[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2012 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          Title 21

Food and Drugs


________________________

Parts 170 to 199

                         Revised as of April 1, 2012

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2012
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

          U.S. GOVERNMENT OFFICIAL EDITION NOTICE

          Legal Status and Use of Seals and Logos
          
          
          The seal of the National Archives and Records Administration 
              (NARA) authenticates the Code of Federal Regulations (CFR) as 
              the official codification of Federal regulations established 
              under the Federal Register Act. Under the provisions of 44 
              U.S.C. 1507, the contents of the CFR, a special edition of the 
              Federal Register, shall be judicially noticed. The CFR is 
              prima facie evidence of the original documents published in 
              the Federal Register (44 U.S.C. 1510).

          It is prohibited to use NARA's official seal and the stylized Code 
              of Federal Regulations logo on any republication of this 
              material without the express, written permission of the 
              Archivist of the United States or the Archivist's designee. 
              Any person using NARA's official seals and logos in a manner 
              inconsistent with the provisions of 36 CFR part 1200 is 
              subject to the penalties specified in 18 U.S.C. 506, 701, and 
              1017.

          Use of ISBN Prefix

          This is the Official U.S. Government edition of this publication 
              and is herein identified to certify its authenticity. Use of 
              the 0-16 ISBN prefix is for U.S. Government Printing Office 
              Official Editions only. The Superintendent of Documents of the 
              U.S. Government Printing Office requests that any reprinted 
              edition clearly be labeled as a copy of the authentic work 
              with a new ISBN.

              
              
          U . S . G O V E R N M E N T P R I N T I N G O F F I C E

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

          U.S. Superintendent of Documents  Washington, DC 
              20402-0001

          http://bookstore.gpo.gov

          Phone: toll-free (866) 512-1800; DC area (202) 512-1800

[[Page iii]]




                            Table of Contents



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

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................     607
      Alphabetical List of Agencies Appearing in the CFR......     627
      List of CFR Sections Affected...........................     637

[[Page iv]]





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

                     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.

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

[[Page v]]



                               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, 2012), 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.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

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.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed 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, 8601 Adelphi Road, College Park, MD 20740-6001, 
or call 202-741-6010.

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 Authorities 
and Rules. A list of CFR titles, chapters, subchapters, 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.

[[Page vii]]

    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.

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 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, 8601 Adelphi Road, College Park, MD 
20740-6001 or e-mail [email protected].

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call toll-free, 
866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or 
fax your order to 202-512-2104, 24 hours a day. For payment by check, 
write to: US Government Printing Office - New Orders, P.O. Box 979050, 
St. Louis, MO 63197-9000.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Public Papers of the Presidents of the United 
States, Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format via www.ofr.gov. For more 
information, contact the GPO Customer Contact Center, U.S. Government 
Printing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-
mail, [email protected].
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal-
register.

    Michael L. White,
    Acting Director,
    Office of the Federal Register.
    April 1, 2012.







[[Page ix]]



                               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 to 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, 2012.

    For this volume, Susannah C. Hurley was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.

[[Page 1]]



                        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

[[Page 3]]



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




                           (Parts 170 to 199)

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


  Editorial Note: Nomenclature changes to chapter I appear at 59 FR 
14366, Mar. 28, 1994, and 69 FR 18803, Apr. 9, 2004.

          SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
Part                                                                Page
170             Food additives..............................           5
171             Food additive petitions.....................          24
172             Food additives permitted for direct addition 
                    to food for human consumption...........          30
173             Secondary direct food additives permitted in 
                    food for human consumption..............         122
174             Indirect food additives: General............         155
175             Indirect food additives: Adhesives and 
                    components of coatings..................         156
176             Indirect food additives: Paper and 
                    paperboard components...................         199
177             Indirect food additives: Polymers...........         238
178             Indirect food additives: Adjuvants, 
                    production aids, and sanitizers.........         362
179             Irradiation in the production, processing 
                    and handling of food....................         456
180             Food additives permitted in food or in 
                    contact with food on an interim basis 
                    pending additional study................         462
181             Prior-sanctioned food ingredients...........         467
182             Substances generally recognized as safe.....         472
184             Direct food substances affirmed as generally 
                    recognized as safe......................         485
186             Indirect food substances affirmed as 
                    generally recognized as safe............         590
189             Substances prohibited from use in human food         595
190             Dietary supplements.........................         602

[[Page 4]]

191-199

[Reserved]

[[Page 5]]



           SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION (CONTINUED)





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.

                    Subpart D_Premarket Notifications

170.100 Submission of a premarket notification for a food contact 
          substance (FCN) to the Food and Drug Administration (FDA).
170.101 Information in a premarket notification for a food contact 
          substance (FCN).
170.102 Confidentiality of information in a premarket notification for a 
          food contact substance (FCN).
170.103 Withdrawal without prejudice of a premarket notification for a 
          food contact substance (FCN).
170.104 Action on a premarket notification for a food contact substance 
          (FCN).
170.105 The Food and Drug Administration's (FDA's) determination that a 
          premarket notification for a food contact substance (FCN) is 
          no longer effective.
170.106 Notification for a food contact substance formulation (NFCSF).

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

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

    Editorial Note: Nomenclature changes to part 170 appear at 66 FR 
56035, Nov. 6, 2001 and 69 FR 13717, Mar. 24, 2004.



                      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.

[[Page 6]]

    (2) Uses of food additives not requiring a listing regulation. Use 
of a substance in a food contact article (e.g., food-packaging or food-
processing equipment) whereby the substance migrates, or may reasonably 
be expected to migrate, into food at such levels that the use has been 
exempted from regulation as a food additive under Sec. 170.39, and food 
contact substances used in accordance with a notification submitted 
under section 409(h) of the act that is effective.
    (3) A food contact substance is any substance that is intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.
    (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 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 at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 7]]

    (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 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.

[[Page 8]]

    (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.
    (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 at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 9]]

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.
    (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; 67 FR 35729, May 21, 2002]

[[Page 10]]



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 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, 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,

[[Page 11]]

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]



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

[[Page 12]]

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 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.

[[Page 13]]



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.
    (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

[[Page 14]]

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 Sec. Sec. 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 
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 at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 15]]

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 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 Division of Dockets Management 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 Division of Dockets Management. Copies of 
all comments received shall be made available for examination in the 
Division of Dockets Management'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.

[[Page 16]]

    (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 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. 25.30 or Sec. 
25.32 of this chapter or an environmental assessment under Sec. 25.40 
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 
Division of Dockets Management 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)(i) If intended uses of the substance include uses in meat, meat 
food product, or poultry product subject to regulation by the U.S. 
Department of Agriculture (USDA) under the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act (FMIA) 
(21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward 
a copy of the petition or relevant portions thereof to the Food Safety 
and Inspection Service, USDA, for simultaneous review under the PPIA and 
FMIA.
    (ii) FDA will ask USDA to advise whether the proposed meat and 
poultry uses comply with the FMIA and PPIA or, if not, whether use of 
the substance would be permitted in products under USDA jurisdiction 
under specified conditions or restrictions.
    (4) 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 Division of Dockets Management. Copies of 
all comments received shall be made available for examination in the 
Division of Dockets Management's office.
    (5) 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.
    (6) 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.
    (7) The notice of filing in the Federal Register will request 
submission of proof of any applicable prior sanction for use of the 
ingredient under

[[Page 17]]

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; 62 FR 40599, July 
29, 1997; 65 FR 51762, Aug. 25, 2000]



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 Division of Dockets Management 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 Division of Dockets Management. Copies of 
all comments shall be made available for examination in the Division of 
Dockets Management's office.
    (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

[[Page 18]]

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 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

[[Page 19]]

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. The request should contain either a 
claim for categorical exclusion as specified in Sec. 25.32 of this 
chapter or an environmental assessment as specified in Sec. 25.40 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), 
5100 Paint Branch Pkwy., College Park, MD 20740.
    (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 Division of Dockets Management. 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), 5100 Paint Branch Pkwy., College Park, MD 20740. For 
actions requiring an environmental assessment, the agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in the petitioner's environmental assessment, also will be 
available for public inspection at the Division of Dockets Management in 
accordance with Sec. 25.51(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

[[Page 20]]

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 Division of Dockets Management 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) Guidance documents to assist requestors in the preparation of 
submissions seeking exemptions from the food additive regulations are 
available from the Food and Drug Administration's Office of Premarket 
Approval (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740. 
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 guidance 
documents.

[60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997; 
65 FR 56479, Sept. 19, 2000]



         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, (b) to that resulting from the fluoridation of bottled 
water within the limitation established in Sec. 165.110(d) of this 
chapter, and (c) to that authorized by regulations (40 CFR part 180) 
under section 408 of the Act.

[42 FR 14483, Mar. 15, 1977, as amended at 72 FR 10357 Mar. 8, 2007]



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:

[[Page 21]]

    (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 Sec. Sec. 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 Sec. Sec. 
172.170 and 172.175 of this chapter that apply to meat curing 
preparations for the home curing of 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.



                    Subpart D_Premarket Notifications

    Source: 67 FR 35729, May 21, 2002, unless otherwise noted.



Sec. 170.100  Submission of a premarket notification for a food contact
substance (FCN) to the Food and Drug Administration (FDA).

    (a) An FCN is effective for the food contact substance manufactured 
or prepared by the manufacturer or supplier identified in the FCN 
submission. If another manufacturer or supplier wishes to market the 
same food contact substance for the same use, that manufacturer or 
supplier must also submit an FCN to FDA.
    (1) An FCN must contain all of the information described in Sec. 
170.101.
    (2) An FCN may incorporate by reference any information in FDA's 
files provided that the manufacturer or supplier is authorized to 
reference the information. The FCN must include information establishing 
that the manufacturer or supplier is authorized to reference information 
in FDA's files.
    (3) Any material submitted in or referenced by an FCN that is in a 
foreign language must be accompanied by an English translation verified 
to be complete and accurate.
    (b) FDA may choose not to accept an FCN for either of the following:

[[Page 22]]

    (1) A use of a food contact substance that is the subject of a 
regulation in parts 173 through 189 of this chapter; or
    (2) A use of a food contact substance that is the subject of an 
exemption under the threshold of regulation process described in Sec. 
170.39.
    (c) A petition must be submitted under Sec. 171.1 of this chapter 
to authorize the safe use of a food contact substance in either of the 
following circumstances, unless FDA agrees to accept an FCN for the 
proposed use.
    (1) The use of the food contact substance increases the cumulative 
dietary concentration to a certain level. For a substance that is a 
biocide (e.g., it is intended to exert microbial toxicity), this level 
is equal to or greater than 200 parts per billion in the daily diet (0.6 
milligram (mg)/person/day). For a substance that is not a biocide, this 
level is equal to or greater than 1 part per million in the daily diet 
(3 mg/person/day); or
    (2) There exists a bioassay on the food contact substance, FDA has 
not reviewed the bioassay, and the bioassay is not clearly negative for 
carcinogenic effects.
    (d) A manufacturer or supplier for which a notification is effective 
must keep a current address on file with FDA.
    (1) The current address may be either the manufacturer's (or 
supplier's) address or the address of the manufacturer's (or supplier's) 
agent.
    (2) FDA will deliver correspondence to the manufacturer's or 
supplier's current address.



Sec. 170.101  Information in a premarket notification for a food contact
substance (FCN).

    An FCN must contain the following:
    (a) A comprehensive discussion of the basis for the manufacturer's 
or supplier's determination that the use of the food contact substance 
is safe. This discussion must:
    (1) Discuss all information and data submitted in the notification; 
and
    (2) Address any information and data that may appear to be 
inconsistent with the determination that the proposed use of the food 
contact substance is safe.
    (b) All data and other information that form the basis of the 
determination that the food contact substance is safe under the intended 
conditions of use. Data must include primary biological data and 
chemical data.
    (c) A good laboratory practice statement for each nonclinical 
laboratory study, as defined under Sec. 58.3(d) of this chapter, that 
is submitted as part of the FCN, in the form of either:
    (1) A signed statement that the study was conducted in compliance 
with the good laboratory practice regulations under part 58 of this 
chapter; or
    (2) A brief signed statement listing the reason(s) that the study 
was not conducted in compliance with part 58 of this chapter.
    (3) Data from any study conducted after 1978 but not conducted in 
compliance with part 58 of this chapter must be validated by an 
independent third party prior to submission to the Food and Drug 
Administration (FDA), and the report and signed certification of the 
validating party must be submitted as part of the notification.
    (d) Information to address FDA's responsibility under the National 
Environmental Policy Act, in the form of either:
    (1) A claim of categorical exclusion under Sec. 25.30 or Sec. 
25.32 of this chapter; or
    (2) An environmental assessment complying with Sec. 25.40 of this 
chapter.
    (e) A completed and signed FDA Form No. 3480.



Sec. 170.102  Confidentiality of information in a premarket notification
for a food contact substance (FCN).

    (a) During the 120-day period of the Food and Drug Administration 
(FDA) review of an FCN, FDA will not disclose publicly any information 
in that FCN.
    (b) FDA will not disclose publicly the information in an FCN that is 
withdrawn prior to the completion of FDA's review.
    (c) Once FDA completes its review of an FCN, the agency will make 
its conclusion about the FCN publicly available. For example, if FDA 
objects to a notification 90 days after the date of receipt, the agency 
would make available its objection at that time.

[[Page 23]]

    (d) By submitting an FCN to FDA, the manufacturer or supplier waives 
any claim to confidentiality of the information required to adequately 
describe the food contact substance and the intended conditions of use 
that are the subject of that FCN.
    (e) The following data and information in an FCN are available for 
public disclosure, unless extraordinary circumstances are shown, on the 
121st day after receipt of the notification by FDA, except that no data 
or information are available for public disclosure if the FCN is 
withdrawn under Sec. 170.103.
    (1) All safety and functionality data and information submitted with 
or incorporated by reference into the notification. Safety and 
functionality data include all studies and tests of a food contact 
substance on animals and humans and all studies and tests on a food 
contact substance for establishing identity, stability, purity, potency, 
performance, and usefulness.
    (2) A protocol for a test or study, unless it is exempt from 
disclosure under Sec. 20.61 of this chapter.
    (3) A list of all ingredients contained in a food contact substance, 
excluding information that is exempt from disclosure under Sec. 20.61 
of this chapter. Where applicable, an ingredient list will be identified 
as incomplete.
    (4) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is exempt from disclosure under 
Sec. 20.61 of this chapter.
    (5) All correspondence and written summaries of oral discussions 
relating to the notification, except information that is exempt for 
disclosure under Sec. 20.61 of this chapter.
    (6) All other information not subject to an exemption from 
disclosure under subpart D of part 20 of this chapter.



Sec. 170.103  Withdrawal without prejudice of a premarket notification
for a food contact substance (FCN).

    A manufacturer or supplier may withdraw an FCN without prejudice to 
a future submission to the Food and Drug Administration (FDA) if FDA has 
not completed review of the FCN. For the purpose of this section, FDA's 
review is completed when FDA has allowed 120 days to pass without 
objecting to the FCN or FDA has issued an objection letter.



Sec. 170.104  Action on a premarket notification for a food contact
substance (FCN).

    (a) If the Food and Drug Administration (FDA) does not object to an 
FCN within the 120-day period for FDA review, the FCN becomes effective.
    (b) If an FCN is complete when received, the 120-day review period 
begins on the date FDA receives the FCN.
    (1) If any element required under Sec. 170.101 is missing from an 
FCN, then FDA will not accept that FCN and FDA will send an FCN 
nonacceptance letter to the manufacturer or supplier. If the 
manufacturer or supplier submits the missing information before FDA 
sends an FCN nonacceptance letter, the 120-day review period begins on 
the date of receipt of the missing information.
    (2) If FDA accepts an FCN, then FDA will acknowledge in writing its 
receipt of that FCN.
    (c) Objection to an FCN:
    (1) If FDA objects to an FCN, then FDA will send an FCN objection 
letter. The date of the letter will be the date of FDA's objection for 
purposes of section 409(h)(2)(A) of the act.
    (2) If FDA objects to an FCN within the 120-day period for FDA 
review, the FCN will not become effective.
    (3) FDA may object to an FCN if any part of FDA's 120-day review 
occurs during a period when this program is not funded as required in 
section 409(h)(5) of the act.
    (d) If FDA and a manufacturer or supplier agree that the notifier 
may submit a food additive petition proposing the approval of the food 
contact substance for the use in the manufacturer's or supplier's FCN, 
FDA will consider that FCN to be withdrawn by the manufacturer or 
supplier on the date the petition is received by FDA.



Sec. 170.105  The Food and Drug Administration's (FDA's) determination
that a premarket notification for a food contact substance (FCN) is 

no longer effective.

    (a) If data or other information available to FDA, including data 
not submitted by the manufacturer or supplier, demonstrate that the 
intended use of the food contact substance is no

[[Page 24]]

longer safe, FDA may determine that the authorizing FCN is no longer 
effective.
    (b) If FDA determines that an FCN is no longer effective, FDA will 
inform the manufacturer or supplier in writing of the basis for that 
determination. FDA will give the manufacturer or supplier an opportunity 
to show why the FCN should continue to be effective and will specify the 
time that the manufacturer or supplier will have to respond.
    (c) If the manufacturer or supplier fails to respond adequately to 
the safety concerns regarding the notified use, FDA will publish a 
notice of its determination that the FCN is no longer effective. FDA 
will publish this notice in the Federal Register, stating that a 
detailed summary of the basis for FDA's determination that the FCN is no 
longer effective has been placed on public display and that copies are 
available upon request. The date that the notice publishes in the 
Federal Register is the date on which the notification is no longer 
effective.
    (d) FDA's determination that an FCN is no longer effective is final 
agency action subject to judicial review.



Sec. 170.106  Notification for a food contact substance formulation 
(NFCSF).

    (a) In order for the Food and Drug Administration (FDA) to accept an 
NFCSF, any food additive that is a component of the formulation must be 
authorized for its intended use in that NFCSF.
    (b) FDA may publish a notice in the Federal Register stating that 
the agency has insufficient resources to review NFCSFs. From the date 
that this notice publishes in the Federal Register, FDA will no longer 
accept NFCSFs.
    (c) An NFCSF must contain the following:
    (1) A completed and signed FDA Form No. 3479; and
    (2) Any additional documentation required to establish that each 
component of the formulation already may be marketed legally for its 
intended use.



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 food-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: 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 Federal Food, Drug, and Cosmetic Act (the act) 
shall be submitted in triplicate (quadruplicate, if intended uses 
include use in meat, meat food product, or poultry product). 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

[[Page 25]]

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__________________________________
________________________________________________________________________

    Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740.

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 (quadruplicate, if intended uses 
include use in meat, meat food product, or poultry product), 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 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

[[Page 26]]

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. 25.30 or 25.32 of this chapter or an 
environmental assessment under Sec. 25.40 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 
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

[[Page 27]]

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 semi quan ti ta tive 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)(i) Within 15 days after receipt, the Food and Drug 
Administration will notify the petitioner of the acceptance or 
nonacceptance of a petition, and if not accepted, the reasons therefor. 
If accepted, the petitioner will be sent a letter stating this and the 
date of the letter shall become the date of filing for the purposes of 
section 409(b)(5) of the act. In cases in which the Food and Drug 
Administration agrees that a premarket notification for a food contact 
substance (Food Contact Notification (FCN)) submitted under section 
409(h) of the act may be converted to a petition, the withdrawal date 
for the FCN will be deemed the date of receipt for the petition.
    (ii) 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, the 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.
    (iii) Notwithstanding paragraph (i)(1)(ii) of this section, the 
petition shall not be filed if the Food and Drug Administration 
determines that the use identified in the petition should be the subject 
of an FCN under section 409(h) of the act rather than a petition.
    (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

[[Page 28]]

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.
    (n)(1) If intended uses of the food additive include uses in meat, 
meat food product, or poultry product subject to regulation by the U.S. 
Department of Agriculture (USDA) under the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act 
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, 
forward a copy of the petition or relevant portions thereof to the Food 
Safety and Inspection Service, USDA, for simultaneous review under the 
PPIA and FMIA.
    (2) FDA will ask USDA to advise whether the proposed meat and 
poultry uses comply with the FMIA and PPIA, or if not, whether use of 
the substance would be permitted in products under USDA jurisdiction 
under specified conditions or restrictions.

[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; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR 
35731, May 21, 2002; 72 FR 10357, Mar. 8, 2007]



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]



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.

[[Page 29]]

    (c) Any petitioner who has a food additive petition pending before 
the agency and who subsequently submits a premarket notification for a 
food contact substance (FCN) for a use or uses described in such 
petition shall be deemed to have withdrawn the petition for such use or 
uses without prejudice to a future filing on the date the FCN is 
received by the Food and Drug Administration.

[42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]



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) The regulation shall describe the conditions under which the 
substance may be safely used in any meat product, meat food product, or 
poultry product subject to the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.).
    (c) 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.

[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]



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 available as to toxicity of the chemical, or that 
experience with the existing regulation or exemption may justify its 
amendment or repeal. New data

[[Page 30]]

shall be furnished in the form specified in Sec. Sec. 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.
172.167 Silver nitrate and hydrogen peroxide solution.
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 acid.
172.365 Kelp.
172.370 Iron-choline citrate complex.
172.372 N-Acetyl-L-methionine.
172.375 Potassium iodide.
172.379 Vitamin D2.
172.380 Vitamin D3.
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 sulfosuccinate 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.
172.712 1,3-Butylene glycol.

[[Page 31]]

172.715 Calcium lignosulfonate.
172.720 Calcium lactobionate.
172.723 Epoxidized soybean oil.
172.725 Gibberellic acid and its potassium salt.
172.730 Potassium bromate.
172.735 Glycerol ester of rosin.
172.736 Glycerides and polyglycides of hydrogenated vegetable oils.
172.755 Stearyl monoglyceridyl citrate.
172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770 Ethylene oxide polymer.
172.775 Methacrylic acid-divinylbenzene copolymer.
172.780 Acacia (gum arabic).
172.785 Listeria-specific bacteriophage preparation.

                    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.
172.809 Curdlan.
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.
172.829 Neotame.
172.830 Succinylated monoglycerides.
172.831 Sucralose.
172.832 Monoglyceride citrate.
172.833 Sucrose acetate isobutyrate (SAIB).
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 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.
172.869 Sucrose oligoesters.
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: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

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

    Editorial Note: Nomenclature changes to part 172 appear at 61 FR 
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 
2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880, July 15, 2005, 70 FR 
67651, Nov. 8, 2005, and 70 FR 72074, Dec. 1, 2005.



                      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

[[Page 32]]

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.



                      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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 33]]

 
Potato granules............................................           10
Sweet potato 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.



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 
C10H12O8N2CaNa2[mi
ddot]2H2O or the trihydrate 
C10H12O8N2CaNa2[mi
ddot]3H2O, 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.
Fermented malt beverages............         25   Antigushing agent.
French dressing.....................         75   Preservative.
Legumes (all cooked canned, other           365   Promote color
 than dried lima beans, pink beans,                retention.
 and red beans).
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.

[[Page 34]]

 
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.
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; 65 FR 48379, Aug. 
8, 2000]



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).

[[Page 35]]

                               calculation
[GRAPHIC] [TIFF OMITTED] TR10MR99.023

    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), 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (b) The additive is used or intended for use as a microbial control 
agent in the following beverages under normal circumstances of bottling, 
canning, or other forms of final packaging, where the viable microbial 
load has been reduced to 500 microorganisms per milliliter or less by 
current good manufacturing practices such as heat treatment, filtration, 
or other technologies prior to the use of dimethyl dicarbonate:
    (1) In wine, dealcoholized wine, and low alcohol wine in an amount 
not to exceed 200 parts per million.
    (2) In ready-to-drink teas in an amount not to exceed 250 parts per 
million.
    (3) In carbonated or noncarbonated, nonjuice-containing (less than 
or equal to 1 percent juice), flavored or unflavored beverages 
containing added electrolytes (5-20 milliequivalents/liter sodium ion 
(Na+) and 3-7 milliequivalents/liter potassium ion (K+)) in an amount 
not to exceed 250 parts per million.
    (4) In carbonated, dilute beverages containing juice, fruit flavor, 
or both, with juice content not to exceed 50 percent, in an amount not 
to exceed 250 parts per million.
    (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) The intended use of the additive.
    (3) Adequate directions for use to ensure compliance with this 
section.

[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; 61 FR 26788, May 29, 
1996; 66 FR 13653, Mar. 7, 2001]



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 
(C10H14O8N2Na2[mid
dot]2H2O).
    (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 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.
Legumes (all cooked canned, other           165   Promote color
 than black-eyed peas).                            retention.
Mayonnaise..........................         75   Preservative.

[[Page 36]]

 
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 ethylenediamine 
tetraacetate; 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 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.

[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]



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 Sec. Sec. 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.

[[Page 37]]



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 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 on cheese, as an antimycotic, in 
amounts not to exceed 20 milligrams per kilogram (20 parts per million) 
in the finished product as determined by International Dairy Federation 
(IDF) Standard 140A:1992, ``Cheese and Cheese Rind-Determination of 
Natamycin Content-Method by Molecular Absorption Spectrometry and by 
High-Performance Liquid Chromatography,'' which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation 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 
(HFS-206), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 
FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001]



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.



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. 172.167  Silver nitrate and hydrogen peroxide solution.

    An aqueous solution containing a mixture of silver nitrate and 
hydrogen peroxide may be safely used in accordance with the following 
prescribed conditions:
    (a) The additive is used as an antimicrobial agent in bottled water.

[[Page 38]]

    (b) Hydrogen peroxide meets the specifications of the ``Food 
Chemicals Codex,'' 6th ed. (2008), pp. 463 and 464, which is 
incorporated by reference. The Director of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the United States Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address 
http://www.usp.org). Copies may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030 or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) The amount of silver added will not exceed 17 micrograms per 
kilogram in the treated bottled water, and the amount of hydrogen 
peroxide will not exceed 23 milligrams per kilogram in the treated 
bottled water. Analyses for silver and hydrogen peroxide shall be 
conducted on samples of treated bottled water at the site of bottling, 
using samples of the water intended for treatment for the blank 
determination.
    (d)(1) The amount of silver in the treated bottled water is 
determined using the method for silver designated in 21 CFR 
165.110(b)(4)(iii)(G)(2)(i).
    (2) The amount of hydrogen peroxide in the treated bottled water is 
determined using a Hydrogen Peroxide Test Kit from the HACH Co., or 
equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-1, 
Catalog Number 22917-00, 1991, is incorporated by reference. The 
Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain copies of the test kit manual from the HACH Co., P.O. Box 389, 
Loveland CO, 80359 (1-800-227-4224), Model HYP-1, Catalog Number 22917-
00. Copies may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 301-436-2163, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030 or go to: http://
www.archives.gov/federal_register/code_of_ federal_regulations/
ibr_locations.html.
    (e) Substances generally recognized as safe in or on food may be 
used to stabilize the additive to ensure that the additive will perform 
its intended technical effect.
    (f) The additive may not be added to bottled water that has been 
filtered or is intended to be filtered through a silver-containing water 
filter.
    (g) Bottled water must meet the quality standards for bottled water 
in Sec. 165.110(b)(2) through (b)(5) of this chapter, including the 
limits specified for total silver and nitrate, unless the water bears a 
label statement of substandard quality, as provided for under Sec. 
165.110(c) of this chapter.

[74 FR 11478, Mar. 18, 2009]



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:

[[Page 39]]

    (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 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

[[Page 40]]

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.
    (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
 wax acids.                       [deg]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, 100 Barr
                                  Harbor Dr., West Conshohocken,
                                  Philadelphia, PA 19428-2959, or at the
                                  National Archives and Records
                                  Administration (NARA). For information
                                  on the availability of this material
                                  at NARA, call 202-741-6030, or go to:
                                  http://www.archives.gov/
                                  federal_register/
                                  code_of_federal_regulations/
                                  ibr_locations.html.) 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.

[[Page 41]]

 
Wood rosin.....................  Color of K or paler.
------------------------------------------------------------------------

    (3) In lieu of the components listed in paragraph (b) (2) and (4) of 
this section, the following copolymer and one or more of the listed 
adjuvants.

------------------------------------------------------------------------
           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.
------------------------------------------------------------------------

    (4) In lieu of the components listed in paragraph (b) (2) and (3) of 
this section, the following rosin derivative and either or both of the 
listed adjuvants:

------------------------------------------------------------------------
           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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
    (2) Refractive index (n\25\/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.

[[Page 42]]

    (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, 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.

[[Page 43]]

    (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 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 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1,000 centimeter 0.005 
centimeter. With distilled water in the cells, determine any absorbance 
difference.
    Spectrophotometer. Spectral range 250-400 m[micro] with spectral 
slit width of 2 m[micro] or less; under instrument operating conditions 
for these absorbance measurements, the spectrophotometer shall also meet 
the following performance requirements:

Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/
federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------

Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 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

[[Page 44]]

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[micro]. 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[micro]. 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[micro]. 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 81-milliliter outer-diameter tube, drawn out 
into a 21-centimeter long and 10.5-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.
    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[micro]. 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[micro].
    The reagent blank absorbance should not exceed 0.04 per centimeter 
path length between 280-289 m[micro]; 0.020 between 290-359 m[micro]; 
and 0.010 between 360-400 m[micro].
    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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/

[[Page 45]]

code_of_federal_regulations/ibr_locations.html.
    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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    (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 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

[[Page 46]]

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, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
    (b) It is used or intended for use as follows:
    (1) As a moisture barrier on soft gelatin capsules in an amount not 
to 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

[[Page 47]]

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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.) 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.) 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 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 48]]

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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 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:
    (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.

[[Page 49]]

    (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 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: AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------

    (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

[[Page 50]]

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,'' 4th ed. (1996), pp. 157-158, 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, Box 285, 2101 Constitution 
Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 
([micro]g) per serving, to breakfast cereals, as defined under Sec. 
170.3(n)(4) of this chapter, and to corn grits at a level such that each 
pound of corn grits contains not more than 1.0 milligram of folic acid.
    (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 [micro]g per serving if the food is a meal-
replacement that is represented for use once per day; or
    (2) Two hundred [micro]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, as amended at 61 FR 27779, June 3, 1996; 64 
FR 1758, Jan. 12, 1999]



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.

[[Page 51]]



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 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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration

[[Page 52]]

(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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.



Sec. 172.379  Vitamin D2.

    Vitamin D2 may be used safely in foods as a nutrient 
supplement defined under Sec. 170.3(o)(20) of this chapter in 
accordance with the following prescribed conditions:
    (a) Vitamin D2, also known as ergocalciferol, is the 
chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin 
D2 is produced by ultraviolet irradiation of ergosterol 
isolated from yeast and is purified by crystallization.
    (b) Vitamin D2 meets the specifications of the Food 
Chemicals Codex, 6th ed. (2008), pp. 1013 and 1014, which is 
incorporated by reference. The Director of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C 552(a) and 1 
CFR part 51. You may obtain a copy from the United States Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet 
address: http://www.usp.org). You may inspect a copy at the Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1071, or at the National Archives and Records Administration

[[Page 53]]

(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (c) The additive may be used as follows:

------------------------------------------------------------------------
                                           Maximum Levels in Food (as
           Category of Food                         Served)
------------------------------------------------------------------------
Soy beverages                          50 International Units (IU)/100
                                        grams (g)
------------------------------------------------------------------------
Soy beverage products                  89 IU/100 g
------------------------------------------------------------------------
Soy-based butter substitute spreads    330 IU/100 g
------------------------------------------------------------------------
Soy-based cheese substitutes and soy-  270 IU/100 g
 based cheese substitute products
------------------------------------------------------------------------


[74 FR 11022, Mar. 16, 2009]



Sec. 172.380  Vitamin D[bdi3].

    Vitamin D3 may be used safely in foods as a nutrient 
supplement defined under Sec. 170.3(o)(20) of this chapter in 
accordance with the following prescribed conditions:
    (a) Vitamin D3, 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 also is 
manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced 
from cholesterol and is purified by crystallization.
    (b) Vitamin D3 meets the specifications of the Food 
Chemicals Codex, 5th ed. (2004), pp. 498-499, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the National Academy Press, 500 
Fifth St. NW., Washington, DC 20001 (Internet address http://
www.nap.edu). Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) The additive may be used as follows:
    (1) At levels not to exceed 100 International Units (IU) per 240 
milliliters (mL) in 100 percent fruit juices (as defined under Sec. 
170.3(n)(35) of this chapter) that are fortified with greater than or 
equal to 33 percent of the reference daily intake (RDI) of calcium per 
240 mL, excluding fruit juices that are specially formulated or 
processed for infants.
    (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks 
(as defined under Sec. 170.3(n)(35) of this chapter) that are fortified 
with greater than or equal to 10 percent of the RDI of calcium per 240 
mL, excluding fruit juice drinks that are specially formulated or 
processed for infants.
    (3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in 
soy-protein based meal replacement beverages (powder or liquid) that are 
represented for special dietary use in reducing or maintaining body 
weight in accordance with Sec. 105.66 of this chapter.
    (4) At levels not to exceed 100 IU per 40 grams in meal replacement 
bars or other-type bars that are represented for special dietary use in 
reducing or maintaining body weight in accordance with Sec. 105.66 of 
this chapter.
    (5) At levels not to exceed 81 IU per 30 grams in cheese and cheese 
products as defined under Sec. 170.3(n)(5) of this chapter, excluding 
cottage cheese, ricotta cheese, and hard grating cheeses such as 
Parmesan and Romano as defined in Sec. Sec. 133.165 and 133.183 of this 
chapter, and those defined by standard of identity in Sec. 133.148 of 
this chapter.

[68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70 
FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005]

[[Page 54]]



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 AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 55]]

    (3) Labels of manufactured foods containing the additive shall bear, 
in the ingredient statement, the name of the 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)6[middot]10H2O 
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

[[Page 56]]

needed to produce its intended effect but not in excess of 13 parts per 
million 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, 
concentrates, 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 sandalwood)..................  Amyris balsamifera L........
Angola weed......................................  Roccella fuciformis Ach.....  In alcoholic 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 B.         Do.
                                                    diocia Jacq.
Buchu leaves.....................................  Barosma betulina Bartl. et
                                                    Wendl., B. crenulata (L.)
                                                    Hook. or B. serratifolia
                                                    Willd.
Buckbean leaves..................................  Menyanthes trifoliata L.....   Do.
Cajeput..........................................  Melaleuca leucadendron L.
                                                    and other Melaleuca spp.
Calumba root.....................................  Jateorhiza palmata (Lam.)      Do.
                                                    Miers.
Camphor tree.....................................  Cinnamomum camphora (L.)      Safrole free
                                                    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), leaves and twigs.......  Thuja occidentalis L........  Finished food thujone free \1\
Centuary.........................................  Centaurium umbellatum Gilib.  In alcoholic beverages only
Cherry pits......................................  Prunus avium L. or P.         Not to exceed 25 p.p.m. prussic
                                                    cerasus L.                    acid
Cherry-laurel leaves.............................  Prunus laurocerasus L.......   Do.
Chestnut leaves..................................  Castanea dentata (Marsh.)
                                                    Borkh.
Chirata..........................................  Swertia chirata Buch.-Ham...  In alcoholic beverages only
Cinchona, red, bark..............................  Cinchona succirubra Pav. or   In beverages only; not more
                                                    its hybrids.                  than 83 p.p.m. total cinchona
                                                                                  alkaloids in finished beverage
Cinchona, yellow, bark...........................  Cinchona ledgeriana Moens,     Do.
                                                    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 Q.       In alcoholic beverages only
                                                    occidentalis F. Gay.
Costmary.........................................  Chrysanthemum balsamita L...   Do.

[[Page 57]]

 
Costus root......................................  Saussurea lappa Clarke......
Cubeb............................................  Piper cubeba L. f...........
Currant, black, buds and leaves..................  Ribes nigrum L..............
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.
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 twigs.................  Abies sibirica 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 Ach......   Do.
Imperatoria......................................  Peucedanum ostruthium (L.).
                                                    Koch (Imperatoria
                                                    ostruthium L.).
Iva..............................................  Achillea moschata Jacq......   Do.
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-veneris L.   Do.
Maple, mountain..................................  Acer spicatum Lam...........
Mimosa (black wattle) flowers....................  Acacia decurrens Willd. var.
                                                    dealbata.
Mullein flowers..................................  Verbascum phlomoides L. or     Do.
                                                    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 (L.) Ach.,  Finished food thujone free \1\
                                                    E. 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.) Batsch..  In alcoholic 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...........

[[Page 58]]

 
Pine, dwarf, needles and twigs...................  Pinus mugo Turra var.
                                                    pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs..................  Pinus sylvestris L..........
Pine, white, bark................................  Pinus strobus L.............  In alcoholic beverages only
Pine, white oil..................................  Pinus palustris Mill., and
                                                    other Pinus spp.
Poplar buds......................................  Populus balsamifera L. (P.     Do.
                                                    tacamahacca Mill.), P.
                                                    candicans Ait., or P. nigra
                                                    L.
Quassia..........................................  Picrasma excelsa (Sw.)
                                                    Planch, or Quassia amara L.
Quebracho bark...................................  Aspidosperma quebracho-       Schinopsis lorentzii (Griseb.)
                                                    blanco Schlecht, or           Engl.
                                                    (Quebrachia lorentzii
                                                    (Griseb)).
Quillaia (soapbark)..............................  Quillaja saponaria Mol......
Red saunders (red sandalwood)....................  Pterocarpus san alinus L....  In alcoholic 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 Mill., and     Do.
                                                    other Pinus spp.
St. Johnswort leaves, flowers, and caulis........  Hypericum perforatum L......  Hypericin-free alcohol
                                                                                  distillate form only; in
                                                                                  alcoholic beverages only
Sandalwood, white (yellow, or East Indian).......  Santalum album L............
Sandarac.........................................  Tetraclinis articulata        In alcoholic beverages only
                                                    (Vahl.), 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 (Nutt.)     Safrole free
                                                    Nees.
Senna, Alexandria................................  Cassia acutifolia Delile....
Serpentaria (Virginia snakeroot).................  Aristolochia serpentaria L..  In alcoholic beverages only
Simaruba bark....................................  Simaruba amara Aubl.........   Do.
Snakeroot, Canadian (wild ginger)................  Asarum canadense L..........
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. erecta  As oil only
                                                    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 thistle)..................  Onicus benedictus L.........  In alcoholic beverages only
Thymus capitatus (Spanish ``origanum'')..........  Thymus capitatus 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 L......   Do.
Vervain, European................................  Verbena officinalis L.......   Do.
Vetiver..........................................  Vetiveria zizanioides Stapf.   Do.
Violet, Swiss....................................  Viola calcarata L...........
Walnut husks (hulls), leaves, and green nuts.....  Juglans nigra L. or J. regia
                                                    L.
Woodruff, sweet..................................  Asperula odorata L..........  In alcoholic beverages only
Yarrow...........................................  Achillea millefolium L......  In beverages 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 AOAC INTERNATIONAL, 481 North
  Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records
  Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go
  to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.



[[Page 59]]

[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; 69 FR 24511, May 4, 
2004; 72 FR 10357, Mar. 8, 2007]



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 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 [alpha]-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.
[alpha]-Amylcinnamaldehyde.
[alpha]-Amylcinnamaldehyde dimethyl acetal.
[alpha]-Amylcinnamyl acetate.
[alpha]-Amylcinnamyl alcohol.
[alpha]-Amylcinnamyl formate.
[alpha]-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; [alpha]-toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl [beta]-methoxyethyl 
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
[beta]-Bourbonene; 1,2,3,3a,3b[beta],4,5,6,6a[beta],6b[alpha]-deca-
hydro-l[alpha]-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.
[alpha]-Butylcinnamaldehyde.
Butyl cinnamate.

[[Page 60]]

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.
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.
[beta]-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
[beta]-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-oxatricylo 
[8.2.0.0 \4,6\] 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-cit ronellol.
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.
[gamma]-Decalactone; 4-hydroxy-decanoic acid, [gamma]-lactone.
[gamma]-Decalactone; 5-hydroxy-decanoic acid, [delta]-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-[gamma]-butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid, 
[gamma]-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.
[alpha],[alpha]-Dimethylbenzyl isobutyrate; phenyldi methylcarbinyl 
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
[alpha],[alpha]-Dimethylphenethyl acetate; benzylpropyl acetate; 
benzyldimethylcarbinyl acetate.
[alpha],[alpha]-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
[alpha],[alpha]-Dimethylphenethyl butyrate; benzyldimethylcarbinyl 
butyrate.
[alpha],[alpha]-Dimethylphenethyl formate; benzyldi methylcarbinyl 
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
[gamma]-Dodecalactone; 4-hydroxydodecanoic acid [gamma]-lactone.
2-Dodecenal.
Estragole.
[rho]-Ethoxybenzaldehyde.
Ethyl acetoacetate.

[[Page 61]]

Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl [rho]-anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
[alpha]-Ethylbenzyl butyrate; [alpha]-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.
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; [mu]-methoxyphenol.
Guaiacyl acetate; [mu]-methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-[Delta]9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-([alpha]-hydroxy-isopropyl)-[delta]9,10-
octahydroazulene acetate.
[gamma]-Heptalactone; 4-hydroxyheptanoic acid, [gamma]-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.
[omega]-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, [omega]-
lactone; ambrettolide.
[gamma]-Hexalactone; 4-hydroxyhexanoic acid, [gamma]-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.
[alpha]-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.

[[Page 62]]

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.
Hydroxycitronellol; 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-hy dro xy ben zyl acetone.
Indole.
[alpha]-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
[beta]-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
[alpha]-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-one; 
6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; [alpha]-isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; [alpha]-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.
[alpha]-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.
[alpha]-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-methyl-
3-buten-2-one; methyl [gamma]-ionone.
Isopropyl acetate.
[rho]-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
[rho]-Isopropylbenzyl alcohol; cuminic alcohol; [rho]-cymen-7-ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
[rho]-Isopropylphenylacetaldehyde; [rho]-cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-([rho]-Isopropylphenyl)-propionaldehyde; [rho]-
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.

[[Page 63]]

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; [alpha]-methylanisylidene acetone; 
ethone.
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-.
[alpha]-Methylbenzyl acetate; styralyl acetate.
[alpha]-Methylbenzyl alcohol; styralyl alcohol.
[alpha]-Methylbenzyl butyrate; styralyl butyrate.
[alpha]-Methylbenzyl isobutyrate; styralyl isobutyrate.
[alpha]-Methylbenzyl formate; styralyl formate.
[alpha]-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.
[alpha]-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methyl cy clo pen tane-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 [alpha]-ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [beta]-ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [Delta]-ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-penten-
3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; [alpha]-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 [beta]-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.
[beta]-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; [alpha]-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.

[[Page 64]]

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.
[gamma]-Nonalactone; 4-hydroxynonanoic acid, [gamma]-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.
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-[beta]-ocimene; 3,7-dimethyl-1,3,6-octatriene.
[gamma]-Octalactone; 4-hydroxyoctanoic acid, [gamma]-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.
[omega]-Pentadecalactone; 15-hydroxypentadeca-noic acid, [omega]-
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.
[alpha]-Phellandrene; [rho]-mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; [beta]-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; [alpha]-toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; [alpha]-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.
[alpha]-Pinene; 2-pinene.
[beta]-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.

[[Page 65]]

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.
[alpha]-Propylphenethyl alcohol.
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, [alpha] and [beta].
Santalyl acetate.
Santalyl phenylacetate.
Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
[alpha]-Terpinene.
[gamma]-Terpinene.
[alpha]-Terpineol; p-menth-1-en-8-ol.
[beta]-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-methyl benzy la ce tone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methyl hy dra tro pic al de hyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
[gamma]-Undecalactone; 4-hydroxyundecanoic acid [gamma]-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) [Delta]-Decalactone and [Delta]-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; 69 FR 24511, May 4, 2004]



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

[[Page 66]]

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.



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

[[Page 67]]

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 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

[[Page 68]]

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:
    (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.

