 
25 deg. C, specific gravity 0.96 to 0.97 at 25 deg. C, refractive index 
1.400 to 1.404 at 25 deg. C).
Linoleamide (linoleic acid amide).
Oleamide (oleic acid amide).
Palmitamide (palmitic acid amide).
Stearamide (stearic acid amide).

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.29   Stabilizers.

    Substances classified as stabilizers, when migrating from food-
packaging material shall include:

Aluminum mono-, di-, and tristearate.
Ammonium citrate.
Ammonium potassium hydrogen phosphate.
Calcium glycerophosphate.
Calcium phosphate.
Calcium hydrogen phosphate.
Calcium oleate.
Calcium acetate.
Calcium carbonate.
Calcium ricinoleate.
Calcium stearate.
Disodium hydrogen phosphate.
Magnesium glycerophosphate.
Magnesium stearate.
Magnesium phosphate.
Magnesium hydrogen phosphate.
Mono-, di-, and trisodium citrate.
Mono-, di-, and tripotassium citrate.
Potassium oleate.
Potassium stearate.
Sodium pyrophosphate.
Sodium stearate.
Sodium tetrapyrophosphate.
Stannous stearate (not to exceed 50 parts per million tin as a migrant 
in finished food).
Zinc orthophosphate (not to exceed 50 parts per million zinc as a 
migrant in finished food).
Zinc resinate (not to exceed 50 parts per million zinc as a migrant in 
finished food).

[42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]



Sec. 181.30   Substances used in the manufacture of paper and paperboard products used in food packaging.

    Substances used in the manufacture of paper and paperboard products 
used in food packaging shall include:

Aliphatic polyoxyethylene ethers.*
---------------------------------------------------------------------------

    *Under the conditions of normal use, these substances would not 
reasonably be expected to migrate to food, based on available scientific 
information and data.
---------------------------------------------------------------------------

1-Alkyl (C6-C18)3-amino-3-aminopropane monoacetate.*
Borax or boric acid for use in adhesives, sizes, and coatings.*
Butadiene-styrene copolymer.

[[Page 416]]

Chromium complex of perfluoro-octane sulfonyl glycine for use on paper 
and paperboard which is waxed.*
Disodium cyanodithioimidocarbamate with ethylene diamine and potassium 
N-methyl dithiocarbamate and/or sodium 2-mercaptobenzothiazole 
(slimicides).*
Ethyl acrylate and methyl methacrylate copolymers of itaconic acid or 
methacrylic acid for use only on paper and paperboard which is waxed.*
Hexamethylene tetramine as a setting agent for protein, including 
casein.*
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl (C6-C17) 
imidazolinium chloride.*
Itaconic acid (polymerized).
Melamine formaldehyde polymer.
Methyl acrylate (polymerized).
Methyl ethers or mono-, di-, and tripropylene glycol.*
Myristo chromic chloride complex.
Nitrocellulose.
Polyethylene glycol 400.
Polyvinyl acetate.
Potassium pentachlorophenate as a slime control agent.*
Potassium trichlorophenate as a slime control agent.*
Resins from high and low viscosity polyvinyl alcohol for fatty foods 
only.
Rubber hydrochloride.
Sodium pentachlorophenate as a slime control agent.*
Sodium-trichlorophenate as a slime control agent.*
Stearato-chromic chloride complex.
Titanium dioxide.*
Urea formaldehyde polymer.
Vinylidine chlorides (polymerized).



Sec. 181.32   Acrylonitrile copolymers and resins.

    (a) Acrylonitrile copolymers and resins listed in this section, 
containing less than 30 percent acrylonitrile and complying with the 
requirements of paragraph (b) of this section, may be safely used as 
follows:
    (1) Films. (i) Acrylonitrile/butadiene/styrene copolymers--no 
restrictions.
    (ii) Acrylonitrile/butadiene copolymers--no restrictions.
    (iii) Acrylonitrile/butadiene copolymer blended with vinyl chloride-
vinyl acetate (optional at level up to 5 percent by weight of the vinyl 
chloride resin) resin--for use only in contact with oleomargarine.
    (iv) Acrylonitrile/styrene copolymer--no restrictions.
    (2) Coatings. (i) Acrylonitrile/butadiene copolymer blended with 
polyvinyl chloride resins--for use only on paper and paperboard in 
contact with meats and lard.
    (ii) Polyvinyl chloride resin blended with either acrylonitrile/
butadiene copolymer or acrylonitrile/butadiene styrene copolymer mixed 
with neoprene, for use as components of conveyor belts to be used with 
fresh fruits, vegetables, and fish.
    (iii) Acrylonitrile/butadiene/styrene copolymer--no restrictions.
    (iv) Acrylonitrile/styrene copolymer--no restrictions.
    (3) Rigid and semirigid containers. (i) Acrylonitrile/butadiene/
styrene copolymer--for use only as piping for handling food products and 
for repeated-use articles intended to contact food.
    (ii) Acrylonitrile/styrene resin--no restrictions.
    (iii) Acrylonitrile/butadiene copolymer blended with polyvinyl 
chloride resin--for use only as extruded pipe.
    (b) Limitations for acrylonitrile monomer extraction for finished 
food-contact articles, determined by using the method of analysis titled 
``Gas-Solid Chromatographic Procedure for Determining Acrylonitrile 
Monomer in Acrylonitrile-Containing Polymers and Food-Simulating 
Solvents,'' which is incorporated by reference. Copies are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408, are as 
follows:
    (1) In the case of single-use articles having a volume to surface 
ratio of 10 milliliters or more per square inch of food-contact 
surface--0.003 milligram/square inch when extracted to equilibrium at 
120 deg. F with food-simulating solvents appropriate to the intended 
conditions of use.
    (2) In the case of single-use articles having a volume to surface 
ratio of less than 10 milliliters per square inch of food-contact 
surface--0.3 part per million calculated on the basis of the volume of 
the container when extracted to equilibrium at 120 deg. F with food-
simulating solvents appropriate to the intended conditions of use.
    (3) In the case of repeated-use articles--0.003 milligram/square 
inch when

[[Page 417]]

extracted at a time equivalent to initial batch usage utilizing food-
simulating solvents and temperatures appropriate to the intended 
conditions of use.

The food-simulating solvents shall include, where applicable, distilled 
water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and 
either n-heptane or an appropriate oil or fat.
    (c) Acrylonitrile monomer may present a hazard to health when 
ingested. Accordingly, any food-contact article containing acrylonitrile 
copolymers or resins that yield acrylonitrile monomer in excess of that 
amount provided for in paragraph (b) of this section shall be deemed to 
be adulterated in violation of section 402 of the Act.

[42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 
54 FR 24899, June 12, 1989]



Sec. 181.33  Sodium nitrate and potassium nitrate.

    Sodium nitrate and potassium nitrate are subject to prior sanctions 
issued by the U.S. Department of Agriculture for use as sources of 
nitrite, with or without sodium or potassium nitrite, in the production 
of cured red meat products and cured poultry products.

[48 FR 1705, Jan. 14, 1983]



Sec. 181.34  Sodium nitrite and potassium nitrite.

    Sodium nitrite and potassium nitrite are subject to prior sanctions 
issued by the U.S. Department of Agriculture for use as color fixatives 
and preservative agents, with or without sodium or potassium nitrate, in 
the curing of red meat and poultry products.

[48 FR 1705, Jan. 14, 1983]



PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents




                      Subpart A--General Provisions

Sec.
182.1  Substances that are generally recognized as safe.
182.10  Spices and other natural seasonings and flavorings.
182.20  Essential oils, oleoresins (solvent-free), and natural 
          extractives (including distillates).
182.40  Natural extractives (solvent-free) used in conjunction with 
          spices, seasonings, and flavorings.
182.50  Certain other spices, seasonings, essential oils, oleoresins, 
          and natural extracts.
182.60  Synthetic flavoring substances and adjuvants.
182.70  Substances migrating from cotton and cotton fabrics used in dry 
          food packaging.
182.90  Substances migrating to food from paper and paperboard products.
182.99  Adjuvants for pesticide chemicals.

            Subpart B--Multiple Purpose GRAS Food Substances

182.1045  Glutamic acid.
182.1047  Glutamic acid hydrochloride.
182.1057  Hydrochloric acid.
182.1073  Phosphoric acid.
182.1087  Sodium acid pyrophosphate.
182.1125  Aluminum sulfate.
182.1127  Aluminum ammonium sulfate.
182.1129  Aluminum potassium sulfate.
182.1131  Aluminum sodium sulfate.
182.1180  Caffeine.
182.1217  Calcium phosphate.
182.1235  Caramel.
182.1320  Glycerin.
182.1480  Methylcellulose.
182.1500  Monoammonium glutamate.
182.1516  Monopotassium glutamate.
182.1711  Silica aerogel.
182.1745  Sodium carboxymethylcellulose.
182.1748  Sodium caseinate.
182.1778  Sodium phosphate.
182.1781  Sodium aluminum phosphate.
182.1810  Sodium tripolyphosphate.
182.1866  High fructose corn syrup.

                      Subpart C--Anticaking Agents

182.2122  Aluminum calcium silicate.
182.2227  Calcium silicate.
182.2437  Magnesium silicate.
182.2727  Sodium aluminosilicate.
182.2729  Sodium calcium aluminosilicate, hydrated.
182.2906  Tricalcium silicate.

                    Subpart D--Chemical Preservatives

182.3013  Ascorbic acid.
182.3041  Erythorbic acid.
182.3089  Sorbic acid.
182.3109  Thiodipropionic acid.
182.3149  Ascorbyl palmitate.
182.3169  Butylated hydroxyanisole.
182.3173  Butylated hydroxytoluene.
182.3189  Calcium ascorbate.
182.3225  Calcium sorbate.
182.3280  Dilauryl thiodipropionate.
182.3616  Potassium bisulfite.
182.3637  Potassium metabisulfite.
182.3640  Potassium sorbate.

[[Page 418]]

182.3731  Sodium ascorbate.
182.3739  Sodium bisulfite.
182.3766  Sodium metabisulfite.
182.3795  Sodium sorbate.
182.3798  Sodium sulfite.
182.3862  Sulfur dioxide.
182.3890  Tocopherols.

                Subpart E--Emulsifying Agents [Reserved]

                     Subpart F--Dietary Supplements

182.5013  Ascorbic acid.
182.5065  Linoleic acid.
182.5159  Biotin.
182.5191  Calcium carbonate.
182.5195  Calcium citrate.
182.5201  Calcium glycerophosphate.
182.5210  Calcium oxide.
182.5212  Calcium pantothenate.
182.5217  Calcium phosphate.
182.5223  Calcium pyrophosphate.
182.5245  Carotene.
182.5250  Choline bitartrate.
182.5252  Choline chloride.
182.5260  Copper gluconate.
182.5301  Ferric phosphate.
182.5304  Ferric pyrophosphate.
182.5306  Ferric sodium pyrophosphate.
182.5308  Ferrous gluconate.
182.5311  Ferrous lactate.
182.5315  Ferrous sulfate.
182.5370  Inositol.
182.5375  Iron reduced.
182.5431  Magnesium oxide.
182.5434  Magnesium phosphate.
182.5443  Magnesium sulfate.
182.5446  Manganese chloride.
182.5449  Manganese citrate.
182.5452  Manganese gluconate.
182.5455  Manganese glycerophosphate.
182.5461  Manganese sulfate.
182.5464  Manganous oxide.
182.5484  Manganese hypophosphite.
182.5530  Niacin.
182.5535  Niacinamide.
182.5580  D-Pantothenyl alcohol.
182.5622  Potassium chloride.
182.5628  Potassium glycerophosphate.
182.5676  Pyridoxine hydrochloride.
182.5695  Riboflavin.
182.5697  Riboflavin-5'-phosphate.
182.5772  Sodium pantothenate.
182.5778  Sodium phosphate.
182.5875  Thiamine hydrochloride.
182.5878  Thiamine mononitrate.
182.5890  Tocopherols.
182.5892  a-Tocopherol acetate.
182.5930  Vitamin A.
182.5933  Vitamin A acetate.
182.5936  Vitamin A palmitate.
182.5945  Vitamin B12.
182.5950  Vitamin D2.
182.5953  Vitamin D3.
182.5985  Zinc chloride.
182.5988  Zinc gluconate.
182.5991  Zinc oxide.
182.5994  Zinc stearate.
182.5997  Zinc sulfate.

                         Subpart G--Sequestrants

182.6085  Sodium acid phosphate.
182.6197  Calcium diacetate.
182.6203  Calcium hexametaphosphate.
182.6215  Monobasic calcium phosphate.
182.6285  Dipotassium phosphate.
182.6290  Disodium phosphate.
182.6757  Sodium gluconate.
182.6760  Sodium hexametaphosphate.
182.6769  Sodium metaphosphate.
182.6778  Sodium phosphate.
182.6787  Sodium pyrophosphate.
182.6789  Tetra sodium pyrophosphate.
182.6810  Sodium tripolyphosphate.

                         Subpart H--Stabilizers

182.7255  Chondrus extract.

                          Subpart I--Nutrients

182.8013  Ascorbic acid.
182.8159  Biotin.
182.8217  Calcium phosphate.
182.8223  Calcium pyrophosphate.
182.8250  Choline bitartrate.
182.8252  Choline chloride.
182.8778  Sodium phosphate.
182.8890  Tocopherols.
182.8892  a-Tocopherol acetate.
182.8985  Zinc chloride.
182.8988  Zinc gluconate.
182.8991  Zinc oxide.
182.8994  Zinc stearate.
182.8997  Zinc sulfate.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 182.1   Substances that are generally recognized as safe.

    (a) It is impracticable to list all substances that are generally 
recognized as safe for their intended use. However, by way of 
illustration, the Commissioner regards such common food ingredients as 
salt, pepper, vinegar, baking powder, and monosodium glutamate as safe 
for their intended use. This part includes additional substances that, 
when used for the purposes indicated, in accordance with good 
manufacturing practice, are regarded by the Commissioner as generaly 
recognized as safe for such uses.

[[Page 419]]

    (b) For the purposes of this section, good manufacturing practice 
shall be defined to include the following restrictions:
    (1) The quantity of a substance added to food does not exceed the 
amount reasonably required to accomplish its intended physical, 
nutritional, or other technical effect in food; and
    (2) The quantity of a substance that becomes a component of food as 
a result of its use in the manufacturing, processing, or packaging of 
food, and which is not intended to accomplish any physical or other 
technical effect in the food itself, shall be reduced to the extent 
reasonably possible.
    (3) The substance is of appropriate food grade and is prepared and 
handled as a food ingredient. Upon request the Commissioner will offer 
an opinion, based on specifications and intended use, as to whether or 
not a particular grade or lot of the substance is of suitable purity for 
use in food and would generally be regarded as safe for the purpose 
intended, by experts qualified to evaluate its safety.
    (c) The inclusion of substances in the list of nutrients does not 
constitute a finding on the part of the Department that the substance is 
useful as a supplement to the diet for humans.
    (d) Substances that are generally recognized as safe for their 
intended use within the meaning of section 409 of the act are listed in 
this part. When the status of a substance has been reevaluated, it will 
be deleted from this part, and will be issued as a new regulation under 
the appropriate part, e.g., ``affirmed as GRAS'' under part 184 or 186 
of this chapter; ``food additive regulation'' under parts 170 through 
180 of this chapter; ``interim food additive regulation'' under part 180 
of this chapter; or ``prohibited from use in food'' under part 189 of 
this chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]



Sec. 182.10   Spices and other natural seasonings and flavorings.

    Spices and other natural seasonings and flavorings that are 
generally recognized as safe for their intended use, within the meaning 
of section 409 of the Act, are as follows:

------------------------------------------------------------------------
           Common name                Botanical name of plant source    
------------------------------------------------------------------------
Alfalfa herb and seed...........  Medicago sativa L.                    
Allspice........................  Pimenta officinalis Lindl.            
Ambrette seed...................  Hibiscus abelmoschus L.               
Angelica........................  Angelica archangelica L. or other spp.
                                   of Angelica.                         
Angelica root...................      Do.                               
Angelica seed...................      Do.                               
Angostura (cusparia bark).......  Galipea officinalis Hancock.          
Anise...........................  Pimpinella anisum L.                  
Anise, star.....................  Illicium verum Hook. f.               
Balm (lemon balm)...............  Melissa officinalis L.                
Basil, bush.....................  Ocimum minimum L.                     
Basil, sweet....................  Ocimum basilicum L.                   
Bay.............................  Laurus nobilis L.                     
Calendula.......................  Calendula officinalis L.              
Camomile (chamomile), English or  Anthemis nobilis L.                   
 Roman.                                                                 
Camomile (chamomile), German or   Matricaria chamomilla L.              
 Hungarian.                                                             
Capers..........................  Capparis spinosa L.                   
Capsicum........................  Capsicum frutescens L. or Capsicum    
                                   annuum L.                            
Caraway.........................  Carum carvi L.                        
Caraway, black (black cumin)....  Nigella sativa L.                     
Cardamom (cardamon).............  Elettaria cardamomum Maton.           
Cassia, Chinese.................  Cinnamomum cassia Blume.              
Cassia, Padang or Batavia.......  Cinnamomum burmanni Blume.            
Cassia, Saigon..................  Cinnamomum loureirii Nees.            
Cayenne pepper..................  Capsicum frutescens L. or Capsicum    
                                   annuum L.                            
Celery seed.....................  Apium graveolens L.                   
Chervil.........................  Anthriscus cerefolium (L.) Hoffm.     
Chives..........................  Allium schoenoprasum L.               
Cinnamon, Ceylon................  Cinnamomum zeylanicum Nees.           
Cinnamon, Chinese...............  Cinnamomum cassia Blume.              
Cinnamon, Saigon................  Cinnamomum loureirii Nees.            
Clary (clary sage)..............  Salvia sclarea L.                     
Clover..........................  Trifolium spp.                        
Coriander.......................  Coriandrum sativum L.                 
Cumin (cummin)..................  Cuminum cyminum L.                    

[[Page 420]]

                                                                        
Cumin, black (black caraway)....  Nigella sativa L.                     
Elder flowers...................  Sambucus canadensis L.                
Fennel, common..................  Foeniculum vulgare Mill.              
Fennel, sweet (finocchio,         Foeniculum vulgare Mill. var. duice   
 Florence fennel).                 (DC.) Alex.                          
Fenugreek.......................  Trigonella foenum-graecum L.          
Galanga (galangal)..............  Alpinia officinarum Hance.            
Geranium........................  Pelargonium spp.                      
Ginger..........................  Zingiber officinale Rosc.             
Grains of paradise..............  Amomum melegueta Rosc.                
Horehound (hoarhound)...........  Marrubium vulgare L.                  
Horseradish.....................  Armoracia lapathifolia Gilib.         
Hyssop..........................  Hyssopus officinalis L.               
Lavender........................  Lavandula officinalis Chaix.          
Linden flowers..................  Tilia spp.                            
Mace............................  Myristica fragrans Houtt.             
Marigold, pot...................  Calendula officinalis L.              
Marjoram, pot...................  Majorana onites (L.) Benth.           
Marjoram, sweet.................  Majorana hortensis Moench.            
Mustard, black or brown.........  Brassica nigra (L.) Koch.             
Mustard, brown..................  Brassica juncea (L.) Coss.            
Mustard, white or yellow........  Brassica hirta Moench.                
Nutmeg..........................  Myristica fragrans Houtt.             
Oregano (oreganum, Mexican        Lippia spp.                           
 oregano, Mexican sage, origan).                                        
Paprika.........................  Capsicum annuum L.                    
Parsley.........................  Petroselinum crispum (Mill.) Mansf.   
Pepper, black...................  Piper nigrum L.                       
Pepper, cayenne.................  Capsicum frutescens L. or Capsicum    
                                   annuum L.                            
Pepper, red.....................      Do.                               
Pepper, white...................  Piper nigrum L.                       
Peppermint......................  Mentha piperita L.                    
Poppy seed......................  Papayer somniferum L.                 
Pot marigold....................  Calendula officinalis L.              
Pot marjoram....................  Majorana onites (L.) Benth.           
Rosemary........................  Rosmarinus officinalis L.             
Saffron.........................  Crocus sativus L.                     
Sage............................  Salvia officinalis L.                 
Sage, Greek.....................  Salvia triloba L.                     
Savory, summer..................  Satureia hortensis L. (Satureja).     
Savory, winter..................  Satureia montana L. (Satureja).       
Sesame..........................  Sesamum indicum L.                    
Spearmint.......................  Mentha spicata L.                     
Star anise......................  Illicium verum Hook. f.               
Tarragon........................  Artemisia dracunculus L.              
Thyme...........................  Thymus vulgaris L.                    
Thyme, wild or creeping.........  Thymus serpyllum L.                   
Turmeric........................  Curcuma longa L.                      
Vanilla.........................  Vanilla planifolia Andr. or Vanilla   
                                   tahitensis J. W. Moore.              
Zedoary.........................  Curcuma zedoaria Rosc.                
------------------------------------------------------------------------

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 
FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 
1996]


Sec. 182.20    Essential oils, oleoresins (solvent-free), and natural 
        extractives (including distillates).

------------------------------------------------------------------------
           Common name                Botanical name of plant source    
------------------------------------------------------------------------
Alfalfa.........................  Medicago sativa L.                    
Allspice........................  Pimenta officinalis Lindl.            
Almond, bitter (free from         Prunus amygdalus Batsch, Prunus       
 prussic acid).                    armeniaca L., or Prunus persica (L.) 
                                   Batsch.                              
Ambrette (seed).................  Hibiscus moschatus Moench.            
Angelica root...................  Angelica archangelica L.              
Angelica seed...................      Do.                               
Angelica stem...................      Do.                               
Angostura (cusparia bark).......  Galipea officinalis Hancock.          

[[Page 421]]

                                                                        
Anise...........................  Pimpinella anisum L.                  
Asafetida.......................  Ferula assa-foetida L. and related    
                                   spp. of Ferula.                      
Balm (lemon balm)...............  Melissa officinalis L.                
Balsam of Peru..................  Myroxylon pereirae Klotzsch.          
Basil...........................  Ocimum basilicum L.                   
Bay leaves......................  Laurus nobilis L.                     
Bay (myrcia oil)................  Pimenta racemosa (Mill.) J. W. Moore. 
Bergamot (bergamot orange)......  Citrus aurantium L. subsp. bergamia   
                                   Wright et Arn.                       
Bitter almond (free from prussic  Prunus amygdalus Batsch, Prunus       
 acid).                            armeniaca L., or Prunus persica (L.) 
                                   Batsch.                              
Bois de rose....................  Aniba rosaeodora Ducke.               
Cacao...........................  Theobroma cacao L.                    
Camomile (chamomile) flowers,     Matricaria chamomilla L.              
 Hungarian.                                                             
Camomile (chamomile) flowers,     Anthemis nobilis L.                   
 Roman or English.                                                      
Cananga.........................  Cananga odorata Hook. f. and Thoms.   
Capsicum........................  Capsicum frutescens L. and Capsicum   
                                   annuum L.                            
Caraway.........................  Carum carvi L.                        
Cardamom seed (cardamon)........  Elettaria cardamomum Maton.           
Carob bean......................  Ceratonia siliqua L.                  
Carrot..........................  Daucus carota L.                      
Cascarilla bark.................  Croton eluteria Benn.                 
Cassia bark, Chinese............  Cinnamomum cassia Blume.              
Cassia bark, Padang or Batavia..  Cinnamomum burmanni Blume.            
Cassia bark, Saigon.............  Cinnamomum loureirii Nees.            
Celery seed.....................  Apium graveolens L.                   
Cherry, wild, bark..............  Prunus serotina Ehrh.                 
Chervil.........................  Anthriscus cerefolium (L.) Hoffm.     
Chicory.........................  Cichorium intybus L.                  
Cinnamon bark, Ceylon...........  Cinnamomum zeylanicum Nees.           
Cinnamon bark, Chinese..........  Cinnamomum cassia Blume.              
Cinnamon bark, Saigon...........  Cinnamomum loureirii Nees.            
Cinnamon leaf, Ceylon...........  Cinnamomum zeylanicum Nees.           
Cinnamon leaf, Chinese..........  Cinnamomum cassia Blume.              
Cinnamon leaf, Saigon...........  Cinnamomum loureirii Nees.            
Citronella......................  Cymbopogon nardus Rendle.             
Citrus peels....................  Citrus spp.                           
Clary (clary sage)..............  Salvia sclarea L.                     
Clover..........................  Trifolium spp.                        
Coca (decocainized).............  Erythroxylum coca Lam. and other spp. 
                                   of Erythroxylum.                     
Coffee..........................  Coffea spp.                           
Cola nut........................  Cola acuminata Schott and Endl., and  
                                   other spp. of Cola.                  
Coriander.......................  Coriandrum sativum L.                 
Cumin (cummin)..................  Cuminum cyminum L.                    
Curacao orange peel (orange,      Citrus aurantium L.                   
 bitter peel).                                                          
Cusparia bark...................  Galipea officinalis Hancock.          
Dandelion.......................  Taraxacum officinale Weber and T.     
                                   laevigatum DC.                       
Dandelion root..................      Do.                               
Dog grass (quackgrass, triticum)  Agropyron repens (L.) Beauv.          
Elder flowers...................  Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon,    Artemisia dracunculus L.              
 tarragon).                                                             
Estragon (tarragon).............      Do.                               
Fennel, sweet...................  Foeniculum vulgare Mill.              
Fenugreek.......................  Trigonella foenum-graecum L.          
Galanga (galangal)..............  Alpinia officinarum Hance.            
Geranium........................  Pelargonium spp.                      
Geranium, East Indian...........  Cymbopogon martini Stapf.             
Geranium, rose..................  Pelargonium graveolens L'Her.         
Ginger..........................  Zingiber officinale Rosc.             
Grapefruit......................  Citrus paradisi Macf.                 
Guava...........................  Psidium spp.                          
Hickory bark....................  Carya spp.                            
Horehound (hoarhound)...........  Marrubium vulgare L.                  
Hops............................  Humulus lupulus L.                    
Horsemint.......................  Monarda punctata L.                   
Hyssop..........................  Hyssopus officinalis L.               
Immortelle......................  Helichrysum augustifolium DC.         
Jasmine.........................  Jasminum officinale L. and other spp. 
                                   of Jasminum.                         
Juniper (berries)...............  Juniperus communis L.                 
Kola nut........................  Cola acuminata Schott and Endl., and  
                                   other spp. of Cola.                  
Laurel berries..................  Laurus nobilis L.                     
Laurel leaves...................  Laurus spp.                           
Lavender........................  Lavandula officinalis Chaix.          
Lavender, spike.................  Lavandula latifolia Vill.             
Lavandin........................  Hybrids between Lavandula officinalis 
                                   Chaix and Lavandula latifolin Vill.  

[[Page 422]]

                                                                        
Lemon...........................  Citrus limon (L.) Burm. f.            
Lemon balm (see balm)...........                                        
Lemon grass.....................  Cymbopogon citratus DC. and Cymbopogon
                                   lexuosus Stapf.                      
Lemon peel......................  Citrus limon (L.) Burm. f.            
Lime............................  Citrus aurantifolia Swingle.          
Linden flowers..................  Tilia spp.                            
Locust bean.....................  Ceratonia siliqua L,                  
Lupulin.........................  Humulus lupulus L.                    
Mace............................  Myristica fragrans Houtt.             
Mandarin........................  Citrus reticulata Blanco.             
Marjoram, sweet.................  Majorana hortensis Moench.            
Mate............................  Ilex paraguariensis St. Hil.          
Melissa (see balm)..............                                        
Menthol.........................  Mentha spp.                           
Menthyl acetate.................      Do.                               
Molasses (extract)..............  Saccarum officinarum L.               
Mustard.........................  Brassica spp.                         
Naringin........................  Citrus paradisi Macf.                 
Neroli, bigarade................  Citrus aurantium L.                   
Nutmeg..........................  Myristica fragrans Houtt.             
Onion...........................  Allium cepa L.                        
Orange, bitter, flowers.........  Citrus aurantium L.                   
Orange, bitter, peel............      Do.                               
Orange leaf.....................  Citrus sinensis (L.) Osbeck.          
Orange, sweet...................      Do.                               
Orange, sweet, flowers..........      Do.                               
Orange, sweet, peel.............      Do.                               
Origanum........................  Origanum spp.                         
Palmarosa.......................  Cymbopogon martini Stapf.             
Paprika.........................  Capsicum annuum L.                    
Parsley.........................  Petroselinum crispum (Mill.) Mansf.   
Pepper, black...................  Piper nigrum L.                       
Pepper, white...................      Do.                               
Peppermint......................  Mentha piperita L.                    
Peruvian balsam.................  Myroxylon pereirae Klotzsch.          
Petitgrain......................  Citrus aurantium L.                   
Petitgrain lemon................  Citrus limon (L.) Burm. f.            
Petitgrain mandarin or tangerine  Citrus reticulata Blanco.             
Pimenta.........................  Pimenta officinalis Lindl.            
Pimenta leaf....................  Pimenta officinalis Lindl.            
Pipsissewa leaves...............  Chimaphila umbellata Nutt.            
Pomegranate.....................  Punica granatum L.                    
Prickly ash bark................  Xanthoxylum (or Zanthoxylum)          
                                   Americanum Mill. or Xanthoxylum clava-
                                   herculis L.                          
Rose absolute...................  Rosa alba L., Rosa centifolia L., Rosa
                                   damascena Mill., Rosa gallica L., and
                                   vars. of these spp.                  
Rose (otto of roses, attar of         Do.                               
 roses).                                                                
Rose buds.......................      Do.                               
Rose flowers....................      Do.                               
Rose fruit (hips)...............      Do.                               
Rose geranium...................  Pelargonium graveolens L'Her.         
Rose leaves.....................  Rosa spp.                             
Rosemary........................  Rosmarinus officinalis L.             
Saffron.........................  Crocus sativus L.                     
Sage............................  Salvia officinalis L.                 
Sage, Greek.....................  Salvia triloba L.                     
Sage, Spanish...................  Salvia lavandulaefolia Vahl.          
St. John's bread................  Ceratonia siliqua L.                  
Savory, summer..................  Satureia hortensis L.                 
Savory, winter..................  Satureia montana L.                   
Schinus molle...................  Schinus molle L.                      
Sloe berries (blackthorn          Prunus spinosa L.                     
 berries).                                                              
Spearmint.......................  Mentha spicata L.                     
Spike lavender..................  Lavandula latifolia Vill.             
Tamarind........................  Tamarindus indica L.                  
Tangerine.......................  Citrus reticulata Blanco.             
Tarragon........................  Artemisia dracunculus L.              
Tea.............................  Thea sinensis L.                      
Thyme...........................  Thymus vulgaris L. and Thymus zygis   
                                   var. gracilis Boiss.                 
Thyme, white....................      Do.                               
Thyme, wild or creeping.........  Thymus serpyllum L.                   
Triticum (see dog grass)........                                        
Tuberose........................  Polianthes tuberosa L.                
Turmeric........................  Curcuma longa L.                      

[[Page 423]]

                                                                        
Vanilla.........................  Vanilla planifolia Andr. or Vanilla   
                                   tahitensis J. W. Moore.              
Violet flowers..................  Viola odorata L.                      
Violet leaves...................      Do.                               
Violet leaves absolute..........      Do.                               
Wild cherry bark................  Prunus serotina Ehrh.                 
Ylang-ylang.....................  Cananga odorata Hook. f. and Thoms.   
Zedoary bark....................  Curcuma zedoaria Rosc.                
------------------------------------------------------------------------

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 
FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 
21044, May 22, 1985]


Sec. 182.40    Natural extractives (solvent-free) used in conjunction 
        with spices, seasonings, and flavorings.

------------------------------------------------------------------------
           Common name                Botanical name of plant source    
------------------------------------------------------------------------
Apricot kernel (persic oil).....  Prunus armeniaca L.                   
Peach kernel (persic oil).......  Prunus persica Sieb. et Zucc.         
Peanut stearine.................  Arachis hypogaea L.                   
Persic oil (see apricot kernel                                          
 and peach kernel).                                                     
Quince seed.....................  Cydonia oblonga Miller.               
------------------------------------------------------------------------


[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]


Sec. 182.50    Certain other spices, seasonings, essential oils, 
        oleoresins, and natural extracts.

------------------------------------------------------------------------
           Common name                          Derivation              
------------------------------------------------------------------------
Ambergris.......................  Physeter macrocephalus L.             
Castoreum.......................  Castor fiber L. and C. canadensis     
                                   Kuhl.                                
Civet (zibeth, zibet, zibetum)..  Civet cats, Viverra civetta Schreber  
                                   and Viverra zibetha Schreber.        
Cognac oil, white and green.....  Ethyl oenanthate, so-called.          
Musk (Tonquin musk).............  Musk deer, Moschus moschiferus L.     
------------------------------------------------------------------------



Sec. 182.60   Synthetic flavoring substances and adjuvants.

    Synthetic flavoring substances and adjuvants that are generally 
recognized as safe for their intended use, within the meaning of section 
409 of the Act, are as follows:

Acetaldehyde (ethanal).
Acetoin (acetyl methylcarbinol).
Anethole (parapropenyl anisole).
Benzaldehyde (benzoic aldehyde).
N-Butyric acid (butanoic acid).
d- or l-Carvone (carvol).
Cinnamaldehyde (cinnamic aldehyde).
Citral (2,6-dimethyloctadien-2,6-al-8, gera-nial, neral).
Decanal (N-decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, 
aldehyde C-10).
Ethyl acetate.
Ethyl butyrate.
3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-
glycidate, so-called strawberry aldehyde, C-16 aldehyde).
Ethyl vanillin.
Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol).
Geranyl acetate (geraniol acetate).
Limonene (d-, l-, and dl-).
Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol).
Linalyl acetate (bergamol).
Methyl anthranilate (methyl-2-aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).

[[Page 424]]

Vanillin.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 
44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 
15, 1983; 54 FR 7402, Feb. 21, 1989]



Sec. 182.70   Substances migrating from cotton and cotton fabrics used in dry food packaging.

    Substances migrating to food from cotton and cotton fabrics used in 
dry food packaging that are generally recognized as safe for their 
intended use, within the meaning of section 409 of the Act, are as 
follows:

Beef tallow.
Carboxymethylcellulose.
Coconut oil, refined.
Cornstarch.
Gelatin.
Lard.
Lard oil.
Oleic acid.
Peanut oil.
Potato starch.
Sodium acetate.
Sodium chloride.
Sodium silicate.
Sodium tripolyphosphate.
Soybean oil (hydrogenated).
Talc.
Tallow (hydrogenated).
Tallow flakes.
Tapioca starch.
Tetrasodium pyrophosphate.
Wheat starch.
Zinc chloride.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 
44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 
27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 
1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 
18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 
62208, Dec. 5, 1995]



Sec. 182.90   Substances migrating to food from paper and paperboard products.

    Substances migrating to food from paper and paperboard products used 
in food packaging that are generally recognized as safe for their 
intended use, within the meaning of section 409 of the Act, are as 
follows:

Alum (double sulfate of aluminum and ammonium potassium, or sodium).
Aluminum hydroxide.
Aluminum oleate.
Aluminum palmitate.
Casein.
Cellulose acetate.
Cornstarch.
Diatomaceous earth filler.
Ethyl cellulose.
Ethyl vanillin.
Glycerin.
Oleic acid.
Potassium sorbate.
Silicon dioxides.
Sodium aluminate.
Sodium chloride.
Sodium hexametaphosphate.
Sodium hydrosulfite.
Sodium phosphoaluminate.
Sodium silicate.
Sodium sorbate.
Sodium tripolyphosphate.
Sorbitol.
Soy protein, isolated.
Starch, acid modified.
Starch, pregelatinized.
Starch, unmodified.
Talc.
Vanillin.
Zinc hydrosulfite.
Zinc sulfate.

[42 FR 14640, Mar. 15, 1977]

    Editorial Note: For additional Federal Register citations affecting 
Sec. 182.90, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 182.99   Adjuvants for pesticide chemicals.

    Adjuvants, identified and used in accordance with 40 CFR 180.1001 
(c) and (d), which are added to pesticide use dilutions by a grower or 
applicator prior to application to the raw agricultural commodity, are 
exempt from the requirement of tolerances under section 409 of the Act.



            Subpart B--Multiple Purpose GRAS Food Substances



Sec. 182.1045   Glutamic acid.

    (a) Product. Glutamic acid.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a salt substitute in 
accordance with good manufacturing practice.



Sec. 182.1047   Glutamic acid hydrochloride.

    (a) Product. Glutamic acid hydrochloride.
    (b) [Reserved]

[[Page 425]]

    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a salt substitute in 
accordance with good manufacturing practice.



Sec. 182.1057   Hydrochloric acid.

    (a) Product. Hydrochloric acid.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a buffer and neutralizing 
agent in accordance with good manufacturing practice.



Sec. 182.1073   Phosphoric acid.

    (a) Product. Phosphoric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1087   Sodium acid pyrophosphate.

    (a) Product. Sodium acid pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1125   Aluminum sulfate.

    (a) Product. Aluminum sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1127   Aluminum ammonium sulfate.

    (a) Product. Aluminum ammonium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1129   Aluminum potassium sulfate.

    (a) Product. Aluminum potassium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1131   Aluminum sodium sulfate.

    (a) Product. Aluminum sodium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1180   Caffeine.

    (a) Product. Caffeine.
    (b) Tolerance. 0.02 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in cola-type beverages in 
accordance with good manufacturing practice.



Sec. 182.1217   Calcium phosphate.

    (a) Product. Calcium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1235   Caramel.

    (a) Product. Caramel.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1320   Glycerin.

    (a) Product. Glycerin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1480   Methylcellulose.

    (a) Product. U.S.P. methylcellulose, except that the methoxy content 
shall not be less than 27.5 percent and not more than 31.5 percent on a 
dry-weight basis.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1500   Monoammonium glutamate.

    (a) Product. Monoammonium glutamate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1516   Monopotassium glutamate.

    (a) Product. Monopotassium glutamate.

[[Page 426]]

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1711   Silica aerogel.

    (a) Product. Silica aerogel as a finely powdered microcellular 
silica foam having a minimum silica content of 89.5 percent.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a component of an anti-foaming 
agent in accordance with good manufacturing practice.



Sec. 182.1745   Sodium carboxymethylcellulose.

    (a) Product. Sodium carboxymethylcellulose is the sodium salt of 
carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, 
with maximum substitution of 0.95 carboxymethyl groups per 
anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 
2 percent by weight aqueous solution at 25 deg. C.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1748   Sodium caseinate.

    (a) Product. Sodium caseinate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1778   Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1781   Sodium aluminum phosphate.

    (a) Product. Sodium aluminum phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1810   Sodium tripolyphosphate.

    (a) Product. Sodium tripolyphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.1866  High fructose corn syrup.

    (a) Product. High fructose corn syrup is a sweet, nutritive 
saccharide mixture containing approximately 52 percent (dry weight) 
glucose, 43 percent (dry weight) fructose, and 5 percent (dry weight) 
other saccharides. It is prepared as a clear aqueous solution from high 
dextrose equivalent corn starch hydrolysate by partial enzymatic 
conversion of glucose (dextrose) to fructose utilizing an insoluble 
glucose isomerase enzyme preparation described in Sec. 184.1372 of this 
chapter.
    (b) Limitations, restrictions, or explanations. This substance is 
generally recognized as safe when used in food as a nutritive 
carbohydrate sweetener at levels not to exceed current good 
manufacturing practice.

[48 FR 5719, Feb. 8, 1983]



                      Subpart C--Anticaking Agents



Sec. 182.2122   Aluminum calcium silicate.

    (a) Product. Aluminum calcium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt in accordance with 
good manufacturing practice.



Sec. 182.2227   Calcium silicate.

    (a) Product. Calcium silicate.
    (b) Tolerance. 2 percent and 5 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used at levels not exceeding 2 percent 
in table salt and 5 percent in baking powder in accordance with good 
manufacturing practice.



Sec. 182.2437   Magnesium silicate.

    (a) Product. Magnesium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt

[[Page 427]]

in accordance with good manufacturing practice.



Sec. 182.2727   Sodium aluminosilicate.

    (a) Product. Sodium aluminosilicate (sodium silicoaluminate).
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 2 percent in accordance with good 
manufacturing practice.



Sec. 182.2729   Sodium calcium aluminosilicate, hydrated.

    (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium 
silicoaluminate).
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 2 percent in accordance with good 
manufacturing practice.



Sec. 182.2906   Tricalcium silicate.

    (a) Product. Tricalcium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt in accordance with 
good manufacturing practice.



                    Subpart D--Chemical Preservatives



Sec. 182.3013   Ascorbic acid.

    (a) Product. Ascorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3041   Erythorbic acid.

    (a) Product. Erythorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3089   Sorbic acid.

    (a) Product. Sorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3109   Thiodipropionic acid.

    (a) Product. Thiodipropionic acid.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of the food, provided the substance is used in accordance with 
good manufacturing practice.



Sec. 182.3149   Ascorbyl palmitate.

    (a) Product. Ascorbyl palmitate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3169   Butylated hydroxyanisole.

    (a) Product. Butylated hydroxyanisole.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of food, provided the substance is used in accordance with good 
manufacturing practice.



Sec. 182.3173   Butylated hydroxytoluene.

    (a) Product. Butylated hydroxytoluene.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of food, provided the substance is used in accordance with good 
manufacturing practice.



Sec. 182.3189   Calcium ascorbate.

    (a) Product. Calcium ascorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3225   Calcium sorbate.

    (a) Product. Calcium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3280   Dilauryl thiodipropionate.

    (a) Product. Dilauryl thiodipropionate.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food

[[Page 428]]

when the total content of antioxidants is not over 0.02 percent of fat 
or oil content, including essential (volatile) oil content of the food, 
provided the substance is used in accordance with good manufacturing 
practice.



Sec. 182.3616   Potassium bisulfite.

    (a) Product. Potassium bisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits and vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 
FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3637   Potassium metabisulfite.

    (a) Product. Potassium metabisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits and vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 
FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3640   Potassium sorbate.

    (a) Product. Potassium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3731   Sodium ascorbate.

    (a) Product. Sodium ascorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3739   Sodium bisulfite.

    (a) Product. Sodium bisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits or vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to the consumer as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 
FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3766   Sodium metabisulfite.

    (a) Product. Sodium metabisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits or vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 
FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3795   Sodium sorbate.

    (a) Product. Sodium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.3798   Sodium sulfite.

    (a) Product. Sodium sulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits or vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 
FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3862   Sulfur dioxide.

    (a) Product. Sulfur dioxide.
    (b) [Reserved]

[[Page 429]]

    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing practice, except that it is not used in meats; in food 
recognized as a source of vitamin B1; on fruits or vegetables 
intended to be served raw to consumers or sold raw to consumers, or to 
be presented to consumers as fresh.

[42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 
FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]



Sec. 182.3890   Tocopherols.

    (a) Product. Tocopherols.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



                Subpart E--Emulsifying Agents [Reserved]



                    Subpart F--Dietary Supplements\1\



Sec. 182.5013   Ascorbic acid.

    (a) Product. Ascorbic acid.
---------------------------------------------------------------------------

    \1\ Amino acids listed in this subpart may be free hydrochloride 
salt, hydrated, or anhydrous form, where applicable.
---------------------------------------------------------------------------

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5065   Linoleic acid.

    (a) Product. Linoleic acid prepared from edible fats and oils and 
free from chickedema factor.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5159   Biotin.

    (a) Product. Biotin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5191   Calcium carbonate.

    (a) Product. Calcium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5195   Calcium citrate.

    (a) Product. Calcium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5201   Calcium glycerophosphate.

    (a) Product. Calcium glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5210   Calcium oxide.

    (a) Product. Calcium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5212   Calcium pantothenate.

    (a) Product. Calcium pantothenate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5217   Calcium phosphate.

    (a) Product. Calcium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5223   Calcium pyrophosphate.

    (a) Product. Calcium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5245   Carotene.

    (a) Product. Carotene.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5250   Choline bitartrate.

    (a) Product. Choline bitartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 430]]

used in accordance with good manufacturing practice.



Sec. 182.5252   Choline chloride.

    (a) Product. Choline chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5260  Copper gluconate.

    (a) Product. Copper gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with current good manufacturing practice.

[49 FR 24119, June 12, 1984]



Sec. 182.5301   Ferric phosphate.

    (a) Product. Ferric phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5304   Ferric pyrophosphate.

    (a) Product. Ferric pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5306   Ferric sodium pyrophosphate.

    (a) Product. Ferric sodium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5308   Ferrous gluconate.

    (a) Product. Ferrous gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5311   Ferrous lactate.

    (a) Product. Ferrous lactate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5315   Ferrous sulfate.

    (a) Product. Ferrous sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5370   Inositol.

    (a) Product. Inositol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5375   Iron reduced.

    (a) Product. Iron reduced.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5431   Magnesium oxide.

    (a) Product. Magnesium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5434   Magnesium phosphate.

    (a) Product. Magnesium phosphate (di- and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5443   Magnesium sulfate.

    (a) Product. Magnesium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5446   Manganese chloride.

    (a) Product. Manganese chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5449   Manganese citrate.

    (a) Product. Manganese citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5452   Manganese gluconate.

    (a) Product. Manganese gluconate.

[[Page 431]]

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5455   Manganese glycerophosphate.

    (a) Product. Manganese glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5461   Manganese sulfate.

    (a) Product. Manganese sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5464   Manganous oxide.

    (a) Product. Manganous oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5484  Manganese hypophosphite.

    (a) Product. Manganese hypophosphite.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.

[45 FR 58838, Sept. 5, 1980. Redesignated at 61 FR 14246, Apr. 1, 1996]



Sec. 182.5530   Niacin.

    (a) Product. Niacin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5535   Niacinamide.

    (a) Product. Niacinamide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5580   D-Pantothenyl alcohol.

    (a) Product. D-Pantothenyl alcohol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5622   Potassium chloride.

    (a) Product. Potassium chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with current good manufacturing practice. 
Preparations containing amounts equal to or greater than 100 milligrams 
of potassium per tablet or capsule, or 20 milligrams of potassium per 
milliliter, are drugs subject to the provisions of Sec. 201.306 of this 
chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 48 FR 51614, Nov. 10, 1983]



Sec. 182.5628   Potassium glycerophosphate.

    (a) Product. Potassium glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5676   Pyridoxine hydrochloride.

    (a) Product. Pyridoxine hydrochloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5695   Riboflavin.

    (a) Product. Riboflavin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5697   Riboflavin-5' phosphate.

    (a) Product. Riboflavin-5' phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice. [42 FR 
14640, Mar. 15, 1977, as amended at 61 FR 14246, Apr. 1, 1996]



Sec. 182.5772   Sodium pantothenate.

    (a) Product. Sodium pantothenate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5778   Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 432]]

used in accordance with good manufacturing practice.



Sec. 182.5875   Thiamine hydrochloride.

    (a) Product. Thiamine hydrochloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5878   Thiamine mononitrate.

    (a) Product. Thiamine mononitrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5890   Tocopherols.

    (a) Product. Tocopherols.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5892   a-Tocopherol acetate.

    (a) Product. a-Tocopherol acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5930   Vitamin A.

    (a) Product. Vitamin A.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5933   Vitamin A acetate.

    (a) Product. Vitamin A acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5936   Vitamin A palmitate.

    (a) Product. Vitamin A palmitate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5945   Vitamin B12.

    (a) Product. Vitamin B12.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5950   Vitamin D2.

    (a) Product. Vitamin D2.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5953   Vitamin D3.

    (a) Product. Vitamin D3.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5985   Zinc chloride.

    (a) Product. Zinc chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5988   Zinc gluconate.

    (a) Product. Zinc gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5991   Zinc oxide.

    (a) Product. Zinc oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5994   Zinc stearate.

    (a) Product. Zinc stearate prepared from stearic acid free from 
chickedema factor.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.5997   Zinc sulfate.

    (a) Product. Zinc sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



                       Subpart G--Sequestrants\1\



Sec. 182.6085   Sodium acid phosphate.

    (a) Product. Sodium acid phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 433]]

used in accordance with good manufacturing practice.



Sec. 182.6197   Calcium diacetate.

    (a) Product. Calcium diacetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6203   Calcium hexametaphosphate.

    (a) Product. Calcium hexametaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6215   Monobasic calcium phosphate.

    (a) Product. Monobasic calcium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6285   Dipotassium phosphate.

    (a) Product. Dipotassium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6290   Disodium phosphate.

    (a) Product. Disodium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6757   Sodium gluconate.

    (a) Product. Sodium gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6760   Sodium hexametaphosphate.

    (a) Product. Sodium hexametaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6769   Sodium metaphosphate.

    (a) Product. Sodium metaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6778   Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6787   Sodium pyrophosphate.

    (a) Product. Sodium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6789   Tetra sodium pyrophosphate.

    (a) Product. Tetra sodium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.6810   Sodium tripolyphosphate.

    (a) Product. Sodium tripolyphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



                         Subpart H--Stabilizers



Sec. 182.7255   Chondrus extract.

    (a) Product. Chondrus extract (carrageenin).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



                          Subpart I--Nutrients

    Source: 45 FR 58838, Sept. 5, 1980, unless otherwise noted.



Sec. 182.8013  Ascorbic acid.

    (a) Product. Ascorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 434]]

used in accordance with good manufacturing practice.



Sec. 182.8159  Biotin.

    (a) Product. Biotin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8217  Calcium phosphate.

    (a) Product. Calcium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8223  Calcium pyrophosphate.

    (a) Product. Calcium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8250  Choline bitartrate.

    (a) Product. Choline bitartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8252  Choline chloride.

    (a) Product. Choline chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8778  Sodium phosphate.

    (a) Product. Sodium phosphate
(mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8890  Tocopherols.

    (a) Product. Tocopherols.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8892  -Tocopherol acetate.

    (a) Product. -Tocopherol acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8985  Zinc chloride.

    (a) Product. Zinc chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8988  Zinc gluconate.

    (a) Product. Zinc gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8991  Zinc oxide.

    (a) Product. Zinc oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8994  Zinc stearate.

    (a) Product. Zinc stearate prepared from stearic acid free from 
chickedema factor.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



Sec. 182.8997  Zinc sulfate.

    (a) Product. Zinc sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing practice.



PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents




                      Subpart A--General Provisions

Sec.
184.1  Substances added directly to human food affirmed as generally 
          recognized as safe (GRAS).

       Subpart B--Listing of Specific Substances Affirmed as GRAS

184.1005  Acetic acid.
184.1007  Aconitic acid.
184.1009  Adipic acid.
184.1011  Alginic acid.
184.1012  -Amylase enzyme preparation from Bacillus 
          stearothermophilus.

[[Page 435]]

184.1021  Benzoic acid.
184.1024  Bromelain.
184.1025  Caprylic acid.
184.1027  Mixed carbohydrase and protease enzyme product.
184.1033  Citric acid.
184.1034  Catalase (bovine liver).
184.1061  Lactic acid.
184.1065  Linoleic acid.
184.1069  Malic acid.
184.1077  Potassium acid tartrate.
184.1081  Propionic acid.
184.1090  Stearic acid.
184.1091  Succinic acid.
184.1095  Sulfuric acid.
184.1097  Tannic acid.
184.1099  Tartaric acid.
184.1101  Diacetyl tartaric acid esters of mono- and diglycerides.
184.1115  Agar-agar.
184.1120  Brown algae.
184.1121  Red algae.
184.1133  Ammonium alginate.
184.1135  Ammonium bicarbonate.
184.1137  Ammonium carbonate.
184.1138  Ammonium chloride.
184.1139  Ammonium hydroxide.
184.1140  Ammonium citrate, dibasic.
184.1141a  Ammonium phosphate, monobasic.
184.1141b  Ammonium phosphate, dibasic.
184.1143  Ammonium sulfate.
184.1155  Bentonite.
184.1157  Benzoyl peroxide.
184.1165  n-Butane and iso-butane.
184.1185  Calcium acetate.
184.1187  Calcium alginate.
184.1191  Calcium carbonate.
184.1193  Calcium chloride.
184.1195  Calcium citrate.
184.1199  Calcium gluconate.
184.1201  Calcium glycerophosphate.
184.1205  Calcium hydroxide.
184.1206  Calcium iodate.
184.1207  Calcium lactate.
184.1210  Calcium oxide.
184.1212  Calcium pantothenate.
184.1221  Calcium propionate.
184.1229  Calcium stearate.
184.1230  Calcium sulfate.
184.1240  Carbon dioxide.
184.1245  Beta-carotene.
184.1257  Clove and its derivatives.
184.1259  Cocoa butter substitute primarily from palm oil.
184.1260  Copper gluconate.
184.1261  Copper sulfate.
184.1262  Corn silk and corn silk extract.
184.1265  Cuprous iodide.
184.1271  L-Cysteine.
184.1272  L-Cysteine monohydrochloride.
184.1277  Dextrin.
184.1278  Diacetyl.
184.1282  Dill and its derivatives.
184.1287  Enzyme-modified fats.
184.1293  Ethyl alcohol.
184.1295  Ethyl formate.
184.1296  Ferric ammonium citrate.
184.1297  Ferric chloride.
184.1298  Ferric citrate.
184.1301  Ferric phosphate.
184.1304  Ferric pyrophosphate.
184.1307  Ferric sulfate.
184.1307a  Ferrous ascorbate.
184.1307b  Ferrous carbonate.
184.1307c  Ferrous citrate.
184.1307d  Ferrous fumarate.
184.1308  Ferrous gluconate.
184.1311  Ferrous lactate.
184.1315  Ferrous sulfate.
184.1316  Ficin.
184.1317  Garlic and its derivatives.
184.1318  Glucono delta-lactone.
184.1321  Corn gluten.
184.1322  Wheat gluten.
184.1323  Glyceryl monooleate.
184.1324  Glyceryl monostearate.
184.1328  Glyceryl behenate.
184.1329  Glyceryl palmitostearate.
184.1330  Acacia (gum arabic).
184.1333  Gum ghatti.
184.1339  Guar gum.
184.1343  Locust (carob) bean gum.
184.1349  Karaya gum (sterculia gum).
184.1351  Gum tragacanth.
184.1355  Helium.
184.1366  Hydrogen peroxide.
184.1370  Inositol.
184.1372  Insoluble glucose isomerase enzyme preparations.
184.1375  Iron, elemental.
184.1386  Isopropyl citrate.
184.1387  Lactase enzyme preparation from Candida pseudotropicalis.
184.1388  Lactase enzyme preparation from Kluyveromyces lactis.
184.1400  Lecithin.
184.1408  Licorice and licorice derivatives.
184.1409  Ground limestone.
184.1415  Animal lipase.
184.1425  Magnesium carbonate.
184.1426  Magnesium chloride.
184.1428  Magnesium hydroxide.
184.1431  Magnesium oxide.
184.1434  Magnesium phosphate.
184.1440  Magnesium stearate.
184.1443  Magnesium sulfate.
184.1443a  Malt.
184.1444  Maltodextrin.
184.1445  Malt syrup (malt extract).
184.1446  Manganese chloride.
184.1449  Manganese citrate.
184.1452  Manganese gluconate.
184.1461  Manganese sulfate.
184.1472  Hydrogenated and partially hydrogenated menhaden oils.
184.1490  Methylparaben.
184.1498  Microparticulated protein product.
184.1505  Mono- and diglycerides.
184.1521  Monosodium phosphate derivatives of mono- and diglycerides.
184.1530  Niacin.
184.1535  Niacinamide.
184.1537  Nickel.
184.1538  Nisin preparation.

[[Page 436]]

184.1540  Nitrogen.
184.1545  Nitrous oxide.
184.1553  Peptones.
184.1555  Rapeseed oil.
184.1560  Ox bile extract.
184.1563  Ozone.
184.1583  Pancreatin.
184.1585  Papain.
184.1588  Pectins.
184.1610  Potassium alginate.
184.1613  Potassium bicarbonate.
184.1619  Potassium carbonate.
184.1622  Potassium chloride.
184.1625  Potassium citrate.
184.1631  Potassium hydroxide.
184.1634  Potassium iodide.
184.1635  Potassium iodate.
184.1639  Potassium lactate.
184.1643  Potassium sulfate.
184.1655  Propane.
184.1660  Propyl gallate.
184.1666  Propylene glycol.
184.1670  Propylparaben.
184.1676  Pyridoxine hydrochloride.
184.1685  Rennet (animal-derived) and chymosin preparation 
          (fermentation-derived).
184.1695  Riboflavin.
184.1697  Riboflavin-5'-phosphate (sodium).
184.1698  Rue.
184.1699  Oil of rue.
184.1721  Sodium acetate.
184.1724  Sodium alginate.
184.1733  Sodium benzoate.
184.1736  Sodium bicarbonate.
184.1742  Sodium carbonate.
184.1751  Sodium citrate.
184.1754  Sodium diacetate.
184.1763  Sodium hydroxide.
184.1764  Sodium hypophosphite.
184.1768  Sodium lactate.
184.1769a  Sodium metasilicate.
184.1784  Sodium propionate.
184.1792  Sodium sesquicarbonate.
184.1801  Sodium tartrate.
184.1804  Sodium potassium tartrate.
184.1807  Sodium thiosulfate.
184.1835  Sorbitol.
184.1845  Stannous chloride (anhydrous and dihydrated).
184.1848  Starter distillate.
184.1851  Stearyl citrate
184.1854  Sucrose.
184.1857  Corn sugar.
184.1859  Invert sugar.
184.1865  Corn syrup.
184.1875  Thiamine hydrochloride.
184.1878  Thiamine mononitrate.
184.1890  -Tocopherols.
184.1901  Triacetin.
184.1903  Tributyrin.
184.1911  Triethyl citrate.
184.1914  Trypsin.
184.1923  Urea.
184.1924  Urease enzyme preparation from Lactobacillus fermentum.
184.1930  Vitamin A.
184.1945  Vitamin B12.
184.1950  Vitamin D.
184.1973  Beeswax (yellow and white).
184.1976  Candelilla wax.
184.1978  Carnauba wax.
184.1979  Whey.
184.1979a  Reduced lactose whey.
184.1979b  Reduced minerals whey.
184.1979c  Whey protein concentrate.
184.1983  Bakers yeast extract.
184.1984  Zein.
184.1985  Aminopeptidase enzyme preparation derived from lactococcus 
          lactis.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 184.1   Substances added directly to human food affirmed as generally recognized as safe (GRAS).

    (a) The direct human food ingredients listed in this part have been 
reviewed by the Food and Drug Administration and determined to be 
generally recognized as safe (GRAS) for the purposes and under the 
conditions prescribed. The regulations in this part shall sufficiently 
describe each ingredient to identify the characteristics of the 
ingredient that has been affirmed as GRAS and to differentiate it from 
other possible versions of the ingredient that have not been affirmed as 
GRAS. Ingredients affirmed as GRAS in this part are also GRAS as 
indirect human food ingredients, subject to any limitations prescribed 
in parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter of in 
part 186 of this chapter. The purity specifications in this part do not 
apply when the ingredient is used in indirect applications. However, 
when used in indirect applications, the ingredient must be of a purity 
suitable for its intended use in accordance with Sec. 170.30(h)(1) of 
this chapter.
    (b) Any ingredient affirmed as GRAS in this part shall be used in 
accordance with current good manufacturing practice. For the purpose of 
this part, current good manufacturing practice includes the requirements 
that a direct human food ingredient be of appropriate food grade; that 
it be prepared and handled as a food ingredient; and that the quantity 
of the ingredient

[[Page 437]]

added to food does not exceed the amount reasonably required to 
accomplish the intended physical, nutritional, or other technical effect 
in food.
    (1) If the ingredient is affirmed as GRAS with no limitations on its 
conditions of use other than current good manufacturing practice, it 
shall be regarded as GRAS if its conditions of use are consistent with 
the requirements of paragraph (b), (c), and (d) of this section. When 
the Food and Drug Administration (FDA) determines that it is 
appropriate, the agency will describe one or more current good 
manufacturing practice conditions of use in the regulation that affirms 
the GRAS status of the ingredient. For example, when the safety of an 
ingredient has been evaluated on the basis of limited conditions of use, 
the agency will describe in the regulation that affirms the GRAS status 
of the ingredient, one or more of these limited conditions of use, which 
may include the category of food(s), the technical effect(s) or 
functional use(s) of the ingredient, and the level(s) of use. If the 
ingredient is used under conditions that are significantly different 
from those described in the regulation, that use of the ingredient may 
not be GRAS. In such a case, a manufacturer may not rely on the 
regulation as authorizing that use but shall independently establish 
that that use is GRAS or shall use the ingredient in accordance with a 
food additive regulation. Persons seeking FDA approval of an independent 
determination that a use of an ingredient is GRAS may submit a GRAS 
petition in accordance with Sec. 170.35 of this chapter.
    (2) If the ingredient is affirmed as GRAS with specific 
limitation(s), it shall be used in food only within such limitation(s), 
including the category of food(s), the functional use(s) of the 
ingredient, and the level(s) of use. Any use of such an ingredient not 
in full compliance with each such established limitation shall require a 
food additive regulation.
    (3) If the ingredient is affirmed as GRAS for a specific use, 
without a general evaluation of use of the ingredient, other uses may 
also be GRAS.
    (c) The listing of a food ingredient in this part does not authorize 
the use of such substance in a manner that may lead to deception of the 
consumer or to any other violation of the Federal Food, Drug, and 
Cosmetic Act (the Act).
    (d) The listing of more than one ingredient to produce the same 
technological effect does not authorize use of a combination of two or 
more ingredients to accomplish the same technological effect in any one 
food at a combined level greater than the highest level permitted for 
one of the ingredients.
    (e) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of an ingredient under conditions different from those 
proposed to be affirmed as GRAS, he will concurrently propose a separate 
regulation covering such use of the ingredient under part 181 of this 
chapter. If the Commissioner is unaware of any such applicable prior 
sanction, the proposed regulation will so state and will require any 
person who intends to assert or rely on such sanction to submit proof of 
its existence. Any regulation promulgated pursuant to this section 
constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof of such an applicable prior sanction in response 
to the proposal.
    (f) The label and labeling of the ingredient and any intermediate 
mix of the ingredient for use in finished food shall bear, in addition 
to the other labeling required by the Act:
    (1) The name of the ingredient, except where exempted from such 
labeling in part 101 of this chapter.
    (2) A statement of concentration of the ingredient in any 
intermediate mix; or other information to permit a food processor 
independently to determine that use of the ingredients will be

[[Page 438]]

in accordance with any limitations and good manufacturing practice 
gudelines prescribed.
    (3) Adequate directions for use to provide a final food product that 
complies with any limitations prescribed for the ingredient(s).

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
48 FR 48457, 48459, Oct. 19, 1983]



       Subpart B--Listing of Specific Substances Affirmed as GRAS



Sec. 184.1005  Acetic acid.

    (a) Acetic acid (C2H4O2, CAS Reg. No. 64-19-7) is 
known as ethanoic acid. It occurs naturally in plant and animal tissues. 
It is produced by fermentation of carbohydrates or by organic synthesis. 
The principal synthetic methods currently employed are oxidation of 
acetaldehyde derived from ethylene, liquid phase oxidation of butane, 
and reaction of carbon monoxide with methanol derived from natural gas.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 8, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The ingredient is used as a curing and pickling agent as defined 
in Sec. 170.3(o)(5) of this chapter; flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter; as a solvent and vehicle 
as defined in Sec. 170.3(o)(27) of this chapter; and as a boiler water 
additive complying with Sec. 173.310 of this chapter.
    (d) The ingredient is used in food at levels not to exceed current 
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current 
good manufacturing practice results in a maximum level as served, of 
0.25 percent for baked goods as defined in Sec. 170.3(n)(1) of this 
chapter; 0.8 percent for cheeses as defined in Sec. 170.3(n)(5) of this 
chapter and dairy product analogs as defined in Sec. 170.3(n)(10) of 
this chapter; 0.5 percent for chewing gum as defined in Sec. 170.3(n)(6) 
of this chapter; 9.0 percent for condiments and relishes as defined in 
Sec. 170.3(n)(8) of this chapter; 0.5 percent for fats and oils as 
defined in Sec. 170.3(n)(12) of this chapter; 3.0 percent for gravies 
and sauces as defined in Sec. 170.3(n)(24) of this chapter; 0.6 percent 
for meat products as defined in Sec. 170.3(n)(29) of this chapter; and 
0.15 percent or less for all other food categories. The ingredient may 
also be used in boiler water additives at levels not to exceed current 
good manufacturing practice.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27814, June 25, 1982]



Sec. 184.1007  Aconitic acid.

    (a) Aconitic acid (1,2,3-propenetricarboxylic acid 
(C6H6O6), CAS Reg. No. 000499-12-7) occurs in the leaves 
and tubers of Aconitum napellus L. and other Ranunculaceae. 
Transaconitic acid can be isolated during sugarcane processing, by 
precipitation as the calcium salt from cane sugar or molasses. It may be 
synthesized by sulfuric acid dehydration of citric acid, but not by the 
methanesulfonic acid method.
    (b) The ingredient meets the following specifications:
    (1) Assay. Not less than 98.0 percent of C3H3(COOH)3, 
using the ``Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, test for 
citric acid, which is incorporated by reference, and a molecular weight 
of 174.11. Copies of the material incorporated by reference may be 
obtained from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Melting point. Not less than 195 deg. C and the determination 
results in decomposition of aconitic acid.
    (3) Heavy metals (as Pb). Not more than 10 parts per million.
    (4) Arsenic (as As). Not more than 3 parts per million.
    (5) Oxalate. Passes test.
    (6) Readily carbonizable substances. Passes ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 86-87, test for citric acid, which is 
incorporated by reference. The availability of this incorporation by 
reference is given in paragraph (b)(1) of this section.
    (7) Residue on ignition. Not more than 0.1 percent as determined by 
``Food Chemicals Codex,'' 3d Ed.

[[Page 439]]

(1981), pp. 86-87, test for citric acid, which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (b)(1) of this section.
The substance should have infrared absorption bands at 3030, 2630, 1720, 
1430, 1300, 1240, 910, 860, 780, and 750 cm-1. Also, an aqueous 
solution of the substance should have major absorption peaks at 411 and 
432 nanometers with little or no absorption at 389 nanometers.
    (c) The ingredient is used as a flavoring substance and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food, in accordance with 
Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice. 
Current good manufacturing practice results in a maximum level, as 
served, of 0.003 percent for baked goods as defined in Sec. 170.3(n)(1) 
of this chapter, 0.002 percent for alcoholic beverages as defined in 
Sec. 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy 
products as defined in Sec. 170.3(n)(20) of this chapter, 0.0035 percent 
for soft candy as defined in Sec. 170.3(n)(38) of this chapter, and 
0.0005 percent or less for all other food categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 47724, Oct. 17, 1978, as amended at 49 FR 5610, Feb. 14, 1984]



Sec. 184.1009  Adipic acid.

    (a) Adipic acid (C6H10O4,CAS Reg. No. 00124-04-9) is 
also known as 1, 4-butanedicarboxylic acid or hexane-dioic acid. It is 
prepared by nitric acid oxidation of cyclohexanol or cyclohexanone or a 
mixture of the two.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 11, which is incorporated by reference (copies 
are available from the National Academy Press, 2101 Constitution Ave., 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408), and the following additional specifications:
    (1) The adipic acid is converted to its corresponding amide. The 
amide is purified by recrystallization from water or aqueous ethanol. 
The melting range of the amide is 219 deg. to 220 deg. C.
    (2) The adipic acid is converted to its corresponding bis-p-p-
bromophenacyl ester. The ester is purified by recrystallization from 
ethanol. The melting range of the ester is 153 deg. to 154 deg. C.
    (c) The ingredient is used as a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter; leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; and pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (d) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current 
good manufacturing practice results in maximum levels, as served, of 
0.05 percent for baked goods as defined in Sec. 170.3(n)(1) of this 
chapter; 0.005 percent for nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; 5.0 percent for condiments and 
relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.45 percent 
for dairy product analogs as defined in Sec. 170.3(n)(10) of this 
chapter; 0.3 percent for fats and oil as defined in Sec. 170.3(n)(12) of 
this chapter; 0.0004 percent for frozen dairy desserts as defined in 
Sec. 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings 
as defined in Sec. 170.3(n)(22) of this chapter; 0.1 percent for gravies 
as defined in Sec. 170.3(n)(24) of this chapter; 0.3 percent for meat 
products as defined in Sec. 170.3(n)(29) of this chapter; 1.3 percent 
for snack foods as defined in Sec. 170.3(n)(37) of this chapter; and 
0.02 percent or less for all other food categories.
    (e) Prior sanctions for adipic acid different from the uses 
established in this section do not exist or have been waived.

[47 FR 27810, June 25, 1982]



Sec. 184.1011  Alginic acid.

    (a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained 
from

[[Page 440]]

certain brown algae by alkaline extraction.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 13, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                   Maximum level of                     
        Category of food            use in food (as     Functional use  
                                        served)                         
------------------------------------------------------------------------
Soup and soup mixes, Sec.         Not to exceed       Emulsifier,       
 170.3(n) (40) of this chapter.    current good        emulsifier salt, 
                                   manufacturing       Sec.  170.3(o)(8)
                                   practice.           of this chapter; 
                                                       formulation aid, 
                                                       Sec.  170.3(o)(14
                                                       ) of this        
                                                       chapter;         
                                                       stabilizer,      
                                                       thickener, Sec.  
                                                       170.3(o)(28) of  
                                                       this chapter.    
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.

[47 FR 47375, Oct. 26, 1982]



Sec. 184.1012  -Amylase enzyme preparation from Bacillus stearothermophilus.

    (a) -Amylase enzyme preparation is obtained from the 
culture filtrate that results from a pure culture fermentation of a 
nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus. 
Its characterizing enzyme activity is -amylase (1,4 -D 
glucan glucanohydrolase (E.C. 3.2.1.1)).
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the ``Food Chemicals Codex,'' 3d ed. (1981), pp. 
107-110, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the National Academy 
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be 
examined at the Office of Premarket Approval (HFS-200), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont 
Ave. NW., suite 1200, Washington, DC, or the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practices. 
The affirmation of this ingredient as GRAS as a direct human food 
ingredient is based upon the following current good manufacturing 
practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, in the hydrolysis of edible starch to 
produce maltodextrins and nutritive carbohydrate sweeteners.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practices.

[60 FR 55789, Nov. 3, 1995]



Sec. 184.1021   Benzoic acid.

    (a) Benzoic acid is the chemical benzenecarboxylic acid 
(C7H6O2), occurring in nature in free and combined forms. 
Among the foods in which benzoic acid occurs naturally are cranberries, 
prunes, plums, cinnamon, ripe cloves, and most berries. Benzoic acid is 
manufactured by treating molten phthalic anhydride with steam in the 
presence of a zinc oxide catalyst, by the hydrolysis of 
benzotrichloride, or by the oxidation of toluene with nitric acid or 
sodium bichromate or with air in the presence of a transition metal salt 
catalyst.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 35, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant 
as defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice. Current usage results in a maximum level of 0.1 
percent in food. (The Food and Drug Administration

[[Page 441]]

has not determined whether significantly different conditions of use 
would be GRAS).
    (e) Prior sanctions for this ingredient different from those uses 
established in this section, or different from that set forth in part 
181 of this chapter, do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]



Sec. 184.1024  Bromelain.

    (a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation 
derived from the pineapples Ananas comosus and A. bracteatus L. It is a 
white to light tan amorphous powder. Its characterizing enzyme activity 
is that of a peptide hydrolase (EC 3.4.22.32).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press,

[[Page 442]]

2101 Constitution Ave. NW., Washington, DC, or may be examined at the 
Office of Premarket Approval (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC, and the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32910, June 26, 1995]



Sec. 184.1025  Caprylic acid.

    (a) Caprylic acid [CH3(CH2)6COOH, CAS Reg. No. 124-
07-2] is the chemical name for octanoic acid. It is considered to be a 
short or medium chain fatty acid. It occurs normally in various foods 
and is commercially prepared by oxidation of n-octanol or by 
fermentation and fractional distillation of the volatile fatty acids 
present in coconut oil.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 207, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in foods in accordance with 
Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice. 
Current good manufacturing practices result in maximum levels, as 
served, of: 0.013 percent for baked goods as defined in Sec. 170.3(n)(1) 
of this chapter; 0.04 percent for cheeses as defined in Sec. 170.3(n)(5) 
of this chapter; 0.005 percent for fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter, for frozen dairy desserts as defined 
in Sec. 170.3(n)(20) of this chapter, for gelatins and puddings as 
defined in Sec. 170.3(n)(22) of this chapter, for meat products as 
defined in Sec. 170.3(n)(29) of this chapter, and for soft candy as 
defined in Sec. 170.3(n)(38) of this chapter; 0.016 percent for snack 
foods as defined in Sec. 170.3(n)(37) of this chapter; and 0.001 percent 
or less for all other food categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 19843, May 9, 1978, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1027  Mixed carbohydrase and protease enzyme product.

    (a) Mixed carbohydrase and protease enzyme product is an enzyme 
preparation that includes carbohydrase and protease activity. It is 
obtained from the culture filtrate resulting from a pure culture 
fermentation of a nonpathogenic strain of B. licheniformis.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 107, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, to hydrolyze proteins or 
carbohydrates.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: alcoholic beverages, as 
defined in Sec. 170.3(n)(2) of this chapter, candy, nutritive 
sweeteners, and protein hydrolyzates.

[48 FR 240, Jan. 4, 1983]



Sec. 184.1033  Citric acid.

    (a) Citric acid (C6H8O7, CAS Reg. No. 77-92-9) is the 
compound 2-hydroxy-1,2,3-propanetricarboxylic acid. It is a naturally 
occurring constituent of plant and animal tissues. It occurs as 
colorless crystals or a white powder and may be anhydrous or contain one 
mole of water per mole of citric acid. Citric acid may be produced by 
recovery from sources such as lemon or pineapple juice; by mycological 
fermentation using Candida spp., described in Secs. 173.160 and 173.165 
of this chapter; and by the solvent extraction process described in 
Sec. 173.280 of this chapter for the recovery of citric acid from 
Aspergillus niger fermentation liquor.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992), 
pp. 107-108, which are incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the 
Center for Food Safety and Applied Nutrition (HFS-200), 200 C St. SW., 
Washington, DC 20204, or may be examined at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[59 FR 63895, Dec. 12, 1994]



Sec. 184.1034  Catalase (bovine liver).

    (a) Catalase (bovine liver) (CAS Reg. No. 9001-05-2) is an enzyme 
preparation obtained from extracts of bovine liver. It is a partially 
purified liquid or powder. Its characterizing enzyme activity is 
catalase (EC 1.11.1.6).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St., SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to decompose hydrogen peroxide.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32910, June 26, 1995]



Sec. 184.1061  Lactic acid.

    (a) Lactic acid (C3H6O3, CAS Reg. Nos.: dl mixture, 
598-82-3; l-isomer, 79-33-4; d-isomer, 10326-41-7), the chemical 2-
hydroxypropanoic acid, occurs naturally in several foods. It is produced 
commercially either by fermentation

[[Page 443]]

of carbohydrates such as glucose, sucrose, or lactose, or by a procedure 
involving formation of lactonitrile from acetaldehyde and hydrogen 
cyanide and subsequent hydrolysis to lactic acid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Avenue, 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter; a curing and pickling agent as defined 
in Sec. 170.3(o)(5) of this chapter; a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; a pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter; and a solvent and vehicle 
as defined in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in food, except in infant foods and 
infant formulas, at levels not to exceed current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 35367, Sept. 7, 1984]



Sec. 184.1065  Linoleic acid.

    (a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid 
(C17H31COOH) (CAS Reg. No. 60-33-3)), a straight chain 
unsaturated fatty acid with a molecular weight of 280.5, is a colorless 
oil at room temperature. Linoleic acid may be prepared from edible fats 
and oils by various methods including hydrolysis and saponification, the 
Twitchell method, low pressure splitting with catalyst, continuous high 
pressure counter current splitting, and medium pressure autoclave 
splitting with catalyst.
    (b) FDA is developing food-grade specifications for linoleic acid in 
cooperation with the National Academy of Sciences. In the interim, this 
ingredient must be of a purity suitable for its intended use. The 
ingredient must also meet the specifications in Sec. 172.860(b) of this 
chapter.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter and as a nutrient 
supplement as defined in Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 48534, Dec. 13, 1984]



Sec. 184.1069  Malic acid.

    (a) Malic acid (C4H6O5, CAS Reg. No. of L-form 97-67-
6, CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 
2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic 
acid, occurs naturally in various foods. Racemic DL-malic acid does not 
occur naturally. It is made commercially by hydration of fumaric acid or 
maleic acid.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 183-184, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal

[[Page 444]]

Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) The ingredients are used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter, flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter, and pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter.
    (d) The ingredients are used in food, except baby food, at levels 
not to exceed good manufacturing practice in accordance with 
Sec. 184.1(b)(1). Current good manufacturing practice results in a 
maximum level, as served, of 3.4 percent for nonalcoholic beverages as 
defined in Sec. 170.3(n)(3) of this chapter; 3.0 percent for chewing gum 
as defined in Sec. 170.3(n)(6) of this chapter; 0.8 percent for 
gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this 
chapter; 6.9 percent for hard candy as defined in Sec. 170.3(n)(25) of 
this chapter; 2.6 percent for jams and jellies as defined in 
Sec. 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and 
fruit juices as defined in Sec. 170.3(n)(35) of this chapter; 3.0 
percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 
and 0.7 percent for all other food categories.
    (e) Prior sanctions for malic acid different from the uses 
established in this section do not exist or have been waived.

[44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1077  Potassium acid tartrate.

    (a) Potassium acid tartrate (C4H5KO6, CAS Reg. No. 
868-14-4) is the potassium acid salt of L-(+)-tartaric acid and is also 
called potassium bitartrate or cream of tartar. It occurs as colorless 
or slightly opaque crystals or as a white, crystalline powder. It has a 
pleasant, acid taste. It is obtained as a byproduct of wine manufacture.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), P. 238, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no

[[Page 445]]

limitation other than current good manufacturing practice. The 
affirmation of this ingredient as generally recognized as safe (GRAS) as 
a direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as an anticaking agent as defined in 
Sec. 170.3(o)(1) of this chapter; an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter; a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; a humectant as defined in 
Sec. 170.3(o)(16) of this chapter; a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; A pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter; and a surface-active agent as 
defined in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; confections and frostings as defined 
in Sec. 170.3(n)(9) of this chapter; gelatins and puddings as defined in 
Sec. 170.3(n)(22) of this chapter; hard candy as defined in 
Sec. 170.3(n)(25) of this chapter; jams and jellies as defined in 
Sec. 170.3(n)(28) of this chapter; and soft candy as defined in 
Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52446, Nov. 18, 1983]



Sec. 184.1081  Propionic acid.

    (a) Propionic acid (C3H6O2, CAS Reg. No. 79-09-4) is 
an oily liquid having a slightly pungent, rancid odor. It is 
manufactured by chemical synthesis or by bacterial fermentation.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 254, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 13141, Apr. 3, 1984]



Sec. 184.1090  Stearic acid.

    (a) Stearic acid (C16H36O2, CAS Reg. No. 57-11-4) is 
a white to yellowish white solid. It occurs naturally as a glyceride in 
tallow and other animal or vegetable fats and oils and is a principal 
constituent of most commercially hydrogenated fats. It is produced 
commercially from hydrolyzed tallow derived from edible sources or from 
hydrolyzed, completely hydrogenated vegetable oil derived from edible 
sources.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and 
the requirements of Sec. 172.860(b)(2) of this chapter. Copies of the 
Food Chemicals Codex are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]



Sec. 184.1091  Succinic acid.

    (a) Succinic acid (C4H6O4, CAS Reg. No. 110-15-6), 
also referred to as amber acid and ethylenesuccinic acid, is the 
chemical 1,4-butanedioic acid. It is commercially prepared by 
hydrogenation of maleic or fumaric acid. It can also be produced by 
aqueous alkali or acid hydrolysis of succinonitrile.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 314-315, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter and pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.084 
percent in condiments and relishes as defined in Sec. 170.3(n)(8) of 
this chapter and 0.0061 percent in meat products as defined in 
Sec. 170.3(n)(29) of this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1095  Sulfuric acid.

    (a) Sulfuric acid (H2SO4, CAS Reg. No. 7664-93-9), also 
known as oil of vitriol, is a clear, colorless, oily liquid. It is 
prepared by reacting sulfur dioxide (SO2) with oxygen and mixing 
the resultant sulfur trioxide (SO3) with

[[Page 446]]

water, or by reacting nitric oxide (NO) with sulfur dioxide and water.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 317-318, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter and processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.014 
percent for alcoholic beverages as defined in Sec. 170.3(n)(2) of this 
chapter and 0.0003 percent for cheeses as defined in Sec. 170.3(n)(5) of 
this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[45 FR 6085, Jan. 25, 1980, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1097  Tannic acid.

    (a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable 
gallotannin, is a complex polyphenolic organic structure that yields 
gallic acid and either glucose or quinic acid as hydrolysis products. It 
is a yellowish-white to light brown substance in the form of an 
amorphous, bulky powder, glistening scales, or spongy masses. It is also 
ordorless, or has a faint characteristic odor, and has an astringent 
taste. Tannic acid is obtained by solvent extraction of nutgalls or 
excrescences that form on the young twigs of Quercus infectoria Oliver 
and related species of Quercus. Tannic acid is also obtained by solvent 
extraction of the seed pods of Tara (Caesalpinia spinosa) or the 
nutgalls of various sumac species, including Rhus semialata, R. 
coriaria, R. galabra, and R. typhia.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 319, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c)(1) In accordance with Sec. 184.1(b)(2), the ingredient is used 
in food only within the following specific limitations:

------------------------------------------------------------------------
                                       Maximum                          
                                    level of use                        
         Category of food            in food (as      Functional use    
                                       served)                          
                                      (percent)                         
------------------------------------------------------------------------
Baked goods and baking mixes, Sec.         0.01   Flavoring agent and   
  170.3(n)(1) of this chapter.                     adjuvant, Sec.       
                                                   170.3(o)(12) of this 
                                                   chapter.             
Alcoholic beverages, Sec.                  0.015  Flavor enhancer, Sec. 
 170.3(n)(2) of this chapter.                      170.3(o)(11) of this 
                                                   chapter; flavoring   
                                                   agent and adjuvant,  
                                                   Sec.  170.3(o)(12) of
                                                   this chapter;        
                                                   processing aid, Sec. 
                                                   170.3(o)(24) of this 
                                                   chapter.             
Nonalcoholic beverages and                 0.005  Flavoring agent and   
 beverage bases, Sec.  170.3(n)(3)                 adjuvant, Sec.       
 of this chapter and for gelatins,                 170.3(o)(12) of this 
 puddings, and fillings, Sec.                      chapter; pH control  
 170.3(n)(22) of this chapter.                     agent, Sec.          
                                                   170.3(o)(23) of this 
                                                   chpater.             
Frozen dairy desserts and mixes,           0.04   Flavoring agent and   
 Sec.  170.3(n)(20) of this                        adjuvant, Sec.       
 chapter and for soft candy, Sec.                  170.3(o)(12) of this 
 170.3(n)(38) of this chapter.                     chapter.             
Hard candy and cough drops, Sec.           0.013      Do.               
 170.3(n)(25) of this chapter.                                          
Meat products, Sec.  170.3(n)(29)          0.001      Do.               
 of this chapter.                                                       
------------------------------------------------------------------------

    (2) Tannic acid may be used in rendered animal fat in accordance 
with 9 CFR 318.7.
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 447]]

this section do not exist or have been waived.

[50 FR 21043, May 22, 1985]



Sec. 184.1099  Tartaric acid.

    (a) Food grade tartaric acid (C4H6O6, CAS Reg. No. 
87-69-4) has the l configuration. The l form of tartaric acid is 
dextrorotatory in solution and is also known as l-(+)-tartaric acid. 
Tartaric acid occurs as colorless or translucent crystals or as a white, 
crystalline powder. It is odorless and has an acid taste. It is obtained 
as a byproduct of wine manufacture.
    (b) The ingredient meets the specifications of the Food Cnemicals 
Codex, 3d Ed. (1981), P. 320, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter; a humectant as defined in 
Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52447, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]



Sec. 184.1101  Diacetyl tartaric acid esters of mono- and diglycerides.

    (a) Diacetyl tartaric acid esters of mono- and diglycerides, also 
know as DATEM, are composed of mixed esters of glycerin in which one or 
more of the hydroxyl groups of glycerin has been esterified by diacetyl 
tartaric acid and by fatty acids. The ingredient is prepared by the 
reaction of diacetyl tartaric anhydride with mono- and diglycerides that 
are derived from edible sources.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies are available from the National 
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20005.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as an emulsifier and emulsifier 
salt as defined in Sec. 170.3(o)(8) of this chapter and a flavoring 
agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods and baking mixes 
as defined in Sec. 170.3(n)(l) of this chapter; nonalcoholic beverages 
as defined in Sec. 170.3(n)(3) of this chapter; confections and 
frostings as defined in Sec. 170.3(n)(9) of this chapter; dairy product 
analogs as defined in Sec. 170.3(n)(10) of this chapter; and fats and 
oils as defined in Sec. 170.3(n)(12) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
    (e) Labeling: The acronym ``DATEM'' may be used on food labeling as 
the alternate common or usual name for the ingredient diacetyl tartaric 
acid esters of mono- and diglycerides.

[54 FR 7403, Feb. 21, 1989, as amended at 54 FR 13168, Mar. 31, 1989; 54 
FR 18382, Apr. 28, 1989; 60 FR 15872, Mar. 28, 1995]

[[Page 448]]



Sec. 184.1115  Agar-agar.

    (a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic, 
colloidal polysaccharide extracted from one of a number of related 
species of red algae (class Rhodophyceae).
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 11, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used in food in accordance with 
Sec. 184.1(b)(2) under the following conditions:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
      Foods (as served)          Percent             Functions          
------------------------------------------------------------------------
Baked goods and baking mixes,         0.8  Drying agent, Sec.           
 Sec.  170.3(n)(1) of this                  170.3(o)(7) of this chapter;
 chapter.                                   flavoring agent, Sec.       
                                            170.3(o)(12) of this        
                                            chapter; stabilizer,        
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Confections and frostings,            2.0  Flavoring agent, Sec.        
 Sec.  170.3(n)(9) of this                  170.3(o)(12) of this        
 chapter.                                   chapter; stabilizer,        
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter; surface finisher,  
                                            Sec.  170.3(o)(30) of this  
                                            chapter.                    
Soft candy, Sec.                      1.2  Stabilizer and thickener,    
 170.3(n)(38) of this chapter.              Sec.  170.3(o)(28) of this  
                                            chapter.                    
All other food categories....         .25  Flavoring agent, Sec.        
                                            170.3(o)(12) of this        
                                            chapter; formulation aid,   
                                            Sec.  170.3(o)(14) of this  
                                            chapter; humectant, Sec.    
                                            170.3(o)(16) of this        
                                            chapter; stabilizer,        
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[44 FR 19391, Apr. 3, 1979, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1120  Brown algae.

    (a) Brown algae are seaweeds of the species Analipus japonicus, 
Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria 
angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica, 
Laminaria longicruris, Laminaria longissima, Laminaria ochotensis, 
Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia, 
Scytosiphon lomentaria and Undaria pinnatifida. They are harvested 
principally in coastal waters of the northern Atlantic and Pacific 
oceans. The material is dried and ground or chopped for use in food.

[[Page 449]]

    (b) The ingredient meets the specifications for kelp in the Food 
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                   Maximum level of                     
        Category of food            use in food (as     Functional use  
                                        served)                         
------------------------------------------------------------------------
Spices, seasonings, and           Not to exceed       Flavor enhancer,  
 flavorings, Sec.  170.3(n) (26)   current good        Sec.  170.3(o)(11
 of this chapter.                  manufacturing       ) of this        
                                   practice.           chapter; flavor  
                                                       adjuvant, Sec.   
                                                       170.3(o)(12) of  
                                                       this chapter.    
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.

[47 FR 47376, Oct. 26, 1982]



Sec. 184.1121  Red algae.

    (a) Red algae are seaweeds of the species Gloiopeltis furcata, 
Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra 
suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and 
Rhodymenia are harvested principally along the coasts of Japan, Korea, 
China, Taiwan, and the East and West coasts of the United States. 
Gloiopeltis is harvested principally in southern Pacific coastal waters. 
The material is dried and ground or chopped for use in food.
    (b) The ingredient meets the specifications for kelp in the Food 
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by 
reference, except that the loss on drying is not more than 20 percent 
and the maximum allowable level for iodine is 0.05 percent. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                   Maximum level of                     
        Category of food            use in food (as     Functional use  
                                        served)                         
------------------------------------------------------------------------
Spices, seasonings, and           Not to exceed       Flavor enhancer,  
 flavorings, Sec.  170.3(n) (26)   current good        Sec.  170.3(o)(11
 of this chapter.                  manufacturing       ) of this        
                                   practice.           chapter; flavor  
                                                       adjuvant, Sec.   
                                                       170.3(o)(12) of  
                                                       this chapter.    
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.

[47 FR 47376, Oct. 26, 1982]



Sec. 184.1133  Ammonium alginate.

    (a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt 
of alginic acid, a natural polyuronide constituent of certain brown 
algae. Ammonium alginate is prepared by the neutralization of purified 
alginic acid with appropriate pH control agents.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 18, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                       Maximum                          
                                       level of                         
                                        use in                          
          Category of food             food (as       Functional use    
                                       served)                          
                                      (percent)                         
------------------------------------------------------------------------
Confections, frostings, Sec.                0.4  Stabilizer, thickener, 
 170.3(n)(9) of this chapter.                     Sec.  170.3(o)(28) of 
                                                  this chapter.         
Fats and oils, Sec.  170.3(n)(12) of        0.5      Do.                
 this chapter.                                                          
Gelatins, puddings, Sec.                    0.5      Do.                
 170.3(n)(22) of this chapter.                                          
Gravies and sauces, Sec.                    0.4      Do.                
 170.3(n)(24) of this chapter.                                          
Jams and jellies, Sec.  170.3(n)(28)        0.4      Do.                
 of this chapter.                                                       
Sweet sauces, Sec.  170.3(n)(43) of         0.5      Do.                
 this chapter.                                                          
All other food categories...........        0.1  Humectant, Sec.        
                                                  170.3(o)(16) of this  
                                                  chapter; stabilizer,  
                                                  thickener, Sec.       
                                                  170.3(o)(28) of this  
                                                  chapter.              
------------------------------------------------------------------------

    (d) Prior sanctions for ammonium alginate different from the uses 
established in this section do not exist or have been waived.

[47 FR 29950, July 9, 1982]



Sec. 184.1135  Ammonium bicarbonate.

    (a) Ammonium bicarbonate (NH4HCO3, CAS Reg. No. 1066-33-7) 
is prepared by reacting gaseous carbon dioxide with aqueous ammonia. 
Crystals of ammonium bicarbonate are precipitated from solution and 
subsequently washed and dried.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon

[[Page 450]]

the following current good manufacturing practice conditions of use:
    (1) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter; a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; and a texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52439, Nov. 18, 1983]



Sec. 184.1137  Ammonium carbonate.

    (a) Ammonium carbonate ((NH4)2CO3, CAS Reg. No. 8000-
73-5) is a mixture of ammonium bicarbonate (NH4HCO3) and 
ammonium carbamate (NH2COONH4). It is prepared by the 
sublimation of a mixture of ammonium sulfate and calcium carbonate and 
occurs as a white powder or a hard, white or translucent mass.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter and a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52439, Nov. 18, 1983]



Sec. 184.1138  Ammonium chloride.

    (a) Ammonium chloride (NH4C1, CAS Reg. No. 12125-02-9) is 
produced by the reaction of sodium chloride and an ammonium salt in 
solution. The less soluble sodium salt separates out at elevated 
temperatures, and ammonium chloride is recovered from the filtrate on 
cooling. Alternatively, hydrogen chloride formed by the burning of 
hydrogen in chlorine is dissolved in water and then reacted with gaseous 
ammonia. Ammonium chloride is crystallized from the solution.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave, 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter; a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; and a processing aid as defined in 
Sec. 107.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52439, Nov. 18, 1983]



Sec. 184.1139  Ammonium hydroxide.

    (a) Ammonium hydroxide (NH4OH, CAS Reg. No. 1336-21-6) is 
produced by passing ammonia gas into water.

[[Page 451]]

    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; a surface-finishing agent as defined 
in Sec. 170.3(o)(30) of this chapter; and as a boiler water additive 
complying with Sec. 173.310 of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. The ingredient may also be used as a boiler 
water additive at levels not to exceed current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994]



Sec. 184.1140  Ammonium citrate, dibasic.

    (a) Ammonium citrate, dibasic ((NH4)2HC6H 
5O7, CAS Reg. No. 3012-65-5) is the diammonium salt of citric 
acid. It is prepared by partially neutralizing citric acid with ammonia.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for ammonium citrate, dibasic. In the interim, this ingredient must be 
of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter and as a pH control agent as defined 
in Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter and in cheeses as defined in 
Sec. 170.3(n)(5) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]



Sec. 184.1141a  Ammonium phosphate, monobasic.

    (a) Ammonium phosphate, monobasic (NH4H2PO4, CAS Reg. 
No. 7722-76-1) is manufactured by reacting ammonia with phosphoric acid 
at a pH below 5.8.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter and a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 452]]

this section do not exist or have been waived.

[48 FR 52440, Nov. 18, 1983]



Sec. 184.1141b  Ammonium phosphate, dibasic.

    (a) Ammonium phosphate, dibasic ((NH4)2HPO4, CAS Reg. 
No. 7783-28-0) is manufactured by reacting ammonia with phosphoric acid 
at a pH above 5.8.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:

[[Page 453]]

    (1) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter; a firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52440, Nov. 18, 1983]



Sec. 184.1143  Ammonium sulfate.

    (a) Ammonium sulfate ((NH4)2SO4, CAS Reg. No. 7783-
20-2) occurs naturally and consists of colorless or white, odorless 
crystals or granules. It is prepared by the neutralization of sulfuric 
acid with ammonium hydroxide.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 22-23, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter, firming agent as defined in 
Sec. 170.3(o)(10) of this chapter, and processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.15 
percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter 
and 0.1 percent for gelatins and puddings as defined in 
Sec. 170.1(n)(22) of this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, 1980, as amended at 49 
FR 5611, Feb. 14, 1984]



Sec. 184.1155  Bentonite.

    (a) Bentonite (Al2O34SiO2nH2O, CAS Reg. No. 
1302-78-9) is principally a colloidal hydrated aluminum silicate. 
Bentonite contains varying quantities of iron, alkalies, and alkaline 
earths in the commercial products. Depending on the cations present, 
natural deposits of bentonite range in color from white to gray, yellow, 
green, or blue. Bentonite's fine particles provide large total surface 
area and, hence, pronounced adsorptive capability.
    (b) FDA is developing food-grade specifications for bentonite in 
cooperation with the National Academy of Sciences. In the interim, the 
ingredient must be of a suitable purity for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice results 
in no significant residue in foods.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 43367, Oct. 1, 1982]



Sec. 184.1157  Benzoyl peroxide.

    (a) Benzoyl peroxide ((C6H5CO)2O2, CAS Reg. No. 
94-36-0) is a colorless, rhombic crystalline solid. It is prepared by 
reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a bleaching agent in food.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: flour; milk used for 
production of Asiago fresh and Asiago soft cheese (Sec. 133.102), Asiago 
medium cheese (Sec. 133.103), Asiago old cheese (Sec. 133.104), Blue 
cheese (Sec. 133.106), Caciocavallo siciliano chesse (Sec. 133.111), 
Gorgonzola cheese (Sec. 133.141), Parmesan and reggiano cheese 
(Sec. 133.165), Provolone cheese (Sec. 133.181), Romano cheese 
(Sec. 133.183), and Swiss and emmentaler cheese (Sec. 133.195) in part 
133 of this chapter; and annatto-colored whey, such that the final 
bleached product conforms to the descriptions and specifications for 
whey, concentrated whey, or dried whey in Sec. 184.1979(a) (1), (2), or 
(3), respectively.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[51 FR 27173, July 30, 1986]



Sec. 184.1165  n-Butane and iso-butane.

    (a) n-Butane and iso-butane (empirical formula C4H10, CAS 
Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, odorless, 
flammable gases at normal temperatures and pressures. They are easily 
liquefied under pressure at room temperature and are stored and shipped 
in the liquid state. The butanes are obtained from natural gas by 
fractionation following absorption in oil, adsorption to surface-active 
agents, or refrigeration.
    (b) The Food and Drug Administration is developing food-grade 
specifications for n-butane and iso-butane in cooperation with the 
National Academy of Sciences. In the interim, the ingredients must be of 
a purity suitable for their intended use.
    (c) In accordance with Sec. 184.1(b)(1), these ingredients are used 
in food with no limitations other than current good manufacturing 
practice. The affirmation of these ingredients as generally recognized 
as safe (GRAS) as direct human food ingredients is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredients are used as propellants, aerating agents, and 
gases as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredients are used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]



Sec. 184.1185  Calcium acetate.

    (a) Calcium acetate (Ca (C2 H3 O2)2, CAS Reg. 
No. 62-54-4), also known as acetate of lime or vinegar salts, is the 
calcium salt of acetic acid. It may be produced by the calcium hydroxide 
neutralization of acetic acid.

[[Page 454]]

    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 44, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The ingredient is used as a firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter; stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter; and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in food at levels not to exceed current 
good manufacturing practices in accordance with Sec. 184.1(b)(1). 
Current good manufacturing practices result in a maximum level, as 
served, of 0.2 percent for baked goods as defined in Sec. 170.3(n)(1) of 
this chapter; 0.02 percent for cheese as defined in Sec. 170.3(n)(5) of 
this chapter; 0.2 percent for gelatins, puddings, and fillings as 
defined in Sec. 170.3(n)(22) of this chapter; 0.15 percent for sweet 
sauces, toppings, and syrups as defined in Sec. 170.3(n)(43) of this 
chapter; and 0.0001 percent for all other food categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section or in part 181 of this chapter do not exist 
or have been waived.

[47 FR 27807, June 25, 1982]



Sec. 184.1187  Calcium alginate.

    (a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of 
alginic acid, a natural polyuronide constituent of certain brown algae. 
Calcium alginate is prepared by the neutralization of purified alginic 
acid with appropriate pH control agents, or from sodium alginate by 
metathesis with appropriate calcium salts.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 45, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                       Maximum                          
                                       level of                         
                                        use in                          
          Category of food             food (as       Functional use    
                                       served)                          
                                      (percent)                         
------------------------------------------------------------------------
Baked goods, Sec.  170.3(n)(1) of         0.002  Stabilizer, thickener, 
 this chapter.                                    Sec.  170.3(o)(28) of 
                                                  this chapter.         
Alcoholic beverages, Sec.                   0.4      Do.                
 170.3(n)(2) of this chapter.                                           
Confections and frostings, Sec.             0.4      Do.                
 170.3(n)(9) of this chapter.                                           
Egg products, Sec.  170.3(n)(11) of         0.6      Do.                
 this chapter.                                                          
Fats and oils, Sec.  170.3(n)(12) of        0.5      Do.                
 this chapter.                                                          
Gelatins, puddings, Sec.                   0.25      Do.                
 170.3(n)(22) of this chapter.                                          
Gravies and sauces, Sec.                    0.4      Do.                
 170.3(n)(24) of this chapter.                                          
Jams and jellies, Sec.  170.3(n)(28)        0.5      Do.                
 of this chapter.                                                       
Sweet sauces, Sec.  170.3(n)(43) of         0.5      Do.                
 this chapter.                                                          
All other food categories...........        0.3      Do.                
------------------------------------------------------------------------

    (d) Prior sanctions for calcium alginate different from the uses 
established in this section do not exist or have been waived.

[47 FR 29951, July 9, 1982]



Sec. 184.1191  Calcium carbonate.

    (a) Calcium carbonate (CaCO3, CAS Reg. No. 471-34-1) is 
prepared by three common methods of manufacture:
    (1) As a byproduct in the ``Lime soda process'';
    (2) By precipitation of calcium carbonate from calcium hydroxide in 
the ``Carbonation process''; or
    (3) By precipitation of calcium carbonate from calcium chloride in 
the ``Calcium chloride process''.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex,

[[Page 455]]

3d Ed. (1981), p. 46, which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from that set forth in part 
181 of this chapter, do not exist or have been waived.

[48 FR 52441, Nov. 18, 1983]



Sec. 184.1193  Calcium chloride.

    (a) Calcium chloride (CaCl22H2O, CAS Reg. No. 
10035-04-8) or anhydrous calcium chloride (CaCl2, CAS Reg. No. 
10043-52-4) may be commercially obtained as a byproduct in the ammonia-
soda (Solvay) process and as a joint product from natural salt brines, 
or it may be prepared by substitution reactions with other calcium and 
chloride salts.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 47, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The ingredient is used as an anticaking agent as defined in 
Sec. 170.3(o)(1) of this chapter; antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter; curing or pickling agent as defined in 
Sec. 170.3(o)(5) of this chapter; firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; humectant as defined in 
Sec. 170.3(o)(16) of this chapter; nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter; pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in 
Sec. 170.3(o)(29) of this chapter; synergist as defined in 
Sec. 170.3(o)(31) of this chapter; and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in foods at levels not to exceed current 
good manufacturing practices in accordance with Sec. 184.1(b)(1). 
Current good manufacturing practices result in a maximum level, as 
served, of 0.3 percent for baked goods as defined in Sec. 170.3(n)(1) of 
this chapter and for dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter; 0.22 percent for nonalcoholic 
beverages and beverage bases as defined in Sec. 170.3(n)(3) of this 
chapter; 0.2 percent for cheese as defined in Sec. 170.3(n)(5) of this 
chapter and for processed fruit and fruit juices as defined in 
Sec. 170.3(n)(35) of this chapter; 0.32 percent for coffee and tea as 
defined in Sec. 170.3(n)(7) of this chapter; 0.4 percent for condiments 
and relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.2 percent 
for gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter; 
0.1 percent for commercial jams and jellies as defined in 
Sec. 170.3(n)(28) of this chapter; 0.25 percent for meat products as 
defined in Sec. 170.3(n)(29) of this chapter; 2.0 percent for plant 
protein products as defined in Sec. 170.3(n)(33) of this chapter; 0.4 
percent for processed vegetables and vegetable juices as defined in 
Sec. 170.3(n)(36) of this chapter; and 0.05 percent for all other food 
categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27808, June 25, 1982, as amended at 61 FR 14247, Apr. 1, 1996]



Sec. 184.1195  Calcium citrate.

    (a) Calcium citrate (Ca3(C6H5O7) 
2.4H2O, CAS Reg. No. 813-94-5) is the calcium salt of 
citric acid. It is prepared by neutralizing citric acid with calcium 
hydroxide or calcium carbonate. It occurs as a fine white, odorless 
powder and usually contains four moles of water per mole of calcium 
citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, 2101 Constitution Ave.

[[Page 456]]

NW., Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or may be 
examined at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
Calcium citrate may also be used in infant formula in accordance with 
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or 
with regulations promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]



Sec. 184.1199  Calcium gluconate.

    (a) Calcium gluconate ([CH2OH(CHOH)4COO]2Ca, CAS Reg. 
No. 299-28-5) is the calcium salt of gluconic acid which may be produced 
by neutralization of gluconic acid with lime or calcium carbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 51, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The ingredient is used as a firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter; stabilizer or thickener as defined in 
Sec. 170.3(o)(28) of this chapter; and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in foods at levels not to exceed current 
good manufacturing practices in accordance with Sec. 184.1(b)(1). 
Current good manufacturing practices result in a maximum level, as 
served, of 1.75 percent for baked goods as defined in Sec. 170.3(n)(1) 
of this chapter; 0.4 percent for dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter; 4.5 percent for gelatins and puddings 
as defined in Sec. 170.3(n)(22) of this chapter; and 0.01 percent for 
sugar substitutes as defined in Sec. 170.3(n)(42) of this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27808, June 25, 1982]



Sec. 184.1201  Calcium glycerophosphate.

    (a) Calcium glycerophosphate (C3H7CaO6P, CAS Reg. No. 
27214-00-2) is a fine, white, odorless, almost tasteless, slightly 
hygroscopic powder. It is prepared by neutralizing glycerophosphoric 
acid with calcium hydroxide or calcium carbonate. The commercial product 
is a mixture of calcium -, and D-, and L--
glycerophosphate.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 51-52, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in gelatins, puddings, and fillings as 
defined in Sec. 170.3(n)(22) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section or different from that as set forth in part 
181 of this chapter, do not exist or have been waived.

[57 FR 10813, Mar. 31, 1992]



Sec. 184.1205  Calcium hydroxide.

    (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305-62-0) is also 
known as slaked lime or calcium hydrate. It is produced by the hydration 
of lime.

[[Page 457]]

    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 52, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 26714, June 29, 1984]



Sec. 184.1206  Calcium iodate.

    (a) Calcium iodate [Ca(IO3)2H2O, CAS Reg. 
No. 7789-80-2], also referred to as lautarite, does not occur naturally 
but can be prepared by passing chlorine into a hot solution of lime 
(CaCO3) in which iodine has been dissolved.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 53, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter.
    (d) The ingredient is used in the manufacture of bread in accordance 
with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 
percent based on the weight of the flour.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 1984]



Sec. 184.1207  Calcium lactate.

    (a) Calcium lactate (C6H10CaO6.xH2O, where x is 
any integer up to 5, CAS Reg. No. 814-80-2) is prepared commercially by 
the neutralization of lactic acid with calcium carbonate or calcium 
hydroxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 53, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Avenue 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a firming agent as defined in 
Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; a leavening agent as 
defined in Sec. 170.3(o)(17) of this chapter; a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter; and a stabilizer and 
thickener as defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredient is used in food, except in infant foods and 
infant formulas, at levels not to exceed current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 35367, Sept. 7, 1984]



Sec. 184.1210  Calcium oxide.

    (a) Calcium oxide (CaO, CAS Reg. No. 1305-78-8) is also known as 
lime, quick lime, burnt lime, or calx. It is produced from calcium 
carbonate, limestone, or oyster shells by calcination at temperatures of 
1,700-2,450  deg.F.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 55, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[[Page 458]]

    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 26714, June 29, 1984]



Sec. 184.1212  Calcium pantothenate.

    (a) Calcium pantothenate ((C9H16NO5)2Ca, CAS 
Reg. No. of the D-isomer, 137-08-6) is a salt of pantothenic acid, one 
of the vitamins of the B complex. Only the D-isomer of pantothenic acid 
has vitamin activity, although both the D-isomer and the DL-racemic 
mixture of calcium pantothenate are used in food. Commercial calcium 
pantothenate is prepared synthetically from isobutyraldehyde and 
formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and 
pantolactone.
    (b) Calcium pantothenate meets the specifications of the Food 
Chemicals Codex, 3d Ed. (1981), p. 56, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. Calcium pantothenate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51908, Nov. 15, 1983]



Sec. 184.1221  Calcium propionate.

    (a) Calcium propionate (C6H10CaO4, CAS Reg. No. 4075-
81-4) is the calcium salt of propionic acid. It occurs as white crystals 
or a crystalline solid, possessing not more than a faint odor of 
propionic acid. It is prepared by neutralizing propionic acid with 
calcium hydroxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 60, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; cheeses as defined in Sec. 170.3(n)(5) 
of this chapter; confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as 
defined in Sec. 170.3(n)(22) of this chapter; and jams and jellies as 
defined in Sec. 170.3(n)(28) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 13141, Apr. 3, 1984]



Sec. 184.1229  Calcium stearate.

    (a) Calcium stearate (Ca(C17H35COO)2, CAS Reg. No. 
1529-23-0) is the calcium salt of stearic acid derived from edible 
sources. It is prepared as a white precipitate by mixing calcium 
chloride

[[Page 459]]

and sodium stearate in aqueous solution.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 64, which is incorporated by reference, and the 
requirements of Sec. 172.860(b)(2) of this chapter. Copies of the Food 
Chemicals Codex are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; a lubricant and release 
agent as defined in Sec. 170.3(o)(18) of this chapter; and a stabilizer 
and thickener as defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52445, Nov. 18, 1983]



Sec. 184.1230  Calcium sulfate.

    (a) Calcium sulfate (CaSO4, CAS Reg. No. 7778-18-9 or 
CaSO42H2O, CAS Reg. No. 10101-41-4), also known as 
plaster of Paris, anhydrite, and gypsum, occurs naturally and exists as 
a fine, white to slightly yellow-white odorless powder. The anhydrous 
form is prepared by complete dehydration of gypsum, below 300 deg. C, in 
an electric oven.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 66, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an anticaking agent as defined in 
Sec. 170.3(o)(1) of this chapter, color and coloring adjunct as defined 
in Sec. 170.3(o)(4) of this chapter, dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter, drying agent as defined in 
Sec. 170.3(o)(7) of this chapter, firming agent as defined in 
Sec. 170.3(o)(10) of this chapter, flour treating agent as defined in 
Sec. 170.3(o)(13) of this chapter, formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter, leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter, nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter, pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter, processing aid as defined in 
Sec. 170.3(o)(24) of this chapter, stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter, synergist as defined in 
Sec. 170.3(o)(31) of this chapter, and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 1.3 
percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter, 
3.0 percent for confections and frostings as defined in Sec. 170.3(n)(9) 
of this chapter, 0.5 percent for frozen dairy desserts and mixes as 
defined in Sec. 170.3(n)(20) of this chapter, 0.4 percent for gelatins 
and puddings as defined in Sec. 170.3(n)(22) of this chapter, 0.5 
percent for grain products and pastas as defined in Sec. 170.3(n)(23) of 
this chapter, 0.35 percent for processed vegetables as defined in 
Sec. 170.3(n)(36) of this chapter, and 0.07 percent or less for all 
other food categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, 1980, as amended at 49 
FR 5611, Feb. 14, 1984]



Sec. 184.1240  Carbon dioxide.