[[Page 69]]

 
  Natural rubber (smoked sheet   Hevea brasiliensis.
   and latex solids).
------------------------------------------------------------------------
                        Synthetic Specifications
------------------------------------------------------------------------
  Butadiene-styrene rubber.....  Basic polymer.
  Isobutylene-isoprene            Do.
   copolymer (butyl rubber).
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[deg]-99 [deg]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 [deg]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, 100 Barr Harbor
                                  Dr., West Conshohocken, Philadelphia,
                                  PA 19428-2959, or may be examined at
                                  the National Archives and Records
                                  Administration (NARA). For information
                                  on the availability of this material
                                  at NARA, call 202-741-6030, or go to:
                                  http://www.archives.gov/
                                  federal_register/
                                  code_of_federal_regulations/
                                  ibr_locations.html.
  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 minimum
 dimerized rosin.                 drop-softening point of 109 [deg]C,
                                  and a color of M or paler.
Glycerol ester of partially      Having an acid number of 3-10, a
 hydrogenated gum or wood rosin.  minimum drop-softening point of 79
                                  [deg]C, and a color of N or paler.
Glycerol ester of polymerized    Having an acid number of 3-12, a
 rosin.                           minimum melting-point of 80 [deg]C,
                                  and a color of M or paler.
Glycerol ester of gum rosin....  Having an acid number of 5-9, a minimum
                                  drop-softening point of 88 [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
 partially hydrogenated gum or    minimum drop-softening point of 102
 wood rosin.                      [deg]C, and a color of K or paler.
Pentaerythritol ester of gum or  Having an acid number of 6-16, a
 wood rosin.                      minimum drop-softening point of 109
                                  [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
                                  [alpha]pinene, [beta]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 [alpha]-
                                  pinene; softening point minimum 155
                                  [deg]C, determined by U.S.P. closed-
                                  capillary method, United States
                                  Pharmacopeia XX (1980) (page 961).
------------------------------------------------------------------------

[[Page 70]]

 
                              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.................  .......................................
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; 66 FR 38153, July 
23, 2001; 66 FR 53711, Oct. 24, 2001]



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 
Sec. Sec. 172.620(c) and 172.626(b), respectively.

[[Page 71]]

    (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.



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.

[[Page 72]]

    (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 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,'' 4th ed. (1996), pp. 437-438, 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, Box 285, 
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address 
http://www.nap.edu), or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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; 
64 FR 1758, Jan. 12, 1999]



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.
    (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

[[Page 73]]

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-dinitro phenyl hydrazine 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 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 
(C10 C18) as a surfactant in emulsifier blends 
that are

[[Page 74]]

added to the herbicide atrazine for application to corn.
    [alpha]-(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.
    [alpha]-[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.
    [alpha]-[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. 172.712  1,3-Butylene glycol.

    The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) It is prepared by the aldol condensation of acetaldehyde 
followed by catalytic hydrogenation.
    (b) The food additive shall conform to the identity and 
specifications listed in the monograph entitled ``1,3-Butylene Glycol'' 
in the Food Chemicals Codex, 4th ed. (1996), p. 52, 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) It is used in the manufacture of sausage casings as a 
formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as 
a processing aid as defined in Sec. 170.3(o)(24) of this chapter.

[62 FR 26228, May 13, 1997]



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-
([beta],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

[[Page 75]]

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 National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (3) The heavy metals (as Pb) content cannot be more than 10 parts 
per million, as determined by the ``Heavy Metals Test,'' of the ``Food 
Chemicals Codex,'' 4th ed. (1996), pp. 760-761, Method II (with a 2-gram 
sample and 20 microgram of lead ion in the control), 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, Box 285, 
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address 
http://www.nap.edu), or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, as amended at 64 FR 1759, Jan. 12, 1999]



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

[[Page 76]]

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 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 rosin.

    Glycerol ester of wood rosin, gum rosin, or tall oil 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 to 
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 or steam stripping.
    (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.

[42 FR 14491, Mar. 15, 1977, as amended at 70 FR 15758, Mar. 29, 2005; 
72 FR 46896, Aug. 22, 2007]



Sec. 172.736  Glycerides and polyglycides of hydrogenated vegetable oils.

    The food additive glycerides and polyglycides of hydrogenated 
vegetable oils may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by heating a mixture of 
hydrogenated oils of vegetable origin and polyethylene glycol in the 
presence of an alkaline catalyst followed by neutralization with any 
acid that is approved or is generally recognized as safe for this use to 
yield the finished product.
    (b) The additive consists of a mixture of mono-, di- and tri-
glycerides and polyethylene glycol mono- and di-esters of fatty acids 
(polyglycides) of hydrogenated vegetable oils and meets the following 
specifications:
    (1) Total ester content, greater than 90 percent as determined by a 
method entitled ``Determination of Esterified Glycerides and 
Polyoxyethylene Glycols,'' approved November 16, 2001, printed by 
Gattefosse S.A.S., and incorporated by reference. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C.

[[Page 77]]

552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food 
Additive Safety, 5100 Paint Branch Pkwy., College Park, MD 20740 or you 
may examine a copy at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (2) Acid value, not greater than 2, and hydroxyl value, not greater 
than 56 as determined by the methods entitled ``Acid Value,'' p. 934 and 
``Hydroxyl Value,'' p. 936, respectively, in the Food Chemicals Codex, 
5th ed., effective January 1, 2004, and incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academies Press, 500 Fifth St. NW., Washington, DC 
20055 (Internet address http://www.nap.edu), or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (3) Lead, not greater than 0.1 mg/kg as determined by the American 
Oil Chemists' Society (A.O.C.S.) method Ca 18c-91, ``Determination of 
Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,'' 
updated 1995, and incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from American Oil 
Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be 
examined in the library at the Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/
kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a 
gas chromatographic method entitled ``Determination of Ethylene Oxide 
and 1,4-Dioxane by Headspace Gas Chromatography,'' approved November 5, 
1998, printed by Gattefosse S.A.S., and incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1) 
of this section for availability of the incorporation by reference.
    (c) The additive is used or intended for use as an excipient in 
dietary supplement tablets, capsules, and liquid formulations that are 
intended for ingestion in daily quantities measured in drops or similar 
small units of measure.

[71 FR 12620, Mar. 13, 2006]



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.

[[Page 78]]



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.
    (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.



Sec. 172.780  Acacia (gum arabic).

    The food additive may be safely used in food in accordance with the 
following prescribed conditions:
    (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,'' 5th Ed. (2004), pp. 210 and 211, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the National Academies Press, 
500 Fifth St. NW., Washington, DC 20001 (Internet address: http://
www.nap.edu). Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federa_regulations/
ibr_locations.html.
    (c) The ingredient is used as a thickener, emulsifier, or stabilizer 
in alcoholic beverages at a use level not to exceed 20 percent in the 
final beverage.

[70 FR 8034, Feb. 17, 2005]



Sec. 172.785  Listeria-specific bacteriophage preparation.

    The additive may be safely used as an antimicrobial agent specific 
for Listeria monocytogenes (L. monocytogenes) in accordance with the 
following conditions:
    (a) Identity. (1) The additive consists of a mixture of equal 
proportions of six different individually purified lytic-type (lacking 
lysogenic activity) bacteriophages (phages) specific against L. 
monocytogenes.
    (2) Each phage is deposited at, and assigned an identifying code by, 
a scientifically-recognized culture collection center, and is made 
available to FDA upon request.

[[Page 79]]

    (3) The additive is produced from one or more cell cultures of L. 
monocytogenes in a safe and suitable nutrient medium.
    (b) Specifications.(1) The additive achieves a positive lytic result 
(OD600 <= 0.06) when tested against any of the following L. 
monocytogenes isolates available from American Type Culture Collection 
(ATCC): ATCC 35152 (serogroup 1/2a), ATCC 19118 (serogroup 4b), and ATCC 
15313 (serogroup 1/2b). The analytical method for determining the 
potency of the additive entitled ``Determination of Potency of LMP-
102\TM\,'' dated October 9, 2003, and printed by Intralytix, Inc., is 
incorporated by reference. The Director of the Office of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office 
of Food Additive Safety (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or you may examine a copy at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (2) The mean phage titer of each monophage in the additive is 1 x 
10\9\ plaque forming units (PFU)/ml. The analytical method for 
determining phage titer entitled ``Method to Determine Lytic Activity/
Phage Titer,'' dated November 6, 2001, and printed by Intralytix, Inc., 
is incorporated by reference. Copies are available at locations cited in 
paragraph (b)(1) of this section.
    (3) The phages present in the preparation must not contain a 
functional portion of any of the toxin-encoding sequences described in 
40 CFR 725.421(d). No sequences derived from genes encoding bacterial 
16S ribosomal RNA are present in the complete genomic sequence of the 
phages.
    (4) L. monocytogenes toxin, listeriolysin O (LLO), is not greater 
than 5 hemolytic units (HU)/ml. The analytical method for determining 
LLO entitled ``Quantitation of Listeriolysin O Levels in LMP-102\TM\,'' 
dated September 27, 2004, and printed by Intralytix, Inc., is 
incorporated by reference. Copies are available at locations cited in 
paragraph (b)(1) of this section.
    (5) The additive is negative for L. monocytogenes. The modified 
version of the U.S. Department of Agriculture's method for determining 
L. monocytogenes entitled ``LMP-102\TM\ Listeria monocytogenes Sterility 
Testing,'' dated May 24, 2004, and printed by Intralytix, Inc., is 
incorporated by reference. Copies are available at locations cited in 
paragraph (b)(1) of this section.
    (6) The additive is negative for gram-positive and gram-negative 
bacteria capable of growing in commonly used microbiological media 
(e.g., Luria-Bertani (LB) medium), including Escherichia coli, 
Salmonella species and coagulase-positive Staphylococci, as determined 
by the ``Method to Determine Microbial Contamination,'' dated July 11, 
2003, and printed by Intralytix, Inc., is incorporated by reference. 
Copies are available at locations cited in paragraph (b)(1) of this 
section.
    (7) Total organic carbon (TOC) is less than or equal to 36 mg/kg. 
The analytical method for determining TOC entitled ``Determination of 
Total Organic Carbon by Automated Analyzer,'' dated March 30, 2001, and 
printed by Intralytix, Inc., is incorporated by reference. Copies are 
available at locations cited in paragraph (b)(1) of this section.
    (c) Conditions of use. The additive is used in accordance with 
current good manufacturing practice to control L. monocytogenes by 
direct application to meat and poultry products that comply with the 
ready-to-eat definition in 9 CFR 430.1. Current good manufacturing 
practice is consistent with direct spray application of the additive at 
a rate of approximately 1 mL of the additive per 500 cm\2\ product 
surface area.

[71 FR 47731, Aug. 18, 2006]

[[Page 80]]



                    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 general-purpose sweetener and 
flavor enhancer in foods generally, except in meat and poultry, in 
accordance with current good manufacturing practice and in an amount not 
to exceed that reasonably required to accomplish the intended technical 
effect in foods for which standards of identity established under 
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude 
such use, under the following 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (c) 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.

[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; 63 FR 
36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003]



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 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 and a flavor 
enhancer

[[Page 81]]

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-[alpha]-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 Ave. NW., 
Washington, DC 20418, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food And Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c)(1) When aspartame is used as a sugar substitute tablet 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.
    (2) When aspartame is used in baked goods and baking mixes, the 
amount of the additive is 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. Copies are available from the 
Office of Premarket Approval (HFS-200), Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
are available for inspection at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, and at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (d) 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.
    (e) 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.

[39 FR 27319, July 26, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
172.804, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

[[Page 82]]



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:
    (1) [alpha]-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) [alpha]-Hydro-omega-hydroxy-poly (oxy 
ethylene)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) [alpha]-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) [alpha]-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. 172.809  Curdlan.

    Curdlan may be safely used in accordance with the following 
conditions:
    (a) Curdlan is a high molecular weight polymer of glucose ([beta]-
1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture 
fermentation

[[Page 83]]

from the nonpathogenic and nontoxicogenic bacterium Alcaligenes faecalis 
var. myxogenes.
    (b) Curdlan meets the following specifications when it is tested 
according to the methods described or referenced in the document 
entitled ``Analytical Methods for Specification Tests for Curdlan,'' by 
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku, 
Tokyo, 103, Japan, 1996, 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 Petition Control (HFS-215), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (1) Positive for curdlan.
    (2) Assay for curdlan (calculated as anhydrous glucose), not less 
than 80 percent.
    (3) pH of 1 percent aqueous suspension, 6.0-7.5.
    (4) Lead, not more than 0.5 mg/kg.
    (5) Heavy metals (as Pb), not more than 0.002 percent.
    (6) Total nitrogen, not more than 0.2 percent.
    (7) Loss on drying, not more than 10 percent.
    (8) Residue on ignition, not more than 6 percent.
    (9) Gel strength of 2 percent aqueous suspension, not less than 
600x10\3\ dyne per square centimeter.
    (10) Aerobic plate count, not more than 10\3\ per gram.
    (11) Coliform bacteria, not more than 3 per gram.
    (c) Curdlan is used or intended for use in accordance with good 
manufacturing practice as a formulation aid, processing aid, stabilizer 
and thickener, and texturizer in foods for which standards of identity 
established under section 401 of the act do not preclude such use.

[61 FR 65941, Dec. 16, 1996]



Sec. 172.810  Dioctyl sodium sulfo suc cinate.

    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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.), 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 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

[[Page 84]]

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 
[alpha]-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 [deg]C-73 [deg]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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) The additive is used or intended for use as follows:

[[Page 85]]



------------------------------------------------------------------------
                   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): 601 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 86]]

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=(ExB)/(Axsample weight in grams)

Percent diethylene glycol=(FxD)/(Cxsample 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 sweeteners identified in Sec. 180.37 of this chapter.

[[Page 87]]

    (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)10CH2OSO2
Na].
    (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.
    (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.

[42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998]

[[Page 88]]



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. 172.829  Neotame.

    (a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).
    (b) Neotame meets the following specifications when it is tested 
according to the methods described or referenced in the document 
entitled ``Specifications and Analytical Methods for Neotame'' dated 
April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount 
Prospect, IL 60056. The Director of the Office of the Federal Register 
has approved the incorporation by reference of this material in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Office of Food Additive Safety (HFS-200), Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 
20740. Copies may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park, 
MD 20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (1) Assay for neotame, not less than 97.0 percent and not more than 
102.0 percent on a dry basis.
    (2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine), not more than 1.5 percent.
    (3) Other related substances, not more than 2.0 percent.
    (4) Lead, not more than 2.0 milligrams per kilogram.
    (5) Water, not more than 5.0 percent.
    (6) Residue on ignition, not more than 0.2 percent
    (7) Specific rotation, determined at 20 [deg]C 
[[alpha]]D: -40.0[deg] to 43.4[deg] calculated on a dry 
basis.
    (c) The food additive neotame may be safely used as a sweetening 
agent and

[[Page 89]]

flavor enhancer in foods generally, except in meat and poultry, in 
accordance with current good manufacturing practice, in an amount not to 
exceed that reasonably required to accomplish the intended technical 
effect, in foods for which standards of identity established under 
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude 
such use.
    (d) When neotame is used as a sugar substitute tablet, L-leucine may 
be used as a lubricant in the manufacture of tablets at a level not to 
exceed 3.5 percent of the weight of the tablet.
    (e) If the food containing the additive purports to be or is 
represented to be for special dietary use, it shall be labeled in 
compliance with part 105 of this chapter.

[67 FR 45310, July 9, 2002]



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. 172.831  Sucralose.

    (a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-[beta]-D-
fructofuranosyl-4-chloro-4-deoxy-[alpha]-D-galactopyranoside (CAS Reg. 
No. 56038-13-2).
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 398-400, 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 (HFS-206), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (c) The additive may be used as a sweetener in foods generally, in 
accordance with current good manufacturing practice in an amount not to 
exceed that reasonably required to accomplish the intended effect.
    (d) If the food containing the additive purports to be or is 
represented to be for special dietary use, it shall be labeled in 
compliance with part 105 of this chapter.

[63 FR 16433, Apr. 3, 1998, as amended at 64 FR 43909, Aug. 12, 1999]



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 90]]

    (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. 172.833  Sucrose acetate isobutyrate (SAIB).

    Sucrose acetate isobutyrate may be safely used in foods in 
accordance with the following prescribed conditions:
    (a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB, 
is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-
oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).
    (b) SAIB, a pale, straw-colored liquid, meets the following 
specifications: (1) Assay: Not less than 98.8 percent and not more than 
101.9 percent, based on the following formula:


Assay = ((SV 0.10586) / 56.1) x 100

Where SV = Saponification value

    (2) Saponification value: 524-540 determined using 1 gram of sample 
by the ``Guide to Specifications for General Notices, General Analytical 
Techniques, Identification Tests, Test Solutions, and Other Reference 
Materials,'' in the ``Compendium of Food Additive Specifications, 
Addendum 4, Food and Agriculture Organization of the United Nations 
(FAO), Food and Nutrition Paper 5, Revision 2'' (1991), pp. 203 and 204, 
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, 5100 Paint Branch Pkwy., College Park, MD 
20740, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (3) Acid value: Not to exceed 0.20 determined using 50 grams of 
sample by the ``Guide to Specifications for General Notices, General 
Analytical Techniques, Identification Tests, Test Solutions, and Other 
Reference Materials,'' in the ``Compendium of Food Additive 
Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 
2,'' p. 189 (1991), which is incorporated by reference; see paragraph 
(b)(2) of this section for availability of the incorporation by 
reference.
    (4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the 
``Atomic Absorption Spectrophotometric Graphite Furnace Method, Method 
I,'' in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 763 and 764, 
with an attached modification to the sample digestion section in 
Appendix III.B (July 1996), which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (5) Triacetin: Not to exceed 0.10 percent determined by gas 
chromatography as described in the ``Guide to Specifications for General 
Notices, General Analytical Techniques, Identification Tests, Test 
Solutions, and Other Reference Materials,'' in the ``Compendium of Food 
Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, 
Revision 2,'' (1991), pp. 13-26, which is incorporated by reference; see 
paragraph (b)(2) of this section for availability of the incorporation 
by reference.
    (c) The food additive is used as a stabilizer (as defined in Sec. 
170.3(o)(28) of this chapter) of emulsions of flavoring oils in 
nonalcoholic beverages.
    (d) The total SAIB content of a beverage containing the additive 
does not

[[Page 91]]

exceed 300 milligrams/kilogram of the finished beverage.

[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999]



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 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.

[[Page 92]]

    (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 Sec. Sec. 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.
    (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.

[[Page 93]]

    (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.
    (16) As an emulsifier in ice cream, frozen custard, fruit sherbet, 
and nonstandardized frozen desserts when used alone or in combination 
with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of 
the additives, alone or in combination, does not exceed 0.1 percent of 
the finished frozen dessert.
    (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; 64 FR 57976, Oct. 
28, 1999]



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 94]]

    (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 95]]

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 
Sec. Sec. 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, or partially reduced by transition metal catalytic 
hydrogenation in aqueous solution.

[[Page 96]]

    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 5th ed. (January 1, 2004), pp. 336-339, and the First 
Supplement to the 5th Edition of the Food Chemicals Codex (March 1, 
2006), p. 37, which are incorporated by reference. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a 
copy from The National Academies Press, 500 Fifth St. NW., Washington, 
DC 20001 (Internet address http://www.nap.edu). You may inspect a copy 
at the Center for Food Safety and Applied Nutrition's Library, Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.
    (c) When standards of identity established under section 401 of the 
act do not preclude such use, polydextrose may be used in accordance 
with current good manufacturing practices as a bulking agent, 
formulation aid, humectant, and texturizer in all foods, except meat and 
poultry, baby food, and infant formula.
    (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; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, June 6, 
1997; 63 FR 57597, Oct. 28, 1998; 65 FR 64605, Oct. 30, 2000; 65 FR 
79719, Dec. 20, 2000; 72 FR 46564, Aug. 21, 2007]



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 Sec. Sec. 163.123, 163.130, 163.135, 163.140, 163.145, and 
163.150 of this chapter, as follows:

[[Page 97]]

    (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 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:

[[Page 98]]

    (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 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.
    (9) As an emulsifier, stabilizer, or texturizer in cream liqueur 
drinks, at a level not to exceed 0.5 percent by weight of the finished 
product.

[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; 65 FR 60859, Oct. 13, 2000]



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....................  ............................

[[Page 99]]

 
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 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

[[Page 100]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.), and the additional specification that it shall 
have up to 85 percent of the carboxylic acid 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/

[[Page 101]]

federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 102]]

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) 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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 103]]

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 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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 104]]

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:
    (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.
    (3) n-Octyl; manufactured by the hydrodimerization of 1,3-butadiene, 
followed by catalytic hydrogenation of the resulting dienol, and 
distillation to produce n-octyl alcohol with a minimum purity of 99 
percent. The analytical method for n-octyl alcohol entitled ``Test 
Method [Normal-octanol]'' dated October 2003, and printed by Kuraray 
Co., Ltd., is incorporated by reference. The Director of the Office of 
the Federal Register approves this incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy 
from the Office of Food Additive Safety, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or you may examine a copy at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to 
http://www.archives.gov/federal_register/

[[Page 105]]

code_of_federal_regulations/ibr_locations.html.
    (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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 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.
    Spectrophotometric cells. Fused quartz ground glass stoppered cells, 
optical path length in the range of 1.000 centimeter 0.005 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, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

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

[[Page 106]]

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 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[micro] and shall not 
exceed 0.01 per centimeter path length between 300 and 400 m[micro].
    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[micro]-400m[micro]. 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 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.

[[Page 107]]

    Weigh out 40 grams 0.1 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; 70 FR 72908, 
Dec. 8, 2005]



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 specifications of the Food Chemicals Codex, 
4th edition, 1st supplement (1997), pp. 33-35, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418 (Internet address http://
www.nap.edu). Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 108]]

    (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 and 
prepackaged, unpopped popcorn kernels that are ready-to-heat. 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 [micro]g 
vitamin K1 per gram olestra.
    (e)(1) 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.
    (i) An asterisk shall follow vitamins A, D, E, and K in the listing 
of ingredients;
    (ii) The asterisk shall appear as a superscript following each 
vitamin;
    (iii) Immediately following the ingredient list an asterisk and 
statement, ``Dietarily insignificant'' shall appear prominently and 
conspicuously as specified in Sec. 101.2(c) of this chapter;
    (2) Olestra shall not be considered as a source of fat or calories 
for purposes of Sec. Sec. 101.9 and 101.13 of this chapter.

[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996, as amended at 68 
FR 46402, Aug. 5, 2003; 69 FR 29432, May 24, 2004]



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. 172.869  Sucrose oligoesters.

    Sucrose oligoesters, as identified in this section, may be safely 
used in accordance with the following conditions:
    (a) Sucrose oligoesters consist of mixtures of sucrose fatty acid 
esters with an average degree of esterification ranging from four to 
seven. It is produced by interesterification of sucrose with methyl 
esters of fatty acids derived from edible fats and oils (including 
hydrogenated fats and oils). The only solvents which may be used in the 
preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl 
alcohol, and those solvents generally recognized as safe in food.
    (b) Sucrose oligoesters meet the specifications in the methods 
listed in the table in this paragraph. The methods cited for determining 
compliance with each specification are incorporated by reference, in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the methods 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, room 1C-100, 5100 Paint Branch Pkwy., College Park, MD 20740, 
or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. Copies 
of the methods are available from the sources listed in the table in 
this paragraph:

[[Page 109]]



----------------------------------------------------------------------------------------------------------------
                                                                                           Source for Obtaining
            Specification                      Limit                  Method Cited                Method
----------------------------------------------------------------------------------------------------------------
(1) Sucrose esters..................  Not less than 90%......  ``Method for Analyzing     Office of Food
                                                                the Purity of Sucrose      Additive Safety,
                                                                Fatty Acid Esters,''       Center for Food
                                                                issued by Mitsubishi       Safety and Applied
                                                                Chemical Corp., June 17,   Nutrition (HFS-200),
                                                                1998.                      Food and Drug
                                                                                           Administration, 5100
                                                                                           Paint Branch Pkwy.,
                                                                                           College Park, MD
                                                                                           20740.
----------------------------------------------------------------------------------------------------------------
(2) Mono-, di-, and tri-esters......  Not more than 45%......  ``Method for Measuring     Do.
                                                                the Ester Distribution
                                                                of Sucrose
                                                                Oligoesters,'' issued by
                                                                Mitsubishi Chemical
                                                                Corp., June 17, 1998.
----------------------------------------------------------------------------------------------------------------
(3) Tetra-, penta-, hexa-, and hepta- Not less than 50%......  Do.                        Do.
 esters.
----------------------------------------------------------------------------------------------------------------
(4) Octa-esters.....................  Not more than 40%......  Do.                        Do.
----------------------------------------------------------------------------------------------------------------
(5) Free Sucrose....................  Not more than 0.5%.....  ``Free Sucrose Method,''   Do.
                                                                issued by Mitsubishi
                                                                Chemical Corp., June 17,
                                                                1998.
----------------------------------------------------------------------------------------------------------------
(6) Acid Value......................  Not more than 4.0......  ``Acid Value,'' Appendix   National Academy
                                                                VII, Method I              Press, 2101
                                                                (Commercial Fatty          Constitution Ave. NW,
                                                                Acids), in the Food        Washington, DC 20418
                                                                Chemicals Codex, 4th ed.   (Internet: http://
                                                                (1996), p. 820.            www.nap.edu).
----------------------------------------------------------------------------------------------------------------
(7) Residue on Ignition.............  Not more than 0.7%.....  ``Residue on Ignition,     Do.
                                                                Appendix IIC, Method I,
                                                                in the Food Chemicals
                                                                Codex, 4th ed. (1996),
                                                                pp. 751-752, (using a 1-
                                                                gram sample).
----------------------------------------------------------------------------------------------------------------
(8) Residual Methanol...............  Not more than 10         Method listed in the       Do.
                                       milligrams/kilogram.     monograph for ``Sucrose
                                                                Fatty Acid Esters'' in
                                                                the First Supplement to
                                                                the 4th ed. of the Food
                                                                Chemicals Codex (1997),
                                                                pp. 44-45.
----------------------------------------------------------------------------------------------------------------
(9) Residual Dimethyl Sulfoxide.....  Not more than 2.0        Do.                        Do.
                                       milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(10) Residual Isobutyl Alcohol......  Not more than 10         Do.                        Do.
                                       milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(11) Lead...........................  Not more than 1.0        ``Atomic Absorption        Do.
                                       milligram/kilogram.      Spectrophotometric
                                                                Graphite Furnace
                                                                Method,'' Method I, in
                                                                the Food Chemicals
                                                                Codex, 4th ed. (1996),
                                                                pp. 763-765.
----------------------------------------------------------------------------------------------------------------

    (c) The additive is used as an emulsifier (as defined in Sec. 
170.3(o)(8) of this chapter) or stabilizer (as defined in Sec. 
170.3(o)(28) of this chapter) in chocolate and in butter-substitute 
spreads, at a level not to exceed 2.0 percent; except that the additive 
may not be used in a standardized food unless permitted by the standard 
of identity.

[68 FR 50072, Aug. 20, 2003]



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:
    (a) The additive consists of one of the following:
    (1) A cellulose ether containing propylene glycol groups attached by 
an ether linkage that contains, on an anhydrous basis, not more than 4.6

[[Page 110]]

hydroxypropyl groups per anhydroglucose unit. The additive has a minimum 
viscosity of 10 centipoises for a 10 percent by weight aqueous solution 
at 25 degrees 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 food, in 
accordance with good manufacturing practice. The additive also may be 
used as a binder in dietary supplements, 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, as amended at 76 FR 41689, July 15, 2011]



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]

[[Page 111]]



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).
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.
16. As a dust control agent for rice........  ISO 100 oil viscosity (100
                                               centistokes (cSt) at 100
                                               [deg]F) applied at a
                                               level of no more than
                                               0.08 percent by weight of
                                               the rice 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; 63 FR 66014, Dec. 1, 1998]

[[Page 112]]



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:

------------------------------------------------------------------------
                                           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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 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, 100

[[Page 113]]

Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.

    (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:

------------------------------------------------------------------------
                   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[micro]                      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.
 yeast.                                      173.340 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
------------------------------------------------------------------------


[[Page 114]]

               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.

                                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 0.1 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 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1.000 centimeter 0.005 
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, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 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

[[Page 115]]

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[micro]. 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 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[micro]-400 m[micro]. 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 reference. The 
absorbance of the solution should not exceed 0.02 per centimeter path 
length in the 280 m[micro]-400 m[micro] 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

[[Page 116]]

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 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 1 [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 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[micro] and 400 m[micro] 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[micro] and 400 
m[micro] 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[micro] to 400 
m[micro]; the absorbance per centimeter path length following the 
complete procedure should not exceed 0.070 in the wavelength range from 
280 m[micro] to 299 m[micro], inclusive, nor 0.045 in the wavelength 
range from 300 m[micro] to 400 m[micro]. If in either spectrum the 
characteristic benzene peaks in the 250 m[micro]-260 m[micro] 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 0.2 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

[[Page 117]]

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 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[micro]-400 m[micro] 
(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

[[Page 118]]

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 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[micro]-400 m[micro]. 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[micro]-260 m[micro] 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, or 
poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long chain 
(C18-C22) methacrylate esters, 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 or alkylmethacrylate 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 in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Office of Premarket Approval 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740 or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Petroleum wax shall 
contain not more than 1,050 parts per million of poly(alkylacrylate) or 
poly(alkylmethacrylate) residues as determined by a method entitled 
``Method for Determining Residual

[[Page 119]]

Level of Poly(alkylacrylate) in Petroleum Wax,'' which is incorporated 
by reference. Copies are available from the addresses cited in this 
paragraph.
    (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; 64 FR 44122, Aug. 13, 1999]



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 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.

[[Page 120]]

 
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.
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.

[[Page 121]]

    (i) Food starch may be modified by treatment with the following 
enzymes:

------------------------------------------------------------------------
                  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.
Beta-amylase (E.C. 3.2.1.2)...............
Glucoamylase (E.C. 3.2.1.3)...............
Isoamylase (E.C. 3.2.1.68)................
Pullulanase (E.C. 3.2.1.41)...............
------------------------------------------------------------------------


[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; 66 FR 17509, Apr. 2, 2001]



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 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.

[[Page 122]]

    (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]



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.
173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme 
          preparation derived from a recombinant Bacillus subtilis.
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 from Mucor miehei.
173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. 
          raffinoseutilizer.
173.150 Milk-clotting enzymes, microbial.
173.160 Candida guilliermondii.
173.165 Candida lipolytica.
173.170 Aminoglycoside 3'-phos pho trans ferase 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 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.
173.325 Acidified sodium chlorite solutions.
173.340 Defoaming agents.
173.342 Chlorofluorocarbon 113 and perfluorohexane.

[[Page 123]]

173.345 Chloropentafluoroethane.
173.350 Combustion product gas.
173.355 Dichlorodifluoromethane.
173.356 Hydrogen peroxide.
173.357 Materials used as fixing agents in the immobilization of enzyme 
          preparations.
173.360 Octafluorocyclobutane.
173.368 Ozone.
173.370 Peroxyacids.
173.375 Cetylpyridinium chloride.
173.385 Sodium methyl sulfate.
173.395 Trifluoromethane sulfonic acid.
173.400 Dimethyldialkylammonium chloride.

    Authority: 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, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 
27, 2001.



  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.
    (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 [beta]-
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 tri methyl amine, di methyl amine, di ethyl 
ene triamine, or di methyl ethanol amine.
    (b) The ion-exchange membrane is manufactured so as to comply with 
the

[[Page 124]]

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-[(tri fluoro ethenyl) oxy] methyl]-1,2,2,2-
tetra fluoro ethoxy]-1,1,2,2,-tetra fluoro-, with tetra fluoro ethylene 
that has been subsequently treated to hydrolyze the sulfonyl fluoride 
group to the sulfonic acid. The Chemical Abstracts Service name of this 
polymer is ethane sulfonic acid, 2-[1-[difluoro-[(tri fluoro 
ethenyl)oxy] methyl]-1,2,2,2-tetra fluoro ethoxy]-1,1,2,2,-tetra fluoro-
, polymer with tetra fluoro ethane (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 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] (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 125]]

    (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-divinyl benzene di ethylene glycol divinyl 
ether terpolymer containing not less than 3.5 percent by weight of di 
vinyl benzene and not more than 0.6 percent by weight of di ethylene 
glycol divinyl ether, aminolyzed with di methyl amino propyl amine.
    (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-di methyl benzyl amine-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 di methyl amino propyl amine 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 epi 
chloro hydrin and propylene oxide, then sulfonated whereby the amount of 
epi chloro hydrin plus propylene oxide employed does not exceed 250 
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

[[Page 126]]

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.
    (i) The ion-exchange resin identified in paragraph (a)(13) of this 
section is 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 bed is maintained at 50 [deg]C or less 
and the flow rate of the water or food passing through the bed is not 
less than 0.5 gallon per cubic foot per minute.
    (ii) The ion-exchange resin identified in paragraph (a)(16) of this 
section is 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 either:
    (A) The temperature of the water or food passing through the resin 
bed is maintained at 50 [deg]C or less and the flow rate of the water or 
food passing through the bed is not less than 0.5 gallon per cubic foot 
per minute; or
    (B) Extracts of the resin will be found to contain no more than 1 
milligram/kilogram dimethylaminopropylamine in each of the food 
simulants, distilled water and 10 percent ethanol, when, following 
washing and pretreatment of the resin in accordance with Sec. 
173.25(c)(1), the resin is subjected to the following test under 
conditions simulating the actual temperature and flow rate of use: ``The 
Determination of 3-Dimethylaminopropylamine in Food Simulating Extracts 
of Ion Exchange Resins,'' February 4, 1998, 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 Petition Control (HFS-215), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (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.

[[Page 127]]

    (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 under the 
following conditions:
    (i) For resins that comply with the requirements in paragraph 
(d)(2)(i) of this section, 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.
    (ii) For resins that comply with the requirements in paragraph 
(d)(2)(ii) of this section, the pH range for the resin shall be no less 
than 2 and no more than 10, and the temperatures of water and food 
passing through the resin shall not exceed 50 [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 128]]

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 either with:
    (i) The extraction requirement in paragraph (c)(4) of this section 
by using dilute sulfuric acid, pH 3.5 as a substitute for acetic acid; 
or
    (ii) The extraction requirement in paragraph (c)(4) of this section 
by using reagent grade hydrochloric acid, diluted to pH 2, as a 
substitute for acetic acid. The resin shall be found to result in no 
more than 25 parts per million of organic extractives obtained with each 
of the following solvents: Distilled water; 15 percent alcohol; and 
hydrochloric acid, pH 2. Blanks should be run for each of the solvents, 
and corrections should be made by subtracting the total extractives 
obtained with the blank from the total extractives obtained in the resin 
test.
    (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; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR 
56173, Oct. 18, 1999]



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, 5100 Paint Branch Pkwy., College Park, MD 20740, or are 
available for inspection at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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]

[[Page 129]]



Sec. 173.50  Polyvinylpolypyrrolidone.

    The food additive polyvinylpoly pyrrolidone 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 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or available for inspection at the National 
Archives and Records Administration (NARA). For

[[Page 130]]

information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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:
    (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 ethyl vinyl benzene, 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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

[[Page 131]]

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, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) The additive is used to control mineral scale during the 
evaporation of 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. 173.115  Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme
preparation derived from a recombinant Bacillus subtilis.

    The food additive alpha-acetolactate decarboxylase ([alpha]-ALDC) 
enzyme preparation, may be safely used in accordance with the following 
conditions:
    (a) The food additive is the enzyme preparation derived from a 
modified Bacillus subtilis strain that contains the gene coding for 
[alpha]-ALDC from Bacillus brevis.

[[Page 132]]

    (b)(1) The manufacturer produces the additive from a pure culture 
fermentation of a strain of Bacillus subtilis that is nonpathogenic and 
nontoxigenic in man or other animals.
    (2) The manufacturer may stabilize the enzyme preparation with 
glutaraldehyde or with other suitable approved food additives or 
generally recognized as safe substances.
    (3) The enzyme preparation must meet the general and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 4th 
ed., 1996, pp. 133-134, which is incorporated by reference. The Director 
of the Office of the Federal Register approves this incorporation 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 20055, or may be examined at the Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (c) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect as a processing aid in the 
production of alcoholic malt beverages and distilled liquors.

[66 FR 27022, May 16, 2001]



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.



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.

[[Page 133]]

    (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:
---------------------------------------------------------------------------

    \1\ Available 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, 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.

[[Page 134]]

    (5) Aspergillus oryzae modified by recombinant deoxyribonucleic 
(DNA) techniques to contain the gene coding for aspartic proteinase from 
Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4) 
of this section, and classified as follows: Class, Blastodeuteromycetes 
(Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus; 
species oryzae.
    (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, as amended at 
62 FR 59284, Nov. 3, 1997]



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:
---------------------------------------------------------------------------

    \1\ Available 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[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 135]]

    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 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, 0.01 at 0.4 
absorbance.
    Wavelength repeatability, 0.2 nanometer.
    Wavelength accuracy, 1.0 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:

[[Page 136]]

    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 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

[[Page 137]]

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 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'-phospho trans ferase 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'-phos pho trans ferase 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.

[[Page 138]]



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\ (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
---------------------------------------------------------------------------

    (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

[[Page 139]]

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:
    (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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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)(1) The additive is generated by one of the following methods:
    (i) Treating an aqueous solution of sodium chlorite with either 
chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid.
    (ii) Treating an aqueous solution of sodium chlorate with hydrogen 
peroxide in the presence of sulfuric acid.
    (iii) Treating an aqueous solution of sodium chlorite by 
electrolysis.

[[Page 140]]

    (2) 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,'' 20th ed., 1998, or an equivalent 
method. Method 4500-ClO2 E (``Amperometric Method II'') is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain a copy from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or the American Public Health 
Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect a 
copy at the Center for Food Safety and Applied Nutrition's Library, 5100 
Paint Branch Pkwy., College Park, MD, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (b)(1) The additive may be used as an antimicrobial agent in water 
used in poultry processing in an amount not to exceed 3 parts per 
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a)(2) of this section, or an 
equivalent method.
    (2) The additive may be used as an antimicrobial agent in water used 
to wash fruits and vegetables that are not raw agricultural commodities 
in an amount not to exceed 3 ppm residual chlorine dioxide as determined 
by Method 4500-ClO2 E, referenced in paragraph (a)(2) of this 
section, or an equivalent method. Treatment of the fruits and vegetables 
with chlorine dioxide shall be followed by a potable water rinse or by 
blanching, cooking, or canning.

[60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, 
as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65 
FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, 2005]



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, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 may be examined at the National
 Archives and Records
 Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-
 741-6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.

[[Page 141]]

 
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
                                      [deg]C; by the method prescribed
                                      in the ``Food Chemicals Codex,''
                                      4th ed. (1996), pp. 744-745, 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, Box 285, 2101
                                      Constitution Ave. NW., Washington,
                                      DC 20055 (Internet address http://
                                      www.nap.edu), or may be examined
                                      at the Center for Food Safety and
                                      Applied Nutrition's Library, Food
                                      and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, or at the National
                                      Archives and Records
                                      Administration (NARA). For
                                      information on the availability of
                                      this material at NARA, call 202-
                                      741-6030, or go to: http://
                                      www.archives.gov/federal_register/
                                      code_of_federal_regulations/
                                      ibr_locations.html.
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................
Sodium nitrate.....................
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate................
Sodium polymethacrylate............
Sodium silicate....................
Sodium sulfate.....................
Sodium sulfite (neutral or
 alkaline).
Sodium tripolyphosphate............
Sorbitol anhydride esters: a         The mixture is used as an
 mixture consisting of sorbitan       anticorrosive agent in steam
 monostearate as defined in Sec. boiler distribution systems, with
 172.842 of this chapter;             each component not to exceed 15
 polysorbate 60 ((polyoxyethylene     parts per million in the steam.
 (20) sorbitan monostearate)) as
 defined in Sec. 172.836 of this
 chapter; and polysorbate 20
 ((polyoxyethylene (20) sorbitan
 monolaurate)), meeting the
 specifications of the Food
 Chemicals Codex, 4th ed. (1996),
 pp. 306-307, 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., Box 285,
 Washington, DC 20055 (Internet
 http://www.nap.edu), or may be
 examined at the Center for Food
 Safety and Applied Nutrition's
 Library, Food and Drug
 Administration, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-
 741-6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
Tannin (including quebracho
 extract).
Tetrasodium EDTA...................
Tetrasodium pyrophosphate..........
------------------------------------------------------------------------


[[Page 142]]

    (d) Substances used alone or in combination with substances in 
paragraph (c) of this section:

------------------------------------------------------------------------
               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; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, 
June 1, 1999]
     



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

    Chemicals may be safely used to wash or to assist in the 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: [alpha]-alkyl    the lye peeling of fruit and
 (C12-C18)-omega-hydroxy-poly             vegetables.
 (oxyethylene) (7.5-8.5 moles)/poly
 (oxypropylene) block copolymer having
 an average molecular weight of 810;
 [alpha]-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 [alpha]-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 parts per
                                          million in wash water.
                                          Contains not more than 0.2
                                          percent acrylamide monomer.
                                          May be used in the washing of
                                          fruits and vegetables.
Potassium bromide......................  May be used in the washing or
                                          to assist in the lye peeling
                                          of fruits and vegetables.
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....................  May be used in the washing or
                                          to assist in the lye peeling
                                          of fruits and vegetables.
Sodium mono- and dimethyl 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.
------------------------------------------------------------------------


[[Page 143]]

    (3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-
260) may be used in the steam/scald vacuum peeling of tomatoes at a 
level not to exceed 0.2 percent in the condensate or scald water.
    (4) Substances identified in this paragraph (a)(4) 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
------------------------------------------------------------------------
[alpha]-Alkyl-omega-hydroxypoly-            Not to exceed 3 ppm.
 (oxyethylene) produced by condensation of
 1 mole of C11-C486315 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.
------------------------------------------------------------------------

    (5) Substances identified in this paragraph (a)(5) for use on fruits 
and vegetables that are not raw agricultural commodities and subject to 
the limitations provided:

------------------------------------------------------------------------
                Substances                          Limitations
------------------------------------------------------------------------
Hydrogen peroxide........................  Used in combination with
                                            acetic acid to form
                                            peroxyacetic acid. Not to
                                            exceed 59 ppm in wash water.
1-Hydroxyethylidene-1,1-diphosphonic acid  May be used only with
                                            peroxyacetic acid. Not to
                                            exceed 4.8 ppm in wash
                                            water.
Peroxyacetic acid........................  Prepared by reacting acetic
                                            acid with hydrogen peroxide.
                                            Not to exceed 80 ppm in wash
                                            water.
------------------------------------------------------------------------

    (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 listed under paragraphs (a)(1), (a)(2), 
and (a)(4) 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; 61 FR 46376, 
46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 
1999]



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

[[Page 144]]

 
Potassium N-methyldithiocarbamate..............................      4.1
------------------------------------------------------------------------

    (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 dietha          application rate not to
 nolamine, 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. 173.325  Acidified sodium chlorite solutions.