    (a) Carbon dioxide (empirical formula CO2,!CAS Reg. No. 124-38-
9) occurs as a colorless, odorless, noncombustible gas at normal 
temperatures and pressures. The solid form, dry ice, sublimes under 
atmospheric pressure at a temperature of -78.5 deg. C. Carbon dioxide is 
prepared

[[Page 460]]

as a byproduct of the manufacture of lime during the ``burning'' of 
limestone, from the combustion of carbonaceous material, from 
fermentation processes, and from gases found in certain natural springs 
and wells.
    (b) The Food and Drug Administration is developing food-grade 
specifications for carbon dioxide in cooperation with the National 
Academy of Sciences. In the interim, the ingredient must be of purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; and a propellant, aerating agent, and 
gas as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]



Sec. 184.1245  Beta-carotene.

    (a) Beta-carotene (CAS Reg. No. 7235-40-7) has the molecular formula 
C40H56. It is synthesized by saponification of vitamin A 
acetate. The resulting alcohol is either reacted to form vitamin A 
Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A Wittig 
reagent and vitamin A aldehyde are reacted together to form beta-
carotene.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washingtion, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: dairy product analogs as 
defined in Sec. 170.3(n)(10) of this chapter; fats and oils as defined 
in Sec. 170.3(n)(12) of this chapter; and processed fruits and fruit 
juices as defined in Sec. 170.3(n)(35) of this chapter. Beta-carotene 
may be used in infant formula as a source of vitamin A in accordance 
with section 412(g) of the Federal Food, Drug, and Cosmetic Act or with 
regulations promulgated under section 412(g) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[52 FR 25211, July 6, 1987]



Sec. 184.1257  Clove and its derivatives.

    (a) Cloves are the dried unopened flower buds and calyx tubes, 
harvested before the flowers have opened, of the clove tree Eugenia 
caryophyllata Thunberg, native to tropical Asia. Their derivatives 
include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves, 
CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol, CAS 
Reg. No. 97-53-0), oleoresins, and natural extractives obtained from 
clove buds, leaves, and stems.
    (b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet 
the specifications of the ``Food Chemicals Codex,'' (FCC), 3d Ed. 
(1981), pp. 87-89, which is incorporated by reference. Copies may be 
obtained from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408. As determined by analytical methods in FCC, clove oleorsin or 
other natural extractives (other than

[[Page 461]]

clove oils) meet FCC specifications for clove (clove bud) oil and the 
following modifications:
    (1) The assay for phenols, as eugenol, by the FCC test, 3d Ed. (pp. 
87-88), or the volatile oils content by the FCC test, 3d Ed. (pp. 87-88) 
should conform to the representation of the vendor;
    (2) Optical rotation of the volatile oil between -2 deg. and 0 deg.;
    (3) Refractive index of the volatile oil between 1.527 and 1.538 at 
20 deg. C;
    (4) Specific gravity of the volatile oil between 1.036 and 1.060; 
and
    (5) Residual solvent free, except those solvents that are GRAS or 
within tolerance levels as specified in part 173, Subpart C, of this 
chapter.
    (c) Clove and its derivatives are used as flavoring agents and 
adjuvants as defined in Sec. 170.3(0)(12) of this chapter.
    (d) The ingredients are used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1).
    (e) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[44 FR 3964, Jan 19, 1979, as amended at 47 FR 11852, Mar. 19, 1982; 49 
FR 5611, Feb. 14, 1984]



Sec. 184.1259  Cocoa butter substitute primarily from palm oil.

    (a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is ``cocoa butter substitute primarily from palm oil.'' 
The ingredient is manufactured by--
    (1) Directed esterification of fully saturated 1,3-diglycerides 
(derived from palm oil) with the anhydride of food-grade oleic acid in 
the presence of the catalyst trifluoromethane sulfonic acid 
(Sec. 173.395 of this chapter), or
    (2) By interesterification of partially saturated 1,2,3-
triglycerides (derived from palm oil) with ethyl stearate in the 
presence of a suitable lipase enzyme preparation that is either GRAS or 
has food additive approval for such use.
    (b) The ingredient meets the following specifications:
    (1) Over 90 percent triglycerides, not more than 7 percent 
diglycerides, not more than 1 percent monoglycerides, and not more than 
1 percent free fatty acids.
    (2) Total glycerides--98 percent minimum.
    (3) Heavy metals (as lead), 10 parts per million maximum (``Food 
Chemicals Codex,'' 3d Ed. (1981), pp. 512-513, which is incorporated by 
reference, copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408).
    (4) Color--clear, bright, and free from suspended matter.
    (5) Odor and taste--free from foreign and rancid odor and taste.
    (6) Residual catalyst (``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), sections 
25.049-25.055, which is incorporated by reference), residual fluorine; 
limit of detection 0.2 part per million F; multiply fluoride result by 
2.63 to convert to residual catalyst. Copies of the material 
incorporated by reference may be obtained from the Association of 
Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, 
Washington, DC 20044, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408. The ingredient shall be washed three times in batches with 0.5 
percent sodium bicarbonate to remove catalyst residuals in accordance 
with good manufacturing practice.
    (7) Residual methanol--5 parts per million maximum.
    (8) Residual fatty acid ethyl esters--not more than 20 parts per 
million as determined by a ``Modification of Japan Institute of Oils and 
Fats: Analysis Method of Residual Ethyl Esters of Fatty Acids'' issued 
by the Fuji Oil Co., which is incorporated by reference. Copies are 
available from the Division of Food and Color Additives, Center for Food 
Safety and Applied Nutrition (HFF-330), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (9) Hexane--not more than 5 parts per million as determined by the 
method of

[[Page 462]]

Dupuy et al., ``Rapid Quantitative Determination of Residual Hexane in 
Oils by Direct Gas Chromatography,'' published in the ``Journal of the 
American Oil Chemists' Society,'' Vol. 52, p. 118-120, 1975, which is 
incorporated by reference. Copies are available from the Division of 
Food and Color Additives, Center for Food Safety and Applied Nutrition 
(HFF-330), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
the following food categories at levels not to exceed current good 
manufacturing practice: Confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter; coatings of soft candy as defined in 
Sec. 170.3(n)(38) of this chapter; and sweet sauces and toppings as 
defined in Sec. 170.3(n)(43) of this chapter; except that the ingredient 
may not be used in a standardized food unless permitted by the standard 
of identity.
    (d) The ingredient is used in food in accordance with 
Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice.

[43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19, 1982; 
49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Dec. 
17, 1987; 52 FR 48905, Dec. 28, 1987]



Sec. 184.1260  Copper gluconate.

    (a) Copper gluconate (cupric gluconate 
(CH2OH(CHOH)4COO)2Cu, CAS Reg. No. 527-09-3) is a 
substance that occurs as light blue to bluish-green, odorless crystals, 
or as a fine, light blue powder. It is prepared by the reaction of 
gluconic acid solutions with cupric oxide or basic cupric carbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 90, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC. 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC. 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter and as a synergist as defined in 
Sec. 170.3(o)(31) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Copper gluconate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 24119, June 12, 1984]



Sec. 184.1261  Copper sulfate.

    (a) Copper sulfate (cupric sulfate, CuSO45H2O, CAS 
Reg. No. 7758-98-7) usually is used in the pentahydrate form. This form 
occurs as large, deep blue or ultramarine, triclinic crystals; as blue 
granules, or as a light blue powder. The ingredient is prepared by the 
reaction of sulfuric acid with cupric oxide or with copper metal.
    (b) FDA is developing food-grade specifications for copper sulfate 
in cooperation with the National Academy of Sciences. In the interim, 
this ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter and as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Copper sulfate

[[Page 463]]

may be used in infant formula in accordance with section 412(g) of the 
Federal Food, Drug, and Cosmetic Act (the Act) or with regulations 
promulgated under section 412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 24119, June 12, 1984]



Sec. 184.1262  Corn silk and corn silk extract.

    (a) Corn silk is the fresh styles and stigmas of Zea mays L. 
collected when the corn is in milk. The filaments are extracted with 
dilute ethanol to produce corn silk extract. The extract may be 
concentrated at a temperature not exceeding 60 deg.C.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for corn silk and corn silk extract. In the interim, this ingredient 
must be of a suitable purity for its intended use.
    (c) In accordance with Sec. 184.1(b)(2), the ingredients are used in 
food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                        Maximum                         
                                       level of                         
          Category of food              use in        Functional use    
                                       food (as                         
                                      served)\1\                        
------------------------------------------------------------------------
Baked goods and baking mixes, Sec.            30  Flavoring agent, Sec. 
 170.3(n)(1) of this chapter.                      170.3(o)(12) of this 
                                                   chapter.             
Nonalcoholic beverages, Sec.                  20    Do.                 
 170.3(n)(3) of this chapter.                                           
Frozen dairy desserts, Sec.                   10    Do.                 
 170.3(n)(20) of this chapter.                                          
Soft candy, Sec.  170.3(n)(38) of             20    Do.                 
 this chapter.                                                          
All other food categories...........           4    Do.                 
------------------------------------------------------------------------
\1\ Parts per million.                                                  

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 29953, July 9, 1982]



Sec. 184.1265  Cuprous iodide.

    (a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681-65-4) 
is a pure white crystalline powder. It is prepared by the reaction of 
copper sulfate with potassium iodide under slightly acidic conditions.
    (b) FDA is developing food-grade specifications for cuprous iodide 
in cooperation with the National Academy of Sciences. In the interim, 
this ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

------------------------------------------------------------------------
                                   Maximum treatment                    
        Category of food             level in food      Functional use  
------------------------------------------------------------------------
Table salt......................  0.01 percent......  Source of dietary 
                                                       iodine.          
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 24119, June 12, 1984]



Sec. 184.1271   L-Cysteine.

    (a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid 
(C3H7O2NS).
    (b) The ingredient meets the appropriate part of the specification 
set forth in the ``Food Chemicals Codex,'' 3d Ed. (1981), pp. 92-93, 
which is incorporated by reference. Copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (c) The ingredient is used to supply up to 0.009 part of total L-
cysteine per 100 parts of flour in dough as a dough strengthener as 
defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked 
goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter.
    (d) This regulation is issued prior to a general evaluation of use 
of this ingredient in order to affirm as GRAS the specific use named.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]

[[Page 464]]



Sec. 184.1272   L-Cysteine monohydrochloride.

    (a) L-Cysteine monohydrochloride is the chemical L-2-amino-3-
mercaptopropanoic acid monohydrochloride monohydrate 
(C3H7O2NS HCl H2O).
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 92-93, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used to supply up to 0.009 part of total L-
cysteine per 100 parts of flour in dough as a dough strengthener as 
defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked 
goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter.
    (d) This regulation is issued prior to a general evaluation of use 
of this ingredient in order to affirm as GRAS the specific use named.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]



Sec. 184.1277  Dextrin.

    (a) Dextrin 
((C6H10O5)n2O, CAS Reg. No. 
9004-53-9) is an incompletely hydrolyzed starch. It is prepared by dry 
heating corn, waxy maize, waxy milo, potato, arrowroot, wheat, rice, 
tapioca, or sago starches, or by dry heating the starches after: (1) 
Treatment with safe and suitable alkalis, acids, or pH control agents 
and (2) drying the acid or alkali treated starch.
    (b) The ingredient meets the specification of the Food Chemicals 
Codex, 3d Ed. (1981), p. 96, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; as a stabilizer and thickener as 
defined in Sec. 170.3(o)(28) of this chapter; and as a surface-finishing 
agent as defined in Sec. 170.3(o)(30) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51909, Nov. 15, 1983]



Sec. 184.1278  Diacetyl.

    (a) Diacetyl (C4H6O2, CAS Reg. No. 431-03-8) is a 
clear yellow to yellowish green liquid with a strong pungent odor. It is 
also known as 2,3-butanedione and is chemically synthesized from methyl 
ethyl ketone. It is miscible in water, glycerin, alcohol, and ether, and 
in very dilute water solution, it has a typical buttery odor and flavor.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 368, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 465]]

this section do not exist or have been waived.

[48 FR 51907, Nov. 15, 1983]



Sec. 184.1282   Dill and its derivatives.

    (a) Dill (American or European) is the herb and seeds from Anethum 
graveolens L., and dill (Indian) is the herb and seeds from Anethum 
sowa, D.C. Its derivatives include essential oils, oleoresins, and 
natural extractives obtained from these sources of dill.
    (b) Dill oils meet the description and specifications of the ``Food 
Chemicals Codex,'' 3d Ed. (1981), pp. 100-102, which is incorporated by 
reference. Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) Dill and its derivatives are used as flavoring agents and 
adjuvants as defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredients are used in food at levels not to exceed good 
manufacturing practice.
    (e) [Reserved]
    (f) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1287  Enzyme-modified fats.

    (a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and 
enzyme-modified steam-rendered chicken fat are prepared from refined 
beef fat; butterfat or milkfat; and steam-rendered chicken fat, 
respectively, with enzymes that are generally recognized as safe (GRAS). 
Enzyme-modified milk powder may be prepared with GRAS enzymes from 
reconstituted milk powder, whole milk, condensed or concentrated whole 
milk, evaporated milk, or milk powder. The lipolysis is maintained at a 
temperature that is optimal for the action of the enzyme until 
appropriate acid development is attained. The enzymes are then 
inactivated. The resulting product is concentrated or dried.
    (b) FDA is developing food-grade specifications for these enzyme-
modified ingredients in cooperation with the National Academy of 
Sciences. In the interim, the ingredients must be of purity suitable for 
their intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of these ingredients as generally recognized as safe 
(GRAS) as direct human food ingredients is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredients are used as flavoring agents and adjuvants as 
defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredients are used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[52 FR 25976, July 10, 1987]



Sec. 184.1293   Ethyl alcohol.

    (a) Ethyl alcohol (ethanol) is the chemical C2H5OH.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 112-113, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter on pizza crusts prior to final baking 
at levels not to exceed 2.0 percent by product weight.
    (d) This regulation is issued prior to general evaluation of use of 
this ingredient in order to affirm as GRAS the specific use named.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]



Sec. 184.1295  Ethyl formate.

    (a) Ethyl formate (C3H6O2, CAS Reg. No. 109-94-4) is 
also referred to as ethyl methanoate. It is an ester of formic acid and 
is prepared by esterification

[[Page 466]]

of formic acid with ethyl alcohol or by distillation of ethyl acetate 
and formic acid in the presence of concentrated sulfuric acid. Ethyl 
formate occurs naturally in some plant oils, fruits, and juices but does 
not occur naturally in the animal kingdom.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 376, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.05 
percent in baked goods as defined in Sec. 170.3(n)(1) of this chapter; 
0.04 percent in chewing gum as defined in Sec. 170.3(n)(6), hard candy 
as defined in Sec. 170.3(n)(25), and soft candy as defined in 
Sec. 170.3(n)(38) of this chapter; 0.02 percent in frozen dairy desserts 
as defined in Sec. 170.3(n)(20) of this chapter; 0.03 percent in 
gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this 
chapter; and 0.01 percent in all other food categories.
    (e) Prior sanctions for ethyl formate different from the uses 
established in this section do not exist or have been waived.

[45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984]



Sec. 184.1296  Ferric ammonium citrate.

    (a) Ferric ammonium citrate (iron (III) ammonium citrate) is 
prepared by the reaction of ferric hydroxide with citric acid, followed 
by treatment with ammonium hydroxide, evaporating, and drying. The 
resulting product occurs in two forms depending on the stoichiometry of 
the initial reactants.
    (1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. 
No. 1332-98-5) is a complex salt of undetermined structure composed of 
16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65 
percent citric acid and occurs as reddish brown or garnet red scales or 
granules or as a brownish-yellowish powder.
    (2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. 
No. 1333-00-2) is a complex salt of undetermined structure composed of 
14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75 
percent citric acid and occurs as thin transparent green scales, as 
granules, as a powder, or as transparent green crystals.
    (b) The ingredients meet the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and 
p. 117 (Ferric ammonium citrate, green), which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in 
food as nutrient supplements as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredients may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[53 FR 16864, May 12, 1988]



Sec. 184.1297  Ferric chloride.

    (a) Ferric chloride (iron (III) chloride, FeC13, CAS Reg. No. 
7705-08-0) may be prepared from iron and chlorine or from ferric oxide 
and hydrogen chloride. The pure material occurs as hydroscopic, 
hexagonal, dark crystals. Ferric chloride hexahydrate (iron (III) 
chloride hexahydrate, FeC13. 6H20, CAS Reg. No. 10025-77-1) is 
readily formed when ferric chloride is exposed to moisture.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferric chloride in cooperation with the National 
Academy of

[[Page 467]]

Sciences. In the interim, this ingredient must be of a purity suitable 
for its intended use.
    (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in 
food as a flavoring agent as defined in Sec. 170.3(o)(12) of this 
chapter, with no limitation other than current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16864, May 12, 1988]



Sec. 184.1298  Ferric citrate.

    (a) Ferric citrate (iron (III) citrate, C6H5FeO7, CAS 
Reg. No. 2338-05-8) is prepared from reaction of citric acid with ferric 
hydroxide. It is a compound of indefinite ratio of citric acid and iron.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferric citrate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]



Sec. 184.1301  Ferric phosphate.

    (a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, 
FePO4xH2O, CAS Reg. No. 10045-86-0) is an odorless, 
yellowish-white to buff-colored powder and contains from one to four 
molecules of water of hydration. It is prepared by reaction of sodium 
phosphate with ferric chloride or ferric citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 118-120, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Ave. NW., Washington, DC 20418, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]



Sec. 184.1304  Ferric pyrophosphate.

    (a) Ferric pyrophosphate (iron (III) pyrophosphate, 
Fe4(P207)3xH2O, CAS Reg. No. 10058-44-3) is 
a tan or yellowish white colorless powder. It is prepared by reacting 
sodium pyrophosphate with ferric citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 120, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 468]]

this section do not exist or have been waived.

[53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988]



Sec. 184.1307  Ferric sulfate.

    (a) Ferric sulfate (iron (III) sulfate, Fe2(SO4)3, 
CAS Reg. No. 10028-22-5) is a yellow substance that may be prepared by 
oxidizing iron (II) sulfate or by treating ferric oxide or ferric 
hydroxide with sulfuric acid.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferric sulfate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a flavoring agent as defined in Sec. 170.3(o)(12) of this 
chapter, with no limitation other than current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]



Sec. 184.1307a  Ferrous ascorbate.

    (a) Ferrous ascorbate (CAS Reg. No. 14536-17-5) is a reaction 
product of ferrous hydroxide and ascorbic acid. It is a blue-violet 
product containing 16 percent iron.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferrous ascorbate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]



Sec. 184.1307b  Ferrous carbonate.

    (a) Ferrous carbonate (iron (II) carbonate, FeCO3, CAS Reg. No. 
563-71-3) is an odorless, white solid prepared by treating solutions of 
iron (II) salts with alkali carbonate salts.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferrous carbonate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Foods, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16865, May 12, 1988]



Sec. 184.1307c  Ferrous citrate.

    (a) Ferrous citrate (iron (II) citrate, (C6H6FeO7), 
CAS Reg. No. 23383-11-1) is a slightly colored powder or white crystals. 
It is prepared from the reaction of sodium citrate with ferrous sulfate 
or by direct action of citric acid on iron filings.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferrous citrate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food,

[[Page 469]]

Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations 
promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16866, May 12, 1988]



Sec. 184.1307d  Ferrous fumarate.

    (a) Ferrous fumarate (iron (II) fumarate, (C4H2FeO4), 
CAS Reg. No. 141-01-5) is an odorless, reddish-orange to reddish-brown 
powder. It may contain soft lumps that produce a yellow streak when 
crushed. It is prepared by admixing hot solutions of ferrous sulfate and 
sodium fumarate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 120-122, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Ave NW., Washington, DC 20418, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)), or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16866, May 12, 1988]



Sec. 184.1308   Ferrous gluconate.

    (a) Ferrous gluconate (iron (II) gluconate dihydrate, 
C12H22FeO142H2O, CAS Reg. No. 6047-12-7) is 
a fine yellowish-gray or pale greenish-yellow powder or granules. It is 
prepared by reacting hot solutions of barium or calcium gluconate with 
ferrous sulfate or by heating freshly prepared ferrous carbonate with 
gluconic acid in aqueous solution.
    (b) The ingredient meets the specifications of the Food Chemcials 
Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Avenue NW., Washington, DC 20418, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16866, May 12, 1988; 53 FR 20939, June 7, 1988]



Sec. 184.1311  Ferrous lactate.

    (a) Ferrous lactate (iron (II) lactate, C6H10FeO6, 
CAS Reg. No. 5905-52-2) in the trihydrate form is a greenish-white 
powder of crystalline mass. It is prepared by reacting calcium lactate 
or sodium lactate with ferrous sulfate or by direct reaction of lactic 
acid with iron filings.
    (b) The Food and Drug Administration is developing food-grade 
specifications for ferrous lactate in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 470]]

this section do not exist or have been waived.

[53 FR 16866, May 12, 1988]



Sec. 184.1315   Ferrous sulfate.

    (a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, 
FeSO47H2O, CAS Reg. No. 7782-63-0) is prepared by the 
action of sulfuric acid on iron. It occurs as pale, bluish-green 
crystals or granules. Progressive heating of ferrous sulfate 
heptahydrate produces ferrous sulfate (dried). Ferrous sulfate (dried) 
consists primarily of ferrous sulfate monohydrate (CAS Reg. No. 17375-
41-6) with varying amounts of ferrous sulfate tetrahydrate (CAS Reg. No. 
20908-72-9) and occurs as a grayish-white to buff-colored powder.
    (b) The ingredients meet the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124 
(ferrous sulfate, dried), which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave., NW., 
Washington, DC 20418, or available for inspection at the Office of 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in 
food as nutrient supplements as defined in Sec. 170.3(o)(20) of this 
chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredients may also be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under 
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[53 FR 16866, May 12, 1988]



Sec. 184.1316  Ficin.

    (a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained 
from the latex of species of the genus Ficus, which include a variety of 
tropical fig trees. It is a white to off-white powder. Its 
characterizing enzyme activity is that of a peptide hydrolase (EC 
3.4.22.3).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St., SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32910, June 26, 1995]



Sec. 184.1317   Garlic and its derivatives.

    (a) Garlic is the fresh or dehydrated bulb or cloves obtained from 
Allium sativum, a genus of the lily family. Its derivatives include 
essential oils, oleo-resins, and natural extractives obtained from 
garlic.
    (b) Garlic oil meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 132, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) Garlic and its derivatives are used as flavoring agents and 
adjuvants as defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredients are used in food at levels not to exceed good 
manufacturing practice.
    (e) [Reserved]

[[Page 471]]

    (f) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1318  Glucono delta-lactone.

    (a) Glucono delta-lactone (C6H10O6, CAS Reg. No. 90-
80-2), also called D-gluconic acid delta-lactone or D-glucono-1,5-
lactone, is the cyclic 1,5-intramolecular ester of D-gluconic acid. It 
is prepared by direct crystallization from the aqueous solution of 
gluconic acid. Gluconic acid may be produced by the oxidation of D-
glucose with bromine water, by the oxidation of D-glucose by 
microorganisms that are nonpathogenic and nontoxicogenic to man or other 
animals, or by the oxidation of D-glucose with enzymes derived from 
these microorganisms.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 134, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a curing and pickling agent as defined 
in Sec. 170.3(o)(5) of this chapter, leavening agent as defined in 
Sec. 170.3(o)(17) of this chapter; pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; and sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[51 FR 33896, Sept. 24, 1986]



Sec. 184.1321  Corn gluten.

    (a) Corn gluten (CAS Reg. No. 66071-96-3), also known as corn gluten 
meal, is the principal protein component of corn endosperm. It consists 
mainly of zein and glutelin. Corn gluten is a byproduct of the wet 
milling of corn for starch. The gluten fraction is washed to remove 
residual water soluble proteins. Corn gluten is also produced as a 
byproduct during the conversion of the starch in whole or various 
fractions of dry milled corn to corn syrups.
    (b) FDA is developing food-grade specifications for corn gluten in 
cooperation with the National Academy of Sciences. In the interim, the 
ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter and a texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 8998, Mar. 6, 1985]



Sec. 184.1322  Wheat gluten.

    (a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein 
component of wheat and consists mainly of gliadin and glutenin. Wheat 
gluten is obtained by hydrating wheat flour and mechanically working the 
sticky mass to separate the wheat gluten from the starch and other flour 
components. Vital gluten is dried gluten that has retained its elastic 
properties.

[[Page 472]]

    (b) FDA is developing food-grade specifications for wheat gluten in 
cooperation with the National Academy of Sciences. In the interim, the 
ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter; a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter; a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter; a surface-finishing agent as 
defined in Sec. 170.3(o)(30) of this chapter; and a texturizing agent as 
defined in Sec. 170.3(o)(32) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 8998, Mar. 6, 1985]



Sec. 184.1323  Glyceryl monooleate.

    (a) Glyceryl monooleate is prepared by esterification of commerical 
oleic acid that is derived either from edible sources or from tall oil 
fatty acids meeting the requirements of Sec. 172.862 of this chapter. It 
contains glyceryl monooleate (C21H40O4, CAS Reg. No. 
25496-72-4) and glyceryl esters of fatty acids present in commercial 
oleic acid.
    (b) FDA is developing food-grade specifications for glyceryl 
monooleate in cooperation with the National Academy of Sciences. In the 
interim, this ingredient must be of a purity suitable for its intended 
use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter and as a solvent and 
vehicle as defined in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods and baking mixes 
as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages 
and beverage bases as defined in Sec. 170.3(n)(3) of this chapter; 
chewing gum as defined in Sec. 170.3(n)(6) of this chapter; and meat 
products as defined in Sec. 170.3(n)(29) of this chapter.
    (d) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.


[54 FR 7403 Feb. 21, 1989]



Sec. 184.1324  Glyceryl monostearate.

    (a) Glyceryl monostearate, also known as monostearin, is a mixture 
of variable proportions of glyceryl monostearate 
(C21H42O4, CAS Reg. No. 31566-31-1), glyceryl 
monopalmitate (C19H38O4, CAS Reg. No. 26657-96-5) and 
glyceryl esters of fatty acids present in commercial stearic acid. 
Glyceryl monostearate is prepared by glycerolysis of certain fats or 
oils that are derived from edible sources or by esterification, with 
glycerin, of stearic acid that is derived from edible sources.
    (b) FDA is developing food-grade specifications for glyceryl 
monostearate in cooperation with the National Academy of Sciences. In 
the interim, this ingredient must be of a purity suitable for its 
intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not not exist or have been waived.


[54 FR 7403 Feb. 21, 1989]

[[Page 473]]



Sec. 184.1328  Glyceryl behenate.

    (a) Glyceryl behenate is a mixture of glyceryl esters of behenic 
acid made from glycerin and behenic acid (a saturated C22 fatty 
acid). The mixture contains predominately glyceryl dibehenate.
    (b) The ingredient meets the following specifications:
    (1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26 
to 38 percent triglyceride, and not more than 2.5 percent free fatty 
acids.
    (2) Behenic acid. Between 80 and 90 percent of the total fatty acid 
content.
    (3) Acid value. Not more than 4.
    (4) Saponification value. Between 145 and 165.
    (5) Iodine number. Not more than 3.
    (6) Heavy metals (as Pb). Not more than 10 parts per million.
    (c) In accordance with Sec. 184.1(b)(1) of this chapter, the 
ingredient is used in food with no limitation other than current good 
manufacturing practice. The affirmation of this ingredient is generally 
recognized as safe (GRAS) as a direct human food ingredient is based 
upon the following current good manufacturing practice conditions of 
use:
    (1) The ingredient is used as a formulation aid, as defined in 
Sec. 170.3(o)(14) of this chapter.
    (2) The ingredient is used in excipient formulations for use in 
tablets at levels not to exceed good manufacturing practice.

[52 FR 42430, Nov. 5, 1987]



Sec. 184.1329   Glyceryl palmitostearate.

    (a) Glyceryl palmitostearate is a mixture of mono-, di-, and 
triglyceryl esters of palmitic and stearic acids made from glycerin, 
palmitic acid, and stearic acid.
    (b) The ingredient meets the following specifications:
    (1) The substance is a mixture of mono-, di-, and triglycerides of 
palmitic acid and stearic acid.
    (2) Heavy metals (as lead): Not more than 10 parts per million.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a formulation aid, as defined in Sec.  
170.3(o)(14) of this chapter.
    (2) The ingredient is used in excipient formulations for use in 
tablets at levels not to exceed good manufacturing practice.

[60 FR 63621, Dec. 12, 1995]



Sec. 184.1330   Acacia (gum arabic).

    (a) Acacia (gum arabic) is the dried gummy exudate from stems and 
branches of trees of various species of the genus Acacia, family 
Leguminosae.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 7, which is incorporated by reference. Copies 
may be obtained from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) The ingredient is used in food under the following conditions:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Beverages and beverage bases,         2.0  Emulsifier and emulsifier    
 Sec.   170.3(n)(3) of this                 salt, Sec.   170.3(o)(8) of 
 chapter.                                   this chapter; flavoring     
                                            agent and adjuvant, Sec.    
                                            170.3(o)(12) of this        
                                            chapter; formulation aid,   
                                            Sec.   170.3(o)(14) of this 
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Chewing gum, Sec.                     5.6  Flavoring agent and adjuvant,
 170.3(n)(6) of this chapter.               Sec.   170.3(o)(12) of this 
                                            chapter; formulation aid,   
                                            Sec.   170.3(o)(14) of this 
                                            chapter; humectant, Sec.    
                                            170.3(o)(16) of this        
                                            chapter; surface-finishing  
                                            agent, Sec.   170.3(o)(30)  
                                            of this chapter.            
Confections and frostings,           12.4  Formulation aid, Sec.        
 Sec.   170.3(n)(9) of this                 170.3(o)(14) of this        
 chapter.                                   chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter; surface-finishing  
                                            agent, Sec.   170.3(o)(30)  
                                            of this chapter.            
Dairy product analogs, Sec.           1.3  Formulation aid, Sec.        
 170.3(n)(10) of this chapter.              170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    

[[Page 474]]

                                                                        
Fats and oils, Sec.                   1.5  Formulation aid, Sec.        
 170.3(n)(12) of this chapter.              170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Gelatins, puddings, and               2.5  Emulsifier and emulsifier    
 fillings, Sec.                             salt, Sec.   170.3(o)(8) of 
 170.3(n)(22) of this chapter.              this chapter; formulation   
                                            aid, Sec.   170.3(o)(14) of 
                                            this chapter.; stabilizer   
                                            and thickener, Sec.         
                                            170.3(o)(28) of this        
                                            chapter.                    
Hard candy and cough drops,          46.5  Flavoring agent and adjuvant,
 Sec.   170.3(n)(25) of this                Sec.   170.3(o)(12) of this 
 chapter.                                   chapter; formulation aid,   
                                            Sec.   170.3(o)(14) of this 
                                            chapter.                    
Nuts and nut products, Sec.           8.3  Formulation aid, Sec.        
 170.3(n)(32) of this chapter.              170.3(o)(14) of this        
                                            chapter; surface-finishing  
                                            agent, Sec.   170.3(o)(30)  
                                            of this chapter.            
Quiescently frozen confection         6.0  Formulation aid, Sec.        
 products.                                  170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Snack foods, Sec.                     4.0  Emulsifier and emulsifier    
 170.3(n)(37) of this chapter.              salt, Sec.   170.3(o)(8) of 
                                            this chapter; formulation   
                                            aid, Sec.   170.3(o)(14) of 
                                            this chapter.               
Soft candy, Sec.                     85.0  Emulsifier and emulsifier    
 170.3(n)(38) of this chapter.              salt, Sec.   170.3(o)(8) of 
                                            this chapter; firming agent,
                                            Sec.   170.3(o)(10) of this 
                                            chapter; flavoring agent and
                                            adjuvant, Sec.              
                                            170.3(o)(12) of this        
                                            chapter; formulation aid,   
                                            Sec.   170.3(o)(14) of this 
                                            chapter, humectant, Sec.    
                                            170.3(o)(16) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter; surface-finishing  
                                            agent, Sec.   170.3(o)(30)  
                                            of this chapter.            
All other food categories....         1.0  Emulsifier and emulsifier    
                                            salt, Sec.   170.3(o)(8) of 
                                            this chapter; flavoring     
                                            agent and adjuvant, Sec.    
                                            170.3(o)(12) of this        
                                            chapter; formulation aid,   
                                            Sec.   170.3(o)(14) of this 
                                            chapter; processing aid,    
                                            Sec.   170.3(o)(24) of this 
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter; surface-finishing  
                                            agent, Sec.   170.3(o)(30)  
                                            of this chapter; texturizer,
                                            Sec.   170.3(o)(32) of this 
                                            chapter.                    
------------------------------------------------------------------------

    (d) [Reserved]
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1983; 53 FR 5766, Feb. 26, 1988]



Sec. 184.1333   Gum ghatti.

    (a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of 
Anogeissus latifolia, a large tree found in the dry deciduous forests of 
India and Ceylon.
    (b) The ingredient complies with the following specifications:
    (1) Viscosity of a 1-percent solution. Not less than the minimum or 
within the range claimed by the vendor.
    (2) Limits of impurities--(i) Arsenic (as AL). Not more than 3 parts 
per million (0.0003 percent);
    (ii) Ash (acid-insoluble). Not more than 1.75 percent;
    (iii) Ash (total). Not more than 6.0 percent;
    (iv) Heavy metals (as Pb). Not more than 40 parts per million (0.004 
percent); and
    (v) Lead. Not more than 10 parts per million (0.001 percent).
    (3) Loss on drying. Not more than 14 percent dried at 105 deg. C for 
5 hours.
    (4) Identification test. Add 0.2 ml of diluted lead acetate as 
outlined in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), section 31.178(b), p. 
529, under ``Dilute Basic Lead Acetate Standard Solution,'' which is 
incorporated by reference (copies are available from the Association of 
Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, 
Washington, DC 20044, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408), to 5 ml of a cold 1-in-100 aqueous solution of the gum. An 
immediate, voluminous, opaque precipitate indicates acacia. A small 
precipitate or clear solution which produces an opaque flocculent 
precipitate upon the additon of 1 ml of 3 N ammonimum hydroxide 
indicates gum ghatti.
    (c) The ingredient is used in food under the following conditions:

[[Page 475]]



                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Beverages and beverage bases,         0.2  Emulsifier and emulsifier    
 nonalcoholic, Sec.                         salt, Sec.   170.3(o)(8) of 
 170.3(n)(3) of this chapter.               this chapter.               
All other food categories....          .1  Emulsifier and emulsifier    
                                            salt, Sec.   170.3(o)(8) of 
                                            this chapter.               
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]



Sec. 184.1339   Guar gum.

    (a) Guar gum is the natural substance obtained from the maceration 
of the seed of the guar plant, Cyamopsis tetragonoloba (Linne) Taub., or 
Cyamopsis psoraloides (Lam.) D.C.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 141, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used in food under the following conditions:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Baked goods and baking mixes,        0.35  Emulsifier and emulsifier    
 Sec.  170.3(n)(1) of this                  salts, Sec.  170.3(o)(8) of 
 chapter.                                   this chapter; formulation   
                                            aid, Sec.  170.3(o)(14) of  
                                            this chapter; stabilizer and
                                            thickener; Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Breakfast cereals, Sec.               1.2  Formulation aid, Sec.        
 170.3(n)(4) of this chapter.               170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Cheese, Sec.  170.3(n)(5) of           .8      Do.                      
 this chapter.                                                          
Dairy products analogs, Sec.          1.0  Firming agent, Sec.          
 170.3(n)(10) of this chapter.              170.3(o)(10) of this        
                                            chapter; formulation aid,   
                                            Sec.  170.3(o)(14) of this  
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Fats and oils, Sec.                   2.0      Do.                      
 170.3(n)(12) of this chapter.                                          
Gravies and sauces, Sec.              1.2  Formulation aid, Sec.        
 170.3(n)(24) of this chapter.              170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Jams and jellies, commercial,         1.0      Do.                      
 Sec.  170.3(n)(28) of this                                             
 chapter.                                                               
Milk products, Sec.                    .6      Do.                      
 170.3(n)(31) of this chapter.                                          
Processed vegetables and              2.0  Formulation aid, Sec.        
 vegetable juices, Sec.                     170.3(o)(14) of this        
 170.3(n)(36) of this chapter.              chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Soups and soup mixes, Sec.             .8      Do.                      
 170.3(n)(40) of this chapter.                                          
Sweet sauces, toppings and            1.0      Do.                      
 syrups, Sec.  170.3(n)(43)                                             
 of this chapter.                                                       
All other food categories....          .5  Emulsifier and emulsifier    
                                            salts, Sec.  170.3(o)(8) of 
                                            this chapter; firming agent,
                                            Sec.  170.3(o)(10) of this  
                                            chapter; formulation aid,   
                                            Sec.  170.3(o)(14) of this  
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
------------------------------------------------------------------------

    (d) [Reserved]
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1343   Locust (carob) bean gum.

    (a) Locust (carob) bean gum is primarily the macerated endosperm of 
the seed of the locust (carob) bean tree, Ceratonia siliqua (Linne), a 
leguminous evergreen tree, with lesser quantities of seed coat and germ.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 174-175, which is incorporated by reference. 
Copies

[[Page 476]]

may be obtained from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) The ingredient is used at levels not to exceed the following 
maximum levels:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Baked goods and baking mixes,        0.15  Stabilizer and thickener,    
 Sec.  170.3(n)(1) of this                  Sec.  170.3(o)(28) of this  
 chapter.                                   chapter.                    
Beverages and beverage bases,         .25      Do.                      
 nonalcoholic, Sec.                                                     
 170.3(n)(3) of this chapter.                                           
Cheeses, Sec.  170.3(n)(5) of          .8      Do.                      
 this chapter.                                                          
Gelatins, puddings, and               .75      Do.                      
 fillings, Sec.  170.3(n)(22)                                           
 of this chapter.                                                       
Jams and jellies, commercial,         .75      Do.                      
 Sec.  170.3(n)(28) of this                                             
 chapter.                                                               
All other food categories....          .5      Do.                      
------------------------------------------------------------------------

    (d) [Reserved]
    (e) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1349   Karaya gum (sterculia gum).

    (a) Karaya gum (sterculia gum) is the dried gummy exudate from the 
trunk of trees of various species of the genus Sterculia.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 157, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used in food under the following conditions:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Frozen dairy desserts and             0.3  Formulation aid, Sec.        
 mixes, Sec.  170.3(n)(20) of               170.3(o)(14) of this        
 this chapter.                              chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Milk products, Sec.                   .02  Stabilizer and thickener,    
 170.3(n)(31) of this chapter.              Sec.  170.3(o)(28) of this  
                                            chapter.                    
Soft candy, Sec.                       .9  Emulsifier and emulsifier    
 170.3(n)(38) of this chapter.              salt, Sec.  170.3(o)(8) of  
                                            this chapter; stabilizer and
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
All other food categories....        .002  Formulation aid, Sec.        
                                            170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
------------------------------------------------------------------------

    (d) [Reserved]
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1351   Gum tragacanth.

    (a) Gum tragacanth is the exudate from one of several species of 
Astragalus gummifier Labillardiere, a shrub that grows wild in 
mountainous regions of the Middle East.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 337, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used in food under the following conditions:

[[Page 477]]



                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
       Food (as served)          Percent              Function          
------------------------------------------------------------------------
Baked goods and baking mixes,         0.2  Emulsifier and emulsifier    
 Sec.  170.3(n)(1) of this                  salt, Sec.  170.3(o)(8) of  
 chapter.                                   this chapter; formulation   
                                            aid, Sec.  170.3(o)(14) of  
                                            this chapter; stabilizer and
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Condiments and relishes, Sec.          .7      Do.                      
  170.3(n)(8) of this chapter.                                          
Fats and oils, Sec.                   1.3      Do.                      
 170.3(n)(12) of this chapter.                                          
Gravies and sauces, Sec.               .8      Do.                      
 170.3(n)(24) of this chapter.                                          
Meat products, Sec.                    .2  Formulation aid, Sec.        
 170.3(n)(29) of this chapter.              170.3(o)(14) of this        
                                            chapter; stabilizer and     
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
Processed fruits and fruit             .2  Emulsifier and emulsifier    
 juices, Sec.  170.3(n)(35)                 salt, Sec.  170.3(o)(8) of  
 of this chapter.                           this chapter; formulation   
                                            aid, Sec.  170.3(o)(14) of  
                                            this chapter; stabilizer and
                                            thickener, Sec.             
                                            170.3(o)(28) of this        
                                            chapter.                    
All other food categories....          .1      Do.                      
------------------------------------------------------------------------

    (d) [Reserved]
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 
49 FR 5612, Feb. 14, 1984]



Sec. 184.1355  Helium.

    (a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a 
colorless, odorless, flavorless, nonflammable, inert gas. It is lighter 
than air and is produced by the liquefaction and purification of natural 
gas.
    (b) The Food and Drug Administration is developing food-grade 
specifications for helium in cooperation with the National Academy of 
Sciences. In the interim, the ingredient must be of a purity suitable 
for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]



Sec. 184.1366  Hydrogen peroxide.

    (a) Hydrogen peroxide (H2O2, CAS Reg. No. 7722-84-1) is 
also referred to as hydrogen dioxide. It is made by the electrolytic 
oxidation of sulfuric acid or a sulfate to persulfuric acid or a 
persulfuric acid salt with subsequent hydrolysis and distillation of the 
hydrogen peroxide formed; by decomposition of barium peroxide with 
sulfuric or phosphoric acid; by hydrogen reduction of 2-
ethylanthraquinone, followed by oxidation with air, to regenerate the 
quinone and produce hydrogen peroxide; or by electrical discharge 
through a mixture of hydrogen, oxygen, and water vapor.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 146-147,1 which is incorporated by 
reference.
---------------------------------------------------------------------------

    1 Copies may be obtained from the National Academy of Sciences, 
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
---------------------------------------------------------------------------

    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to 
treat food only within the following specific limitations:

[[Page 478]]



------------------------------------------------------------------------
                                   Maximum treatment                    
              Food                   level in food      Functional use  
                                       (percent)                        
------------------------------------------------------------------------
Milk, intended for use during     0.05..............  Antimicrobial     
 the cheesemaking process as                           agent as defined 
 permitted in the appropriate                          in Sec.  170.3   
 standards of identity for                             (o)(2) of this   
 cheese and related cheese                             chapter          
 products under part 133 of this                                        
 chapter.                                                               
Whey, during the preparation of   0.04..............  do.               
 modified whey by                                                       
 electrodialysis methods.                                               
Dried eggs, dried egg whites,     Amount sufficient   Oxidizing and     
 and dried egg yolks as in Secs.   for the purpose.    reducing agent as
 160.105, 160.145, and 160.185                         defined in Sec.  
 of this chapter.                                      170.3 (o)(22) of 
                                                       this chapter     
Tripe...........................  do................  Bleaching agent.  
Beef feet.......................  Amount sufficient   Bleaching agent.  
                                   for the purpose.                     
                                   (Hydrogen                            
                                   peroxide may be                      
                                   in the form of a                     
                                   compound salt,                       
                                   sodium carbonate                     
                                   peroxide).                           
Herring.........................  Amount sufficient   do.               
                                   for the purpose.                     
Wine............................  do................  Oxidizing and     
                                                       reducing agent as
                                                       defined in Sec.  
                                                       170.3 (o)(22) of 
                                                       this chapter.    
Starch..........................  0.15..............  Antimicrobial     
                                                       agent as defined 
                                                       in Sec. 170.3    
                                                       (o)(2) of this   
                                                       chapter, to      
                                                       produce          
                                                       thermophile-free 
                                                       starch;          
                                                      Remove sulfur     
                                                       dioxide from     
                                                       starch slurry    
                                                       following        
                                                       steeping and     
                                                       grinding         
                                                       operations of    
                                                       corn refining.   
Instant tea.....................  Amount sufficient   Bleaching agent.  
                                   for the purpose.                     
Corn syrup......................  0.15..............  Reduce sulfur     
                                                       dioxide levels in
                                                       the finished corn
                                                       syrup.           
Colored (annatto) cheese whey...  0.05..............  Bleaching agent.  
Wine vinegar....................  Amount sufficient   Remove sulfur     
                                   for the purpose.    dioxide from wine
                                                       prior to         
                                                       fermentation to  
                                                       produce vinegar. 
Emulsifiers containing fatty      1.25..............  Bleaching agent.  
 acid esters.                                                           
------------------------------------------------------------------------

    (d) Residual hydrogen peroxide is removed by appropriate physical 
and chemical means during the processing of food where it has been used 
according to paragraph (c) of this section.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[46 FR 44439, Sept. 4, 1981, as amended at 51 FR 27172, July 30, 1986]



Sec. 184.1370  Inositol.

    (a) Inositol, or myo-inositol (C6H12O6, CAS Reg. No. 
87-89-8), is cis-1,2,3,5-trans-4,6-cyclohexanehexol. It occurs naturally 
and is prepared from an aqueous (0.2 percent sulfur dioxide) extract of 
corn kernels by precipitation and hydrolysis of crude phytate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 150, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in special dietary foods as defined in 
part 105 of this chapter at levels not to exceed current good 
manufacturing practice. It may also be used in infant formula in 
accordance with section 412(g) of the Act, or with regulations 
promulgated under section 412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established by

[[Page 479]]

this section do not exist or have been waived.

[47 FR 38278, Aug. 31, 1982]



Sec. 184.1372  Insoluble glucose isomerase enzyme preparations.

    (a) Insoluble glucose isomerase enzyme preparations are used in the 
production of high fructose corn syrup described in Sec. 182.1866 of 
this chapter. They are derived from recognized species of precisely 
classified, nonpathogenic, and nontoxicogenic microorganisms, including 
Streptomyces rubiginosus, Actinoplanes missouriensis, Streptomyces 
olivaceus, Streptomyces olivochromogenes, and Bacillus coagulans, that 
have been grown in a pure culture fermentation that produces no 
antibiotics. They are fixed (rendered insoluble) for batch production 
with GRAS ingredients or may be fixed for further immobilization with 
either GRAS ingredients or materials approved under Sec. 173.357 of this 
chapter.
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107, 
which is incorporated by reference. Copies are available from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, to convert glucose to fructose.
    (2) The ingredient is used in high fructose corn syrup, at levels 
not to exceed current good manufacturing practice.

[48 FR 5720, Feb. 8, 1983]



Sec. 184.1375  Iron, elemental.

    (a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron 
obtained by any of the following processes: reduced iron, electrolytic 
iron, and carbonyl iron.
    (1) Reduced iron is prepared by reacting ground ferric oxide with 
hydrogen or carbon monoxide at an elevated temperature. The process 
results in a grayish-black powder, all of which should pass through a 
100-mesh sieve. It is lusterless or has not more than a slight luster. 
When viewed under a microscope, it appears as an amorphous powder free 
from particles having a crystalline structure. It is stable in dry air.
    (2) Electrolytic iron is prepared by electrodeposition. It is an 
amorphous, lusterless, grayish-black powder. It is stable in dry air.
    (3) Carbonyl iron is prepared by the decomposition of iron 
pentacarbonyl. It occurs as a dark gray powder. When viewed under a 
microscope, it appears as spheres built up with concentric shells. It is 
stable in dry air.
    (b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the 
specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron, 
carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp. 
152-153), which is incorporated by reference. Copies are available from 
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this 
chapter, with no limitation other than current good manufacturing 
practice. The ingredient may also be used in accordance with section 
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
350a(g)) or with regulations promulgated under section 412(a)(2) of the 
act (21 U.S.C. 350a(2)).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16867, May 12, 1988]



Sec. 184.1386  Isopropyl citrate.

    (a) Isopropyl citrate is a mixture of the mono-, di-, and 
triisopropyl esters of citric acid. It is prepared by

[[Page 480]]

esterifying citric acid with isopropanol.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for isopropyl citrate. In the interim, this ingredient must be of a 
purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; a sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter; and a solvent and vehicle as defined 
in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in margarine in accordance with 
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]



Sec. 184.1387  Lactase enzyme preparation from Candida pseudotropicalis.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase 
(-D-galactoside galactohydrolase, EC 3.2.1.23), which converts 
lactose to glucose and galactose. It is prepared from yeast that has 
been grown by a pure culture fermentation process.
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), pp. 107-110, which are incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, to convert lactose to glucose and 
galactose.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice is 
limited to use of this ingredient to reduce the lactose content in milk 
and milk-derived food products where food standards do not preclude such 
use.

[61 FR 7704, Feb. 29, 1996]



Sec. 184.1388  Lactase enzyme preparation from Kluyveromyces lactis.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic yeast Kluyveromyces lactis (previously named 
Saccharomyces lactis). It contains the enzyme -galactoside 
galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose 
and galactose. It is prepared from yeast that has been grown in a pure 
culture fermentation and by using materials that are generally 
recognized as safe or are food additives that have been approved for 
this use by the Food and Drug Administration.
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107-
110, which is incorporated by reference. Copies are available from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.

[[Page 481]]

    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to convert lactose to glucose and 
galactose.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice is to 
use this ingredient in milk to produce lactase-treated milk, which 
contains less lactose than regular milk, or lactose-reduced milk, which 
contains at least 70 percent less lactose than regular milk.

[49 FR 47387, Dec. 4, 1984]



Sec. 184.1400  Lecithin.

    (a) Commercial lecithin is a naturally occurring mixture of the 
phosphatides of choline, ethanolamine, and inositol, with smaller 
amounts of othe lipids. It is isolated as a gum following hydration of 
solvent-extracted soy, safflower, or corn oils. Lecithin is bleached, if 
desired, by hydrogen peroxide and benzoyl peroxide and dried by heating.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 166-167, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Ave. NW., Washington, DC 20418, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51150, Nov. 7, 1983]



Sec. 184.1408  Licorice and licorice derivatives.

    (a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome 
and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza. 
Licorice extract is that portion of the licorice root that is, after 
maceration, extracted by boiling water. The extract can be further 
purified by filtration and by treatment with acids and ethyl alcohol. 
Licorice extract is sold as a liquid, paste (``block''), or spray-dried 
powder.
    (2) Ammoniated glycyrrhizin is prepared from the water extract of 
licorice root by acid precipitation followed by neutralization with 
dilute ammonia. Monoammonium glycyrrhizinate 
(C42H61O16NH45H2O, CAS Reg. No. 1407-03-0) is 
prepared from ammoniated glycyrrhizin by solvent extraction and 
separation techniques.
    (b) The ingredients shall meet the following specifications when 
analyzed:
    (1) Assay. The glycyrrhizin content of each flavoring ingredient 
shall be determined by the method in the Official Methods of Analysis of 
the Association of Official Analytical Chemists, 13th Ed., Secs. 19.136-
19.140, which is incorporated by reference, or by methods 19.CO1 through 
19.CO4 in the Journal of the Association of Official Analytical 
Chemists, 65:471-472 (1982), which are also incorporated by reference. 
Copies of all of these methods are available from the Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) Ash. Not more than 9.5 percent for licorice, 2.5 percent for 
ammoniated glycyrrhizin, and 0.5 percent for monoammonium 
glycyrrhizinate on an anhydrous basis as determined by the method in the 
Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.

[[Page 482]]

    (3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an 
anhydrous basis as determined by the method in the Food Chemicals Codex, 
3d Ed. (1981), p. 466, which is incorporated by reference.
    (4) Heavy metals (as Pb). Not more than 40 parts per million as 
determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p. 
512, which is incorporated by reference.
    (5) Arsenic (As). Not more than 3 parts per million as determined by 
the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which is 
incorporated by reference.
    (c) In accordance with Sec. 184.1(b)(2), these ingredients are used 
in food only within the following specific limitations:

------------------------------------------------------------------------
                                   Maximum level in                     
                                    food (percent                       
        Category of food             glycyrrhizin       Functional use  
                                   content of food)                     
                                     (as served)                        
------------------------------------------------------------------------
Baked foods, Sec. 170.3(n)(1) of               0.05  Flavor enhancer,   
 this chapter.                                        Sec. 170.3(o)(11) 
                                                      of this chapter;  
                                                      flavoring agent,  
                                                      Sec. 170.3(o)(12) 
                                                      of this chapter.  
Alcoholic beverages, Sec.                      0.1   Flavor enhancer,   
 170.3(n)(2) of this chapter.                         Sec. 170.3(o)(11) 
                                                      of this chapter;  
                                                      flavoring agent,  
                                                      Sec. 170.3(o)(12) 
                                                      of this chapter;  
                                                      surface-active    
                                                      agent, Sec.       
                                                      170.3(o)(29) of   
                                                      this chapter.     
Nonalcoholic beverages, Sec.                   0.15      Do.            
 170.3(n)(3) of this chapter.                                           
Chewing gum, Sec. 170.3(n)(6) of               1.1   Flavor enhancer,   
 this chapter.                                        Sec. 170.3(o)(11) 
                                                      of this chapter;  
                                                      flavoring agent,  
                                                      Sec. 170.3(n)(12) 
                                                      of this chapter.  
Hard candy, Sec. 170.3(n)(25) of              16.0       Do.            
 this chapter.                                                          
Herbs and seasonings, Sec.                     0.15      Do.            
 170.3(n)(26) of this chapter.                                          
Plant protein products, Sec.                   0.15      Do.            
 170.3(n)(33) of this chapter.                                          
Soft candy, Sec. 170.3(n)(38) of               3.1       Do.            
 this chapter.                                                          
Vitamin or mineral dietary                     0.5       Do.            
 supplements.                                                           
All other foods except sugar                   0.1       Do.            
 substitutes, Sec. 170.3(n)(42)                                         
 of this chapter. The ingredient                                        
 is not permitted to be used as                                         
 a nonnutritive sweetener in                                            
 sugar substitutes.                                                     
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989]



Sec. 184.1409  Ground limestone.

    (a) Ground limestone consists essentially (not less than 94 percent) 
of calcium carbonate (CaCO3) and is prepared by the crushing, 
grinding, and classifying of naturally occurring limestone.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 173, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52442, Nov. 18, 1983]



Sec. 184.1415  Animal lipase.

    (a) Animal lipase (CAS Reg. No. 9001-62-1) is an enzyme preparation 
obtained from edible forestomach tissue of calves, kids, or lambs, or 
from animal pancreatic tissue. The enzyme preparation may be produced as 
a tissue preparation or as an aqueous extract. Its characterizing enzyme 
activity is that of a triacylglycerol hydrolase (EC 3.1.1.3).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from

[[Page 483]]

the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 
20418, or may be examined at the Office of Premarket Approval (HFS-200), 
Food and Drug Administration, 200 C St., SW., Washington, DC, and the 
Office of the Federal Register, 800 North Capitol St., NW., suite 700, 
Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze fatty acid glycerides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]



Sec. 184.1425  Magnesium carbonate.

    (a) Magnesium carbonate (molecular formula approximately 
(MgCO3)4Mg(OH)25H2O, CAS Reg. No. 
39409-82-0) is also known as magnesium carbonate hydroxide. It is a 
white powder formed either by adding an alkaline carbonate (such as 
sodium carbonate) to a solution of magnesium sulfate or by carbonation 
of a slurry of magnesium hydroxide followed by boiling of the resulting 
magnesium carbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an anticaking and free-flow agent as 
defined in Sec. 170.3(o)(1) of this chapter; a flour treating agent as 
defined in Sec. 170.3(o)(13) of this chapter; a lubricant and release 
agent as defined in Sec. 170.3(o)(18) of this chapter; a nutrient 
supplement as defined in Sec. 170.3(o)(20) of this chapter; a pH control 
agent as defined in Sec. 170.3(o)(23) of this chapter; a processing aid 
as defined in Sec. 170.3(o)(24) of this chapter; and a synergist as 
defined in Sec. 170.3(o)(31) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985]



Sec. 184.1426  Magnesium chloride.

    (a) Magnesium chloride (MgC126H2O, CAS Reg. No. 
7786-30-3) is a colorless, deliquescent, crystalline material that 
occurs naturally as the mineral bischofite. It is prepared by dissolving 
magnesium oxide, hydroxide, or carbonate in aqueous hydrochloric acid 
solution and crystallizing out magnesium chloride hexahydrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter and a nutrient supplement 
as defined in Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient also may be used in infant 
formula in accordance with section 412(g) of the

[[Page 484]]

Federal Food, Drug, and Cosmetic Act (the act) or with regulations 
promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985]



Sec. 184.1428  Magnesium hydroxide.

    (a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1409-42-8) 
occurs naturally as the colorless, crystalline mineral brucite. It is 
prepared as a white precipitate by the addition of sodium hydroxide to a 
water soluble magnesium salt or by hydration of reactive grades of 
magnesium oxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter; a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13559, Apr. 5, 1985]



Sec. 184.1431  Magnesium oxide.

    (a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally 
as the colorless, crystalline mineral periclase. It is produced either 
as a bulky white powder (light) or a relatively dense white powder 
(heavy) by heating magnesium hydroxide or carbonate. Heating these 
magnesium salts under moderate conditions (400 deg. to 900 deg. C for a 
few hours) produces light magnesium oxide. Heating the salts under more 
rigorous conditions (1200 deg. C for 12 hours) produces heavy magnesium 
oxide. Light magnesium oxide is converted to heavy magnesium oxide by 
sustained heating at high temperatures.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an anticaking and free-flow agent as 
defined in Sec. 170.3(o)(1) of this chapter; a firming agent as defined 
in Sec. 170.3(o)(10) of this chapter; a lubricant and release agent as 
defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter; and a pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in foods at levels not be exceed current 
good manufacturing practice. The ingredient also may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13559, Apr. 5, 1985]



Sec. 184.1434  Magnesium phosphate.

    (a) Magnesium phosphate includes both magnesium phosphate, dibasic,

[[Page 485]]

and magnesium phosphate, tribasic. Magnesium phosphate, dibasic 
(MgHPO43H2O, CAS Reg. No. 7782-75-4) occurs naturally 
as the white, crystalline mineral newberyite. It is prepared 
commercially as a precipitate formed by treating a solution of magnesium 
sulfate with disodium phosphate under controlled conditions. Magnesium 
phosphate, tribasic (Mg3(PO4)2xH2O, CAS Reg. No. 
7727-87-1) may contain 4, 5, or 8 molecules of water of hydration. It is 
produced as a precipitate from a solution of magnesite with phosphoric 
acid.
    (b) Magnesium phosphate, dibasic, meets the specifications of the 
Food Chemicals Codex, 3d Ed. (1981), p. 179, which is incorporated by 
reference. Magnesium phosphate, tribasic, meets the specifications of 
the Food Chemicals Codex, 3d Ed. (1981), p. 180, which is incorporated 
by reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter and a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient also may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13560, Apr. 5, 1985]



Sec. 184.1440  Magnesium stearate.

    (a) Magnesium stearate (Mg(C17H34COO)2, CAS Reg. No. 
557-04-0) is the magnesium salt of stearic acid. It is produced as a 
white precipitate by the addition of an aqueous solution of magnesium 
chloride to an aqueous solution of sodium stearate derived from stearic 
acid that is obtained from edible sources and that conforms to the 
requirements of Sec. 172.860(b)(2) of this chapter.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 182, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a lubricant and release agent as 
defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter; and a processing aid as 
defined in Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13560, Apr. 5, 1985]



Sec. 184.1443  Magnesium sulfate.

    (a) Magnesium sulfate (MgSO47H2O, CAS Reg. No. 
10034-99-8) occurs naturally as the mineral epsomite. It is prepared by 
neutralization of magnesium oxide, hydroxide, or carbonate with sulfuric 
acid and evaporating the solution to crystallization.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex,

[[Page 486]]

3d Ed. (1981), p. 183, which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter; and a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 13560, Apr. 5, 1985]



Sec. 184.1443a  Malt.

    (a) Malt is an enzyme preparation obtained from barley which has 
been softened by a series of steeping operations and germinated under 
controlled conditions. It is a brown, sweet, and viscous liquid or a 
white to tan powder. Its characterizing enzyme activities are -
amylase (EC 3.2.1.1.) and -amylase (EC 3.2.1.2).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St., SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze starch or starch-derived 
polysaccharides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]



Sec. 184.1444  Maltodextrin.

    (a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050-
36-6) is a nonsweet nutritive saccharide polymer that consists of D-
glucose units linked primarily by -1-4 bonds and that has a 
dextrose equivalent (D.E.) of less than 20. It is prepared as a white 
powder or concentrated solution by partial hydrolysis of corn starch or 
potato starch with safe and suitable acids and enzymes.
    (b)(1) Maltodextrin derived from corn starch must be of a purity 
suitable for its intended use.
     (2) Maltodextrin derived from potato starch meets the 
specifications of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p. 
125, which are incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the National Academy 
Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be 
examined at the Office of the Federal Register, 800 North Capital St. 
NW., suite 700, Washington, DC 20408, or at the Division of Petition 
Control (HFS-217), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51911, Nov. 15, 1983; as amended at 60 FR 48893, Sept. 21, 1995]

[[Page 487]]



Sec. 184.1445  Malt syrup (malt extract).

    (a) Malt is the product of barley (Hordeum vulgare L.) germinated 
under controlled conditions. Malt syrup and malt extract are 
interchangeable terms for a viscous concentrate of water extract of 
germinated barley grain, with or without added safe preservative. Malt 
syrup is usually a brown, sweet, and viscous liquid containing varying 
amounts of amylolytic enzymes and plant constituents. Barley is first 
softened after cleaning by steeping operations and then allowed to 
germinate under controlled conditions. The germinated grain then 
undergoes processing, such as drying, grinding, extracting, filtering, 
and evaporating, to produce malt syrup (malt extract) with 75 to 80 
percent solids or dried malt syrup with higher solids content.
    (b) FDA is developing food-grade specifications for malt syrup (malt 
extract) in cooperation with the National Academy of Sciences. In the 
interim, the ingredient must be of a purity suitable for its intended 
use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51613, Nov. 10, 1983]



Sec. 184.1446  Manganese chloride.

    (a) Manganese chloride (MnCl24H2O, CAS Reg. No. 
7773-01-5) is a pink, translucent, crystalline product. It is also known 
as manganese dichloride. It is prepared by dissolving manganous oxide, 
pyrolusite ore (MnO2), or reduced manganese ore in hydrochloric 
acid. The resulting solution is neutralized to precipitate heavy metals, 
filtered, concentrated, and crystallized.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient may be used in infant formulas in accordance with 
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or 
with regulations promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 19165, May 7, 1985]



Sec. 184.1449  Manganese citrate.

    (a) Manganese citrate (Mn3(C6H5O7)2, CAS 
Reg. No. 1002-46-65) is a pale orange or pinkish white powder. It is 
obtained by precipitating manganese carbonate from manganese sulfate and 
sodium carbonate solutions. The filtered and washed precipitate is 
digested first with sufficient citric acid solution to form manganous 
citrate and then with sodium citrate to complete the reaction.
    (b) FDA is developing food-grade specifications for manganese 
citrate in cooperation with the National Academy of Sciences. In the 
interim, this ingredient must be of purity suitable for its intended 
use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 488]]

manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe (GRAS) as a direct human food ingredient is based 
upon the following current good manufacturing practice conditions of 
use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter; fish products as defined in 
Sec. 170.3(n)(13) of this chapter; meat products as defined in 
Sec. 170.3(n)(29) of this chapter; milk products as defined in 
Sec. 170.3(n)(31) of this chapter; and poultry products as defined in 
Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant 
formulas in accordance with section 412(g) of the Federal Food, Drug, 
and Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 19166, May 7, 1985]



Sec. 184.1452  Manganese gluconate.

    (a) Manganese gluconate 
(C12H22MnO142H2O, CAS Reg. No. 648-53-98) is 
a slightly pink colored powder. It is obtained by reacting manganese 
carbonate with gluconic acid in aqueous medium and then crystallizing 
the product.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter; fish products as defined in 
Sec. 170.3(n)(13) of this chapter; meat products as defined in 
Sec. 170.3(n)(29) of this chapter; milk products as defined in 
Sec. 170.3(n)(31) of this chapter; and poultry products as defined in 
Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant 
formulas in accordance with section 412(g) of the Federal Food, Drug, 
and Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 19166, May 7, 1985]



Sec. 184.1461  Manganese sulfate.

    (a) Manganese sulfate (MnSO4H2O, CAS Reg. No. 
7785-87-7) is a pale pink, granular, odorless powder. It is obtained by 
reacting manganese compounds with sulfuric acid. It is also obtained as 
a byproduct in the manufacture of hydroquinone. Other manufacturing 
processes include the action of sulfur dioxide on a slurry of manganese 
dioxide in sulfuric acid, and the roasting of pyrolusite (MnO2) ore 
with solid ferrous sulfate and coal, followed by leaching and 
crystallization.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 188, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 489]]

manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe (GRAS) as a direct human food ingredient is based 
upon the following current good manufacturing practice conditions of 
use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter; fish products as defined in 
Sec. 170.3(n(13) of this chapter; meat products as defined in 
Sec. 170.3(n)(29) of this chapter; milk products as defined in 
Sec. 170.3(n)(31) of this chapter; and poultry products as defined in 
Sec. 170.3(n)(34) of this chapter.

The ingredient may be used in infant formulas in accordance with section 
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with 
regulations promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 19166, May 7, 1985]



Sec. 184.1472  Hydrogenated and partially hydrogenated menhaden oils.

    (a) Partially hydrogenated and hydrogenated menhaden oils are 
prepared by feeding hydrogen gas under pressure to a converter 
containing crude menhaden oil and a nickel catalyst. The reaction is 
begun at 150 to 160  deg.C and after 1 hour the temperature is raised to 
180  deg.C until the desired degree of hydrogenation is reached. 
Hydrogenated menhaden oil is fully hydrogenated.
    (b) Partially hydrogenated and hydrogenated menhaden oils meet the 
following specifications:
    (1) Color. Opaque white solid.
    (2) Odor. Odorless.
    (3) Saponification value. Between 180 and 200.
    (4) Iodine number. Not more than 85 for partially hydrogenated 
menhaden oil and not more than 10 for fully hydrogenated menhaden oil.
    (5) Unsaponifiable matter. Not more than 1.5 percent.
    (6) Free fatty acids. Not more than 0.1 percent.
    (7) Peroxide value. Not more than 5 milliequivalents per kilogram of 
oil.
    (8) Nickel. Not more than 0.5 part per million.
    (9) Mercury. Not more than 0.5 part per million.
    (10) Arsenic (as As). Not more than 0.1 part per million.
    (11) Lead. Not more than 0.1 part per million.
    (c) Partially hydrogenated and hydrogenated menhaden oils are used 
as edible fats or oils, as defined in Sec. 170.3(n)(12) of this chapter, 
in food at levels not to exceed current good manufacturing practice.
    (d) If the fat or oil is fully hydrogenated, the name to be used on 
the label of a product containing it shall include the term 
``hydrogenated,'' or if it is partially hydrogenated, the name shall 
include the term ``partially hydrogenated,'' in accordance with 
Sec. 101.4(b)(14) of this chapter.


[54 FR 38223, Sept. 15, 1989]



Sec. 184.1490   Methylparaben.

    (a) Methylparaben is the chemical methyl p-hydroxybenzoate. It is 
produced by the methanol esterification of p-hydroxybenzoic acid in the 
presence of sulfuric acid, with subsequent distillation.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 199, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practices. Current good manufacturing practice results in 
a maximum level of 0.1 percent in food.
    (e) Prior sanctions for this ingredient different from the uses 
established in

[[Page 490]]

this regulation do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]



Sec. 184.1498  Microparticulated protein product.

    (a) Microparticulated protein product is prepared from egg whites or 
milk protein or a combination of egg whites and milk protein. These 
protein sources may be used alone or in combination with other safe and 
suitable ingredients to form the microparticulated product. The mixture 
of ingredients is high-shear heat processed to achieve a smooth and 
creamy texture similar to that of fat. Safe and suitable ingredients 
used in the preparation of the microparticulated protein product must be 
used in compliance with the limitations of the appropriate regulations 
in parts 172, 182, and 184 of this chapter.
    (b) The ingredient is used in food in accordance with 
Sec. 184.1(b)(2) at levels not to exceed current good manufacturing 
practice. The affirmation of the use of this ingredient as generally 
recognized as safe (GRAS) as a direct human food ingredient is based 
upon the following conditions of use:
    (1) The ingredient is used in food as a thickener as defined in 
Sec. 170.3(o)(28) of this chapter or as a texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (2) The ingredient is used in frozen dessert-type products except 
that the ingredient may not be used to replace the milk fat required in 
standardized frozen desserts.
    (3) The name of the ingredient used in the ingredient statement on 
both bulk and packaged food must include the source of the protein 
(e.g., ``microparticulated egg white protein''), followed by a 
parenthetical listing of each of the ingredients in the 
microparticulated protein product, in descending order of predominance. 
Microparticulated protein product must be used in accordance with this 
requirement or its addition to food will be considered by FDA to 
constitute the use of an unapproved food additive (see 
Sec. 184.1(b)(2)).

[55 FR 6391, Feb. 23, 1990]



Sec. 184.1505  Mono- and diglycerides.

    (a) Mono- and diglycerides consist of a mixture of glyceryl mono- 
and diesters, and minor amounts of triesters, that are prepared from 
fats or oils or fat-forming acids that are derived from edible sources. 
The most prevalent fatty acids include lauric, linoleic, myristic, 
oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by 
the reaction of glycerin with fatty acids or the reaction of glycerin 
with triglycerides in the presence of an alkaline catalyst. The products 
are further purified to obtain a mixture of glycerides, free fatty 
acids, and free glycerin that contains at least 90 percent-by-weight 
glycerides.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20005.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as a dough strengthener as 
defined in Sec. 170.3(o)(6) of this chapter; an emulsifier and 
emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter; a 
flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this 
chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this 
chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18) 
of this chapter; a solvent and vehicle as defined in Sec. 170.3(o)(27) 
of this chapter; a stabilizer and thickener as defined in 
Sec. 170.3(o)(28) of this chapter; a surface-active agent as defined in 
Sec. 170.3(o)(29) of this chapter; a surface-finishing agent as defined 
in Sec. 170.3(o)(30) of this chapter; and a texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.

[[Page 491]]

    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar.27, 1992]



Sec. 184.1521  Monosodium phosphate derivatives of mono- and diglycerides.

    (a) Monosodium phophate derivatives of mono- and diglycerides are 
composed of glyceride derivatives formed by reacting mono- and 
diglycerides that are derived from edible sources with phosphorus 
pentoxide (tetraphosphorus decoxide) followed by neutralization with 
sodium carbonate.
    (b) FDA is developing food-grade specifications for monosodium 
phosphate mono- and diglycerides in cooperation with the National 
Academy of Sciences. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as an emulsifier and emulsifier 
salt as defined in Sec. 170.3(o)(8) of this chapter, a lubricant and 
release agent as defined in Sec. 170.3(o)(18) of this chapter, and as a 
surface-active agent as defined in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: dairy product analogs as 
defined in Sec. 170.3(n)(10) of this chapter and soft candy as defined 
in Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[54 FR 7404, Feb. 21, 1989]



Sec. 184.1530  Niacin.

    (a) Niacin (C6H5NO2, CAS Reg. No. 59-67-6) is the 
chemical 3-pyridinecarboxylic acid (nicotinic acid). It is a non-
hygroscopic, stable, white, crystalline solid that sublimes without 
decomposition at about 230 deg. C. It is soluble in water and alcohol. 
It is insoluble in ether.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 205, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may also be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]



Sec. 184.1535  Niacinamide.

    (a) Niacinamide (C6H6N2O, CAS Reg. No. 98-92-0) is 
the chemical 3-pyridinecarboxylic acid amide (nicotinamide). It is a 
white crystalline powder that is soluble in water, alcohol, ether, and 
glycerol. It melts between 128 deg. and 131 deg. C.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex,

[[Page 492]]

3d Ed. (1981), p. 205, which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may also be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]



Sec. 184.1537  Nickel.

    (a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from 
nickel ore by transforming it to nickel sulfide (Ni3S2). The 
sulfide is roasted in air to give nickel oxide (NiO). The oxide is then 
reduced with carbon to give elemental nickel.
    (b) The Food and Drug Administration is developing food-grade 
specifications for nickel in cooperation with the National Academy of 
Sciences. In the interim, this ingredient must be of a purity suitable 
for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a catalyst as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in the hydrogenation of fats and oils as 
defined in Sec. 170.3(n)(12) of this chapter at levels not to exceed 
current good manufacturing practice. Current good manufacturing practice 
includes the removal of nickel from fats and oils following 
hydrogenation.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51618, Nov. 10, 1983]



Sec. 184.1538  Nisin preparation.

    (a) Nisin preparation is derived from pure culture fermentations of 
certain strains of Streptococcus lactis Lancefield Group N. Nisin 
preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related 
peptides with antibiotic activity.
    (b) The ingredient is a concentrate or dry material that meets the 
specifications that follow when it is tested as described in 
``Specifications for Identity and Purity of Some Antibiotics,'' World 
Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969, 
which is incorporated by reference. Copies are available from the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (1) Nisin content, not less than 900 international units per 
milligram.
    (2) Arsenic, not more than 1 part per million.
    (3) Lead, not more than 2 parts per million.
    (4) Zinc, not more than 25 parts per million.
    (5) Copper, zinc plus copper not more than 50 parts per million.
    (6) Total plate count, not more than 10 per gram.
    (7) Escherichia coli, absent in 10 grams.
    (8) Salmonella, absent in 10 grams.
    (9) Coagulase positive staphylococci, absent in 10 grams.

[[Page 493]]

    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter to inhibit the outgrowth of Clostridium 
botulinum spores and toxin formation in pasteurized cheese spreads and 
pasteurized process cheese spreads listed in Sec. 133.175; pasteurized 
cheese spread with fruits, vegetables, or meats as defined in 
Sec. 133.176; pasteurized process cheese spread as defined in 
Sec. 133.179; pasteurized process cheese spread with fruits, vegetables, 
or meats as defined in Sec. 133.180 of this chapter.
    (d) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1) of this 
chapter. The current good manufacturing practice level is the quantity 
of the ingredient that delivers a maximum of 250 parts per million of 
nisin in the finished product as determined by the British Standards 
Institution Methods, ``Methods for the Estimation and Differentiation of 
Nisin in Processed Cheese,'' BS 4020 (1974), which is incorporated by 
reference. Copies are available from the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.

[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994]



Sec. 184.1540  Nitrogen.

    (a) Nitrogen (empirical formula N2, CAS Reg. No. 7727-37-9) is 
a colorless, odorless, flavorless gas that is produced commercially by 
the fractionation of liquid air.
    (b) The Food and Drug Administration is developing food-grade 
specifications for nitrogen in cooperation with the National Academy of 
Sciences. In the interim, the ingredient must be of a purity suitable 
for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a propellant, aerating agent, and gas 
as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]



Sec. 184.1545  Nitrous oxide.

    (a) Nitrous oxide (empirical formula N2O, CAS Reg. No. 10024-
97-2) is also known as dinitrogen monoxide or laughing gas. It is a 
colorless gas, about 50 percent heavier than air, with a slightly sweet 
smell. It does not burn but will support combustion. Nitrous oxide is 
manufactured by the thermal decomposition of ammonium nitrate. Higher 
oxides of nitrogen are removed by passing the dry gas through a series 
of scrubbing towers.
    (b) The Food and Drug Administration is developing food-grade 
specifications for nitrous oxide in cooperation with the National 
Academy of Sciences. In the interim, the ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a propellant, aerating agent, and gas 
as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredient is used in dairy product analogs as defined in 
Sec. 170.3(n)(10) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 57270, Dec. 29, 1983]



Sec. 184.1553  Peptones.

    (a) Peptones are a variable mixture of polypeptides, oligopeptides, 
and

[[Page 494]]

amino acids that are produced by partial hydrolysis of casein, animal 
tissue, soy protein isolate, gelatin, defatted fatty tissue, egg 
albumin, or lactalbumin (whey protein). Peptones are produced from these 
proteins using proteolytic enzymes that either are considered to be 
generally recognized as safe (GRAS) or are regulated as food additives. 
Peptones are also produced by denaturing any of the proteins listed in 
this paragraph with safe and suitable acids or heat.
    (b) FDA is developing food-grade specifications for peptones in 
cooperation with the National Academy of Sciences. In the interim, these 
ingredients must be of a purity suitable for their intended use.
    (c) In accordance with Sec. 184.1(b)(1), these ingredients are used 
in food with no limitation other than current good manufacturing 
practice. The affirmation of these ingredients as GRAS as direct human 
food ingredients is based upon the following current good manufacturing 
practice conditions of use:
    (1) These ingredients are used as nutrient supplements as defined in 
Sec. 170.3(o)(20) of this chapter; as processing aids as defined in 
Sec. 170.3(o)(24) of this chapter; and as surface-active agents as 
defined in Sec. 170.3(o)(29) of this chapter.
    (2) These ingredients are used in food at levels not to exceed 
current good manufacturing practice.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985]



Sec. 184.1555  Rapeseed oil.

    (a) Fully hydrogenated rapeseed oil. (1) Fully hydrogenated rapeseed 
oil is a mixture of triglycerides in which the fatty acid composition is 
a mixture of saturated fatty acids. The fatty acids are present in the 
same porportions which result from the full hydrogenation of fatty acids 
occurring in natural rapeseed oil. The rapeseed oil is obtained from the 
napus and campestris varieties of Brassica of the family Cruciferae. It 
is prepared by fully hydrogenating refined and bleached rapeseed oil at 
310-375 deg. F, using a catalyst such as nickel, until the iodine number 
is 4 or less.
    (2) The ingredient meets the following specifications: Acid value 
not more than 6, arsenic not more than 3 parts per million, free 
glycerin not more than 7 percent, heavy metals (as Pb) not more than 10 
parts per million, iodine number not more than 4, residue on ignition 
not more than 0.5 percent.
    (3) The ingredient is used as a stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter in peanut butter. The use level of 
the ingredient is limited by good manufacturing practice (GMP) to the 
minimum amount required to produce the intended effect. Current good 
manufacturing practices result in a maximum level of 2 percent in peanut 
butter.
    (b) Superglycerinated fully hydrogenated rapeseed oil. (1) 
Superglycerinated fully hydrogenated rapeseed oil is a mixture of mono- 
and diglycerides with triglycerides as a minor component. The fatty acid 
composition is a mixture of saturated fatty acids present in the same 
proportions as those resulting from the full hydrogenation of fatty 
acids in natural rapeseed oil. It is made by adding excess glycerol to 
the fully hydrogenated rapeseed oil and heating, in the presence of a 
sodium hydroxide catalyst, to 330 deg. F under partial vacuum and steam 
sparging agitation.
    (2) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 201, relating to mono- and diglycerides, 
which is incorporated by reference. Copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408. An 
additional specification requires the iodine number to be 4 or less.
    (3) The ingredient is used as an emulsifier as defined in 
Sec. 170.3(o)(8) of this chapter in shortenings for cake mixes. The use 
level of the ingredient is limited by good manufacturing practice (GMP) 
to the minimum amount required to produce the intended effect. Current 
good manufacturing practices result in a maximum level, as served, of 4 
percent of the shortening or 0.5

[[Page 495]]

percent of the total weight of the cake mix.
    (c) Low erucic acid rapeseed oil. (1) Low erucic acid rapeseed oil, 
also known as canola oil, is the fully refined, bleached, and deodorized 
edible oil obtained from certain varieties of Brassica Napus or B. 
Campestris  of the family Cruciferae. The plant varieties are those 
producing oil-bearing seeds with a low erucic acid content. Chemically, 
low erucic acid rapeseed oil is a mixture of triglycerides, composed of 
both saturated and unsaturated fatty acids, with an erucic acid content 
of no more than 2 percent of the component fatty acids.
    (2) Low erucic acid rapeseed oil as defined in paragraph (c)(1) of 
this section may be partially hydrogenated to reduce the proportion of 
unsaturated fatty acids. When the partially hydrogenated low erucic acid 
rapeseed oil is used, it shall be referred to as partially hydrogenated 
low erucic acid rapeseed oil.
    (3) In addition to limiting the content of erucic acid to a level 
not exceeding 2 percent of the component fatty acids, FDA is developing 
other food-grade specifications for low erucic acid rapeseed oil and 
partially hydrogenated low erucic acid rapeseed oil in cooperation with 
the National Academy of Sciences. In the interim, the ingredients must 
be of a purity suitable for their intended use.
    (4) Low erucic acid rapeseed oil and partially hydrogenated low 
erucic acid rapeseed oil are used as edible fats and oils in food, 
except in infant formula, at levels not to exceed current good 
manufacturing practice.

[42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 
50 FR 3755, Jan. 28, 1985; 53 FR 52682, Dec. 29, 1988]



Sec. 184.1560  Ox bile extract.

    (a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified 
oxgall or sodium choleate, is a yellowish green, soft solid, with a 
partly sweet, partly bitter, disagreeable taste. It is the purified 
portion of the bile of an ox obtained by evaporating the alcohol extract 
of concentrated bile.
    (b) Food-grade ox bile extract shall meet the specifications of the 
U.S. Pharmacopeia (USP), XIV, 1950, p. 410.\1\
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: U.S. Pharmacopeial Convention, 
Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
---------------------------------------------------------------------------

    (c) The ingredient is used as a surfactant as defined in Sec. 170.3 
(o)(29) of this chapter.
    (d) The ingredient is used in food in accordance with 
Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice. 
Current good manufacturing practice results in a maximum level, as 
served, of 0.002 percent for cheese as defined in Sec. 170.3(n)(5) of 
this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, 
Dec. 3, 1985]



Sec. 184.1563  Ozone.

    (a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable blue gas 
with a pungent, characteristic odor, which occurs freely in nature, It 
is produced commercially by passing electrical discharges or ionizing 
radiation through air or oxygen.
    (b) The ingredient must be of a purity suitable for its intended use 
in accordance with Sec. 170.30(h)(1) of this chapter.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to 
treat food only within the following specific limitations:

------------------------------------------------------------------------
                                   Maximum treatment                    
        Category of food             level in food      Functional use  
------------------------------------------------------------------------
Bottled water that prior to       Not to exceed       Antimicrobial     
 ozonation meets the               current good        agent, Sec.      
 microbiological, physical,        manufacturing       170.3 (o)(2) of  
 chemical, and radiological        practice. Current   this chapter.    
 quality standards of Sec.         good                                 
 165.110 (b)(2) through (b)(5)     manufacturing                        
 of this chapter.                  practice results                     
                                   in a maximum                         
                                   residual level at                    
                                   the time of                          
                                   bottling of 0.4                      
                                   milligram of                         
                                   ozone per liter                      
                                   of bottled water.                    
------------------------------------------------------------------------


[47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995]

    Effective Date Note: At 60 FR 57130, Nov. 13, 1995, Sec. 184.1563 
was amended by revising

[[Page 496]]

paragraph (c), effective May 13, 1996. For the convenience of the user 
the superseded text appears as set forth below.
Sec. 184.1563  Ozone.

                                * * * * *

    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to 
treat food only within the following specific limitations:

                                                                        
------------------------------------------------------------------------
                                  Maximum treatment                     
        Category of food            level in food       Functional use  
------------------------------------------------------------------------
Bottled water that prior to      Not to exceed        Antimicrobial     
 ozonation meets the              current good         agent, Sec.      
 microbiological, physical,       manufacturing        170.3 (o)(2) of  
 chemical, and radiological       practice. Current    this chapter.    
 quality standards of Sec.        good manufacturing                    
 103.35 (b) through (e) of this   practice results                      
 chapter.                         in a maximum                          
                                  residual level at                     
                                  the time of                           
                                  bottling of 0.4                       
                                  milligram of ozone                    
                                  per liter of                          
                                  bottled water.                        
------------------------------------------------------------------------



Sec. 184.1583  Pancreatin.

    (a) Pancreatin (CAS Reg. No. 8049-47-6) is an enzyme preparation 
obtained from porcine or bovine pancreatic tissue. It is a white to tan 
powder. Its characterizing enzyme activity that of a peptide hydrolase 
(EC 3.4.21.36).
    (b) The ingredient meets the general requirements and additional 
requirements in the Food Chemicals Codex, 3d ed. (1981), p. 110, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of Premarket Approval (HFS-200), Food and Drug Administration, 
200 C St. SW., Washington, DC, and the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]



Sec. 184.1585  Papain.

    (a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived 
from Carica papaya L. Crude latex containing the enzyme is collected 
from slashed unripe papaya. The food-grade product is obtained by 
repeated filtration of the crude latex or an aqueous solution of latex 
or by precipitation from an aqueous solution of latex. The resulting 
enzyme preparation may be used in a liquid or dry form.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 107-110, which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Ave. NW., Washington, DC 20418, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than currect good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter; processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 48806, Oct. 21, 1983]



Sec. 184.1588  Pectins.

    (a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex, 
high molecular weight polysaccharides found in plants and composed 
chiefly of partially methylated polygalacturonic acid units. Portions of 
the carboxly

[[Page 497]]

group occur as methyl esters, and the remaining carboxyl groups exist in 
the form of the free acid or as its ammonium, potassium, or sodium (CAS 
Reg. No. 9000-59-8) salts, and in some types as the acid amide. Thus, 
the pectins regulated in this section are the high-ester pectins, low-
ester pectins, amidated pectins, pectinic acids, and pectinates. Pectin 
is produced commercially by extracting citrus peel, apple pomace, or 
beet pulp with hot dilute acid (pH 1.0 to 3.5, 70 deg. to 90 deg. C). 
The extract is filtered, and pectin is then precipitated from the clear 
extract with ethanol or isopropanol, or as the copper or aluminum salt. 
The acid extract is sometimes spray- or roller-dried, or it is 
concentrated to be sold as liquid pectin.
    (b) The ingredients meet the specifications of the Food Chemical 
Codex, 3d Ed. (1981), p. 215, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of these ingredients as generally recognized as safe 
(GRAS) as direct human food ingredients is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredients are used as emulsifiers as defined in 
Sec. 170.3(o)(8) of this chapter and as stabilizers and thickeners as 
defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredients are used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[48 FR 51149, Nov. 7, 1983]



Sec. 184.1595  Pepsin.

    (a) Pepsin (CAS Reg. No. 9001-75-6) is an enzyme preparation 
obtained from the glandular layer of hog stomach. It is a white to light 
tan powder, amber paste, or clear amber to brown liquid. Its 
characterizing enzyme activity is that of a peptide hydrolase (EC 
3.4.23.1).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]



Sec. 184.1610  Potassium alginate.

    (a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium 
salt of alginic acid, a natural polyuronide constituent of certain brown 
algae. Potassium alginate is prepared by the neutralization of purified 
alginic acid with appropriate pH control agents.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

[[Page 498]]


                                                                        
------------------------------------------------------------------------
                                       Maximum                          
                                       level of                         
                                        use in                          
          Category of food             food (as       Functional use    
                                       served)                          
                                      (percent)                         
------------------------------------------------------------------------
Confections and frostings, Sec.             0.1  Stabilizer, thickener, 
 170.3(n)(9) of this chapter..                    Sec.  170.3(o)(28) of 
                                                  this chapter          
Gelatins and puddings, Sec.                 0.7      Do.                
 170.3(n)(22) of this chapter.                                          
Processed fruits and fruit juices,         0.25      Do.                
 Sec.  170.3(n)(35) of this chapter.                                    
All other food categories...........       0.01      Do.                
------------------------------------------------------------------------

    (d) Prior sanctions for potassium alginate different from the uses 
established in this section do not exist or have been waived.

[47 FR 29951, July 9, 1982]



Sec. 184.1613  Potassium bicarbonate.

    (a) Potassium bicarbonate (KHCO3, CAS Reg. No. 298-14-6) is 
made by the following processes:
    (1) By treating a solution of potassium hydroxide with carbon 
dioxide;
    (2) By treating a solution of potassium carbonate with carbon 
dioxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; nutrient supplemlent as defined in 
Sec. 170.3(o)(20) of this chapter; pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter; and processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52442, Nov. 18, 1983]



Sec. 184.1619  Potassium carbonate.

    (a) Potassium carbonate (K2CO3, CAS Reg. No. 584-08-7) is 
produced by the following methods of manufacture:
    (1) By electrolysis of potassium chloride followed by exposing the 
resultant potassium to carbon dioxide;
    (2) By treating a solution of potassium hydroxide with excess carbon 
dioxide to produce potassium carbonate;
    (3) By treating a solution of potassium hydroxide with carbon 
dioxide to produce potassium bicarbonate, which is then heated to yield 
potassium carbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 240, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, D.C. 20418, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
the affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as a flavoring agent and adjuvant 
as defined in Sec. 170.3(o)(12) of this chapter; nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter; pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter; and processing aid as 
defined in Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 499]]

this section do not exist or have been waived.

[48 FR 52442, Nov. 18, 1983]



Sec. 184.1622   Potassium chloride.

    (a) Potassium chloride (KCl, CAS Reg. No. 7447-40-7) is a white, 
odorless solid prepared from source minerals by fractional 
crystallization or flotation. It is soluble in water and glycerol and 
has a saline taste at low concentration levels.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 241, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; as a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter; as a nutrient supplement as defined 
in Sec. 170.3(o)(20) of this chapter; as a pH control agent as defined 
in Sec. 170.3(o)(23) of this chapter; and as a stabilizer or thickener 
as defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Potassium chloride may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51614, Nov. 10, 1983]



Sec. 184.1625  Potassium citrate.

    (a) Potassium citrate (C6H5K3O7 .H2O, 
CAS Reg. No. 006100-05-6) is the potassium salt of citric acid. It is 
prepared by neutralizing citric acid with potassium hydroxide or 
potassium carbonate. It occurs as transparent crystals or a white 
granular powder, is odorless and deliquescent, and contains one mole of 
water per mole of potassium citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), p. 242, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., Washington, 
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 200 C St. SW., Washington, DC 20204, or may be examined at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]



Sec. 184.1631  Potassium hydroxide.

    (a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known 
as caustic potash, potash lye, and potassa. The empirical formula is 
KOH. It is a white, highly deliquescent caustic solid, which is marketed 
in several forms, including pellets, flakes, sticks, lumps, and powders. 
Potassium hydroxide is obtained commercially from the electrolysis of 
potassium chloride solution in the presence of a porous diaphragm.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available from inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 500]]

manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe (GRAS) as a direct human food ingredient is based 
upon the following current good manufacturing practice conditions of 
use:
    (1) The ingredient is used as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; a pH control agent as defined in 
Sec. 170.3(o)(23) of the chapter; a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as 
defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52444, Nov. 18, 1983]



Sec. 184.1634  Potassium iodide.

    (a) Potassium iodide (KI, CAS Reg. No. 7681-11-0) is the potassium 
salt of hydriodic acid. It occurs naturally in sea water and in salt 
deposits, but can be prepared by reacting hydriodic acid (HI) with 
potassium bicarbonate (KHCO3).
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 246-247, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (d) The ingredient is used in table salt in accordance with 
Sec. 184.1(b)(2) of this chapter as a source of dietary iodine at a 
maximum level of 0.01 percent.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 61 
FR 14247, Apr. 1, 1996]



Sec. 184.1635  Potassium iodate.

    (a) Potassium iodate (KIO3, CAS Reg. No. 7758-05-6) does not 
occur naturally but can be prepared by reacting iodine with potassium 
hydroxide.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 245-246, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter.
    (d) The ingredient is used in the manufacture of bread in accordance 
with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 
percent based on the weight of the flour.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1983]



Sec. 184.1639  Potassium lactate.

    (a) Potassium lactate (C3H5O3K, CAS Reg. No. 996-31-
6) is the potassium salt of lactic acid. It is a hydroscopic, white, 
odorless solid and is prepared commercially by the neutralization of 
lactic acid with potassium hydroxide.
    (b) FDA is developing food-grade specifications for potassium 
lactate in cooperation with the National Academy of Sciences. In the 
interim, this ingredient must be of a purity suitable for its intended 
use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
This regulation does not authorize its use in infant foods and infant 
formulas. The affirmation of this ingredient as generally recognized as 
safe (GRAS) as a direct human food ingredient is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as 
defined in Sec. 170.3(o)(12) of this

[[Page 501]]

chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter; 
and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[52 FR 10886, Apr. 6, 1987]



Sec. 184.1643  Potassium sulfate.

    (a) Potassium sulfate (K2SO4, CAS Reg. No. 7778-80-5) 
occurs naturally and consists of colorless or white crystals or 
crystalline powder having a bitter, saline taste. It is prepared by the 
neutralization of sulfuric acid with potassium hydroxide or potassium 
carbonate.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 252, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with Sec. 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.015 
percent for nonalcoholic beverages as defined in Sec. 170.3(n)(3) of 
this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[45 FR 6086, Jan. 25, 1980, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 184.1655  Propane.

    (a) Propane (empirical formula C3H8, CAS Reg. No. 74-98-6) 
is also known as dimethylmethane or propyl hydrid. It is a colorless, 
odorless, flammable gas at normal temperatures and pressures. It is 
easily liquefied under pressure at room temperature and is stored and 
shipped in the liquid state. Propane is obtained from natural gas by 
fractionation following absorption in oil, adsorption to surface-active 
agents, or refrigeration.
    (b) The Food and Drug Administration is developing food-grade 
specifications for propane in cooperation with the National Academy of 
Sciences. In the interim, the ingredient must be of a purity suitable 
for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a propellant, aerating agent, and gas 
as defined in Sec. 170.3(o)(25) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 57271, Dec. 29, 1983]



Sec. 184.1660   Propyl gallate.

    (a) Propyl gallate is the n-propylester of 3,4,5-trihydroxybenzoic 
acid (C10H12O5). Natural occurrence of propyl gallate has 
not been reported. It is commercially prepared by esterification of 
gallic acid with propyl alcohol followed by distillation to remove 
excess alcohol.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 257-258, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice in accordance with

[[Page 502]]

Sec. 184.1(b)(1). Good manufacturing practice results in a maximum total 
content of antioxidants of 0.02 percent of the fat or oil content, 
including the essential (volatile) oil content, of the food.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section, or different from that stated in part 181 
of this chapter, do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11, 1979; 
49 FR 5613, Feb. 14, 1984]



Sec. 184.1666  Propylene glycol.

    (a) Propylene glycol (C3H8O2,!CAS Reg. No. 57-55-6) 
is known as 1,2-propanediol. It does not occur in nature. Propylene 
glycol is manufactured by treating propylene with chlorinated water to 
form the chlorohydrin which is converted to the glycol by treatment with 
sodium carbonate solution. It is also prepared by heating glyercol with 
sodium hydroxide.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 255, which is incorporated by reference. Copies 
may be obtained from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418. It is also available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an anticaking agent as defined in 
Sec. 170.3(o)(1) of this chapter; antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; dough strengthener as defined in 
Sec. 170.3(o)(6) of this chapter; emulsifier as defined in 
Sec. 170.3(o)(8) of this chapter; flavor agent as defined in 
Sec. 170.3(o)(12) of this chapter; formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; humectant as defined in 
Sec. 170.3(o)(16) of this chapter; processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; solvent and vehicle as defined in 
Sec. 170.3(o)(27) of this chapter; stabilizer and thickener as defined 
in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in 
Sec. 170.3(o)(29) of this chapter; and texturizer as defined in 
Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current 
good manufacturing practice results in maximum levels, as served, of 5 
percent for alcoholic beverages, as defined in Sec. 170.3(n)(2) of this 
chapter; 24 percent for confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter; 2.5 percent for frozen dairy products 
as defined in Sec. 170.3(n)(20) of this chapter; 97 percent for 
seasonings and flavorings as defined in Sec. 170.3(n)(26) of this 
chapter; 5 percent for nuts and nut products as defined in 
Sec. 170.3(n)(32) of this chapter; and 2.0 percent for all other food 
categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27812, June 25, 1982]



Sec. 184.1670   Propylparaben.

    (a) Propylparaben is the chemical propyl p-hydroxybenzoate. It is 
produced by the n-propanol esterification of p-hydroxybenzoic acid in 
the presence of sulfuric acid, with subsequent distillation.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 258, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practices. Current good manufacturing practice results in 
a maximum level of 0.1 percent in food.
    (e) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 184.1676  Pyridoxine hydrochloride.

    (a) Pyridoxine hydrochloride (C8H11NO3HC1, 
CAS Reg. No. 58-56-0) is the chemical

[[Page 503]]

3-hydroxy-4,5-dihydroxymethy-2-methylpyridine hydrochloride that is 
prepared by chemical synthesis.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 260, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage 
bases as defined in Sec. 170.3(n)(3) of this chapter; breakfast cereals 
as defined in Sec. 170.3(n)(4) of this chapter; dairy product analogs as 
defined in Sec. 170.3(n)(10) of this chapter; meat products as defined 
in Sec. 170.3(n)(29) of this chapter; milk products as defined in 
Sec. 170.3(n)(31) of this chapter; plant protein products as defined in 
Sec. 170.3(n)(33) of this chapter; and snack foods as defined in 
Sec. 170.3(n)(37) of this chapter. Pyridoxine hydrochloride may be used 
in infant formula in accordance with section 412(g) of the Federal Food, 
Drug, and Cosmetic Act (the Act) or with regulations promulgated under 
section 412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51615, Nov. 10, 1983]



Sec. 184.1685  Rennet (animal-derived) and chymosin preparation (fermentation-derived).

    (a)(1) Rennet and bovine rennet are commercial extracts containing 
the active enzyme rennin (CAS Reg. No. 9001-98-3), also known as 
chymosin (International Union of Biochemistry Enzyme Commission (E.C.) 
3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen, 
salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs. 
Bovine rennet is the product from adults of the animals listed above. 
Both products are called rennet and are clear amber to dark brown liquid 
preparations or white to tan powders.
    (2) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Escherichia coli K-12 
containing the prochymosin gene. The prochymosin is isolated as an 
insoluble aggregate that is acid-treated to destroy residual cellular 
material and, after solubilization, is acid-treated to form chymosin. It 
must be processed with materials that are generally recognized as safe, 
or are food additives that have been approved by the Food and Drug 
Administration for this use.
    (3) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety 
lactis, containing the prochymosin gene. The prochymosin is secreted by 
cells into fermentation broth and converted to chymosin by acid 
treatment. All materials used in the processing and formulating of 
chymosin must be either generally recognized as safe (GRAS), or be food 
additives that have been approved by the Food and Drug Administration 
for this use.
    (4) Chymosin preparation is a clear solution containing the active 
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a 
nonpathogenic and nontoxigenic strain of Aspergillus niger van Tieghem 
variety awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa) 
containing the prochymosin gene. Chymosin is recovered from the 
fermentation broth after acid treatment. All materials used in the 
processing and formulating of chymosin preparation must be either 
generally recognized as safe (GRAS) or

[[Page 504]]

be food additives that have been approved by the Food and Drug 
Administration for this use.
    (b) Rennet and chymosin preparation meet the general and additional 
requirements for enzyme preparations of the ``Food Chemicals Codex,'' 3d 
Ed. (1981), pp. 107-110, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies are available from the National 
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or 
are available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 505]]

manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe as a direct human food ingredient is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter; a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as 
defined in Sec. 170.3(o)(28) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: In cheeses as defined in 
Sec. 170.3(n)(5) of this chapter; frozen dairy desserts and mixes as 
defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings, and 
fillings as defined in Sec. 170.3(n)(22) of this chapter; and milk 
products as defined in Sec. 170.3(n)(31) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992; 58 
FR 27202, May 7, 1993]



Sec. 184.1695  Riboflavin.

    (a) Riboflavin (C17H20N4O6, CAS Reg. No. 83-88-
5) occurs as yellow to orange-yellow needles that are crystallized from 
2N acetic acid, alcohol, water, or pyridine. It may be prepared by 
chemical synthesis, biosynthetically by the organism Eremothecium 
ashbyii, or isolated from natural sources.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 262, which is incorporated by reference. Copies 
are available from the National Academy Press,

[[Page 506]]

2101 Constitution Ave. NW., Washington, DC 20418, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may also be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51148, Nov. 7, 1983]



Sec. 184.1697  Riboflavin-5'-phosphate (sodium).

    (a) Riboflavin-5'-phosphate (sodium) 
(C17H20N4O9PNa2H2O, CAS Reg. No 130-40-
5) occurs as the dihydrate in yellow to orange-yellow crystals. It is 
prepared by phosphorylation of riboflavin with chlorophosphoric acid, 
pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic 
phosphate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 263, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in milk products, as defined in 
Sec. 170.3(n)(31) of this chapter, at levels not to exceed current good 
manufacturing practice. The ingredient may also be used in infant 
formulas in accordance with section 412(g) of the Federal Food, Drug, 
and Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51148, Nov. 7, 1983]



Sec. 184.1698  Rue.

    (a) Rue is the perennial herb of several species of Ruta (Ruta 
montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis 
L.). The leaves, buds, and stems from the top of the plant are gathered, 
dried, and then crushed in preparation for use, or left whole.
    (b) The ingredient is used in all categories of food in accordance 
with Sec. 184.1(b)(2) of this chapter at concentrations not to exceed 2 
parts per million.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 3705, Jan. 27, 1978]



Sec. 184.1699   Oil of rue.

    (a) Oil of rue is the natural substance obtained by steam 
distillation of the fresh blossoming plants of rue, the perennial herb 
of several species of Ruta--Ruta montana L., Ruta graveolens L., Ruta 
bracteosa L., and Ruta calepensis L.
    (b) Oil of rue meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 266, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used in food under the following conditions:

                     Maximum Usage Levels Permitted                     
------------------------------------------------------------------------
                                Parts per                               
       Food (as served)          million              Function          
------------------------------------------------------------------------
Baked goods and baking mixes,          10  Flavoring agent and adjuvant,
 Sec.  170.3(n)(1), of this                 Sec.  170.3(o)(12) of this  
 chapter.                                   chapter.                    
Frozen dairy desserts and              10      Do.                      
 mixes, Sec.  170.3 (n)(20)                                             
 of this chapter.                                                       
Soft candy, Sec.                       10      Do.                      
 170.3(n)(38) of this chapter.                                          
All other food categories....           4      Do.                      
------------------------------------------------------------------------

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 184.1721  Sodium acetate.

    (a) Sodium acetate (C2H3O2Na, CAS Reg. No. 127-09-3 
or C2H3O2Na3H2O, CAS Reg. No. 6131-90-4) is 
the sodium salt of acetic acid and occurs naturally in plant and animal 
tissues. Sodium acetate may occur in either the anhydrous or trihydrated 
form. It is produced synthetically by the neutralization of acetic acid 
with sodium carbonate or by treating calcium acetate with sodium sulfate 
and sodium bicarbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 272, 273 which is incorporated by reference. 
Copies are available from the National Academy Press, 2101 Constitution 
Ave. NW., Washington, DC 20418, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; and as a pH control agent 
as defined in Sec. 170.3(o)(23) of this chapter.
    (d) The ingredient is used in food at levels not to exceed current 
good manufacturing practice in accordance with 184.1(b)(1). Current good 
manufacturing practice results in a maximum level, as served, of 0.007 
percent for breakfast cereals as defined in Sec. 170.3(n)(4) of this 
chapter; 0.5 percent for fats and oils as defined in Sec. 170.3(n)(12) 
of this chapter; 0.6 percent for grain products and pastas as defined in 
Sec. 170.3(n)(23) of this chapter and snack foods as defined in 
Sec. 170.3(n)(37) of this chapter; 0.15 percent for hard candy as 
defined in Sec. 170.3(n)(25) of this chapter; 0.12 percent for jams and 
jellies as defined in Sec. 170.3(n)(28) of this chapter and meat 
products as defined in Sec. 170.3(n)(29) of this chapter; 0.2 percent 
for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.05 
percent for soups and soup mixes as defined in Sec. 170.3(n)(40) of this 
chapter and sweet sauces as defined in Sec. 170.3(n)(43) of this 
chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27815, June 25, 1982]



Sec. 184.1724  Sodium alginate.

    (a) Sodium alginate (CAS Reg. No. 9005-38-3) is the sodium salt of 
alginic acid, a natural polyuronide constituent of certain brown algae. 
Sodium alginate is prepared by the neutralization of purified alginic 
acid with appropriate pH control agents.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 274, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in 
food only within the following specific limitations:

------------------------------------------------------------------------
                                       Maximum                          
                                       level of                         
                                        use in                          
          Category of food             food (as       Functional use    
                                       served)                          
                                      (percent)                         
------------------------------------------------------------------------
Condiments and relishes, Sec.               1.0  Texturizer, Sec.       
 170.3(n)(8) of this chapter, except              170.3(o)(32) of this  
 pimento ribbon for stuffed olives.               chapter, formulation  
                                                  aid Sec.  170.3(o)(14)
                                                  of this chapter,      
                                                  stabilizer, thickener,
                                                  Sec.  170.3(o)(28) of 
                                                  this chapter.         
Pimento ribbon for stuffed olives...        6.0      Do.                
Confections and frostings, Sec.             0.3  Stabilizer, thickener, 
 170.3(n)(9) of this chapter.                     Sec.  170.3(o)(28) of 
                                                  this chapter.         
Gelatins and puddings, Sec.                 4.0  Firming agent, Sec.    
 170.3(n)(22) of this chapter.                    170.3(o)(10) of this  
                                                  chapter; flavor       
                                                  adjuvant, Sec.        
                                                  170.3(o)(12) of this  
                                                  chapter; stabilizer,  
                                                  thickener, Sec.       
                                                  170.3(o)(28) of this  
                                                  chapter.              
Hard candy, Sec.  170.3(n)(25) of          10.0  Stabilizer, thickener, 
 this chapter.                                    Sec.  170.3(o)(28) of 
                                                  this chapter.         
Processed fruits and fruit juices,          2.0  Formulation aid, Sec.  
 Sec.  170.3(n)(35) of this chapter.              170.3(o)(14) of this  
                                                  chapter; texturizer,  
                                                  Sec.  170.3(o)(32) of 
                                                  this chapter.         
All other food categories...........        1.0  Emulsifier, Sec.       
                                                  170.3(o)(8) of this   
                                                  chapter; firming      
                                                  agent, Sec.           
                                                  170.3(o)(10) of this  
                                                  chapter; flavor       
                                                  enhancer, Sec.        
                                                  170.3(o)(11) of this  
                                                  chapter; flavor       
                                                  adjuvant, Sec.        
                                                  170.3(o)(12) of this  
                                                  chapter; processing   
                                                  aid, Sec.             
                                                  170.3(o)(24) of this  
                                                  chapter; stabilizer   
                                                  and thickener, Sec.   
                                                  170.3(o)(28) of this  
                                                  chapter; surface      
                                                  active agent, Sec.    
                                                  170.3(o)(29) of this  
                                                  chapter.              
------------------------------------------------------------------------

    (d) Prior sanctions for sodium alginate different from the uses 
established in this section do not exist or have been waived.

[47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983]



Sec. 184.1733   Sodium benzoate.

    (a) Sodium benzoate is the chemical benzoate of soda 
(C7H5NaO2), produced

[[Page 507]]

by the neutralization of benzoic acid with sodium bicarbonate, sodium 
carbonate, or sodium hydroxide. The salt is not found to occur 
naturally.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 278, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant 
as defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practice. Current usage results in a maximum level of 0.1 
percent in food. (The Food and Drug Administration has not determined 
whether significally different conditions of use would be GRAS.)
    (e) Prior sanctions for this ingredient different from the uses 
established in this section, or different from that set forth in part 
181 of this chapter, do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 184.1736  Sodium bicarbonate.

    (a) Sodium bicarbonate (NaHCO3, CAS Reg. No. 144-55-8) is 
prepared by treating a sodium carbonate or a sodium carbonate and sodium 
bicarbonate solution with carbon dioxide. As carbon dioxide is absorbed, 
a suspension of sodium bicarbonate forms. The slurry is filtered, 
forming a cake which is washed and dried.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 278, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52442, Nov. 18, 1983]



Sec. 184.1742  Sodium carbonate.

    (a) Sodium carbonate (Na2CO3, CAS Reg. No. 497-19-8) is 
produced (1) from purified trona ore that has been calcined to soda ash; 
(2) from trona ore calcined to impure soda ash and then purified; or (3) 
synthesized from limestone by the Solvay process.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 280, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; curing and pickling agent as defined 
in Sec. 170.3(o)(5) of this chapter; flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter; and processing aid as 
defined in Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52442, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]



Sec. 184.1751  Sodium citrate.

    (a) Sodium citrate (C6H5Na3O7 .2H2O, 
CAS Reg. No. 68-04-2) is the sodium salt of citric acid. It is prepared 
by neutralizing citric acid with sodium

[[Page 508]]

hydroxide or sodium carbonate. The product occurs as colorless crystals 
or a white crystalline powder. It may be prepared in an anhydrous state 
or may contain two moles of water per mole of sodium citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 283-284, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., Washington, 
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 200 C St. SW., Washington, DC 20204, or may be examined at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63896, Dec. 12, 1994]



Sec. 184.1754  Sodium diacetate.

    (a) Sodium diacetate (C4H7O4NaxH2O, CAS 
Reg. No. 126-96-5) is a molecular compound of acetic acid, sodium 
acetate, and water of hydration. The technical grade is prepared 
synthetically by reacting sodium carbonate with acetic acid. Special 
grades are produced by reacting anhydrous sodium acetate and acetic 
acid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 284, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter; flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; and pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter.
    (d) The ingredient is used in food at levels not to exceed current 
good manufacturing practice in accordance with Sec. 184.1(b)(1). Current 
good manufacturing practice results in a maximum level, as served, 0.4 
percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 
0.1 percent for fats and oils as defined in Sec. 170.3(n)(12) of this 
chapter, meat products as defined in Sec. 170.3(n)(29) of this chapter 
and soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.25 
percent for gravies and sauces as defined in Sec. 170.3(n)(24) of this 
chapter; and 0.05 percent for snack foods as defined in 
Sec. 170.3(n)(37) of this chapter and soups and soup mixes as defined in 
Sec. 170.3(n)(40) of this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 27815, June 25, 1982]



Sec. 184.1763  Sodium hydroxide.

    (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310-73-2) is also known as 
sodium hydrate, soda lye, caustic soda, white caustic, and lye. The 
empirical formula is NaOH. Sodium hydroxide is prepared commercially by 
the electrolysis of sodium chloride solution and also by reacting 
calcium hydroxide with sodium carbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter and as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.

[[Page 509]]

    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52444, Nov. 18, 1983]



Sec. 184.1764  Sodium hypophosphite.