    Acidified sodium chlorite solutions may be safely used in accordance 
with the following prescribed conditions:
    (a) The additive is produced by mixing an aqueous solution of sodium 
chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe 
(GRAS) acid.
    (b)(1) The additive is used as an antimicrobial agent in poultry 
processing water in accordance with current industry practice under the 
following conditions:
    (i) As a component of a carcass spray or dip solution prior to 
immersion of the intact carcass in a prechiller or chiller tank;
    (ii) In a prechiller or chiller solution for application to the 
intact carcass;
    (iii) As a component of a spray or dip solution for application to 
poultry carcass parts;
    (iv) In a prechiller or chiller solution for application to poultry 
carcass parts; or
    (v) As a component of a post-chill carcass spray or dip solution 
when applied to poultry meat, organs, or related parts or trim.
    (2) When used in a spray or dip solution, the additive is used at 
levels that result in sodium chlorite concentrations between 500 and 
1,200 parts per

[[Page 145]]

million (ppm), in combination with any GRAS acid at a level sufficient 
to achieve a solution pH of 2.3 to 2.9.
    (3) When used in a prechiller or chiller solution, the additive is 
used at levels that result in sodium chlorite concentrations between 50 
and 150 ppm, in combination with any GRAS acid at levels sufficient to 
achieve a solution pH of 2.8 to 3.2.
    (c) The additive is used as an antimicrobial agent in accordance 
with current industry practice in the processing of red meat, red meat 
parts, and organs as a component of a spray or in the processing of red 
meat parts and organs as a component of a dip. Applied as a dip or 
spray, the additive is used at levels that result in sodium chlorite 
concentrations between 500 and 1,200 ppm in combination with any GRAS 
acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.
    (d)(1) The additive is used as an antimicrobial agent in water and 
ice that are used to rinse, wash, thaw, transport, or store seafood in 
accordance with current industry standards of good manufacturing 
practice. The additive is produced by mixing an aqueous solution of 
sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 
to 2.9 and diluting this solution with water to achieve an actual use 
concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any 
seafood that is intended to be consumed raw shall be subjected to a 
potable water rinse prior to consumption.
    (2) The additive is used as a single application in processing 
facilities as an antimicrobial agent to reduce pathogenic bacteria due 
to cross-contamination during the harvesting, handling, heading, 
evisceration, butchering, storing, holding, packing, or packaging of 
finfish and crustaceans; or following the filleting of finfish; in 
accordance with current industry standards of good manufacturing 
practice. Applied as a dip or spray, the additive is used at levels that 
result in a sodium chlorite concentration of 1,200 ppm, in combination 
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. 
Treated seafood shall be cooked prior to consumption.
    (e) The additive is used as an antimicrobial agent on raw 
agricultural commodities in the preparing, packing, or holding of the 
food for commercial purposes, consistent with section 201(q)(1)(B)(i) of 
the act, and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with 
current industry standards of good manufacturing practice. Applied as a 
dip or a spray, the additive is used at levels that result in chlorite 
concentrations of 500 to 1200 parts per million (ppm), in combination 
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. 
Treatment of the raw agricultural commodities with acidified sodium 
chlorite solutions shall be followed by a potable water rinse, or by 
blanching, cooking, or canning.
    (f) The additive is used as an antimicrobial agent on processed, 
comminuted or formed meat food products (unless precluded by standards 
of identity in 9 CFR part 319) prior to packaging of the food for 
commercial purposes, in accordance with current industry standards of 
good manufacturing practice. Applied as a dip or spray, the additive is 
used at levels that result in sodium chlorite concentrations of 500 to 
1200 ppm, in combination with any GRAS acid at levels sufficient to 
achieve a pH of 2.5 to 2.9.
    (g) The additive is used as an antimicrobial agent in the water 
applied to processed fruits and processed root, tuber, bulb, legume, 
fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and 
tomato), and cucurbit vegetables in accordance with current industry 
standards of good manufacturing practices, as a component of a spray or 
dip solution, provided that such application be followed by a potable 
water rinse and a 24-hour holding period prior to consumption. However, 
for processed leafy vegetables (i.e., vegetables other than root, tuber, 
bulb, legume, fruiting, and cucurbit vegetables) and vegetables in the 
Brassica [Cole] family, application must be by dip treatment only, and 
must be preceded by a potable water rinse and followed by a potable 
water rinse and a 24-hour holding period prior to consumption. When used 
in a spray or dip solution, the additive is used at levels

[[Page 146]]

that result in sodium chlorite concentrations between 500 and 1,200 ppm, 
in combination with any GRAS acid at a level sufficient to achieve a 
solution pH of 2.3 to 2.9.
    (h) The concentration of sodium chlorite is determined by a method 
entitled ``Determination of Sodium Chlorite: 50 ppm to 1500 ppm 
Concentration,'' September 13, 1995, developed by Alcide Corp., Redmond, 
WA, 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 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, 
MD 20740 20204-0001, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 
FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 
12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 
31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, 
2004]



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.
[alpha]-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.
------------------------------------------------------------------------

    (3) Substances listed in this paragraph (a)(3), provided they are 
components of defoaming agents limited to use in processing beet sugar 
and yeast, and subject to any limitations imposed:

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Aluminum stearate......................  As defined in Sec. 172.863 of
                                          this chapter.

[[Page 147]]

 
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)     10 percent by weight of
 of this chapter and providing the        defoamer formulation.
 oleic 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
 acids.                                   of 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 148]]

    (4) The substances listed in this paragraph (a)(4), provided they 
are components of defoaming agents limited to use in processing beet 
sugar only, and subject to the limitations imposed:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
n-Butoxypoly(oxyethylene)-                  Viscosity range, 4,850-5,350
 poly(oxypropylene)glycol.                   Saybolt Universal Seconds
                                             (SUS) at 37.8 [deg]C (100
                                             [deg]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,
                                             5100 Paint Branch Pkwy.,
                                             College Park, MD 20740, and
                                             may be examined at the
                                             Center for Food Safety and
                                             Applied Nutrition's
                                             Library, 5100 Paint Branch
                                             Pkwy., College Park, MD
                                             20740, or at the National
                                             Archives and Records
                                             Administration (NARA). For
                                             information on the
                                             availability of this
                                             material at NARA, call 202-
                                             741-6030, or go to: http://
                                             www.archives.gov/ federal _
                                             register/ code _ of _
                                             federal _ regulations/ ibr
                                             _ locations.html.
Monoester of alpha-hydro-omega-hydroxy-     ............................
 poly(oxyethylene) poly(oxypropylene)
 poly(oxyethylene) (15 mole minimum)
 blocked copolymer derived from low erucic
 acid rapeseed oil.
------------------------------------------------------------------------

    (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; 63 FR 29134, May 28, 1998]



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''.

[[Page 149]]

    (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:
    (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

[[Page 150]]

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 more than 
one-third of the standard reference absorbance.



Sec. 173.355  Dichlorodifluoromethane.

    The food additive dichlorodi fluoromethane 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. 173.356  Hydrogen peroxide.

    Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to 
treat food in accordance with the following conditions:
    (a) The additive meets the specifications of the Food Chemicals 
Codex, 7th ed. (2010), pp. 496 and 497, which is incorporated by 
reference. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain copies from the United States Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address 
http://www.usp.org). Copies may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (b) The additive is used as an antimicrobial agent in the production 
of modified whey (including, but not limited to, whey protein 
concentrates and whey protein isolates) by ultrafiltration methods, at a 
level not to exceed 0.001 percent by weight of the whey, providing that 
residual hydrogen peroxide is removed by appropriate chemical or 
physical means during the processing of the modified whey.

[76 FR 11330, Mar. 2, 2011]



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
------------------------------------------------------------------------
Acrylamide-acrylic acid resin:         May be used as a fixing material
 Complying with Sec. 173.5(a)(1)      in the immobilization of glucose
 and (b) of this chapter.               isomerase enzyme preparations
                                        for use in the manufacture of
                                        high fructose corn syrup, in
                                        accordance with Sec. 184.1372
                                        of this chapter.
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.

[[Page 151]]

 
Dimethylamine-epichlorohydrin resin:   May be used as a fixing material
 Complying with Sec. 173.60(a) and    in the immobilization of glucose
 (b) of this chapter.                   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.      in the immobilization of
 No. 68130-97-2) is the reaction        glucoamylase enzyme preparations
 product of homopolymerization of       from Aspergillus niger for use
 ethylenimine in aqueous hydrochloric   in the manufacture of beer.
 acid at 100 [deg]C and of cross-      May be used as a fixing material
 linking 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
 200), 5100 Paint Branch Pkwy.,         spectrometry. The residual
 College Park, MD 20740, and may be     ethylenimine is determined by an
 examined at the Center for Food        analytical method entitled
 Safety and Applied Nutrition's         ``Methodology for Ethylenimine
 Library, 5100 Paint Branch Pkwy.,      Detection in Polyethylenimine,''
 College Park, MD 20740, or at the      which is incorporated by
 National Archives and Records          reference in accordance with 5
 Administration (NARA). For             U.S.C. 552(a) and 1 CFR part 51.
 information on the availability of     Residual 1,2-dichloroethane in
 this material at NARA, call 202-741-   the finished polyethylenimine
 6030, or go to: http://                polymer will be less than 1 part
 www.archives.gov/federal_register/     per million as determined by gas
 code_of_federal_regulations/           chromatography. The residual 1,2-
 ibr_locations.html..                   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), 5100 Paint
                                        Branch Pkwy., College Park, MD
                                        20740, or may be examined at the
                                        Center for Food Safety and
                                        Applied Nutrition's Library,
                                        5100 Paint Branch Pkwy., College
                                        Park, MD 20740, or at the
                                        National Archives and Records
                                        Administration (NARA). For
                                        information on the availability
                                        of this material at NARA, call
                                        202-741-6030, or go to: http://
                                        www.archives.gov/
                                        federal_register/
                                        code_of_federal_regulations/
                                        ibr_locations.html.
------------------------------------------------------------------------

    (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; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002]



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:
    (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. 173.368  Ozone.

    Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, 
storage, and processing of foods, including meat and poultry (unless 
such use is precluded by standards of identity in 9 CFR part 319), in 
accordance with the following prescribed conditions:
    (a) The additive is an unstable, colorless gas with a pungent, 
characteristic odor, which occurs freely in nature. It

[[Page 152]]

is produced commercially by passing electrical discharges or ionizing 
radiation through air or oxygen.
    (b) The additive is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (c) The additive meets the specifications for ozone in the Food 
Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation 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 20055, or may be examined at the 
Office of Premarket Approval (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, and at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (d) The additive is used in contact with food, including meat and 
poultry (unless such use is precluded by standards of identity in 9 CFR 
part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase 
in accordance with current industry standards of good manufacturing 
practice.
    (e) When used on raw agricultural commodities, the use is consistent 
with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act 
(the act) and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]



Sec. 173.370  Peroxyacids.

    Peroxyacids may be safely used in accordance with the following 
prescribed conditions:
    (a) The additive is a mixture of peroxyacetic acid, octanoic acid, 
acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-
hydroxyethylidene-1,1-diphosphonic acid.
    (b)(1) The additive is used as an antimicrobial agent on meat 
carcasses, parts, trim, and organs in accordance with current industry 
practice where the maximum concentration of peroxyacids is 220 parts per 
million (ppm) as peroxyacetic acid, and the maximum concentration of 
hydrogen peroxide is 75 ppm.
    (2) The additive is used as an antimicrobial agent on poultry 
carcasses, poultry parts, and organs in accordance with current industry 
standards of good manufacturing practice (unless precluded by the U.S. 
Department of Agriculture's standards of identity in 9 CFR part 381, 
subpart P) where the maximum concentration of peroxyacids is 220 parts 
per million (ppm) as peroxyacetic acid, the maximum concentration of 
hydrogen peroxide is 110 ppm, and the maximum concentration of 1-
hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm.
    (c) The concentrations of peroxyacids and hydrogen peroxide in the 
additive are determined by a method entitled ``Hydrogen Peroxide and 
Peracid (as Peracetic Acid) Content,'' July 26, 2000, developed by 
Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The 
concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined 
by a method entitled ``Determination of 1-hydroxyethylidene-1,1-
diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions,'' 
August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is 
incorporated by reference. The Director of the Office of the Federal 
Register approves these incorporations by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods 
from the Division of Petition Review, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or you may examine a copy at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/
federal_register/

[[Page 153]]

code_of_federal_regulations/ibr_locations.html.

[65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 
67 FR 61784, Oct. 2, 2002]



Sec. 173.375  Cetylpyridinium chloride.

    Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used 
in food in accordance with the following conditions:
    (a) The additive meets the specifications of the United States 
Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, 
May 1, 2007, pp. 1700-1701, which is incorporated by reference. The 
Director of the Office of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. You may obtain copies from the United States Pharmacopeial 
Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may 
examine a copy at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.
    (b) The additive is used in food as an antimicrobial agent as 
defined in Sec. 170.3(o)(2) of this chapter to treat the surface of raw 
poultry carcasses. The solution in which the additive is used to treat 
raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 
57-55-6) complying with Sec. 184.1666 of this chapter, at a 
concentration of 1.5 times that of cetylpyridinium chloride.
    (c) The additive is used as follows:
    (1) As a fine mist spray of an ambient temperature aqueous solution 
applied to raw poultry carcasses prior to immersion in a chiller, at a 
level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw 
poultry carcass, provided that the additive is used in systems that 
collect and recycle solution that is not carried out of the system with 
the treated poultry carcasses; or
    (2) As a liquid aqueous solution applied to raw poultry carcasses 
either prior to or after chilling at an amount not to exceed 5 gallons 
of solution per carcass, provided that the additive is used in systems 
that recapture at least 99 percent of the solution that is applied to 
the poultry carcasses. The concentration of cetylpyridinium chloride in 
the solution applied to the carcasses shall not exceed 0.8 percent by 
weight. When application of the additive is not followed by immersion in 
a chiller, the treatment will be followed by a potable water rinse of 
the carcass.

[72 FR 67576, Nov. 29, 2007, as amended at 76 FR 59248, Sept. 26, 2011]



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 
CF3SO3H (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

[[Page 154]]

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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 
54 FR 24897, June 12, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, 
Nov. 8, 2005]



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 di methyl dihexa decyl ammonium 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 known as dimethyl(2-ethylhexyl) hydrogenated tallow 
ammonium chloride and consisting primarily of dimethyl (2-ethyl hexyl) 
octa decyl ammonium chloride and dimethyl (2-ethyl hexyl) hexa decyl 
ammonium 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and from the American Oil 
Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 155]]

CFR part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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: 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.
    (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.
    (5) Food contact substances used in accordance with an effective 
premarket notification for a food contact substance (FCN) submitted 
under section 409(h) of the act.

[42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]



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

[[Page 156]]

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 coating.
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: 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, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 
2005.

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 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

[[Page 157]]

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................
2-Acrylamido-2-methyl-propanesulfonic
 acid, homopolymer, sodium salt (CAS
 Reg. No. 35641-59-9).
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-[beta]-Aminoethyl-gamma-aminopropyl
 trimethoxysilane.
3-(Aminomethyl)-3,5,5-
 trimethylcyclohexylamine.
Aminomethylpropanol....................
Ammonium benzoate......................  For use as preservative only.
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.........................

[[Page 158]]

 
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([alpha],[alpha]-
 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.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in adhesives.
 known as butanedioic acid, sulfo-1,4-
 diisodecyl ester, ammonium salt [CAS
 Reg. No. 144093-88-9])..
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...................  ...............................
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.................

[[Page 159]]

 
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.....
([eta]\5\-Cyclopentadienyl)-([eta]\6\-   For use only as a
 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.....................  ...............................
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).
2,2-Dibromo-3-nitrilopropionamide (CAS   For use as a preservative only.
 Reg. No. 10222-01-2)..
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...........................

[[Page 160]]

 
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-[beta]-naphthyl-p-phenylenediamine..
4,6-Dinonyl-o-cresol...................
Dinonylphenol..........................
Di-n-octyldecyl adipate................
Dioctyldiphenylamine...................
Dioctylphthalate.......................
Dioctylsebacate........................
Dioxane................................
Dipentaerythritol pentastearate........
Dipentamethylene-thiuram-tetrasulfide..
Dipentene..............................  ...............................
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.

[[Page 161]]

 
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..........................
2,2'-Ethylidenebis(4,6-di-tert-          For use as an antioxidant and/
 butylphenyl)fluorophosphonite (CAS       or stabilizer only.
 Reg. No. 118337-09-0).
Ethyl phthalyl ethyl glycolate.........
Ethyl-p-toluene sulfonamide............  ...............................
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...............................

[[Page 162]]

 
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..................
2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]- For use only as a
 2-methyl-1-propanone(CAS Reg. No.        photoinitiator at a level not
 106797-53-9).                            to exceed 5 percent by weight
                                          of the adhesive.
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2
 alkyl (C6-C17) imidazolinium chloride.
Hydroxyethyldiethylenetriamine.........
[beta]-Hydroxyethyl pyridinium 2-
 mercaptobenzothiazol.
Hydroxyethyl starch....................
Hydroxyethylurea.......................  ...............................
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.......................
Isobutyl alcohol (isobutanol)..........
Isobutylene-isoprene copolymer.........
Isodecyl benzoate (CAS Reg. No. 131298-
 44-7).
Isophorone.............................
Isopropanolamine (mono-, di-, tri-)....
Isopropyl acetate......................
Isopropyl alcohol (isopropanol)........
Isopropyl-m- and p-cresol (thymol
 derived).
4,4'-Isopropylidenediphenol............

[[Page 163]]

 
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).
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.
[alpha]-Naphthylamine..................
[alpha],[alpha]',[alpha]'',[alpha]'''-
 Neopentane tetrayltetrakis [omega-
 hydroxypoly (oxypropylene) (1-2
 moles)], average molecular weight 400.
Nitric acid............................
[micro]-Nitrobiphenyl..................
Nitrocellulose.........................
2-Nitropropane.........................

[[Page 164]]

 
[alpha]-(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.
[alpha](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.
[alpha]-(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.
[alpha]-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..............................
[alpha]-(oxiranylmethyl)-[omega]-        For use as a reactant in the
 (oxiranylmethoxy)poly[oxy(methyl-1,2-    preparation of epoxy-based
 ethanediyl)], (alternative name:         resins.
 epichlorohydrin-polypropylene glycol)
 (CAS Reg. No. 26142-30-3).
2,2'-[oxybis[(methyl-2,1-ethanediyl)-    For use as a reactant in the
 oxymethylene]]bisoxirane, (alternative   preparation of epoxy-based
 name: epichlorohydrin-dipropylene        resins.
 glycol) (CAS Reg. No. 41638-13-5).
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-[beta]-naphthylamine (free of
 [beta]-naphthylamine).
o-Phenylphenol.........................  For use as preservative only.
o-Phthalic acid........................
Pimaric acid...........................  ...............................
Pine oil...............................
Piperazine.............................
Piperidinium
 pentamethylenedithiocarbamate.
Poly(acrylamide-[2-acrylamide-2-
 methylpropylsulfonate]-
 dimethylidiallyl ammonium chloride)
 sodium salt (CAS Reg. No. 72275-68-4).
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.

[[Page 165]]

 
        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 1,4-
         cyclohexanedicarboxylate (CAS
         Reg. No. 94-60-0).
        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 glycol mono-isotridecyl
 ether sulfate, sodium salt (CAS Reg.
 No. 150413-26-6).
Polyethyleneglycol alkyl(C10-C12) ether  ...............................
 sulfosuccinate, disodium salt (CAS
 Reg. No. 68954-91-6).
Polyethylene, oxidized.................
Polyethylene resins, carboxyl modified,
 identified in Sec. 177.1600 of this
 chapter.
Polyethylenimine.......................
Polyethylenimine-epichlorohydrin resins
Poly(ethyloxazoline) (CAS Reg. No.
 25805-17-8).
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........................
  Decyl acrylate.......................
  Diallyl fumarate.....................
  Diallyl maleate......................
  Diallyl phthalate....................
  Dibutyl fumarate.....................
  Dibutyl itaconate....................

[[Page 166]]

 
  Dibutyl maleate......................
  Di(2-ethylhexyl) maleate.............
  Dimethyl-[alpha]-methylstyrene.......
  Dioctyl fumarate.....................
  Dioctyl maleate......................
  Divinylbenzene.......................
  Ethyl acrylate.......................
  Ethylene.............................
  Ethylene cyanohydrin.................
  2-Ethylhexyl acrylate................
  Ethyl methacrylate...................
  Fatty acids, C10-13-branched, vinyl
   esters (CAS Reg. No. 184785-38-4).
  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.
  1-Octene (CAS Reg. No. 111-66-0).....
  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
Polyoxypropylene (20 moles) oleate
 butyl ether.
Polyoxypropylene-polyoxyethylene
 condensate (minimum molecular weight
 1,900).

[[Page 167]]

 
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-
 [alpha]-(p-nonyl-phenyl)-omega-(p-
 vinyl-benzyl)poly(oxyethylene)]
 terpolymer.
Polytetrafluoroethylene................
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: (i) 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 (ii) a fumaric acid-
 modified polypropylene glycol or
 fumaric acid-modified tripropylene
 glycol), triethylamine (CAS Reg. No.
 107-15-3), and ethylenediamine (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.............
[alpha], [alpha]', [alpha]''-1,2,3-
 Propanetriyltris [omega-(2,3-
 epoxypropoxy) poly (oxypropylene) (24
 moles)].
[beta]-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..........
[alpha], [alpha]', [alpha]''-
 [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 168]]

 
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 [mu]-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 169]]

 
Sodium hypochlorite....................
Sodium isododecylphenoxypolyethoxy (40
 moles) sulfate.
Sodium N-lauroyl sarcosinate...........
Sodium metaborate......................
Sodium [alpha]-naphthalene sulfonate...
Sodium nitrate.........................
Sodium nitrite.........................
Sodium oleoyl isopropanolamide
 sulfosuccinate.
Sodium pentachlorophenate..............  For use as preservative only.
Sodium perborate.......................
Sodium persulfate......................
Sodium [mu]-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
 Sec. Sec. 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.
[alpha]-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 ([alpha]-and [beta]-      ...............................
 pinene) homopolymers, copolymers, and
 condensates with phenol, formaldehyde,
 coumarone, and/or indene.

[[Page 170]]

 
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-[beta]-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 171]]

 
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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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.
    (7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. 
No. 7128-64-5) as an optical brightener at a level not to exceed 0.05 
percent by weight of the finished pressure-sensitive adhesive.
    (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) phenyl]-2-methyl-1-propanone 
(CAS Reg. No. 106797-53-9) as a photoinitiator at a level not to exceed 
5 percent by weight of the pressure-sensitive adhesive.
    (9) Butanedioic acid, sulfo-1,4-di-(C9-C11 
alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4-
diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]) as a surface 
active agent at a level not to exceed 3.0 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

[[Page 172]]

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), (a)(2), (a)(3), (a)(5), 
(a)(6), (a)(7), (a)(8), and (a)(9) 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.
Butylated reaction product of p-cresol and dicyclopentadiene produced by 
reacting p-cresol and dicyclopentadiene in an approximate mole ratio of 
1.5 to 1.0, respectively, followed by alkylation with isobutylene so 
that the butyl content of the final product is not less than 18 percent, 
for use at levels not to exceed 1.0 percent by weight of the adhesive 
formulation.
Chlorinated natural rubber.
Isobutylene-styrene copolymer.
Petrolatum.
Polybutene-1.
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 ([alpha]- and [beta]-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; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, 
Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]



         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.

[[Page 173]]



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, 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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 174]]

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.



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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 175]]

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 pre poly merized 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.
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.


[[Page 176]]


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

Maleic anhydride.
o-, m-, and p-substituted phenol-form alde hydes 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.
    (a) Polybasic acids:

Adipic.
1,4-cyclohexanedicarboxylic (CAS Reg. No. 1076-97-7).
Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of 
this section.
Fumaric.
Isophthalic.
Maleic.
2,6-Naphthalenedicarboxylic.
2,6-Naphthalenedicarboxylic, dimethyl ester.
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.
[alpha]-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

[[Page 177]]

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.
    2,2'-[(1-methylethylidene)bis[4,1-phenyleneoxy[1-(butoxymethyl)-2,1-
ethanediyl]oxymethylene]]bisoxirane, CAS Reg. No. 71033-08-4, for use 
only in coatings intended for contact with bulk dry foods at 
temperatures below 100 [deg]F.
    Phenol-formaldehyde.
    Urea-formaldehyde.

    (b) Catalysts and cross-linking agents for epoxy resins:

3-(Aminomethyl)-3,5,5-trimethyl cyclo hexyl amine 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-amino propyl tri meth oxysilane (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 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.
Catalysts and cross-linking agents for epoxy resins:
    3-Aminomethyl-3,5,5-trimethylcyclohexylamine (CAS Reg. No. 2855-
0913-092).
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.
3-Pentadecenyl phenol mixture (obtained from cashew nutshell liquid) 
reacted with formaldehyde and ethylenediamine in a ratio of 1:2:2 (CAS 
Reg. No. 68413-28-5).

[[Page 178]]

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.
Polyethylenepolyamine (CAS Reg. No. 68131-73-7), for use only in 
coatings intended for repeated use in contact with food, at temperatures 
not to exceed 180 [deg]F (82 [deg]C).
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, 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-benzene di methan amine, 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 benzene di methan amine, 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-

[[Page 179]]

aminopropyltrimethoxy silane, mono hydro gen 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.
[alpha]-Pinene.
[beta]-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.
    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.

[[Page 180]]

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.
[alpha]-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
    Acrylonitrile.
    [alpha]-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 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    (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

[[Page 181]]

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 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.


[[Page 182]]


    (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.
Siloxane resins originating from the platinum-catalyzed reaction product 
of vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083-18-1 and 
CAS Reg. No. 68083-19-2) with methylhydrogen polysiloxane (CAS Reg. No. 
63148-57-2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037-
59-2), where the platinum content does not exceed 150 parts per million. 
The following substances may be used as optional polymerization 
inhibitors:
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107-54-0), at a level not to 
exceed 0.53 weight-percent;
1-Ethynylcyclohexene (CAS Reg. No. 931-49-7), at a level not to exceed 
0.64 weight-percent;
Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054-10-4), at a level 
not to exceed 1.0 weight-percent;
Methylvinyl cyclosiloxane (CAS Reg. No. 68082-23-5); and
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554-06-5).

    (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):

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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.), 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.

[[Page 183]]

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-[beta]-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-(Diiodomethylsulfonyl) 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.
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).

[[Page 184]]

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.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-
methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) mixture, at a ratio 
of 3 parts to 1 part, respectively, manufactured from methyl-3-
mercaptopropionate (CAS Reg. No. 2935-90-2) and optionally containing 
magnesium nitrate (CAS Reg. No. 10377-60-3) at a concentration 
equivalent to the isothiazolone active ingredients (weight/weight). For 
use only as an antimicrobial agent in emulsion-based silicone coatings 
at a level not to exceed 50 milligrams per kilogram (based on 
isothiazolone active ingredient) in the coating formulations.
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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. 35691-65-7). For use as an 
antimicrobial agent at levels not to exceed 500 milligrams per kilogram 
in emulsion-based silicone coatings.
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 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.

[[Page 185]]

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 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

[[Page 186]]

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).

[[Page 187]]



    Table 2--Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and
                                                                        Beverages
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Extractant
                                      Types of food (see  ----------------------------------------------------------------------------------------------
         Condition of use                  Table 1)                                            Heptane\1,2\ (time and           8% alcohol (time and
                                                            Water (time and temperature)            temperature)                    temperature)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. High temperature heat-           I, IV-B..............  250 [deg]F, 2 hr..............  ..............................
 sterilized (e.g., over 212
 [deg]F).
                                    III, IV-A, VII.......  do............................  150 [deg]F, 2 hr..............
B. Boiling water-sterilized.......  II...................  212 [deg]F, 30 min............  ..............................
                                    III, VII.............  do............................  120 [deg]F, 30 min............
C. Hot filled or pasteurized above  II, IV-B.............  Fill boiling, cool to 100       ..............................
 150 [deg]F.                                                [deg]F.
                                    III, IV-A............  do............................  120 [deg]F, 15 min............
                                    V....................  ..............................  do............................
D. Hot filled or pasteurized below  II, IV-B, VI-B.......  150 [deg]F, 2 hr..............  ..............................
 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      II, IV-B, VI-B.......  120 [deg]F, 24 hr.............  ..............................
 stored (no thermal treatment in
 the container).
                                    III, IV-A............  do............................  70 [deg]F, 30 min.............
                                    V, VII...............  ..............................  do............................
                                    VI-A.................  ..............................  ..............................  120 [deg]F, 24 hr.
F. Refrigerated storage (no         I, II, III, IV-A, IV-  70 [deg]F, 48 hr..............  ..............................
 thermal treatment in the            B, VI-B,VII.
 container).
                                    VI-A.................  ..............................  ..............................  70 [deg]F, 48 hr.
G. Frozen storage (no thermal       I, II, III, IV-B, VII  70 [deg]F, 24 hr..............  ..............................
 treatment in the container).
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.


[[Page 188]]

    (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 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.

[[Page 189]]

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 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] 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

[[Page 190]]

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.
    (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

[[Page 191]]

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 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.

[[Page 192]]

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-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 2 [deg]F (water bath may be substituted).
    Incubator, inside dimensions (minimum) 19 x 19 
x 19 for use at 100 [deg]F2 [deg]F 
explosion proof (water bath may be substituted).
    Constant-temperature room or chamber 70 [deg]F2 [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.

[[Page 193]]

    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 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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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....................
  [alpha]-Methyl styrene polymer.......
  [alpha]-Methylstyrene-vinyltoluene     For use only in coatings that
   copolymer resins (molar ratio 1        contact food under conditions
   [alpha]-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 [alpha]-
                                          methylstyrene-vinyltoluene
                                          copolymer resins in the
                                          finished food-contact coating
                                          does not exceed 1.0 milligram
                                          per square inch of food-
                                          contact surface.

[[Page 194]]

 
  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.
  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 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 glycol..............
      Diethylene glycol................
      2,2-Dimethyl-1,3-propanediol.....
      Dipropylene glycol...............
      Ethylene glycol..................
      Glycerol.........................
      Mannitol.........................
      [alpha]-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 195]]

 
Siloxanes and silicones: platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     150 parts per million.
 containing dimethylpolysiloxane (CAS
 Reg. No. 68083-18-1 and CAS Reg. No.
 68083-19-2) with methylhydrogen
 polysiloxane (CAS Reg. No. 63148-57-2)
 and dimethylmethylhydrogen
 polysiloxane (CAS Reg. No. 68037-59-
 2). The following substances may be
 used as optional polymerization
 inhibitors:.
  3,5-Dimethyl-1-hexyne-3-ol (CAS Reg.
   No. 107-54-0), at a level not to
   exceed 0.53 weight percent;.
  1-Ethynylcyclohexene (CAS Reg. No.
   931-49-7), at a level not to exceed
   0.64 weight percent;.
    Bis(methoxymethyl)ethyl maleate
     (CAS Reg. No. 102054-10-4), at a
     level not to exceed 1.0 weight
     percent;.
  Methylvinyl cyclosiloxane (CAS Reg.
   No. 68082-23-5); and.
  Tetramethyltetravinylcyclotetrasiloxa
   ne (CAS Reg. No. 2554-06-5)..
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......................
    [alpha]-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 [alpha]-pinene, [beta]-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 methacrylate, sodium      For use only in copolymer
   salt Chemical Abstracts Service No.    coatings under conditions of
   1804-87-1].                            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................

[[Page 196]]

 
  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..................  ...............................
  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.........................
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
 4-isothiazolin-3-one (CAS Reg. No.       emulsion-based silicone
 2682-20-4) mixture, at a ratio of 3      coatings at a level not to
 parts to 1 part, respectively,           exceed 50 milligrams per
 manufactured from methyl-3-              kilogram (based on
 mercaptopropionate (CAS Reg. No. 2935-   isothiazolone active
 90-2) and optionally containing          ingredient) in the coating
 magnesium nitrate (CAS Reg. No. 10377-   formulation.
 60-3) at a concentration equivalent to
 the isothiazolone active ingredients
 (weight/weight)..
  1,2-Dibromo-2,4-dicyanobutane (CAS     For use as an antimicrobial
   Reg. No. 35691-65-7).                  agent at levels not to exceed
                                          500 milligrams per kilogram in
                                          emulsion-based silicone
                                          coating.
  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..............................
(iv) Preservatives:
  Silver chloride-coated titanium        For use only as a preservative
   dioxide.                               in latex emulsions at a level
                                          not to exceed 2.2 parts per
                                          million (based on silver ion
                                          concentration) in the dry
                                          coating.
------------------------------------------------------------------------


[[Page 197]]

    (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; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000]



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.
    (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

[[Page 198]]

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.
    (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

[[Page 199]]

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.
    (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 table 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.

[[Page 200]]

176.300 Slimicides.
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.

    Authority: 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, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 
2005.

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 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:

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Ammonium fructoheptonate..................
Ammonium glucoheptonate...................
Disodium ethylenediamine tetraacetate.....
Pentasodium salt of diethylenetriamine
 pentaacetate.

[[Page 201]]

 
Sodium fructoheptonate....................
Sodium glucoheptonate.....................
Tetrasodium ethylenediamine tetra acetate.
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.



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:

[[Page 202]]



------------------------------------------------------------------------
           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       additive at a level not in
 [deg]F, as determined by LVG-series      excess of 0.05 percent by
 Brookfield viscometer (or equivalent)    weight of dry fibers in the
 using a No. 2 spindle at 30 r.p.m.       finished paper and paperboard.
Acrylamide-[beta]-                       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 [beta]-                       and paperboard.
 methacrylyloxyethyltrimethylammonium
 methyl sulfate and containing less
 than 0.2% of residual acrylamide
 monomer.
Acrylic acid, sodium salt copolymer      For use only in paper mill
 with polyethyleneglycol allyl ether      boilers.
 (CAS Reg. No. 86830-15-1).
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
 [deg]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 [deg]C as
 determined by LVT-series Brookfield
 viscometer using a No. 4 spindle at 50
 r.p.m. (or by other equivalent method).
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.

[[Page 203]]

 
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 with
 No. 149564-62-5), ammonium zirconium     protein binders in coatings
 lactate-citrate (CAS Reg. No. 149564-    for paper and paperboard, at a
 64-7), ammonium zirconium lactate (CAS   level not to exceed 1.4
 Reg. No. 149564-63-6).                   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 [deg]C (75 [deg]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.
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        and G identified in table 2 of
 [deg]C (428 [deg]F), and the             paragraph (c) of this section.
 subsequent catalytic reduction of the
 resulting aromatic petroleum
 hydrocarbon resin. The resin meets the
 following specifications: softening
 point 85 [deg]C (185 [deg]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
 [deg]C (158 [deg]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, 100 Barr
 Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/ federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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/in\2\
                                          (0.0016 mg/cm\2\) 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.

[[Page 204]]

 
Bis(methoxymethyl)tetrakis-              For use only under the
 [(octadecyloxy)-methyl]melamine resins   following conditions:
 having a 5.8-6.5 percent nitrogen       1. As a water repellant
 content (CAS Reg. No. 68412-27-1).       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.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
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 Sec. Sec. 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.
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 [deg]C (72
 [deg]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 [deg]C (71.6 [deg]F), as
 determined by LVF-series Brookfield
 viscometer using a No. 1 spindle at 60
 r.p.m. (or by other equivalent method).

[[Page 205]]

 
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 [deg]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 [deg]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
 [deg]C as determined by Brookfield
 viscometer Model RVF, using a No. 1
 spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS   For use as a preservative at a
 Reg. No.10222-01-2)..                    level not to exceed 100 parts
                                          per million in coating
                                          formulations and in component
                                          slurries and emulsions, used
                                          in the production of paper and
                                          paperboard and coatings for
                                          paper and paperboard.
2,5-Di-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:
                                         1. As an adjuvant to control
                                          pulp absorbency and pitch
                                          content in the manufacture of
                                          paper and paperboard prior to
                                          the sheet-forming operation.
                                         2.In paper mill boilers.
Diethanolamine salts of mono- and bis    For use only as an oil and
 (1H,1H,2H,2H-perfluo roalkyl)            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).

[[Page 206]]

 
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 [deg]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 employed
 of dimethylamine may be replaced by an   before the sheet-forming
 equimolar amount of ethylenediamine      operation in the manufacture
 and in which the ratio of total amine    of paper and paperboard and
 to epichlorohydrin does not exceed       limited to use at a level not
 1:1. The nitrogen content of the         to exceed 1 percent by weight
 copolymer shall be 9.4 to 10.8 weight    of the finished paper and
 percent on a dry basis and a 10          paperboard.
 percent by weight aqueous solution of   2. At the size press at a level
 the final product has a minimum          not to exceed 0.017 percent by
 viscosity of 5.0 centipoises at 25       weight of the finished paper
 [deg]C, as determined by LVT-series      and paperboard.
 Brookfield 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.
 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 Sec. Sec. 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.

[[Page 207]]

 
Glyceryl lactostearate.................
Glyceryl mono-1,2-hydroxystearate......
Glyceryl monoricinoleate...............
Guar gum modified by treatment with      For use only as a retention aid
 [beta]-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      paper and paperboard fibers
 [deg]F, as determined by RV-series       intended for use in contact
 Brookfield viscometer (or equivalent)    with all types of foods,
 using a No. 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
 [alpha]-octadecenyl-omega-               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.
Hydroxymethyl-5,5-dimethylhydantoin      For use only as a preservative
 (CAS Reg. No. 27636-82-4), mixture       in clay-type fillers at a
 with 1,3-bis(hydroxymethyl)-5,5-         level not to exceed a combined
 dimethylhydantoin (CAS Reg. No. 6440-    total of 1,200 milligrams/
 58-0).                                   kilograms hydroxymethyl-5,5-
                                          dimethylhydantoin and 1,3-
                                          bis(hydroxymethyl)-5,5-
                                          dimethylhydantoin in the
                                          filler.
Hydroxypropyl guar gum having a minimum  For use only as a dry strength
 viscosity of 5,000 centipoises at 25     and formation aid agent
 [deg]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 200) with 12-           to the sheet forming operation
 hydroxystearic acid.                     in the manufacture of paper
                                          and paperboard.
Imidazolium compounds, 2-(C17 and C17-   For use only at a level not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
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.
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 [deg]C, as             exceed 1.5 percent by weight
 determined by LVF Model Brookfield       of the dry paper and
 viscometer using a No. 1 spindle at 60   paperboard.
 r.p.m. (or equivalent method).

[[Page 208]]

 
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..................
Monoisopropanolamine (CAS Reg. No. 78-   For use as a dispersant for
 96-6).                                   titanium dioxide suspensions
                                          at a level not to exceed 0.68
                                          percent by weight of titanium
                                          dioxide. The finished paper
                                          and paperboard will be used in
                                          contact with all food types
                                          under conditions of use E
                                          through G described in table 2
                                          of paragraph (c) of this
                                          section.
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[                 to exceed 0.44 percent
 ([gamma],[omega]-perfluoroC4-20          perfluoroalkyl actives by
 alkylthio) 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;
                                          and in contact with food of
                                          types III, IV-A, V, VII-A, and
                                          IX described in table 1 of
                                          paragraph (c) of this section
                                          under conditions of use C
                                          through G 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          paperboard intended for use in
 88[deg] C to 93[deg] C, as determined    contact only with raw fruits,
 by ASTM method D36-76, ``Standard Test   raw vegetables, and dry food
 Method for Softening Point of Bitumen    of the type identified under
 (Ring-and-Ball Apparatus);''             Type VIII of table 1 in
 penetration at 25[deg] C not to exceed   paragraph (c) of this section,
 0.3 mm, as determined by ASTM method     and provided that the asphalt
 D5-73 (Reapproved 1978), ``Standard      is used at a level not to
 Test Method for Penetration of           exceed 5% by weight of the
 Bituminous Materials,'' which are        finished dry paper and
 incorporated by reference (Copies may    paperboard fibers.
 be obtained from the American Society
 for Testing Materials, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html.); and maximum
 weight loss not to exceed 3% when
 distilled to 371[deg] C, nor to exceed
 an additional 1.1% when further
 distilled between 371[deg] 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-[beta]-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 209]]

 
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
 [deg]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/in\2\ 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
 [deg]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 [deg]C, as determined by
 Brookfield viscom eter 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 employed
 adipic acid with diethylenetriamine to   prior to the sheet-forming
 form a basic polyamide and further       operation in the manufacture
 reacting the polyamide with an           of paper and paperboard and
 epichlorohydrin and dimethylamine        limited to use at a level not
 mixture such that the finished resins    to exceed 0.12 percent by
 have a nitrogen content of 17.0 to       weight of dry paper or
 18.0 percent of a dry basis, and that    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 [deg]C, as         contact with food only of the
 determined by a Brookfield viscometer    types identified in paragraph
 using a No. 3 spindle at 30 r.p.m. (or   (c) of this section, table 1,
 equivalent 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.
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.
Polyamidoamine-ethyleneimine-            For use only as a retention aid
 epichlorohydrin resin prepared by        employed prior to the sheet-
 reacting hexanedioic acid, N-(2-         forming operation in the
 aminoethyl)-1,2-ethanediamine,           manufacture of paper and
 (chloromethyl)oxirane, ethyleneimine     paperboard at a level not to
 (aziridine), and polyethylene glycol,    exceed 0.12 percent resin by
 partly neutralized with sulfuric acid    weight of the finished dry
 (CAS Reg. No. 167678-45-7).              paper or paperboard.

[[Page 210]]

 
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
 25 [deg]C, as determined by a            section.
 Brookfield 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 prepoly mer 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 25 [deg]C, 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 [deg]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 [deg]C (68 [deg]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
 [deg]C (68 [deg]F), as determined by
 Brookfield HAT model viscometer using
 a No. 1H spindle at 50 r.p.m. (or
 equivalent method).
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-
 di chloroethane 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 [deg]C., as
 determined on a Brookfield HAT model
 viscometer using a No. 1H spindle at
 50 r.p.m. (or equivalent method).

[[Page 211]]

 
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 [deg]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 dichlor         paperboard, and used at a
 oethyl 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 [deg]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       Sec. Sec. 175.300, 178.3740
 Sec. 178.3740(b) of this chapter.      and 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 on a dry weight basis     level not to exceed 10 pounds
 and a minimum viscosity in a 40          of active polymer per ton of
 percent by weight aqueous solution of    finished paper and paperboard.
 1,000 centipoises at 25 [deg]C (77      2. As a pigment dispersant in
 [deg]F), determined by LVF Model         coatings at a level not to
 Brookfield Viscometer using a No. 3      exceed 3.5 pounds of active
 spindle at 30 r.p.m. (or equivalent      polymer per ton of finished
 method). The level of residual monomer   paper and paperboard.
 is not to exceed 1 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 8.660.4 percent on a dry basis and a      (10 parts per million) of
 minimum viscosity in a 15 weight-        influent water.
 percent aqueous solution of 10
 centipoises at 25 [deg]C (77 [deg]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 [deg]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
 [deg]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.
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 [deg]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.

[[Page 212]]

 
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 [deg]C as determined   not to exceed 0.3% by weight
 by 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 [deg]C, as             not to exceed 0.1% by weight
 determined by LV-series Brookfield       of coating solids.
 viscometer (or equivalent) using a No.
 2 spindle at 30 r.p.m.
Poly[(methylimino)(2-                    For use only as a retention aid
 hydroxytrimethylene)hydrochlo ride]      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[deg] C has a      additive at a level not in
 Stokes 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, 100
 Barr Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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[deg] C with a reduced        limited to use at a level not
 viscosity of not less than 0.15          to exceed 0.1 percent by
 deciliter per gram as determined by      weight of the finished dry
 ASTM method D1243-79, ``Standard Test    paper and paperboard fibers.
 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, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html.). 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.
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.

[[Page 213]]

 
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 [deg]F (94
                                          [deg]C).
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 [deg]C after 24 hours as           employed prior to the sheet-
 determined by RV-series Brookfield       forming operation in the
 viscometer (or equivalent) using a No.   manufacture of paper and
 4 spindle at 20 r.p.m. and using a       paperboard and used at a level
 test sample prepared by dissolving 8     not to exceed 1% by weight of
 grams of sodium carboxymethyl guar gum   finished dry paper or
 in 392 milliliters of 0.2-percent-by-    paperboard fibers.
 weight 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
 [deg]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   1. As a coating thickening
 30,000).                                 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 214]]

 
Synthetic wax polymer prepared by the    For use only as a component of
 catalytic po lymerization 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 [deg]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 ft\2\ 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 215]]

    (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.
2-Acrylamido-2-methyl-propanesulfonic    For use only in coatings at a
 acid, homopolymer, sodium salt (CAS      level not to exceed 0.01 mg/
 Reg. No. 35641-59-9).                    in\2\
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,        For use only:
 sodium salts (produced from n-alkanes   1. 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.
                                         2. 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.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
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.