    (a) Sodium hypophosphite (NaH2PO2, CAS Reg. No. 7681-53-0) 
is a white, odorless, deliquescent granular powder with a saline taste. 
It is also prepared as colorless, pearly crystalline plates. It is 
soluble in water, alcohol, and glycerol. It is prepared by 
neutralization of hypophosphorous acid or by direct aqueous alkaline 
hydrolysis of white phosphorus.
    (b) FDA is developing food-grade specifications for sodium 
hypophosphite in cooperation with the National Academy of Sciences. In 
the interim, the ingredient must be of a suitable purity for its 
intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an emulsifier or stabilizer, as 
defined in Secs. 170.3(o)(8) and 170.3(o)(28) of this chapter.
    (2) The ingredient is used in cod-liver oil emulsions at levels not 
to exceed current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.

[47 FR 38277, Aug. 31, 1982]



Sec. 184.1768  Sodium lactate.

    (a) Sodium lactate (C3H5O3Na, CAS Reg. No. 72-
17-3) is the sodium salt of lactic acid. It is prepared commercially by 
the neutralization of lactic acid with sodium hydroxide.
    (b) FDA is developing food-grade specifications for sodium lactate 
in cooperation with the National Academy of Sciences. In the interim, 
this ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
This regulation does not authorize its use in infant foods and infant 
formulas. The affirmation of this ingredient as generally recognized as 
safe (GRAS) as a direct human food ingredient is based upon the 
following current good manufacturing practice conditions of use:
    (1) The ingredient is used as an emulsifier as defined in 
Sec. 170.3(o)(8) of this chapter; a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter; a humectant as defined in 
Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[52 FR 10886, Apr. 6, 1987]



Sec. 184.1769a  Sodium metasilicate.

    (a) Sodium metasilicate (CAS Reg. No. 6834-92-0) is a strongly 
alkaline white powder. It does not occur naturally but rather is 
synthesized by melting sand with sodium carbonate at 1400  deg.C. The 
commercially available forms of sodium metasilicate are the anhydrous 
form (Na2SiO3), the pentahydrate 
(Na2SiO3bullet5H2O), and the nonahydrate 
(Na2SiO3bullet9H2O).
    (b) FDA is developing food-grade specifications for sodium 
metasilicate in cooperation with the National Academy of Sciences. In 
the interim, the ingredient must be of a purity suitable for its 
intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:

[[Page 510]]

    (1) The ingredient is used as a processing aid as defined in 
Sec. 170.3(o)(24) of this chapter.
    (2) The ingredient is used to treat the following foods at levels 
not to exceed current good manufacturing practice: for use in washing 
and lye peeling of fruits, vegetables, and nuts when used in accordance 
with Sec. 173.315 of this chapter; for use as a denuding agent in tripe; 
for use as a hog scald agent in removing hair; and for use as a 
corrosion preventative in canned and bottled water when used in 
accordance with Sec. 103.35 of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985]



Sec. 184.1784  Sodium propionate.

    (a) Sodium propionate (C3H5NaO2, CAS Reg. No. 137-40-
6) is the sodium salt of propionic acid. It occurs as colorless, 
transparent crystals or a granular crystalline powder. It is odorless, 
or has a faint acetic-butyric acid odor, and is deliquescent. It is 
prepared by neutralizing propionic acid with sodium hydroxide.
    (b) The ingredients meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 296, which is incorporated by reference. Copies 
are available from the the National Academy Press, 2101 Constitution 
Ave. NW., Washington DC 20418, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; cheeses as defined in Sec. 170.3(n)(5) 
of this chapter; confections and frostings as defined in 
Sec. 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as 
defined in Sec. 170.3(n)(22) of this chapter; jams and jellies as 
defined in Sec. 170.3(n)(28) of this chapter; meat products as defined 
in Sec. 170.3(n)(29) of this chapter; and soft candy as defined in 
Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 13142, Apr. 3, 1984]



Sec. 184.1792  Sodium sesquicarbonate.

    (a) Sodium sesquicarbonate (Na2CO3.NaHCO3.2H2O, 
CAS Reg. No. 533-96-0) is prepared by: (1) Partial carbonation of soda 
ash solution followed by crystallization, centrifugation, and drying; 
(2) double refining of trona ore, a naturally occurring impure sodium 
sesquicarbonate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 299, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in cream at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice 
utilizes a level of the ingredient sufficient to control lactic acid 
prior to pasteurization and churning of cream into butter.
    (d) Prior sanctions for this ingredient different from the uses 
established in

[[Page 511]]

this section do not exist or have been waived.

[48 FR 52443, Nov. 18, 1983]



Sec. 184.1801  Sodium tartrate.

    (a) Sodium tartrate (C4H4Na2O6.2H2O, CAS 
Reg. No. 868-18-8) is the disodium salt of l-(+)-tartaric acid. It 
occurs as transparent, colorless, and odorless crystals. It is obtained 
as a byproduct of wine manufacture.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 303, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an emulsifier as defined in 
Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: cheeses as defined 
inSec. 170.3(n)(5) of this chapter; fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter; and jams and jellies as defined in 
Sec. 170.3(n)(28) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52447, Nov. 18, 1983]



Sec. 184.1804  Sodium potassium tartrate.

    (a) Sodium potassium tartrate (C4H4KNaO6.4H2O, 
CAS Reg. No. 304-59-6) is the sodium potassium salt of l-(+)-tartaric 
acid and is also called the Rochelle salt. It occurs as colorless 
crystals or as a white, crystalline powder and has a cooling saline 
taste. It is obtained as a byproduct of wine manufacture.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 296, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an emulsifier as defined in 
Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in 
Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: cheeses as defined in 
Sec. 170.3(n)(5) of this chapter and jams and jellies as defined in 
Sec. 170.3(n)(28) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 52447, Nov. 18, 1983]



Sec. 184.1807  Sodium thiosulfate.

    (a) Sodium thiosulfate (Na2S2O3
5H2O, CAS Reg. No. 010102-17-7) is also known as sodium 
hyposulfite. It is prepared synthetically by the reaction of sulfides 
and sulfur dioxide (SO2), the reaction of sulfur and sulfite, or 
the oxidation of metal sulfides and hydrosulfides.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 304, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter and reducing agent as defined in 
Sec. 170.3(o)(22) of this chapter.

[[Page 512]]

    (d) The ingredient is used in alcoholic beverages and table salt in 
accordance with Sec. 184.1(b)(1) at levels not to exceed good 
manufacturing practice. Current good manufacturing practice results in a 
maximum level, as served, of 0.00005 percent for alcoholic beverages as 
defined in Sec. 170.3(n)(2) of this chapter and 0.1 percent for table 
salt as defined in Sec. 170.3(n)(26) of this chapter.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984]



Sec. 184.1835   Sorbitol.

    (a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol 
(C6H14O6), a hexahydric alcohol, differing from mannitol 
principally by having a different optical rotation. Sorbitol is produced 
by the electrolytic reduction, or the transition metal catalytic 
hydrogenation of sugar solutions containing glucose or fructose.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 308, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an anticaking agent and free-flow 
agent as defined in Sec. 170.3(o)(1) of this chapter, curing and 
pickling agent as defined in Sec. 170.3(o)(5) of this chapter, drying 
agent as defined in Sec. 170.3(o)(7) of this chapter, emulsifier and 
emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter, firming 
agent as defined in Sec. 170.3(o)(10) of this chapter, flavoring agent 
and adjuvant as defined in Sec. 170.3(o)(12) of this chapter, 
formulation aid as defined in Sec. 170.3(o)(14) of this chapter, 
humectant as defined in Sec. 170.3(o)(16) of this chapter, lubricant and 
release agent as defined in Sec. 170.3(o)(18) of this chapter, nutritive 
sweetener as defined in Sec. 170.3(o)(21) of this chapter, sequestrant 
as defined in Sec. 170.3(o)(26) of this chapter, stabilizer and 
thickener as defined in Sec. 170.3(o)(28) of this chapter, surface-
finishing agent as defined in Sec. 170.3(o)(30) of this chapter, and 
texturizer as defined in Sec. 170.3(o)(32) of this chapter.
    (d) The ingredient is used in food at levels not to exceed good 
manufacturing practices. Current good manufacturing practice in the use 
of sorbitol results in a maximum level of 99 percent in hard candy and 
cough drops as defined in Sec. 170.3(n)(25) of this chapter, 75 percent 
in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 98 
percent in soft candy as defined in Sec. 170.3(n)(38) of this chapter, 
30 percent in nonstandardized jams and jellies, commercial, as defined 
in Sec. 170.3(n)(28) of this chapter, 30 percent in baked goods and 
baking mixes as defined in Sec. 170.3(n)(1) of this chapter, 17 percent 
in frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of 
this chapter, and 12 percent in all other foods.
    (e) The label and labeling of food whose reasonably foreseeable 
consumption may result in a daily ingestion of 50 grams of sorbitol 
shall bear the statement: ``Excess consumption may have a laxative 
effect.''
    (f) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 184.1845  Stannous chloride (anhydrous and dihydrated).

    (a) Stannous chloride is anhydrous or contains two molecules of 
water of hydration. Anhydrous stannous chloride (SnCl2,CAS Reg. No. 
7772-99-8) is the chloride salt of metallic tin. It is prepared by 
reacting molten tin with either chlorine or gaseous tin tetrachloride. 
Dihydrated stannous chloride (SnCl22H2O, CAS Reg. No. 
10025-69-1) is the chloride salt of metallic tin that contains two 
molecules of water. It is prepared from granulated tin suspended in 
water and hydrochloric acid or chlorine.
    (b) Both forms of the ingredient meet the specifications of the Food 
Chemicals Codex, 3d Ed. (1981), p. 312, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal

[[Page 513]]

Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (c) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter.
    (d) The ingredient is used in food at levels not to exceed current 
good manufacturing practice in accordance with Sec. 184.(b)(1). Current 
good manufacturing practice results in a maximum level, as served, of 
0.0015 percent or less; calculated as tin, for all food categories.
    (e) Prior sanctions for this ingredient different from those uses 
established in this section do not exist or have been waived.

[47 FR 27816, June 25, 1982]



Sec. 184.1848  Starter distillate.

    (a) Starter distillate (butter starter distillate) is a steam 
distillate of the culture of any or all of the following species of 
bacteria grown on a medium consisting of skim milk usually fortified 
with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris, 
S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L. 
dextranicum. The ingredient contains more than 98 percent water, and the 
remainder is a mixture of butterlike flavor compounds. Diacetyl is the 
major flavor component, constituting as much as 80 to 90 percent of the 
mixture of organic flavor compounds. Besides diacetyl, starter 
distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl 
acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin.
    (b) FDA is developing food-grade specifications for starter 
distillate in cooperation with the National Academy of Sciences. In the 
interim, this ingredient must be of a purity suitable for its intended 
use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51907, Nov. 15, 1983]



Sec. 184.1851  Stearyl citrate.

    (a) Stearyl citrate is a mixture of the mono-, di-, and tristearyl 
esters of citric acid. It is prepared by esterifying citric acid with 
stearyl alcohol.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for stearyl citrate. In the interim, this ingredient must be of a purity 
suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; an emulsifier and emulsifier salt as 
defined in Sec. 170.3(o)(8) of this chapter; a sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter; and a surface-active agent as defined 
in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in margarine in accordance with 
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63897, Dec. 12, 1994]



Sec. 184.1854  Sucrose.

    (a) Sucrose (C12H22O11, CAS Reg. No. 57-50-11-1) 
sugar, cane sugar, or beet sugar is the chemical -D-
fructofuranosyl--D-glucopyranoside.

[[Page 514]]

Sucrose is obtained by crystallization from sugar cane or sugar beet 
juice that has been extracted by pressing or diffusion, then clarified 
and evaporated.
    (b) FDA is developing food-grade specifications for sucrose in 
cooperation with the National Academy of Sciences. In the interim, this 
ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989]



Sec. 184.1857  Corn sugar.

    (a) Corn sugar (C6H12O6, CAS Reg. No. 50-99-7), 
commonly called D-glucose or dextrose, is the chemical -D-
glucopyranose. It occurs as the anhydrous or the monohydrate form and is 
produced by the complete hydrolysis of corn starch with safe and 
suitable acids or enzymes, followed by refinement and crystallization 
from the resulting hydrolysate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 97-98 under the heading ``Dextrose,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 1. Copies are available from the National Academy Press, 2101 
Constitution Ave., NW., Washington, DC 20418, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 44876, Nov. 7, 1988]



Sec. 184.1859  Invert sugar.

    (a) Invert sugar (CAS Reg. No. 8013-17-0) is an aqueous solution of 
inverted or partly inverted, refined or partly refined sucrose, the 
solids of which contain not more than 0.3 percent by weight of ash. The 
solution is colorless, odorless, and flavorless, except for sweetness. 
It is produced by the hydrolysis or partial hydrolysis of sucrose with 
safe and suitable acids or enzymes.
    (b) FDA is developing food-grade specifications for invert sugar in 
cooperation with the National Academy of Sciences. In the interim, this 
ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989]



Sec. 184.1865  Corn syrup.

    (a) Corn syrup, commonly called ``glucose sirup'' or ``glucose 
syrup,'' is obtained by partial hydrolysis of corn starch with safe and 
suitable acids or enzymes. It may also occur in the dehydrated form 
(dried glucose sirup). Depending on the degree of hydrolysis, corn syrup 
may contain, in addition to glucose, maltose and higher saccharides.
    (b) The ingredient meets the specifications as defined and 
determined in Sec. 168.120(b) or Sec. 168.121(a) of this chapter, as 
appropriate. FDA, in cooperation with the National Academy of Sciences, 
is undertaking a study to determine if additional food-grade 
specifications for corn syrup are necessary.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 44876, Nov. 7, 1988]



Sec. 184.1875  Thiamine hydrochloride.

    (a) Thiamine hydrochloride (C12H17C1N4OSHCl, 
CAS Reg. No. 67-03-8)

[[Page 515]]

is the chloride-hydrochloride salt of thiamine. It occurs as hygroscopic 
white crystals or a white crystalline powder. The usual method of 
preparing this substance is by linking the preformed thiazole and 
pyrimidine ring systems.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 324, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter or as a nutrient supplement 
as defined in Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Thiamine hydrochloride may be used in 
infant formula in accordance with section 412(g) of the Federal Food, 
Drug, and Cosmetic Act (the Act) or with regulations promulgated under 
section 412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 55124, Dec. 9, 1983]



Sec. 184.1878  Thiamine mononitrate.

    (a) Thiamine mononitrate (C12H17N5O4S, CAS Reg. 
No. 532-43-4) is the mononitrate salt of thiamine. It occurs as white 
crystals or a white crystalline powder and is prepared from thiamine 
hydrochloride by dissolving the hydrochloride salt in alkaline solution 
followed by precipitation of the nitrate half-salt with a stoichiometric 
amount of nitric acid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 325, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Thiamine mononitrate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 55124, Dec. 9, 1983]



Sec. 184.1890  -Tocopherols.

    (a) The -tocopherols that are the subject of this GRAS 
affirmation regulation are limited to the following:
    (1) d--Tocopherol (CAS Reg. No. 59-02-9) is the chemical 
[2R,4'R,8'R]-2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-6-
chromanol. It occurs commercially as a concentrate and is a red, nearly 
odorless, viscous oil. It is obtained by vacuum steam distillation of 
edible vegetable oil products.
    (2) dl--Tocopherol (CAS Reg. No. 10191-41-0) is a mixture 
of stereoisomers of 2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-
tridecyl)-6-chromanol. It is chemically synthesized by condensing 
racemic isophytol with trimethyl hydroquinone. It is a pale yellow 
viscous oil at room temperature.
    (b) The ingredients meet the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference. 
Copies are available from the National Academy Press,

[[Page 516]]

2101 Constitution Ave. NW., Washington, DC 20418, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408..
    (c) In accordance with Sec. 184.1(b)(3), the affirmation of the 
ingredients as generally recognized as safe is limited to the following 
conditions of use while the agency concludes the general evaluation of 
all food uses of tocopherols:
    (1) The ingredients are used as inhibitors of nitrosamine formation.
    (2) The ingredients are used in pump-cured bacon at levels not to 
exceed current good manufacturing practice.

[49 FR 13348, Apr. 4, 1984]



Sec. 184.1901  Triacetin.

    (a) Triacetin (C8H1406, CAS Reg. No. 102-76-1), also 
known as 1,2,3,-propanetriol triacetate or glyceryl triacetate, is the 
triester of glycerin and acetic acid. Triacetin can be prepared by 
heating glycerin with acetic anhydride alone or in the presence of 
finely divided potassium hydrogen sulfate. It can also be prepared by 
the reaction of oxygen with a liquid-phase mixture of allyl acetate and 
acetic acid using a bromide salt as a catalyst.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), pp. 337-338, as revised by the First Supplement to 
the 3d Ed., which is incorporated by reference in accordance with 5 
U.S.C. 552(a). Copies are available from the National Academy Press, 
2102 Constitution Ave., NW., Washington, DC 20418, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20005.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used in food as a flavoring agent and adjuvant 
as defined in Sec. 170.3(o)(12) of this chapter; a formulation aid as 
defined in Sec. 170.3(o)(14) of this chapter; and humectant as defined 
in Sec. 170.3(o)(16) of this chapter; and a solvent and vehicle as 
defined in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods and baking mixes 
as defined in Sec. 170.3(n)(1) of this chapter, alcoholic beverages as 
defined in Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages and 
beverage bases as defined in Sec. 170.3(n)(3) of this chapter; chewing 
gum as defined in Sec. 170.3(n)(6) of this chapter; confections and 
frostings as defined in Sec. 170.3(n)(9) of this chapter; frozen dairy 
dessert and mixes as defined in Sec. 170.3(n)(20) of this chapter; 
gelatins, puddings, and fillngs as defined in Sec. 170.3(n)(22) of this 
chapter; hard candy as defined in Sec. 170.3(n)(25) of this chapter; and 
soft candy as defined in Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.


[54 FR 7404, Feb. 21, 1989]



Sec. 184.1903  Tributyrin.

    (a) Tributyrin (C15H2606, CAS Reg. No. 60-01-5), also 
known as butyrin or glyceryl tributyrate, is the triester of glycerin 
and butyric acid. It is prepared by esterification of glycerin with 
excess butyric acid.
    (b) The ingredient meets the specification of the Food Chemicals 
Codex, 3d Ed. (1981), p. 416, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a). Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20005.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generaly recognized as safe (GRAS) 
as a direct human food ingredient is based upon the following current 
good manufacturing practice conditions of use:
    (1) The ingredient is used in food as a flavoring agent and adjuvant 
as defined in Sec. 170.3(o)(12) of this chapter.

[[Page 517]]

    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice; baked goods as defined in 
Sec. 170.3(n)(1) of this chapter; alcoholic beverages as defined in 
Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter; frozen dairy desserts and mixes as 
defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings and 
fillngs as defined in Sec. 170.3(n)(22) of this chapter; and soft candy 
as defined in Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 1989]



Sec. 184.1911  Triethyl citrate.

    (a) Triethyl citrate (C12H20O7, CAS Reg. No. 77-93-0) 
is the triethyl ester of citric acid. It is prepared by esterifying 
citric acid with ethyl alcohol and occurs as an odorless, practically 
colorless, oily liquid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), p. 339, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., Washington, 
DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-
200), 200 C St. SW., Washington, DC 20204, or may be examined at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter; a solvent and vehicle as defined in 
Sec. 170.3(o)(27) of this chapter; and a surface-active agent as defined 
in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

[59 FR 63897, Dec. 12, 1994]



Sec. 184.1914  Trypsin.

    (a) Trypsin (CAS Reg. No. 9002-07-7) is an enzyme preparation 
obtained from purified extracts of porcine or bovine pancreas. It is a 
white to tan amorphous powder. Its characterizing enzyme activity is 
that of a peptide hydrolase (EC 3.4.21.4).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. 
(1981), p. 110, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 200 C St. SW., Washington, DC, and the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as an enzyme as defined in 
Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[60 FR 32911, June 26, 1995]



Sec. 184.1923  Urea.

    (a) Urea (CO(NH2)2, CAS Reg. No. 57-13-6) is the diamide 
of carbonic acid and is also known as carbamide. It is a white, odorless 
solid and is commonly produced from CO2 by ammonolysis or from 
cyanamide by hydrolysis.

[[Page 518]]

    (b) FDA is developing food-grade specifications for urea in 
cooperation with the National Academy of Sciences. In the interim, this 
ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter and as a fermentation aid.
    (2) The ingredient is used in yeast-raised bakery products; in 
alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; and 
in gelatin products.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984]



Sec. 184.1924  Urease enzyme preparation from Lactobacillus fermentum.

    (a) This enzyme preparation is derived from the nonpathogenic, 
nontoxicogenic bacterium Lactobacillus fermentum. It contains the enzyme 
urease (CAS Reg. No. 9002-13-5), which facilitates the hydrolysis of 
urea to ammonia and carbon dioxide. It is produced by a pure culture 
fermentation process and by using materials that are generally 
recognized as safe (GRAS) or are food additives that have been approved 
for this use by the Food and Drug Administration (FDA).
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the ``Food Chemicals Codex,'' 3d ed. (1981), pp. 
107-110, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the National Academy 
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as GRAS as a direct human food 
ingredient is based upon the following current good manufacturing 
practice conditions of use:
    (1) The ingredient is used in wine, as defined in 27 CFR 2.5 and 
4.10, as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to 
convert urea to ammonia and carbon dioxide.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Current good manufacturing practice is 
limited to use of this ingredient in wine to inhibit formation of ethyl 
carbamate.

[57 FR 60473, Dec. 21, 1992]



Sec. 184.1930  Vitamin A.

    (a)(1) Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol 
9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5-yl)-7,9,11,13-
nonatetraen-15-ol. It may be nearly odorless or have a mild fishy odor. 
Vitamin A is extracted from fish liver oils or produced by total 
synthesis from -ionone and a propargyl halide.
    (2) Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is 
the acetate ester of retinol. It is prepared by esterifying retinol with 
acetic acid.
    (3) Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is 
the palmitate ester of retinol. It is prepared by esterifying retinol 
with palmitic acid.
    (b) The ingredient meets the specifications for vitamin A in the 
Food Chemicals Codex, 3d Ed. (1981), p. 342, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:

[[Page 519]]

    (1) The ingredient is used in food as a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. Vitamin A may be used in infant formula in 
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic 
Act (the act) or with regulations promulgated under section 412(a)(2) of 
the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51610, Nov. 10, 1983]



Sec. 184.1945  Vitamin B12.

    (a) Vitamin B12, also known as cyanocobalamin 
(C63H88CoN14O14P, CAS Reg. No. 68-19-9), is produced 
commercially from cultures of Streptomyces griseus.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 343, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec. 170.3(o)(20) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Vitamin B12 also may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 6341, Feb. 15, 1985]



Sec. 184.1950  Vitamin D.

    (a) Vitamin D is added to food as the following food ingredients:
    (1) Crystalline vitamin D2 (C28H44O, CAS Reg. No. 50-
14-6), also known as ergocalciferol, is the chemical 9,10-
seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient is 
produced by ultraviolet irradiation of ergosterol isolated from yeast 
and related fungi and is purified by crystallization.
    (2) Crystalline vitamin D3 (C27H44O, CAS Reg. No. 67-
97-0), also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E,)-
5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in, and is 
isolated from, fish liver oils. It is also manufactured by ultraviolet 
irradiation of 7-dehydrocholesterol produced from cholesterol. It is 
purified by crystallization. Vitamin D3 is the vitamin D form that 
is produced endogenously in humans through sunlight activation of 7-
dehydrocholesterol in the skin.
    (3) Vitamin D2 resin and vitamin D3 resin are the 
concentrated forms of irradiated ergosterol (D2) and irradiated 7-
dehydrocholesterol (D3) that are separated from the reacting 
materials in paragraphs (a) (1) and (2) of this section. The resulting 
products are sold as food sources of vitamin D without further 
purification.
    (b) Vitamin D2 and vitamin D3 as crystals meet the 
specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 344 and 
345, which is incorporated by reference. Copies are available from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408. FDA is developing food-grade specifications for vitamin D2 
resin and vitamin D3 resin in cooperation with the National Academy 
of Sciences. In the interim, these resins must be of a purity suitable 
for their intended use.
    (c)(1) In accordance with Sec. 184.1(b)(2), the ingredients are used 
in food as the sole source of added vitamin D only within the following 
specific limitations:

[[Page 520]]



------------------------------------------------------------------------
                                   Maximum levels in                    
        Category of food           food (as served)     Functional use  
------------------------------------------------------------------------
Breakfast cereals, Sec.           350 (IU/100 grams)  Nutrient          
 170.3(n)(4) of this chapter.                          supplement, Sec. 
                                                       170.3(o)(20) of  
                                                       this chapter.    
Grain products and pastas, Sec.   90(IU/100 grams)..      Do.           
 170.3(n)(23) of this chapter.                                          
Milk, Sec.  170.3(n)(30) of this  42 (IU/100 grams).      Do.           
 chapter.                                                               
Milk products, Sec.               89 (IU/100 grams).      Do.           
 170.3(n)(31) of this chapter.                                          
------------------------------------------------------------------------

    (2) Vitamin D may be used in infant formula in accordance with 
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or 
with regulations promulgated under section 412(a)(2) of the act.
    (3) Vitamin D may be used in margarine in accordance with 
Sec. 166.110 of this chapter.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[50 FR 30152, July 24, 1985]



Sec. 184.1973  Beeswax (yellow and white).

    (a) Beeswax (CAS Reg. No. 8012-89-3) is a secretory product of honey 
bees used as a structural material in honeycombs. Beeswax is prepared 
from honeycombs after removal of the honey by draining or centrifuging. 
The combs are melted in hot water or steam or with solar heat, and 
strained. The wax is refined by melting in hot water to which sulfuric 
acid or alkali may be added to extract impurities. The resulting wax is 
referred to as yellow beeswax. White beeswax is produced by bleaching 
the constituent pigments of yellow beeswax with peroxides, or preferably 
it is bleached by sun light.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 34-35, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter, as a lubricant as defined 
in Sec. 170.3(o)(18) of this chapter, and as a surface-finishing agent 
as defined in Sec. 170.3(o)(30) of this chapter.
    (d) The ingredient is used in food, in accordance with 
Sec. 184.1(b)(1) of this chapter, at levels not to exceed good 
manufacturing practice. Current good manufacturing practice results in a 
maximum level, as served, of: 0.065 percent for chewing gum as defined 
in Sec. 170.3(n)(6) of this chapter; 0.005 percent for confections and 
frostings as defined in Sec. 170.3(n)(9) of this chapter; 0.04 percent 
for hard candy as defined in Sec. 170.3(n)(25) of this chapter; 0.1 
percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 
and 0.002 percent or less for all other food categories.

[43 FR 14644, Apr. 7, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 50 
FR 49536, Dec. 3, 1985]



Sec. 184.1976  Candelilla wax.

    (a) Candelilla wax (CAS Reg. No. 8006-44-8) is obtained from the 
candelilla plant. It is a hard, yellowish-brown, opaque-to-translucent 
wax. Candelilla wax is prepared by immersing the plants in boiling water 
containing sulfuric acid and skimming off the wax that rises to the 
surface. It is composed of about 50 percent hydrocarbons with smaller 
amounts of esters and free acids.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 67, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a lubricant as defined in 
Sec. 170.3(o)(18) of this chapter and as a surface-finishing

[[Page 521]]

agent as defined in Sec. 170.3(o)(30) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: in chewing gum as defined in 
Sec. 170.3(n)(6) of this chapter and in hard candy as defined in 
Sec. 170.3(n)(25) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51617, Nov. 10, 1983]



Sec. 184.1978   Carnauba wax.

    (a) Carnauba wax (CAS Reg. No. 008-015-869) is obtained from the 
leaves and buds of the Brazilian wax palm Copernicia cerifera Martius. 
The wax is hard, brittle, sparingly soluble in cold organic solvents and 
insoluble in water. It is marketed in five grades designated No. 1 
through No. 5. Grades No. 4 and No. 5 represent the bulk of the 
commercial trade volume. These commercial grades consist chiefly of 
C24 to C32 normal saturated monofunctional fatty acids and 
normal saturated monofunctional primary alcohols.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an anticaking agent as defined 
Sec. 170.3(o)(1) of this chapter; as a formulation aid as defined in 
Sec. 170.3(o)(14) of this chapter; as a lubricant and release agent as 
defined in Sec. 170.3(o)(18) of this chapter; and as a surface-finishing 
agent as defined in Sec. 170.3(o)(30) of this chapter.
    (2) The ingredient is used in the following foods at levels not to 
exceed current good manufacturing practice: baked goods and baking mixes 
as defined in Sec. 170.3(n)(1) of this chapter; chewing gun as defined 
in Sec. 170.3(n)(6) of this chapter; confections and frostings as 
defined in Sec. 170.3(n)(9) of this chapter; fresh fruits and fruit 
juices as defined in Sec. 170.3(n)(16) of this chapter; gravies and 
sauces as defined in Sec. 170.3(n)(24) of this chapter; processed fruits 
and fruit juices as defined in Sec. 170.3(n)(35) of this chapter; and 
soft candy as defined in Sec. 170.3(n)(38) of this chapter.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[48 FR 51147, Nov. 7, 1983]



Sec. 184.1979  Whey.

    (a)(1) Whey. Whey is the liquid substance obtained by separating the 
coagulum from milk, cream, or skim milk in cheesemaking. Whey obtained 
from a procedure, in which a significant amount of lactose is converted 
to lactic acid, or from the curd formation by direct acidification of 
milk, is known as acid whey. Whey obtained from a procedure in which 
there is insignificant conversion of lactose to lactic acid is known as 
sweet whey. Sweet whey has a maximum titratable acidity of not more than 
0.16 percent, calculated as lactic acid, and an alkalinity of ash of not 
more than 225 milliliters of 0.1N hydrochloric acid per 100 grams. The 
acidity of whey, sweet or acid, may be adjusted by the addition of safe 
and suitable pH-adjusting ingredients.
    (2) Concentrated whey. Concentrated whey is the liquid substance 
obtained by the partial removal of water from whey, while leaving all 
other constituents in the same relative proportions as in whey.
    (3) Dry or dried whey. Dry or dried whey is the dry substance 
obtained by the removal of water from whey, while leaving all other 
constituents in the same relative proportions as in whey.
    (b) The ingredients meet the following specifications:
    (1) The analysis of whey, concentrated whey, and dry (dried) whey,

[[Page 522]]

on a dry product basis, based on analytical methods in the referenced 
sections of ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th ed. (1980),\1\ which is 
incorporated by reference, is:
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
examined at the office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    (i) Protein content, 10 to 15 percent--as determined by the methods 
prescribed in section 16.036 (liquid sample), entitled ``Total 
Nitrogen--Official Final Action'' under the heading ``Total Solids,'' or 
in section 16.193 (dry sample), entitled ``Kjeldahl Method'' under the 
heading ``Protein--Official Final Action.''
    (ii) Fat content, 0.2 to 2.0 percent--as determined by the methods 
prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method 
[Reference Method] (11)--Official Final Action'' under the heading 
``Fat,'' or in section 16.199 (dry sample), entitled ``Fat in Dried Milk 
(45)--Official Final Action.''
    (iii) Ash content, 7 to 14 percent--as determined by the methods 
prescribed in section 16.035 (liquid sample), entitled ``Ash (5)--
Official Final Action'' under the heading ``Total Solids,'' or in 
section 16.196 (dry sample), entitled ``Ash--Official Final Action'' 
under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.''
    (iv) Lactose content, 61 to 75 percent--as determined by the methods 
prescribed in section 16.057 (liquid sample), entitled ``Gravimetric 
Method--Official Final Action'' under the heading ``Lactose,'' or in 
section 31.061 (dry sample), entitled ``Lane-Eynon General Volumetric 
Method'' under the heading ``Lactose--Chemical Methods--Official Final 
Action.''
    (v) Moisture content, 1 to 8 percent--as determined by the methods 
prescribed in section 16.192, entitled ``Moisture (41)--Official Final 
Action'' under the heading ``Dried Milk, Nonfat Dry Milk, and Malted 
Milk.''
    (vi) Solids content, variable--as determined by the methods 
prescribed in section 16.032, entitled ``Method I--Official Final 
Action'' under the heading ``Total Solids.''
    (vii) Titratable Acidity, variable--as determined by the methods 
prescribed in section 16.023, entitled ``Acidity (2)--Official Final 
Action'' under the heading ``Milk,'' or by an equivalent potentiometric 
method.
    (2) Limits of impurities are:

Heavy metals (as lead). Not more than 10 parts per million (0.001 
percent) as determined by the method described in the Food Chemicals 
Codex, 3d ed. (1981), pp. 512-513,\2\ which is incorporated by 
reference.
---------------------------------------------------------------------------

    \2\ Copies may be obtained from the National Academy of Sciences, 
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
---------------------------------------------------------------------------

    (3) The whey must be derived from milk that has been pasteurized, or 
the whey and modified whey product must be subjected to pasteurization 
techniques or its equivalent before use in food.
    (c) Whey, concentrated whey, and dry (dried) whey may be used in 
food in accordance with good manufacturing practice as indicated in 
Sec. 184.1(b)(1).
    (d) The label on the whey form sold to food manufacturers shall read 
as follows:
    (1) For whey: ``(Sweet or acid) whey'' or ``whey (____% titratable 
acidity).
    (2) For concentrated whey: ``Concentrated (sweet or acid) whey, 
____% solids'' or ``Concentrated whey (____% titratable acidity), ____% 
solids''.
    (3) For dry (dried) whey: ``Dry (dried) (sweet or acid) whey'' or 
``dry (dried) whey, (____% titratable acidity)''.
    (e) Whey, concentrated whey, or dry (dried) whey in a finished food 
product shall be listed as ``whey.''

[46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, 1982; 54 FR 24899, 
June 12, 1989]



Sec. 184.1979a  Reduced lactose whey.

    (a) Reduced lactose whey is the substance obtained by the removal of 
lactose from whey. The lactose content of the finished dry product shall 
not exceed 60 percent. Removal of the lactose is accomplished by 
physical separation techniques such as precipitation, filtration, or 
dialysis. As with whey, reduced lactose whey can be used as a fluid, 
concentrate, or a dry product form.

[[Page 523]]

The acidity of reduced lactose whey may be adjusted by the addition of 
safe and suitable pH-adjusting ingredients.
    (b) The reduced lactose whey meets the following specifications:
    (1) The analysis of reduced lactose whey, on a dry product basis, 
based on analytical methods in the referenced sections of ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th ed. (1980),\1\ which is incorporated by reference, is:
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
examined at the office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    (i) Protein content, 16 to 24 percent--as determined by the methods 
prescribed in section 16.036 (liquid sample), entitled ``Total 
Nitrogen--Official Final Action'' under the heading ``Total Solids,'' or 
in section 16.193 (dry sample), entitled ``Kjeldahl Method'' under the 
heading ``Protein--Official Final Action.''
    (ii) Fat content, 1 to 4 percent--as determined by the methods 
prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method 
[Reference Method] (11)--Official Final Action'' under the heading 
``Fat,'' or in section 16.199 (dry sample), entitled ``Fat in Dried Milk 
(45)--Official Final Action.''
    (iii) Ash content, 11 to 27 percent--as determined by the methods 
prescribed in section 16.035 (liquid sample), entitled ``Ash (5)--
Official Final Action'' under the heading ``Total Solids,'' or in 
section 16.196 (dry sample), entitled ``Ash--Official Final Action'' 
under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.''
    (iv) Lactose content, not more than 60 percent--as determined by the 
methods prescribed in section 16.057 (liquid sample), entitled 
``Gravimetric Method--Official Final Action'' under the heading 
``Lactose,'' or in section 31.061 (dry sample), entitled ``Lane-Eynon 
General Volumetric Method'' under the heading ``Lactose--Chemical 
Methods--Official Final Action.''
    (v) Moisture content, 1 to 6 percent--as determined by the method 
prescribed in section 16.192, entitled ``Moisture (41)--Official Final 
Action'' under the heading ``Dried Milk, Nonfat Dry Milk, and Malted 
Milk.''
    (vi) Solids content, variable--as determined by the methods 
prescribed in section 16.032, entitled ``Method I--Official Final 
Action'' under the heading ``Total Solids.''
    (vii) Titratable Acidity, variable--as determined by the methods 
prescribed in section 16.023, entitled ``Acidity (2)--Official Final 
Action'' under the heading ``Milk,'' or by an equivalent potentiometric 
method.
    (2) Limits of impurities are:

Heavy metals (as lead). Not more than 10 parts per million (0.001 
percent), as determined by the method described in the Food Chemicals 
Codex, 3d ed. (1981), pp. 512-513,\2\ which is incorporated by 
reference.
---------------------------------------------------------------------------

    \2\ Copies may be obtained from the National Academy of Sciences, 
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
---------------------------------------------------------------------------

    (3) The reduced lactose whey shall be derived from milk that has 
been pasteurized, or the reduced lactose whey shall be subjected to 
pasteurization techniques or its equivalent before use in food.
    (c) Reduced lactose whey may be used in food in accordance with good 
manufacturing practice as indicated in Sec. 184.1(b)(1).
    (d) The percent of lactose present on a dry product basis, i.e., 
``reduced lactose whey (____% lactose)'', shall be declared on the label 
of the package sold to food manufacturers. The percent of lactose may be 
declared in 5-percent increments, expressed as a multiple of 5, not 
greater than the actual percentage of lactose in the product, or as a 
actual percentage provided that an analysis of the product on which the 
actual percentage is based is supplied to the food manufacturer.
    (e) The presence of reduced lactose whey in a finished food product 
shall be listed as ``reduced lactose whey.''

[46 FR 44440, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989]



Sec. 184.1979b  Reduced minerals whey.

    (a) Reduced minerals whey is the substance obtained by the removal 
of a

[[Page 524]]

portion of the minerals from whey. The dry product shall not contain 
more than 7 percent ash. Reduced minerals whey is produced by physical 
separation techniques such as precipitation, filtration, or dialysis. As 
with whey, reduced minerals whey can be used as a fluid, concentrate, or 
a dry product form. The acidity of reduced minerals whey may be adjusted 
by the additional of safe and suitable pH-adjusting ingredients.
    (b) The reduced minerals whey meets the following specifications:
    (1) The analysis of reduced minerals whey, on a dry product basis, 
based on analytical methods in the referenced sections of ``Official 
Methods of Analysis of the Association of Official Analytical Chemists, 
13th ed. (1980),\1\ which is incorporated by reference, is:
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    (i) Protein content, 10 to 24 percent--as determined by the methods 
prescribed in section 16.036 (liquid sample), entitled ``Total 
Nitrogen--Official Final Action'' under the heading ``Total Solids,'' or 
in section 16.193 (dry sample), entitled ``Kjeldahl Method'' under the 
heading ``Protein--Official Final Action.''
    (ii) Fat content, 1 to 4 percent--as determined by the methods 
prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method 
[Reference Method] (11)--Official Final Action'' under the heading 
``Fat,'' or in section 16.199 (dry sample), entitled ``Fat in Dried Milk 
(45)--Official Final Action.''
    (iii) Ash content, maximum 7 percent--as determined by the methods 
prescribed in section 16.035 (liquid sample), entitled ``Ash (5)--
Official Final Action'' under the heading ``Total Solids,'' or in 
section 16.196 (dry sample), entitled ``Ash--Official Final Action'' 
under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.''
    (iv) Lactose content, maximum 85 percent--as determined by the 
methods prescribed in section 16.057 (liquid sample), entitled 
``Gravimetric Method--Official Final Action'' under the heading 
``Lactose,'' or in section 31.061 (dry sample), entitled ``Lane-Eynon 
General Volumetric Method'' under the heading ``Lactose--Chemical 
Methods--Official Final Action.''
    (v) Moisture content, 1 to 6 percent--as determined by the methods 
prescribed in section 16.192, entitled ``Moisture (41)--Official Final 
Action'' under the heading ``Dried Milk, Nonfat Dry Milk, and Malted 
Milk.''
    (vi) Solids content, variable--as determined by the methods 
prescribed in section 16.032, entitled ``Method I--Official Final 
Action'' under the heading ``Total Solid.''
    (vii) Titratable Acidity, variable--as determined by the methods 
prescribed in section 16.023, entitled ``Acidity (2)--Official Final 
Action'' under the heading ``Milk,'' or by an equivalent potentiometric 
method.
    (2) Limits of impurities are: Heavy metals (as lead). Not more than 
10 parts per million (0.001 percent), as determined by the method 
described in the Food Chemicals Codex, 3d ed. (1981), pp. 512-513,\2\ 
which is incorporated by reference.
---------------------------------------------------------------------------

    \2\ Copies may be obtained from the National Academy of Sciences, 
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
---------------------------------------------------------------------------

    (3) The reduced minerals whey shall be derived from milk that has 
been pasteurized, or the reduced minerals whey shall be subjected to 
pasteurization techniques or its equivalent before use in food.
    (c) The reduced minerals whey may be used in food in accordance with 
good manufacturing practice as indicated in Sec. 184.1(b)(1).
    (d) The percent of minerals present on a dry product basis, i.e., 
``reduced minerals whey (____% minerals)'', shall be declared on the 
label of the package sold to food manufacturers. The percent of minerals 
may be declared in 2-percent increments expressed as a multiple of 2, 
not greater than the actual percentage of minerals in the product, or as 
an actual percentage provided that an analysis of the product on which 
the actual percentage is based is supplied to the food manufacturer.

[[Page 525]]

    (e) The presence of reduced minerals whey in a finished food product 
shall be listed as ``reduced minerals whey''.

[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989]



Sec. 184.1979c  Whey protein concentrate.

    (a) Whey protein concentrate is the substance obtained by the 
removal of sufficient nonprotein constituents from whey so that the 
finished dry product contains not less than 25 percent protein. Whey 
protein concentrate is produced by physical separation techniques such 
as precipitation, filtration, or dialysis. As with whey, whey protein 
concentrate can be used as a fluid, concentrate, or dry product form. 
The acidity of whey protein concentrate may be adjusted by the addition 
of safe and suitable pH-adjusting ingredients.
    (b) The whey protein concentrate meets the following specifications:
    (1) The analysis of whey protein concentrate, on a dry product 
basis, based on analytical methods in the referenced sections of 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists,'' 13th ed. (1980),\1\ which is incorporated by reference, is:
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington VA 22201-3301, or 
examined at the office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------

    (i) Protein content, minimum 25 percent--as determined by the 
methods prescribed in section 16.036 (liquid sample), entitled ``Total 
Nitrogen--Officials Final Action'' under the heading ``Total Solids,'' 
or in section 16.193 (dry sample), entitled ``Kjeldahl Method'' under 
the heading ``Protein--Official Final Action.''
    (ii) Fat content, 1 to 10 percent--as determined by the methods 
prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method 
[Reference Method] (11)--Official Final Action'' under the heading 
``Fat,'' or in section 16.199 (dry sample), entitled ``Fat in Dried Milk 
(45)--Official Final Action.''
    (iii) Ash content, 2 to 15 percent--as determined by the methods 
prescribed in section 16.035 (liquid sample), entitled ``Ash (5)--
Official Final Action'' under the heading ``Total Solids,'' or in 
section 16.196 (dry sample), entitled ``Ash--Official Final Action'' 
under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.''
    (iv) Lactose content, maximum 60 percent--as determined by the 
methods prescribed in section 16.057 (liquid sample), entitled 
``Gravimetric Method--Official Final Action'' under the heading 
``Lactose,'' or in section 31.061 (dry sample), entitled ``Lane-Eynon 
General Volumetric Method'' under the heading ``Lactose--Chemical 
Methods--Official Final Action.''
    (v) Moisture content, 1 to 6 percent--as determined by the methods 
prescribed in section 16.192, entitled ``Moisture (41)--Official Final 
Action'' under the heading ``Dried Milk, Nonfat Dry Milk, and Malted 
Milk.''
    (vi) Solids content, variable--as determined by the methods 
prescribed in section 16.032, entitled ``Method I--Official Final 
Action'' under the heading ``Total Solids.''
    (vii) Titratable Acidity, variable--as determined by the methods 
prescribed in section 16.023, entitled ``Acidity (2)--Official Final 
Action'' under the heading ``Milk,'' or by an equivalent potentiometric 
method.
    (2) Limits of impurities are:

Heavy metals (as lead). Not more than 10 parts per million (0.001 
percent), as determined by the method described in the Food Chemicals 
Codex, 3d ed. (1981), pp. 512-513,\2\ which is incorporated by 
reference.
---------------------------------------------------------------------------

    \2\ Copies may be obtained from the National Academy of Sciences, 
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
---------------------------------------------------------------------------

    (3) The whey protein concentrate shall be derived from milk that has 
been pasteurized, or the whey protein concentrate shall be subjected to 
pasteurization techniques or its equivalent before use in food.
    (c) The whey protein concentrate may be used in food in accordance 
with good manufacturing practice as indicated in Sec. 184.1(b)(1).
    (d) The percent of protein present on a dry product basis, i.e., 
``whey protein concentrate (____% protein)'', shall be

[[Page 526]]

declared on the label of the package sold to food manufacturers. The 
percent of protein may be declared in 5-percent increments, expressed as 
a multiple of 5, not greater than the actual percentage of protein in 
the product, or as an actual percentage provided that an analysis of the 
product on which the actual percentage is based is supplied to the food 
manufacturer.
    (e) The presence of whey protein concentrate in a finished food 
product shall be listed as ``whey protein concentrate''.

[46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989]



Sec. 184.1983   Bakers yeast extract.

    (a) Bakers yeast extract is the food ingredient resulting from 
concentration of the solubles of mechanically ruptured cells of a 
selected strain of yeast, Saccharomyces cerevisiae. It may be 
concentrated or dried.
    (b) The ingredient meets the following specifications on a dry 
weight basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm 
cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm 
zinc.
    (c) The viable microbial content of the finished ingredient as a 
concentrate or dry material is:
    (1) Less than 10,000 organisms/gram by aerobic plate count.
    (2) Less than 10 yeasts and molds/gram.
    (3) Negative for Salmonella, E. coli, coagulase positive 
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any 
other recognized microbial pathogen or any harmful microbial toxin.
    (d) The ingredient is used as a flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter at a level not to exceed 5 
percent in food.
    (e) This regulation is issued prior to general evaluation of use of 
this ingredient in order to affirm as GRAS the specific use named.



Sec. 184.1984  Zein.

    (a) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn 
gluten. It is produced commercially by extraction from corn gluten with 
alkaline aqueous isopropyl alcohol containing sodium hydroxide. The 
extract is then cooled, which causes the zein to precipitate.
    (b) FDA is developing food-grade specifications for zein in 
cooperation with the National Academy of Sciences. In the interim, the 
igredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a surface-finishing agent as defined 
in Sec. 170.3(o)(30) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[50 FR 8999, Mar. 6, 1985]



Sec. 184.1985  Aminopeptidase enzyme preparation derived from lactococcus lactis.

    (a) Aminopeptidase enzyme preparation is derived from the 
nonpathogenic and nontoxicogenic bacterium Lactococcus lactis 
(previously named Streptococcus lactis). The preparation contains the 
enzyme aminopeptidase (CAS Reg. No. 9031-94-1; EC 3.4.11.1) and other 
peptidases that hydrolyze milk proteins. The preparation is produced by 
pure culture fermentation.
    (b) The ingredient meets the specifications for enzyme preparations 
in the Food Chemicals Codex, 3d ed. (1981), pp. 107-110, which are 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Division of Petition Control (HFS-215), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., 
suite 1200, Washington, DC, or at the Office of the Federal Register, 
800

[[Page 527]]

North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe as a 
direct human food ingredient is based upon the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, as an optional ingredient for flavor 
development in the manufacture of cheddar cheese, in accordance with 
Sec. 133.113 of this chapter, and in the preparation of protein 
hydrolysates.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.

[60 FR 54193, Oct. 20, 1995]



PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents




                      Subpart A--General Provisions

Sec.
186.1  Substances added indirectly to human food affirmed as generally 
          recognized as safe (GRAS).

       Subpart B--Listing of Specific Substances Affirmed as GRAS

186.1025  Caprylic acid.
186.1093  Sulfamic acid.
186.1256  Clay (kaolin).
186.1275  Dextrans.
186.1300  Ferric oxide.
186.1316  Formic acid.
186.1374  Iron oxides.
186.1551  Hydrogenated fish oil.
186.1555  Japan wax.
186.1557  Tall oil.
186.1673  Pulp.
186.1750  Sodium chlorite.
186.1756  Sodium formate.
186.1770  Sodium oleate.
186.1771  Sodium palmitate.
186.1797  Sodium sulfate.
186.1839  Sorbose.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14658, Mar. 15, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 186.1  Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).

    (a) The indirect human food ingredients listed in this part have 
been reviewed by the Food and Drug Administration and determined to be 
generally recognized as safe (GRAS) for the purposes and under the 
conditions prescribed, providing they comply with the purity 
specifications listed in this part or, in the absence of purity 
specifications, are of a purity suitable for their intended use in 
accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients 
in this part may also be used in food-contact surfaces in accordance 
with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter. 
Ingredients affirmed as GRAS for direct use in part 184 of this chapter 
are also GRAS as indirect human food ingredients in accordance with 
Sec. 184.1(a) of this chapter.
    (b) The regulations in this part do not authorize direct addition of 
any food ingredient to a food. They authorize only the use of these 
ingredients as indirect ingredients of food, through migration from 
their immediate wrapper, container, or other food-contact surface. Any 
ingredient affirmed as GRAS in this part shall be used in accordance 
with current good manufacturing practice. For the purpose of this part, 
current good manufacturing practice includes the requirements that an 
indirect human food ingredient be of a purity suitable for its intended 
use, and that it be used at a level no higher than reasonably required 
to achieve its intended technical effect in the food-contact article.
    (1) If the ingredient is affirmed as GRAS with no limitations on its 
conditions of use other than current good manufacturing practice, it 
shall be regarded as GRAS if its conditions of use are consistent with 
the requirements of paragraphs (b), (c), and (d) of this section. When 
the Food and Drug Administration (FDA) determines that it is 
appropriate, the agency will describe one or more current good 
manufacturing practice conditions of use in the regulation that affirms 
the GRAS status of the indirect ingredient. For example, when the safety 
of an ingredient

[[Page 528]]

has been evaluated on the basis of limited conditions of use, the agency 
will describe in the regulation that affirms the GRAS status of the 
indirect ingredient, one or more of these limited conditions of use, 
which may include the category of food-contact surface(s), technical 
effect(s) or functional use(s) of the indirect ingredient, and the 
level(s) of use. If the ingredient is used under conditions that are 
significantly different from those described in the regulation, such use 
of a substance may not be GRAS. In such a case, a manufacturer may not 
rely on the regulation as authorizing that use but shall independently 
establish that the use is GRAS or shall use the ingredient in accordance 
with a food additive regulation. Persons seeking FDA approval of an 
independent determination that a use of an ingredient is GRAS may submit 
a GRAS petition in accordance with Sec. 170.35 of this chapter.
    (2) If the ingredient is affirmed as GRAS with specific 
limitation(s), it shall be used in food-contact surfaces only within 
such limitation(s), including the category of food-contact surface(s), 
the functional use(s) of the ingredient, and the level(s) of use. Any 
use of such an ingredient not in full compliance with each such 
established limitation shall require a food additive regulation.
    (3) If the ingredient is affirmed as GRAS for a specific use, prior 
to general evaluation of use of the ingredient, other uses may also be 
GRAS.
    (c) The listing of a food ingredient in this part does not authorize 
the use of such substance for the purpose of adding the ingredient to 
the food through extraction from the food-contact surface.
    (d) The listing of a food ingredient in this part does not authorize 
the use of such substance in a manner that may lead to deception to the 
consumer or to any other violation of the Federal Food, Drug, and 
Cosmetic Act (the Act).
    (e) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of an ingredient under conditions different from those 
proposed to be affirmed as GRAS, he will concurrently propose a separate 
regulation covering such use of the ingredient under part 181 of this 
chapter. If the Commissioner is unaware of any such applicable prior 
sanction, the proposed regulation will so state and will require any 
person who intends to assert or rely on such sanction to submit proof of 
its existence. Any regulation promulgated pursuant to this section 
constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof of such an applicable prior sanction in response 
to the proposal.

[42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 
1983]



       Subpart B--Listing of Specific Substances Affirmed as GRAS



Sec. 186.1025  Caprylic acid.

    (a) Caprylic acid [CH3(CH2)6COOH, CAS Reg. No. 124-
07-2] is the chemical name for octanoic acid. It is considered to be a 
short or medium chain fatty acid. It occurs normally in various foods 
and is commercially prepared by oxidation of n-octanol or by 
fermentation and fractional distillation of the volatile fatty acids 
present in coconut oil.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 207, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredient is used as an antimicrobial (preservative) in 
cheese wraps as defined in Sec. 170.3(o)(2) at levels not to exceed good 
manufacturing practice.

[[Page 529]]

    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 19843, May 9, 1978, as amended at 49 FR 5613, Feb. 14, 1984]



Sec. 186.1093  Sulfamic acid.

    (a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-14-6) is a 
white crystalline solid manufactured from urea, sulfur trioxide, and 
sulfuric acid. It is soluble and highly ionized in water.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect food ingredient with no limitations other than current good 
manufacturing practice. The affirmation of this ingredient as generally 
recognized as safe (GRAS) as an indirect human food ingredient is based 
upon the current good manufacturing practice of using this ingredient in 
the manufacture of paper and paperboard that contact food.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[47 FR 29954, July 9, 1982]



Sec. 186.1256  Clay (kaolin).

    (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-
7) consists of hydrated aluminum silicate. The commercial products of 
clay (kaolin) contain varying quantities of alkalies and alkaline 
earths. Clay (kaolin) is a white to yellowish or grayish fine powder. 
There are at least three different minerals, kaolinite, dickite, and 
nacrite, classified as kaolin. Kaolinite or china clay is whiter, less 
contaminated with extraneous minerals, and less plastic in water.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used in the manufacture of paper and 
paperboard that contact food.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[47 FR 43367, Oct. 1, 1982]



Sec. 186.1275  Dextrans.

    (a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight 
polysaccharides produced by bacterial fermentation of sucrose. 
Commercially available dextrans are synthesized from sucrose by 
Leuconostoc mesenteroides strain NRRL B-512(F). Partial depolymerization 
and purification of the fermented mixture shall produce a product that 
is free of viable microorganisms.
    (b) The ingredient is used or intended for use as a constituent of 
food-contact surfaces.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983]



Sec. 186.1300  Ferric oxide.

    (a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No. 
1309-37-1) occurs naturally as the mineral hematite. It may be prepared 
synthetically by heating brown iron hydroxide oxide. The product is red-
brown to black trigonal crystals.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.

[[Page 530]]

    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]



Sec. 186.1316  Formic acid.

    (a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) is also 
referred to as methanoic acid or hydrogen carboxylic acid. It occurs 
naturally in some insects and is contained in the free acid state in a 
number of plants. Formic acid is prepared by the reaction of sodium 
formate with sulfuric acid and is isolated by distillation.
    (b) Formic acid is used as a constituent of paper and paperboard 
used for food packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for formic acid different from the uses 
established in this section do not exist or have been waived.

[45 FR 22915, Apr. 4, 1980]



Sec. 186.1374  Iron oxides.

    (a) Iron oxides (oxides of iron, CAS Reg. No. 97705-33-85) are 
undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black 
cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown 
to black trigonal crystals).
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based upon the following current good manufacturing practice 
conditions of use:
    (1) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]



Sec. 186.1551  Hydrogenated fish oil.

    (a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of 
oils produced by partial hydrogenation of oils expressed from fish, 
primarily menhaden, and secondarily herring or tuna. Hydrogenation of 
fish oils uses catalysts composed of either elemental nickel, elemental 
copper, or a mixture of these elements. The crude hydrogenated fish oil 
is further processed by alkali refining, bleaching, and deodorization by 
steam stripping.
    (b) Hydrogenation of fish oils results in a final product with a 
melting point greater than 32 deg. C as determined by Section Cc 1-25, 
Official and Tentative Methods of the American Oil Chemists' Society 
method (reapproved 1973) or equivalent. The product has an approximate 
fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 
55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 
to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic 
or higher polyenoic fatty acids. The approximate percentages of total 
fatty acids by carbon chain length are 15 to 30 percent each of 
C16, C18, C20, C22, less than 10 percent C14 or 
lower carbon chain length, and less than 1 percent C24 or higher 
carbon chain length fatty acids.
    (c) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (d) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (e) Prior sanctions for this ingredient different from the use 
established in this section do not exist or have been waived.

[44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14. 1984; 58 
FR 17099, Apr. 1, 1993]



Sec. 186.1555  Japan wax.

    (a) Japan wax (CAS Reg. No. 8001-39-6), also known as Japan tallow 
or sumac wax, is a pale yellow vegetable tallow, containing glycerides 
of the C19-C23 dibasic acids and a high content of 
tripalmitin. It is prepared from the mesocarp by hot pressing of 
immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, 
and Indo-China), R. vernicifera (Japan), and R.

[[Page 531]]

trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble 
in hot alcohol, benzene, and naphtha, and insoluble in water and in cold 
alcohol.
    (b) In accordance with paragraph (b)(1) of this section, the 
ingredient is used as an indirect human food ingredient with no 
limitation other than current good manufacturing practice. The 
affirmation of this ingredient as generally recognized as safe (GRAS) as 
an indirect human food ingredient is based on the following current good 
manufacturing practice conditions of use:
    (1) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[60 FR 62208, Dec. 5, 1995]



Sec. 186.1557  Tall oil.

    (a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the 
pine tree. It is obtained commercially from the waste liquors of 
pinewood pulp mills and consists mainly of tall oil resin acids and tall 
oil fatty acids.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as 
an indirect human food ingredient with no limitation other than current 
good manufacturing practice. The affirmation of this ingredient as 
generally recognized as safe (GRAS) as an indirect human food ingredient 
is based on the following current good manufacturing practice conditions 
of use:
    (1) The ingredient is used as a constituent of cotton and cotton 
fabrics used for dry food packaging.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section, or from those listed in part 181 of this 
chapter, do not exist or have been waived.

[51 FR 16830, May 7, 1986]



Sec. 186.1673   Pulp.

    (a) Pulp is the soft, spongy pith inside the stem of a plant such as 
wood, straw, sugarcane, or other natural plant sources.
    (b) The ingredient is used or intended for use as a constituent of 
food packaging containers.
    (c) The ingredient is used in paper and paperboard made by 
conventional paper-making processes at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.



Sec. 186.1750  Sodium chlorite.

    (a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) exists as 
slightly hygroscopic white crystals or flakes. It is manufactured by 
passing chlorine dioxide into a solution of sodium hydroxide and 
hydrogen peroxide.
    (b) the ingredient is used at levels from 125 to 250 parts per 
million as a slimicide in the manufacture of paper and paperboard that 
contact food.

[45 FR 16470, Mar. 14, 1980]



Sec. 186.1756  Sodium formate.

    (a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the 
sodium salt of formic acid. It is produced by the reaction of carbon 
monoxide with sodium hydroxide.
    (b) The ingredient is used as a constituent of paper and paperboard 
used for food packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for sodium formate different from the uses 
established in this section do not exist or have been waived.

[45 FR 22915, Apr. 4, 1980]



Sec. 186.1770  Sodium oleate.

    (a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143-19-1) 
is the sodium salt of oleic acid (cis-9-octadecenoic acid). It exists as 
a white to yellowish powder with a slight tallow-like odor. 
Commercially, sodium oleate is made by mixing and heating flaked sodium 
hydroxide and oleic acid.

[[Page 532]]

    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a 
constituent of paper and paperboard for food packaging and as a 
component of lubricants with incidental food contact in accordance with 
Sec. 178.3570 of this chapter, with no limitation other than current 
good manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[51 FR 39372, Oct. 28, 1986]



Sec. 186.1771  Sodium palmitate.

    (a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408-
35-5) is the sodium salt of palmitic acid (hexadecanoic acid). It exists 
as a white to yellow powder. Commercially, sodium palmitate is made by 
mixing and heating flaked sodium hydroxide and palmitic acid.
    (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a 
constituent of paper and paperboard for food packaging with no 
limitation other than current good manufacturing practice.
    (c) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[51 FR 39372, Oct. 28, 1986]



Sec. 186.1797  Sodium sulfate.

    (a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-82-6), also 
known as Glauber's salt, occurs naturally and exists as colorless 
crystals or as a fine, white crystalline powder. It is prepared by the 
neutralization of sulfuric acid with sodium hydroxide.
    (b) The ingredient is used as a constituent of paper and paperboard 
used for food packaging, and cotton and cotton fabric used for dry food 
packaging.
    (c) The ingredient is used at levels not to exceed good 
manufacturing practice in accordance with Sec. 186.1(b)(1).
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[45 FR 6086, Jan. 25, 1980]



Sec. 186.1839  Sorbose.

    (a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg. 
No. 87-79-6) is an orthorhombic, bisphenoidal crystalline ketohexose. It 
was originally identifed in the juice of mature berries from the 
mountain ash (Sorbus aucuparia) where it occurs as the result of 
microbial oxidation of sorbitol. It also occurs naturally in other 
plants. Sorbose can be synthesized by the catalytic hydrogenation of 
glucose to D-sorbitol. The resulting sorbitol can be oxidized by 
Acetobacter xylinum or by Acetobacter suboxydans.
    (b) The ingredient is used or intended for indirect food use as a 
constituent of cotton, cotton fabrics, paper, and paperboard in contact 
with dry food.
    (c) The ingredient migrates to food at levels not to exceed good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983]



PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents




                      Subpart A--General Provisions

Sec.
189.1  Substances prohibited from use in human food.

 Subpart B--Substances Generally Prohibited From Direct Addition or Use 
                              as Human Food

189.110  Calamus and its derivatives.
189.113  Cinnamyl anthranilate.
189.120  Cobaltous salts and its derivatives.
189.130  Coumarin.
189.135  Cyclamate and its derivatives.
189.140  Diethylpyrocarbonate (DEPC).
189.145  Dulcin.
189.155  Monochloroacetic acid.
189.165  Nordihydroguaiaretic acid (NDGA).
189.175  P-4000.
189.180  Safrole.
189.190  Thiourea.
189.191  Chlorofluorocarbon propellants.

 Subpart C--Substances Prohibited From Indirect Addition to Human Food 
                      Through Food-Contact Surfaces

189.220  Flectol H.
189.240  Lead solders.
189.250  Mercaptoimidazoline and 2-mercaptoimidazoline.
189.280  4,4'-Methylenebis (2-chloroanaline).

[[Page 533]]

189.300  Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester 
          resins.
189.301  Tin-coated lead foil capsules for wine bottles.

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 189 appear at 61 FR 
14482, Apr. 2, 1996.



                      Subpart A--General Provisions



Sec. 189.1   Substances prohibited from use in human food.

    (a) The food ingredients listed in this section have been prohibited 
from use in human food by the Food and Drug Administration because of a 
determination that they present a potential risk to the public health or 
have not been shown by adequate scientific data to be safe for use in 
human food. Use of any of these substances in violation of this section 
causes the food involved to be adulterated in violation of the act.
    (b) This section includes only a partial list of substances 
prohibited from use in human food, for easy reference purposes, and is 
not a complete list of substances that may not lawfully be used in human 
food. No substance may be used in human food unless it meets all 
applicable requirements of the act.
    (c) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
publish a proposal to establish, amend, or repeal a regulation under 
this section on the basis of new scientific evaluation or information. 
Any such petition shall include an adequate scientific basis to support 
the petition, pursuant to part 10 of this chapter, and will be published 
for comment if it contains reasonable grounds.

[42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989]



 Subpart B--Substances Generally Prohibited From Direct Addition or Use 
                              as Human Food



Sec. 189.110   Calamus and its derivatives.

    (a) Calamus is the dried rhizome of Acorus calamus L. It has been 
used as a flavoring compound, especially as the oil or extract.
    (b) Food containing any added calamus, oil of calamus, or extract of 
calamus is deemed to be adulterated in violation of the act based upon 
an order published in the Federal Register of May 9, 1968 (33 FR 6967).
    (c) The analytical method used for detecting oil of calamus 
(-asarone) is in the ``Journal of the Association of Official 
Analytical Chemists,'' Volume 56, (Number 5), pages 1281 to 1283, 
September 1973, which is incorporated by reference. Copies are available 
from the Association of Official Analytical Chemists International, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, also from 
the Division of Food and Color Additives, Center for Food Safety and 
Applied Nutrition (HFF-330), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982; 
54 FR 24899, June 12, 1989]



Sec. 189.113  Cinnamyl anthranilate.

    (a) The food additive cinnamyl anthranilate 
(C16H15NO2, CAS Reg. No. 87-29-6) is the ester of 
cinnamyl alcohol and anthranilic acid. Cinnamyl anthranilate is a 
synthetic chemical that has not been identified in natural products at 
levels detectable by available methodology. It has been used as a 
flavoring agent in food.
    (b) Food containing any added cinnamyl anthranilate is deemed to be 
adulterated in violation of the act based upon an order published in the 
Federal Register of October 23, 1985.

[50 FR 42932, Oct. 23, 1985]



Sec. 189.120   Cobaltous salts and its derivatives.

    (a) Cobaltous salts are the chemicals, CoC4H6O4, 
CoCl2, and CoSO4.They have been used in fermented malt 
beverages as a foam stabilizer and to prevent ``gushing.''
    (b) Food containing any added cobaltous salts is deemed to be 
adulterated in violation of the act based upon an

[[Page 534]]

order published in the Federal Register of August 12, 1966 (31 FR 8788).



Sec. 189.130   Coumarin.

    (a) Coumarin is the chemical 1,2-benzopyrone, C9H6O2. 
It is found in tonka beans and extract of tonka beans, among other 
natural sources, and is also synthesized. It has been used as a 
flavoring compound.
    (b) Food containing any added coumarin as such or as a constituent 
of tonka beans or tonka extract is deemed to be adulterated under the 
act, based upon an order published in the Federal Register of March 5, 
1954 (19 FR 1239).
    (c) The analytical methods used for detecting coumarin in food are 
in sections 19.016-19.024 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24899, June 12, 1989]



Sec. 189.135   Cyclamate and its derivatives.

    (a) Calcium, sodium, magnesium and potassium salts of cyclohexane 
sulfamic acid, (C6H12NO3S)2Ca, 
(C6H12NO3S)Na, (C6H12NO3S)2 Mg, and 
(C6H12NO3S)K. Cyclamates are synthetic chemicals having a 
sweet taste 30 to 40 times that of sucrose, are not found in natural 
products at levels detectable by the official methodology, and have been 
used as artificial sweeteners.
    (b) Food containing any added or detectable level of cyclamate is 
deemed to be adulterated in violation of the act based upon an order 
published in the Federal Register of October 21, 1969 (34 FR 17063).
    (c) The analytical methods used for detecting cyclamate in food are 
in sections 20.162-20.172 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24899, June 12, 1989]



Sec. 189.140   Diethylpyrocarbonate (DEPC).

    (a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl 
ester, C6H10O5. It is a synthetic chemical not found in 
natural products at levels detectable by available methodology and has 
been used as a ferment inhibitor in alcoholic and nonalcoholic 
beverages.
    (b) Food containing any added or detectable level of DEPC is deemed 
to be adulterated in violation of the act based upon an order published 
in the Federal Register of August 2, 1972 (37 FR 15426).



Sec. 189.145   Dulcin.

    (a) Dulcin is the chemical 4-ethoxyphenylurea, 
C9H12N2O2. It is a synthetic chemical having a sweet 
taste about 250 times that of sucrose, is not found in natural products 
at levels detectable by the official methodology, and has been proposed 
for use as an artificial sweetener.
    (b) Food containing any added or detectable level of dulcin is 
deemed to be adulterated in violation of the act, based upon an order 
published in the Federal Register of January 19, 1950 (15 FR 321).
    (c) The analytical methods used for detecting dulcin in food are in 
sections 20.173-20.176 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office

[[Page 535]]

of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24899, June 12, 1989]



Sec. 189.155   Monochloroacetic acid.

    (a) Monochloroacetic acid is the chemical chloroacetic acid, 
C2H3C1O2. It is a synthetic chemical not found in natural 
products, and has been proposed as a preservative in alcoholic and 
nonalcoholic beverages. Monochloroacetic acid is permitted in food 
package adhesives with an accepted migration level up to 10 parts per 
billion (ppb) under Sec. 175.105 of this chapter. The official methods 
do not detect monochloroacetic acid at the 10 ppb level.
    (b) Food containing any added or detectable level of 
monochloroacetic acid is deemed to be adulterated in violation of the 
act based upon trade correspondence dated December 29, 1941 (TC-377).
    (c) The analytical methods used for detecting monochloroacetic acid 
in food are in sections 20.067-20.072 of the ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 13th Ed. 
(1980), which is incorporated by reference. Copies may be obtained from 
the Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24899, June 12, 1989]



Sec. 189.165   Nordihydroguaiaretic acid (NDGA).

    (a) Nordihydroguaiaretic acid is the chemical 4,4'-(2,3-
dimethyltetramethylene) dipyrocatechol, C18H22O4. It 
occurs naturally in the resinous exudates of certain plants. The 
commercial product, which is synthesized, has been used as an 
antioxidant in foods.
    (b) Food containing any added NDGA is deemed to be adulterated in 
violation of the act based upon an order published in the Federal 
Register of April 11, 1968 (33 FR 5619).
    (c) The analytical method used for detecting NDGA in food is in 
section 20.008(b) of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24900, June 12, 1989]



Sec. 189.175   P-4000.

    (a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, 
C9H12N2O3. It is a synthetic chemical having a sweet 
taste about 4000 times that of sucrose, is not found in natural products 
at levels detectable by the official methodology, and has been proposed 
for use as an artificial sweetener.
    (b) Food containing any added or detectable level of P-4000 is 
deemed to be adulterated in violation of the act based upon an order 
published in the Federal Register of January 19, 1950 (15 FR 321).
    (c) The analytical methods used for detecting P-4000 in food are in 
sections 20.177-20.181 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24900, June 12, 1989]



Sec. 189.180   Safrole.

    (a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, 
C10H10O2. It is a natural constituent of the sassafras 
plant. Oil of sassafras is about 80 percent safrole. Isosafrole and

[[Page 536]]

dihydrosafrole are derivatives of safrole, and have been used as 
flavoring compounds.
    (b) Food containing any added safrole, oil of sassafras, isosafrole, 
or dihydrosafrole, as such, or food containing any safrole, oil of 
sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is 
intended solely or primarily as a vehicle for imparting such substances 
to another food, e.g., sassafras tea, is deemed to be adulterated in 
violation of the act based upon an order published in the Federal 
Register of December 3, 1960 (25 FR 12412).
    (c) The analytical method used for detecting safrole, isosafrole and 
dihydrosafrole is in the ``Journal of the Association of Official 
Analytical Chemists,'' Volume 54 (Number 4), pages 900 to 902, July 
1971, which is incorporated by reference. Copies are available from the 
Division of Food and Color Additives, Center for Food Safety and Applied 
Nutrition (HFF-330), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28, 1977; 
47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989]



Sec. 189.190   Thiourea.

    (a) Thiourea is the chemical thiocarbamide, CH4N2S. It is 
a synthetic chemical, is not found in natural products at levels 
detectable by the official methodology, and has been proposed as an 
antimycotic for use in dipping citrus.
    (b) Food containing any added or detectable level of thiourea is 
deemed to be adulterated under the act.
    (c) The analytical methods used for detecting thiourea are in 
sections 20.115-20.126 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24900, June 12, 1989]



Sec. 189.191  Chlorofluorocarbon propellants.

    The use of chlorofluorocarbons in human food as propellants in self-
pressurized containers is prohibited as provided by Sec. 2.125 of this 
chapter.

[43 FR 11317, Mar. 17, 1978]



 Subpart C--Substances Prohibited From Indirect Addition to Human Food 
                      Through Food-Contact Surfaces



Sec. 189.220   Flectol H.

    (a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, 
polymerized, C12H15N. It is a synthetic chemical not found in 
natural products, and has been used as a component of food packaging 
adhesives.
    (b) Food containing any added or detectable level of this substance 
is deemed to be adulterated in violation of the act based upon an order 
published in the Federal Register of April 7, 1967 (32 FR 5675).

[42 FR 14659, Mar.15, 1977, as amended at 58 FR 17099, Apr. 1, 1993]



Sec.  189.240  Lead solders.

    (a) Lead solders are alloys of metals that include lead and are used 
in the construction of metal food cans.
    (b) Food packaged in any container that makes use of lead in can 
solder is deemed to be adulterated in violation of the Federal Food, 
Drug, and Cosmetic Act, based upon an order published in the Federal 
Register of June 27, 1995.

[60 FR 33109, June 27, 1995]



Sec. 189.250   Mercaptoimidazoline and 2-mercaptoimidazoline.

    (a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the 
molecular formula C3H6N2S. They are synthetic chemicals 
not found in natural products and have been used in the production of 
rubber articles that may come into contact with food.

[[Page 537]]

    (b) Food containing any added or delectable levels of these 
substances is deemed to be adulterated in violation of the act based 
upon an order published in the Federal Register of November 30, 1973 (38 
FR 33072).



Sec. 189.280   4,4'-Methylenebis (2-chloroanaline).

    (a) 4,4'-Methylenebis (2-chloroanaline) has the molecular formula, 
C13H12Cl2N2. It is a synthetic chemical not found in 
natural products and has been used as a polyurethane curing agent and as 
a component of food packaging adhesives and polyurethane resins.
    (b) Food containing any added or detectable level of this substance 
is deemed to be adulterated in violation of the act based upon an order 
published in the Federal Register of December 2, 1969 (34 FR 19073).



Sec. 189.300  Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins.

    (a) Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins 
are the condensation product of 1 mole of triphenyl phosphite and 1.5 
moles of hydrogenated 4,4'-isopropylidene-diphenol such that the 
finished resins have a molecular weight in the range of 2,400 to 3,000. 
They are synthetic chemicals not found in natural products and have been 
used as antioxidants and as stabilizers in vinyl chloride polymer resins 
when such polymer resins are used in the manufacture of rigid vinyl 
chloride polymer bottles.
    (b) Food containing any added or detectable levels of these 
substances is deemed to be adulterated and in violation of the Federal 
Food, Drug, and Cosmetic Act, based upon an order published in the 
Federal Register of September 9, 1987 (52 FR 33929).

[54 FR 7188, Feb. 17, 1989]



Sec. 189.301  Tin-coated lead foil capsules for wine bottles.

    (a) Tin-coated lead foil is composed of a lead foil coated on one or 
both sides with a thin layer of tin. Tin-coated lead foil has been used 
as a capsule (i.e., as a covering applied over the cork and neck areas) 
on wine bottles to prevent insect infestation, as a barrier to oxygen, 
and for decorative purposes. Information received by the Food and Drug 
Administration establishes that the use of such a capsule on wine 
bottles may reasonably be expected to result in lead becoming a 
component of the wine.
    (b) The capping of any bottles of wine after February 8, 1996, with 
a tin-coated lead foil capsule renders the wine adulterated and in 
violation of section 402(a)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act because lead from the capsule, which is an unsafe food 
additive within the meaning of section 409 of the act, may reasonably be 
expected to become a component of the wine.

[61 FR 4820, Feb. 8, 1996]



PART 197--SEAFOOD INSPECTION PROGRAM--Table of Contents




                        Subparts A--C  [Reserved]

                 Subpart D--Inspection of Canned Oysters

Sec.
197.310  Application for inspection service.
197.312  Granting or refusing inspection service; cancellation of 
          application.
197.315  Suspension and withdrawal of inspection service.
197.320  Inspection periods.
197.325  Assignment of inspectors.
197.329  Uninspected oysters excluded from inspected establishments.
197.330  General requirements for plant and equipment.
197.340  General operating conditions.
197.350  Code marking.
197.355  Processing.
197.360  Examination after canning.
197.370  Labeling.
197.380  Certificates of inspection; warehousing and export permits.
197.385  Inspection fees.

                        Subparts E--H  [Reserved]

                Subpart I--Inspection of Processed Shrimp

197.810  Application for inspection service.
197.812  Granting or refusing inspection service; cancellation of 
          application.
197.815  Suspension and withdrawal of inspection service.
197.820  Inspection periods.
197.825  Assignment of inspectors.
197.829  Uninspected shrimp excluded from inspected establishments.

[[Page 538]]

197.830  General requirements for plant and equipment.
197.840  General operating conditions.
197.850  Code marking.
197.855  Processing.
197.860  Examination after processing.
197.870  Labeling.
197.880  Certificates of inspection; warehousing and export permits.
197.885  Inspection fees.

    Authority: Secs. 701, 702a, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371, 372a, 374).

    Source: 42 FR 14661, Mar. 15, 1977, unless otherwise noted.



                        Subparts A--C  [Reserved]



                 Subpart D--Inspection of Canned Oysters



Sec. 197.310   Application for inspection service.

    (a) Applications for inspection service on canned oysters under the 
provisions of section 702a of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 372a) shall be on forms supplied by the Food and Drug 
Administration. No application for a regular inspection period filed 
with the Food and Drug Administration after September 1 preceding such 
period in any year shall be considered unless the applicant shows 
substantial cause for failure to file such application on or before 
September 1 of such year. The opening date of the canning season in each 
State shall be the date set by the State agency responsible for 
controlling the opening date of the canning season in that State. A 
separate application shall be made for each inspection period in each 
establishment for which the service is applied. Each application for a 
regular inspection period shall be accompanied by a payment of $600.00 
as prescribed by Sec. 197.385(a)(1). Such deposit shall be paid in the 
manner prescribed by Sec. 197.385(e).
    (b) For the purpose of Secs. 197.310 through 197.385, an 
establishment is defined as a factory where oysters may be processed and 
warehouses under the control and direction of the packer where such 
canned oysters are stored.



Sec. 197.312   Granting or refusing inspection service; cancellation of application.

    (a) The Secretary of Health and Human Services may grant the 
inspection service applied for upon determining that the establishment 
covered by such application complies with the requirements of 
Sec. 197.330.
    (b) The Secretary may refuse to grant the inspection service at any 
establishment for cause. In case of refusal the applicant shall be 
notified of the reason therefor and shall have returned to him all 
advance payments and production deposits made, less any expenses 
incurred for preliminary inspection of the establishment, or for other 
purposes incident to such application.
    (c) The applicant, by written notice to the Secretary, may withdraw 
his application for inspection service before an inspector is assigned 
to the establishment. In case of such withdrawal, the Secretary shall 
return to such applicant all advance payments and production deposits 
made, less any salary and other expense incurred incident to such 
application.



Sec. 197.315   Suspension and withdrawal of inspection service.

    (a) The Administration may suspend and the Secretary may withdraw 
inspection service in any establishment upon failure of the packer to 
comply with any applicable provision of Secs. 197.310 through 197.385 or 
upon the dissemination by the packer or any person in privity with him 
of any representation that is false or misleading in any particular 
regarding the application to any seafood of the inspection service 
provided by the regulations in this part.
    (b) When inspection service is suspended in an establishment, as 
authorized by paragraph (a) of this section, the Food and Drug 
Administration shall not lengthen the inspection period in such 
establishment to compensate for any of the time of suspension.



Sec. 197.320   Inspection periods.

    (a) The regular inspection period in each establishment in which 
inspection service under Secs. 197.310 through 197.385

[[Page 539]]

is granted consists of 4 consecutive months. The date of the beginning 
of such regular inspection period shall be regarded as the date, on or 
after October 1 but not later than March 1, specified for the beginning 
of the service in the application therefor, or such other date as may be 
specified by amendment to such application and approved; but if the 
Secretary is not prepared to begin the service on the specified date 
then the period shall start on the date on which service is begun.
    (b) Extension inspection periods shall begin at the close of the 
preceding inspection period. Extension inspection periods may be granted 
for periods of 1 month and/or fractional parts of 1 month, but in no 
case less than 1 day. Extension inspection periods for 1 month may be 
granted in such establishment if application therefor, accompanied by a 
payment of $600.00, as prescribed by Sec. 197.385(a)(3), is made at 
least 2 weeks in advance of the close of such preceding inspection 
period. Applications for extension inspection periods for fractional 
parts of a month may be accepted when accompanied by the payment 
prescribed by Sec. 197.385(a)(3) for such extensions. No regular or 
extension inspection period shall extend beyond June 30 of any year.
    (c) Upon request of the packer, and with the approval of the Food 
and Drug Administration, such service during any inspection period may 
be transferred from one establishment to another to be operated by the 
same packer; but such transfer shall not serve to lengthen any 
inspection period or to take the place of an extension inspection 
period. In case of such transfer the packer shall furnish all necessary 
transportation of inspectors.
    (d) The inspection service shall be continuous throughout the 
inspection period.



Sec. 197.325   Assignment of inspectors.

    (a) An initial assignment of at least one inspector shall be made to 
each establishment in which inspection service under Secs. 197.310 
through 197.385 is granted. Thereafter, the Food and Drug Administration 
shall adjust the number of inspectors assigned to each establishment and 
tour of duty of each inspector to the requirements for continuous and 
efficient inspection.
    (b) Any inspector of the Food and Drug Administration shall have 
free access at all times to all parts of the establishment and to all 
fishing and freight boats and other conveyances dredging oysters for or 
transporting oysters to such establishments.



Sec. 197.329   Uninspected oysters excluded from inspected establishments.

    (a) No establishment to which inspection service on canned oysters 
has been granted shall at any time thereafter can oysters that have not 
been so inspected, or handle or store in such establishment any canned 
oysters that have not been so inspected; but this paragraph shall not 
apply to an establishment after termination of inspection service 
therein, or withdrawal therefrom as authorized by Sec. 197.315.
    (b) All oysters delivered to or held in an inspected establishment 
may be subject to inspection, but certificates of inspection shall be 
issued under Sec. 197.380 only on canned oysters.



Sec. 197.330   General requirements for plant and equipment.

    (a) All exterior openings of the cannery, including those of the 
shucking sheds, shall be adequately screened, and roofs and exterior 
walls shall be tight. When necessary, fly traps, fans, blowers, or other 
approved insect-control devices shall be installed.
    (b) Shucking sheds and packing rooms shall be separate, and fixtures 
and equipment shall be so constructed and arranged as to permit thorough 
cleaning. Such sheds and rooms shall be adequately lighted and 
ventilated, and the floors shall be tight and arranged for thorough 
cleaning and proper drainage. Open drains from shucking shed shall not 
enter packing room. If shucking shed and packing room are in separate 
buildings, such buildings shall be not more than 100 yards apart, unless 
adequate provisions are made to enable efficient inspection.
    (c) All surfaces of washers, tanks, belts, tables, flumes, utensils, 
and other equipment with which unshucked or shucked oysters come in 
contact after delivery to the establishment

[[Page 540]]

shall be of metal or of other smooth nonporous and easily cleanable 
material, provided such materials are not lead or other toxic 
substances. Metal seams shall be smoothly soldered or smoothly welded. 
Shucking tables shall be so constructed as to preclude contamination of 
working surfaces or products thereon from foot traffic or wheelbarrows 
or other containers used in delivering steamed oysters to such tables.
    (d) Adequate supplies of suitable detergents and sanitizing agents 
approved by the Food and Drug Administration; clean, unpolluted running 
water; and steam shall be provided for washing, cleaning, and otherwise 
maintaining the establishment in a sanitary condition.
    (e) Adequate toilet facilities of sanitary type which comply fully 
with applicable State laws and local ordinances shall be provided.
    (f) An adequate number of sanitary washbasins, with liquid or 
powdered soap, shall be provided in both the shucking shed and the 
packing room. Paper towels shall be provided in the packing room.
    (g) Signs requiring employees handling oysters to wash their hands 
after each absence from post of duty shall be conspicuously posted in 
the shucking shed and packing room and elsewhere about the premises as 
conditions require.
    (h) One or more suitable washing devices and one or more suitable 
inspection belts shall be installed for the washing and subsequent 
inspection of the oysters before delivery for steaming or other means of 
opening.
    (i) If steam boxes are used for opening the oysters, they shall be 
provided with adequate steam inlets, exhausts, drains, a safety valve, 
and a pressure gauge.
    (j) Suitable means shall be provided for removing shells and debris 
from shucking shed.
    (k) One or more suitable devices shall be provided for removing 
shell and grit from shucked oysters, for washing such oysters, and for 
their subsequent drainage.
    (l) One or more suitable inspection belts shall be installed for the 
inspection of shucked oysters.
    (m) Equipment shall be provided for code-marking cans.
    (n) An automatic container-counting device shall be installed in 
each cannery line.
    (o) Each sterilizing retort shall be fitted with at least the 
following equipment:
    (1) An automatic control for regulating temperatures.
    (2) An indicating mercury thermometer of a range from 170 deg. F to 
270 deg. F, with scale divisions not greater than 2 deg. F, installed 
either within a fitting attached to the shell of the retort or within 
the door or shell of the retort. If the thermometer is installed within 
a fitting, such fitting shall communicate with the chamber of the retort 
through an opening at least 1 inch in diameter. Such fitting shall be 
equipped with a bleeder at least one-eighth inch in diameter. If the 
thermometer is installed within the door or shell of the retort, the 
bulb shall project at least two-thirds of its length into the principal 
chamber.
    (3) A recording thermometer of a range from 170 deg. F to 270 deg. 
F, with scale divisions not greater than 2 deg. F. The bulb of such 
thermometer shall be installed as prescribed for the indicating mercury 
thermometer. The case which houses the charts and recording mechanism 
shall be provided with an approved lock, all keys to which shall be in 
the sole custody of the inspector.
    (4) A pressure gauge of a range from 0 to 30 pounds, with scale 
divisions not greater than 1 pound and diameter of not less than 5 
inches. Such gauge shall be connected to the chamber of the retort by a 
short gooseneck tube. The gauge shall be not more than 4 inches higher 
than the gooseneck.
    (5) A blow-off vent of at least \3/4\-inch inside diameter in the 
top of the retort.
    (6) A \1/8\-inch bleeder in top of the retort.
    (p) Suitable space and facilities shall be provided for the 
inspector to prepare records and examine samples and for the safekeeping 
of records and equipment.



Sec. 197.340   General operating conditions.

    (a) The decks and holds of all boats tonging or dredging oysters for 
or

[[Page 541]]

transporting oysters to an inspected establishment, and the bodies of 
other conveyances so transporting oysters shall be kept in a sanitary 
condition. Such boats shall be equipped with adequate means for 
protecting the oysters against contamination with bilge water.
    (b) Inspected establishments, freight boats, and other conveyances 
serving such establishments shall accept only live, clean, sound oysters 
taken from unpolluted areas. When necessary, ice or other suitable 
refrigeration shall be provided to prevent spoilage.
    (c) After delivery of each load of oysters to the establishment, 
decks and holds of each boat and the body of each other conveyance or 
container making such delivery shall be washed down with clean, 
unpolluted water, and all debris shall be cleaned therefrom before such 
boat or other conveyance or container leaves the establishment premises.
    (d) Before being steamed or opened by other means, the oysters shall 
be washed with clean, unpolluted water and then passed over the 
inspection belt and culled to remove dirty, muddy, dead, or decomposed 
oysters and extraneous material. Muddy oysters may be returned to the 
washer for rewashing.
    (e) As often as is necessary to maintain sanitary conditions, 
unloading platforms and equipment shall be washed with clean, unpolluted 
water, and all debris shall be cleaned therefrom.
    (f) Shells shall be removed from the shucking shed continuously.
    (g) Offal, debris, or refuse from any source whatever shall not be 
allowed to accumulate in the cannery or, except for shells, about the 
premises. Shells shall not be allowed to accumulate about the premises 
in such a manner as to create a nuisance.
    (h) The delivery of steamed oysters to shuckers by means of manually 
rolling, trundling, or wheelbarrowing such oysters on or above shucking 
tables will not be permitted.
    (i) Shucking knives and shucking cups shall be thoroughly washed 
with soap and water and chlorinated before use each day. Chlorine 
solution shall be maintained at a strength of 200 parts per million.
    (j) No shucked oysters shall be returned to shucker after delivery 
to the weigher. Shucking cups shall be cleaned and sanitized after each 
delivery to the weigher.
    (k) Shucked oysters being transported from one building to another 
shall be properly covered and protected against contamination.
    (l) The shucked oysters shall be washed, separated from the shell 
and grit by suitable devices, and then immediately drained. The time of 
washing shall not exceed the minimum time necessary for cleansing.
    (m) From the time of delivery to the cannery up to the time of final 
processing, oysters shall be handled expeditiously and under such 
conditions as to prevent contamination or spoilage.
    (n) The packer shall destroy for food purposes under the immediate 
supervision of the inspector all oysters in his possession condemned by 
the inspector as filthy, decomposed, putrid, or unfit for food. Oysters 
condemned on the boat or on the unloading platform shall not be taken 
into the cannery, but shall be either destroyed or returned to a bedding 
ground.
    (o) All portions of the establishment shall be adequately lighted to 
enable the inspector to perform his duties properly.
    (p) All floors and other parts of the establishment, including 
unloading platforms, and all fixtures, equipment, and utensils shall be 
cleaned as often as may be necessary to maintain them in a sanitary 
condition.
    (q) The packer shall require all employees handling oysters to wash 
their hands after each absence from post of duty and to observe other 
proper habits of cleanliness.
    (r) The packer shall not knowingly employ in or about the 
establishment any person afflicted with an infectious or contagious 
disease or with any open sores on exposed portions of the body.



Sec. 197.350   Code marking.

    (a) Code marks shall be affixed to all cans and other immediate 
containers before they are placed in the processing retorts. Such marks 
shall show at least:

[[Page 542]]

    (1) The date of packing;
    (2) The establishment where packed;
    (3) The conveyance; and
    (4) The size of the oysters when such oysters are graded for size.
    (b) Keys to all code marks shall be given to the inspector.
    (c) Each lot shall be stored separately pending final inspection, 
with a space of not less than 6 inches between stacks of each lot. For 
the purposes of the regulations in this part all cans or other 
containers bearing the same code marks shall be regarded as comprising a 
lot.



Sec. 197.355   Processing.

    (a) The closure of the can or other immediate container and the time 
and temperature of sterilizing the canned oysters shall be adequate to 
prevent bacterial spoilage.
    (b) The following times and temperatures shall be the minimum 
employed for the containers indicated:

                             Canned Oysters                             
------------------------------------------------------------------------
                                         Initial     Time at    Time at 
                                       temperature   240 deg.   250 deg.
                 Size                    (degrees       F          F    
                                       Fahrenheit)  (minutes)  (minutes)
------------------------------------------------------------------------
211 by 212...........................  ...........  .........  .........
211 by 300...........................          70          24         14
211 by 306...........................         130          23         13
211 by 400...........................  ...........  .........  .........
307 by 400...........................          70          28         14
307 by 409...........................         130          27         13
------------------------------------------------------------------------

For the purposes of this section, initial temperature is defined as the 
average temperature of the contents of the container at the moment steam 
is admitted to the sterilizing retort.
    (c) The blow-off vent shall be open during the coming-up period 
until the mercury thermometer registers at least 215 deg. F. Bleeders 
shall emit steam during the entire cooking period.
    (d) The inspector shall identify each record on the thermometer 
chart with the code mark of the lot to which such record relates and the 
date of such record. The Food and Drug Administration shall keep such 
charts for at least 5 years, and upon request shall make them available 
to the packer.
    (e) The packer shall keep for at least 2 years all shipping records 
covering shipments from each lot, and upon request shall furnish such 
records to any inspector of the Food and Drug Administration.



Sec. 197.360   Examination after canning.

    (a) Adequate samples shall be drawn by the inspector from each lot 
of canned oysters and shall be examined to determine whether or not such 
canned oysters conform to all requirements of the Federal Food, Drug, 
and Cosmetic Act, amendments thereto, and regulations thereunder.
    (b) The packer shall destroy for food purposes, under the immediate 
supervision of the inspector, all canned oysters condemned by the 
inspector as not complying with Sec. 197.355, or as filthy, decomposed, 
putrid, or otherwise unfit for food.



Sec. 197.370   Labeling.

    (a) Labels on canned oysters packed and certified under 
Secs. 197.310 through 197.385 may bear the mark ``Production Supervised 
by the U.S. Food and Drug Administration.'' Such mark, if used, shall be 
plainly and conspicuously displayed, in type of uniform size and style, 
on a strongly contrasting, uniform background.
    (b) Two proofs, or one proof and one photostat thereof, or eight 
specimens of all labeling intended for use on inspected canned oysters 
or on or within the cases therefor shall be submitted to the Food and 
Drug Administration for approval. If the proofs or photostat and proof 
are submitted, eight specimens of the labeling shall be sent to the Food 
and Drug Administration after printing. The Food and Drug Administration 
is hereby authorized to approve labeling for use on canned oysters 
inspected under Secs. 197.310 through 197.385. Approval shall be subject 
to the condition that such labeling shall be so used as to comply with 
the provisions of the Federal Food, Drug and Cosmetic Act, amendments, 
thereto, and regulations thereunder. The Food and Drug Administration is 
also authorized to revoke any such approval for cause. The Food and Drug 
Administration shall not approve labeling for canned oysters intended 
for export under the provisions of Sec. 197.380(e).

[[Page 543]]

    (c) No commercial brand or brand name appearing on labeling approved 
as authorized under paragraph (b) of this section and bearing the mark 
described in paragraph (a) of this section, and no labeling simulating 
any such approved labeling, shall be used after such approval on canned 
oysters other than those that have been handled, prepared, and packed in 
compliance with all provisions of Secs. 197.310 through 197.385; but 
this section shall not apply to any packer's labeling not bearing such 
mark after termination of inspection or withdrawal thereof as authorized 
by Sec. 197.315 or to any distributor's labeling not bearing such mark 
after written notice by the owner thereof to the Food and Drug 
Administration that the use of such labeling on inspected canned oysters 
has been discontinued and will not be resumed.
    (d) Canned-oyster labeling authorized by paragraph (a) of this 
section or approved under paragraph (b) of this section shall be used 
only as authorized by Secs. 197.310 through 197.385. Unauthorized use of 
such labeling renders the user liable to the penalties prescribed by the 
Food, Drug, and Cosmetic Act, as amended.



Sec. 197.380   Certificates of inspection; warehousing and export permits.

    (a) After finding that the canned oysters comprising any parcel have 
been handled, prepared, and packed in compliance with all provisions of 
Secs. 197.310 through 197.385; bear labeling approved as authorized 
under Sec. 197.370(b); and comply with all the provisions of the Federal 
Food, Drug, and Cosmetic Act, amendments thereto, and regulations 
thereunder, the inspector shall issue a certificate showing that such 
canned oysters so comply. The certificate shall specify the code marks 
to which it applies, the quantity of the parcel so marked, the place 
where such parcel is stored, the size and kind of containers, the 
commercial brand name on the labels, the condition of the oysters if 
they are broken or if they are substandard in fill, and the destination 
of the lot if known. Such certificate shall become void if such labeling 
is removed, altered, obliterated, or replaced; but such canned oysters 
may be relabeled under supervision of an inspector and recertified if 
the inspector finds that, after being relabeled, they comply with the 
requirements laid down by this paragraph for the issuance of a 
certificate.
    (b) Unless covered by certificate, canned oysters shall be moved 
from an inspected establishment only for storage authorized under 
paragraph (c) of this section, or for export authorized under paragraph 
(e) of this section, or for destruction as provided by Sec. 197.360(b).
    (c) Applications to move unlabeled canned oysters for storage in a 
warehouse elsewhere than in the establishment where such oysters were 
packed shall be on forms supplied by the Administration. The application 
shall give the name and location of the warehouse in which such canned 
oysters are to be stored, and shall be accompanied by an agreement 
signed by the operator of such warehouse that inspectors shall have free 
access at all times to all canned oysters so stored, and that conditions 
which will preserve the identity of each parcel of such canned oysters 
shall be continuously maintained pending issuance of a certificate 
thereon or removal as authorized by paragraph (d) of this section. If 
such application is approved and it appears to the inspector that the 
canned oysters comprising any parcel have been packed in compliance with 
Secs. 197.310 through 197.385 and conform, except for the absence of 
labeling, to all requirements of the Federal Food, Drug, and Cosmetic 
Act, amendments thereto, and regulations thereunder, the inspector shall 
issue to the applicant, on his request, a warehousing permit covering 
such canned oysters. Such permit shall specify the code marks to which 
it applies, the quantity of the parcel so marked, the place from and to 
which such parcel is to be moved, the size of the oysters, the size and 
kind of containers, and the condition of the oysters if they are broken 
or if they are substandard in fill and, if such be the case, that they 
are intended for export under paragraph (e) of this section. When any 
provision of the agreement is violated, the Food and Drug Administration 
may revoke any permit issued pursuant to such agreement, and may

[[Page 544]]

also revoke its approval of the application for warehousing which 
accompanied such agreement.
    (d) Unless covered by certificate, canned oysters stored under the 
authority of paragraph (c) of this section shall be moved from the 
warehouse where stored only for re-storage under such authority, or for 
return upon written permission of the inspector to the establishment 
where packed, or for export authorized under paragraph (e) of this 
section, or for destruction as provided by Sec. 197.360(b).
    (e) An application to export canned oysters under the provisions of 
section 801(d) of the act shall be accompanied by the original or a 
verified copy of the specifications of the foreign purchaser; if 
required by the Food and Drug Administration, evidence showing that such 
canned oysters are not in conflict with the laws of the country to which 
they are intended for export; and, if shipment of labeled canned oysters 
is specified or directed, eight specimens of the labeling therefor. If 
canned oysters prepared or packed according to such specifications are 
not in conflict with the laws of such country, the Administration shall 
direct the inspector to issue to the applicant an export permit covering 
such canned oysters comprising any parcel ordered by such purchaser 
under such specifications, when the inspector finds that such canned 
oysters were packed in compliance with the requirements of Secs. 197.310 
through 197.385 regarding sanitary conditions and processing; are not 
filthy, decomposed, putrid, or otherwise unfit for food; accord to such 
specifications, and are labeled on the outside of the shipping package 
to show that they are intended for export. Such permit shall specify the 
code marks to which it applies and the quantity of the parcel so marked, 
and shall show that such canned oysters were packed under sanitary 
conditions, are wholesome, and accord to such specifications. The 
applicant shall furnish to the inspector documentary evidence showing 
the exportation of all such canned oysters.



Sec. 197.385   Inspection fees.

    (a)(1) Except as otherwise provided by the regulations in this part, 
an initial payment of $600.00 shall accompany each application; 
thereafter, three additional advance payments of $600.00 each shall be 
made, as follows: One payment on or before the date of the beginning of 
the regular inspection period specified in the application for 
inspection; the remaining two payments on or before the first day of 
each succeeding month, except that the Food and Drug Administration may 
require the full amount of all advance payments prescribed by this 
paragraph to accompany the application of an applicant who has defaulted 
in any payment due for any prior packing season: Provided, That a packer 
who is concurrently receiving inspection service and making payments 
under the regulations for the inspection of processed shrimp shall not 
make any additional payments under this subparagraph.
    (2) Whenever it is determined, without hearing, by the Food and Drug 
Administration that an establishment having the inspection service has 
been damaged by wind, fire, flood, or other calamity to such an extent 
that packing operations cannot be resumed before the end of the fiscal 
year then current, no advance payments falling due after such calamity 
shall be required from the packer for that fiscal year; but whenever it 
is determined, without hearing, by the Food and Drug Administration that 
an establishment having the inspection service has been so damaged by 
any such calamity that operations must be suspended temporarily, but can 
be resumed before the end of the fiscal year then current, advance 
payments falling due after such calamity and before the month of 
resumption of operations shall be postponed until operations are 
resumed, and thereupon shall be paid in equal monthly installments 
during the period between the time of resumption of operations and June 
1 of the fiscal year then current: Provided, That in the event of a 
determination described in this subparagraph the total payments and 
production deposits made by the packer involved shall be charged with 
the cost of the service made available for the establishment, without 
regard to the method provided hereinafter for computing charges against 
payments and production deposits, and the balance of

[[Page 545]]

the total payments and deposits remaining after such charges shall be 
refunded by the Food and Drug Administration to the packer after the 
completion of the fiscal year.
    (3) Each application for an extension inspection period of 1 month 
shall be accompanied by a payment of $600.00, and at subsequent monthly 
intervals thereafter additional payments of $600.00 shall be made; but 
if the final payment is to cover a period of less than 30 days, then 
such payment shall be at the rate of $20.00 for each day of such period.
    (b)(1) In addition to the payments prescribed in paragraph (a) of 
this section, advance deposits based upon the quantity of oysters canned 
by the subscribing establishment shall be made to underwrite adequately 
the cost of the inspection service. Such deposits shall be paid in 
advance in amounts of not less than $300.00, unless the Food and Drug 
Administration on an estimate of production authorizes other amounts, 
and shall be computed at the rate of 15 cents for each case of 48 cans, 
size 211 x 300. Any advance production deposits in excess of those 
required for actual oysters canned for the fiscal year (July 1 through 
June 30) will be refunded to the packers by the Food and Drug 
Administration after the completion of the fiscal year.
    (2) Production deposits as computed under paragraph (b)(1) of this 
section, together with deposits for shrimp received as prescribed under 
Sec. 197.885(b)(1), in the case of processed shrimp, shall be charged 
with the balance of the total cost of the inspection service which has 
not been provided for by the combined total payments under paragraph (a) 
of this section and paragraph (a) of Sec. 197.885, in the case of 
processed shrimp. The balance of the production deposits remaining after 
such charges have been made shall be refunded by the Administration to 
the packers after the completion of the fiscal year in the ratio which 
each packer's production deposits for oysters canned and deposits for 
shrimp received bears to the combined total of such deposits for oysters 
canned and shrimp received by all packers for the fiscal year.
    (3) When inspection service is withdrawn from an establishment as 
authorized under Sec. 197.315(a), the Food and Drug Administration shall 
not return to the packer any advance payments and/or deposits required 
to the date of withdrawal of the service. Such payments and/or deposits 
shall be charged with the cost of the service made available for the 
establishment, without regard to the method described in this section, 
and the balance that would have accrued to such packer shall remain to 
the credit of the Food and Drug Administration in the special account 
``Salaries and Expenses, Certification and Inspection Services.''
    (c) A separate fee shall be paid to cover all expenses incurred in 
accordance with the regulations of the United States Government, for 
salary, travel, subsistence, and for other purposes incident to 
inspection for the purpose of issuing a certificate or warehousing or 
export permit on canned oysters stored or held at any place other than 
an establishment to which a seafood inspector is then assigned.
    (d) When the cannery and the cannery warehouse of an establishment 
are located at different points of such distance apart that 
transportation between them is required for the inspector to perform his 
duties in the establishment, the packer shall furnish such 
transportation or shall pay a separate fee to cover all expenses 
therefor.
    (e) All payments required by the regulations in this part shall be 
by bank draft or certified check, collectible at par drawn to the order 
of the Food and Drug Administration, and payable at Washington, DC. All 
such drafts and checks except those for the payment required by 
Sec. 197.310(a), shall be delivered to the inspector and promptly 
scheduled to the Food and Drug Administration, Department of Health and 
Human Services, Washington, DC, whereupon after appropriate records 
thereof have been made they shall be transmitted to the Chief Disbursing 
Officer, Division of Disbursement, Treasury Department, for deposit to 
the special account ``Certification and Inspection Services, Food and 
Drug Administration.''
    (f) All refunds to packers shall be by check drawn on the Treasury 
of the

[[Page 546]]

United States pursuant to refund vouchers duly certified and approved by 
the designated administrative officers.



                        Subparts E-H  [Reserved]



                Subpart I--Inspection of Processed Shrimp



Sec. 197.810   Application for inspection service.

    (a) Applications for inspection service on the processing of shrimp 
under the provisions of section 702a of the Federal Food, Drug, and 
Cosmetic Act shall be on forms supplied by the Food and Drug 
Administration. The processing of shrimp comprises all the operations 
including labeling and storage, necessary to prepare for the market 
shrimp in any of the following forms: Iced or frozen raw headless, raw 
peeled or cooked peeled (any of which may be deveined); iced or frozen 
deveined shrimp, partially or completely peeled (which may be battered 
and breaded before freezing), and canned shrimp. No application for a 
regular inspection period filed with the Food and Drug Administration 
after May 1, preceding such period in any year, shall be considered 
unless the applicant shows substantial cause for failure to file such 
application on or before May 1 of such year. A separate application 
shall be made for each inspection period in each establishment for which 
the service is applied. Each application for a regular inspection period 
shall be accompanied by an advance payment of $500.00 as prescribed by 
Sec. 197.885(a)(1). Such payment shall be made in the manner prescribed 
by Sec. 197.885(e).
    (b) For the purposes of Secs. 197.810 through 197.885, an 
establishment is defined as a factory where shrimp may be processed and 
warehouses and cold storage plants under the control and direction of 
the packer where such shrimp is stored.



Sec. 197.812   Granting or refusing inspection service; cancellation of application.

    (a) The Secretary of Health and Human Services may grant the 
inspection service applied for upon determining that the establishment 
covered by such application complies with the requirements of 
Sec. 197.830.
    (b) The Secretary may refuse to grant inspection service at any 
establishment for cause. In case of refusal, the applicant shall be 
notified of the reason therefor and shall have returned all advance 
payments and deposits made, less any expenses incurred for preliminary 
inspection of the establishment or for other purposes incident to such 
application.
    (c) The applicant, by written notice to the Secretary, may withdraw 
his application for inspection service before July 1 preceding the 
inspection period covered by the application. In case of such 
withdrawal, the Secretary shall return to such applicant all advance 
payments and deposits made, less any salary and other expense incurred 
incident to such application.



Sec. 197.815   Suspension and withdrawal of inspection service.

    (a) The Food and Drug Administration may suspend and the Secretary 
may withdraw inspection service in any establishment:
    (1) Upon failure of the packer to comply with any applicable 
provision of Secs. 197.810 through 197.885; or
    (2) Upon the dissemination by the packer or any person in privity 
with him of any representation that is false or misleading in any 
particular regarding the application to any seafood of the inspection 
service provided by the regulations in this part.
    (b) When inspection service is suspended in an establishment, as 
authorized by paragraph (a) of this section, the Food and Drug 
Administration shall not lengthen the inspection period in such 
establishment to compensate for any of the time of suspension.



Sec. 197.820   Inspection periods.

    (a) The regular inspection period in each establishment in which 
inspection service under Secs. 197.810 through 197.885 is granted 
consists of 9 consecutive months. The date of the beginning of such 
regular inspection period shall be regarded as the date, on or after 
July 1, but not later than October 1, specified for the beginning of the 
service in the application therefor, or such other date

[[Page 547]]

as may be specified by amendment to such application and approved; but 
if the Secretary is not prepared to begin the service on the specified 
date, then the period shall start on the date on which service is begun.
    (b) Extension inspection periods shall begin at the close of the 
preceding inspection period. Extension inspection periods may be granted 
for periods of 1 month and/or fractional parts of 1 month, but in no 
case less than 1 day. Extension inspection periods for 1 month may be 
granted in such establishment if application therefor, accompanied by a 
payment of $600.00 as prescribed by Sec. 197.885(a)(3), is made at least 
2 weeks in advance of the close of such preceding inspection period. 
Applications for extension inspection periods for fractional parts of a 
month may be accepted when accompanied by the payment prescribed by 
Sec. 197.885(a)(3) for such extensions. No regular or extension 
inspection period shall extend beyond June 30 of any year.
    (c) Upon request of the packer, and with the approval of the Food 
and Drug Administration, such service during any inspection period may 
be transferred from one establishment to another to be operated by the 
same packer; but such transfer shall not serve to lengthen any 
inspection period or to take the place of an extension inspection 
period. In case of such transfer the packer shall furnish all necessary 
transportation of inspectors.
    (d) The inspection service shall be continuous throughout the 
inspection period.



Sec. 197.825   Assignment of inspectors.

    (a) An initial assignment of at least one inspector shall be made to 
each establishment in which inspection service under Secs. 197.810 
through 197.885 is granted. Thereafter, the Food and Drug Administration 
shall adjust the number of inspectors assigned to each establishment and 
tour of duty of each inspector to the requirements for continuous and 
efficient inspection.
    (b) Any inspector of the Food and Drug Administration shall have 
free access at all times to all parts of the establishment, to plants 
supplying materials to the inspected establishment, and to all fishing 
and freight boats and other conveyances catching shrimp for, or 
transporting shrimp to, such establishment.



Sec. 197.829   Uninspected shrimp excluded from inspected establishments.

    (a) No establishment to which inspection service has been granted 
shall at any time thereafter process shrimp which has not been so 
inspected or handle or store in such establishment any processed shrimp 
which has not been so inspected; but this paragraph shall not apply to 
an establishment after termination of inspection service therein or 
withdrawal therefrom as authorized by Sec. 197.815.
    (b) All shrimp and other ingredients entering into the finished 
product may be subject to inspection prior to delivery to the 
establishment or at any time thereafter, and all shrimp processed in 
such establishment shall be subject to certification under Sec. 197.880.



Sec. 197.830   General requirements for plant and equipment.

    (a) All exterior openings of the establishment shall be adequately 
screened and roofs and exterior walls shall be tight. When necessary fly 
traps, fans, blowers, or other approved insect-control devices shall be 
installed.
    (b) Except for raw headless shrimp which may or may not be deveined, 
picking and packing rooms shall be separate, provided that this 
requirement may be waived by the Food and Drug Administration where 
separation of picking and packing rooms is not necessary for adequate 
sanitation. Blanching tanks shall not be located in picking room. 
Fixtures and equipment shall be so constructed and arranged as to permit 
thorough cleaning. Such rooms shall be adequately lighted and 
ventilated, and the floors shall be tight and arranged for thorough 
cleaning and proper drainage. Open drains from picking room shall not 
enter packing or blanching room. If picking and packing rooms are in 
separate buildings, such buildings shall be not more than 100 yards 
apart unless adequate provisions are made to enable efficient 
inspection.