[[Page 216]]

 
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.
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 in
 2682-20-4) mixture at a ratio of 3       paper coatings at a level not
 parts to 1 part, manufactured from       to exceed 50 parts per million
 methyl-3-mercaptopropionate (CAS Reg.    (based on isothiazolone active
 No. 2935-90-2). The mixture may          ingredients) in the coating
 contain magnesium nitrate (CAS Reg.      formulation.
 No. 10377-60-3) at a concentration      2. As an antimicrobial agent
 equivalent to the isothiazolone active   for finished coating
 ingredients (weight/weight).             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 [deg]C to 155 [deg]C as     in paragraph (c) of this
 determined by ASTM method E28-67         section, table 1, under Types
 (Reapproved 1982), ``Standard Test       VIII and IX.
 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, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html.), 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,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or available for inspection
 at the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.

[[Page 217]]

 
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.
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, 100 Barr Harbor Dr., West
 Conshohocken, Philadelphia, PA 19428-
 2959, or may be examined at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.
[alpha]-Methylstyrene-vinyltoluene
 copolymer resins (molar ratio 1[alpha]-
 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 218]]

 
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 [deg]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      a level not to exceed 30
 [deg]C minimum, as determined by ASTM    weight-percent of the coating
 method D611-82, ``Standard Test          solids.
 Methods for 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, 100 Barr Harbor
 Dr., West Conshohocken, Philadelphia,
 PA 19428-2959, or may be examined at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html.). Specific gravity
 0.96-0.99 (20 [deg]C/20 [deg]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 [deg]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
 [deg]C-92 [deg]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, sodium 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 [deg]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 and silicones; platinum-       For use only as a surface
 catalyzed reaction product of vinyl-     coating. Platinum content not
 containing dimethyl polysiloxane (CAS    to exceed 200 parts per
 Reg. Nos. 68083-19-2 and 68083-18-1)     million.
 with methyl hydrogen polysiloxane (CAS  1. In coatings for paper and
 Reg. No. 63148-57-2) or dimethyl         paperboard provided the
 (methyl hydrogen) polysiloxane (CAS      coating contacts food only of
 Reg. No. 68037-59-2). Diallyl maleate    the types identified in
 (CAS Reg No. 999-21-3), dimethyl         paragraph (c) of this section,
 maleate (CAS Reg. No. 624-48-6), 1-      table 1, under Types I, II,
 ethynyl-1-cyclohexanol (CAS Reg. No.     VI, and VII-B when used under
 78-27-3) and vinyl acetate (CAS Reg.     conditions of use E, F, and G
 No. 108-05-4) may be used as optional    described in table 2 of
 polymerization inhibitors.               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.

[[Page 219]]

 
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.....
Sodium xylenesulfonate (CAS Reg. No.     For use only in paper and
 1300-72-7).                              paperboard coatings at levels
                                          not to exceed 0.01 percent by
                                          weight of the finished paper
                                          and paperboard.
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 [beta]-nitrostyrene as a     paper or paperboard substrate.
 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 copol ymers. 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 220]]

 
Styrene-dimethylstyrene-[alpha]-         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 copol ymers 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, 100
 Barr Harbor Dr., West Conshohocken,
 Philadelphia, PA 19428-2959, or may be
 examined at the National Archives and
 Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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 copol ymers  For use only as coatings or
 containing not more than 40 weight       components of coatings.
 percent of vinylidene chloride in the
 finished copol ymers. 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.
[alpha][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 [alpha]-[p-(1,1,3,3-   vinyl acetate polymer with
 tetramethylbutyl)-phenyl]-omega-         ethylene and N-(hydroxymethyl)
 hydroxypoly (oxyethylene) with both      acrylamide intended for use in
 substances having a poly(oxyethylene)    coatings for paper and
 content averaging 3 moles.               paperboard intended for use in
                                          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.

[[Page 221]]

 
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.
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  1. Of the types identified in
 from N-(hydroxymethyl) acrylamide.       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 tri stearate   Do.
  Aluminum silicate (China clay).......   Do.
  Barium sulfate.......................   Do.
  Bentonite............................   Do.
  Bentonite, modified with                Do.
   dimethyldioctadecylammonium ion.
  Burnt umber..........................   Do.

[[Page 222]]

 
  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.
  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.

 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 [deg]F, 2    ...............  ...............  ..............
 sterilized (e.g., over 212                     hr.
 [deg]F).
                              III, IV-A, VII-  ......do.......  150 [deg]F, 2    ...............  ..............
                               A.                                hr.
B. Boiling water sterilized.  II, VII-B......  212 [deg]F, 30
                                                min.
                              III, VII-A.....  ......do.......  120 [deg]F, 30   ...............  ..............
                                                                 min.

[[Page 223]]

 
C. Hot filled or pasteurized  II, IV-B, VII-B  Fill boiling,    ...............  ...............  ..............
 above 150 [deg]F.                              cool to 100
                                                [deg]F.
                              III, IV-A, VII-  ......do.......  120 [deg]F, 15   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
D. Hot filled or pasteurized  II, IV-B, VI-B,  ...............  ...............  ...............  ..............
 below 150 [deg]F.
                              VII-B..........  150 [deg]F, 2    ...............  ...............  ..............
                                                hr.
                              III, IV-A, VII-  ......do.......  100 [deg]F, 30   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  150 [deg]F, 2    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   150 [deg]F, 2
                                                                                                             hr.
E. Room temperature filled    I, II, IV-B, VI- 120 [deg]F, 24   ...............  ...............  ..............
 and stored (no thermal        B, VII-B.        hr.
 treatment in the container).
                              III, IV-A, VII-  ......do.......  70 [deg]F, 30    ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  120 [deg]F, 24   ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............  120 [deg]F, 24
                                                                                                             hr.
F. Refrigerated storage (no   III, IV-A, VII-  70 [deg]F, 48    70 [deg]F, 30    ...............  ..............
 thermal treatment in the      A.               hr.              min.
 container).
                              I, II, IV-B, VI- ......do.......  ...............  ...............  ..............
                               B, VII-B.
                              VI-A...........  ...............  ...............  70 [deg]F, 48    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   70 [deg]F, 48
                                                                                                             hr.
G. Frozen storage (no         I, II, IV-B,     70 [deg]F, 24    ...............  ...............  ..............
 thermal treatment in the      VII-B.           hr.
 container).
                              III, VII-A.....  ......do.......  70 [deg]F, 30    ...............  ..............
                                                                 min.
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 [deg]F, 30   ...............  ...............  ..............
   emulsion of high- or low-   VII-B.           min.
   fat.
  2. Aqueous, high- or low-   III, IV-A, VII-  ......do.......  120 [deg]F, 30   ...............  ..............
   free oil or fat.            A, IX.                            min.
----------------------------------------------------------------------------------------------------------------
\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

[[Page 224]]

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 AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.); 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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.), 
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 (1.0 [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

[[Page 225]]

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).
    (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 ('). This ' 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 (') to obtain the zinc-
corrected 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.
    (b) Correction for wax, petrolatum, and mineral oil--(1) Apparatus. 
Standard 10 millimeter inside diameter x 60 centimeter chromatographic 
column (or

[[Page 226]]

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 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 (') to obtain the wax-, 
petrolatum-, and mineral oil-corrected 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.
    (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 (') to obtain the wax-, petrolatum-, and mineral oil-corrected 
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. 
(Note: In the case of chloroform-

[[Page 227]]

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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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, 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
------------------------------------------------------------------------
Acrylamide polymer with sodium 2-        For use at a level not to
 acrylamido-2-methylpropane-sulfonate     exceed 0.015 weight percent of
 (CAS Reg. No. 38193-60-1).               dry fiber.
(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/in\2\
                                          (0.0031 mg/cm\2\) 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.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
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.........

[[Page 228]]

 
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 National
 Archives and Records Administration
 (NARA). For information on the
 availability of this material at NARA,
 call 202-741-6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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..
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.
Imidazolium compounds, 2-(C17 and C17-   For use only at levels not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
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 ethers of mono-, di-, and
 tripropylene glycol..

[[Page 229]]

 
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.................................
[beta]-Nitrostyrene....................  Basic polymer.
Octadecanoic acid, reaction products     For use prior to sheet forming
 with 2-[(2-aminoethyl)amino]ethanol      at levels not to exceed 12
 and urea (CAS Reg. No. 68412-14-6),      pounds per ton of paper.
 and the acetate salts thereof (CAS
 Reg. No. 68784-21-4), which may be
 emulsified with ethoxylated tallow
 alkyl amines (CAS Reg. No. 61791-26-2).
[alpha]-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..
[alpha]-(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..
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 is prepared by reacting
 equimolar amounts of adipic acid and
 three amines (21 mole percent of 1,2-
 ethanediamine, 51 mole percent of N-(2-
 aminoethyl)-1,3-propanediamine, and 28
 mole percent of N, N'-1,2-
 ethanediylbis(1,3-propanediamine)) to
 form a basic polyamidoamine which is
 modified by reaction with
 ethyleneimine (5.5:1.0
 ethyleneimine:polyamidoamine). The
 modified polyamidoamine is reacted
 with a crosslinking agent made by
 condensing approximately 34 ethylene
 glycol units with
 (chloromethyl)oxirane, followed by pH
 adjustment with formic acid or
 sulfuric acid to provide a finished
 product as a formate (CAS Reg. No.
 114133-44-7) or a sulfate (CAS Reg.
 No. 167678-43-5), having a weight-
 average molecular weight of 1,300,000
 and a number-average molecular weight
 of 16,000..

[[Page 230]]

 
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-[alpha]-hydro-
 omega-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....
Polyethylene glycol monoisotridecyl      For use only as a surfactant at
 ether sulfate, sodium salt (CAS Reg.     levels not to exceed 3 percent
 No. 150413-26-6).                        in latex formulations used in
                                          pigment binders for paper and
                                          paperboard.
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.
 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
 K2Ti4O9 and K2Ti 6O13..

[[Page 231]]

 
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.
[alpha]-[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..
[alpha]-[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]

    Editorial Note: For additional Federal Register citations affecting 
Sec. 176.180, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and at www.fdsys.gov.



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.

[[Page 232]]

    (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...................
[alpha]-(Dinonylphenyl)-[omega]-hydroxy- For use only in defoaming
 poly(oxy-1,2-ethanediyl), containing 7   agents for the production of
 to 24 moles of ethylene oxide per mole   styrene-butadiene coatings at
 of dinonylphenol (CAS Reg. No. 9014-93-  a level not to exceed 0.05
 1).                                      percent by weight of the
                                          finished coating.
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.......................
Naphtha................................
[beta]-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...........................

[[Page 233]]

 
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.

[42 FR 14554, Mar. 15, 1977, as amended at 62 FR 39772, July 24, 1997]



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.
    (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,

[[Page 234]]

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 tetra sodium 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.
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.

[[Page 235]]

Morpholine.
Myristyl alcohol.
Naphtha.
[beta]-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 hex ano ate).
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, meth yl hy drogen, reaction products 
with polyethylene-polypropylene glycol mono allyl 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.
[alpha]-[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.
    (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.

[[Page 236]]



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.
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.
[beta]-Bromo-[beta]-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.........................

[[Page 237]]

 
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.............
4,5-dichloro-1, 2-dithiol-3-one (CAS     For use only at levels not to
 Reg. No. 1192-52-5).                     exceed 10 milligrams per
                                          kilogram in the pulp slurry.
1,3-Dihalo-5,5-dimethylhydantoin (where  At a maximum level of 1.0
 the dihalo (halogen) may be bromine      kilogram (kg) per 1,000 kg of
 and/or chlorine) that may contain no     dry weight fiber.
 more than 20 weight percent 1,3-dihalo-
 5-ethyl-5-methylhydantoin (where the
 dihalo (halogen) may be bromine and/or
 chlorine)..
4-(Diiodomethylsulfonyl) toluene (CAS    At a maximum level of 0.2 pound
 Reg. No. 20018-09-1)..                   per ton (100 grams/1,000
                                          kilograms) of dry weight
                                          fiber.
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-[[alpha]-(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.
Tetrakis(hydroxymethyl)phosphonium       Maximum use level of 84 mg/kg
 sulfate (CAS Reg. No. 55566-30-8).       in the pulp slurry. The
                                          additive may also be added to
                                          water, which when introduced
                                          into the pulp slurry, results
                                          in a concentration in the pulp
                                          slurry not to exceed 84 mg/kg.
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-tetra methyl butyl)-o-phenylene]] 
bis[omega-hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene 
oxide per hydroxyl group.
Monomethyl ethers of mono-, di-, and tri propyl ene 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; 64 FR 46130, Aug. 24, 
1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, June 30, 2000; 65 FR 
70790, Nov. 28, 2000; 69 FR 24512, May 4, 2004]

[[Page 238]]



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 copolymer.
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.
177.1211 Cross-linked polyacrylate copolymers.
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 iso pht ha late/tere phtha 
          late 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.
177.1556 Polyaryletherketone 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).

[[Page 239]]

177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) 
          resins.
177.1640 Polystyrene and rubber-modified polystyrene.
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.
177.2415 Poly(aryletherketone) resins.
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 Polymethylmethacrylate/poly(tri methoxysilylpropyl) 
          methacrylate copolymers.
177.2470 Polyoxymethylene copolymer.
177.2480 Polyoxymethylene homopolymer.
177.2490 Polyphenylene sulfide resins.
177.2500 Polyphenylene sulfone 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: 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, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 
2001, 68 FR 15355, Mar. 31, 2003, and 70 FR 72074, Dec. 1, 2005.

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.

[[Page 240]]

Methyl acrylate.
Methyl methacrylate.

    (2) Copolymers produced by copolymerizing one or more of the 
monomers listed in paragraph (a)(1) of this section with one or more of 
the following monomers:

Acrylonitrile.
Methacrylonitrile.
[alpha]-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-hydroxy hydro cinna mate (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.

[[Page 241]]

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.
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 0.5-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[micro]. 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[micro]. 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[micro]. 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[micro].
    (iii) Duplicate ultraviolet blank determinations shall be run on 
samples of each solvent that has been exposed to the temperature-time 
conditions of the

[[Page 242]]

extraction test without the plastic sample. An aliquot of the exposed 
solvent shall be measured versus the unexposed solvent in the reference 
cell. The average difference in the absorbances at any wavelength in the 
region of 245 to 310 m[micro] 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[micro] 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[micro] 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

[[Page 243]]

the p-methoxyphenol solution in the reference beam. Spectro photo metric 
measurement is conducted as in paragraph (c)(7)(iv) of this section. The 
absorbance reading in the region 544-552 m[micro] 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[micro] 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

    (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[micro] 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)

[[Page 244]]

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 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[micro]. The spectrum is scanned on the absorbance 
scale from 700 m[micro] to 500 m[micro] in such a way that the region 
544 m[micro] to 552 m[micro] 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[micro] in 5-
centimeter silica spectro photo metric absorption cells versus a 
distilled water reference. The absorbance at the wavelength of maximum 
absorbance (should be about 285 m[micro]) 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[micro] 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]

[[Page 245]]



Sec. 177.1020  Acrylonitrile/butadiene/sty rene co-polymer.

    Acrylonitrile/butadiene/styrene copolymer identified in this section 
may 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
                                             [beta]-(2-
                                             Hydroxyethylmercapto)
                                             propionitrile,'' which is
                                             incorporated by reference.
                                             Copies are available from
                                             the Bureau of Foods (HFS-
                                             200), Food and Drug
                                             Administration, 5100 Paint
                                             Branch Pkwy., College Park,
                                             MD 20740, or available for
                                             inspection at the National
                                             Archives and Records
                                             Administration (NARA). For
                                             information on the
                                             availability of this
                                             material at NARA, call 202-
                                             741-6030, or go to: http://
                                             www.archives.gov/
                                             federal_register/
                                             code_of_federal_regulations/
                                             ibr_locations.html.
------------------------------------------------------------------------

    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 246]]

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 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
                                             [beta]-(2-Hydroxyethylmerca
                                             pto) propionitrile,'' which
                                             is incorporated by
                                             reference. Copies are avail
                                             able from the Bureau of
                                             Foods (HFS-200), Food and
                                             Drug Administration, 5100
                                             Paint Branch Pkwy., College
                                             Park, MD 20740, or
                                             available for inspection at
                                             the National Archives and
                                             Records Administration
                                             (NARA). For information on
                                             the availability of this
                                             material at NARA, call 202-
                                             741-6030, or go to: http://
                                             www.archives.gov/
                                             federal_register/
                                             code_of_federal_regulations/
                                             ibr_locations.html.
------------------------------------------------------------------------

    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 247]]

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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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]



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 [deg]C (150
 table 2 of Sec. 176.170(c) of                                      [deg]F).
 this chapter.                                                       The extracted
                                                                      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 [deg]C (150
                                                                      [deg]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 [deg]C
 copolymer produced by                                                exceed 2.0 ppm in   (77 [deg]F) is 10cP.
 polymerization of 45-65 parts                                        aqueous extract     \1\
 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 [deg]C (200                                             a U.S. Standard
 [deg]F)), C, D, E, F, G                                              Sieve No. 6 and
 described in table 2 of Sec. that will be held
 176.170(c) of this 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\

[[Page 248]]

 
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
 copolymer produced by             the basis of                       to exceed 0.01 mg/  [deg]C (73 [deg]F) for
 polymerization of 66-72 parts     the weight of                      in \2\ surface      the finished article
 by weight of acrylonitrile and    the                                area of the food    is 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 [deg]C (150
 described in table 2 of Sec. [deg]F).
 176.170(c) of this chapter.                                         The extracted
                                                                      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 [deg]C (150
                                                                      [deg]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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records
  Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go
  to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
\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), 5100 Paint Branch Pkwy., College
  Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information
  on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
  federal_register/code_of_federal_regulations/ibr_locations.html.
\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), 5100 Paint Branch Pkwy., College Park, MD 20740,
  and the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
  2959, or may be examined at the National Archives and Records Administration (NARA). For information on the
  availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/
  code_of_federal_regulations/ibr_locations.html.

    (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:

[[Page 249]]



------------------------------------------------------------------------
                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 [beta]-
                                             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, 5100 Paint
                                             Branch Pkwy., College Park,
                                             MD 20740, or available for
                                             inspection at the National
                                             Archives and Records
                                             Administration (NARA). For
                                             information on the
                                             availability of this
                                             material at NARA, call 202-
                                             741-6030, or go to: http://
                                             www.archives.gov/
                                             federal_register/
                                             code_of_federal_regulations/
                                             ibr_locations.html.
------------------------------------------------------------------------

    (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 the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (d) Extractives limitations. The following extractives limitations 
are determined by an infrared spectro photo metric method titled 
``Infrared Spectro photo metric Determination of Polymer Extracted from 
Borex [reg] 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. Copies 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

[[Page 250]]

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, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (d) Limitations. (1) The n-alkyl glutar imide/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.

[[Page 251]]

    (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-diethyl ene 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..........................
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.

[[Page 252]]

 
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 National Archives
 and Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html.), 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.
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.
[alpha]-Methylstyrene-vinyltoluene
 copolymer resins (molar ratio 1[alpha]-
 methylstyrene to 3 vinyltoluene).
Mineral oil, white.....................
Mono- and bis-(octadecyldiethylene       For use only as a release agent
 oxide) phosphates (CAS Reg. No. 62362-   at a level not to exceed 0.6
 49-6).                                   percent by weight of coatings
                                          for cellophane.
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......................

[[Page 253]]

 
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.
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........................

[[Page 254]]

 
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; 
64 FR 57978, Oct. 28, 1999]



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

[[Page 255]]

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 AOAC INTERNATIONAL, 481 North
 Frederick Ave., Suite 500,
 Gaithersburg, MD 20877-2504 and the
 Center for Food Safety and Applied
 Nutrition (HFS-200), Food and Drug
 Administration, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 available for inspection at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.
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.
Di-2-ethylhexyl terephthalate (CAS Reg.  For use as a plasticizer at
 No. 006422-86-2)..                       levels not exceeding 75 parts
                                          per hundred by weight of
                                          permitted vinyl chloride homo-
                                          and/or copolymer resins used
                                          in contact with food of Types
                                          I, II, IV-B, VI-A, VI-B, VI-C
                                          (up to 15 percent alcohol by
                                          volume), VII-B, and VIII
                                          described in Sec. 176.170(c)
                                          of this chapter, table 1, and
                                          under conditions of use A
                                          through H described in Sec.
                                          176. 170 (c) of this chapter,
                                          table 2.
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-[beta]-naphthyl-p-phenylenediamine..  1 percent.
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.

[[Page 256]]

 
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).
[alpha]-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.
Polyurethane resins manufactured from    For use only:
 diphenylmethane diisocyanate, 1,4-       No limitation on amount used,
 butanediol, and adipic acid (CAS Reg.    but for use only in closure
 No. 26375-23-5)..                        gasket compositions used in
                                          contact with food types VI-A
                                          and VI-C (up to 15 percent
                                          alcohol) under conditions of
                                          use D, E, F, and G, as
                                          described in Sec. 176.170(c)
                                          of this chapter, tables 1 and
                                          2, respectively.
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.
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).

[[Page 257]]

 
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,                   50          500           50
 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............
2. Preformed overall discs or              50          250           50
 annular rings of plasticized
 polymers, including unvulcanized
 natural or synthetic rubber.....
3. Preformed overall discs or              50           50           50
 annular rings of vulcanized
 plasticized polymers, including
 natural or synthetic rubber.....
4. Preformed overall discs or              50          250           50
 annular rings of polymeric or
 resinous-coated paper,
 paperboard, plastic, or metal
 foil substrates.................
5. Closures with sealing gaskets        (\1\)        (\1\)        (\1\)
 or sealing compositions as
 described in 1, 2, 3, and 4, and
 including paper, paperboard, and
 glassine used for dry foods only
------------------------------------------------------------------------
\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 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:

[[Page 258]]

    A. Containing alcohol.
    B. Nonalcoholic.
VII. Bakery products.
VIII. Dry solids (no end-test required).

[[Page 259]]



 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)                                             Heptane\1\ (time and            8% alcohol (time and
                                                            Water (time and temperature)            temperature)                    temperature)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. High temperature heat-           I, IV-B..............  250 [deg]F, 2 hr..............  ..............................
 sterilized (e.g., over 212
 [deg]F).
                                    III, IV-A, VII.......  do............................  150 [deg]F, 2 hr..............
B. Boiling water-sterilized.......  II...................  212 [deg]F, 30 min............  ..............................
                                    III, VII.............  do............................  120 [deg]F, 30 min............
C. Hot filled or pasteurized above  II, IV-B.............  Fill boiling, cool to 100       ..............................
 150 [deg]F.                                                [deg]F.
                                    III, IV-A............  do............................  120 [deg]F, 15 min............
                                    V....................  ..............................  do............................
D. Hot filled or pasteurized below  II, IV-B, VI-B.......  150 [deg]F, 2 hr..............  ..............................
 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      II, IV-B, VI-B.......  120 [deg]F, 24 hr.............  ..............................
 stored (no thermal treatment in
 the container).
                                    III, IV-A............  do............................  70 [deg]F, 30 min.............
                                    V....................  ..............................  do............................
                                    VI-A.................  ..............................  ..............................  120 [deg]F, 24 hr.
F. Refrigerated storage (no         I, II, III, IV-A, IV-  70 [deg]F, 48 hr..............  70 [deg]F, 30 min.............
 thermal treatment).                 B, VI-B,VII.
                                    VI-A.................  ..............................  ..............................  70 [deg]F, 48 hr.
G. Frozen storage (no thermal       I, II, III, IV-B, VII  70 [deg]F, 24 hr..............  ..............................
 treatment in the container).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.



[[Page 260]]

[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; 65 FR 26745, May 9, 2000; 65 FR 
52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 
2011]



Sec. 177.1211  Cross-linked polyacrylate copolymers.

    Cross-linked polyacrylate 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 in accordance with the following 
prescribed conditions:
    (a) Identity. For the purpose of this section, the cross-linked 
polyacrylate copolymers consist of:
    (1) The grafted copolymer of cross-linked sodium polyacrylate 
identified as 2-propenoic acid, polymers with N,N-di-2-propenyl-2-
propen-1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft 
(CAS Reg. No. 166164-74-5); or
    (2) 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2-
propenyl)oxy)methyl)-1,3-propanediyl di-2-propenoate and sodium 2-
propenoate (CAS Reg. No. 76774-25-9).
    (b) Adjuvants. The copolymers identified in paragraph (a) of this 
section may contain optional adjuvant substances required in the 
production of such copolymers. The 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) Extractives limitations. The copolymers identified in paragraph 
(a) of this section, in the finished form in which they will contact 
food, must yield low molecular weight (less than 1,000 Daltons) 
extractives of no more than 0.15 percent by weight of the total polymer 
when extracted with 0.2 percent by weight of aqueous sodium chloride 
solution at 20 [deg]C for 24 hours. The low molecular weight extractives 
shall be determined using size exclusion chromatography or an equivalent 
method. When conducting the extraction test, the copolymer, with no 
other absorptive media, shall be confined either in a finished absorbent 
pad or in any suitable flexible porous article, (such as a ``tea bag'' 
or infuser), under an applied pressure of 0.15 pounds per square inch 
(for example, a 4x6 inch square pad is subjected to a 1.6 kilograms 
applied mass). The solvent used shall be at least 60 milliliters aqueous 
sodium chloride solution per gram of copolymer.
    (d) Conditions of use. The copolymers identified in paragraph (a)(1) 
of this section are limited to use as a fluid absorbent in food-contact 
materials used in the packaging of frozen or refrigerated poultry. The 
copolymers identified in paragraph (a)(2) of this section are limited to 
use as a fluid absorbent in food-contact materials used in the packaging 
of frozen or refrigerated meat and poultry.

[64 FR 28098, May 25, 1999, as amended at 65 FR 16817, Mar. 30, 2000]



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 iso phtha late 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-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

[[Page 261]]

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 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

[[Page 262]]

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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 263]]



----------------------------------------------------------------------------------------------------------------
                                                            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-             square inch) of                         percent (by
 acid with a mixture containing    tetrachloroethane   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 [deg]C (180                        beverages and
 trans isomer, 30 percent cls      determined by       [deg]F) and                             beer. Conditions
 isomer).                          using a Wagner      allowed to cool                         of hot fill not
                                   viscometer (or      to 48.9 [deg]C                          to exceed 82.2
                                   equivalent) and     (120 [deg]F) in                         [deg]C (180
                                   calculated from     contact with the                        [deg]F), storage
                                   the following       food-contact                            at temperatures
                                   equation:           article.                                not in excess of
                                   Inherent                                                    48.9 [deg]C (120
                                   viscosity =                                                 [deg]F). No
                                   (Natural                                                    thermal treatment
                                   logarithm of (Nr)/                                          in the container.
                                   (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 [deg]C
                                                       (180 [deg]F) and
                                                       allowed to cool
                                                       to 48.9 [deg]C
                                                       (120 [deg]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
                                                       [deg]C (120
                                                       [deg]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
                                                       [deg]C (120
                                                       [deg]F).

[[Page 264]]

 
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 [deg]C (150    foods including
 reaction product of dimethyl                          micrograms per      [deg]F) for 2       carbonated
 terephthalate or terephthalic                         square inch) of     hours:              beverages.
 acid with a mixture containing                        food-contact        terephthaloyl       Conditions of hot
 99 to 85 mole percent ethylene                        surface of the      moieties do not     fill not
 glycol and 1 to 15 mole percent                       oriented            exceed 0.09         exceeding 87.8
 of 1,4-cyclohexane-di-methanol                        copolymer when      microgram per       [deg]C (190
 (70 percent trans isomer, 30                          extracted with      square centimeter   [deg]F), storage
 percent cls isomer).                                  water added at      (0.60 microgram     at temperatures
                                                       87.8 [deg]C (190    per square inch)    not in excess of
                                                       [deg]F) and         of food-contact     48.9 [deg]C (120
                                                       allowed to cool     surface.            [deg]F). No
                                                       to 48.9 [deg]C                          thermal treatment
                                                       (120 [deg]F) in                         in the 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 [deg]C
                                                       (190 [deg]F) and
                                                       allowed to cool
                                                       to 48.9 [deg]C
                                                       (120 [deg]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
                                                       [deg]C (120
                                                       [deg]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 [deg]C (150
                                                       volume) aqueous                         [deg]F) for 20
                                                       ethanol heated to                       minutes. Storage
                                                       65.6 [deg]C (150                        at temperatures
                                                       [deg]F) for 20                          not in excess of
                                                       minutes and                             48.9 [deg]C (120
                                                       allowed to cool                         [deg]F).
                                                       to 48.9 [deg]C
                                                       (120 [deg]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 [deg]C (120
                                                       percent (by                             [deg]F). No
                                                       volume) aqueous                         thermal treatment
                                                       ethanol at 48.9                         in the container.
                                                       [deg]C (120
                                                       [deg]F) for 24
                                                       hours.

[[Page 265]]

 
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).
----------------------------------------------------------------------------------------------------------------

    (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

[[Page 266]]

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, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (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

[[Page 267]]

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 
inch \1\ (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 10 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 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 50 percent.
---------------------------------------------------------------------------

    (ii) Alternatively, the net acidified chloroform-soluble extractives 
shall not exceed 0.05 milligram/square inch \3\ (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.
---------------------------------------------------------------------------

    \3\ See footnote 2 to paragraph (d)(2)(i) of this section.
---------------------------------------------------------------------------

    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-

[[Page 268]]

temperature exaggeration over normal use, follow the applicable 
extraction procedure.
    (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 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, 5100 Paint Branch Pkwy., College Park, MD 
20740, and the American Society for Testing Materials, 100 Barr Harbor 
Dr., West Conshohocken, Philadelphia, PA 19428-2959, respectively, or 
may be examined at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 269]]

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).
    (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.
------------------------------------------------------------------------


[[Page 270]]

    (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.
    (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 iso phtha late/ tere
phtha late 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 1.330.02 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, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (2) Softening point. Ethylene/1,3-phenylene oxyethylene 
isophthalate/terephthalate copolymer identified in

[[Page 271]]

paragraph (a) of this section has a softening point of 635 [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, VII-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; 62 FR 34628, June 27, 1997]



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)(1) 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:
    (i) Substances generally recognized as safe in food and food 
packaging.
    (ii) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, prior sanction, or 
approvals.
    (iii) 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.
    (iv) Erucamide as identified in Sec. 178.3860 of this chapter.
    (v) 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.
    (vi) 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.
    (2) Maleic anhydride-grafted ethylene-vinyl acetate copolymers (CAS 
Reg. No. 28064-24-6) consist of basic resins produced by the catalytic 
copolymerization of ethylene and vinyl acetate, followed by reaction 
with maleic anhydride. Such polymers shall contain not more than 11 
percent of polymer units derived from vinyl acetate by weight of total 
polymer prior to reaction with maleic anhydride, and not more than 2 
percent of grafted maleic anhydride by weight of the finished polymer. 
Optional adjuvant substances that may be added to the copolymers include 
substances generally recognized as safe in food and food packaging, 
substances the use of which is permitted under applicable regulations in 
parts 170 through 189 of this chapter, and substances identified in 
Sec. 175.300(b)(3)(xxv), (xxvii), (xxxiii), and (xxx) of this chapter 
and colorants for polymers used in accordance with the provisions of 
Sec. 178.3297 of this chapter.
    (b)(1) 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

[[Page 272]]

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.
    (2) Maleic anhydride grafted ethylene-vinyl acetate copolymers shall 
have a melt flow index not to exceed 2.1 grams per 10 minutes as 
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). Copies may 
be obtained from the American Society for Testing Materials, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the 
Division of Petition Control (HFS-215), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Compliance of the melt 
flow index specification shall be determined using conditions and 
procedures corresponding to those described in the method as Condition 
E, Procedure A). The copolymers shall be used in blends with other 
polymers at levels not to exceed 17 percent by weight of total polymer, 
subject to the limitation that when contacting food of types III, IV-A, 
V, VI-C, VII-A, and IX, identified in Sec. 176.170(c) of this chapter, 
Table 1, the polymers shall be used only under conditions of use C, D, 
E, F, and G, described in Sec. 176.170(c) of this chapter, Table 2.
    (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; 64 FR 47108, Aug. 30, 1999]



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

[[Page 273]]

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.
    (3) Those copolymers containing 17 to 40 percent ethylene and 60 to 
83 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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 Methods 
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 ethylene-vinyl acetate-vinyl alcohol oligomers not to exceed 
0.093 milligram per square centimeter (0.6 milligram per square inch) of 
food contact surface as determined by a method entitled ``Analytical 
Method of Determining the Amount of EVOH in the Extractives Residue of 
EVOH Film,'' dated March 23, 1987, as developed by the Kuraray Co., 
Ltd., 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 Office of 
Premarket Approval (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's

[[Page 274]]

Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 
65 FR 17135, Mar. 31, 2000]



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 
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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 275]]

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 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) Nylon MXD-6 resins that comply with item 10.3 of the table in 
Sec. 177.1500(b) of this chapter when extracted with water and heptane 
under the conditions of time and temperature specified for condition of 
use A, as set forth in Table 2 of Sec. 176.170(c) of this chapter.
    (f) Nylon \6/12\ resins (CAS Reg. No. 25191-04-2) complying with 
item 13.3 of the table in Sec. 177.1500(b), for use as nonfood-contact 
layers of laminated films and in rigid multilaminate constructions with 
polypropylene outer layers. Laminate structures with authorized food-
contact materials yield no more than 0.15 milligrams of epsilon-
caprolactam and 0.04 milligrams of omega-laurolactam per square inch 
when extracted with 95 percent ethanol at 121 [deg]C (250 [deg]F) for 2 
hours.
    (g) 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:

[[Page 276]]

    (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:
    (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).
    (vii) Polyester-polyurethane resin-acid dianhydride adhesives for 
use at temperatures not to exceed 121 [deg]C (250 [deg]F), in contact 
only with food Types I, II, VIA, VIB, VIIB, and VIII as described in 
Table I of Sec. 176.170 of this chapter, and formulated from the 
following mixture:
    (a)(1) Polyesterpolyurethanediol 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). Additionally, 
dimethylol propionic acid and 1,6-hexanediol may be used alone or in 
combination as reactants in lieu of a polybasic acid and a polyhydric 
alcohol.

[[Page 277]]

    (2) Acid dianhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-
5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No. 
73003-90-4), comprising not more than one percent of the cured adhesive.
    (b) Urethane cross-linking agent, comprising not more than twelve 
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) and/or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 363-48-31).
    (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), (c)(2)(ii), (c)(2)(iii), (c)(2)(iv), and (c)(2)(vii) of this 
section shall not exceed 0.0016 milligram per square centimeter (0.01 
milligram per square inch) as determined by a method entitled 
``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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, and may be examined at the Center for Food Safety and 
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 not exceed 0.008 milligram per square 
centimeter (0.05 milligram per square inch) as determined by a method 
entitled, ``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.

[[Page 278]]

    (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; 63 
FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, 1999; 64 FR 46272, Aug. 25, 
1999; 69 FR 15668, Mar. 26, 2004]



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 copolymer (CAS   polyethylene terephthalate
 Reg. No. 87365-98-8) complying with Sec. as the food-contact layer,
  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 [deg]C (212
                                             [deg]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 [deg]C (212 [deg]F)
                                             for 5 hours.
Nylon 6/66 resins complying with Sec. For use only with:
 177.1500(b), item 4.2 of this chapter      1. Nonalcoholic foods at
 (CAS Reg. 24993-04-2).                      temperatures not to exceed
                                             82.2 [deg]C (180 [deg]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 [deg]C
                                             (180 [deg]F) for 5 hours.
                                            2. Nonalcoholic foods at
                                             temperatures not to exceed
                                             100 [deg]C (212 [deg]F).
                                             Laminate films with
                                             authorized food-contact
                                             materials yield no more
                                             than 0.15 milligram of
                                             epsilon-caprolactam per
                                             square inch when extracted
                                             with water at 100 [deg]C
                                             (212 [deg]F) for 5 hours.

[[Page 279]]

 
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
                                             [deg]C (212 [deg]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; 62 FR 53957, Oct. 
17, 1997]



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 280]]

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 or polypropylene                                     [deg]F.
 complying with Sec. 177.1520, and
 in polystyrene complying with Sec.
 177.1640.
3. Used as components of nonfood        300 to 5,000............  40 to 20,000 seconds Saybolt at 200         40
 articles complying with Sec. Sec. [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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, as amended at 63 FR 36175, July 2, 1998]



Sec. 177.1440  4,4'-Isopropylidenediphenol-epichlorohydrin 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.

[[Page 281]]

    (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:

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

[[Page 282]]

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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 [reg] 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.Copies 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 (d) 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 43.10.2 
weight percent hexamethyl-enediamine, 35.31.2 
weight percent adipic acid, and 21.61.2 weight 
percent terephthalic acid.

[[Page 283]]

    (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.
    (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 alpha-(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 
34.41.5 weight percent omega-laurolactam, 
26.80.4 weight percent isophthalic acid, and 
38.80.5 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.
    (15) Nylon 46 resins (CAS Reg. No. 50327-77-0) are manufactured by 
the condensation of 1,4-butanediamine and adipic acid.
    (16) Nylon resins PA 6-3-T (CAS Registry No. 26246-77-5) are 
manufactured by the condensation of 50 mol percent 1,4-
benzenedicarboxylic acid, dimethyl ester and 50 mol percent of an 
equimolar mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-
trimethyl-1,6-hexanediamine.
    (b) Specifications:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Maximum extractable fraction in
                                                                                                                        selected solvents (expressed in
                                                      Melting                                                             percent by weight of resin)
                                         Specific      point       Solubility in boiling                              ----------------------------------
             Nylon resins                 gravity     (degrees            4.2N HC1             Viscosity No. (mL/g)               95
                                                    Fahrenheit)                                                                percent   Ethyl
                                                                                                                        Water   ethyl   acetate  Benzene
                                                                                                                               alcohol
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Nylon 66 resins....................  1.14140 using the      3.0
 specified in 21 CFR 177.1395 of this   minus 110..........   0.007     0.64    0.003        0
 use (excluding bottles) in contact     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

[[Page 289]]

(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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA-6-3-T 
resins 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 by reference. The availability of this 
incorporation by reference is given in paragraph (d)(5)(i) of this 
section.

[42 FR 14572, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
177.1500, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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)(i) Polypropylene consists of basic polymers manufactured by the 
catalytic polymerization of propylene.
    (ii) Propylene homopolymer consists of basic polymers manufactured 
by the catalytic polymerization of propylene with a metallocene 
catalyst.
    (2)(i) Polyethylene consists of basic polymers manufactured by the 
catalytic polymerization of ethylene.
    (ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6) 
consists of basic polymers manufactured by the catalytic polymerization 
of ethylene followed by reaction with fumaric acid in the absence of 
free radical initiators. Such polymers shall contain grafted fumaric 
acid at levels not to exceed 2 percent by weight of the finished 
polymer.
    (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.
    (3) Olefin basic copolymers manufactured by the catalytic 
copolymerization of ethylene and pentene-1 shall contain not less than 
90 weight-percent of polymer units derived from ethylene.
    (4) Olefin basic copolymers manufactured by the catalytic 
polymerization of ethylene and octene-1 shall contain not less than 50 
weight-percent of polymer units derived from ethylene.

[[Page 290]]

    (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 from 6 to 18 carbon 
atoms. Such olefin basic copolymers shall contain not less than 95 molar 
percent of polymer units derived from 4-methylpentene-1, except that 
copolymers manufactured with 1-alkenes having from 12 to 18 carbon atoms 
shall contain not less than 97 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.
    (vi) Olefin basic copolymers (CAS Reg. No. 61615-63-2) manufactured 
by the catalytic copolymerization of ethylene and propylene with 1,4-
hexadiene, followed by reaction with fumaric acid in the absence of free 
radical initiators. Such polymers shall contain not more than 4.5 
percent of polymer units deriving from 1,4-hexadiene by weight of total 
polymer prior to reaction with fumaric acid and not more than 2.2 
percent of grafted fumaric acid by weight of the finished polymer.
    (vii) Ethylene and 2-norbornene (CAS Reg. No. 26007-43-2) copolymers 
that shall contain not less than 30 and not more than 70 mole percent of 
polymer units derived from 2-norbornene.
    (4) Poly(methylpentene) consists of basic polymers manufactured by 
the catalytic polymerization of 4-methylpentene-1.
    (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:

[[Page 291]]



------------------------------------------------------------------------
               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 [deg]C (428          polymer may be used in contact
 [deg]F), and the subsequent catalytic    with food Types I, II, IV-B,
 hydrogenation of the resulting           VI-A through VI-C, VII-B, and
 aromatic petroleum hydrocarbon resin,    VIII identified in table 1 of
 having a minimum softening point of      Sec. 176.170(c) of this
 110 [deg]C (230 [deg]F), as determined   chapter and under conditions
 by ASTM Method E 28-67 (Reapproved       of use B through H described
 1982), ``Standard Test Method for        in table 2 of Sec.
 Softening Point by Ring-and-Ball         176.170(c) of this chapter;
 Apparatus,'' and a minimum aniline       and with food Types III, IV-A,
 point of 107 [deg]C (225 [deg]F), as     V, VII-A, and IX identified in
 determined by ASTM Method D 611-82,      table 1 of Sec. 176.170(c)
 ``Standard Test Methods for Aniline      of this chapter and under
 Point and Mixed Aniline Point of         conditions of use D through G
 Petroleum Products and Hydrocarbon       described in table 2 of Sec.
 Solvents,'' both of which are            176.170(c) of this chapter.
 incorporated by reference in
 accordance with 5 U.S.C. 552(a) and 1
 CFR part 51. Copies are available from
 the American Society for Testing and
 Materials, 100 Barr Harbor Dr., West
 Conshohocken, Philadelphia, PA 19428-
 2959, or from the Center for Food
 Safety and Applied Nutrition (HFS-
 200), Food and Drug Administration,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or may be examined at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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,
                                          5100 Paint Branch Pkwy.,
                                          College Park, MD 20740, or
                                          available for inspection at
                                          the National Archives and
                                          Records Administration (NARA).
                                          For information on the
                                          availability of this material
                                          at NARA, call 202-741-6030, or
                                          go to: http://www.archives.gov/
                                          federal_register/
                                          code_of_federal_regulations/
                                          ibr_locations.html.
Methyl methacrylate/butyl acrylate-      For use only at levels not to
 grafted polypropylene copolymer          exceed 6 percent by weight of
 containing methyl methacrylate/butyl     olefin polymers complying with
 acrylate-grafted polypropylene (CAS      paragraph (c) of this section,
 Reg. No. 121510-09-6), methyl            items 1.1, 3.1a, 3.2a, and
 methacrylate/butyl acrylate copolymer    3.2b, where the copolymers
 (CAS Reg. No. 25852-37-3), methyl        complying with items 3.1a,
 methacrylate homopolymer (CAS Reg. No.   3.2a, and 3.2b contain not
 9011-14-7), and polypropylene (CAS       less than 85 weight-percent of
 Reg. No. 9003-07-0), resulting from      polymer units derived from
 the reaction of a mixture of methyl      propylene.
 methacrylate and butyl acrylate with
 polypropylene. The finished product
 contains no more than 55 percent by
 weight of polymer units derived from
 methyl methacrylate and butyl acrylate
 as determined by a method entitled,
 ``Determination of the Total Acrylic
 in PP-MMA/BA Polymers,'' 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, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or may
 be examined at the Center for Food
 Safety and Applied Nutrition's
 Library, 5100 Paint Branch Pkwy.,
 College Park, MD 20740, or at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..

[[Page 292]]

 
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 [deg]C minimum as determined by   paragraph (c), item 3.2 of
 ASTM 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 [deg]C, as   finished polymer may be used
 determined by ASTM Method D 3236-88,     in contact with (1) Food types
 ``Standard Test Method for Apparent      I, II, IV-B, VI-A, VI-B, VII-
 Viscosity of Hot Melt Adhesives and      B, and VIII identified in
 Coating Materials,'' both of which are   table 1 of Sec. 176.170(c)
 incorporated by reference in             of this chapter and under
 accordance with 5 U.S.C. 552(a) and 1    conditions of use C through G
 CFR part 51. Copies are available from   described in table 2 of Sec.
 the American Society for Testing and     176.170(c) of this chapter;
 Materials, 100 Barr Harbor Dr., West     and (2) food types III, IV-A,
 Conshohocken, Philadelphia, PA 19428-    V, VI-C, VII-A, and IX
 2959, or from the Center For Food        identified in table 1 of Sec.
 Safety and Applied Nutrition (HFS-        176.170(c) of this chapter
 200), Food and Drug Administration,      and under conditions of use D
 5100 Paint Branch Pkwy., College Park,   through G described in table 2
 MD 20740, or may be examined at the      of Sec. 176.170(c) of this
 National Archives and Records            chapter.
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
Polymethylsilsesquioxane (CAS Reg. No.   For use only as a surface
 68554-70-1).                             lubricant or anti-blocking
                                          agent in films.
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,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or may be examined at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.

[[Page 293]]

 
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, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or may
 be examined at the National Archives
 and Records Administration (NARA). For
 information on the availability of
 this material at NARA, call 202-741-
 6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or may be examined at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
------------------------------------------------------------------------

    (c) Specifications:

----------------------------------------------------------------------------------------------------------------
                                                                                 Maximum
                                                                               extractable      Maximum soluble
                                                                                fraction           fraction
                                                        Melting Point (MP)    (expressed as      (expressed as
                                                        or softening point     percent by      percent by weight
           Olefin polymers                 Density         (SP) (Degrees      weight of the     of polymer) in
                                                           Centigrade)--     polymer) in N-        xylene at
                                                                                hexane at          specified
                                                                                specified        temperatures
                                                                              temperatures
----------------------------------------------------------------------------------------------------------------
  1.1a. Polypropylene described in    0.880-0.913       MP: 160[deg]-180    6.4 pct at        9.8 pct at 25
   paragraph (a)(1)(i) of this                           [deg]C.             reflux            [deg]C
   section                                                                   temperature
  1.1b. Propylene homopolymer         0.880-0.913-      MP: 150[deg]-180    6.4 pct at        9.8 pct at 25
   described in paragraph (a)(1)(ii)                     [deg]C.             reflux            [deg]C
   of this section                                                           temperature
1.2. Polypropylene, noncrystalline;   0.80-0.88
 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, noncrystalline,   0.80-0.88         SP:115[deg]-138
 for use only: To plasticize                             [deg]C.
 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     11.3 pct at 25
 articles that contact food except                                           [deg]C            [deg]C
 for articles used for packing or
 holding food during cooking

[[Page 294]]

 
2.2. Polyethylene for use in          0.85-1.00         ..................  2.6 pct at 50      Do.
 articles used for packing or                                                [deg]C
 holding food during cooking
2.3. Polyethylene for use only as     0.85-1.00         ..................  53 pct at 50      75 pct at 25
 component of food-contact coatings                                          [deg]C            [deg]C
 at levels up to and including 50
 percent by weight of any mixture
 employed as a food-contact coating
2.4. Olefin polymers described in
 paragraph (a)(2)(ii) of this
 section, having a melt flow index
 not to exceed 17 grams/per 10
 minutes as determined by the method
 described in paragraph (d)(7) of
 this section, for use in blends
 with other polymers at levels not
 to exceed 20 percent by weight of
 total polymer, subject to the
 limitation that when contacting
 food of types III, IV-A, V, VI-C,
 VII-A, and IX identified in Sec.
 176.170(c) of this chapter, Table
 1, the polymers shall be used only
 under conditions of use C, D, E, F,
 and G, described in Sec.
 176.170(c) of this chapter, Table
 2.
3.1a. Olefin copolymers described in  0.85-1.00         ..................  5.5 pct at 50     30 pct at 25
 paragraph (a)(3)(i) of this section                                         [deg]C            [deg]C
 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)(a)(3) of this section and
 listed in item 3.1c of this table
 and 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 described in  0.9-1.00          ..................   Do                Do.
 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
3.1c. Olefin copolymers described in  Not less than
 paragraph (a)(3)(i)(a)(3) of this     0.92
 section for use in contact with
 food only under conditions of use
 B, C, D, E, F, G, and H described
 in Sec. 176.170(c) of this
 chapter, table 2; except that such
 copolymers when used in contact
 with food of the types identified
 in Sec. 176.170(c), table 1,
 under types III, IVA, V, VIIA, and
 IX, shall be used only under
 conditions of use D, E, F, and G
 described in Sec. 176.170(c) of
 this chapter, table 2

[[Page 295]]

 
3.2a. Olefin copolymers described in  0.85-1.00         ..................  2.6 pct at 50      Do.
 paragraph (a)(3)(i) of this section                                         [deg]C
 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 described in   Do.
 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
3.2c. Olefin copolymers described in   0.85-0.92
 paragraph (a)(3)(i)(a)(4) of this
 section have a melt flow index no
 greater than 50 grams per 10
 minutes as determined by the method
 described in paragraph (d)(7) of
 this section. Articles manufactured
 using these polymers may be used
 with all types of food under
 conditions of use C through H as
 described in table 2 of Sec.
 176.170(c) of this chapter
3.3a. Olefin copolymers described in
 paragraph (a)(3)(ii) of this
 section and manufactured with 1-
 alkenes having from 6 to 10 carbon
 atoms
3.3b. Olefin copolymers 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.

[[Page 296]]

 
3.4. Olefin copolymers, primarily     0.85-0.90
 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, primarily     0.85-0.90
 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 described in   Not less than
 paragraph (a)(3)(v) of this section   0.88
 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

[[Page 297]]

 
3.7. Ethylene/propylene copolymers,   Not less than
 meeting the identity described in     0.86
 paragraph (a)(3)(i) of this
 section, containing not less than
 80 mole-percent of polymer units
 derived from ethylene and having a
 minimum viscosity average molecular
 weight of 95,000 as determined by
 the method described in paragraph
 (d)(5) of this section, and a
 minimum Mooney viscosity of 13 as
 determined by the method described
 in paragraph (d)(6) of this
 section. Ethylene/propylene
 copolymers described in this item
 3.7 are to be used only in blends
 with other olefin polymers
 complying with this section, at
 levels not to exceed 30 percent by
 weight of the total polymer blend,
 and in contact with food only of
 types identified in Sec.
 176.170(c) of this chapter, Table
 1, under Types I, II, III, IV-B,
 VI, VII, VIII, and IX.
 Additionally, optional adjuvants
 permitted for use in olefin
 copolymers complying with item 3.4
 of this table may be used in the
 production of this copolymer
3.8. Olefin polymers described in
 paragraph (a)(3)(vi) of this
 section, having a melt flow index
 not to exceed 9.2 grams per 10
 minutes as determined by the method
 described in paragraph (d)(7) of
 this section, for use in blends
 with other polymers at levels not
 to exceed 8 percent by weight of
 total polymer, subject to the
 limitation that when contacting
 food of types III, IV-A, V, VI-C,
 VII-A, and IX, identified in Sec.
 176.170(c) of this chapter, Table
 1, the polymers shall be used only
 under conditions of use C, D, E, F,
 and G, described in Sec.
 176.170(c) of this chapter, Table
 2.
3.9. Olefin copolymers described in   Not less than
 paragraph (a)(3)(vii) of this         1.0
 section may only be used in contact
 with dry foods, Type VIII, as
 identified in Sec. 176.170(c) of
 this chapter, Table 1
4. Poly(methylpentene)                0.82-0.85         MP: 235[deg]-250    6.6 pct at        7.5 pct at 25
                                                         [deg]C.             reflux            [deg]C
                                                                             temperature
5. Polyethylene copolymer described   Not less than     ..................  0.45 pct at 15    1.8 pct at 25
 in paragraph (a)(5) of this section   0.94                                  [deg]C            [deg]C
 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 or greater   ..................  1.36 pct at 50    2.28 pct at 25
 copolymers described in paragraph                                           [deg]C            [deg]C
 (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
 [deg]C (120 [deg]F)
----------------------------------------------------------------------------------------------------------------

    (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.

[[Page 298]]

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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 fraction. The

[[Page 299]]

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. Spec tro grade 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 300]]

    (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/in\2\, 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]C 5 [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]C 5 [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 301]]

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]C0.5 [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-
[beta]- 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]C 0.5 [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 302]]


    (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]C 
0.1 [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 10\4\ 
parts per million oxygen.
    (c) Procedure. Transfer 5 grams 0.001 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 0.1 [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 303]]

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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.) 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.
Olefin polymers described in paragraph   Condition E, procedure A.
 (a)(2)(ii) of this section.
Olefin polymers described in paragraph   Condition E, procedure A.
 (a)(3)(vi) 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.

[[Page 304]]

    (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 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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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 [deg]C
                                             (700 [deg]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.

[[Page 305]]

    (2) Melt-viscosity. (i) The per fluoro carbon resins identified in 
paragraph (a)(1) of this section shall have a melt viscosity of not less 
than 10\4\ poises at 380 [deg]C (716 [deg]F) 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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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 10\4\ 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
---------------------------------------------------------------------------

    (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

[[Page 306]]

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 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. 177.1556  Polyaryletherketone resins.

    The poly(oxy-1,4-phenylenecarbonyl-1,4-phenyleneoxy-1,4-
phenylenecarbonyl-1,4-phenylenecarbonyl-1,4-phenylene) resins (CAS Reg. 
No. 55088-54-5 and CAS Reg. No. 60015-05-6 and commonly referred to as 
polyaryletherketone 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, subject to the provisions of this 
section.
    (a) Identity. Polyaryletherketone resins consist of basic resins 
produced by reacting 4,4'-diphenoxy benzophenone and terephthaloyl 
dichloride in such a way that the finished resins have a minimum weight 
average molecular weight of 20,000 grams per mole, as determined by 
light scattering measurements in sulfuric acid at room temperature.
    (b) Optional adjuvant substances. The basic polyaryletherketone 
resins identified in paragraph (a) of this section may contain optional 
adjuvant substances required in the production of such basic resins. 
These adjuvants may include substances used in accordance with Sec. 
174.5 of this chapter and the following:
    (1) Benzoyl chloride, poly(tetrafluoro ethylene).
    (2) [Reserved]
    (c) Extractive limitations. The finished food-contact article yields 
net total extractives in each extracting solvent not to exceed 0.052 
milligram per square inch (corresponding to 0.008 milligram per square 
centimeter) of food-contact surface, when extracted at reflux 
temperature for 2 hours with the following solvents: Distilled water, 50 
percent (by volume) ethyl alcohol in

[[Page 307]]

distilled water, 3 percent acetic acid (by weight) in distilled water, 
and n-heptane.
    (d) In testing the finished food-contact article made of 
polyaryletherketone resin, use a separate test sample for each required 
extracting solvent.

[61 FR 42381, Aug. 15, 1996]



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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 at 100 [deg]C (212 [deg]F), and n-heptane at 
65.6 [deg]C (150 [deg]F).

    Note: In testing the finished poly aryl sulfone 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

[[Page 308]]

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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (iii) Density. Poly-1-butene resins have a density of 0.904 to 0.920 
gms/cm\3\, and butene/ethylene copolymers have a density of 0.890 to 
0.916 gms/cm\3\ 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 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'-isopro 
pylidenediphenol.
    (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

[[Page 309]]

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 finished 
resins are composed of 45 to 85 molepercent ester, of which up to 55 
mole-percent is the terephthaloyl isomer. The resins are manufactured 
using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1 
and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or 
greater. The resins are also properly identified by CAS Reg. No. 114096-
64-9 when produced with the use of greater than 2 but not greater than 5 
weight percent p-cumylphenol (CAS Reg. No. 599-64-4), as an optional 
adjuvant substance in accordance with paragraph (b)(2) of this section.
    (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.

[[Page 310]]

    (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 resins shall comply with either or both of the 
following specifications:
    (i) The solution intrinsic viscosity of the polyestercarbonate 
resins shall be a minimum of 0.44 deciliter per gram, as determined by a 
method entitled ``Intrinsic Viscosity (IV) of Lexan [reg] 
Polyestercarbonate 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 Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (ii) A minimum weight-average molecular weight of 27,000, as 
determined by gel permeation chromatography using polystyrene standards.
    (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 poly ester carbonate 
resins. Poly ester carbonate 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, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999]



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 (oxytetramethylene) and/or 1,4-

[[Page 311]]

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, 
100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or 
may be examined at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 ethylene-methyl acrylate 
basic copolymers, containing no more than 25 weight percent of polymer 
units derived from methyl acrylate, are made

[[Page 312]]

to react in an aqueous medium with one or more of the following 
substances:

Ammonium hydroxide.
Calcium carbonate.
Potassium hydroxide.
Sodium hydroxide.

    (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 1method 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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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

[[Page 313]]

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]



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 Sec. Sec. 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 
Sec. Sec. 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

[[Page 314]]

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, 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:
Acrylic copolymers (CAS Reg. No. 30394-86-6): Prepared by reaction of 
ethyl acrylate (CAS Reg. No. 140-88-5), methyl methacrylate (CAS Reg. 
No. 80-62-6), and methacrylamide (CAS Reg. No. 79-39-0) blended with 
melamine-formaldehyde resin (CAS Reg. No. 68002-20-0). For use in 
coatings for polyethylene phthalate films complying with paragraph (a) 
of this section.--
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 (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection, at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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.

[[Page 315]]

    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.
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 [alpha]-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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    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/in\2\ 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 
0.5 mg/in\2\ 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.

[[Page 316]]

    (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/in\2\ 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/inch \2\ 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/inch \2\ 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/inch \2\ 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/in \2\.
    (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/in \2\.
    (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; 61 FR 46718, Sept. 5, 1996]



Sec. 177.1632  Poly(phenyl enetereph thala mide) 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.

[[Page 317]]

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.
Poly(oxyethylene/oxypropylene)mono
 butylether (CAS Reg. No. 9038-95-3).
Poly(oxyethylene) mono(nonylphenyl)ether
 (CAS Reg. No. 9016-45-9).
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, as amended at 69 FR 24512, May 4, 2004]



Sec. 177.1635  Poly(p-methylstyrene) and rubber-modified poly(p-methyl
styrene).

    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

[[Page 318]]

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 Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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. 177.1637  
Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

    Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) 
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 conditions:
    (a) Identity. For the purpose of this section, poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 
24968-11-4) are polymers formed by catalytic transesterification of 2,6-
dimethylnaphthalene dicarboxylate with ethylene glycol followed by 
catalytic polycondensation.
    (b) Specifications--(1) Density. The density of poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be 
between 1.33 and 1.40 grams per cubic centimeter.
    (2) Inherent viscosity. The finished food-contact article shall have 
a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 
0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/
weight) solution of p-chlorophenol/tetrachloroethane/phenol. The 
viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-
5, ``Determination of Dilute Solution Viscosity of Polyesters,'' dated 
May 31, 1988, 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-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration

[[Page 319]]

(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet 
of resin when extracted with water at 121 [deg]C (250 [deg]F) for 2 
hours shall yield total nonvolatile extractives not exceeding 2.0 
micrograms per square inch of exposed resin surface.
    (d) Conditions of use. The finished food contact article shall be:
    (1) Used in contact only with food of Types I, II, IVB, VIA, VIB, 
VIIB, and VIII identified in table 1 of Sec. 176.170(c) of this 
chapter, under conditions of use A through H described in table 2 of 
Sec. 176.170(c) of this chapter; and with food of Types III, IVA, V, 
VIC, VIIA, and IX identified in table 1 of Sec. 176.170(c) of this 
chapter, under conditions of use C through H described in table 2 of 
Sec. 176.170(c) of this chapter; and
    (2) Identified in a manner that will differentiate the article from 
articles made of other polymeric resins to facilitate collection and 
sorting.

[61 FR 14965, Apr. 4, 1996]



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.
    (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.

[[Page 320]]

    (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 
2x10\2\.
    (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 standardxpeak 
area of sample/Peak area of monomer standardxsample weight in gramsx30

    (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..............
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.

[[Page 321]]

 
Sodium dibutyl naphthalene sulfonate...  Wetting agent.
Sodium hydrosulfide....................
Sodium polysulfide.....................
[beta],[beta]',[gamma],[gamma]'-         Cross-linking agent.
 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, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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 are:
    (1) Poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-
phenyleneisopropylidene-p-phenylene) resins (CAS Reg. No. 25154-01-2) 
consisting 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; or
    (2) 1,1'-Sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (minimum 92 percent) and 4,4'-
sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0) 
produced when a mixture of 4,4'-isopropylidenediphenol (minimum 92 
percent) and 4,4'-sulfonylbis[phenol] (maximum 8 percent) is made to 
react with 4,4'-dichlorodiphenyl sulfone in such a way that the finished 
resin has a minimum number average molecular weight of 26,000, as 
determined by osmotic pressure in dimethylformamide.
    (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 in
                                         paragraph (a)(1) of this
                                         section.
Monochlorobenzene.....................  Not to exceed 500 parts per
                                         million as residual solvent in
                                         finished basic resin in
                                         paragraph (a)(1) of this
                                         section.
N-methyl-2-pyrrolidone................  Not to exceed 0.01 percent (100
                                         parts per million) as residual
                                         solvent in finished basic resin
                                         in paragraph (a)(2) of this
                                         section.
------------------------------------------------------------------------

    (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

[[Page 322]]

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; 61 FR 29475, June 
11, 1996]



Sec. 177.1660  Poly (tetra methyl ene tere phtha late).

    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 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(tetra methy lene tere phtha late) 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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this

[[Page 323]]

material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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:
    (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 - tri methyl cyclo hexyl 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).[alpha]-Hydro-[omega]-
hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1).
[alpha]-Hydro-omega-hydroxypoly (oxy tetra methyl ene).
[alpha],[alpha]'-(Isopropylidenedi-p-phenylene)bis[omega-hydroxypoly 
(oxy pro pylene)(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).
[alpha],[alpha]'[alpha]'',[alpha]'''-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.
[alpha],[alpha]',[alpha]''-1,2,3-Propanetriyltris [omega-hydroxypoly 
(oxypropylene) (15-18 moles)], average molecular weight 3,000.
Propylene glycol.
[alpha],[alpha]',[alpha]''-[Propylidynetris (methylene)] tris [omega-
hydroxypoly (oxypropylene) (minimum 1.5 moles)], minimum molecular 
weight 400.
[alpha]-[[rho](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.

[[Page 324]]

 
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-hydroxy hydro cinna mate)]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).
------------------------------------------------------------------------

    (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, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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 [deg]C (-  0.0039 mg/cm\2\    0.002 mg/cm\2\
 with 1,3-butadiene; for use as               soluble in      144 [deg]F)    (0.025 mg/in\2\)   (0.01 mg/in\2\)
 articles or as components of                 toluene.        to -71         of surface at      of surface at 66
 articles that contact food of                                [deg]C (-96    reflux             [deg]C (150
 Types I, II, IV-B, VI, VII-B,                                [deg]F) and    temperature for    [deg]F) for 2 hr
 and VIII identified in table 1                               86 [deg]C      30 min on a 0.19   on a 0.19 cm
 in Sec. 176.170(c) of this                                 (187 [deg]F)   cm (0.075 in)      (0.075 in) thick
 chapter under conditions of                                  to 122         thick sample.      sample.
 use D, E, F, and G described                                 [deg]C (252
 in table 2 in Sec. [deg]F).
 176.170(c) of this chapter.

[[Page 325]]

 
(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.
2. Styrene block polymers with       29,000  ......do......  -65 [deg]C (-  0.002 mg/cm\2\     0.002 mg/cm\2\
 2-methyl-1,3-butadiene; for                                  85 [deg]F)     (0.01 mg/in\2\)    (0.01 mg/in\2\)
 use as articles or as                                        to -47         of surface at      of surface at 66
 components of articles that                                  [deg]C (-53    reflux             [deg]C (150
 contact food of Types I, II,                                 [deg]F) and    temperature for    [deg]F) for 2 hr
 IV-B, VI, VII-B, and VIII                                    86 [deg]C      2 hr on a 0.071    on a 0.071 cm
 identified in table 1 in Sec. (187 [deg]F)   cm (0.028 in)      (0.028 in) thick
  176.170(c) of this chapter.                                 to 122         thick sample.      sample.
                                                              [deg]C (252    (Optionally,       (Optionally,
                                                              [deg]F).       maximum net        maximum net
                                                                             residue soluble    residue soluble
                                                                             in chloroform      in chloroform
                                                                             shall not exceed   shall not exceed
                                                                             0.00020 mg/cm\2\   0.00040 mg/cm\2\
                                                                             (0.0013 mg/        (0.0025 mg/
                                                                             in\2\) of          in\2\) of
                                                                             surface.).         surface.)
3. (i) Styrene block polymers        16,000  ......do......  -50 [deg]C (-  0.002 mg/cm\2\     0.002 mg/cm\2\
 with 1,3-butadiene,                                          58 [deg]F)     (0.01 mg/in\2\)    (0.01 mg/in\2\)
 hydrogenated (CAS Reg. No.                                   to -30         of surface at      of surface at 66
 66070-58-4): for use as                                      [deg]C (-22    reflux             [deg]C (150
 articles or as components of                                 [deg]F) and    temperature for    [deg]F) for 2 hr
 articles that contact food of                                92 [deg]C      2 hr on a 0.071    on a 0.071 cm
 Types I, II, IV-B, VI, VII-B,                                (198 [deg]F)   cm (0.028 in)      (0.028 in) thick
 and VIII identified in table 1                               to 98 [deg]C   thick sample.      sample.
 in Sec. 176.170(c) of this                                 (208 [deg]F).
 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), 100

[[Page 326]]

Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.) 
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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.), 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 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:

[[Page 327]]



----------------------------------------------------------------------------------------------------------------
                                                                                 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)                                                will be held on    a U.S. standard
 of this chapter under                                                       a U.S. standard    sieve No. 20.
 conditions of use B, C, D, E,                                               sieve No. 20.
 F, G, and H 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
 99-9) containing not more than                                              temperature for    [deg]F) for 2
 15 percent maleic anhydride                                                 1 hour utilizing   hours 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:
    (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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 328]]

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.
 terephthalate resins.                       177.1630.
(2) Fibryls prepared from vinyl chloride-   As the basic polymer.
 vinyl acetate copolymer.
(3) Adjuvant substance, dimethylformamide.  As a solvent in the
                                             preparation of fibryl.
------------------------------------------------------------------------

    (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.

[[Page 329]]



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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 0.5 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

[[Page 330]]

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 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.

[[Page 331]]

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)xnormality 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 Sec. Sec. 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 methyl cellulose and trichloroethylene 
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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 332]]

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 cylcoHhexanone 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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.
    (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

[[Page 333]]

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 cyclo hexanone 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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 334]]

    (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 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

[[Page 335]]

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 
titrationxnormality of silver nitrate solution.
C=milliliters of silver nitrate solution used in blank 
titrationxnormality 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 
titrationxnormality of silver nitrate solution.
E=milliliters of silver nitrate solution used in blank 
titrationxnormality 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.

[[Page 336]]

    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 337]]

    (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/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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-

[[Page 338]]

2959, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, chloro sulfonated.

    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, chloro sulfonated is produced by chloro 
sulfonation of a carbon tetrachloride solution of polyethylene with 
chlorine and sulfuryl chloride.
    (b) Ethylene polymer, chloro sulfonated 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 [reg] 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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959. Copies of the other two methods are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740. Copies of all three methods may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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

[[Page 339]]

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.
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

[[Page 340]]

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 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

[[Page 341]]

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'-Isopropyl idenedi phenol epichloro hydrin thermo 
setting 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 epi chloro hydrin.
    (b) The resin may contain one or more of the following optional 
substances provided the quantity used 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
 epichlorohydrin with mixed dimers and       weight 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]

[[Page 342]]



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. 26658-70-8) 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

[[Page 343]]

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 [reg] 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, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 hydroxide..........................  For use as catalyst.
Calcium stearate..........................  For use as lubricant.
Carbon black (channel process)............
Diatomaceous earth........................
Glass fiber...............................
Hexamethylenetetramine....................  For use as curing agent.
Mica......................................
Oxalic acid...............................  For use as catalyst.

[[Page 344]]

 
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. 177.2415  Poly(aryletherketone) resins.

    Poly(aryletherketone) 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 subject to the provisions 
of this section.
    (a) Identity. For the purposes of this section, 
poly(aryletherketone) resins are poly(p-oxyphenylene p-oxyphenylene p-
carboxyphenylene) resins (CAS Reg. No. 29658-26-2) produced by the 
polymerization of hydroquinone and 4,4'-difluorobenzophenone, and have a 
minimum weight-average molecular weight of 12,000, as determined by gel 
permeation chromatography in comparison with polystyrene standards, and 
a minimum mid-point glass transition temperature of 142 [deg]C, as 
determined by differential scanning calorimetry.
    (b) Optional adjuvant substances. The basic resins identified in 
paragraph (a) may contain optional adjuvant substances used in their 
production. These adjuvants may include substances described in Sec. 
174.5(d) of this chapter and the following:

------------------------------------------------------------------------
                 Substance                           Limitations
------------------------------------------------------------------------
Diphenyl sulfone..........................  Not to exceed 0.2 percent by
                                             weight as a residual
                                             solvent in the finished
                                             basic resin.
------------------------------------------------------------------------

    (c) Extractive limitations. The finished food contact article, when 
extracted at reflux temperatures for 2 hours with the following four 
solvents, yields in each extracting solvent net chloroform soluble 
extractives not to exceed 0.05 milligrams per square inch of food 
contact surface: Distilled water, 50 percent (by volume) ethanol in 
distilled water, 3 percent acetic acid in distilled water, and n-
heptane. In testing the final food contact article, a separate test 
sample shall be used for each extracting solvent.

[63 FR 20315, Apr. 24, 1998]



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-epi chloro hydrin.
Mannitol.
a-Methyl glucoside.

[[Page 345]]

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.
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.............
  [alpha]-Methylstyrene................

[[Page 346]]

 
  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 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, chlori nated.

    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-methyl 
ethyl idene)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, 100 Barr Harbor Dr., 
West Conshohocken, Philadelphia, PA 19428-2959, 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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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:

[[Page 347]]



------------------------------------------------------------------------
            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 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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 348]]

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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.).
    (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:
    (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; 70 FR 40880, July 15, 2005; 70 
FR 67651, Nov. 8, 2005]



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 than 0.30 
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

[[Page 349]]

reference, modified as follows. Copies of the incorporation by reference 
may be obtained from the American Society for Testing Materials, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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:

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; 
63 FR 8852, Feb. 23, 1998]



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(tri meth 
oxy silyl propyl)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]

[[Page 350]]



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 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-hydroxy hydro cinnamate) (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) Poly oxy meth ylene 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (d) Extractive limitations. (1) Poly oxy methylene 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

[[Page 351]]

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 homopolymer.

    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 homo 
poly mer 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:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
Hexamethylenebis(3,5-di-tert-butyl-4-       At a maximum level of 1
 hydroxy-hydrocinnamate) (CAS Reg. No.       percent by weight of
 35074-77-2).                                homopolymer. 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) Poly oxy methy lene homo polymer 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, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (d) Extractive limitations. (1) Polyoxymethylene homopolymer, in the 
finished form which is to contact

[[Page 352]]

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, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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) Poly oxy methy lene 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 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 353]]

    (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. 177.2500  Polyphenylene sulfone resins.

    The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1) 
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, subject to the provisions of this section.
    (a) Identity. For the purpose of this section, polyphenylene sulfone 
resins consist of basic resin produced by reacting polyphenylene sulfide 
with peracetic acid such that the finished resins meet the 
specifications set forth in paragraph (c) of this section. The 
polyphenylene sulfide used to manufacture polyphenylene sulfone is 
prepared by the reaction of sodium sulfide and p-dichlorobenzene, and 
has a minimum weight average molecular weight of 5,000 Daltons.
    (b) Optional adjuvant substances. The basic polyphenylene sulfone 
resins identified in paragraph (a) of this section may contain optional 
adjuvant substances required in the production of such basic resins. 
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, or substances used in 
accordance with a prior sanction or approval.
    (c) Specifications. The glass transition temperature of the polymer 
is 3605 [deg]C as determined by the use of 
differential scanning calorimetry.

[65 FR 15058, Mar. 21, 2000]



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 regulation. (Note: In testing the finished food-contact article, 
use a separate test sample for each required extracting solvent.)

[[Page 354]]

    (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 with all types of liquid food at temperatures up to 80 
[deg]C (176 [deg]F).

[[Page 355]]

    (2) Reverse osmosis membranes described in paragraph (a)(4) of this 
section may be used in contact with 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 either: (1) Not more 
than 10 percent trans olefinic unsaturation and no [alpha], [beta]-
olefinic unsaturation as determined by a method entitled ``Determination 
of Residual [alpha], [beta]-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; or (2) 0.4 
percent to 20 percent olefinic unsaturation and Mooney viscosities 
greater than 45 (ML 1 + 4 @ 100 [deg]C), as determined by ASTM Standard 
Method D1646-92, ``Standard Test Method for Rubber--Viscosity and 
Vulcanization Characteristics (Mooney Viscometer),'' which are both 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of these methods may be obtained from the Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, 
MD 20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/

[[Page 356]]

code_of_federal_regulations/ibr_locations.html. A copy of ASTM Standard 
Method D1646-92 may also be obtained from the American Society for 
Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428-
2959.
Isobutylene-isoprene copolymer.
Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 prepared 
by reacting a copolymer of omega-laurolactam and adipic acid with 
poly(tetramethylene ether glycol). The polyamide and polyether 
components are reacted in ratios such that the polyamide component 
constitutes a minimum of 30 weight-percent of total polymer units. The 
copolymers may be used in contact with foods of Types I, II, III, IV, V, 
VI, VII, VIII, and IX identified in table 1 of Sec. 176.170(c) of this 
chapter at temperatures not to exceed 150 [deg]F except that those 
copolymers prepared with less than 50 weight-percent of polyamide are 
limited to use in contact with such foods at temperatures not to exceed 
100 [deg]F.
Polybutadiene.
Polyester elastomers derived from the reaction of dimethyl 
terephthalate, 1,4-butanediol, and [alpha]-hydro-omega-hydroxypoly 
(oxytetramethylene). Additionally, trimethyl trimellitate may be used as 
a reactant. The polyester elastomers may be used only in contact with 
foods containing 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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    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.

[[Page 357]]

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(4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a 
crosslinking agent in silicone polymers and elastomers identified under 
paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by 
weight of such polymers and elastomers where the total of all 
accelerators does not exceed 1.5 percent by weight of rubber product.
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibu ty ldithio carb amic 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 pyro cate cholbo rate.
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.
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-triazine (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, dibuty lamine salt (dibu tylammo nium 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).

[[Page 358]]

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-[beta]-naphthyl-p-phenylenediamine.
Phenyl-a-naphthylamine.
Phenyl-[beta]-naphthylamine.
Phenyl-[beta]-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.

    (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.

[[Page 359]]

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 chloroprene polymers and not to exceed 0.03 percent by 
weight of the chloroprene polymers.
1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5) for use as a biocide 
in uncured liquid rubber latex not to exceed 0.02 percent by weight of 
the latex solids, where the total of all items listed in paragraph 
(c)(4)(ix) of this section does not exceed 5 percent of the rubber 
product.
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

[[Page 360]]

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]

    Editorial Note: For Federal Register citations affecting Sec. 
177.2600, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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. 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................................

[[Page 361]]

 
(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...............................
  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'-[beta]-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......................
------------------------------------------------------------------------


[[Page 362]]

    (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).
    (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.

[[Page 363]]

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 [alpha]-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.
178.3725 Pigment dispersants.
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.
178.3930 Terpene resins.
178.3940 Tetraethylene glycol di-(2-ethyl-hexoate).
178.3950 Tetrahydrofuran.

    Authority: 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, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 
2001, 68 FR 15355, Mar. 31, 2003, and 70 FR 72074, Dec. 1, 2005.

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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.), 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

[[Page 364]]

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 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

[[Page 365]]

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 [alpha]-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 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

[[Page 366]]

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 ethylenediaminetetraacetate. 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. 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.

[[Page 367]]

    (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 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. 113669-58-2); 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-

[[Page 368]]

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 (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.
    (45) An aqueous solution of hydrogen peroxide, acetic acid, 
peroxyacetic acid, octanoic acid, peroxyoctanoic acid, sodium 1-
octanesulfonate, and 1-hydroxyethylidene-1,1-diphosphonic acid. In 
addition to use on food-processing equipment and utensils, this solution 
may be used on food-contact surfaces in public eating places, subject to 
the limitations in paragraph (c)(39) of this section.
    (46) An aqueous solution of chlorine dioxide and related oxychloro 
species generated by acidification of an aqueous solution of sodium 
chlorite with a solution of sodium gluconate, citric acid, phosphoric 
acid, and sodium mono- and didodecylphenoxybenzenedisulfonate. 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

[[Page 369]]

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 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]

[[Page 370]]

    (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 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 371]]

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 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-

[[Page 372]]

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.
    (39)(i) The solution identified in paragraph (b)(45) of this 
section, when used on food processing equipment and utensils, including 
dairy and beverage-processing equipment but excluding food-contact 
surfaces in public eating places and dairy and beverage containers, 
shall provide when ready for use at least 72 parts per million and not 
more than 216 parts per million of hydrogen peroxide; at least 46 parts 
per million and not more than 138 parts per million of peroxyacetic 
acid; at least 40 parts per million and not more than 122 parts per 
million of octanoic acid (including peroxyoctanoic acid); at least 281 
parts per million and not more than 686 parts per million of acetic 
acid; at least 7 parts per million and not more than 34 parts per 
million of 1-hydroxyethylidene-1,1-diphosphonic acid; and at least 36 
parts per million and not more than 109 parts per million of sodium 1-
octanesulfonate.
    (ii) The solution identified in paragraph (b)(45) of this section, 
when used on food-contact equipment and utensils in warewashing 
machines, including warewashing machines in public eating places, at 
temperatures no less than 120 [deg]F (49 [deg]C) shall provide when 
ready for use at least 30 parts per million and not more than 91 parts 
per million of hydrogen peroxide; at least 19 parts per million and not 
more than 58 parts per million of peroxyacetic acid; at least 17 parts 
per million and not more than 52 parts per million of octanoic acid 
(including peroxyoctanoic acid); at least 119 parts per million and not 
more than 290 parts per million of acetic acid; at least 3 parts per 
million and not more than 14 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 15 parts per million and not more 
than 46 parts per million of sodium 1-octanesulfonate.
    (iii) The solution identified in paragraph (b)(45) of this section, 
when used on dairy or beverage containers, shall provide when ready for 
use at least 36 parts per million and not more than 108 parts per 
million of hydrogen peroxide; at least 23 parts per million and not more 
than 69 parts per million of peroxyacetic acid; at least 20 parts per 
million and not more than 61 parts per million of octanoic acid 
(including peroxyoctanoic acid); at least 140 parts per million and not 
more than 343 parts per million of acetic acid; at least 3 parts per 
million and not more than 17 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 18 parts per million and not more 
than 55 parts per million of sodium 1-octanesulfonate.
    (40) The solution identified in paragraph (b)(46) of this section 
shall provide, when ready for use, at least 100 parts per million and 
not more than 200 parts per million of chlorine dioxide as determined by 
the method developed

[[Page 373]]

by Bio-cide International, Inc., entitled, ``Iodometric Method for the 
Determination of Available Chlorine Dioxide (50-250 ppm Available 
ClO2),'' dated June 11, 1987, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of this method are available from the Division of Petition Control, 
Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html; at least 380 parts per 
million and not more than 760 parts per million of sodium gluconate; and 
at least 960 parts per million and not more than 1,920 parts per million 
of sodium mono- and didodecylphenoxybenzenedisulfonate. Other components 
listed under paragraph (b)(46) of this section shall be used in the 
minimum amount necessary to produce the intended effect.
    (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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



                 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:

------------------------------------------------------------------------
           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 Sec. Sec. 175.105
 the range C14	C18 and the         and 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.
Alkylthiophenolics:.............  For use only:
1. Acid-catalyzed condensation    1. At levels not to exceed 2 percent
 reaction products of 4-           by weight of adhesives complying with
 nonylphenol, formaldehyde, and    Sec. 175.105 of this chapter, of
 1-dodecanethiol (CAS Reg. No.     pressure-sensitive adhesives
 164907-73-7)..                    complying with Sec. 175.125 of this
                                   chapter, and of rubber articles
                                   complying with Sec. 177.2600 of
                                   this chapter.
2. Acid-catalyzed condensation    2. Do.
 reaction products of branched 4-
 nonylphenol, formaldehyde, and
 1-dodecanethiol (CAS Reg. No.
 203742-97-6)..
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.

[[Page 374]]

 
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 percent
 phenylethyl)phenol (CAS Reg.      by weight of polyethylene phthalate
 No. 70321-86-7).                  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.
2-[4,6-Bis(2,4-dimethylphenyl)-   For use only:
 1,3,5-triazin-2-yl]-5-           1. At levels not to exceed 0.3 percent
 (octyloxy)phenol (CAS Reg. No.    by weight of olefin polymers
 2725-22-6)..                      complying with Sec. 177.1520(c) of
                                   this chapter in contact with food
                                   types I, II, IV-B, VI, VII-B, and
                                   VIII described in Sec. 176.170(c)
                                   of this chapter, table 1, under
                                   conditions of use D through G as
                                   described in Sec. 176.170(c), table
                                   2, of this chapter.
                                  2. At levels not to exceed 0.1 percent
                                   by weight of polypropylene complying
                                   with Sec. 177.1520(c) of this
                                   chapter, items 1.1a, 1.2, and 1.3 in
                                   contact with food under conditions of
                                   use A through H as described in Sec.
                                    176.170(c), table 2, of this
                                   chapter.
                                  3. At levels not to exceed 0.04
                                   percent by weight of polyethylene and
                                   olefin copolymers complying with Sec.
                                     177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c,
                                   3.2a, and 3.2b having a minimum
                                   density of 0.94 gram per cubic
                                   centimeter, in contact with food
                                   under conditions of use A through H
                                   as described in Sec. 176.170, table
                                   2, of this chapter provided that the
                                   finished articles used in contact
                                   with fatty food types III, IV-A, V,
                                   VII-A, and IX as described in table 1
                                   of Sec. 176.170(c) of this chapter
                                   hold a minimum of 2 gallons (7.6
                                   liters) of food.
                                  4. At levels not to exceed 0.4 percent
                                   by weight of ethylene copolymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 3.1a, 3.1b, 3.1c,
                                   3.2a, and 3.2b, having a density of
                                   less than 0.94 gram per cubic
                                   centimeter, in contact with food
                                   under conditions of use B through H,
                                   as described in Sec. 176.170(c),
                                   table 2, of this chapter provided
                                   that the finished articles used in
                                   contact with fatty food types III, IV-
                                   A, V, VII-A, and IX hold a minimum of
                                   5 gallons (18.9 liters) of food.
                                  5. At levels not to exceed 0.04
                                   percent by weight of polyethylene
                                   having a density of less than 0.94
                                   gram per cubic centimeter, and olefin
                                   polymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5,
                                   3.6, 4, 5, and 6, in contact with
                                   food under conditions of use D
                                   through G as described in Sec.
                                   176.170(c) of this chapter, table 2,
                                   provided that the finished articles
                                   used in contact with fatty food types
                                   III, IV-A, V, VII-A, and IX hold a
                                   minimum of 5 gallons (18.9 liters) of
                                   food.
[beta], 3(or 4)-                  For use only:
 Bis(octadecylthio)cyclohexyleth  1. At levels not to exceed 0.3 percent
 ane (CAS Reg. No. 37625-75-5);    by weight of all polymers for use in
 CAS synonym: 1-[(beta-            contact with foods of Types I, II, IV-
 (octadecylthio)ethyl]-3(or 4)-    B, VI, VII-B, and VIII under
 (octadecylthio)cyclohexane.       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.
Bis(2,2,6,6-tetramethyl-4-        For use only:
 piperidinyl) sebacate (CAS Reg.  1. In adhesives complying with Sec.
 No. 52829-07-9).                  175.105 of this chapter.
                                  2. At levels not to exceed 0.1 percent
                                   by weight of pressure-sensitive
                                   adhesives complying with Sec.
                                   175.125 of this chapter.

[[Page 375]]

 
Bis(2,4-di-tert-butyl-6-          For use only:
 methylphenyl) ethyl phosphite    1. At levels not to exceed 0.3 percent
 (CAS Reg. No. 145650-60-8).       by weight of olefin polymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter. The finished polymers
                                   may only be used with food of the
                                   types identified in Sec. 176.170(c)
                                   of this chapter, table 1, under
                                   Categories I, II, IV-B, VI-A, VI-B,
                                   VII-B, and VIII, 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 0.1 percent
                                   by weight of propylene polymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 1.1, 1.2, 1.3,
                                   3.2b, 3.4, or 3.5, or 3.1a (where the
                                   density of this polymer is at least
                                   0.85 gram per cubic centimeter and
                                   less than 0.91 gram per cubic
                                   centimeter). 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 III, IV-A, V, VI-C,
                                   VII-A, and IX, and 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 0.1 percent
                                   by weight of high-density ethylene
                                   polymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or
                                   3.6 (where the density of each of
                                   these polymers is at least 0.94 gram
                                   per cubic centimeter), or 5. 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 III, IV-A, V, VI-C, VII-A,
                                   and IX, and under conditions of use C
                                   (maximum temperature 70 [deg]C)
                                   through G described in table 2 of
                                   Sec. 176.170(c) of this chapter.
                                   Provided, that the finished food
                                   contact articles have a volume of at
                                   least 18.9 liters (5 gallons).
                                  4. At levels not to exceed 0.01
                                   percent by weight of low-density
                                   ethylene polymers complying with Sec.
                                     177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4,
                                   3.5, or 3.6 (where the density of
                                   each of these polymers is less than
                                   0.94 gram per cubic centimeter). 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 III, IV-A, V, VI-C, VII-A,
                                   and IX, and under conditions of use B
                                   through H described in table 2 of
                                   Sec. 176.170(c) of this chapter.
                                   Provided, that the average thickness
                                   of such polymers in the form in which
                                   they contact food shall not exceed
                                   0.001 inch.
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[2,4-bis(1-methyl-1-       For use only:
 phenylethyl)phenoxy]-2,4,8,10-   1. At levels not to exceed 0.15
 tetraoxa-3,9-                     percent by weight of all polymers,
 diphosphaspiro[5.5]undecane       except as specified below.
 (CAS Reg. No. 154862-43-8),      2. At levels not to exceed 0.2 percent
 which may contain not more than   by weight of polycarbonate resins
 2 percent by weight of            complying with Sec. 177.1580 of
 triisopropanolamine (CAS Reg.     this chapter.
 No. 122-20-3).                   3. At levels not to exceed 0.3 percent
                                   by weight of polyetherimide resins
                                   complying with Sec. 177.1595 of
                                   this chapter.