[[Page 548]]

    (c) All surfaces of tanks, belts, tables, flumes, utensils, and 
other equipment with which either picked or unpicked shrimp come in 
contact after delivery to the establishment shall be of metal or of 
other smooth nonporous and easily cleanable materials, provided such 
materials are not lead or other toxic substances. Metal seams shall be 
smoothly soldered or smoothly welded.
    (d) Adequate supplies of suitable detergents and sanitizing agents 
approved by the Food and Drug Administration; clean, unpolluted running 
water; and, if necessary, steam shall be provided for washing, cleaning, 
and otherwise maintaining the establishment in a sanitary condition.
    (e) Adequate toilet facilities of sanitary type which comply fully 
with applicable State laws and local ordinances shall be provided.
    (f) An adequate number of sanitary washbasins, with liquid or 
powdered soap, shall be provided in both the picking and packing rooms. 
Paper towels shall be provided in the packing room. Provision shall be 
made for sanitizing the hands of employees by the use of suitable 
sanitizing agents.
    (g) Signs requiring employees handling shrimp to wash and sanitize 
their hands after each absence from post of duty shall be conspicuously 
posted in the picking and packing rooms and elsewhere about the premises 
as conditions require.
    (h) One or more suitable washing devices and one or more suitable 
inspection belts shall be installed for the washing and subsequent 
inspection of the shrimp before processing.
    (i) Suitable containers, flumes, chutes, or conveyors shall be 
provided for removing offal from picking room.
    (j) Picking or heading tables shall be equipped with flumes supplied 
with clean, unpolluted water or with mechanical conveyors for removing 
the picked or headed shrimp.
    (k) Equipment shall be provided for code-marking cans and other 
immediate containers and master cartons used in packaging other than 
canned shrimp.
    (l) An automatic container-counting device shall be installed in 
each cannery line.
    (m) Each sterilizing retort shall be fitted with at least the 
following equipment:
    (1) An automatic control for regulating temperatures.
    (2) An indicating mercury thermometer of a range from 170 deg. F to 
270 deg. F with scale divisions not greater than 2 deg. F. For steam 
cook such thermometers shall be installed either within a fitting 
attached to the shell of the retort or within the door or shell of the 
retort. For water cook such thermometers shall be installed in the door 
or shell of the retort below the water level. If the thermometer is 
installed within a fitting such fitting shall communicate with the 
chamber of the retort through an opening at least 1 inch in diameter. 
Such fitting shall be equipped with a bleeder at least one-eighth of an 
inch in diameter. If the thermometer is installed within the door or 
shell of the retort, the bulb shall project at least two-thirds of its 
length into the principal chamber.
    (3) A recording thermometer of a range from 170 deg. F to 270 deg. F 
with scale divisions not greater than 2 deg. F. The bulb of such 
thermometer shall be installed as prescribed for the indicating mercury 
thermometer. The case which houses the charts and recording mechanism 
shall be provided with an approved lock, all keys to which shall be in 
the sole custody of the inspector.
    (4) A pressure gauge of a range from 0 to 30 pounds, with scale 
divisions not greater than 1 pound and diameter of not less than 5 
inches. Such gauge shall be connected to the chamber of the retort by a 
short gooseneck tube. The gauge shall be not more than 4 inches higher 
than the gooseneck.
    (5) For steam cook, a blow-off vent of at least \3/4\-inch inside 
diameter in the top of the retort.
    (6) For steam cook, a \1/8\-inch bleeder in top of retort.
    (n) Each cold storage compartment shall be fitted with at least the 
following equipment:
    (1) An automatic control for regulating temperature.
    (2) An indicating thermometer so installed as to indicate accurately 
the temperature within the storage compartment.

[[Page 549]]

    (3) A recording thermometer so installed as to indicate accurately 
the temperature within the compartment at all times. The case which 
houses the charts and recording mechanism shall be provided with an 
approved lock, all keys to which shall be in the sole custody of the 
inspector.
    (o) Provision shall be made for water-glazing where such glazing is 
necessary to maintain the quality of frozen shrimp. Glazing shall be 
done with clean, unpolluted water.
    (p) Provision shall be made for immediate icing or cold storage of 
all packaged shrimp which is destined for sale as unfrozen shrimp.
    (q) Suitable space and facilities shall be provided for the 
inspector to prepare records and examine samples, and for the 
safekeeping of records and equipment.



Sec. 197.840   General operating conditions.

    (a) Plants supplying raw headless or frozen raw headless shrimp to 
an inspected establishment, decks and holds of all boats catching shrimp 
for or transporting shrimp to an inspected establishment, and the bodies 
of other conveyances so transporting shrimp shall be kept in a sanitary 
condition.
    (b) Inspected establishments, plants supplying inspected 
establishments, freight boats, and other conveyances serving such 
establishments shall accept only fresh, clean, sound shrimp. The shrimp 
shall be iced or refrigerated immediately after they are caught, and 
shall be kept adequately iced or refrigerated until delivery to the 
establishment.
    (c) After delivery of each load of shrimp to the establishment, 
decks and holds of each boat and the body of each other conveyance or 
container making such delivery shall be washed down with clean, 
unpolluted water, and all debris shall be cleaned therefrom before such 
boat or other conveyance or container leaves the establishment premises.
    (d) Before being headed, picked, or deveined, the shrimp shall be 
adequately washed with clean, unpolluted water and then passed over the 
inspection belt and culled to remove all shrimp that are filthy, 
decomposed, putrid, or otherwise unfit for food, and all extraneous 
material.
    (e) Offal from picking tables shall not be piled on the floor, but 
shall be placed in suitable containers for frequent removal, or shall be 
removed by flumes, conveyors, or chutes. Offal, debris, or refuse from 
any source whatever shall not be allowed to accumulate in or about the 
establishment.
    (f) Shrimp shall be picked into flumes that immediately remove the 
picked meats from the picking tables; except that shrimp may be picked 
into seamless containers of not more than 3 pints capacity if the picked 
meats are not held in such containers for more than 20 minutes before 
being flumed or conveyed from the picking tables. If shrimp are picked 
into such containers, the containers shall be cleaned and sanitized as 
often as may be necessary to maintain them in a sanitary condition, but 
in no case less frequently than every 2 hours. Whenever a picker is 
absent from his or her post of duty, the container used by such picker 
shall be cleaned and sanitized before picking is resumed. For the 
purposes of this paragraph, the term ``picked'' shall include the 
operation whereby a portion of the shell is removed, leaving the tail in 
place, and the back of the shrimp is sliced open to remove the 
alimentary canal or vein.
    (g) Picked shrimp being transported from one building to another 
shall be properly covered and protected against contamination.
    (h) From the time of delivery to the establishment up to the time of 
final processing, shrimp shall be handled expeditiously and under such 
conditions as to prevent contamination or spoilage. Shrimp other than 
that to be canned shall be precooled immediately after the final 
cleaning or blanching operation to a temperature not exceeding 50 deg. F 
if it is to be packaged immediately, or to a temperature not exceeding 
40 deg. F if it is not to be packaged immediately. If such shrimp are to 
be frozen, they shall be placed in the freezing compartment within 1 
hour after final preparation.
    (i) If batter is employed, it shall be used within 1 hour after it 
is prepared. The temperature of the batter shall not exceed 50 deg. F.

[[Page 550]]

    (j) The packer shall destroy for food purposes under the immediate 
supervision of the inspector all shrimp in his possession condemned by 
the inspector as filthy, decomposed, putrid, or otherwise unfit for 
food. Shrimp condemned on boat or unloading platform shall not be taken 
into the icebox or picking room.
    (k) Raw materials other than shrimp that enter into the finished 
product shall not be used if condemned by the inspector as unfit for 
food. Such condemned raw materials shall be segregated from usable 
materials and be held for disposal as directed by the inspector, or they 
may be destroyed forthwith by the packer if he so desires.
    (l) All portions of the establishment shall be adequately lighted to 
enable the inspector to perform his duties properly.
    (m) All floors and other parts of the establishment, including 
unloading platforms, and all fixtures, equipment, and utensils shall be 
cleaned as often as may be necessary to maintain them in a sanitary 
condition. Containers for mixing or holding batter shall be adequately 
cleaned and sanitized before they are used for a new batch of batter. 
Equipment for applying batter shall be adequately cleaned and sanitized 
at least once each hour while in operation.
    (n) The packer shall require all employees handling shrimp to wash 
and sanitize their hands after each absence from post of duty, and to 
observe other proper habits of cleanliness.
    (o) The packer shall not knowingly employ in or about the 
establishment any person afflicted with an infectious or contagious 
disease, or with any open sores on exposed portions of the body.



Sec. 197.850   Code marking.

    (a) Permanently legible code marks shall be placed on all immediate 
containers at the time of packaging. Such marks shall show at least:
    (1) The date of packing;
    (2) The establishment where packed; and
    (3) The size of the shrimp when such shrimp are graded for size and 
are not in containers through which they are clearly visible.

Corresponding code marks shall also be placed on the master cartons 
containing individual packages of shrimp other than canned.
    (b) Keys to all code marks shall be given to the inspector.
    (c) Each lot shall be stored separately pending final inspection, 
with a space of not less than 6 inches between stacks of each lot. For 
the purposes of the regulations in this part, all cans or other 
containers bearing the same code marks shall be regarded as comprising a 
lot.



Sec. 197.855   Processing.

    (a) The closure of the can or other immediate container and the time 
and temperature of sterilizing the canned shrimp shall be adequate to 
prevent bacterial spoilage.
    (b) The following times and temperatures shall be the minimums 
employed for the containers indicated:

                                                    Dry Pack                                                    
----------------------------------------------------------------------------------------------------------------
                                                                                             Time at    Time at 
                                                                                 Initial     240 deg.   250 deg.
         Kind of container and liner                        Size               temperature      F          F    
                                                                                            (minutes)  (minutes)
----------------------------------------------------------------------------------------------------------------
Tin: 1-piece liner..........................  211 by 400 and smaller.........  70 deg. F          80         60 
----------------------------------------------------------------------------------------------------------------
                                              ......do.......................  70 deg. F          70         50 
No liner....................................  307 by 208.....................  70 deg. F          70         50 
                                              307 by 400.....................  70 deg. F          75         55 
----------------------------------------------------------------------------------------------------------------


                                Wet Pack                                
------------------------------------------------------------------------
                                                     Time at    Time at 
                                         Initial     240 deg.   250 deg.
      Kind of container and size       temperature      F          F    
                                                    (minutes)  (minutes)
------------------------------------------------------------------------
Tin:                                                                    
  211 by 400 (and smaller)...........  90 deg. F          25         13 
  307 by 208.........................  90 deg. F          25         13 
  307 by 400.........................  90 deg. F          25         13 
  502 by 510.........................  90 deg. F          27         16 
Glass: 2 to 9 fluid ounces, inclusive  ...........        22         14 
------------------------------------------------------------------------

For wet-pack shrimp in cans 307 x 400 and smaller, a cook of 12 minutes 
at 250 deg. F, and for wet-pack shrimp in cans 502 x 510, a cook of 15 
minutes at 250 deg. F, may be approved if adequate provisions are made 
to insure an initial temperature of not less than 120 deg. F in each 
individual can. For the purposes of this section, initial temperature is 
defined as the average temperature of the contents of the container at 
the moment

[[Page 551]]

steam is admitted to the sterilizing retort.
    (c) For steam cook, blow-off vent shall be open during the coming-up 
period until the mercury thermometer registers at least 215 deg. F. 
Bleeders shall emit steam during the entire cooking period.
    (d) The method of freezing is not specified by the regulations in 
this part. Whatever method is used must be such as will produce a hard-
frozen product in a sufficiently short time to prevent decomposition. 
Bulk packages containing 5 pounds or more of shrimp per package shall be 
hard frozen within 24 hours; smaller packages should be hard frozen 
within 12 hours. After freezing, the shrimp shall be stored in such a 
manner that its temperature does not exceed 0 deg. F, and shall be 
handled in such manner as will maintain the hard-frozen condition.
    (e) The storage temperatures for shrimp that are not frozen or 
canned are as follows:
    (1) Cooked and peeled shrimp shall be stored at a room temperature 
not exceeding 35 deg. F.
    (2) Raw headless shrimp shall be stored at a room temperature not 
exceeding 35 deg. F, except that it may be stored at a higher room 
temperature if sufficiently iced at all times to prevent spoilage.
    (f) The inspector shall identify each record on the thermometer 
chart with the code mark of the lot to which such record relates and the 
date of such record. The Food and Drug Administration shall keep such 
charts for at least 5 years, and upon request shall make them available 
to the packer.
    (g) The packer shall keep for at least 2 years all shipping records 
covering shipments from each lot, and upon request shall furnish such 
records to any inspector of the Food and Drug Administration.



Sec. 197.860   Examination after processing.

    (a) Adequate samples shall be drawn by the inspector from each lot 
of processed shrimp and shall be examined to determine whether or not 
such processed shrimp conforms to all requirements of the Federal Food, 
Drug, and Cosmetic Act, amendments thereto, and regulations thereunder.
    (b) The packer shall destroy for food purposes, under the immediate 
supervision of the inspector, all processed shrimp condemned by the 
inspector as not complying with Sec. 197.855(a), or as filthy, 
decomposed, putrid, or otherwise unfit for food.



Sec. 197.870   Labeling.

    (a) Labels on shrimp packed and certified under Secs. 197.810 
through 197.885 may bear a mark attesting to such packing and 
certification. Depending upon the type of processing, such marks, if 
used, shall read as follows:
    (1) For canned shrimp: ``Production supervised by U.S. Food and Drug 
Administration.''
    (2) For frozen shrimp: ``Packing and freezing supervised by U.S. 
Food and Drug Administration. Perishable product--Not warranted against 
mishandling after freezing.''
    (3) For fresh, iced, or refrigerated shrimp: ``Packing supervised by 
U.S. Food and Drug Administration. Perishable product--Not warranted 
against mishandling after packing.'' Such marks if used shall be plainly 
and conspicuously displayed in type of uniform size and style on a 
strongly contrasting uniform background. The marks referred to in 
paragraph (a) (2) and (3) of this section shall not be used on the 
master carton unless such marks will be defaced by the opening of the 
cartons.
    (b) Labels on inspected processed shrimp, other than canned shrimp, 
not bearing the marks referred to in paragraph (a) (2) and (3) of this 
section, and all master cartons for inspected shrimp other than canned 
shrimp, shall bear the statement ``Perishable--Keep frozen'' or 
``Perishable--Keep refrigerated,'' whichever is applicable to the 
product.
    (c) Two proofs, or one proof and one photostat thereof, or eight 
specimens of all labeling intended for use on inspected shrimp, or on or 
within the cases therefor, shall be submitted to the Food and Drug 
Administration for approval. If proofs or photostat and proof are 
submitted, eight specimens of the labeling shall be sent to the Food

[[Page 552]]

and Drug Administration after printing. The Food and Drug Administration 
is authorized to approve labeling for use on or with processed shrimp 
inspected under Secs. 197.810 through 197.885; approval shall be subject 
to the condition that such labeling shall be so used as to comply with 
the provisions of the Federal Food, Drug, and Cosmetic Act, amendments 
thereto and regulations thereunder. The Food and Drug Administration is 
also authorized to revoke any such approval for cause. The Food and Drug 
Administration shall not approve labeling for processed shrimp intended 
for export under the provisions of Sec. 197.880(e).
    (d) No commercial brand or brand name appearing on labeling approved 
as authorized under paragraph (c) of this section and bearing the marks 
described in paragraph (a) of this section, and no labeling simulating 
any such approved labeling, shall be used, after such approval, on 
processed shrimp other than that which has been handled, prepared, 
packed, and stored in compliance with all provisions of Secs. 197.810 
through 197.885; but this section shall not apply to any packer's 
labeling not bearing such mark after termination of inspection or 
withdrawal thereof as authorized by Sec. 197.815 or to any distributor's 
labeling not bearing such mark after written notice by the owner thereof 
to the Food and Drug Administration that the use of such labeling on 
inspected processed shrimp has been discontinued and will not be 
resumed.
    (e) Shrimp labeling authorized by paragraph (a) of this section or 
approved under paragraph (c) of this section shall be used only as 
authorized by Secs. 197.810 through 197.885. Unauthorized use of such 
labeling renders the user liable to the penalties prescribed by the 
Federal Food, Drug, and Cosmetic Act, as amended.



Sec. 197.880   Certificates of inspection; warehousing and export permits.

    (a) After finding that the processed shrimp comprising any parcel 
has been handled, prepared, and packed in compliance with all provisions 
of Secs. 197.810 through 197.885, bears labeling approved as authorized 
under Sec. 197.870(c), and complies with all the provisions of the 
Federal Food, Drug, and Cosmetic Act, amendments thereto, and 
regulations thereunder, the inspector shall issue a certificate showing 
that such processed shrimp so complies. The certificate shall specify 
the code marks to which it applies, the quantity of the parcel so 
marked, the place where such parcel is stored, the size of the shrimp, 
the size and kind of containers, the type of pack, the commercial brand 
name on the labels, the quality grade of the shrimp if it is fancy, the 
condition of the shrimp if it is broken or if it is substandard in fill 
and the destination of the lot if known. Such certificate shall become 
void if such labeling is removed, altered, obliterated, or replaced, or 
if mishandling, improper storage, or other circumstances so change the 
product that it no longer complies with the requirements for the 
issuance of a certificate; but such processed shrimp may be relabeled 
under the supervision of an inspector and recertified if the inspector 
finds that, after being relabeled, it complies with the requirements 
laid down by this paragraph for the issuance of a certificate.
    (b) Unless covered by certificate, processed shrimp shall be moved 
from an inspected establishment only for storage authorized under 
paragraph (c) of this section, or for export authorized under paragraph 
(e) of this section, or for destruction as provided by Sec. 197.860(b).
    (c) Applications to move unlabeled processed shrimp for storage in a 
warehouse or cold storage plant elsewhere than in the establishment 
where such shrimp was processed shall be on forms supplied by the Food 
and Drug Administration. The application shall give the name and 
location of the warehouse or cold storage plant in which such processed 
shrimp is to be stored, and shall be accompanied by an agreement signed 
by the operator of such warehouse or cold storage plant that inspectors 
shall have free access at all times to all processed shrimp so stored 
and that conditions which will preserve the identity of each parcel of 
such processed shrimp shall be continuously maintained pending issuance 
of a certificate thereon or removal as authorized by paragraph (d) of 
this section. If

[[Page 553]]

such application is approved and it appears to the inspector that the 
processed shrimp comprising any parcel has been packed in compliance 
with Secs. 197.810 through 197.885 and conforms, except for the absence 
of labeling, to all requirements of the Federal Food, Drug, and Cosmetic 
Act, amendments thereto, and regulations thereunder, the inspector shall 
issue to the applicant, on his request, a warehousing permit covering 
such processed shrimp. Such permit shall specify the code marks to which 
it applies, the quantity of the parcel so marked, the places from and to 
which such parcel is to be moved, the size of the shrimp, the size and 
kind of containers, the type of pack, whether or not it is fancy grade, 
the condition of the shrimp if it is broken or if it is substandard in 
fill, and, if such be the case, that it is intended for export under 
paragraph (e) of this section. When any provision of the agreement is 
violated, the Food and Drug Administration may revoke any permit issued 
pursuant to such agreement, and may also revoke its approval of the 
application for warehousing or cold storage which accompanied such 
agreement.
    (d) Unless covered by certificate, processed shrimp stored under the 
authority of paragraph (c) of this section shall be moved from the 
warehouse or cold storage plant where stored only for re-storage under 
such authority, or for return upon written permission of the inspector 
to the establishment where processed, or for export authorized under 
paragraph (e) of this section, or for destruction as provided by 
Sec. 197.860(b).
    (e) An application to export processed shrimp under the provisions 
of section 801(d) of the act shall be accompanied by the original or a 
verified copy of the specifications of the foreign purchaser; if 
required by the Food and Drug Administration, evidence showing that such 
processed shrimp is not in conflict with the laws of the country to 
which it is intended for export; and, if shipment of labeled processed 
shrimp is specified or directed, eight specimens of the labeling 
therefor. If processed shrimp prepared or packed according to such 
specifications is not in conflict with the laws of such country, the 
Food and Drug Administration shall direct the inspector to issue to the 
applicant an export permit covering such processed shrimp comprising any 
parcel ordered by such purchaser under such specifications when the 
inspector finds that such processed shrimp was packed in compliance with 
the requirements of Secs. 197.810 through 197.885 regarding sanitary 
conditions and processing; is not filthy, decomposed, putrid, or 
otherwise unfit for food, accords to such specifications; and is labeled 
on the outside of the shipping package to show that it is intended for 
export. Such permit shall specify the code marks to which it applies and 
the quantity of the parcel so marked, and shall show that such processed 
shrimp was packed under sanitary conditions, is wholesome, and accords 
to such specifications. The applicant shall furnish to the inspector 
documentary evidence showing the exportation of all such processed 
shrimp.



Sec. 197.885   Inspection fees.

    (a)(1) Except as otherwise provided by the regulations in this part, 
an initial payment of $500.00 shall accompany each application; 
thereafter, eight additional advance payments of $500.00 shall be made 
on or before the first day of each month beginning July 1 and continuing 
through February 1 for the regular inspection period; except that the 
Food and Drug Administration may require the full amount of advance 
payments prescribed by this paragraph to accompany the application of an 
applicant who has defaulted in any payment due for any prior packing 
season.
    (2) Whenever it is determined, without hearing, by the Food and Drug 
Administration that an establishment having the inspection service has 
been damaged by wind, fire, flood, or other calamity, to such an extent 
that packing operations cannot be resumed before the end of the fiscal 
year then current, no advance payments falling due after such calamity 
shall be required from the packer for that fiscal year; but whenever it 
is determined, without hearing, by the Food and Drug Administration that 
an establishment having

[[Page 554]]

the inspection service has been so damaged by any such calamity that 
operations must be suspended temporarily, but can be resumed before the 
end of the fiscal year then current, advance payments falling due after 
such calamity and before the month of resumption of operations shall be 
postponed until operations are resumed, and thereupon shall be paid in 
equal monthly installments during the period between the time of 
resumption of operations and June 1 of the fiscal year then current: 
Provided, That in the event of a determination described in paragraph 
(a)(2) of this section the total payments and deposits made by the 
packer involved shall be charged with the cost of the service made 
available for the establishment without regard to the method provided 
hereinafter for computing charges against payments and deposits for 
shrimp received, and the balance of the total payments and deposits for 
shrimp received remaining after such charges shall be refunded by the 
Administration to the packer after the completion of the fiscal year.
    (3) Each application for an extension inspection period of 1 month 
shall be accompanied by a payment of $600.00, and at subsequent monthly 
intervals thereafter additional payments of $600.00 shall be made; but 
if the final payment is to cover a period of less than 30 days, then 
such payment shall be at the rate of $20.00 for each day of such period.
    (b)(1) In addition to the payments prescribed in paragraph (a) of 
this section, advance deposits based upon the quantity of shrimp 
received by the subscribing establishment shall be made to underwrite 
adequately the cost of the inspection service. Such deposits shall be 
paid in advance in amounts of not less than $300.00, unless the Food and 
Drug Administration on an estimate of receipt of shrimp authorizes other 
amounts, and shall be computed at the rate of 20 cents per 100 pounds of 
whole raw shrimp, or 35 cents per 100 pounds of raw headless shrimp, 
received by the plant. For the purposes of this section, the quantity of 
shrimp received by an establishment shall be determined by weighing on a 
suitable scale immediately after such shrimp leaves the initial 
inspection belt: Provided, however, That other arrangements for 
determining accurately the weight of shrimp received may be employed if 
approved in advance by the Food and Drug Administration. A record of 
such weights shall be maintained and made available to the inspector 
upon his request. Any advance deposits in excess of those required for 
actual shrimp received for the fiscal year (July 1 through June 30) 
shall be refunded to the packer by the Food and Drug Administration 
after the completion of the fiscal year.
    (2) Deposits for shrimp received as computed under paragraph (b)(1) 
of this section, together with production deposits prescribed for 
oysters canned under Sec. 197.385(b)(1), shall be charged with the 
balance of the total cost of the inspection service that has not been 
provided for by the combined total payments under paragraph (a) of this 
section and Sec. 197.385(a), in the case of canned oysters. The balance 
of the deposits remaining for shrimp received after such charges have 
been made shall be refunded by the Food and Drug Administration to the 
packers after the completion of the fiscal year, in the ratio which each 
packer's deposits for shrimp received and production deposits for 
oysters canned bears to the combined total of such deposits for shrimp 
received and oysters canned by all packers for the fiscal year.
    (3) When inspection service is withdrawn from an establishment as 
authorized under Sec. 197.815(a), the Food and Drug Administration shall 
not return to the packer any advance payments and/or deposits required 
to the date of withdrawal of the service. Such payments and/or deposits 
shall be charged with the cost of the service made available for the 
establishment, without regard to the method described in this section, 
and the balance which would have accrued to such packer shall remain to 
the credit of the Food and Drug Administration in the special account 
``Salaries and Expenses, Certification and Inspection Services.''
    (c) A separate fee shall be paid to cover all expenses, incurred in 
accordance with the regulations of the United States Government for 
salary, travel, subsistence, and other purposes incident to inspection 
described under

[[Page 555]]

Sec. 197.825(b) of suppliers of any materials to establishments under 
the inspection service or for the purpose of issuing a certificate or 
warehousing or export permit on processed shrimp stored or held at any 
place other than an establishment to which a seafood inspector is then 
assigned.
    (d) When the processing plant and the warehouse or cold storage 
plant of an establishment are located at different points of such 
distance apart that transportation between them is required for the 
inspector to perform his duties in the establishment, the packer shall 
furnish such transportation or shall pay a separate fee to cover all 
expenses therefor.
    (e) All payments required by the regulations in this part shall be 
by bank draft or certified check collectible at par drawn to the order 
of the Food and Drug Administration, and payable at Washington, DC. All 
such drafts and checks, except those for the payment required by 
Sec. 197.810(a), shall be delivered to the inspector and promptly 
scheduled to the Food and Drug Administration, Department of Health and 
Human Services, Washington, DC, whereupon after appropriate records 
thereof have been made, they shall be transmitted to the Chief 
Disbursing Officer, Division of Disbursement, Treasury Department, for 
deposit to the special account, ``Certification and Inspection Services, 
Food and Drug Administration.''
    (f) All refunds to the packers shall be by check drawn on the 
Treasury of the United States pursuant to refund vouchers duly certified 
and approved by the designated administrative officers.



PARTS 198-199 [RESERVED]--Table of Contents





                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  Redesignation Table
  List of CFR Sections Affected

[[Page 559]]

            Material Approved for Incorporation by Reference

                      (Revised as of April 1, 1996)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


21 CFR CHAPTER I (PARTS 170 TO 199)

FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES


American Oil Chemist's Society

  P.O. Box 5037, Station A, Champaign, IL 61820
AOCS Method Cd 9-57, ``Oxirane Oxygen,'' 
  Reapproved 1989.................................               172.723
AOCS Method Cd 1-25, ``Iodine Value of Fats and 
  Oils Wijs Method; Revised 1993..................               172.723
AOCS Method Trla-64T Titer Test...................        178.3780(b)(2)
AOCS Method Tlla-64T Saponification Value.........        178.3780(b)(3)
AOCS Method Te 3a-64 Acid Value and Free Amine 
  Value of Fatty Quaternary Ammonium Chlorides, 
  Second Printing including additions and 
  revisions, 1990.................................            173.400(b)
Official Methods and Recommended Practices of the 
  American Oil Chemists' Society, 3d Edition 
  (1985) Vol. 1, ``Free Fatty Acids''.............               172.867
Official Methods and Recommended Practices of the 
  American Oil Chemists' Society, 4th Ed. (1989) 
  Vol. 1, ``Moisture''............................               172.867
Official Methods and Recommended Practices of the 
  American Oil Chemists' Society, 4th Ed. (1989) 
  Vol. 1, ``Peroxide Value''......................               172.867


American Society for Testing and Materials

  1916 Race St. Philadelphia, PA 19103
ASTM D 5-73 (Reapproved 1978) Standard Method of 
  Test for Penetration of Bituminous Materials....         176.170(a)(5)
ASTM D 36-76 Standard Test Method for Softening 
  Point of Asphalts and Tar Pitches (Ring and Ball 
  Apparatus)......................................         176.170(a)(5)
ASTM D 86-82 Standard Method of Test for 
  Distillation of Petroleum Products..............       172.250(b)(3); 
                                                         172.864(b)(2); 
                                                            172.882(a); 
                                                           178.3530(a); 
                                                     178.3620(d)(1)(i); 
                                                    178.3910(a)(4)(i)(a)
ASTM D 88-81 Standard Method of Test for Saybolt 
  Viscosity.......................................      178.3870(f)(4); 
                                                                178.3910
ASTM D 127-60 Standard Method of Test for Melting 
  Point of Petrolatum and Microcrystalline Wax....       176.180(b)(2); 
                                                             177.1200(c)
ASTM D 156-82 Standard Method of Test for Saybolt 
  Color of Petroluem Products (Saybolt Chromometer 
  Method).........................................   178.3620(b)(1)(i); 
                                                    178.3910(a)(4)(i)(c)

[[Page 560]]

ASTM D 381-80 Standard Method of Test for Existent 
  Gum in Fuels by Jet Evaporation................. 172.882(a); 172.250; 
                                                           178.3530(a); 
                                                   178.3910(a)(4)(i)(b) 
                                                              and (b)(2)
ASTM D 388-38 Standard Specifications for 
  Classification of Coals by Rank.................          173.25(a)(2)
ASTM D 445-74 Standard Test Method for Kinematic 
  Viscosity of Transparent and Opaque Liquids (and 
  the Calculations of Dynamic Viscosity)..........      177.1430(c)(2); 
                                                        177.1520(d)(5); 
                                                             178.3740(b)
ASTM D 445-82 Test Method for Kinematic Viscosity 
  of Transparent Opaque Liquids (and the 
  Calculations of Dynamic Viscosity)..............           178.3740(b)
ASTM D 465-82 Standard Test Methods of Test for 
  Acid Number of Rosin............................        178.3870(f)(3)
ASTM D 509-70 (Reapproved 1981) Standard Methods 
  of Sampling and Grading Rosin...................        178.3870(f)(1)
ASTM D 566-76 (Reapproved 1982) Standard Method 
  for Dropping Point of Lubricating Grease........             172.210; 
                                                        178.3690(b)(1); 
                                                        178.3770(a)(1), 
                                                      (b)(1), and (d)(1)
ASTM D 611-82 Standard Test Methods for Aniline 
  Point and Mixed Aniline Point of Petroleum 
  Products and Hydrocarbon Solvents...............  176.170; 177.1520(b)
ASTM D 721-56T Tentative Method of Test for Oil 
  Content of Petroleum Waxes......................          172.615(a); 
                                                           175.250(b)(2)
ASTM D 729-81 Standard Specifications for 
  Vinylidene Chloride Molding Compounds...........                179.45
ASTM D 938-71 (Reapproved 1980) Standard Method of 
  Test for Congealing Point of Petroleum Waxes, 
  including Petrolatum............................          172.615(a); 
                                                           175.250(b)(1)
ASTM D 968-81 Standard Test Methods for Abrasion 
  Resistance of Organic Coatings by the Falling 
  Abrasive Tester.................................    177.1590; 177.1650
ASTM D 1218-82 Standard Test Method for Refractive 
  Index and Refractive Dispersion of Hydrocarbon 
  Liquids.........................................              178.2010
ASTM D 1238-82 Standard Method of Measuring Flow 
  Rates of Thermoplastics by Extrusion Plastometer       176.170(b)(2); 
                                                        177.1312(c)(2); 
                                                        177.1520(d)(7); 
                                                        177.1550(d)(2); 
                                                     177.1570(b)(1)(iii)
ASTM D 1240-82 Standard Method of Test for Rosin 
  Acids in Fatty Acids............................         172.862(b)(2)
ASTM D 1243-79 Standard Methods of Test for Dilute 
  Solution Viscosity of Vinyl Chloride Polymers...          175.270(b); 
                                                   175.300(b)(3) (xxix); 
                                                         176.170(a)(5); 
                                                   177.1480(b)(1) (ii); 
                                                   177.1950(c) (1)(ii); 
                                                   177.1960(b) (1)(ii); 
                                                        177.2460(c)(1); 
                                                   177.1970(c) (1)(ii); 
                                                   177.1980(c) (1)(ii); 
                                                        179.45(c)(2)(iv)
ASTM D 1303-55 (Reapproved 1979) Standard Method 
  of Test for Total Chlorine in Vinyl Chloride 
  Polymers and Copolymers.........................           177.1610(a)

[[Page 561]]

ASTM D 1353-78 Standard Test Method for 
  Nonvolatile Matter in Volatile Solvents for Use 
  in Paint, Varnish, Lacquer, and Related Products   172.882; 178.3530; 
                                                                178.3910
ASTM D 1386-78 Standard Test Method for Acid 
  Number (Empirical) of Synthetic and Natural 
  Waxes...........................................      178.3690(b)(2); 
                                                        178.3770(a)(2), 
                                                      (b)(2), and (d)(2)
ASTM D 1387-78 Standard Test Method for 
  Saponification Number (Empirical) of Synthetic 
  and Natural Waxes...............................      178.3690(b)(3); 
                                                        178.3770(a)(3), 
                                                      (b)(3), and (d)(3)
ASTM D 1418-81 Standard Practice for Rubber and 
  Rubber Latices--Nomenclature....................     177.2600(c)(4)(i)
ASTM D 1434-82 Standard Method for Determining Gas 
  Permeability Characteristics of Plastic Film and 
  Sheeting........................................              177.1040
ASTM D 1457-56T Test for Thermal Instability Index 
  of Tetrafluoroethylene Homopolymer..............        177.1550(d)(3)
ASTM D 1492-78 Standard Test Method for Bromine 
  Index of Aromatic Hydrocarbons by Coulometric 
  Titration.......................................      177.1430(c)(3); 
                                                                178.3740
ASTM D 1500-82 Standard Method of Test for ASTM 
  Color of Petroleum Products (ASTM Color Scale)..    178.3620(c)(1)(ii)
ASTM D 1505-68 (Reapproved 1979) Standard Test 
  Method for Density of Plastics by the Density-
  Gradient Technique.............................. 177.1320(c)(1)(iii); 
                                                              177.1570; 
                                                        177.1520(d)(1); 
                                                              177.1630; 
                                                          177.2480(c)(3)
ASTM D 1505-85 (Reapproved 1990) Standard Test 
  Method for Density of Plastics by Density-
  Gradient Technique..............................           177.1345(b)
ASTM D 1525-87 Standard Test Method for Vicat 
  Softening Temperature of Plastics...............           177.1345(b)
ASTM D 1545-76 (Reapproved 1981) Standard Method 
  of Test for Viscosity of Transparent Liquids by 
  Bubble Time Method..............................         176.170(a)(5)
ASTM D 1601-78 Standard Test Method for Dilute 
  Solution Viscosity of Ethylene Polymers.........      177.1520(d)(9); 
                                                      177.1570(b)(1)(ii)
ASTM D 1646-81 Standard Test Method for Rubber-
  Viscosity and Volcanization Characteristics 
  (Mooney Viscometer).............................      177.1210(b)(5); 
                                                          177.1520(d)(6)
ASTM D 1747-62 (Reapproved 1978) Standard Test 
  Method for Refractive Index of Viscous Materials 
  and Organosols at Low Shear Rates by Brookfield 
  Viscometer......................................        178.3870(f)(2)
ASTM D 1824-66 (Reapproved 1980) Standard Test 
  Method for Apparent Viscosity of Plastisols and 
  Organosols at Low Shear Rates by Brookfield 
  Viscometer......................................        178.3870(f)(4)
ASTM D 1962-67 (Reapproved 1979) Saponification 
  Value of Drying Oils, Fatty Acids, and 
  Polymerized Fatty Acids.........................           178.2010(b)
ASTM D 2117-62T Tentative Method of Test for 
  Melting Point of Semicrystalline Polymers by the 
  Hot Stage Microscopy Method.....................   177.1520(d)(2)(i); 
                                                       177.1630(d)(4)(v)
ASTM D 2133-66 Specifications for Acetal Resin 
  Injection Molding and Extrusion Materials.......        177.2480(c)(4)
ASTM D 2236-70 Standard Method of Test for Dynamic 
  Mechanical Properties of Plastics by Means of a 
  Torsional Pendulum..............................     177.1810(c)(1)(i)
ASTM D 2161-66 Standard Method of Conversion of 
  Kinematic Viscosity to Saybolt Universal 
  Viscosity or to Saybolt Furol Viscosity.........           178.3740(b)

[[Page 562]]

ASTM D 2503-82 Standard Method of Test for 
  Molecular Weight of Hydrocarbons by 
  Thermoelectric Measurement of Vapor Pressure.... 175.300(b)(3)(xxxiii);
                                                         176.170(b)(2); 
                                                          177.1430(c)(1)
ASTM D 2857-70 (Reapproved 1977) Standard Method 
  of Test for Dilute Solution Viscosity of 
  Polymers........................................            177.1560; 
                                                           177.2210(b); 
                                                             177.2440(a)
ASTM Method D 3236-88, Standard Test Method for 
  Apparent Viscosity of Hot Metal Adhesives and 
  Coating Materials...............................           177.1520(b)
ASTM D 3275-89 Standard Specification for E-CTFE-
  Flouroplastic Molding, Extrusion, and Coating 
  Materials.......................................        177.1380(a)(4)
ASTM D 3418-82 Standard Test Method for Transition 
  Temperatures of Polymers by Thermal Analysis....        177.1520(d)(8)
ASTM D 3536-76 Standard Test Method for Molecular 
  Weight Averages and Molecular Weight 
  Distribution of Polystyrene by Liquid Exclusion 
  Chromatography (Gel Permeation Chromatography--
  GPC)............................................    177.1990; 177.2000
ASTM D 3835-79 (Reapproved 1983) Standard Test 
  Method for Rheological Properties of 
  Thermoplastics with a Capillary Rheometer.......           177.1520(b)
ASTM E 28-67 (Reapproved 1982) Standard Test 
  Method for Softening Point by Ring-and-Ball 
  Apparatus.......................................    172.215; 172.280; 
                                                   176.170; 177.1520(b); 
                                                            (d)(2)(ii); 
                                                          178.3870(b)(5)
ASTM E 131-61T Definition of Terms and Symbols 
  Relating to Absorption Spectroscopy (Revised 
  1961)...........................................         175.250(b)(3)
ASTM E 169-63 (Reapproved 1981) Recommended 
  Practices for General Techniques of Ultraviolet 
  Quantitative Analysis...........................        178.3620(d)(3)
ASTM E 324-79 Standard Test Method for Relative 
  Initial and Final Melting Range of Organic 
  Chemicals.......................................              178.2010
ASTM F 34-76 (Reapproved 1980) Standard Test 
  Methods for Liquid Extraction of Flexible 
  Barrier Materials...............................       176.170(d)(3); 
                                                        177.1330(e)(4); 
                                                           177.1360(b); 
                                                             177.1670(b)


AOAC International (Association of Official Analytical Chemists)

  481 N. Frederick Ave., Suite 500, Gaithersburg, MD 20877-2407


Journal of the Association of Official Analytical Chemists

Changes in Methods: ``Glycyrrhizic Acid or 
  Glycyrrhizic Acid Salts in Licorice'' Vol. 65, 
  pp. 471-472 (1982)..............................              184.1408
``Flavors and Nonalcoholic Beverages'' Vol. 56(5) 
  1281-1283 (1973)................................            189.110(c)
``Gas Chromatographc Determination of Safrole and 
  Related Compounds in Nonalcoholic Beverages: 
  Collaborative'' Vol. 54(4) 900-902 (1971).......            189.180(c)
``Gas-Solid Chromatographic Procedures for 
  Determining Acrylonitrile Monomer in 
  Acrylonitrile-Containing Polymers and Food 
  Simulating Solvents'' (Vol. 61, No. 6, pp. 1383-
  1388)...........................................      177.1030(c)(2); 
                                                        177.1050(e)(4); 
                                                               180.22(a)
``Headspace Sampling and Gas-Solid Chromatographic 
  Determination of Residual Acrylonitrile in 
  Acrylonitrile Copolymer Solutions'' Vol. 65, No. 
  2, p. 270 (1981)................................              177.1040
``Oils, Fats, and Waxes'' Vol. 50(1) 216-218 
  (1967)..........................................         172.860(c)(3)
``Oils, Fats, and Waxes'' Vol. 51(2) 489-490 
  (1968)..........................................         172.860(c)(3)

[[Page 563]]

``Spectrophotometric Measurements under 
  Specification'' Vol. 45, p. 66 (1962)...........       172.878(a)(3); 
                                                            172.882(a); 
                                                           178.3530(a); 
                                                      178.3620(b)(1)(ii)
Official Methods of Analysis, 13th Ed., 1980...... 172.340(b); 172.372; 
                                                      172.385; 172.510; 
                                                      172.860; 173.395; 
                                                         176.170(d)(3); 
                                                    177.2450; 178.3690; 
                                                    184.1245; 184.1366; 
                                                        184.1408(b)(1); 
                                                        184.1979(a) and 
                                                           (b)(1); 184. 
                                                           1979a(b)(1); 
                                                       184.1979b(b)(1); 
                                                       184.1979c(b)(1); 
                                                      189.130; 189.135; 
                                                      189.145; 189.155; 
                                                      189.165; 189.175; 
                                                                 189.190


National Academy of Sciences, National Research Council

  2101 Constitution Ave. NW., Washington, DC 20037.
Food Chemicals Codex, 3rd Ed., 1981...............             172.280; 
                                                         172.320(b)(1); 
                                                   172.345(b); 172.723; 
                                                      172.800; 172.804; 
                                                      172.810; 172.812; 
                                                   172.841(b); 172.846; 
                                                      172.852; 172.858; 
                                                      172.862; 173.160; 
                                                      173.165; 173.228; 
                                                      173.280; 173.310; 
                                                      178.1005; 180.25; 
                                                        180.30; 180.37; 
                                                    182.1625; 184.1005; 
                                                     184.1007; 184.1009;

[[Page 564]]

Food Chemicals Codex, 3rd Ed., 1981 (continued)...            184.1011; 
                                                           184.1012(b); 
                                                              184.1021; 
                                                           184.1024(b); 
                                                              184.1025; 
                                                           184.1027(b); 
                                                              184.1033; 
                                                           184.1034(b); 
                                                    184.1061; 184.1062; 
                                                    184.1069; 184.1077; 
                                                    184.1081; 184.1090; 
                                                    184.1091; 184.1095; 
                                                    184.1099; 184.1101; 
                                                    184.1115; 184.1120; 
                                                    184.1121; 184.1133; 
                                                    184.1135; 184.1137; 
                                                    184.1138; 184.1139; 
                                                           184.1141(a); 
                                                           184.1141(b); 
                                                    184.1143; 184.1157; 
                                                    184.1165; 184.1185; 
                                                    184.1187; 184.1191; 
                                                    184.1193; 184.1195; 
                                                              184.1199; 
                                                            184.1201(b);

[[Page 565]]

Food Chemicals Codex, 3rd Ed., 1981 (continued)...  184.1205; 184.1206; 
                                                    184.1207; 184.1210; 
                                                    184.1212; 184.1221; 
                                                    184.1229; 184.1230; 
                                                    184.1240; 184.1243; 
                                                           184.1245(b); 
                                                    184.1257; 184.1259; 
                                                    184.1260; 184.1271; 
                                                    184.1272; 184.1277; 
                                                    184.1278; 184.1282; 
                                                    184.1293; 184.1295; 
                                                    184.1296; 184.1301; 
                                                    184.1304; 184.1307; 
                                                    184.1308; 184.1315; 
                                                           184.1316(b); 
                                                    184.1317; 184.1318; 
                                                    184.1330; 184.1333; 
                                                    184.1339; 184.1349; 
                                                    184.1351; 184.1355; 
                                                    184.1366; 184.1370; 
                                                    184.1372; 184.1375; 
                                                               184.1388;

[[Page 566]]

Food Chemicals Codex, 3rd Ed., 1981 (continued)...  184.1400; 184.1408; 
                                                              184.1409; 
                                                           184.1415(b); 
                                                    184.1425; 184.1426; 
                                                    184.1428; 184.1431; 
                                                              184.1434; 
                                                          184.1443a(b); 
                                                    184.1444; 184.1445; 
                                                    184.1446; 184.1452; 
                                                    184.1461; 184.1490; 
                                                              184.1505; 
                                                           184.1519(b); 
                                                    184.1530; 184.1535; 
                                                    184.1537; 184.1540; 
                                                    184.1545; 184.1555; 
                                                           184.1583(b); 
                                                    184.1585; 184.1588; 
                                                           184.1595(b); 
                                                    184.1610; 184.1613; 
                                                    184.1619; 184.1622; 
                                                    184.1625; 184.1631; 
                                                    184.1634; 184.1635; 
                                                    184.1643; 184.1655; 
                                                    184.1660; 184.1666; 
                                                    184.1670; 184.1676; 
                                                    184.1685; 184.1695; 
                                                     184.1697; 184.1699;

[[Page 567]]

Food Chemicals Codex, 3rd Ed., 1981 (continued)...  184.1721; 184.1724; 
                                                    184.1733; 184.1736; 
                                                    184.1742; 184.1751; 
                                                    184.1754; 184.1763; 
                                                    184.1764; 184.1784; 
                                                    184.1792; 184.1801; 
                                                    184.1804; 184.1807; 
                                                    184.1835; 184.1845; 
                                                    184.1848; 184.1857; 
                                                    184.1875; 184.1878; 
                                                    184.1890; 184.1901; 
                                                    184.1903; 184.1911; 
                                                    184.1923; 184.1924; 
                                                    184.1930; 184.1945; 
                                                    184.1950; 184.1973; 
                                                    184.1976; 184.1978; 
                                                              184.1979; 
                                                           184.1979(a); 
                                                           184.1979(b); 
                                                           184.1979(c); 
                                                    184.1985; 186.1025; 
                                                                186.1551
Food Chemicals Codex, 3d Ed., 3d Supp. (1992).....               172.867

  NOTE: The following materials are available through the Food and Drug 
  Administration at the addresses indicated.



Food and Drug Administration, Office of Premarket Approval, Center for 
Food Safety and Applied Nutrition (HFF-260)

  200 C St. SW., Washington DC 20204
Absorptivity Methods ``Determination of Softening 
  Point (Drop Method)'' Appendix A-2 
  ``Determination of Unsaturation of Resin 1977'' 
  Appendix A-3....................................           178.3610(a)
Acesulfame Potassium Assay........................
172.800(b)(1).....................................
``Amide-Imide Polymer Content--Analysis of Monomer 
  Content''.......................................        177.2450(b)(3)
``Analysis of Cycopaco Resin for Residual B-(2-
  Hydroxyethyl mercapto) propionitrile''..........         177.1020(b); 
                                                             177.1030(b)

[[Page 568]]

``Analysis for Dicholorbenzene in Ryton 
  Polyphenylene Sulfide''.........................        177.2490(a)(3)
Analytical Chemistry, Vol. 49 P. 1090 (1977) 
  ``Atomic Absorption Spectrometric Determination 
  of Sub-Part-Per-Million Quantities of Tin in 
  Extracts and Biological Materials with a 
  Graphite Furnace''..............................    178.2650(b)(1)(ii)
Analytical Method for 10% Solution Viscosity of 
  Tyril...........................................        177.1040(c)(2)
Analytical Method, ``Determination of Free Phenol 
  in Cyclized Rubber Resin''......................         176.170(b)(2)
Analytical Methods ``Determination of Abietic Acid 
  and Dehydroabietic Acid, in Rosins,'' 
  ``Determination of Softening Point of Solid 
  Resins,'' ``Determination of Saponification 
  Number of Rosin Esters,'' and ``Determination of 
  Phenolic Modification of Rosin Derivatives''....        178.3870(f)(6)
``Analytical Method for the Determination of 
  Aspartame and Diketopiperazine in Baked Goods 
  and Baking Mixes,'' October 8, 1992, as 
  developed by the NutraSweet Co..................        172.804(c)(23)
Analytical Method for Determination of Residual 
  Methylene Chloride in Polyestercarbonate Resin, 
  as developed by the General Electric Co., dated 
  July 23, 1991...................................           177.1585(c)
``Chlorine and Bromine--Coulmetric Method by 
  Aminco Chloridometer''..........................           177.2210(b)
Colorimetric Determination of Residual Quaternary 
  Ammonium Compounds (Arquad HTL8) in Sugar and 
  Sugar Solutions, June 13, 1990..................            173.400(c)
``Determination of B-Dodecylmercaplopropionitrile 
  in NR-16 Polymer''..............................           177.1050(b)
Determination of Copolymer Ratio in Vinylidene 
  Chloride/Methyl Acrylate Copolymer..............              177.1990
``Determination of Dimethyl Sulfoxide.............               172.859
Determination of Divinylbenzene in Alcohol 
  Extracts in Amberlite XAD-4.....................                173.65
``Determination of Ethyl Acetate'' Test Method 
  U.1, Sept. 29, 1981.............................               172.859
Determination of Isobutyl Alcohol.................               172.859
``Determination of Melt Viscosity, Molecular 
  Weight Distribution Index and Viscosity 
  Stability''.....................................    177.1550(d)(2)(ii)
Determination of Molecular Weight Distribution of 
  Poly (Maleic Acid) dated March 17, 1992.........             173.45(a)
Determination of Olestra by Size Exclusion 
  Chromatography, dated December 19, 1995.........               172.867
``Determination of Residual Acrylonitrile and 
  Styrene Monomers Gas Chromatographic Internal 
  Standard Method''...............................      177.1020(c)(2); 
                                                        177.1030(c)(2); 
                                                           177.1040(c); 
                                                          177.1050(c)(3)
``Determination of Residual ,-
  Olefinic and Trans Olefinic Unsaturation Levels 
  in HNBR,'' developed October 1, 1991 by Polysar 
  Rubber Corp.....................................     177.2600(c)(4)(i)
``Determination of Residual Maleic Anhydride in 
  Polymers by Gas Chromatography''................        177.1820(c)(3)
Determination of Residual Vinylidene Chloride and 
  Methyl Acrylate in Vinylidene Chloride/Methyl 
  Acrylate Copolymer Resins and Films.............           177.1990(c)
Determination of Tert-Butyl Alcohol in 
  Polypropylene...................................              177.1520

[[Page 569]]

Determination of Weight Average and Number Average 
  Molecular Weight of 60/40 AA/AMPS (October 23, 
  1987)...........................................            173.310(c)
Determination of Weight Average and Number Average 
  Molecular Weight of Sodium Polyacrylate.........             173.73(a)
``Differentiation of Nisin in Processed Cheese'', 
  British Standards Institution, BS 4020, 1974....              184.1538
Exhibit 33B of the report of the NAS/NRC A 
  Comprehensive Survey of Industry on the use of 
  Food Chemicals--GRAS, Sept. 1972................      170.3(n) and (o)
Fishers Johns Method 18 in ``Semimiero 
  Qualitative Organic Analysis'' Second Ed........        178.3780(b)(1)
Food Chemicals Codex, 2nd Ed., 1972...............            172.804(b)
``Formaldehyde Release and Formaldehyde Analysis''     177.2480(d)(2)(i)
Gas Chromatographic Determination of PMS and PET 
  in PPMS Basic Polymers..........................           177.1635(c)
Gas Chromatography Method for Dimethyl Carbonate 
  Impurity in Dimethyl Dicarbonate................         172.133(a)(2)
``General Procedure for Determining Relative 
  Viscosity of Polymers''.........................              177.1630
``Hypalon   Synthetic Rubber--Determination of 
  Sulfur by Parr Bomb''...........................           177.2210(b)
``Infrared Spectrophotometric Determination of 
  Polymers Extracted from Borex 210 
  Resin Pellets''.................................         177.1050(d); 
                                                          177.1480(b)(2)
Intrinsic Viscosity (IV) of Lexan 
  Polycarbonate Resin By a Single Point Method 
  Using Dichloromethane as the solvent, July 23, 
  1991............................................        177.1585(c)(1)
Intrinsic Viscosity Method-E-4 ``Molecular Weight 
  of Matrix Copolymer by Solution Viscosity''.....        177.1050(c)(2)
Intrinsic Viscosity (IV) of Lexan Polycarbonate 
  Resin by a Single Point Method Using 
  Dichloromethane as the Solvent, as developed by 
  the General Electric Co., dated September 20, 
  1985............................................           177.1585(c)
Intrinsic Viscosity of ULTEM Polyetherimide Using 
  chloroform as a Solvent.........................              177.1595
Iodometric Method for the Determination of 
  Available Chlorine Dioxide (50-250 ppm available 
  Cl02)...........................................       178.1010(c)(29)
Japan Institute of Fats and Oils Analysis Method 
  of Residual Ethyl Esters of Fatty Acids.........              184.1259
Journal of the American Oil Chemists' Society, 
  Volume 52, January 4, 1975, ``Rapid Quantitative 
  Determination of Residual Hexane in Oils by 
  Direct Gas Chromatography''.....................              184.1259
Low Molecular Weight Anoxomer Analysis............               172.105
Measurement of Fatty Acid Composition of Olestra 
  Test Material, dated December 19, 1995..........               172.867
Measurement of Relative Esther Distribution of 
  Olestra Test Material, dated December 19, 1995..               172.867
Method for Determination of Intrinsic Viscosity of 
  Maleic Anhydride Adduct of Crystalline 
  Polypropylene...................................    175.300(b)(3)(xix)
Method for Determining Residual Level of 
  Poly(alkylacrylate) in Petroleum Wax............               177.866
Method for Determining Weight-Average and Number-
  Average Molecular Weight and for Determining 
  Alkylcrylate Monomer Content of 
  Poly(alkylacrylate) used as Processing Aid in 
  Manufacture of Petroleum Wax....................               177.866
Method for Measurement of the Stiffness of 
  Olestra, dated December 19, 1995................               172.867

[[Page 570]]

Methodology for Ethylenimine Detection in 
  Polyethylinimine................................               173.357
Methodology for Ethylene-dichloride Detection in 
  Polyethylenimine................................               173.357
Methodology for Molecular Weight Determination of 
  Polyethylenimine................................               173.357
Measurement of B-(2-Hydroxyethylmercapto) 
  Propionitrile in Heptane Food-Stimulating 
  Solvent.........................................             180.22(b)
Methyl Ethyl Ketone Test; Methyl Alcohol Test.....         172.859(b)(9)
Mooney Viscosity..................................              177.1520
NBS Circular 484, U.S. Dept. of Commerce, 1949....       172.250(b)(3); 
                                                            172.886(b); 
                                                        178.3770(a)(4); 
                                                     178.3910(a)(4)(iii)
Nonviolative Extractives Method ``Determination of 
  Non-Volative Chloroform Soluble Residues in 
  Retort Pouch Water Extractives''................     177.1390(c)(3)(i)
Number Average Molecular Weight 2.4 ``Osmometry''.        177.2470(c)(2)
Plastics-Polyamides-Determination of Viscosity 
  Number, ISO 307-1984(E).........................        177.1500(c)(5)
Phillips Petroleum Company Method VO-65R ``Oxygen 
  Flask Combustion-Gravemetric Method For 
  Determination of Sulfur in Organic Compounds'' 
  (1965)..........................................        177.2490(a)(1)
Phillips Petroleum Company Method 6936-BH 
  ``Determination of the Inherent Viscosity of 
  Polyphenylene Sulfide (1969)....................        177.2490(a)(2)
``Preparation of Extracts''.......................           177.1550(e)
``Protein,'' NAS in RDA's, NAS Pub. No. 1694, 7th 
  Ed., 1968.......................................         172.320(c)(1)
``Qualitative Identification of Kalrez 
  by Infrared Examination of Pyrolystate''........           177.2400(c)
Recommended Dietary Allowances, NAS Publication 
  No. 1694, 7th Ed. (1968)........................         172.320(c)(1)
Residual Acrylonitrile Monomer Method ``Extracted 
  Acrylonitrile Monomer by Differential Pulse 
  Polarography'' ``Procedure'' for the 
  Determination of Molecular Weight of 
  Acrylonitrile/Styrene Copolymers................      177.1020(c)(2); 
                                                        177.1030(d)(2); 
                                                             177.1040(c)
Residual Methyl Acrylate and Vinylidene Chloride 
  Monomers in Saran MA/VDC Resins and Pellets by 
  Headspace Gas Chromatography, March 3, 1986.....        177.1990(c)(3)
``Solution Viscosity''............................        177.2450(b)(2)
Specifications and Criteria for Biochemical 
  Compounds, NAS/NRC Pub. 3rd Ed., 1972...........         172.320(b)(2)
``Specifications for Identity and Purity of Some 
  Antibiotics'', WHO, FAO, Nutrition Report 
  Series, No. 45A, 1969...........................              184.1538
Standard Test Method for Molecular Weight Averages 
  and Molecular Weight Distribution of Polystyrene 
  by Liquid Chromatography (Gel Permation 
  Chromatography-GPC).............................              177.1990
Sucrose Fatty Acid Esters, Method of Assay........               172.859
Synthetic Fatty Alcohols Method ``Diols in 
  Monohydroxy Alcohol by Miniature Thin Layer 
  Chromatography (MTLC)''.........................           178.3480(c)
The Determination of Epichlorophydrin and 1,3-
  Dichloro-2-Propanol in Dimethylamine-
  Epichlorohydrin Copolymer.......................             173.60(b)
Total Amine Value.................................           178.3130(b)
Total Available Methanol Method, dated December 
  19, 1995........................................               172.867
Viscoelastometric method ``Direct Reading 
  Viscoelastometric Method for Determining Class 
  Transition Points of Styrene Block Polymers''...    177.1810(c)(1)(ii)

[[Page 571]]

Viscosity Determination of n-
  butoxypoly(oxyethylene)poly(oxypropylene) 
  glycol, dated April 26, 1995....................         173.340(a)(4)
``Yeasts--A Toxonomic Study,'' 2nd Ed., 1970 by 
  Jacomina Lodder.................................       173.160(b)(2); 
                                                           173.165(b)(2)

[[Page 573]]



                                                                    Chap.