[[Page 376]]

 
5,7-Bis(1,1-dimethylethyl)-3-     For use only:
 hydroxy-2(3H)-benzofuranone,     1. At levels not to exceed 0.1 percent
 reaction products with o-xylene   by weight of olefin polymers
 (CAS Reg. No. 181314-48-7).       complying with Sec. 177.1520(c) 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-A,
                                   VI-B, VII-B, and VIII, 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 0.02
                                   percent by weight of:
                                  (a) Propylene polymers and copolymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 1.1, 1.2, 3.1a,
                                   3.2a, 3.2b, 3.4, or 3.5. The finished
                                   polymer may only be used in contact
                                   with food of types identified in Sec.
                                     176.170(c) of this chapter, Table
                                   1, under Categories III, IV-A, V, VI-
                                   C, VII-A, and IX, and under
                                   conditions of use B through H
                                   described in Table 2 of Sec.
                                   176.170(c) of this chapter; or
                                  (b) Ethylene polymers and copolymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 2.1, 2.2, 2.3,
                                   3.1a, 3.1b, 3.2a, or 3.6 (where the
                                   density of each of these polymers is
                                   at least 0.94 gram per cubic
                                   centimeter), or 5. 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 III, IV-A,
                                   V, VI-C, VII-A, and IX, and under
                                   conditions of use B through H
                                   described in Table 2 of Sec.
                                   176.170(c) of this chapter; provided
                                   that the finished food-contact
                                   articles have a volume of at least
                                   18.9 liters (5 gallons).
                                  3. At levels not to exceed 0.02
                                   percent by weight of ethylene
                                   polymers and copolymers complying
                                   with Sec. 177.1520(c) of this
                                   chapter, items 2.1, 2.2, 2.3, 3.1a,
                                   3.1b, 3.2a, 3.4, 3.5, or 3.6 (where
                                   the density of each of these polymers
                                   is less than 0.94 gram per cubic
                                   centimeter). 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 III, IV-A, V, VI-C,
                                   VII-A, and IX, and under conditions
                                   of use B through H described in Table
                                   2 of Sec. 176.170(c) of this
                                   chapter; provided that the average
                                   thickness of such polymers in the
                                   form in which they contact food shall
                                   not exceed 50 micrometers (0.002
                                   inch).
3,9-Bis[2-{3-(3-tert-butyl-4-     For use only:
 hydroxy-5-                       1. At levels not to exceed 0.2 percent
 methylphenyl)propionyloxy{time}   by weight of polypropylene complying
  -1,1-dimethylethyl]-2,4,8,10-    with Sec. 177.1520(c), item 1.1 of
 tetraoxaspiro[5.5]undecane (CAS   this chapter. The finished polymer is
 Reg. No. 90498-90-1).             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.
                                  3. At levels 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, 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 propylene.
                                   The finished polymer is to be used in
                                   contact with food of types I, II, IV-
                                   B, VI-A, VI-B, VI-C, VII-B, and VIII
                                   under conditions of use A through H
                                   described in tables 1 and 2 of Sec.
                                   176.170(c) of this chapter.

[[Page 377]]

 
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 percent
 butylphenol (CAS Reg. No. 991-    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([alpha],[alpha]-         For use at levels not to exceed 0.3
 dimethylbenzyl)diphenyl amine     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:
 cresol and dicyclopentadiene     1. As components of nonfood articles
 produced by reacting p-cresol     complying with Sec. Sec. 175.105
 and dicyclopentadiene in an       and 177.2600(c)(4)(iii) of this
 approximate mole ratio of 1.5     chapter.
 to 1, respectively, followed by  2. At levels not to exceed 1.0 percent
 alkylation with isobutylene so    by weight of acrylonitrile/butadiene/
 that the butyl content of the     styrene copolymers. The finished
 final product is not less than    copolymers may be used in contact
 18 percent.                       with food of Types I, II, IV-B, VI-A,
                                   VI-B, 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, and with
                                   food of Types III, IV-A, V, VI-C, 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.

[[Page 378]]

 
Butylated, styrenated cresols     For use only:
 produced when equal moles of     1. As provided in Sec. Sec. 175.105
 isobutylene, styrene, and a       and 177.2600 of this chapter.
 metacresol-paracresol mixture    2. At levels not to exceed 0.5 percent
 having a no more than 3 [deg]C    by weight of polystyrene, rubber-
 distillation range including      modified polystyrene, or olefin
 202 [deg]C are made to react so   polymers complying with Sec.
 that the final product meets      177.1520 (c) of this chapter, items
 the following specifications:     1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1,
 Not less than 95 percent by       3.2, 3.3, or 4, or complying with
 weight of total alkylated         other sections in parts 174, 175,
 phenols consisting of 13-25       176, 177, 178 and Sec. 179.45 of
 percent by weight of butylated    this chapter, used in articles that
 m- and p-cresols, 26-38 percent   contact food only unded the
 by weight of styre nated m- and   conditions described in Sec.
 p-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 [deg]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, 100 Barr Harbor Dr.,
 West Conshohocken,
 Philadelphia, PA 19428-2959, or
 may be examined at the National
 Archives and Records
 Administration (NARA). For
 information on the availability
 of this material at NARA, call
 202-741-6030, or go to: http://
 www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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 Sec. Sec. 175.105
 nonyl group is a propylene        and 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 Sec. Sec. 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:
 butyl-4-hydroxyphenyl)ethylene   1. At levels not to exceed 0.5 percent
 ester (CAS Reg. No. 32509-66-3).  by weight of 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................

[[Page 379]]

 
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.
                                  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.
                                  15. At levels not to exceed 0.3
                                   percent by weight of polyethylene
                                   phthalate polymers, complying with
                                   Sec. 177.1630 of this chapter.
                                   Provided, that the finished polymers
                                   contact food only under conditions of
                                   use B through H described in Table 2
                                   of Sec. 176.170(c) of this chapter.
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.

[[Page 380]]

 
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.
                                  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[deg]-62     any other permitted antioxidants in
 [deg]C as determined by ASTM      the finished food-contact article
 method E324-79, ``Standard Test   shall not exceed a total of 0.5
 Method for Relative Initial and   milligram per square inch of food-
 Final Melting Points and the      contact surface.
 Melting 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,
 100 Barr Harbor Dr., West
 Conshohocken, Philadelphia, PA
 19428-2959, or may be examined
 at the National Archives and
 Records Administration (NARA).
 For information on the
 availability of this material
 at NARA, call 202-741-6030, or
 go to: http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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
 ate (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([alpha]-methyl benzyl)-4-  For use only at levels not to exceed
 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.
2,4-Dimethyl-6-(1-                For use only:
 methylpentadecyl)phenol (CAS     1. At levels not to exceed 0.3 percent
 Reg. No. 134701-20-5).            by weight of acrylonitrile-butadiene-
                                   styrene copolymers used in accordance
                                   with applicable regulations in parts
                                   175, 176, 177, and 181 of this
                                   chapter, under conditions of use C
                                   through H as described in table 2 of
                                   Sec. 176.170(c) of this chapter.
                                  2. At levels not to exceed 0.033
                                   percent by weight of rigid polyvinyl
                                   chloride, under conditions of use A
                                   through H as described in table 2 of
                                   Sec. 176.170(c) of this chapter.

[[Page 381]]

 
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
 95 percent by weight of           this chapter or Sec. 177.1980 of
 dimethyltin bis                   this chapter for use in contact with
 (isooctylmercaptoacetate) (CAS    food 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. 57583-35-4), 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 [deg]C
 specifications: Tin content (as   (190 [deg]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.
Dimyristyl thiodipropionate       Finished food-contact articles
 having a melting point of         containing this additive shall meet
 48[deg]-52 [deg]C as determined   the extractives limitations
 by ASTM method E324-79,           prescribed in Sec. 176.170(c) of
 ``Standard Test Method for        this chapter.
 Relative Initial and 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 National Archives and
 Records Administration (NARA).
 For information on the
 availability of this material
 at NARA, call 202-741-6030, or
 go to: http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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 Sec. Sec. 177.1020 and
 having a saponification number    177.1030 of this chapter and used in
 of 260 to 280. The additive is    contact with all food types under
 made from di(n-octyl)tin oxide    conditions of use C through G
 meeting the specifications of     described in table 2 of Sec.
 Sec. 178.2650(a)(1).            176.170(c) of this chapter.
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-(4,6-Diphenyl-1,3,5-triazin-2-  For use only
 yl)-5-hexyloxy)phenol (CAS Reg.  1. At levels not to exceed 0.5 percent
 No. 147315-50-2).                 by weight of polycarbonate resins
                                   complying with Sec. 177.1580 of
                                   this chapter.
                                  2. At levels not to exceed 0.5 percent
                                   by weight of polyester elastomers
                                   complying with Sec. 177.1590 of
                                   this chapter.
                                  3. At levels not to exceed 0.5 percent
                                   by weight of polyethylene phthalate
                                   polymers complying with Sec.
                                   177.1630 of this chapter, in contact
                                   with food under conditions of use A
                                   through H described in Table 2 of
                                   Sec. 176.170(c) of this chapter.

[[Page 382]]

 
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 percent
 triester with 1,3,5-tris(2-       by weight of polypropylene complying
 hydroxyethyl)-s-triazine-2,4,6-   with Sec. 177.1520 of this chapter
 (1H,3H,5H)-trione (CAS Reg. No.   in articles that contact food not in
 34137-09-2).                      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
                                   [deg]F.
Di-tert-butyl-m-cresyl            For use only:
 phosphonite condensation         1. At levels not to exceed 0.1 percent
 product with biphenyl (CAS Reg.   by weight of olefin polymers
 No. 178358-58-2) produced by      complying with Sec. 177.1520(c) of
 the condensation of 4,6-di-tert-  this chapter, items 1.1, 2.1, 2.2,
 butyl-m-cresol with the Friedel-  3.1(a), 3.1(b), 3.2(a), or 3.2(b).
 Crafts addition product
 (phosphorus trichloride and
 biphenyl) so that the food
 additive has a minimum
 phosphorus content of 5.0
 percent.
Di-tert-butylphenyl phosphonite   For use only:
 condensation product with        1. At levels not to exceed 0.1 percent
 biphenyl (CAS Reg. No. 119345-    by weight of olefin polymers
 01-6) produced by the             complying with Sec. 177.1520(c) of
 condensation of 2,4-di-tert-      this chapter, items 1.1, 1.2, 1.3,
 butylphenol with the Friedel-     3.2b, 3.3a, 3.3b, 3.4, 3.5, and 3.1a
 Crafts addition product           (where the density is not less than
 (phosphorus trichloride and       0.85 gram per cubic centimeter and
 biphenyl) so that the food        not more than 0.91 gram per cubic
 additive has a minimum            centimeter); and 2.1, 2.2, 2.3, 3.1a,
 phosphorus content of 5.4         3.1b, 3.2a, and 3.6 (where the
 percent, an acid value not        density is not less than 0.94 gram
 exceeding 10 mg KOH/gm, and a     per cubic centimeter) and 5.
 melting range of 85 [deg]C to    2. At levels not to exceed 0.1 percent
 110 [deg]C (185 [deg]F to 230     by weight of polycarbonate resins
 [deg]F).                          complying with Sec. 177.1580 of
                                   this chapter.
                                  3. At levels not to exceed 0.2 percent
                                   by weight of polystyrene and 0.3
                                   percent by weight of rubber-modified
                                   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, items 2.1, 2.2, 2.3,
                                   3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6
                                   (where the polyethylene component has
                                   a density less than 0.94 gram per
                                   cubic centimeter).
                                  5. At levels not to exceed 0.1 percent
                                   by weight of repeated use rubber
                                   articles complying with Sec.
                                   177.2600 of this chapter.

[[Page 383]]

 
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-                   1. At levels not to exceed 0.2 percent
 hydroxyphenyl)ethyl]phenyl        by weight of polypropylene complying
 acrylate (CAS Reg. No. 123968-    with Sec. 177.1520 of this chapter
 25-2).                            in contact with food under conditions
                                   of use D through G as described in
                                   Table 2 of Sec. 176.170(c) of this
                                   chapter, except that polypropylene
                                   containing the additive at levels not
                                   to exceed 0.075 percent by weight may
                                   contact food 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 1.0 percent
                                   by weight of of styrene block
                                   polymers complying with Sec.
                                   177.1810 of this chapter. The
                                   additive is used under conditions of
                                   use D through G as described in Table
                                   2 of Sec. 176.170(c) of this
                                   chapter.
                                  3. At levels not to exceed 1.0 percent
                                   by weight of polystyrene and rubber
                                   modified polystyrene complying with
                                   Sec. 177.1640 of this chapter in
                                   contact with food under conditions of
                                   use D through G as described in Table
                                   2 of Sec. 176.170(c) of this
                                   chapter.
N,N''-1,2-Ethanediylbis[N-[3-[[4  For use only:
 ,6-bis[butyl(1,2,2,6,6-          1. At levels not to exceed 0.06
 pentamethyl-4-                    percent by weight of olefin polymers
 piperidinyl)amino]-1,3,5-         complying with Sec. 177.1520(c) of
 triazin-2-yl]amino]propyl]-       this chapter, items 1.1a, 1.1b, 1.2,
 N',N''-dibutyl-N',N''-            or 1.3. The finished polymers may
 bis(1,2,2,6,6-pentamethyl-4-      only be used in contact with food of
 piperidinyl)-1,3,5-triazine-      the Types III, IV-A, V, VI-C, VII-A,
 2,4,6-triamine] (CAS Reg. No.     and IX as described in table 1 of
 106990-43-6).                     Sec. 176.170(c) of this chapter,
                                   and under conditions of use A through
                                   H as described in table 2 of Sec.
                                   176.170(c) of this chapter.
                                  2. At levels not to exceed 0.08
                                   percent by weight of olefin polymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter. The finished polymers
                                   may only be used in contact with food
                                   of the Types I, II, IV-B, VI-A, VI-B,
                                   VII-B, and VIII as described in table
                                   1 of Sec. 176.170(c) of this
                                   chapter, and under conditions of use
                                   A through H 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.

[[Page 384]]

 
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).
                                  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.

[[Page 385]]

 
2,2'-Ethylidenebis(4,6-di-tert-   For use only:
 butylphenyl)fluorophosphonite    1. As provided in Sec. 175.105 of
 (CAS Reg. No. 118337-09-0).       this chapter.
                                  2. In all polymers used in contact
                                   with food of types I, II, IV-B, VI-A,
                                   VI-B, VII-B, and VIII, under
                                   conditions of use B through H
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter at levels
                                   not to exceed 0.25 percent by weight
                                   of polymers.
                                  3. In polypropylene complying with
                                   Sec. 177.1520(c) of this chapter,
                                   item 1.1, in contact with food of
                                   types III, IV-A, V, VII-A, and IX,
                                   under:
                                  (a) Conditions of use B through H
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter at levels
                                   not to exceed 0.25 percent by weight
                                   of the polymer; or
                                  (b) Condition of use A, limited to
                                   levels not to exceed 0.1 percent by
                                   weight of the polymer; provided that
                                   the food-contact surface has an
                                   average thickness not exceeding 375
                                   micrometers (0.015 inch).
                                  4. In olefin copolymers complying with
                                   Sec. 177.1520(c) of this chapter,
                                   items 3.1a or 3.2a, and containing
                                   not less than 85 percent by weight of
                                   polymer units derived from propylene,
                                   in contact with food of types III, IV-
                                   A, V, VII-A, and IX, and under:
                                  (a) Conditions of use C through G,
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter, limited
                                   to levels no greater than 0.2 percent
                                   by weight of the copolymers; or
                                  (b) Conditions of use A, B, and H,
                                   limited to levels no greater than 0.1
                                   percent by weight of the olefin
                                   copolymers; provided that the food-
                                   contact surface has an average
                                   thickness not exceeding 375
                                   micrometers (0.015 inch).
                                  5. In olefin polymers complying with
                                   Sec. 177.1520(c) of this chapter,
                                   items 1.2 or 1.3 in contact with food
                                   of types III, IV-A, V, VII-A, and IX,
                                   under conditions of use A through H,
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter at levels
                                   not to exceed 0.1 percent by weight
                                   of the polymers; provided that the
                                   food-contact surface has an average
                                   thickness not exceeding 375
                                   micrometers (0.015 inch).
                                  6. In polyethylene complying with Sec.
                                     177.1520(c) of this chapter, items
                                   2.1 or 2.2, having a density of not
                                   less than 0.94, in contact with food
                                   of types III, IV-A, V, VII-A, and IX,
                                   and under:
                                  (a) Conditions of use B through H,
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter limited to
                                   levels not to exceed 0.2 percent by
                                   weight of the polymers; or
                                  (b) Condition of use A, described in
                                   Tables 1 and 2 of Sec. 176.170(c)
                                   of this chapter, limited to levels
                                   not to exceed 0.1 percent by weight
                                   of the polymer; provided that the
                                   food-contact surface has an average
                                   thickness not exceeding 125
                                   micrometers (0.005 inch).
                                  7. In olefin copolymers complying with
                                   Sec. 177.1520(c) of this chapter,
                                   items 3.1a, 3.1b, 3.2a, or 3.2b,
                                   containing not less than 85 percent
                                   by weight of polymer units derived
                                   from ethylene and having a density of
                                   not less than 0.94, in contact with
                                   food of types III, IV-A, V, VII-A,
                                   and IX, and under:
                                  (a) Conditions of use C through G,
                                   described in Tables 1 and 2 of Sec.
                                   176.170(c) of this chapter limited to
                                   levels not to exceed 0.2 percent by
                                   weight of the copolymers; or
                                  (b) Conditions of use A, B, and H,
                                   limited to levels not to exceed 0.1
                                   percent by weight of the copolymers;
                                   provided that the food-contact
                                   surface has an average thickness not
                                   exceeding 125 micrometers (0.005
                                   inch).
                                  8. In olefin polymers complying with
                                   Sec. 177.1520(c) of this chapter,
                                   items 3.1a, 3.1b, 3.2a, or 3.2b
                                   containing not less than 85 percent
                                   by weight of polymer units derived
                                   from ethylene, in contact with food
                                   of types III, IV-A, V, VII-A, and IX,
                                   under conditions of use A through H,
                                   as described in Tables 1 and 2 of
                                   Sec. 176.170(c) of this chapter at
                                   levels not to exceed 0.1 percent by
                                   weight of the copolymer; provided
                                   that the food-contact surface has an
                                   average thickness not exceeding 75
                                   micrometers (0.003 inch).
                                  9. In polyethylene phthalate polymers
                                   complying with Sec. 177.1630 of
                                   this chapter in contact with food of
                                   types III, IV-A, V, VI-C, VII-A, and
                                   IX, and under:
                                  (a) Conditions of use B through H,
                                   described in tables 1 and 2 of Sec.
                                   176.170(c) of this chapter, limited
                                   to levels not to exceed 0.3 percent
                                   by weight of the polymers; or
                                  (b) Condition of use A with food of
                                   types III, IV-A, V, VII-A, and IX,
                                   and limited to levels not to exceed
                                   0.1 percent by weight of the
                                   polymers; provided that the film
                                   thickness does not exceed 875
                                   micrometers (0.035 inch).
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.

[[Page 386]]

 
Hexamethylenebis (3,5-di-tert-    For use only:
 butyl-4-hydroxyhydrocinnamate)   1. As provided in Sec.
 (CAS Reg. No. 35074-77-2).        177.2470(b)(1) 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.
1,6-Hexanediamine, N, N'-         For use only as a stabilizer at levels
 bis(2,2,6,6-tetramethyl-4-        not to exceed 0.3 percent by weight
 piperidinyl)-, polymers with      of olefin polymers complying with
 morpholine-2,4,6-trichloro-       Sec. 177.1520(c) of this chapter.
 1,3,5-triazine reaction           The finished polymers are to contact
 products, methylated (CAS Reg.    food only under conditions of use C,
 No. 193098-40-7).                 D, E, F, and G, as described in Table
                                   2 of Sec. 176.170(c) of this
                                   chapter. Provided that the finished
                                   food-contact articles have a volume
                                   of at least 18.9 liters (5 gallons).

[[Page 387]]

 
1,6-Hexanediamine, N,N'-          For use only:
 bis(2,2,6,6-tetramethyl-4-       1. At levels not to exceed 0.5 percent
 piperidinyl)-, polymer with       by weight of propylene polymers and
 2,4,6-trichloro-1,3,5-triazine,   copolymers complying with Sec.
 reaction products with N-butyl-   177.1520(c) of this chapter, items
 1-butanamine and N-butyl-         1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or
 2,2,6,6-tetramethyl-4-            3.5. The finished polymers may
 piperidinamine (CAS Reg. No.      contact food only of the types
 192268-64-7).                     identified in Sec. 176.170(c) of
                                   this chapter, table 1, under
                                   categories I, II, IV-B, VI-A, VI-B,
                                   VII-B, and VIII, 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 propylene polymers and
                                   copolymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or
                                   3.5. The finished polymers may
                                   contact food only of the types
                                   identified in Sec. 176.170(c) of
                                   this chapter, table 1, under
                                   categories III, IV-A, V, VI-C, VII-A,
                                   and IX, and 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 0.5 percent
                                   by weight of ethylene polymers and
                                   copolymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or
                                   3.6 (where the density of each of
                                   these polymers is at least 0.94 gram
                                   per cubic centimeter), or 5. The
                                   finished polymers may contact food
                                   only of the types identified in Sec.
                                    176.170(c) of this chapter, table 1,
                                   under categories I, II, IV-B, VI-A,
                                   VI-B, VII-B, and VIII, and under
                                   conditions of use B through H
                                   described in table 2 of Sec.
                                   176.170(c) of this chapter.
                                  4. At levels not to exceed 0.05
                                   percent by weight of ethylene
                                   polymers and copolymers complying
                                   with Sec. 177.1520(c) of this
                                   chapter, items 2.1, 2.2, 2.3, 3.1a,
                                   3.1b, 3.2a, or 3.6 (where the density
                                   of each of these polymers is at least
                                   0.94 gram per cubic centimeter), or
                                   5. The finished polymers may contact
                                   food only of the types identified in
                                   Sec. 176.170(c) of this chapter,
                                   table 1, under categories III, IV-A,
                                   V, VI-C, VII-A, and IX, and under
                                   conditions of use B through H
                                   described in table 2 of Sec.
                                   176.170(c) of this chapter.
                                  5. At levels not to exceed 0.5 percent
                                   by weight of ethylene polymers and
                                   copolymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4,
                                   3.5, or 3.6 (where the density of
                                   each of these polymers is less than
                                   0.94 gram per cubic centimeter), or
                                   5. The finished polymers may contact
                                   food only of the types identified in
                                   Sec. 176.170(c) of this chapter,
                                   table 1, under categories I, II, IV-
                                   B, VI-A, VI-B, VII-B, and VIII, 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 0.01
                                   percent by weight of ethylene
                                   polymers and copolymers complying
                                   with Sec. 177.1520(c) of this
                                   chapter, items 2.1, 2.2, 2.3, 3.1a,
                                   3.1b, 3.2a, 3.4, 3.5, or 3.6 (where
                                   the density of each of these polymers
                                   is less than 0.94 gram per cubic
                                   centimeter), or 5. The finished
                                   polymers may contact food only of the
                                   types identified in Sec. 176.170(c)
                                   of this chapter, table 1, under
                                   categories III, IV-A, V, VI-C, VII-A,
                                   and IX, and under conditions of use C
                                   through G described in table 2 of
                                   Sec. 176.170(c) of this chapter.
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,
 33059-05-1.                       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.

[[Page 388]]

 
2(2'-Hydroxy-5'-                  For use only:
 methylphenyl)benzotriazole       1. As component of nonfood articles
 meeting the following             complying with Sec. 177.1010 of
 specification: melting point      this chapter.
 126[deg] -132 [deg]C             2. At levels not to exceed 0.25
 (258.8[deg] -269.6 [deg]F) (CAS   percent by weight of rigid polyvinyl
 Reg. No. 2440-22-4).              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(C12-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
                                   Sec. Sec. 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)(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 petrolium
                                   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 1.7 percent
                                   by weight of the 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
                                   hydrocarbon resins complying with
                                   Sec. 175.320 of this chapter;
                                   rubber-modified polystyrene complying
                                   with Sec. 177.1640 of this chapter;
                                   and petroleum hydrocarbon resins and
                                   rosins 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 polymenrs
                                   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 389]]

 
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-     For use only:
 tert-butylphenol) monoacrylate   1. At levels not to exceed 0.5 percent
 (CAS 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).

[[Page 390]]

 
Methyltin-2-mercaptoethyloleate   For use only in rigid poly(vinyl
 sulfide, which is defined as      chloride) and rigid vinyl chloride
 one or more of the following:     copolymers complying with Sec. Sec.
                                    177.1950 and 177.1980 of this
                                   chapter, respectively, used in the
                                   manufacture of pipes and pipe
                                   fittings intended for contact with
                                   water in food processing plants, at
                                   levels not to exceed:
                                  1. 1.0 percent by weight in pipes, and
                                  2. 2.0 percent by weight in pipe
                                   fittings.
  1. 9-Octadecenoic acid (Z)-, 2-
   mercaptoethyl ester, reaction
   products with dichlorodime
   thylstannane, sodium sulfide,
   and trichloromethylstannane
   (CAS Reg. No. 68442-12-6);
  2. Fatty acids, tall oil, 2-
   mercaptoethyl esters,
   reaction products with
   dichlorodimethylstannane, 2-
   mercaptoethyl decanoate, 2-
   mercaptoethyl octanoate,
   sodium sulfide, and
   trichloromethylstannane (CAS
   Reg. No. 151436-98-5); or
  3. Fatty acids, tall oil, 2-
   mercaptoethyl esters,
   reaction products with
   dichlorodimethylstannane,
   sodium sulfide, and
   trichloromethylstannane (CAS
   Reg. No. 201687-57-2);and
   which has the following
   specifications: Tin content
   (as Sn) 5 to 21 percent by
   weight; mercaptosulfur
   content 5 to 13 percent by
   weight; acid value no greater
   than 4.
  Methyltin-2-
   Mercaptoethyloleate sulfide
   may also be used with one or
   more of the following
   optional substances:
  1.1a 2-Mercaptoethyl oleate
   (CAS Reg. No. 59118-78-4),
  1.1b 2-Mercaptoethyl tallate
   (CAS Reg. No. 68440-24-4),
  1.1c 2-Mercaptoethyl octanoate
   (CAS Reg. No. 57813-59-9),
  1.1d 2-Mercaptoethyl decanoate
   (CAS Reg. No. 68928-33-6),
   alone or in combination; not
   to exceed 40 percent by
   weight of the stabilizer
   formulation;
  2.1 2-Mercaptoethanol (CAS
   Reg. No. 60-24-2): Not to
   exceed 2 percent by weight of
   the stabilizer formulation.
  3.1 Mineral oil (CAS Reg. No.
   8012-95-1): Not to exceed 40
   percent by weight of the
   stabilizer formulation.
  4.1 Butylated hydroxytoluene
   (CAS Reg. No. 128-37-0): Not
   to exceed 5 percent by weight
   of the stabilizer
   formulation.
  The total of the optional
   substances (1.1a through 4.1)
   shall not exceed 60 percent
   by weight of the stabilizer
   formulation.
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.
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).

[[Page 391]]

 
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 Sec. Sec. 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 copol
                                   ymers 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 copol ymer 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
                                   co poly mers 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 co poly mers 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.

[[Page 392]]

 
7-Oxa-3,20-diazadispiro-          For use only:
 [5.1.11.2]-heneicosan-21-        1. At levels not to exceed 0.5 percent
 one,2,2,4,4-tetramethyl-          by weight of olefin polymers
 ,hydrochloride, reaction          complying with Sec. 177.1520 of
 products with epichlorohydrin,    this chapter, items 1.1, 3.1, and
 hydrolyzed, polymerized (CAS      3.2, where the copolymers complying
 Reg. No. 202483-55-4).            with items 3.1 and 3.2 contain not
                                   less than 85 weight percent of
                                   polymer units derived from propylene;
                                   in contact with all types of food
                                   described in Table 1 of Sec.
                                   176.170 of this chapter, provided
                                   that the finished food-contact
                                   article will have a capacity of at
                                   least 18.9 liters (5 gallons) when in
                                   contact with food of types III, IV-A,
                                   V, VII-A, and IX, described in Table
                                   1 of Sec. 176.170 of this chapter.
                                  2. At levels not to exceed 0.5 percent
                                   by weight of olefin polymers
                                   complying with Sec. 177.1520 of
                                   this chapter, items 2.1, 2.2, 3.1,
                                   and 3.2, having a density of not less
                                   than 0.94 gram/milliliter, where the
                                   copolymers complying with items 3.1
                                   and 3.2 contain not less than 85
                                   weight percent of polymer units
                                   derived from ethylene; in contact
                                   with food only under conditions of
                                   use C, D, E, F, and G, described in
                                   Table 2 of Sec. 176.170 of this
                                   chapter, provided that the finished
                                   food-contact article will have a
                                   capacity of at least 18.9 liters (5
                                   gallons) when in contact with food of
                                   types III, IV-A, V, VII-A, and IX,
                                   described in Table 1 of Sec.
                                   176.170 of this chapter.
                                  3. At levels not to exceed 0.3 percent
                                   by weight of olefin polymers
                                   complying with Sec. 177.1520 of
                                   this chapter, items 2.1, 2.2, 3.1,
                                   3.2, 3.3, 3.4, 3.5, 3.6, and 4.0,
                                   having a density of less than 0.94
                                   gram/milliliter, in contact with food
                                   only under conditions of use D, E, F,
                                   and G, described in Table 2 of Sec.
                                   176.170 of this chapter, provided
                                   that the finished food-contact
                                   article will have a capacity of at
                                   least 18.9 liters (5 gallons) except
                                   that, films and molded articles
                                   containing not more than 0.2 percent
                                   by weight of the stabilizer may
                                   contact aqueous food of types I, II,
                                   IV-B, VI, and VIII, described in
                                   Table 1 of Sec. 176.170 of this
                                   chapter with no restrictions on the
                                   amount of food contacted.
Oxidized bis (hydrogenated        For use only:
 tallow alkyl) amines.            1. At levels not to exceed 0.1 percent
                                   by weight of polypropylene polymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, item 1.1, 1.2, 1.3,
                                   3.1a (density not less than 0.85 gram
                                   per cubic centimeter and less than
                                   0.91 gram per cubic centimeter),
                                   3.2b, 3.4, and 3.5. 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. At levels not to exceed 0.075
                                   percent by weight of high-density
                                   polyethylene polymers complying with
                                   Sec. 177.1520(c) of this chapter,
                                   item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a,
                                   3.6 (density not less than 0.94 gram
                                   per cubic centimeter), and 5. 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.
                                  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.

[[Page 393]]

 
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:
 butylethyl propanediol, 2,4,6-   1. At levels not to exceed 0.2 percent
 tri-tert-butylphenyl ester (CAS   by weight of olefin polymers
 Reg. No. 161717-32-4), which      complying with Sec. 177.1520(c) of
 may contain not more than 1       this chapter, items 1.1, 1.2, or 1.3,
 percent by weight of              and items 2.1, 2.2, or 2.3 (where the
 triisopropanolamine (CAS Reg.     density of these polymers is not less
 No. 122-20-3).                    than 0.94 gram per cubic centimeter),
                                   and items 3.1 or 3.2, provided that
                                   the finished polymer contacts foods
                                   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.
                                  2. 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, or 1.3,
                                   that contact food of types III, IV,
                                   V, VI-A, VI-C, VII, VIII, and IX as
                                   described in table 1 of Sec.
                                   176.170(c) of this chapter, only
                                   under conditions of use C, D, E, F,
                                   and G as described in table 2 of Sec.
                                     176.170(c) of this chapter.
                                  3. At levels not to exceed 0.1 percent
                                   by weight of olefin copolymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 3.1a, 3.1b, 3.2a,
                                   or 3.2b, having a density less than
                                   0.94 grams per cubic centimeter, in
                                   contact with food only of types III,
                                   IV, V, VI-A, VI-C, VII, VIII, and IX
                                   and under conditions of use B, C, D,
                                   E, F, G, and H as described in tables
                                   1 and 2 of Sec. 176.170(c) of this
                                   chapter; provided that the food-
                                   contact surface does not exceed 0.003
                                   inch (0.076 mm) in thickness.
                                  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(a), 3.1(b), 3.1(c), 3.2 (a), or
                                   3.2(b), having a density not less
                                   than 0.94 grams per cubic centimeter,
                                   in contact with foods only of types
                                   III, IV, V, VI-A, VI-C, VII, VIII,
                                   and IX identified in Table 1 of Sec.
                                    176.170(c) of this chapter, and
                                   under conditions of use B through H
                                   as described in Table 2 of Sec.
                                   176.170(c) of this chapter; provided
                                   that the food-contact surface does
                                   not exceed 0.003 inch (0.076 mm) in
                                   thickness.
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:
 neopentanetetrayl bis (2,6-di-   1. At levels not to exceed 0.25
 tert-butyl-4-methylphenyl)ester   percent by weight of polypropylene
 (CAS Reg. No. 80693-00-1).        homopolymer and copolymers complying
                                   with Sec. 177.1520 of this chapter,
                                   for use with all food types described
                                   in table 1 of Sec. 176.170(c) of
                                   this chapter only 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 0.05
                                   percent by weight of polymers
                                   complying with Sec. 177.1520(c) of
                                   this chapter, item 3.1 or 3.2, and
                                   with a maximum thickness of 100
                                   micrometers (0.004 inch) for use 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.

[[Page 394]]

 
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 Sec.
                                   Sec. 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).
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]hexa            by weight of polypropylene complying
 methylene [(2,2,6,6-tetramethyl-  with Sec. 177.1520(c) of this
 4-piperidyl)imino]] (CAS Reg.     chapter, items 1.1, 1.2, and 1.3, and
 No. 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).

[[Page 395]]

 
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.
1,3-propanediamine, N,N-1,2-      For use only:
 ethanediylbis-, polymer with     1. At levels not to exceed 0.3 percent
 2,4,6-trichloro-1,3,5-triazine,   by weight of polypropylene complying
 reaction products with N-butyl-   with Sec. 177.1520(c) of this
 2,2,6,6-tetramethyl-4-            chapter, items 1.1, 1.2, and 1.3.
 piperidinamine (CAS Reg. No.     2. At levels not to exceed 0.2 percent
 136504-96-6).                     by weight of olefin polymers having a
                                   density greater than or equal to 0.94
                                   grams per cubic centimeter and
                                   complying with Sec. 177.1520(c) of
                                   this chapter, items 2.1, 2.2, 2.3,
                                   3.1, and 3.2.
                                  3. At levels not to exceed 0.3 percent
                                   by weight of olefin polymers having a
                                   density less than 0.94 grams per
                                   cubic centimeter and 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, 3.6, and 4.0. 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
                                   used in contact with fatty foods of
                                   Types III, IV-A, V, VII-A, and IX as
                                   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).
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.
Siloxanes and silicones, methyl   For use as an ultraviolet (UV)
 hydrogen, reaction products       stabilizer only at levels not to
 with 2,2,6,6-tetramethyl-4-(2-    exceed 0.33 percent by weight of
 propenyloxy)piperidine (CAS       polypropylene complying with Sec.
 Reg. No. 182635-99-0).            177.1520(c) of this chapter, items
                                   1.1a, 1.1b, 1.2, and 1.3, under
                                   conditions of use D, E, F, and G, as
                                   described in Table 2 of Sec.
                                   176.170 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 [beta]-diketones       chloride homopolymers modified in
 produced by the condensation of   accordance with Sec.
 acetophenone and technical        178.3790(b)(1). The finished polymers
 methyl stearate..                 may be used in 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.
Tetradecanoic acid, lithium salt  For use only at levels not to exceed
 (CAS Reg. No. 20336-96-3).        0.15 percent by weight of
                                   polypropylene and polypropylene
                                   copolymers complying with Sec.
                                   177.1520(c) of this chapter, items
                                   1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a,
                                   and 3.2b. The finished polymers may
                                   only be used in contact with food of
                                   Types I, II, IV-B, VI-B, VII-B, and
                                   VIII as described in table 1 of Sec.
                                    176.170(c) of this chapter under
                                   conditions of use B through H as
                                   described in table 2 of Sec.
                                   176.170(c) of this chapter, and with
                                   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
                                   under conditions of use C through G
                                   as described in table 2 of Sec.
                                   176.170(c) of this chapter.
2-[[2,4,8,10-Tetrakis(1,1-        For use only at levels not to exceed
 dimethylethyl)dibenzo[d,f][1,3,   0.075 percent by weight of olefin
 2]-dioxaphosphepin-6-yl]oxy]-     copolymers complying with Sec.
 N,N-bis[2-[[2,4,8,10-             177.1520(c) of this chapter, items
 tetrakis(1,1-                     1.1, 1.2, 1.3, 2.1, 2.2, or 2.3:
 dimethylethyl)dibenzo[d,f][1,3,   Provided, That the density of the
 2]dioxaphosphepin-6-              olefin polymers complying with items
 yl]oxy]ethyl]ethanamine (CAS      2.1, 2.2, or 2.3 is not less than
 Reg. No. 80410-33-9).             0.94 gram per cubic centimeter: And
                                   further provided, That the finished
                                   polymers contact food only of Types
                                   I, II, IV-B, VI-A, VI-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 food
                                   only of Types III, IV-A, V, VI-C, VII-
                                   A, and IX described in table 1 of
                                   Sec. 176.170(c) of this chapter,
                                   under conditions of use C through G
                                   described in table 2 of Sec.
                                   176.170(c) of this chapter.

[[Page 396]]

 
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 Sec. Sec. 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-    by weight of polymers except nylon
 2).                               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, 11-(3, 6, 9-Trioxaundecyl)     For use only as provided in Sec.
 bis-3-(dodecylthio) propionate    175.300(b)(3)(xxxi) of this chapter
 (CAS Reg. No. 64253-30-1).        at 4.0 parts per 100 parts rubber.
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.
                                  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.

[[Page 397]]

 
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
 1].                               this 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.

[[Page 398]]

 
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, items 2.1, 2.2, 2.3,
                                   3.1(a), 3.1(b), 3.1(c), 3.2(a), or
                                   3.2(b). The finished polymers
                                   complying with items 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), either shall have a level of
                                   tris(2,4-di-tert-
                                   butylphenyl)phosphite that shall not
                                   exceed 0.062 milligram per square
                                   inch of food-contact surface or shall
                                   contact all food types identified in
                                   Table 1 of Sec. 176.170(c) of this
                                   chapter 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.
                                  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.

[[Page 399]]

 
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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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:
    (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)

[[Page 400]]

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(SCH2CO2C8H
17)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 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)

[[Page 401]]

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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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.

[[Page 402]]

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
                                         pol yethylene 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. 75-37- For use as a blowing agent in
 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:
    (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:

[[Page 403]]



------------------------------------------------------------------------
            List of substances                      Limitations
------------------------------------------------------------------------
Alum (double sulfate of aluminum and
 ammonium, potassium, or sodium).
4-Chloro-3-methylphenol(p-chlorome-        For use as preservative only.
 tacresol).
Chromium potassium sulfate (chrome alum).  For use only in glue used as
                                            a 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-tetrahydrothiadia-    For use as preservative only.
 zine-2-thione.
Disodium cyanodithioimidocarbonate.......   Do.
Defoaming agents.........................  As provided in Sec. 176.210
                                            of this chapter.
Ethanolamine.............................
Ethylenediamine..........................
Formaldehyde.............................  For use as a preservative
                                            only.
Potassium N-methyldithiocarbamate........   Do.
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 anti fogging 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
------------------------------------------------------------------------
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.

[[Page 404]]

 
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.
Alkyl mono- and disulfonic acids,        For use only:
 sodium salts (produced from n-alkanes   1. As antistatic agents at
 in the range of C10-C18 with not less    levels not to exceed 0.1
 than 50 percent C14-C16).                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.
Aluminum Borate                          For use only:
 ((9Al2O3)[middot]2(B2O3), CAS Reg. No.   1. At levels not to exceed 1
 11121-16-7) produced by reaction         percent by weight of
 between aluminum oxide and/or aluminum   polypropylene films complying
 hydroxide with boric acid and/or         with Sec. 177.1520(c) of
 metaboric acid at temperatures in        this chapter, item 1.1, of
 excess of 1000 [deg]C.                   polyethylene films complying
                                          with Sec. 177.1520(c) of
                                          this chapter, items 2.1 and
                                          2.2 and having a density
                                          greater than 0.94 gram per
                                          cubic centimeter, and of
                                          polyolefin copolymer films
                                          complying with Sec.
                                          177.1520(c) of this chapter,
                                          items 3.1(a), 3.1(b), 3.2(a),
                                          and 3.2(b). The finished
                                          polymers may be used in
                                          contact with all food types
                                          identified in Table 1 of Sec.
                                           176.170(c) of this chapter,
                                          under conditions of use A
                                          through H as described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter. The thickness
                                          of the films shall not exceed
                                          0.005 inch.
                                          2. At levels not to exceed 2
                                          percent by weight of
                                          polypropylene films complying
                                          with Sec. 177.1520(c) of
                                          this chapter, item 1.1, of
                                          polyethylene films complying
                                          with Sec. 177.1520(c) of
                                          this chapter, items 2.1 and
                                          2.2 and having a density
                                          greater than 0.94 gram per
                                          cubic centimeter, and of
                                          polyolefin copolymer films
                                          complying with Sec.
                                          177.1520(c) of this chapter,
                                          items 3.1(a), 3.1(b), 3.2(a),
                                          and 3.2(b). The finished
                                          polymers may be used in
                                          contact with all food types
                                          identified in Table 1 of Sec.
                                           176.170(c) of this chapter
                                          under conditions of use B
                                          through H as described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter. The thickness
                                          of the films shall not exceed
                                          0.005 inch.
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-C15)   For use only:
 amine (CAS Reg. No. 70955-14-5).        1. As an antistatic agent at
                                          levels not to exceed 0.2
                                          percent by weight in molded or
                                          extruded high-density
                                          polyethylene (having a density
                                          =0.95 g/cm\3\ 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.
                                         2. As an antistatic agent at
                                          levels not to exceed 0.1
                                          percent by weight in molded or
                                          extruded polypropylene
                                          homopolymers and copolymers
                                          that contact food only of the
                                          types identified in Sec.
                                          176.170(c) of this chapter,
                                          Table 1, under Types II, III,
                                          IV, V, VII-A, and IX, under
                                          the conditions of use C
                                          through G described in Table 2
                                          of Sec. 176.170(c) of this
                                          chapter.

[[Page 405]]

 
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:
 produced when diethanolamine is made    1. As an antistatic agent at
 to react with methyl laurate such that   levels not to exceed 0.5
 the finished product: Has a minimum      percent by weight of molded or
 melting point of 36 [deg]C; has a        extruded polyethylene
 minimum amide assay of 90 percent;       containers intended for
 contains no more than 2 percent by       contact with honey, chocolate
 weight of free diethanolamine; and       syrup, liquid sweeteners,
 contains no more than 0.5 percent by     condiments, flavor extracts
 weight of N,N, bis(2-                    and liquid flavor
 hydroxyethyl)piperazine, as determined   concentrates, grated cheese,
 by paper chromatography method.          light and heavy cream, yogurt,
                                          and foods of Type VIII as
                                          described in table 1 of Sec.
                                          176.170(c) of this chapter.
                                         2. As an antistatic agent at
                                          levels not to exceed 0.2
                                          percent by weight in
                                          polypropylene films complying
                                          with Sec. 177.1520 of this
                                          chapter, and used in contact
                                          with food of Types I, II, III,
                                          IV, V, VI-B, VII, VIII, and IX
                                          described in table 1 of Sec.
                                          176.170(c) of this chapter,
                                          and under conditions of use B
                                          through H described in table 2
                                          of Sec. 176.170(c) of this
                                          chapter. The average thickness
                                          of such polypropylene film
                                          shall not exceed 0.001 inches
                                          (30 micrometers).
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.
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.
[alpha]-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-[alpha]-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).

[[Page 406]]

 
Octadecanoic acid 2-[2-hydroxy ethyl)    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
 diethyl ene 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        conditions of use B through H
 866 mg KOH/g as    described in table 2 of Sec.
 determined by a method entitled          176.170(c) of this chapter.
 ``Total Amine 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, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 available for inspection at the
 National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
------------------------------------------------------------------------


[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; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 
64 FR 62585, Nov. 17, 1999; 76 FR 59249, Sept. 26, 2011]



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
 polymeric coatings.                      of this chapter.
4. As a component of paper and           Complying with Sec. 176.170
 paperboard in contact with aqueous and   of 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.
------------------------------------------------------------------------


[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.

[[Page 407]]



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
------------------------------------------------------------------------
Aluminum, hydroxybis[2,4,8,10-           For use only as a clarifying
 tetrakis(1,1-dimethylethyl)-6-hydroxy-   agent at levels not to exceed
 12H-dibenzo[d,g][1,3,2]dioxaphosphocin   0.25 percent by weight of
 6-oxidato]-(CAS Reg. No. 151841-65-5).   polypropylene and
                                          polypropylene copolymers
                                          complying with Sec.
                                          177.1520(c) of this chapter,
                                          items 1.1, 3.1, or 3.2. The
                                          finished polymers contact food
                                          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,
                                          under conditions of use B
                                          through H described in Table 2
                                          of Sec. 176.170(c) of this
                                          chapter or foods only of types
                                          III, IV-A, V, VI-A, VI-C, VII-
                                          A, and IX as identified in
                                          Table 1 of Sec. 176.170(c)
                                          of this chapter, under
                                          conditions of use C through G
                                          described in Table 2 of Sec.
                                          176.170(c) of this chapter.
Bis(p-ethylbenzylidene) sorbitol (CAS    For use only as a clarifying
 Reg. No. 79072-96-1).                    agent at a level not to exceed
                                          0.35 percent by weight of
                                          olefin polymers complying with
                                          Sec. 177.1520(c) of this
                                          chapter, items 1.1a, 1.1b,
                                          3.1a, 3.2a, or 3.2b, where the
                                          copolymers complying with
                                          items 3.1a, 3.2a, or 3.2b
                                          contain not less than 85
                                          weight percent of polymer
                                          units derived from propylene.
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. The finished
                                          polymers shall 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.
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 408]]

 
Sodium 2,2'-methylenebis(4,6-di-tert-    For use only:
 butylphenyl)phosphate (CAS Reg. No.     1. As a clarifying agent at a
 85209-91-2).                             level not exceeding 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), or foods of all
                                          types, limited to conditions
                                          of use C through H described
                                          in table 2 of Sec.
                                          176.170(c).
                                         2. As a clarifying agent at
                                          levels not exceeding 0.10
                                          percent by weight of
                                          polypropylene complying with
                                          Sec. 177.1520(c) of this
                                          chapter, items 1.1(a) or
                                          1.1(b) and of olefin polymers
                                          complying with Sec.
                                          177.1520(c) of this chapter,
                                          items 3.1(a), 3.1(b), 3.1(c),
                                          3.2(a), or 3.2(b) (where the
                                          copolymers contain not less
                                          than 85 weight percent of the
                                          polymer units derived from
                                          polypropylene.) The finished
                                          polymers shall be used in
                                          contact with foods only under
                                          conditions of use A through H
                                          described in Table 2 of Sec.
                                          176.170(c) of this chapter.
                                         3. As a clarifying agent at a
                                          level not exceeding 0.30
                                          percent by weight of olefin
                                          polymers complying with Sec.
                                          177.1520(c) of this chapter,
                                          item 2.2, where the finished
                                          polymer contacts food only of
                                          types I, II, IV-B, VI-A, VI-B,
                                          and VII-B 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 types III, IV-A,
                                          V, VI-C, and VII-A as
                                          identified in Table 1 of Sec.
                                           176.170(c) of this chapter
                                          and limited to conditions of
                                          use C through G 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; 61 FR 33847, July 1, 
1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 
56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 
1999; 65 FR 16316, Mar. 28, 2000]



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, 5100 Paint Branch Pkwy., College 
Park, MD 20740.

[[Page 409]]

    (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 exceed
 amino]carbonyl]- 2-methoxyphenyl]azo]-   1 percent by weight of
 N-(5-chloro-2,4-dimethoxyphenyl)-3-      polymers. The finished
 hydroxy-2-naphthalene-carboxamide        articles are to contact foods
 (C.I. Pigment Red 187, CAS Reg. No.      only under conditions of use B
 59487-23-9).                             through H described in table 2
                                          of Sec. 176.170(c) of this
                                          chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1-       For use at levels not to exceed
 [[(2,3-dihydro-2-oxo-1H-benzimidazol-5-  1 percent by weight of
 yl)amino]carbonyl]-2-                    polymers. The finished
 oxopropyl]azo]benzamide (C. I. Pigment   articles are to contact food
 Yellow 181, CAS Reg. No. 74441-05-7).    only under conditions of use B
                                          through H described in table 2
                                          of Sec. 176.170(c) of this
                                          chapter.
Anthra(2,1,9-def:(6,5,10-                For use at levels not to exceed
 d'e'f)diisoquinoline-1,3,8,10(2H,9H)-    1% by weight of polymers. The
 tetrone (C.I. Pigment Violet 29; CAS     finished articles are to
 Reg. No. 81-33-4).                       contact food only under
                                          conditions of use B through H
                                          as described in Table 2 of
                                          Sec. 176.170(c) of this
                                          chapter.
Barium sulfate.........................
Bentonite..............................
Bentonite, modified with 3-
 dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]-   For use at levels not to exceed
 9,10-anthracenedione (CAS Reg. No. 116-  0.0004 percent by weight of
 75-6).                                   polyethylene phthalate
                                          polymers complying with Sec.
                                          177.1630 of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-     For use only at levels not to
 pyrrolo[3,4-c]pyrrole-1,4-dione (C.I.    exceed 1 percent by weight of
 Pigment Red 254, CAS Reg. No. 84632-65-  polymers. The finished
 5).                                      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.
4,4'-Bis(4-anilino-6-diethanolamine-     For use only in the textile
 [alpha]-triazin-2-ylamino)-2,2'-         fibers specified in Sec.
 stilbene disulfonic acid, disodium       177.2800 of this chapter.
 salt.
4,4'-Bis(4-anilino-6-methylethanolamine-  Do.
 [alpha]-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 exceed
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-     1.0 percent by weight of the
 methylbenzenesulfonic acid, calcium      finished polymers. The
 salt (1:1); (C.I. Pigment Yellow 191,    finished articles are to
 CAS Reg. No. 129423-54-7).               contact food only under
                                          conditions of use B through H
                                          as described in table 2 of
                                          Sec. 176.170(c) of this
                                          chapter.
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-    For use at levels not to exceed
 sulfophenyl)-1H-pyrazol-4-yl]azo]-5-     0.5 percent by weight of
 methylbenzenesulfonic acid, diammonium   polymers. The finished
 salt (1:2): (C.I. Pigment Yellow         articles are to contact food
 191:1, CAS Reg. No. 154946-66-4).        under conditions of use A
                                          through H described in Table 2
                                          of Sec. 176.170(c) of this
                                          chapter.
Chrome antimony titanium buff rutile     For use at levels not to exceed
 (C.I. Pigment Brown 24, CAS Reg. No.     1 percent by weight of
 68186-90-3).                             polymers. The finished
                                          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, Cr2O3 (C.I.        For use only:
 Pigment Green 17, C.I. No. 77288).      1. In polymers used in contact
                                          with food at a level not to
                                          exceed 5 percent by weight of
                                          the polymer, except as
                                          specified below.
                                         2. In olefin polymers complying
                                          with Sec. 177.1520 of this
                                          chapter.
                                         3. 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.

[[Page 410]]

 
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.       For use at levels not to exceed
 Pigment Black 28, CAS Reg. No. 68186-    5 percent by weight of
 91-4).                                   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 exceed
 9,9',10,10'-tetrone (CAS Reg. No. 4051-  1 percent by weight of
 63-2).                                   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.
2,9-Dichloro-5,12-dihydroquinone[2,3-    For use at levels not to exceed
 b]acridine-7,14-dione (C.I. Pigment      1.0 percent by weight of
 Red 202, CAS Reg. No. 3089-17-6).        polymers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-   For use only:
 (3-sulfophenyl)-1H-pyrazol-4-           1. At levels not to exceed 1
 yl)azo)benzenesulfonic acid, calcium     percent by weight of
 salt(1:1), (C.I. Pigment Yellow 183,     polypropylene polymers and
 CAS Reg. No. 65212-77-3).                copolymers complying with Sec.
                                            177.1520(c) of this chapter,
                                          items 1.1a, 1.1b, 1.2, 1.3,
                                          3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
                                          3.4, or 3.5. The finished
                                          articles are to contact food
                                          only under conditions of use E
                                          through G, as described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter.
                                         2. At levels not to exceed 1
                                          percent by weight of high
                                          density polyethylene polymers
                                          and copolymers complying with
                                          Sec. 177.1520(c) of this
                                          chapter, items 2.1, 2.2, 2.3,
                                          3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
                                          3.6 (density not less than
                                          0.94 grams per cubic
                                          centimeter), or 5. The
                                          finished articles are to
                                          contact food only under
                                          conditions of use E through G,
                                          as 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 exceed
 benzimidazol-5-yl)azo]-2,4,6(1H, 3H,     1 percent by weight of
 5H)-pyrimidinetrione (CAS Reg. No.       polymers. The finished
 72102-84-2).                             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.
2,9-Dimethylanthra(2,1,9-def:6,5,10-     For use at levels not to exceed
 d'e'f')diisoquinoline-1,3,8,10(2H,9H)-   1 percent by weight of
 tetrone (C.I. Pigment Red 179, CAS       polymers. The finished
 Reg. No. 5521-31-3).                     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.
3,3'-[(2,5-Dimethyl-1,4-                 For use at levels not to exceed
 phenylene)bis[imino(1-acetyl-2-oxo-2,1-  1 percent by weight of
 ethanediyl)azo]]bis[4-chloro-N-(5-       polymers. The finished
 chloro-2-methylphenyl)-benzamide] (CAS   articles are to contact food
 Reg. No. 5280-80-8).                     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 exceed
 phenylene)bis[imino-carbonyl(2-hydroxy-  1 percent by weight of
 3,1-naphthalenediyl) azo]] bis(4-        polymers. The finished
 methylbenzoic acid), bis(2-              articles are to contact food
 chloroethyl) ester (CAS Reg. No. 68259-  only under conditions of use B
 05-2).                                   through H described in table 2
                                          of Sec. 176.170(c) of this
                                          chapter.
2,2'-[1,2-Ethanediylbis(oxy-2,1-         For use at levels not to exceed
 phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-  1.0 percent by weight of
 1H-benzimidazol-5-yl)]-3-oxo-            polymers. The finished
 butanamide (C.I. Pigment Yellow 180,     articles are to contact food
 CAS Reg. No. 77804-81-0).                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-  brightener for all polymers at
 5).                                      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 [deg]F.

[[Page 411]]

 
High-purity furnace black (CAS Reg. No.  For use at levels not to exceed
 1333-86-4) containing total              2.5 percent by weight of the
 polynuclear aromatic hydrocarbons not    polymer.
 to exceed 0.5 parts per million, and
 benzo[a]pyrene not to exceed 5.0 parts
 per billion, as determined by a method
 entitled ``Determination of PAH
 Content of Carbon Black,'' dated July
 8, 1994, as developed by the Cabot
 Corp., 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 Office of
 Premarket Approval (HFS-200), Center
 for Food Safety and Applied Nutrition,
 Food and Drug Administration, 5100
 Paint Branch Pkwy., College Park, MD
 20740, or may be examined at the
 Center for Food Safety and Applied
 Nutrition's Library, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or at
 the National Archives and Records
 Administration (NARA). For information
 on the availability of this material
 at NARA, call 202-741-6030, or go to:
 http://www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
Iron oxides............................
Kaolin-modified, produced by treating    For use only in olefin polymers
 kaolin with a reaction product of        complying with Sec. 177.1520
 isopropyl titanate and oleic acid in     of this chapter at levels not
 which 1 mole of isopropyl titanate is    to exceed 40 percent by weight
 reacted with 1 to 2 moles of oleic       of olefin polymer.
 acid. The reaction product will not
 exceed 8 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)..............
Manganese Violet (manganese ammonium     For use at levels not to exceed
 pyrophosphate; CAS Reg. No. 10101-66-    2 percent by weight of
 3)..                                     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.
Mixed methylated 4,4'-bis(2-             For use as an optical
 benzoxazolyl)stilbenes with the major    brightener only at levels not
 portion consisting of 4-(2-              to exceed 0.05 percent by
 benzoxazolyl)-4'-(5-methyl-2-            weight of rigid and semirigid
 benzoxazolyl)stilbene (CAS Registry      polyvinyl chloride and not to
 No. 5242-49-9) and lesser portions       exceed 0.03 percent by weight
 consisting of 4,4'-bis(5-methyl-2-       in all other polymers. The
 benzoxazolyl)stilbene (CAS Registry      finished food-contact articles
 No. 2397-00-4) and 4,4'-bis(2-           shall be used only under
 benzoxazolyl)stilbene (CAS Registry      conditions of use D, E, F, and
 No. 1533-45-5).                          G described in table 2 of Sec.
                                            176.170(c) of this chapter.
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-     For use as an optical
 phenylcoumarin (CAS Reg. No. 3333-62-    brightener only in:
 8) having a melting point of 250        1. Olefin polymers complying
 [deg]C to 251 [deg]C and a nitrogen      with Sec. 177.1520 of this
 content of 10.7 to 11.2 percent.         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.
Nickel antimony titanium yellow rutile   For use at levels not to exceed
 (C.I. Pigment Yellow 53, CAS Reg. No.    1 percent by weight of
 8007-18-9).                              polymers. The finished
                                          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.
1,1'-[(6-Phenyl-1,3,5-triazine-2,4-      For use at levels not to exceed
 diyl)diimino]bis-9,10-anthracenedione    0.25 percent by weight of
 (CAS Reg. No. 4118-16-5).                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.

[[Page 412]]

 
Quinacridone red (C.I. Pigment violet
 19, C.I. No. 73900).
Sienna (raw and burnt).................
Silica.................................
2,3,4,5-Tetrachloro-6-cyanobenzoic       For use only at levels not to
 acid, methyl ester reaction products     exceed 1 percent by weight of
 with p-phenyllenediamine and sodium      polymers. The finished
 methoxide (CAS reg. No. 106276-80-6).    articles are to contact food
                                          only under conditins of use B
                                          through H, described in table
                                          2, of Sec. 176.170(c) of
                                          this chapter.
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-       For use only at levels not to
 tetrachloro-2,3-dihydro-1,3-dioxo-1H-    exceed 1 percent by weight of
 inden-2-yl)-8-quinolinyl]-1H-isoindole-  polymers. The finished
 1,3(2H)-dione (C. I. Pigment Yellow      articles are to contact food
 138, CAS Reg. No.30125-47-4).            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
                                          [deg]F (70 [deg]C).
2,2'-(2,5-Thiophenediyl)-bis(5-tert-     For use as an optical
 butylbenzoxazole) (CAS Reg. No. 7128-    brightener:
 64-5).                                  1. In all polymers at levels
                                          not to exceed 0.015 percent by
                                          weight of the polymer. The
                                          finished articles are to
                                          contact food only under
                                          conditions of use A through H
                                          described in table 2 of Sec.
                                          176.170(c) of this chapter.
                                         2. In all polymers at levels
                                          not to exceed 0.05 percent by
                                          weight of the polymer. The
                                          finished articles 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, VI-C,
                                          VII-B, and VIII under
                                          conditions of use A 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
                                          and in pressure-sensitive
                                          adhesives complying with Sec.
                                           175.125 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 46775, Oct. 14, 1983]

    Editorial Note: For Federal Register citations affecting Sec. 
178.3297, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

[[Page 413]]



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..........................
------------------------------------------------------------------------



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
------------------------------------------------------------------------
[alpha]-Alkyl-, [alpha]-alkenyl-, and    For use only at levels not to
 [alpha]-alkylaryl-omega-                 exceed 0.5 pct by weight of
 hydroxypoly(oxyethylene) mixture         coatings complying with Sec.
 consisting of 30 weight pct of [alpha]-  175.320 of this chapter and
 (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.
 weight ratio mixture of [alpha]-(Z)-9-   178.3770(b). The weight of the
 octadecenyl-omega-                       finished coating shall not
 hydroxypoly(oxyethylene) having an       exceed 2 milligrams per square
 average poly(oxyethylene) content of     inch of food-contact surface.
 18 moles and [alpha]-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 Sec. Sec.
 sodium salts.                            175.300, 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.

[[Page 414]]

 
Alkyl mono- and disulfonic acids,        For use only:
 sodium salts (produced from n-alkanes   1. As provided in Sec.
 in the range of C10-C18 with not less    176.170 of this chapter.
 than 50 percent C14-C16).               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.
[alpha]-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.
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. 32612-48-9).          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 Sec.
 groups 0-0.4 percent.                    Sec. 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 Sec. Sec. 175.105,
                                          175.300, 176.170, 176.180, and
                                          177.1210 of this chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent as provided in Sec.
 known as butanedioic acid, sulfo-1,4-    Sec. 175.105, 175.125,
 diisodecyl ester, ammonium salt [CAS     176.170, and 176.180 of this
 Reg. No. 144093-88-9])..                 chapter.
[alpha]-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.
Disodium 4-isodecyl sulfosuccinate (CAS  For use only as an emulsifier
 Reg. No. 37294-49-8).                    at levels not to exceed 5
                                          percent by weight of polymers
                                          intended for use in coatings.
[alpha]-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.

[[Page 415]]

 
[alpha]-(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.
Naphthalene sulfonic acid-formaldehyde   For use only:
 condensate, sodium salt (CAS Reg. No.   1. At levels not to exceed 10
 9084-06-4).                              micrograms/in\2\ (0.16 mg/
                                          dm\2\) in vinylidene chloride
                                          copolymer or homopolymer
                                          coatings applied to films of
                                          propylene polymers complying
                                          with Sec. 177.1520 of this
                                          chapter.
                                         2. At levels not to exceed 14
                                          micrograms/in\2\ (0.21 mg/
                                          dm\2\) in vinylidene chloride
                                          copolymer or homopolymer
                                          coatings applied to films of
                                          polyethylene phthalate
                                          polymers complying with Sec.
                                          177.1630 of this chapter.
[alpha]-(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.
[alpha]-(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.
[alpha]-(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
 [alpha]-(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.
[alpha]-(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.
[alpha]-(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.
Polyethyleneglycol alkyl(C10-C12) ether  For use only at levels not to
 sulfosuccinate, disodium salt (CAS       exceed 5 percent by weight of
 Reg. No. 68954-91-6).                    total monomers used in the
                                          emulsion polymerization of
                                          polyvinyl acetate, acrylic,
                                          and vinyl/acrylic polymers
                                          intended for use as coatings
                                          for paper and paperboard.
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;                polyolefin film and polyolefin
 [middot]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.

[[Page 416]]

 
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 C8C16.
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.
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.
Sulfosuccinic acid 4-ester with          For use only at levels not to
 polyethylene glycol nonylphenyl ether,   exceed 5 percent by weight of
 disodium salt (alcohol moiety produced   the total coating monomers
 by condensation of 1 mole nonylphenol    used in the emulsion
 and an average of 9-10 moles of          polymerization of polyvinyl
 ethylene oxide) (CAS Reg. No. 9040-38-   acetate and vinyl-acrylate
 4).                                      copolymers intended for use as
                                          coatings for paper and
                                          paperboard.
[alpha]-[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-sulfosuccin ate.               polymerization emulsifier for
                                          resins applied to tea-bag
                                          material.
[alpha]-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.
[alpha]-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]

    Editorial Note: For Federal Register citations affecting Sec. 
178.3400, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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:

[[Page 417]]

    (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 incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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-acetoxy stearate).

    Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be 
safely

[[Page 418]]

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.
[beta]-Diethylaminoethyl chloride
 hydrochloride, not to exceed 4 pct.
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).

[[Page 419]]

 
  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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

    (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]

[[Page 420]]



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....................................
[alpha]-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.
[alpha]-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.
Di (n-octyl) phosphite (CAS Reg. No.     For use only as an extreme
 1809-14-9).                              pressure-antiwear adjuvant at
                                          a level not to exceed 0.5
                                          percent by weight of the
                                          lubricant.
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.

[[Page 421]]

 
[alpha]-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-[alpha]-and/or phenyl-[beta]-     For use only, singly or in
 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.
Phosphorothioic acid, O, O, O-triphenyl  For use only as an extreme
 ester, tert-butyl derivatives (CAS       pressure-antiwear adjuvant at
 Reg. No. 192268-65-8).                   a level not to 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.
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, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

[[Page 422]]



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  [b.alpha]-Methylstyrene-vinyltoluene resins, hydrogenated.

    Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins 
having a molar ratio of 1 [alpha]-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 [alpha]-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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 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, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (ii) Ultraviolet absorbance limits as follows:

------------------------------------------------------------------------
                                                                Maximum
                                                                absorb
                                                               ance per
                    Wavelength (m[micro])                     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

[[Page 423]]

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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), 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[micro], inclusive, compared to the 
solvent control. If the absorbance so measured exceeds 2.0 at any point 
in range 280-350 m[micro], 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 
Sec. Sec. 175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 
of this chapter and Sec. Sec. 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
                                                                absorb
                                                               ance per
                    Wavelength (m[micro])                     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 a component of nonfood articles complying with Sec. Sec. 
175.105 and 176.210 of this chapter and Sec. 178.3910 (for use only in 
rolling of metallic foil and sheet stock), Sec. Sec. 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.

[[Page 424]]

    Chromatographic tube. 180 millimeters in length, inside diameter to 
be 15.7 millimeters 0.1 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 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1,000 centimeter 0.005 
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, 0.01 at 0.4 
absorbance.
    Absorbance accuracy \1\ 0.05 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
---------------------------------------------------------------------------

    Wavelength accuracy, 1.0 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[micro]. 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.

[[Page 425]]

    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[micro]-400 m[micro]. 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).

------------------------------------------------------------------------
                                                                Absorb
                         Wavelength                              ance
                                                               (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 1 [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]C 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 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[micro] and 400 m[micro] 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 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[micro] to 400 m[micro]; the 
absorbance per centimeter pathlength following the complete procedure 
should not exceed 0.02 in the wavelength range from 280 m[micro] to 400 
m[micro]. If in either spectrum the characteristic benzene peaks in the 
250 m[micro]-260 m[micro] 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

[[Page 426]]

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[micro]-400 m[micro] (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 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

[[Page 427]]

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[micro]-400 m[micro]. 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[micro]-260 m[micro] 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
                                                                absorb-
                                                               ance per
                    Wavelength (m[micro])                     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.
    D. A chromatographic column made from nominal 1.7 centimeters 
outside diameter x 115 centimeters glass tubing tapered at one

[[Page 428]]

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[micro] with a spectral slit width of 2 m[micro] or 
less. At an absorbance level of about 0.4, absorbance measurements shall 
be repeatable within 0.01 and accurate within 
0.05. Wavelength measurements shall be repeatable 
with 0.2 m[micro] and accurate within 1.0 m[micro]. 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[micro], 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 1.000.005 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[micro].
    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.
    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

[[Page 429]]

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 1 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 0.1 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 1 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 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

[[Page 430]]

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.
    19. Record the spectrum of the sample solution in a 1-centimeter 
cell compared to isooctane from 270 to 400 m[micro]. After making 
necessary corrections in the spectrum for cell differences and for the 
blank absorbance, record the maximum absorbance in each of

[[Page 431]]

the wavelength intervals (m[micro]), 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[micro], 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[micro], 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
                                                                absorb
                                                               ance per
                    Wavelength (M[micro])                     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
 paper and paperboard.                    of this chapter.
As a defoamer in coatings..............  Complying with Sec. 176.200
                                          of this chapter.
------------------------------------------------------------------------


[[Page 432]]



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, 
100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or 
may be examined at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]



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

[[Page 433]]

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:
    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: Sec. Sec. 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. 178.3725  Pigment dispersants.

    Subject to the provisions of this regulation, the substances listed 
in this section may be safely used as pigment dispersants in food-
contact materials.

[[Page 434]]



------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Dimethylolpropionic acid (CAS Reg. No.   For use only at levels not to
 4767-03-7).                              exceed 0.45 percent by weight
                                          of the pigment. The pigmented
                                          articles may contact all foods
                                          under conditions of use A
                                          through H as described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter.
Phosphorylated tall oil fatty acids      For use only at levels not to
 (CAS Reg. No. 68604-99-9), prepared by   exceed 1.0 percent by weight
 the reaction of dimethyl hydrogen        of the pigment. The pigmented
 phosphite with tall oil fatty acids.     polymeric films may contact
                                          all food under conditions of
                                          use D, E, F, and G described
                                          in table 2 of Sec.
                                          176.170(c) of this chapter.
Propanoic acid, 3-hydroxy-2-             For use only at levels not to
 (hydroxymethyl)-2-methyl-, compd. with   exceed 0.45 percent by weight
 1,1',1''-nitrilotris [2-propanol]        of the pigment. The pigmented
 (1:1) (CAS Reg. No. 221281-21-6).        articles may contact all food
                                          under conditions of use A
                                          through H as described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter.
Siloxanes and silicones; cetylmethyl,    For use only at levels not to
 dimethyl, methyl 11-methoxy-11-          exceed 0.5 percent by weight
 oxoundecyl (CAS Reg. No. 155419-59-3).   of the pigment. The pigmented
                                          polymers may contact all foods
                                          under conditions of use C, D,
                                          E, F, and G described in Table
                                          2 of Sec. 176.170(c) of this
                                          chapter.
Trimethylolethane (CAS Reg. No. 77-85-   For use only at levels not to
 0).                                      exceed 0.45 percent by weight
                                          of inorganic pigment. The
                                          pigmented articles may contact
                                          all food under conditions of
                                          use A through H described in
                                          Table 2 of Sec. 176.170(c)
                                          of this chapter.
------------------------------------------------------------------------


[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 
FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 
31, 2000]



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 Sec. Sec. 561.310 and 561.340 of this 
chapter, or that are intended for use in contact with dried food in 
compliance with Sec. Sec. 193.60 and 193.390 of this chapter.



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 Sec. Sec. 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.

[[Page 435]]

 
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.
                                  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 Sec. Sec.
                                   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........  ......................................

[[Page 436]]

 
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.
                                  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..............

[[Page 437]]

 
Polybutene, hydrogenated          For use only:
 (minimum viscosity at 99         1. In polymeric substances used in
 [deg]F, 39 Saybolt Universal      contact with non-fatty food.
 seconds, as determined by ASTM   2. In polyethylene complying with Sec.
 methods D445-82 (``Standard         177.1520 of this chapter and used
 Test Method for Kinematic         in contact with fatty food, provided
 Viscosity of Transparent and      that the hydrogenated polybutene is
 Opaque Liquids (and the           added in an amount not to exceed 0.5
 Calculation of Dynamic            pct by weight of the polyethylene,
 Viscosity)'') and D2161-82        and further provided that such
 (``Standard Method for            plasticized polyethylene shall not be
 Conversion of Kinematic           used as a component of articles
 Viscosity to Saybolt Universal    intended for packing or holding food
 Viscosity or to Saybolt Furol     during cooking.
 Viscosity''), and bromine        3. In polystyrene complying with Sec.
 number of 3 or less, as            177.1640 of this chapter and used in
 determined by ASTM method D1492-  contact with fatty food, provided
 78 (``Standard Test Method for    that the hydrogenated polybutene is
 Bromine Index of Aromatic         added in an amount not to exceed 5
 Hydrocarbons by Coulometric       pct by weight of the polystyrene, and
 Titration''), which are           further provided that such
 incorporated by reference.        plasticized polystyrene shall not be
 Copies may be obtained from the   used as a component of articles
 American Society for Testing      intended for packing or holding food
 Materials, 100 Barr Harbor Dr.,   during cooking.
 West Conshohocken,
 Philadelphia, PA 19428-2959, or
 may be examined at the National
 Archives and Records
 Administration (NARA). For
 information on the availability
 of this material at NARA, call
 202-741-6030, or go to: http://
 www.archives.gov/
 federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
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.



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

[[Page 438]]

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, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
2959, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.) 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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.) 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

[[Page 439]]

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. 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 0.5 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 0.005 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, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 at 0.4 
absorbance.
---------------------------------------------------------------------------

    \1\ As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 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.

[[Page 440]]

    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[micro] and 400 m[micro].
    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[micro]-400 m[micro]. 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[micro]-400 m[micro] 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

[[Page 441]]

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 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[micro] and 400 m[micro] 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[micro] and 400 
m[micro] 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[micro] to 299 m[micro], inclusive, nor 
0.02 in the wavelength range from 300 m[micro] to 400 m[micro]. If in 
either spectrum the characteristic benzene peaks in the 250 m[micro]-260 
m[micro] 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

[[Page 442]]

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 
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[micro]-400 m[micro]. 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[micro]-260 m[micro] 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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
2959, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.) 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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.) using xylene-ethyl alcohol in a 2:1 ratio instead 
of ethyl alcohol in preparation of potassium hydroxide solution.

[[Page 443]]

    (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.
    (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. 9004-98-
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 Sec. Sec. 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; 69 
FR 24512, May 4, 2004]



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

[[Page 444]]

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:
    (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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.


[[Page 445]]


    (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.
    (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.

[[Page 446]]

 
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.
    (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).........
Formaldehyde, polymer with 1-     For use only as an antiscaling or
 naphthalenol (CAS Reg. No.        release agent, applied on the
 25359-91-5).                      internal parts of reactors employed
                                   in the production of polyvinyl
                                   chloride and acrylic copolymers,
                                   provided that the residual levels of
                                   the additive in the ploymer do not
                                   exceed 4 parts per million.
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).

[[Page 447]]

 
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; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 
15, 1996]



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.
    (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.

[[Page 448]]

    (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.
    (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[micro] (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.

[[Page 449]]

    (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, 100 Barr Harbor Dr., West 
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-
2959, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/

[[Page 450]]

code_of_federal_regulations/ibr_locations.html.

[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
------------------------------------------------------------------------
[alpha]-Butyl-[Omega]--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.
[alpha]-Butyl-[Omega]-hydroxypoly(oxypr
 opylene) (CAS Reg. No. 9003-13-8)
 having a minimum molecular weight of
 1000.
[alpha]-Lauroyl-[Omega]-hydroxpoly(oxye
 thylene) (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).
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 laurate (CAS Reg. No. 10233-   For use at a level not to
 13-3).                                   exceed 10 percent by weight of
                                          the finished lubricant
                                          formulation.
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).

[[Page 451]]

 
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. 68608-26-4) derived from
 naphthenic oil having a Saybolt
 viscosity range of 500-600 Saybolt
 Universal Seconds (SUS at 37-8 [deg]C
 (100 [deg]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 National
 Archives and Records Administration
 (NARA). For information on the
 availability of this material at NARA,
 call 202-741-6030, or go to: http://
 www.archives.gov/federal_register/
 code_of_federal_regulations/
 ibr_locations.html..
Synthetic alcohol mixture of straight-
 and branched-chain alcohols that have
 even numbers of carbon atoms in the
 range C4C18 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,
 2074; 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 1945; hydroxyl number, 283-296.
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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this

[[Page 452]]

material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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[micro])                     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 
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 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1.000 centimeter 0.005 
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, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 at 0.4 
absorbance.
---------------------------------------------------------------------------

    \1\ As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. The 
accuracy is to be determined by comparison with the standard values at 
210, 345, and 400 millimicrons.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 millimicron.

[[Page 453]]

    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[micro]. 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[micro]-400 m[micro]. 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[micro] and 400 m[micro] 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 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[micro] to 400 
m[micro].
    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.

[[Page 454]]

    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[micro]-400m[micro] (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:
    (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.

[[Page 455]]

 
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 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; 64 FR 47110, Aug. 30, 1999; 69 FR 
24512, May 4, 2004]



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

[[Page 456]]

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.
179.41 Pulsed light for the treatment of food.

           Subpart C_Packaging Materials for Irradiated Foods

179.45 Packaging materials for use during the irradiation of prepackaged 
          foods.

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

    Source: 42 FR 14635, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 179 appear at 70 FR 
72074, Dec. 1, 2005.

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 a voltage of 500 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.
    (4) Machine sources producing X-radiation at energies no greater 
than 10 million electron volts (MeV).
    (5) Monoenergetic neutron sources producing neutrons at energies not 
less than 1 MeV but no greater than 14 MeV.
    (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.

[[Page 457]]

    (iii) The maximum energy of X-radiation emitted by machine source.
    (iv) The minimum and maximum energy of radiation emitted by neutron 
source.
    (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.
    (iv) A statement that no food shall be exposed to a radiation source 
listed in paragraph (a)(4) of this section so as to receive a dose in 
excess of 0.5 gray (Gy).
    (v) A statement that no food shall be exposed to a radiation source 
listed in paragraph (a)(5) of this section so as to receive a dose in 
excess of 0.01 gray (Gy).

[42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 
61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, Apr. 
10, 2001; 69 FR 76404, Dec. 21, 2004]



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 food shall be in 
compliance with Sec. 179.45, shall be the subject of an exemption for 
such use under Sec. 170.39 of this chapter, or shall be the subject of 
an effective premarket notification for a food contact substance for 
such use submitted under Sec. 170.100 of this chapter.
    (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.

[51 FR 13399, Apr. 18, 1986, as amended at 67 FR 9585, Mar. 4, 2002; 67 
FR 35731, May 21, 2002]



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 (MeV), except as

[[Page 458]]

permitted by paragraph (a)(4) of this section.
    (4) X rays generated from machine sources using tantalum or gold as 
the target material and using energies not to exceed 7.5 (MeV).
    (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.
8. For control of foodborne pathogens in,   Not to exceed 4.5 kGy
 and extension of the shelf-life of,         maximum for refrigerated
 refrigerated or frozen, uncooked products   products; not to exceed 7.0
 that are meat within the meaning of 9 CFR   kGy maximum for frozen
 301.2(rr), meat byproducts within the       products.
 meaning of 9 CFR 301.2(tt), or meat food
 products within the meaning of 9 CFR
 301.2(uu), with or without nonfluid
 seasoning, that are otherwise composed
 solely of intact or ground meat, meat
 byproducts, or both meat and meat
 byproducts.
9. For control of Salmonella in fresh       Not to exceed 3.0 kGy.
 shell eggs..
10. For control of microbial pathogens on   Not to exceed 8.0 kGy.
 seeds for sprouting..
11. For the control of Vibrio bacteria and  Not to exceed 5.5 kGy.
 other foodborne microorganisms in or on
 fresh or frozen molluscan shellfish..
12. For control of food-borne pathogens     Not to exceed 4.0 kGy.
 and extension of shelf-life in fresh
 iceberg lettuce and fresh spinach..
------------------------------------------------------------------------

    (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

[[Page 459]]

[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. The radiation disclosure statement is not 
required to be more prominent than the declaration of ingredients 
required under Sec. 101.4 of this chapter. As used in this provision, 
the term ``radiation disclosure statement'' means the written statement 
that discloses that a food has been intentionally subject to 
irradiation.
    (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 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; 62 FR 
64121, Dec. 3, 1997; 63 FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, 
2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846, Dec. 23, 2004; 70 FR 
48072, Aug. 16, 2005; 73 FR 49603, Aug. 22, 2008]



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 low pressure mercury lamps 
emitting 90 percent of the emission at a wavelength of 253.7 nanometers 
(2,537 Angstroms).

[[Page 460]]

    (b) The ultraviolet radiation is used or intended for use as 
follows:

----------------------------------------------------------------------------------------------------------------
             Irradiated food                              Limitations                            Use
----------------------------------------------------------------------------------------------------------------
Food and food products...................  Without ozone production: high fat-       Surface microorganism
                                            content food irradiated in vacuum or in   control.
                                            an inert atmosphere; intensity of
                                            radiation, 1 W (of 2,537 A. radiation)
                                            per 5 to 10 ft.\2\.
Potable water............................  Without ozone production; coefficient of  Sterilization of water used
                                            absorption, 0.19 per cm or less; flow     in food production.
                                            rate, 100 gal/h per watt of 2,537 A.
                                            radiation; water depth, 1 cm or less;
                                            lamp-operating temperature, 36 to 46
                                            [deg]C..
Juice products...........................  Turbulent flow through tubes with a       Reduction of human
                                            minimum Reynolds number of 2,200..        pathogens and other
                                                                                      microorganisms.
----------------------------------------------------------------------------------------------------------------


[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]



Sec. 179.41  Pulsed light for the treatment of food.

    Pulsed light may be safely used for treatment of foods under the 
following conditions:
    (a) The radiation sources consist of xenon flashlamps designed to 
emit broadband radiation consisting of wavelengths covering the range of 
200 to 1,100 nanometers (nm), and operated so that the pulse duration is 
no longer than 2 milliseconds (msec);
    (b) The treatment is used for surface microorganism control;
    (c) Foods treated with pulsed light shall receive the minimum 
treatment reasonably required to accomplish the intended technical 
effect; and
    (d) The total cumulative treatment shall not exceed 12.0 Joules/
square centimeter (J/cm\2\.)

[61 FR 42383, Aug. 15, 1996]



           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, electron beam, or X-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 Sec. Sec. 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.
    (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

[[Page 461]]

this chapter. The finished film may contain:
    (i) Adjuvant substances used in compliance with Sec. Sec. 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 
Sec. Sec. 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 Sec. Sec. 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, 100 Barr Harbor Dr., West Conshohocken, 
Philadelphia, PA 19428-2959, or may be examined at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. The finished film may contain adjuvant substances 
used in compliance with Sec. Sec. 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, 
electron beam, 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       of the polymer.
 this chapter.
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.
------------------------------------------------------------------------


[[Page 462]]

    (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; 66 FR 10575, Feb. 16, 2001]



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: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.

    Editorial Note: Nomenclature changes to part 180 appear at 61 FR 
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.



                      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 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

[[Page 463]]

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 Sec. Sec. 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 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

[[Page 464]]

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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, 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 [beta]-Dodecyl-
mercaptopropionitrile in NR-16R Aqueous Extracts'' and ``Measurement of 
[beta]-(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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 465]]

    (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, 5100 Paint Branch 
Pkwy., College Park, MD 20740.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740. 
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 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.
    (3) A pure culture fermentation of sugars such as fructose, glucose, 
or maltose using the nonpathogenic,

[[Page 466]]

nontoxicogenic bacterium Lactobacillus intermedius (fermentum).
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 69 FR 65542, Nov. 15, 2004]



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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 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

[[Page 467]]

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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 of this chapter.

[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 72 
FR 10357, Mar. 8, 2007]



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.

[[Page 468]]

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: 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, and 66 FR 56035, Nov. 6, 2001.



                      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 
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

[[Page 469]]

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 Sec. Sec. 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.
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:


[[Page 470]]


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.
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).

[[Page 471]]

Melamine formaldehyde polymer.
Methyl acrylate (polymerized).
Methyl ethers of 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, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 472]]

    (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.

                       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.
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 [Reserved]

[[Page 473]]

                         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 [alpha]-Tocopherol acetate.
182.8985 Zinc chloride.
182.8988 Zinc gluconate.
182.8991 Zinc oxide.
182.8994 Zinc stearate.
182.8997 Zinc sulfate.

    Authority: 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.
    (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:

[[Page 474]]



------------------------------------------------------------------------
           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.
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).

[[Page 475]]

 
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).

    Essential oils, oleoresins (solvent-free), and natural extractives 
(including distillates) 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.........................  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.
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.

[[Page 476]]

 
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.
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.
Mat[eacute].....................  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.

[[Page 477]]

 
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.
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.

    Natural extractives (solvent-free) used in conjunction with spices, 
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
------------------------------------------------------------------------
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]

[[Page 478]]



Sec. 182.50  Certain other spices, seasonings, essential oils, 
oleoresins, and natural extracts.

    Certain other spices, seasonings, essential oils, oleoresins, and 
natural extracts that are generally recognized as safe for their 
intended use, within the meaning of section 409 of the Act, are as 
follows:

------------------------------------------------------------------------
           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).
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.

[[Page 479]]

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, which appears in 
the Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 182.99  Adjuvants for pesticide chemicals.

    Adjuvants, identified and used in accordance with 40 CFR 180.910 and 
40 CFR 180.920, 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348).

[76 FR 59249, Sept. 26, 2011]



             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]
    (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.

[[Page 480]]



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.
    (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 carboxymethylcellu lose.

    (a) Product. Sodium carboxy methylcellulose 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

[[Page 481]]

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.



                       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 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.

[[Page 482]]

    (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 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]

[[Page 483]]

    (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]
    (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 [Reserved]



                       Subpart G_Sequestrants \1\
---------------------------------------------------------------------------

    \1\ For the purpose of this subpart, no attempt has been made to 
designate those sequestrants that may also function as chemical 
preservatives.
---------------------------------------------------------------------------



Sec. 182.6085  Sodium acid phosphate.

    (a) Product. Sodium acid phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when 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.

[[Page 484]]



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 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.

[[Page 485]]

    (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  [b.alpha]-Tocopherol acetate.

    (a) Product. [alpha]-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 [alpha]-Amylase enzyme preparation from Bacillus 
          stearothermophilus.
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.
184.1063 Enzyme-modified lecithin.
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.
184.1148 Bacterially-derived carbohydrase enzyme preparation.
184.1150 Bacterially-derived protease enzyme preparation.
184.1155 Bentonite.
184.1157 Benzoyl peroxide.

[[Page 486]]

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.
184.1250 Cellulase enzyme preparation derived from Trichoderma longi 
          brachi atum.
184.1257 Clove and its derivatives.
184.1259 Cocoa butter substitute.
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.
184.1420 Lipase enzyme preparation derived from Rhizopus niveus.
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 Menhaden oil.
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.
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.
184.1595 Pepsin.
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.

[[Page 487]]

184.1699 Oil of rue.
184.1702 Sheanut oil.
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.
184.1866 High fructose corn syrup.
184.1875 Thiamine hydrochloride.
184.1878 Thiamine mononitrate.
184.1890 [alpha]-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: 21 U.S.C. 321, 342, 348, 371.

    Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 184 appear at 66 FR 
56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 2001, 68 FR 15355, Mar. 31, 
2003, 69 FR 13717, Mar. 24, 2004, 70 FR 40880, July 15, 2005, and 70 FR 
67651, Nov. 8, 2005.



                      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 or 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 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

[[Page 488]]

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 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; 62 FR 15110, Mar. 31, 1997]



        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

[[Page 489]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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,'' 4th ed. (1996), pp. 102-103, test for citric acid, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, and a molecular weight of 174.11. Copies of the material 
incorporated by reference are available from the National Academy Press, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 the test for citric acid 
of the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103, which is 
incorporated by

[[Page 490]]

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.
    (7) Residue on ignition. Not more than 0.1 percent as determined by 
the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103, test for 
citric acid, 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.
    (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; 64 
FR 1759, Jan. 12, 1999]



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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.), 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 certain brown algae by alkaline extraction.

[[Page 491]]

    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
                                   practice.           170.3(o)(8) 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  [b.alpha]-Amylase enzyme preparation from Bacillus 
stearothermophilus.

    (a) [alpha]-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 [alpha]-amylase (1,4 [alpha]-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 at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/

[[Page 492]]

code_of_federal_regulations/ibr_locations.html.
    (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 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, 2101 Constitution Ave. NW., Washington, DC, or may be 
examined at the Office of Premarket Approval (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 493]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 Sec. Sec. 
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), 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be examined at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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. 81457-95-6) 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

[[Page 494]]

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, 5100 Paint Branch Pkwy., College Park, MD 
20740, and at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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, as amended at 69 FR 24512, May 4, 2004]



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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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. 184.1063  Enzyme-modified lecithin.