                    Table of CFR Titles and Chapters



                     (Revised as of March 29, 1996)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                          Title 2--[Reserved]

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  General Accounting Office (Parts 1--99)
        II  Federal Claims Collection Standards (General 
                Accounting Office--Department of Justice) (Parts 
                100--299)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Advisory Committee on Federal Pay (Parts 1400--1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
       VII  Advisory Commission on Intergovernmental Relations 
                (Parts 1700--1799)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3202)
      XXVI  Department of Defense (Part 3601)

[[Page 574]]

       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)
    LXXVII  Office of Management and Budget (Part 8701)

                          Title 6--[Reserved]

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Consumer Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)

[[Page 575]]

        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
       XXI  Foreign Economic Development Service, Department of 
                Agriculture (Parts 2100--2199)
      XXII  Office of International Cooperation and Development, 
                Department of Agriculture (Parts 2200--2299)
       XXV  Office of the General Sales Manager, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy, Department of Agriculture (Parts 
                2900--2999)
       XXX  Office of Finance and Management, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  [Reserved]
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of Agriculture (Parts 3400--
                3499)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
     XXXIX  Economic Analysis Staff, Department of Agriculture 
                (Parts 3900--3999)
        XL  Economics Management Staff, Department of Agriculture 
                (Parts 4000--4099)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 576]]

                    Title 8--Aliens and Nationality

         I  Immigration and Naturalization Service, Department of 
                Justice (Parts 1--499)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Meat and Poultry 
                Inspection, Department of Agriculture (Parts 300--
                399)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
        XI  United States Enrichment Corporation (Parts 1100--
                1199)
        XV  Office of the Federal Inspector for the Alaska Natural 
                Gas Transportation System (Parts 1500--1599)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Thrift Depositor Protection Oversight Board (Parts 
                1500--1599)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700-1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

[[Page 577]]

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Office of Commercial Space Transportation, Department 
                of Transportation (Parts 400--499)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Export Administration, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
       XII  United States Travel and Tourism Administration, 
                Department of Commerce (Parts 1200--1299)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399)

[[Page 578]]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  United States Customs Service, Department of the 
                Treasury (Parts 1--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Employment Standards Administration, Department of 
                Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training, Department of Labor 
                (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

[[Page 579]]

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development, International 
                Development Cooperation Agency (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Information Agency (Parts 500--599)
        VI  United States Arms Control and Disarmament Agency 
                (Parts 600--699)
       VII  Overseas Private Investment Corporation, International 
                Development Cooperation Agency (Parts 700--799)
        IX  Foreign Service Grievance Board Regulations (Parts 
                900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Board for International Broadcasting (Parts 1300--
                1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)

[[Page 580]]

         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs and Section 202 Direct Loan Program) 
                (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--999)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3699)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--799)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Part 1001)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--799)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Bureau of Alcohol, Tobacco and Firearms, Department of 
                the Treasury (Parts 1--299)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--199)

[[Page 581]]

       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Programs, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Pension and Welfare Benefits Administration, 
                Department of Labor (Parts 2500--2599)
      XXVI  Pension Benefit Guaranty Corporation (Parts 2600--
                2699)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
        VI  Bureau of Mines, Department of the Interior (Parts 
                600--699)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

[[Page 582]]

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)
      XXIX  Presidential Commission on the Assignment of Women in 
                the Armed Forces (Part 2900)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)

[[Page 583]]

            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799)
        XI  National Institute for Literacy (Parts 1100-1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                        Title 35--Panama Canal

         I  Panama Canal Regulations (Parts 1--299)

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
       XIV  Assassination Records Review Board (Parts 1400-1499)

             Title 37--Patents, Trademarks, and Copyrights

         I  Patent and Trademark Office, Department of Commerce 
                (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

[[Page 584]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--799)
         V  Council on Environmental Quality (Parts 1500--1599)

          Title 41--Public Contracts and Property Management

            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans 
                Employment and Training, Department of Labor 
                (Parts 61-1--61-999)
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99)
            Subtitle F--Federal Travel Regulation System
       301  Travel Allowances (Parts 301-1--301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Parts 303-1--303-2)
       304  Payment from a Non-Federal Source for Travel Expenses 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)

[[Page 585]]

        IV  Health Care Financing Administration, Department of 
                Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10005)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services, 
                General Administration (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  ACTION (Parts 1200--1299)

[[Page 586]]

      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
      XXII  Christopher Columbus Quincentenary Jubilee Commission 
                (Parts 2200--2299)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Saint Lawrence Seaway Development Corporation (Great 
                Lakes Pilotage), Department of Transportation 
                (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Department of Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)

[[Page 587]]

        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  United States Information Agency (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        22  Small Business Administration (Parts 2200--2299)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Part 
                5452)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Research and Special Programs Administration, 
                Department of Transportation (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Highway Administration, Department of 
                Transportation (Parts 300--399)

[[Page 588]]

        IV  Coast Guard, Department of Transportation (Parts 400--
                499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Regulatory Agencies (Fishing and 
                Whaling) (Parts 300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR

[[Page 589]]





           Alphabetical List of Agencies Appearing in the CFR



                     (Revised as of March 29, 1996)

                                                  CFR Title, Subtitle or
                     Agency                               Chapter

ACTION                                            45, XII
Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Commission on Intergovernmental          5, VII
     Relations
Advisory Committee on Federal Pay                 5, IV
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Commodity Credit Corporation                    7, XIV
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Analysis Staff                         7, XXXIX
  Economic Research Service                       7, XXXVII
  Economics Management Staff                      7, XL
  Energy, Office of                               7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Finance and Management, Office of               7, XXX
  Food and Consumer Service                       7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force Department                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Alaska Natural Gas Transportation System, Office  10, XV
     of the Federal Inspector
Alcohol, Tobacco and Firearms, Bureau of          27, I
AMTRAK                                            49, VII

[[Page 590]]

American Battle Monuments Commission              36, IV
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Arms Control and Disarmament Agency, United       22, VI
     States
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Assassination Records Review Board                36, XIV
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase From People Who Are
Board for International Broadcasting              22, XIII
Census Bureau                                     15, I
Central Intelligence Agency                       32, XIX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Christopher Columbus Quincentenary Jubilee        45, XXII
     Commission
Civil Rights, Commission on                       45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Commerce Department                               44, IV
  Census Bureau                                   15, I`
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Export Administration, Bureau of                15, VII
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  Foreign-Trade Zones Board                       15, IV
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office                     37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
  Travel and Tourism Administration, United       15, XII
       States
Commercial Space Transportation, Office of        14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Product Safety Commission                16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Customs Service, United States                    19, I
Defense Contract Audit Agency                     32, I
Defense Department                                5, XXVI; 32, Subtitle A
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII

[[Page 591]]

  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Defense Mapping Agency                          32, I
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 2
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Mapping Agency                            32, I
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Analysis Staff                           7, XXXIX
Economic Development Administration               13, III
Economics Management Staff                        7, XL
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Elementary and Secondary Education, Office of     34, II
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             10, II, III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Enrichment Corporation, United States             10, XI
Environmental Protection Agency                   40, I
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                25, III, LXXVII; 48, 99
  National Drug Control Policy, Office of         21, III
  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export Administration, Bureau of                  15, VII
Export-Import Bank of the United States           5, LII; 12, IV
Family Assistance, Office of                      45, II

[[Page 592]]

Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Farmers Home Administration                       7, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
Federal Claims Collection Standards               4, II
Federal Communications Commission                 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II; 49, III
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Board                     12, IX
Federal Information Resources Management          41, Subtitle E, Ch. 201
     Regulations
Federal Inspector for the Alaska Natural Gas      10, XV
     Transportation System, Office of
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
Federal Law Enforcement Training Center           31, VII
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  29, XXVII
Federal Pay, Advisory Committee on                5, IV
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Property Management Regulations System    41, Subtitle C
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Finance and Management, Office of                 7, XXX
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
Fishing and Whaling, International Regulatory     50, III
     Agencies
Food and Drug Administration                      21, I
Food and Consumer Service                         7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Accounting Office                         4, I, II
General Services Administration
  Contract Appeals, Board of                      48, 61

[[Page 593]]

  Federal Acquisition Regulation                  48, 5
  Federal Information Resources Management        41, Subtitle E, Ch. 201
       Regulations
  Federal Property Management Regulations System  41, 101, 105
  Federal Travel Regulation System                41, Subtitle F
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Travel Allowances                               41, 301
Geological Survey                                 30, IV
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes Pilotage                              46, III
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          45, Subtitle A
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Health Care Financing Administration            42, IV
  Human Development Services, Office of           45, XIII
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Health Care Financing Administration              42, IV
Housing and Urban Development, Department of      24, Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Human Development Services, Office of             45, XIII
Immigration and Naturalization Service            8, I
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Information Agency, United States                 22, V
  Federal Acquisition Regulation                  48, 19
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Intergovernmental Relations, Advisory Commission  5, VII
     on
Interior Department
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I

[[Page 594]]

  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  Minerals Management Service                     30, II
  Mines, Bureau of                                30, VI
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, Agency for             22, II
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
  International Development, Agency for           22, II; 48, 7
  Overseas Private Investment Corporation         5, XXXIII; 22, VII
International Investment, Office of               31, VIII
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Regulatory Agencies (Fishing and    50, III
     Whaling)
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                28, I
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             4, II
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration and Naturalization Service          8, I
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department
  Benefits Review Board                           20, VII
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Relations and Cooperative      29, II
       Programs, Bureau of
  Labor-Management Programs, Office of            29, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Pension and Welfare Benefits Administration     29, XXV
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training, Office of    41, 61; 20, IX
       the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Relations and Cooperative        29, II
     Programs, Bureau of
Labor-Management Programs, Office of              29, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII

[[Page 595]]

  Copyright Office                                37, II
Management and Budget, Office of                  5, III, LXXVII; 48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II
Mines, Bureau of                                  30, VI
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
National Aeronautics and Space Administration     5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National Archives and Records Administration      36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National and Community Service, Corporation for   45, XXV
National Council on Disability                    34, XII
National Credit Union Administration              12, VII
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Panama Canal Commission                           48, 35
Panama Canal Regulations                          35, I
Patent and Trademark Office                       37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       22, III
Pennsylvania Avenue Development Corporation       36, IX

[[Page 596]]

Pension and Welfare Benefits Administration       29, XXV
Pension Benefit Guaranty Corporation              29, XXVI
Personnel Management, Office of                   5, I; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Postal Rate Commission                            5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Commission on the Assignment of      32, XXIX
     Women in the Armed Forces
Presidential Documents                            3
Prisons, Bureau of                                28, V
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Regional Action Planning Commissions              13, V
Relocation Allowances                             41, 302
Research and Special Programs Administration      49, I
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Saint Lawrence Seaway Development Corporation     33, IV; 46, III
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
  Federal Acquisition Regulation                  48, 22
Smithsonian Institution                           36, V
Social Security Administration                    20, III
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  22, I
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        18, XIII
Thrift Depositor Protection Oversight Board       12, XV
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of
  Coast Guard                                     33, I; 46, I; 49, IV
  Commercial Space Transportation, Office of      14, III
  Contract Appeals, Board of                      48, 63
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II; 49, III
  Federal Railroad Administration                 49, II

[[Page 597]]

  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 49, V
  Research and Special Programs Administration    49, I
  Saint Lawrence Seaway Development Corporation   33, IV; 46, III
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
Transportation, Office of                         7, XXXIII
Travel Allowances                                 41, 301
Travel and Tourism Administration, United States  15, XII
Treasury Department                               5, XXI; 17, IV
  Alcohol, Tobacco and Firearms, Bureau of        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs Service, United States                  19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
United States Enrichment Corporation              10, XI
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training, Office of the  41, 61; 20, IX
     Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 599]]

                                     

                                     



                           Redesignation Table



------------------------------------------------------------------------
                  Old section                          New section      
------------------------------------------------------------------------
193.10                                                          185.100 
193.15                                                          185.150 
193.20                                                          185.200 
193.25                                                          185.250 
193.30                                                          185.350 
193.40                                                          185.500 
193.43                                                          185.600 
193.45                                                          185.650 
193.50                                                          185.700 
193.60                                                          185.750 
193.65                                                          185.1150
193.80                                                          185.410 
193.83                                                          185.800 
193.85                                                          185.1000
193.90                                                          185.1200
193.97                                                          185.1300
193.98                                                          185.1250
193.99                                                          185.3300
193.100                                                         185.1450
193.105                                                         185.1500
193.130                                                         185.1650
193.135                                                         185.1700
193.137                                                         185.1850
193.140                                                         185.1900
193.142                                                         185.1750
193.150                                                         185.2225
193.151                                                         185.2250
193.152                                                         185.2150
193.156                                                         185.2200
193.160                                                         185.2500
193.170                                                         185.2600
193.180                                                         185.2650
193.186                                                         185.2700
193.190                                                         185.2750
193.200                                                         185.2850
193.210                                                         185.2900
193.212                                                         185.3000
193.220                                                         185.3450
193.225                                                         185.3475
193.230                                                         185.3480
193.235                                                         185.3500
193.236                                                         185.3550
193.240                                                         185.3600
193.250                                                         185.3700
193.251                                                         185.425 
193.253                                                         185.3750
193.255                                                         185.3800
193.260                                                         185.3850
193.270                                                         185.3900
193.275                                                         185.3950
193.277                                                         185.4000
193.280                                                         185.4025
193.285.                                                        185.4150
193.290                                                         185.4200
193.300                                                         185.4250
193.310                                                         185.4300
193.320                                                         185.4500
193.323                                                         185.4400
193.324                                                         185.4450
193.325                                                         185.4600
193.330                                                         185.4650
193.331                                                         185.4700
193.340                                                         185.4800
193.350                                                         185.4850
193.360                                                         185.4900
193.370                                                         185.5000
193.375                                                         185.5100
193.380                                                         185.5150
193.390                                                         185.5200
193.400                                                         185.5350
193.410                                                         185.1550
193.418                                                         185.5450
193.420                                                         185.5475
193.430                                                         185.1350
193.440                                                         185.5900
193.450                                                         185.5750
193.460                                                         185.6300
193.462                                                         185.4550
193.463                                                         185.2950
193.464                                                         185.5300
193.465                                                         185.1800
193.466                                                         185.3250
193.467                                                         185.3650
193.468                                                         185.4950
193.470                                                         185.5550
193.471                                                         185.1050
193.472                                                         185.1100
193.473                                                         185.300 
193.475                                                         185.4100
193.476                                                         185.5950
193.477                                                         185.4350
193.479                                                         185.2800
193.480                                                         185.2275
193.481                                                         185.5250
193.520                                                         185.7000
------------------------------------------------------------------------


[[Page 601]]






List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations which were 
made by documents published in the Federal Register since January 1, 
1986, are enumerated in the following list. Entries indicate the nature 
of the changes effected. Page numbers refer to Federal Register pages. 
The user should consult the entries for chapters and parts as well as 
sections for revisions.
For the period before January 1, 1986, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, and 1973-1985'' published in seven 
separate volumes.

                                  1986

21 CFR
                                                                   51 FR
                                                                    Page
Chapter I
Mandatory compliance date 1-1-89...................................34085
172.210  (b)(2) table amended.......................................2693
172.515  (b) amendment confirmed; request for deferral denied......37909
172.804  (c) (8) and (9) added.....................................43000
    (c)(10) added..................................................43001
    (c)(5)(ii) amended; (c)(11) added..............................43002
172.834  Technical correction.......................................1495
172.846  Introductory text corrected..........................1495, 3333
172.859  (a) amended; (b)(10) and (11) added.......................40161
172.886  (c)(2) revised............................................19544
173.5--173.75 (Subpart A)  Heading revised.........................11719
173.45  Added.......................................................5315
173.60  Technical correction........................................1495
173.75  Added......................................................11720
175  Authority citation revised; section authority citations 
        removed....................................................19545
175.105  (c)(5) table amended......................................5316,
19545, 30059-60, 31099, 33889
    Technical correction...........................................1495,
                                                             6520, 43120
175.250  (a) amended; (b)(1) revised...............................47010
175.300  (b)(3)(xxxi) amended.......................................4312
176.170  (b)(2) table amended.......................................881,
                                                            28546, 47011
    Technical correction............................................1495
176.180  (b)(2) table amended.....................................16167,
                                                            17012, 47011
176.300  (c) table amended.........................................19059
    (d) amended....................................................43734
177.1310  (a) and (b) revised; (c) redesignated as (d); new (c) 
        added......................................................19060
177.1315  (b) revised..............................................22929
177.1500  (a)(10) revised; (b) table amended.......................33250
177.1520  (b) table amended........................................43191
    (a)(3)(i)(b) and (c) amended; (a)(3)(i)(d) added...............45315
177.1630  (e)(4) amended............................................3772
177.1655  Added......................................................882
    (b) table and (d) corrected.....................................4165
177.1810  (b) table and (c)(3) revised.............................16828
    Technical correction...........................................18774
177.2500  Removed....................................................883
178  Authority citation revised; section authority citations 
        removed....................................................19544
    Authority citation corrected...................................43120
178.1005  (e)(1) revised...........................................45881
178.1010  (b)(29) and (c)(24) added.................................7437
    (b)(30) and (c)(25) added.......................................7438
    (b)(31) and (c)(26) added......................................33892
    (b)(33) and (c)(28) added......................................47226
178.2010  (b) table amended........................................5317,
12608, 19061, 29462, 31100, 32212, 35512, 47012
    (b) table corrected.....................................15763, 39372

[[Page 602]]

    Technical correction......................................1495, 6520
178.3130  (b) table amended........................................28932
178.3297  (e) table amended..................................7552, 19168
    (e) table corrected............................................23535
178.3400  (c) table amended........................................31763
    Technical correction...........................................39747
178.3570  (a)(3) table amended......................................7552
178.3710  (f) added................................................19545
178.3740  (b) table amended........................................47011
178.3770  (c) added................................................33895
179  Authority citation revised....................................13398
179.21  Authority citation removed.................................13398
179.22  Removed....................................................13398
179.24  Removed....................................................13398
179.25  Added......................................................13399
179.26  Added......................................................13399
179.45  Authority citation removed.................................13398
182  Authority citation revised.............................16830, 25025
182.70  Amended.............................................16830, 27171
    Effective date corrected.......................................18774
182.90  Amended....................................................39372
182.1366  Removed..................................................27171
182.3616  (c) revised..............................................25025
    Effective date corrected.......................................25198
    Technical correction...........................................26876
182.3637  (c) revised..............................................25025
    Effective date corrected.......................................25198
    Technical correction...........................................26876
182.3739  (c) revised..............................................25025
    Effective date corrected.......................................25198
    Technical correction...........................................26876
182.3766  (c) revised..............................................25025
    Effective date corrected.......................................25198
    Technical correction...........................................26876
182.3798  (c) revised..............................................25026
    Effective date corrected.......................................25198
    Technical correction...........................................26876
182.3862  (c) revised..............................................25026
    Effective date corrected.......................................25198
    Technical correction...........................................26876
184  Authority citation corrected...................................1495
184.1157  Added....................................................27173
184.1318  Added....................................................33896
184.1366  (c), (d), and (e) revised................................27172
186  Authority citation revised; section authority citations 
        removed....................................................16830
186.1557  Added....................................................16830
    Effective date corrected.......................................18774
186.1770  Added....................................................39372
186.1771  Added....................................................39372
189.113  Addition confirmed; request for deferral denied...........37909
193.35  Removed....................................................25686
193.110  Removed...................................................46617
193.120  Removed...................................................46617
193.137  Added.....................................................11437
193.186  (b) table amended.........................................31325
193.450  Revised...................................................46617
193.468  (c) added.................................................28224

                                  1987

21 CFR
                                                                   52 FR
                                                                    Page
Chapter I
172.210  (b)(4) table amended......................................18911
172.859  (a) amended...............................................10883
173.357  (a)(2) table amended......................................39512
175.105  (c)(5) table amended.....................................10884,
12380, 27800, 29180
    (c)(5) table corrected.........................................19857
175.300  (b)(3)(xxxii) amended.....................................41987
176.170  (b)(2) table amended.................................530, 19724
    (a)(5) table amended...........................................3604,
17553, 29667, 43058, 46746
    Technical correction............................................6649
177  Authority citation revised.............................33803, 39635
177.1040  (c) table amended........................................33803
177.1390  Heading revised..........................................33575
177.1395  Added....................................................33575
    Technical correction...........................................36863
177.1430  Revised..................................................11641
177.1500  (a)(12) added; (b) table amended.........................26667
    Technical correction...........................................28067
    (a)(4) revised; (b) table amended..............................33575
    (a)(13) and (c)(5) added; (b) table amended....................39635
    (b) table corrected............................................42760
177.1520  (b) table amended........................................23804
177.1555  Added....................................................35540
177.1630  (e)(4)(i) amended........................................32917
177.1660  (c)(1) amended...........................................20069
177.2470  (a) revised; (b)(1) amended...............................4493
177.2550  (a) revised..............................................29668
177.2600  (c)(4)(iii) amended......................................35910
178.1005  (d) revised..............................................26146
178.1010  (b)(32) and (c)(27) added..................................409
    (b)(34) and (c)(29) added......................................29842
    (c)(29) corrected..............................................34047

[[Page 603]]

178.2010  (b) table amended; eff. 4-2-87............................6324
    (b) table amended.............................................20070,
22301, 30150, 33930, 35541, 35911, 37446, 43059, 43323
    Technical correction...........................................24090
    (b) table corrected............................................26764
178.3295  Table amended............................................30920
178.3910  (a)(4)(i)(a) amended.....................................10223
179.22  Petitions for deferral of effective date denied.............5450
179.24  Petitions for deferral of effective date denied.............5450
179.25  Petitions for deferral of effective date denied.............5450
179.26  Petitions for deferral of effective date denied.............5450
182.8245  Removed..................................................25211
184.1245  Added....................................................25211
184.1259  (a) revised; (b) (8) and (9) revised.....................47920
    (a)(2) corrected...............................................48905
184.1287  Added....................................................25976
184.1328  Added....................................................42430
184.1639  Added....................................................10886
184.1768  Added....................................................10886
193.98  Added......................................................29009
    (b) corrected..................................................31846
193.137  Existing text designated as (a); (b) added................17941
193.142  Heading and text nomenclature change......................32293
193.253  Table amended.............................................10562
193.277  (d) added.................................................41418
    (d) corrected..................................................42760
193.410  Revised...................................................27543
193.430  Heading and text nomenclature change......................32293
193.472  Added.....................................................10563
193.473  Added.....................................................17942
    Technical correction..........................................23137,
                                                            23916, 34903
193.475  Added.....................................................43324
193.476  Added.....................................................39222

                                  1988

21 CFR
                                                                   53 FR
                                                                    Page
Chapter I
Uniform compliance date 1-1-91.....................................44861
170  Authority citation revised....................................16546
170.3  (f) revised.................................................16546
170.30  (c) redesignated as (c)(1); new (c)(1) amended; (c)(2) 
        added......................................................16546
170.35  (c)(1) introductory text revised; OMB number...............16547
172.133  Added.....................................................41329
    Technical correction...........................................49638
172.800  Added.....................................................28382
172.804  (c) (8), (9), (10), and (11) request for stay denied and 
        effective date confirmed....................................6595
    (c)(13) added..................................................20838
    (c)(12) added..................................................20839
    (c)(14) added..................................................20840
    (c)(15) added..................................................20841
    (c) (16) and (17) added........................................20842
    Technical correction...........................................23340
    (c)(18) added..................................................40879
    (b) revised....................................................51273
172.811  Added.....................................................21632
172.859  (c)(3) revised............................................22294
    (a) amendment and (b) (10) and (11) additions in 51 FR 40161 
republished........................................................22297
    Technical correction....................................26559, 36785
173  Authority citation revised.............................15199, 39456
173.73  Added......................................................39456
    (a)(2) corrected........................................43319, 49823
173.310  (c) table amended.........................................15199
    (c) table corrected............................................18194
175.105  (c)(5) table amended.....................................29454,
                                                            32606, 52131
175.300  (b)(3)(xxxiii) amended....................................34279
176.170  (a)(5) table corrected.......................................97
    (a)(5) table amended................8620, 28636, 34045, 50211, 50952
177.1310  (b) revised..............................................44009
177.1330  (c) amended..............................................44009
177.1390  (c)(3)(i)(a) (1) and (2) and (b) (1) and (2) amended; 
        (c)(2)(vi) and (3)(i)(b)(3) added..........................39084
177.1395  (b)(4) table amended.....................................19773
177.1500  (a)(14) added; (b) table amended; (c)(5) redesignated as 
        (c)(5)(i); (c)(5)(ii) added................................19773
177.1580  (b) table amended........................................29656
177.1990  (c)(3) and (e) revised...................................47185
177.2550  (a) revised..............................................31835
    (a)(3) added...................................................32215
    Technical correction...........................................36391
177.2910  Introductory text revised; (a) redesignated as (a)(1) 
        and revised; new (a)(2) added..............................17925

[[Page 604]]

178.1005  (e)(1) revised...........................................47186
178.1010  (b)(35) and (c)(30) added................................31837
178.2010  (b) table amended.......................................15200,
18087, 29657, 32375, 47526, 49551, 52133
178.3295  Table amended............................................30049
    Technical correction...........................................18194
178.3297  (e) table amended........................................52132
178.3570  (a)(3) table amended...............................8441, 44397
179.26  (c)(4) amended.............................................12757
    Effective date corrected.......................................16615
    (b) table amended..............................................53209
182  Authority citation revised....................................16864
182.1  (a) amended.................................................44875
182.90  Amended.............................................16864, 44876
182.8301  Removed..................................................16864
182.8304  Removed..................................................16864
182.8306  Removed..................................................16864
182.8308  Removed..................................................16864
182.8311  Removed..................................................16864
182.8315  Removed..................................................16864
182.8375  Removed..................................................16864
184.1259  Technical correction......................................4384
184.1296  Added....................................................16864
184.1297  Added....................................................16864
184.1298  Added....................................................16865
184.1301  Added....................................................16865
184.1304  Added....................................................16865
    (a) and (d) corrected..........................................20939
184.1307  Added....................................................16865
184.1307a  Added...................................................16865
184.1307b  Added...................................................16865
184.1307c  Added...................................................16866
184.1307d  Added...................................................16866
184.1308  Added....................................................16866
    (b) corrected..................................................20939
184.1311  Added....................................................16866
184.1315  Added....................................................16866
184.1375  Added....................................................16867
184.1538  Added....................................................11250
    Technical correction...........................................16837
184.1555  (c)(1) amended...........................................52682
184.1854  Added....................................................44876
184.1857  Added....................................................44876
184.1859  Added....................................................44876
184.1865  Added....................................................44876
186.1300  Added....................................................16867
    (b)(2) corrected...............................................20939
184.1330  (c) table amended.........................................5766
186.1374  Added....................................................16867
    (b)(2) corrected...............................................20939
193  Redesignated as 40 CFR Part 185...............................24666
    Correctly redesignated as 40 CFR Part 185......................26131
193.15  (b) removed.................................................8874
193.70  Removed.....................................................9434
193.84  Removed.....................................................8874
193.85  (c) removed.................................................9434
193.87  Removed.....................................................8874
193.98  (a) added...................................................1917
    (c) added......................................................18837
193.100  Revised....................................................9434
193.137  (b) amended...............................................20308
193.142  Introductory text revised.................................23389
193.145  Removed....................................................9434
193.152  (c) removed................................................8874
193.156  (b), (c) and (d) removed...................................8874
193.186  (a) table amended..........................................5367
193.215  Removed....................................................9434
193.219  Removed....................................................9434
193.235  (b) removed................................................9434
193.277  (c) removed................................................8874
193.284  Removed....................................................9434
193.301  Removed....................................................9434
193.400  Revised....................................................9434
193.415  Removed....................................................9434
193.430  Revised...................................................23389
193.468  Revised....................................................8874
193.469  Removed....................................................8874
193.473  Amended...................................................23107
193.477  Added.................................................21, 12943
193.479  Added.......................................................234
    Amended........................................................23388
193.480  Added; eff. to 6-30-89....................................23386
193.481  Added.....................................................23387

                                  1989

21 CFR
                                                                   54 FR
                                                                    Page
Chapter I
170  Authority citation revised; sectional authority citations 
        removed....................................................39634
170.3  (n) and (o) introductory text amended.......................24896
170.6  (e) amended.................................................24896
170.38  (b)(3) amended.............................................24896
171  Authority citation revised....................................39634
172  Authority citation revised; sectional authority citations 
        removed....................................................39634
172.105  (b) (1), (2), and (3) amended.............................24896

[[Page 605]]

172.250  (b)(3) footnote 1 amended.................................24896
172.320  (b)(2), (c)(1), and (d) amended...........................24897
172.340  (b) introductory text footnote 1 amended..................24897
172.372  (d) amended...............................................24897
172.385  (c)(1) amended............................................24897
172.510  (b) table footnote 1 amended..............................24897
172.515  (b) amended................................................7402
172.804  (c)(19) added.............................................23647
    (c)(20) added..................................................23647
    (c)(21) added..................................................31333
172.859  (b) (1), (5), and (9) amended.............................24897
172.860  (c) (1) and (2) amended...................................24897
172.864  (b)(3) footnote 1 amended.................................24897
172.878  (a)(3) amended............................................24897
172.882  (a) amended...............................................24897
172.886  (b) footnote 1 amended....................................24897
173  Authority citation revised; sectional authority citations 
        removed....................................................39634
173.60  (b)(3) amended.............................................24897
173.145  (b) footnote 1 amended....................................24897
173.160  (b)(1) footnote 1 and (2) amended.........................24897
173.165  (b)(2) amended............................................24897
173.310  (c) table amended.........................................31012
173.395  (d) amended...............................................24897
174  Authority citation revised....................................39634
175  Authority citation revised....................................39634
175.105  (c)(5) table amended........................15750, 24554, 50500
175.300  (b)(3)(xix) amended.......................................24897
    (b)(3)(xxxiii) amended........................................30732,
                                                            47765, 47766
    (b)(3)(vii)(e) added...........................................48858
176  Authority citation revised....................................39634
176.170  (a)(5) table amended...............................19363, 38968
    Authority citation removed.....................................39634
    (d)(3) introductory text amended...............................24897
176.180  (b)(2) table amended........................10630, 13881, 14075
    Technical correction...........................................13606
176.210  (d)(3) amended............................................24897
176.300  (c) table revised.........................................18103
177  Authority citation revised; sectional authority citations 
        removed....................................................39634
177.1020  (c)(2) and (d)(2) amended................................24897
177.1030  (c)(2) and (d)(2) amended................................24898
177.1050  (b) table, (c) (2) and (3), (d) introductory text, and 
        (e)(4) amended.............................................24898
177.1060  Added....................................................20382
177.1330  (e)(4) amended...........................................24898
177.1350  (d) (1), (3), and (e)(1) revised.........................35874
177.1390  (c)(3)(i)(a)(1) amended..................................24898
177.1480  (b)(2) introductory text amended.........................24898
177.1500  (b) table amended........................................29019
177.1520  (b) table amended........................................10632
    (a)(5) added; (c) table amended................................40383
    (a)(3)(i)(c) redesignated as (a)(3)(i)(c)(1); (a)(3)(i)(c)(2) 
added; (c) table amended; (d)(7) revised...........................49079
    (c) table corrected............................................51342
177.1550  (e) footnote 1 amended...................................24898
177.1630  (j) added................................................15750
    Technical correction...........................................19283
    (e)(4)(iii) amended............................................24898
177.1635  (c)(1) amended...........................................24898
177.1810  (c)(2)(ii) amended.......................................24898
177.1820  (c)(3) amended...........................................24898
177.1990  (c)(1) amended...........................................24898
177.2210  (b)(3) amended...........................................24898
177.2420  (b) table amended........................................48858
177.2450  (b) (1), (2), and (3) amended............................24898
    (a) and (b) revised; (c) introductory text amended.............43170
177.2470  (c)(2) amended...........................................24898
177.2480  (d)(2)(i) amended........................................24898
177.2490  (a) introductory text amended............................24898
177.2600  (c)(4)(iv) heading revised and text amended..............35638
    (c)(4)(i) amended..............................................38969
178  Authority citation revised....................................39634
178.1005  (e)(1) table amended...............................5604, 13167
    (e)(1) table corrected..........................................6365

[[Page 606]]

178.1010  (b)(36) and (c)(31) added................................21621
    (b)(38) and (c)(33) added......................................21939
    (b)(36) corrected..............................................23739
    Technical correction...........................................24789
    (b)(16) amended................................................24898
    (b)(37) and (c)(32) added......................................31014
178.2010  (b) table amended..............6125, 9775, 13878, 17705, 39357
    Technical correction...........................................42886
178.2650  Introductory text and (a) introductory text revised; 
        (a)(7) and (b)(1)(iii) added................................6658
    (b)(1)(ii) amended.............................................24898
178.3295  Table amended............................................12432
    Table corrected................................................14734
178.3297  (e) table amended.................................21053, 35875
    (c) amended....................................................24898
178.3480  (c) introductory text amended............................24898
178.3570  (a)(3) table amended.....................................31519
178.3610  (a) amended..............................................24898
178.3620  (b)(1)(ii) and (c)(3) footnote 1 amended.................24898
178.3690  (b)(4) amended...........................................24898
178.3770  (a)(4) footnote 1 amended................................24898
178.3780  (b)(1) amended...........................................24899
178.3870  (f)(6)(iv) amended.......................................24899
178.3910  (a)(2) table amended......................................6124
    Technical correction............................................7920
    (a)(4)(iii) footnote 1 and (b) introductory text amended.......24899
179  Authority citation revised....................................39634
179.26  Technical correction........................................6475
    Regulation at 53 FR 53209 effective date confirmed.............32335
179.45  (c) and (d) redesignated as (d) and (e); new (c) added......7405
    (b)(6) introductory text amended...............................24899
180  Authority citation revised....................................39635
180.1  Authority citation removed..................................39634
180.22  (a) introductory text, (b), (e), and (f) (1) and (2) 
        amended....................................................24899
181  Authority citation revised....................................39635
181.1  Authority citation removed..................................39635
181.32  (b) introductory text amended..............................24899
182  Authority citation corrected...................................6365
    Authority citation revised.....................................39635
182.60  Amended.....................................................7402
182.90  Amended.....................................................7402
182.1324  Removed...................................................7402
182.1901  Removed...................................................7402
182.4101  Removed...................................................7402
182.4505  Removed...................................................7402
182.4521  Removed...................................................7402
184  Authority citation revised....................................39635
184.1101  Added.....................................................7403
    (a) revised; (e) added; eff. 5-1-89............................13168
    Effective date and (e) corrected...............................18382
184.1323  Added.....................................................7403
184.1324  Added.....................................................7403
184.1408  (b)(1) amended...........................................24899
184.1472  Added....................................................38223
184.1505  Added.....................................................7403
184.1521  Added.....................................................7404
184.1854  (b) corrected..............................................228
184.1859  (a) corrected..............................................228
184.1901  Added.....................................................7404
184.1903  Added.....................................................7404
    (c)(2) corrected...............................................10482
184.1979  (b)(1) introductory text footnote 2 amended..............24899
184.1979a  (b)(1) introductory text footnote 2 amended.............24899
184.1979b  (b)(1) introductory text footnote 2 amended.............24899
184.1979c  (b)(1) introductory text footnote 2 amended.............24899
186  Authority citation revised....................................39635
189  Authority citation revised; sectional authority citations 
        removed....................................................39635
189.1  (c) amended.................................................24899
189.110  (c) amended...............................................24899
189.130  (c) amended...............................................24899
189.135  (c) amended...............................................24899
189.145  (c) amended...............................................24899
189.155  (c) amended...............................................24899
189.165  (c) amended...............................................24900
189.175  (c) amended...............................................24900
189.180  (c) amended...............................................24900
189.190  (c) amended...............................................24900
189.300  Added......................................................7188
197  Authority citation revised....................................39635

[[Page 607]]

                                  1990

21 CFR
                                                                   55 FR
                                                                    Page
Chapter I
172.665  Added.....................................................39614
173.310  (c) table amended.........................................12172
173.342  Added......................................................8913
173.357  (a)(2) table amended......................................12172
175.105  (c)(5) table amended...............................10235, 30215
176.170  (a)(5) table amended................................1673, 10236
    (b)(2) table amended...........................................13520
176.300  (c) table amended.........................................31825
177.1210  (b)(5) table amended.....................................34555
177.1350  (a)(6) added.............................................18595
177.1520  (b) table amended........................................18596
    (c) table amended..............................................31826
    (b) table corrected............................................19701
    (b) table amended..............................................34710
177.1635  (e) revised..............................................52989
177.2550  (d)(1) revised; (d)(2) and (3) redesignated as (d)(3) 
        and (4); (a)(4) and new (d)(2) added........................8139
177.2600  (c)(4)(i) amended........................................34555
178  Technical correction..........................................50279
178.1005  (e)(1) table amended.....................................47055
178.2010  (b) table amended...................13521, 18597, 22901, 30216
178.3280  (b) table amended.........................................8914
178.3295  Table amended............................................52990
178.3297  (e) table amended....................3585, 12344, 18721, 31827
178.3570  (a)(3) table amended..............................30218, 47323
178.3700  (a) and (d) amended......................................12172
178.3770  Heading, introductory text, (a) introductory text, (b) 
        introductory text, (c) introductory text and (c)(1) 
        amended; (d) added.........................................28020
179  Authority citation revised.....................................9079
179.26  (c)(4) removed.............................................14415
    (c)(4) correctly removed.......................................18227
    (b) Table revised..............................................18544
    Technical correction...........................................19701
182.3616  (c) revised; eff. 4-16-90.................................9832
182.3637  (c) revised; eff. 4-16-90.................................9832
182.3739  (c) revised; eff. 4-16-90.................................9832
182.3766  (c) revised; eff. 4-16-90.................................9833
182.3798  (c) revised; eff. 4-16-90.................................9833
182.3862  (c) revised; eff. 4-16-90.................................9833
184.1498  Added.....................................................6391
    Technical correction...........................................10030
184.1685  Revised..................................................10935

                                  1991

21 CFR
                                                                   56 FR
                                                                    Page
Chapter I
172.540  Added......................................................6968
172.712  Removed...................................................42686
    Technical correction...........................................46667
172.861  Added.....................................................66970
173.25  (a)(20) and (b)(5) added; (b) introductory text and (d) 
        revised....................................................16268
173.400  Added.....................................................42686
    Technical correction...........................................46667
175.105  (c)(5) table amended......................................14316
175.300  (b)(3)(xxvi) revised......................................42932
175.320  (b)(3) table amended......................................49674
176  Technical correction...........................................2585
176.170  (a)(5) table amended....................................18, 368
    (b)(2) table amended....................................19930, 49674
    (b)(1) and (2) table amended...................................42932
    (b)(2) table corrected.........................................65782
177.1350  (a)(3) revised...........................................42932
177.1460  (b) table amended........................................42933
177.1520  (b) table amended.................................21447, 42933
    (b) table corrected............................................25446
177.1680  (a)(2) and (b) table amended.............................15278
    Technical correction...........................................22910
    (b) table amended..............................................42933
177.2250  (d) revised..............................................42933
177.2260  (d)(5) revised...........................................42933
177.2600  (c)(4)(vi) revised.......................................42933
177.2800  (d)(5) table amended.....................................42933
178.2010  (b) table amended..................................1084, 43698
178.3130  (b) table amended........................................41457
178.3295  Table amended.............................................1085
178.3297  (c) revised; (d) added; (e) table amended................42933
    (e) table corrected............................................65782
178.3400  (c) table amended........................................41457
178.3550  Removed..................................................42935
178.3570  (a)(3) table amended.....................................41456
178.3910  (a)(2) table amended.....................................55456
178.3970  Removed..................................................42935

[[Page 608]]

                                  1992

21 CFR
                                                                   57 FR
                                                                    Page
Chapter I
172  Hearing denied.................................................3698
      Technical correction..........................................9472
172.225  Revised...................................................12711
172.270  Added.....................................................12711
172.665  (a) amended; (e) revised..................................55445
172.800  (c)(7) added..............................................57961
172.804  (c)(22) added..............................................3702
    (c)(1) and (3) revised; (e)(4) added............................3703
    (c)(13) revised.................................................3704
172.861  Heading corrected..........................................2814
172.880  Request for stay and hearing denied........................6667
172.892  (h) amended; (i) added....................................54700
173.320  (b) introductory text amended; (b)(6) added................8065
175.105  (c)(5) table amended......................................10810
176.170  (a)(5) table amended.......................................3123
    (a)(5) table amended...........................................10616
    Regulation at 57 FR 10616 effective date corrected.............11797
    (b)(2) table amended...........................................20200
    (a)(5) table amended....................................23949, 34867
176.210  (d)(3) amended............................................31313
177.1312  Added....................................................32422
177.1345  Added....................................................43399
177.1380  (a)(4) added; (b) revised..................................185
177.1395  (b)(4) table amended.....................................43399
177.1520  (c) table amended........................................10616
    Regulation at 57 FR 10616 effective date corrected.............11797
177.1585  Added.....................................................3940
    Technical correction............................................5294
177.1632  Added.....................................................3125
177.2600  (c)(4)(i) amended.........................................3128
178  Technical correction..........................................37867
178.1005  (e)(1) table amended.....................................32423
178.1010  (b)(39) and (c)(34) added................................11682
    (b)(40) and (c)(35) added......................................35463
    (b)(41) and (c)(36) added......................................43614
    (b)(42) and (c)(37) added......................................54701
178.2010  (b) table amended...........................2019, 10811, 10992
    table amended.............................10992, 18081, 48724, 48980
178.3690  (a) revised; (b)(1) amended..............................18082
178.3910  (a)(2) table amended.....................................23952
182.8201  Removed; eff. 4-30-92....................................10813
182.8455  Removed; eff. 4-30-92....................................10813
182.8628  Removed; eff. 4-30-92....................................10813
184.1201  Added; eff. 4-30-92......................................10813
184.1505  (c) introductory text and (1) amended....................10616
    Regulation at 57 FR 10616 effective date corrected.............11797
184.1685  (a)(3) added..............................................6479
184.1924  Added....................................................60473

                                  1993

21 CFR
                                                                   58 FR
                                                                    Page
Chapter I
Chapter I  Technical correction....................................17085
172  Authority citation revised.............................48598, 52221
172.120  (b)(1) table amended......................................52222
172.133  Introductory text, (b) and (c)(2) revised..................6091
172.490  (a) ameended..............................................17098
172.804  (c)(10) and (d) revised...................................19771
    (c)(5)(ii) and (6) revised; (c)(8), (11) and (12) removed......21097
    (d) revised....................................................21098
    (c)(23) added..................................................21099
    (c)(18) revised................................................48598
172.892  (d) table amended.........................................21100
175  Authority citation revised....................................39655
175.105  (c)(5) table amended........................21256, 21257, 39656
176  Authority citation revised....................................51996
    Authority citation corrected...................................65284
176.170  (a)(5) table amended...............................21103, 51996
176.180  (b)(2) table amended......................................60112
177  Authority citation revised....................................48599
177.1060  (e) amended..............................................17098
177.1395  (b)(4) table amended.....................................32610
177.1500  (b) table amended.........................................2977
    Technical correction............................................8820
    (a)(13) revised; (b) table amended.............................32610
177.1520  (c) table ammended.......................................17098
    (d)(3)(ii) introductory text revised; (d)(3)(ii)(e) through 
(i) added..........................................................21258
177.1810  (b) table amended........................................65546
177.2600  (c)(4)(ii)(b) amended....................................60554
177.2910  Introductory text revised; (a)(3) added..................48599

[[Page 609]]

178  Authority citation revised....................................37855
178.1010  (b)(41) corrected........................................17099
    (b)(43) added; (c)(19) amended.................................57555
178.2010  (b) table amended.................................17515, 37855
178.3010  Table amended............................................64895
178.3130  (b) table amended........................................57556
178.3297  (e) table amended........................................17514
    (c) and (e) table amended; (d) revised.........................67323
178.3400  (c) table amended........................................26687
178.3770  (a)(2), (3), (b)(2), (3), (d)(2) and (3) amended.........17512
178.3910  (b)(2) table amended.....................................17513
184.1685  (a)(4) added.............................................27202
    Technical correction...........................................30220
186.1551  (a) amended..............................................17099
189.220  (a) amended...............................................17099

                                  1994

21 CFR
                                                                   59 FR
                                                                    Page
Chapter I
172.133  Introductory text, (b) and (c)(2) revised..................5319
172.320  (b)(1) amended............................................14550
172.800  (c)(9), (10) and (11) added...............................61540
    (c)(1) revised; (c)(2) removed.................................61543
    (c)(8) added...................................................61545
172.811  (b) revised...............................................24924
172.841  (b), (c), and (d) redesignated as (c), (d), and (e); new 
        (b) added; new (c) revised.................................37421
172.888  (a) revised...............................................10986
173.21  Added......................................................15623
173.170  Added.....................................................26711
173.357  (a)(2) table amended......................................36937
175.105  (c)(5) table amended......................................47080
175.300  (b)(3)(xxxiii) amended.....................................8854
    (d) Table 2 corrected; CFR correction..........................58775
    (b)(3)(xxxvii) added...........................................63894
176.170  (a)(5)  table amended.................2293, 14550, 33195, 48391
177.1345  Introductory text revised; (d) added.....................62318
177.1520  (a)(3)(i)(e)  added; (c) table amended...................10987
    (b) table amended.......................................26422, 43730
177.1580  (b) table amended........................................43731
177.1610  (a) amended; (b) added...................................14550
177.2465  Added.....................................................5948
177.2550  (a)(5) added; (d)(1) revised..............................9925
177.2600  (c)(4)(i) amended........................................46171
178.2010  (b)  table amended.......................................2735,
8855, 33196, 45973, 62319
    (b) table corrected............................................54130
178.3295  Table amended.....................................13650, 25323
178.3297  (e)  table amended....................3654, 5705, 10065, 10066
178.3570  (a)(3) table amended.....................................14551
179.45  (b)(4)(i), (6)(i), (d)(2)(ii), (iii) and (iv) amended......14551
182.1033  Removed..................................................63895
182.1195  Removed..................................................63895
182.1625  Removed..................................................63895
182.1751  Removed..................................................63895
182.1911  Removed..................................................63895
182.3616  (c) revised..............................................65939
182.3637  (c) revised..............................................65939
182.3739  (c) revised..............................................65939
182.3766  (c) revised..............................................65939
182.3798  (c) revised..............................................65939
182.3862  (c) revised..............................................65939
182.6033  Removed..................................................63895
182.6195  Removed..................................................63895
182.6386  Removed..................................................63895
182.6511  Removed..................................................63895
182.6625  Removed..................................................63895
182.6751  Removed..................................................63895
182.6851  Removed..................................................63895
182.8195  Removed..................................................63895
184.1033  Added....................................................63895
184.1139  (c)(2) amended...........................................14551
184.1140  Added....................................................63896
184.1195  Added....................................................63896
184.1386  Added....................................................63896
184.1538  (b) and (d) amended......................................14364
184.1625  Added....................................................63896
184.1751  Added....................................................63896
184.1851  Added....................................................63897
184.1911  Added....................................................63897

                                  1995

21 CFR
                                                                   60 FR
                                                                    Page
Chapter I
170.3  (e) redesignated as (e)(1); (e)(2) added....................36594
170.39  Added......................................................36595
171.8  Added.......................................................36596
172.120  (b)(1) table amended......................................33710
172.723  Added.....................................................32903
172.800  (c)(12) added.............................................21702
172.841  (a)(1) revised............................................54425
172.859  (c)(1) and (2) revised....................................44756

[[Page 610]]

173.69  Added......................................................11900
173.340  (a)(3) table amended......................................54036
174.6  Added.......................................................36596
175.105  (c)(5) table amended...............................47480, 49337
175.250  (a), (b)(1) and (2) amended...............................39645
175.300  (b)(3)(viii)(b) and (xxxiii) amended......................48646
    (b)(3)(xi) amended.............................................49337
    (b)(3)(xxxiii) amended.........................................57339
176.170  (b)(2) table amended......................................18350
    (a)(5) table amended......................34135, 39646, 44757, 62207
    Regulation at 60 FR 34135 eff. date corrected to 7-31-95.......47205
176.180  (b)(2) table amended......................................18350
177.1315  (b) table amended........................................57926
177.1520  (a)(3)(i)(a) redesignated as (a)(3)(i)(a)(1); 
        (a)(3)(i)(a)(2) added; (c) table amended...................40074
    (a)(6) added; (c) table amended................................54189
177.1630  (a), (b) and (j) introductory text revised; (e)(4)(ii) 
        amended....................................................57927
    (e)(4) amended.................................................61654
177.2440  (a) and (b) revised......................................48648
177.2600  (c)(4)(ii)(a) and (b) amended............................39648
177.2910  Introductory text revised; (e) and (f) redesignated as 
        (f) and (g); (a)(4) and new (e) added......................54426
178.1010  (b)(44) and (c)(38) added................................18740
178.2010  (b) table amended.....8546, 18353, 22269, 33711, 43371, 49338, 
                                                            49507, 54428
178.3130  (b) table amended.................................18351, 54430
178.3297  (e) table amended.................................31244, 39649
178.3400  (c) table amended........................................18351
178.3570  (a)(3) table amended.....................................44758
179.26  (b) table amended..........................................12670
182.70  Amended....................................................62208
184.1012  Added....................................................55789
184.1024  Added....................................................32910
184.1034  Added....................................................32910
184.1101  (a) and (e) revised; eff. 4-27-95........................15872
184.1316  Added....................................................32910
184.1329  Added....................................................63621
184.1415  Added....................................................32911
184.1443a  Added...................................................32911
184.1444  (a) amended; (b) revised.................................48893
184.1563  (c) revised; eff. 5-13-96................................57130
184.1583  Added....................................................32911
184.1595  Added....................................................32911
184.1914  Added....................................................32911
184.1985  Added....................................................54193
186.1555  Added....................................................62208
189.240  Added.....................................................33109

                                  1996

   (Regulations published from January 1, 1996 through April 1, 1996)

21 CFR
                                                                   61 FR
                                                                    Page
172.133  (a)(2) amended............................................14245
172.210  (b)(3) amended............................................14245
172.345  Revised....................................................8807
172.515  (b) amended...............................................14245
172.867  Added......................................................3171
    (d), (e)(1) and (2)(iv) corrected..............................11546
173.45  (a) and (c) revised..........................................386
173.69  Redesignated as 173.300....................................14245
173.300  Redesignated from 173.69..................................14245
173.310  (c) amended...............................................14245
173.340  (a)(4) table amended........................................632
173.357  (a)(2) table amended................................4873, 14245
175.105  (c)(5) table amended...........................2113, 6940, 9904
175.320  (b)(3)(i) table amended...................................14246
176.170  (b)(2) amended............................................14246
176.210  (d)(3) amended............................................14246
177.1520  (b) amended..............................................14246
177.2600  (c)(4)(i) amended........................................14246
178.2010  (b) table amended..................................1831, 14246
178.3297  (e) table amended..................................2116, 14246
178.3570  (a)(3) table amended................................1713, 1830
179.21  (b)(2)(ii) and (iii) amended...............................14246
179.45  (b) introductory text, (5) and (d) amended.................14246
180  Heading revised...............................................14246
180.22  (b), (e) and (f)(1) amended................................14246
180.25  (a) revised.................................................7991
182.10  Table amended..............................................14246
182.5484  Redesignated from 182.8458...............................14246
182.8458  Redesignated as 182.5484.................................14246
182.5697  Heading and (a) amended..................................14246
184.1193  (c) amended..............................................14247

[[Page 611]]

184.1387  Added.....................................................7704
184.1634  (a) amended..............................................14247
189.301  Added......................................................4820

                                  1996

                  (Regulations published April 2, 1996)

21 CFR
                                                                   61 FR
                                                                    Page
172  Nomenclature change...........................................14482
172.320  (b)(2) and (c)(1) amended.................................14480
172.804  (c)(23) amended...........................................14480
172.841  (b) amended...............................................14480
173  Nomenclature change...........................................14482
173.69  (a) amended................................................14480
175  Nomenclature change...........................................14482
176  Nomenclature change...........................................14482
176.170  (b)(2) amended............................................14480
177  Nomenclature change...........................................14482
177.1210  (b)(5) table amended.....................................14480
177.1345  (b)(1) amended...........................................14481
177.1390  (c)(3)(i)(a)(1) amended..................................14481
177.1480  (b)(2) amended...........................................14481
177.1500  (c)(5)(i) amended........................................14481
177.1520  (b) amended..............................................14481
177.1550  (d)(2)(ii) amended.......................................14481
177.2450  (b)(2) and (3) amended...................................14481
178  Nomenclature change...........................................14482
178.3297  (c) amended..............................................14481
178.3780  (b)(1) amended...........................................14481
180  Nomenclature change...........................................14482
181  Nomenclature change...........................................14482
189  Nomenclature change...........................................14482