    (a) Enzyme-modified lecithin is prepared by treating lecithin with 
either phospholipase A2 (EC 3.1.1.4) or pancreatin.
    (b) The ingredient meets the specifications in paragraphs (b)(1) 
through (b)(8) of this section. Unless otherwise noted, compliance with 
the specifications listed below is determined according to the methods 
set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 
220-221, 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/


[[Page 495]]

federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) Acetone-insoluble matter (phosphatides), not less than 50.0 
percent.
    (2) Acid value, not more than 40.
    (3) Lead, not more than 1.0 part per million, as determined by 
atomic absorption spectroscopy.
    (4) Heavy metals (as Pb), not more than 20 parts per million.
    (5) Hexane-insoluble matter, not more than 0.3 percent.
    (6) Peroxide value, not more than 20.
    (7) Water, not more than 4.0 percent.
    (8) Lysolecithin, 50 to 80 mole percent of total phosphatides as 
determined by ``Determination of Lysolecithin Content of Enzyme-Modified 
Lecithin: Method I,'' dated 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 Division of Petition Control, Center for Food Safety and 
Applied Nutrition (HFS-215), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 emulsifier as defined in Sec. 
170.3(o)(8) of this chapter.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practice.

[61 FR 45889, Aug. 30, 1996]



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) The 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, as amended at 73 FR 8606, Feb. 14, 2008]



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

[[Page 496]]

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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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

[[Page 497]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 (C18H36O2, 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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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; 69 
FR 24512, May 4, 2004]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 498]]

    (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 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c)(1) In accordance with Sec. 184.1(b)(2), the ingredient is used 
in food only within the following specific limitations:

[[Page 499]]



------------------------------------------------------------------------
                                       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. adjuvant, Sec.
 170.3(n)(3) of this chapter and                   170.3(o)(12) of this
 for gelatins, puddings, and                       chapter; pH control
 fillings, Sec. 170.3(n)(22) of                  agent, Sec.
 this chapter.                                     170.3(o)(23) of this
                                                   chapter.
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 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 Chemicals 
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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 500]]

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 National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, Sec. 2.0  Flavoring agent, Sec.
   170.3(n)(9) of this chapter.             170.3(o)(12) of this
                                            chapter; stabilizer,
                                            thickener, Sec.
                                            170.3(o)(28) of this
                                            chapter; surface finisher,
                                            Sec. 170.3(o)(30) of this
                                            chapter.
Soft candy, Sec. 170.3(n)(38)       1.2  Stabilizer and thickener,
 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

[[Page 501]]

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.
    (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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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)       current good        Sec.
 (26) of this chapter.             manufacturing       170.3(o)(11) of
                                   practice.           this 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)       current good        Sec.
 (26) of this chapter.             manufacturing       170.3(o)(11) of
                                   practice.           this 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or

[[Page 502]]

go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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)          0.5   Do.
 of 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. 0.4   Do.
 170.3(n)(28) 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 503]]

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 (NH4Cl, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 504]]

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)2HC6H5O7, 
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 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, as amended at 73 FR 8606, Feb. 14, 2008]



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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)

[[Page 505]]

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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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. 184.1148  Bacterially-derived carbohydrase enzyme preparation.

    (a) Bacterially-derived carbohydrase enzyme preparation is obtained 
from the culture filtrate resulting from a pure culture fermentation of 
a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. 
amyloliquefaciens. The preparation is characterized by the presence of 
the enzymes [alpha]-amylase (EC 3.2.1.1) and [beta]-glucanase (EC 
3.2.1.6), which catalyze the hydrolysis of O-glycosyl bonds in 
carbohydrates.
    (b) The ingredient meets the general requirements and additional 
requirements in the monograph on enzyme preparations in the Food 
Chemicals Codex, 4th ed. (1996), pp. 128-135, 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. In addition, antibiotic 
activity is absent in the enzyme preparation when determined by an 
appropriate validated method such as the method ``Determination of 
antibiotic activity'' in the Compendium of Food Additive Specifications, 
vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food 
and Agriculture Organization of the United Nations, Rome, 1992. Copies 
are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 
20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 
32, New York, NY 10017, or by inquiries sent to http://www.fao.org. 
Copies may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.

[[Page 506]]

    (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 polysaccharides (e.g., starch).
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[64 FR 19894, Apr. 23, 1999]



Sec. 184.1150  Bacterially-derived protease enzyme preparation.

    (a) Bacterially-derived protease enzyme preparation is obtained from 
the culture filtrate resulting from a pure culture fermentation of a 
nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. 
amyloliquefaciens. The preparation is characterized by the presence of 
the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC 
3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.
    (b) The ingredient meets the general requirements and additional 
requirements in the monograph on enzyme preparations in the Food 
Chemicals Codex, 4th ed. (1996), pp. 128-135, 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. In addition, antibiotic 
activity is absent in the enzyme preparation when determined by an 
appropriate validated method such as the method ``Determination of 
antibiotic activity'' in the Compendium of Food Additive Specifications, 
vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food 
and Agriculture Organization of the United Nations, Rome, 1992. Copies 
are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 
20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 
32, New York, NY 10017, or by inquiries sent to http://www.fao.org. 
Copies may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
    (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.

[64 FR 19895, Apr. 23, 1999]



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) 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 processing aid as defined in Sec. 
170.3(o)(24) of this chapter.

[[Page 507]]

    (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, as amended at 73 FR 8606, Feb. 14, 2008; 76 
FR 59249, Sept. 26, 2011]



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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 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 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, as amended at 73 FR 8607, Feb. 14, 2008; 76 
FR 59249, Sept. 26, 2011]



Sec. 184.1185  Calcium acetate.

    (a) Calcium acetate (Ca 
(C2H3O2)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 508]]

    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)          0.5   Do.
 of 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. 0.5   Do.
 170.3(n)(28) 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:

[[Page 509]]

    (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, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 (CaCl2[middot]2H2O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 510]]

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[midd
ot]4H2O, CAS Reg. No. 813-0994-095) 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. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or 
may be examined at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 [beta]-, and D-, and L-[alpha]-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

[[Page 511]]

the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)2[middot]H2O, 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this

[[Page 512]]

material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 513]]

    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 
CaSO4[middot]2H2O, 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

[[Page 514]]

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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



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

[[Page 515]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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. 184.1250  Cellulase enzyme preparation derived from Trichoderma
longibrachiatum.

    (a) Cellulase enzyme preparation is derived from a nonpathogenic, 
nontoxicogenic strain of Trichoderma longibrachiatum (formerly T. 
reesei). The enzyme, cellulase, catalyzes the endohydrolysis of 1,4-
beta-glycosidic linkages in cellulose. It is obtained from the culture 
filtrate resulting from a pure culture fermentation process.
    (b) The ingredient meets the general and additional requirements for 
enzyme preparations in the monograph specifications on enzyme 
preparations in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 129 to 
134, 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., Box 285, Washington, DC 20055 
(Internet http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 enzyme as defined in Sec. 
170.3(o)(9) of this chapter for the breakdown of cellulose.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[64 FR 28361, May 26, 1999]



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.

[[Page 516]]

    (b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet 
the specifications of the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 
104-105, 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, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 
(Internet address http://www.nap.edu), or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. As determined by 
analytical methods in the ``Food Chemicals Codex,'' clove oleoresin or 
other natural extractives (other than clove oils) meet the ``Food 
Chemicals Codex'' specifications for clove (clove bud) oil and the 
following modifications:
    (1) The assay for phenols, as eugenol, by the ``Food Chemicals 
Codex'' test, 4th ed. (pp. 104-105), or the volatile oils content by the 
``Food Chemicals Codex'' test, 4th ed. (pp. 104-105) 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; 64 FR 1759, Jan. 12, 1999]



Sec. 184.1259  Cocoa butter substitute.

    (a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is ``cocoa butter substitute primarily from palm oil.'' 
The common or usual name for the triglyceride 1-3-distearoyl-2-olein is 
``cocoa butter substitute primarily from high-oleic safflower or 
sunflower oil.''
    (1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured 
by:
    (i) 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
    (ii) 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 
generally recognized as safe (GRAS) or has food additive approval for 
such use.
    (2) The ingredient 1-3-distearoyl-2-olein is manufactured by 
interesterification of partially unsaturated 1,2,3-triglycerides 
(derived from high-oleic safflower or sunflower oil) with ethyl stearate 
or stearic acid 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), not more than 10 milligrams per 
kilogram, as determined by the Heavy Metals Test of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 760-761, 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, Box 285, 2101 Constitution

[[Page 517]]

Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 AOAC INTERNATIONAL, 
481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. 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 (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (9) Hexane--not more than 5 parts per million as determined by the 
method of 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 (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 61 FR 36290, July 10, 1996; 64 FR 
1760, Jan. 12, 1999]



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

[[Page 518]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, CuSO4[middot]5 
H2O, CAS Reg. No. 7758-99-8) 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) 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 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 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, as amended at 73 FR 8607, Feb. 14, 2008; 76 
FR 59249, Sept. 26, 2011]



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 ingredient must be of a purity suitable 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
                                        use in
          Category of food             food (as       Functional use
                                       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.

[[Page 519]]

 
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, as amended at 73 FR 8607, Feb. 14, 2008]



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) The 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, as amended at 73 FR 8607, Feb. 14, 2008]



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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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. 184.1272  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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)n[middot]H2
O, CAS Reg. No. 9004-53-9) is an incompletely

[[Page 520]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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. 184.1282  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,'' 4th ed. (1996), pp. 122-123, 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, Box 285, 2101 
Constitution Ave. NW., Washington, DC 20055 (Internet address http://
www.nap.edu), or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy.,

[[Page 521]]

College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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; 64 FR 1760, Jan. 12, 1999]



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) The ingredients must be of a 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1293  Ethyl alcohol.

    (a) Ethyl alcohol (ethanol) is the chemical 
C2H5OH.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), 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, Box 285, 2101 Constitution Ave. NW., 
Washington, DC 20055 (Internet address http://www.nap.edu), or may be 
examined at the Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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; 64 
FR 1760, Jan. 12, 1999]



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 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

[[Page 522]]

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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 523]]

    (b) 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



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 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1301  Ferric phosphate.

    (a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, 
FePO4[middot]xH2O, 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)3[middot]xH2O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)

[[Page 524]]

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; 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1307a  Ferrous ascorbate.

    (a) Ferrous ascorbate (CAS Reg. No. 24808-52-4) is a reaction 
product of ferrous hydroxide and ascorbic acid. It is a blue-violet 
product containing 16 percent iron.
    (b) 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 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, as amended at 69 FR 24512, May 4, 2004; 73 
FR 8607, Feb. 14, 2008]



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 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, as amended at 73 FR 8607, Feb. 14, 2008]



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 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 525]]

this section do not exist or have been waived.

[53 FR 16866, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 
C12H22FeO14[middot]2H2O, 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 or crystalline mass. It 
is prepared by reacting calcium lactate or sodium lactate with ferrous 
sulfate, direct reaction of lactic acid with iron filings, reaction of 
ferrous chloride with sodium lactate, or reaction of ferrous sulfate 
with ammonium lactate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 4th ed. (1996), pp. 154 to 155, 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, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For

[[Page 526]]

information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 and as a color fixative for ripe olives, with no other 
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, as amended at 61 FR 40319, Aug. 2, 1996]



Sec. 184.1315  Ferrous sulfate.

    (a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, 
FeSO4[middot]7H2O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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:

[[Page 527]]

    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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]
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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) The ingredient must be of a purity suitable for its intended 
use.

[[Page 528]]

    (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, as amended at 73 FR 8607, Feb. 14, 2008]



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.
    (b) 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, as amended at 73 FR 8607, Feb. 14, 2008]



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) 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1324  Glyceryl monostearate.

    (a) Glyceryl monostearate, also known as monostearin, is a mixture 
of

[[Page 529]]

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) 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.
    (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, as amended at 73 FR 8607, Feb. 14, 2008]



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 National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 530]]

    (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. 170.3(n)(6)       5.6  Flavoring agent and adjuvant,
 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, Sec. 12.4  Formulation aid, Sec.
   170.3(n)(9) of this chapter.             170.3(o)(14) 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.
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.
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. 170.3(n)(22)              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.
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. 170.3(n)(38)      85.0  Emulsifier and emulsifier
 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;

[[Page 531]]

    (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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.), 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 
addition of 1 ml of 3 N ammonimum hydroxide indicates gum ghatti.
    (c) The ingredient is used in food under the following conditions:

                     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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 532]]

 
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 may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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)            .8   Do.
 of 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 533]]

    (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)                 170.3(o)(14) of this
 of 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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,         0.2  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 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

[[Page 534]]

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, as amended at 73 FR 8607, Feb. 14, 2008]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------

    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to 
treat food only within the following specific limitations:

------------------------------------------------------------------------
                                   Maximum treatment
             Food                    level in food       Functional use
                                       (percent)
------------------------------------------------------------------------
Milk, intended for use during   0.05..................  Antimicrobial
 the cheesemaking process as                             agent as
 permitted in the appropriate                            defined in Sec.
 standards of identity for                                 170.3 (o)(2)
 cheese and related cheese                               of this chapter
 products under part 133 of
 this chapter.
Whey, during the preparation    0.04..................  do.
 of modified whey by
 electrodialysis methods.
Dried eggs, dried egg whites,   Amount sufficient for   Oxidizing and
 and dried egg yolks as in       the purpose.            reducing agent
 Sec. Sec. 160.105,                                   as defined in
 160.145, and 160.185 of this                            Sec. 170.3
 chapter.                                                (o)(22) of this
                                                         chapter
Tripe.........................  do....................  Bleaching agent.
Beef feet.....................  Amount sufficient for   Bleaching agent.
                                 the purpose.
                                 (Hydrogen peroxide
                                 may be in the form of
                                 a compound salt,
                                 sodium carbonate
                                 peroxide).
Herring.......................  Amount sufficient for   do.
                                 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 for   Bleaching agent.
                                 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 for   Remove sulfur
                                 the purpose.            dioxide from
                                                         wine prior to
                                                         fermentation to
                                                         produce
                                                         vinegar.
Emulsifiers containing fatty    1.25..................  Bleaching agent.
 acid esters.
------------------------------------------------------------------------


[[Page 535]]

    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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. 184.1866. 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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.

[[Page 536]]

    (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, as amended at 61 FR 43450, Aug. 23, 1996]



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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 esterifying citric 
acid with isopropanol.
    (b) 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



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 
([beta]-D-galactoside

[[Page 537]]

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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 [Beta]-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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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,

[[Page 538]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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., Sec. Sec. 
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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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:

[[Page 539]]



------------------------------------------------------------------------
                                   Maximum level in
                                    food (percent
        Category of food             glycyrrhizin       Functional use
                                   content of food)
                                     (as served)
------------------------------------------------------------------------
Baked foods, Sec. 170.3(n)(1)                0.05  Flavor enhancer,
 of 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)                1.1   Flavor enhancer,
 of 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)               16.0    Do.
 of 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)                3.1    Do.
 of 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 540]]

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. 184.1420  Lipase enzyme preparation derived from Rhizopus niveus.

    (a) Lipase enzyme preparation contains lipase enzyme (CAS Reg. No. 
9001-62-1), which is obtained from the culture filtrate resulting from a 
pure culture fermentation of a nonpathogenic and nontoxigenic strain of 
Rhizopus niveus. The enzyme preparation also contains diatomaceous earth 
as a carrier. The characterizing activity of the enzyme, which catalyzes 
the interesterification of fats and oils at the 1- and 3-positions of 
triglycerides, is triacylglycerol lipase (EC 3.1.1.3).
    (b) The ingredient meets the general requirements and additional 
requirements for enzyme preparations in the monograph on Enzyme 
Preparations in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 133 
and 134, 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 for the interesterification of fats and 
oils.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice.

[63 FR 24419, May 4, 1998]



Sec. 184.1425  Magnesium carbonate.

    (a) Magnesium carbonate (molecular formula approximately 
(MgCO3)4[middot]Mg(OH)2[middot]5H2
O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 541]]

    (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 (MgC12[middot]6H2O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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. 1309-42-8) 
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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, as amended at 64 FR 405, Jan. 5, 1999]



Sec. 184.1431  Magnesium oxide.

    (a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally 
as the colorless, crystalline mineral periclase.

[[Page 542]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 
and magnesium phosphate, tribasic. Magnesium phosphate, dibasic 
(MgHPO4[middot]3H2O, CAS Reg. No. 7782-0975-094) 
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)2[middot]xH2O, CAS Reg. No. 
7757-87-1) 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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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

[[Page 543]]

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, as amended at 69 FR 24512, May 4, 2004]



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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 (MgSO4[middot]7H2O, 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, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 544]]

characterizing enzyme activities are [alpha]-amylase (EC 3.2.1.1.) and 
[beta]-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, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 [alpha]-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, 
potato starch, or rice 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 at the Division of 
Petition Control (HFS-217), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html..
    (3) Maltodextrin derived from rice starch meets the specifications 
of the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240, 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, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 
63 FR 14611, Mar. 26, 1998]



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,

[[Page 545]]

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) 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1446  Manganese chloride.

    (a) Manganese chloride (MnCl2, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, as amended at 76 FR 59250, Sept. 26, 2011]



Sec. 184.1449  Manganese citrate.

    (a) Manganese citrate 
(Mn3(C6H5O7)2, 
CAS Reg. No. 10024-66-5) 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) 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.
    (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

[[Page 546]]

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, as amended at 73 FR 8607, Feb. 14, 2008; 76 
FR 59250, Sept. 26, 2011]



Sec. 184.1452  Manganese gluconate.

    (a) Manganese gluconate 
(C12H22MnO14[middot]2H2O, 
CAS Reg. No. 648-0953-0998) 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 (MnSO4[middot]H2O, CAS 
Reg. No. 7785-0987-097) 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 547]]

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  Menhaden oil.

    (a) Menhaden oil. (1) Menhaden oil is prepared from fish of the 
genus Brevoortia, commonly known as menhaden, by cooking and pressing. 
The resulting crude oil is then refined using the following steps: 
Storage (winterization), degumming (optional), neutralization, 
bleaching, and deodorization. Winterization may separate the oil and 
produce a solid fraction.
    (2) Menhaden oil meets the following specifications:
    (i) Color and state. Yellow liquid to white solid.
    (ii) Odor. Odorless to slightly fishy.
    (iii) Saponification value. Between 180 and 200 as determined by the 
American Oil Chemists' Society Official Method Cd 3-25--``Saponification 
Value'' (reapproved 1989), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this 
publication are available from the Office of Food Additive Safety, 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (iv) Iodine number. Not less than 120 as determined by the American 
Oil Chemists' Society Recommended Practice Cd 1d-92--``Iodine Value of 
Fats and Oils, Cyclohexane--Acetic Acid Method,'' 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 
(a)(2)(iii) of this section.
    (v) Unsaponifiable matter. Not more than 1.5 percent as determined 
by the American Oil Chemists' Society Official Method Ca 6b-53--
``Unsaponifiable Matter'' (reapproved 1989), 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 
(a)(2)(iii) of this section.
    (vi) Free fatty acids. Not more than 0.1 percent as determined by 
the American Oil Chemists' Society Official Method Ca 5a-40--``Free 
Fatty Acids'' (reapproved 1989), 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 (a)(2)(iii) of 
this section.
    (vii) Peroxide value. Not more than 5 milliequivalents per kilogram 
of oil as determined by the American Oil Chemists' Society Official 
Method Cd 8-53--``Peroxide Value, Acetic Acid--Chloroform Method'' 
(updated 1992) or Recommended Practice Cd 8b-90--``Peroxide Value, 
Acetic Acid--Isooctane Method'' (updated 1992), which are incorporated 
by reference in accordance

[[Page 548]]

with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this 
incorporation by reference is given in paragraph (a)(2)(iii) of this 
section.
    (viii) Lead. Not more than 0.1 part per million as determined by the 
American Oil Chemists' Society Official Method Ca 18c-91--
``Determination of Lead by Direct Graphite Furnace Atomic Absorption 
Spectrometry'' (revised 1992), 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 (a)(2)(iii) of 
this section.
    (ix) Mercury. Not more than 0.5 part per million as determined by 
the method entitled ``Biomedical Test Materials Program: Analytical 
Methods for the Quality Assurance of Fish Oil,'' published in the ``NOAA 
Technical Memorandum NMFS-SEFC-211,'' F. M. Van Dolah and S. B. 
Galloway, editors, National Marine Fisheries Service, U. S. Department 
of Commerce, pages 71-88, November, 1988, 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 
(a)(2)(iii) of this section.
    (3) In accordance with Sec. 184.1(b)(2), the ingredient may be used 
in food only within the following specific limitations to ensure that 
total intake of eicosapentaenoic acid or docosahexaenoic acid does not 
exceed 3.0 grams/person/day:

------------------------------------------------------------------------
                                            Maximum level of use in food
             Category of food                        (as served)
------------------------------------------------------------------------
Baked goods, baking mixes, Sec. 5.0 percent
 170.3(n)(1) of this chapter.
Cereals, Sec. 170.3(n)(4) of this         4.0 percent
 chapter.
Cheese products, Sec. 170.3(n)(5) of      5.0 percent
 this chapter.
Chewing gum, Sec. 170.3(n)(6) of this     3.0 percent
 chapter.
Condiments, Sec. 170.3(n)(8) of this      5.0 percent
 chapter.
Confections, frostings, Sec. 170.3(n)(9)  5.0 percent
 of this chapter.
Dairy product analogs, Sec. 170.3(n)(10)  5.0 percent
 of this chapter.
Egg products, Sec. 170.3(n)(11) of this   5.0 percent
 chapter.
Fats, oils, Sec. 170.3(n)(12) of this     12.0 percent
 chapter, but not in infant formula.
Fish products, Sec. 170.3(n)(13) of this  5.0 percent
 chapter.
Frozen dairy desserts, Sec. 170.3(n)(20)  5.0 percent
 of this chapter.
Gelatins, puddings, Sec. 170.3(n)(22) of  1.0 percent
 this chapter.
Gravies, sauces, Sec. 170.3(n)(24) of     5.0 percent
 this chapter.
Hard candy, Sec. 170.3(n)(25) of this     10.0 percent
 chapter.
Jams, jellies, Sec. 170.3(n)(28) of this  7.0 percent
 chapter.
Meat products, Sec. 170.3(n)(29) of this  5.0 percent
 chapter.
Milk products, Sec. 170.3(n)(31) of this  5.0 percent
 chapter.
Nonalcoholic beverages, Sec. 170.3(n)(3)  0.5 percent
 of this chapter.
Nut products, Sec. 170.3(n)(32) of this   5.0 percent
 chapter.
Pastas, Sec. 170.3(n)(23) of this         2.0 percent
 chapter.
Plant protein products, Sec. 5.0 percent
 170.3(n)(33) of this chapter.
Poultry products, Sec. 170.3(n)(34) of    3.0 percent
 this chapter.
Processed fruit juices, Sec. 1.0 percent
 170.3(n)(35) of this chapter.
Processed vegetable juices, Sec. 1.0 percent
 170.3(n)(36) of this chapter.
Snack foods, Sec. 170.3(n)(37) of this    5.0 percent
 chapter.
Soft candy, Sec. 170.3(n)(38) of this     4.0 percent
 chapter.
Soup mixes, Sec. 170.3(n)(40) of this     3.0 percent
 chapter.
Sugar substitutes, Sec. 170.3(n)(42) of   10.0 percent
 this chapter.
Sweet sauces, toppings, syrups, Sec. 5.0 percent
 170.3(n)(43) of this chapter.
White granulated sugar, Sec. 4.0 percent
 170.3(n)(41) of this chapter.
------------------------------------------------------------------------

    (4) To ensure safe use of the substance, menhaden oil shall not be 
used in combination with any other added oil that is a significant 
source of eicosapentaenoic acid or docosahexaenoic acid.
    (b) Hydrogenated and partially hydrogenated menhaden oils. (1) 
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.
    (2) Partially hydrogenated and hydrogenated menhaden oils meet the 
following specifications:
    (i) Color. Opaque white solid.
    (ii) Odor. Odorless.
    (iii) Saponification value. Between 180 and 200.
    (iv) Iodine number. Not more than 119 for partially hydrogenated 
menhaden oil and not more than 10 for fully hydrogenated menhaden oil.
    (v) Unsaponifiable matter. Not more than 1.5 percent.--
    (vi) Free fatty acids. Not more than 0.1 percent.
    (vii) Peroxide value. Not more than 5 milliequivalents per kilogram 
of oil.

[[Page 549]]

    (viii) Nickel. Not more than 0.5 part per million.
    (ix) Mercury. Not more than 0.5 part per million.
    (x) Arsenic (as As). Not more than 0.1 part per million.
    (xi) Lead. Not more than 0.1 part per million.
    (3) 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.
    (4) 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.

[62 FR 30756, June 5, 1997, as amended at 70 FR 14531, Mar. 23, 2005]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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]

[[Page 550]]



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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.
    (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) 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 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1530  Niacin.

    (a) Niacin (C6H5NO2, CAS Reg. No. 
59-67-6) is the chemical 3-

[[Page 551]]

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,'' 4th ed. (1996), p. 264, 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, Box 285, 2101 Constitution Ave. NW., 
Washington, DC 20055 (Internet address http://www.nap.edu), or may be 
examined at the Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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, as amended at 64 
FR 1760, Jan. 12, 1999]



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, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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

[[Page 552]]

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, as amended at 73 FR 8607, Feb. 14, 2008]



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 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.
    (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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 68 
FR 24879, May 9, 2003]



Sec. 184.1540  Nitrogen.

    (a) Nitrogen (empirical formula N2, CAS Reg. No. 7727-37-
9) is a colorless,

[[Page 553]]

odorless, flavorless gas that is produced commercially by the 
fractionation of liquid air.
    (b) 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, as amended at 73 FR 8607, Feb. 14, 2008]



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 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, as amended at 73 FR 8607, Feb. 14, 2008]



Sec. 184.1553  Peptones.

    (a) Peptones are a variable mixture of polypeptides, oligopeptides, 
and 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) 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 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; 73 
FR 8607, Feb. 14, 2008]



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

[[Page 554]]

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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. 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 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, low erucic acid 
rapeseed oil and partially hydrogenated low erucic acid rapeseed oil 
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; 73 FR 8608, Feb. 
14, 2008]

[[Page 555]]



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 manufacturing
 165.110 (b)(2) through (b)(5)    practice results
 of this chapter.                 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]



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, 
5100 Paint Branch Pkwy., College Park, MD 20740, and at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 556]]

    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 557]]

    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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,

[[Page 558]]

2101 Constitution Ave. NW., Washington, DC 20418, or available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good

[[Page 559]]

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[middot]H2
O, CAS Reg. No. 006100-0905-096) 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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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; 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.

[[Page 560]]

    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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, 1984]



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) 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. 
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 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

[[Page 561]]

this section do not exist or have been waived.

[52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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, as amended at 73 FR 8608, Feb. 14, 2008]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 Sec. 184.1(b)(1). Good 
manufacturing practice results in a maximum total content of 
antioxidants of 0.02 percent of

[[Page 562]]

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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 563]]

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 
(C8H11NO3[middot]HCl, CAS Reg. No. 58-
56-0) is the chemical 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.

[[Page 564]]

    (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 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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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; 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, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 565]]

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) 
(C17H20N4O9PNa[middot]2H2
O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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,'' 4th ed. (1996), pp. 342-343, 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, Box 285, 2101 Constitution 
Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (c) The ingredient is used in food under the following conditions:

[[Page 566]]



                     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; 64 
FR 1760, Jan. 12, 1999]



Sec. 184.1702  Sheanut oil.

    (a) Sheanut oil is produced from sheanuts derived from the Shea tree 
Butyrospermum parkii and is composed principally of triglycerides 
containing an oleic acid moiety at the 2-position and saturated fatty 
acids, usually stearic or palmitic acids, at the 1- and 3-positions.
    (b) The ingredient meets the following specifications when tested 
using any appropriate validated methodology:
    (1) Saponification value of 185 to 195,
    (2) Iodine value of 28 to 43,
    (3) Unsaponifiable matter not to exceed 1.5 percent,
    (4) Free fatty acids not more than 0.1 percent as oleic acid,
    (5) Peroxide value not more than 10 milliequivalents/equivalent 
(meq/eq),
    (6) Lead not more than 0.1 part per million (ppm),
    (7) Copper not more than 0.1 ppm.
    (c) In accordance with Sec. 184.1(b)(3), the ingredient is used in 
the following food categories at levels not to exceed current good 
manufacturing practice, except that the ingredient may not be used in a 
standardized food unless permitted by the standard of identity: 
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.

[63 FR 28895, May 27, 1998]



Sec. 184.1721  Sodium acetate.

    (a) Sodium acetate (C2H3O2Na, CAS 
Reg. No. 127-09-3 or 
C2H3O2Na[middot]3H2O, 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 567]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[[Page 568]]

    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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[middot]2H2
O, CAS Reg. No. 68-0904-092) is the sodium salt of citric acid. It is 
prepared by neutralizing citric acid with sodium hydroxide or sodium 
carbonate. The

[[Page 569]]

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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 
(C4H7O4Na[middot]xH2O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no

[[Page 570]]

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.
    (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) 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 an emulsifier or stabilizer, as 
defined in Sec. Sec. 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, as amended at 73 FR 8608, Feb. 14, 2008]



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) 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. 
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, as amended at 73 FR 8608, Feb. 14, 2008]



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 
(Na2SiO3[middot]5H2O), and the 
nonahydrate (Na2SiO3[middot]9H2O).
    (b) 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

[[Page 571]]

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 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. 165.110 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, as amended at 
72 FR 10357, Mar. 8, 2007; 73 FR 8608, Feb. 14, 2008]



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 National Academy Press, 2101 Constitution Ave. 
NW., Washington DC 20418, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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[middot]NaHCO3[middot]2H2
O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 572]]

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 this section do not exist or have been waived.

[48 FR 52443, Nov. 18, 1983]



Sec. 184.1801  Sodium tartrate.

    (a) Sodium tartrate 
(C4H4Na2O6[middot]2H2
O, 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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[middot]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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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]

[[Page 573]]



Sec. 184.1807  Sodium thiosulfate.

    (a) Sodium thiosulfate 
(Na2S2O3[middot]5H2O, CAS 
Reg. No. 010102-0917-097) 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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 574]]

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 
(SnCl2[middot]2H2O, 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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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, as amended at 76 FR 59250, Sept. 26, 2011]



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) 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 51907, Nov. 15, 1983, as amended at 73 FR 8608, Feb. 14, 2008]



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 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

[[Page 575]]

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, as amended at 73 FR 8608, Feb. 14, 2008]



Sec. 184.1854  Sucrose.

    (a) Sucrose (C12H22O11, CAS Reg. 
No. 57-50-11-1) sugar, cane sugar, or beet sugar is the chemical [beta]-
D-fructofuranosyl-[alpha]-D-glucopyranoside. 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) 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.
    (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, as amended at 73 FR 
8608, Feb. 14, 2008]



Sec. 184.1857  Corn sugar.

    (a) Corn sugar (C6H12O6, CAS Reg. 
No. 50-99-7), commonly called D-glucose or dextrose, is the chemical 
[alpha]-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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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) 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.
    (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, as amended at 73 FR 
8608, Feb. 14, 2008]



Sec. 184.1865  Corn syrup.

    (a) Corn syrup, commonly called ``glucose sirup'' or ``glucose 
syrup,'' is

[[Page 576]]

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.
    (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, as amended at 73 FR 8608, Feb. 14, 2008]



Sec. 184.1866  High fructose corn syrup.

    (a) High fructose corn syrup, a sweet, nutritive saccharide mixture 
containing either approximately 42 or 55 percent fructose, is prepared 
as a clear aqueous solution from high dextrose-equivalent corn starch 
hydrolysate by partial enzymatic conversion of glucose (dextrose) to 
fructose using an insoluble glucose isomerase enzyme preparation 
described in Sec. 184.1372. The product containing more than 50 percent 
fructose (dry weight) is prepared through concentration of the fructose 
portion of the mixture containing less than 50 percent fructose.
    (b) The ingredient shall conform to the identity and specifications 
listed in the monograph entitled ``High-Fructose Corn Syrup'' in the 
Food Chemicals Codex, 4th ed. (1996), pp. 191-192, 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.

[61 FR 43450, Aug.23, 1996]



Sec. 184.1875  Thiamine hydrochloride.

    (a) Thiamine hydrochloride 
(C12H17C1N4OS[middot]HCl, CAS Reg. No. 
67-03-8) 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 577]]

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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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  [b.alpha]-Tocopherols.

    (a) The [alpha]-tocopherols that are the subject of this GRAS 
affirmation regulation are limited to the following:
    (1) d-[alpha]-Tocopherol (CAS Reg. No. 59-02-9) is the chemical 
[2R,4'R,8prime;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-[alpha]-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, 2101 Constitution 
Ave. NW., Washington, DC 20418, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 (C8 H14O6, 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

[[Page 578]]

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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 (C15H26O6, 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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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.
    (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

[[Page 579]]

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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, and at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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.
    (b) 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

[[Page 580]]

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; 73 
FR 8608, Feb. 14, 2008]



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 National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 [beta]-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 National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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 581]]

    (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 B[bdi1][bdi2].

    (a) Vitamin B12, also known as cyanocobalamin 
(C63H88CoN14O14P, CAS Reg. 
No. 68-0919-099), 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations_/ibr_locations.html. 
Vitamin D2 resin and vitamin D3 resin 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

[[Page 582]]

sole source of added vitamin D only within the following specific 
limitations:

------------------------------------------------------------------------
                                   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      42 (IU/100 grams).   Do.
 this 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, as amended at 73 FR 8608, Feb. 14, 2008]



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 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/

[[Page 583]]

code_of_federal_regulations/ibr_locations.html.
    (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 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 National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 584]]

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, 
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), which is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is 
given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. 
Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (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,'' 4th ed. (1996), pp. 760-761, 
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, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/

[[Page 585]]

federal_register/code_of_federal_regulations/ibr_locations.html.
    (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, as amended at 54 
FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, 1999]



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. 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), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in 
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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

[[Page 586]]

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,'' 4th ed. (1996), pp. 760-761, 
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, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 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 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; 
64 FR 1760, Jan. 12, 1999]



Sec. 184.1979b  Reduced minerals whey.

    (a) Reduced minerals whey is the substance obtained by the removal 
of a 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), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in 
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.''

[[Page 587]]

    (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,'' 4th ed. (1996), pp. 760-761, 
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, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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.
    (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; 
64 FR 1761, Jan. 12, 1999]



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

[[Page 588]]

on analytical methods in the referenced sections of ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 13th 
ed. (1980), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) 
through (b)(1)(vii) of this section. Copies may be obtained from the 
AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, 
MD 20877, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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,'' 4th ed. (1996), pp. 760-761, 
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, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address http://www.nap.edu), or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (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 declared on the 
label of the package sold to food manufacturers. The percent of protein 
may be declared in 5-

[[Page 589]]

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; 
64 FR 1761, Jan. 12, 1999]



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) 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 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, as amended at 73 FR 8608, Feb. 14, 2008]



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 National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/

[[Page 590]]

code_of_federal_regulations/ibr_locations.html.
    (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

186.1093 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: 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 591]]

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. 186.1093  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

[[Page 592]]

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.
    (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. 1332-37-2) are 
undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black 
cubic crystals) and iron

[[Page 593]]

(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, as amended at 69 
FR 24512, May 4, 2004]



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. 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

[[Page 594]]

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.
    (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]

[[Page 595]]



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_Prohibited cattle materials

189.5 Prohibited cattle materials.

Subpart C_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 D_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).
189.300 Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins.
189.301 Tin-coated lead foil capsules for wine bottles.

    Authority: 21 U.S.C. 321, 342, 348, 371, 381.

    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, 66 FR 56035, Nov. 6, 2001, 70 FR 40880, July 15, 
2005, and 70 FR 67651, Nov. 8, 2005.



                      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

[[Page 596]]

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_Prohibited Cattle Materials



Sec. 189.5  Prohibited cattle materials.

    (a) Definitions. The definitions and interpretations of terms 
contained in section 201 of the Federal Food, Drug, and Cosmetic Act 
(the act) apply to such terms when used in this part. The following 
definitions also apply:
    (1) Prohibited cattle materials means specified risk materials, 
small intestine of all cattle except as provided in paragraph (b)(2) of 
this section, material from nonambulatory disabled cattle, material from 
cattle not inspected and passed, or mechanically separated (MS) (Beef). 
Prohibited cattle materials do not include the following:
    (i) Tallow that contains no more than 0.15 percent insoluble 
impurities, tallow derivatives, hides and hide-derived products, and 
milk and milk products, and
    (ii) Cattle materials inspected and passed from a country designated 
under paragraph (e) of this section.
    (2) Inspected and passed means that the product has been inspected 
and passed for human consumption by the appropriate regulatory 
authority, and at the time it was inspected and passed, it was found to 
be not adulterated.
    (3) Mechanically Separated (MS)(Beef) means a meat food product that 
is finely comminuted, resulting from the mechanical separation and 
removal of most of the bone from attached skeletal muscle of cattle 
carcasses and parts of carcasses that meets the specifications contained 
in 9 CFR 319.5, the regulation that prescribes the standard of identity 
for MS (Species).
    (4) Nonambulatory disabled cattle means cattle that cannot rise from 
a recumbent position or that cannot walk, including, but not limited to, 
those with broken appendages, severed tendons or ligaments, nerve 
paralysis, fractured vertebral column, or metabolic conditions.
    (5) Specified risk material means the brain, skull, eyes, trigeminal 
ganglia, spinal cord, vertebral column (excluding the vertebrae of the 
tail, the transverse processes of the thoracic and lumbar vertebrae, and 
the wings of the sacrum), and dorsal root ganglia of cattle 30 months 
and older and the tonsils and distal ileum of the small intestine of all 
cattle.
    (6) Tallow means the rendered fat of cattle obtained by pressing or 
by applying any other extraction process to tissues derived directly 
from discrete adipose tissue masses or to other carcass parts and 
tissues. Tallow must be produced from tissues that are not prohibited 
cattle materials or must contain not more than 0.15 percent insoluble 
impurities as determined by the method entitled ``Insoluble Impurities'' 
(AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 
5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or another method equivalent in accuracy, 
precision, and sensitivity to AOCS Official Method Ca 3a-46. You may 
obtain copies of the method from AOCS (http://www.aocs.org) 2211 W. 
Bradley Ave. Champaign, IL 61821. Copies may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at

[[Page 597]]

the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (7) Tallow derivative means any chemical obtained through initial 
hydrolysis, saponification, or trans-esterification of tallow; chemical 
conversion of material obtained by hydrolysis, saponification, or trans-
esterification may be applied to obtain the desired product.
    (b) Requirements. (1) No human food shall be manufactured from, 
processed with, or otherwise contain, prohibited cattle materials.
    (2) The small intestine is not considered prohibited cattle material 
if the distal ileum is removed by a procedure that removes at least 80 
inches of the uncoiled and trimmed small intestine, as measured from the 
caeco-colic junction and progressing proximally towards the jejunum, or 
by a procedure that the establishment can demonstrate is equally 
effective in ensuring complete removal of the distal ileum.
    (c) Records. (1) Manufacturers and processors of a human food that 
is manufactured from, processed with, or otherwise contains, material 
from cattle must establish and maintain records sufficient to 
demonstrate that the food is not manufactured from, processed with, or 
does not otherwise contain, prohibited cattle materials.
    (2) Records must be retained for 2 years after the date they were 
created.
    (3) Records must be retained at the manufacturing or processing 
establishment or at a reasonably accessible location.
    (4) The maintenance of electronic records is acceptable. Electronic 
records are considered to be reasonably accessible if they are 
accessible from an onsite location.
    (5) Records required by this section and existing records relevant 
to compliance with this section must be available to FDA for inspection 
and copying.
    (6) When filing entry with U.S. Customs and Border Protection, the 
importer of record of a human food manufactured from, processed with, or 
otherwise containing, cattle material must affirm that the food was 
manufactured from, processed with, or otherwise contains, cattle 
material and must affirm that the food was manufactured in accordance 
with this section. If a human food is manufactured from, processed with, 
or otherwise contains, cattle material, then the importer of record 
must, if requested, provide within 5 days records sufficient to 
demonstrate that the food is not manufactured from, processed with, or 
does not otherwise contain, prohibited cattle material.
    (7) Records established or maintained to satisfy the requirements of 
this subpart that meet the definition of electronic records in Sec. 
11.3(b)(6) of this chapter are exempt from the requirements of part 11 
of this chapter. Records that satisfy the requirements of this subpart 
but that are also required under other applicable statutory provisions 
or regulations remain subject to part 11 of this chapter.
    (d) Adulteration. (1) Failure of a manufacturer or processor to 
operate in compliance with the requirements of paragraphs (b) or (c) of 
this section renders human food adulterated under section 402(a)(4) of 
the act.
    (2) Human food manufactured from, processed with, or otherwise 
containing, prohibited cattle materials is unfit for human food and 
deemed adulterated under section 402(a)(3) of the act.
    (3) Food additive status. Prohibited cattle materials for use in 
human food are food additives subject to section 409 of the act, except 
when used as dietary ingredients in dietary supplements. The use or 
intended use of any prohibited cattle material in human food causes the 
material and the food to be adulterated under section 402(a)(2)(C) of 
the act if the prohibited cattle material is a food additive, unless it 
is the subject of a food additive regulation or of an investigational 
exemption for a food additive under Sec. 170.17 of this chapter.
    (e) Process for designating countries. A country seeking designation 
must send a written request to the Director, Office of the Center 
Director, Center for Food Safety and Applied Nutrition,

[[Page 598]]

Food and Drug Administration, at the address designated in 21 CFR 
5.1100. The request shall include information about a country's bovine 
spongiform encephalopathy (BSE) case history, risk factors, measures to 
prevent the introduction and transmission of BSE, and any other 
information relevant to determining whether specified risk materials, 
the small intestine of cattle except as provided in paragraph (b)(2) of 
this section, material from nonambulatory disabled cattle, or MS (Beef) 
from cattle from the country should be considered prohibited cattle 
materials. FDA shall respond in writing to any such request and may 
impose conditions in granting any such request. A country designation 
granted by FDA under this paragraph will be subject to future review by 
FDA, and may be revoked if FDA determines that it is no longer 
appropriate.

[70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 
73 FR 20793, Apr. 17, 2008]



Subpart C_Substances Generally Prohibited From Direct Addition or Use as 
                               Human Food

    Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. 
Redesignated at 69 FR 42273, July 14, 2004.



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 ([beta]-
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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, also from the Division of Food and Color Additives, Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[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 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

[[Page 599]]

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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[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)2Mg, 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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24899, June 12, 1989]

[[Page 600]]



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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or may be examined at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[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-
dimethyltetrame thylene) 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 AOAC 
INTERNATIONAL,'' 13th Ed. (1980), which is incorporated by reference. 
Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[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

[[Page 601]]

plant. Oil of sassafras is about 80 percent safrole. Isosafrole and 
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 (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

[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 AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.

[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 D_Substances Prohibited From Indirect Addition to Human Food 
                      Through Food-Contact Surfaces

    Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. 
Redesignated at 69 FR 42273, July 14, 2004.



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

[[Page 602]]

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.
    (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-chloro analine).

    (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'-isopropyl idene-diphenol phosphite 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 190_DIETARY SUPPLEMENTS--Table of Contents



Subpart A [Reserved]

              Subpart B_New Dietary Ingredient Notification

Sec.
190.6 Requirement for premarket notification.

    Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 371).

    Source: 62 FR 49891, Sept. 23, 1997, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 190 appear at 66 FR 
56035, Nov. 6, 2001.

Subpart A [Reserved]

[[Page 603]]



              Subpart B_New Dietary Ingredient Notification



Sec. 190.6  Requirement for premarket notification.

    (a) At least 75 days before introducing or delivering for 
introduction into interstate commerce a dietary supplement that contains 
a new dietary ingredient that has not been present in the food supply as 
an article used for food in a form in which the food has not been 
chemically altered, the manufacturer or distributor of that supplement, 
or of the new dietary ingredient, shall submit to the Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-820), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, information including 
any citation to published articles that is the basis on which the 
manufacturer or distributor has concluded that a dietary supplement 
containing such dietary ingredient will reasonably be expected to be 
safe. An original and two copies of this notification shall be 
submitted.
    (b) The notification required by paragraph (a) of this section shall 
include:
    (1) The name and complete address of the manufacturer or distributor 
of the dietary supplement that contains a new dietary ingredient, or of 
the new dietary ingredient;
    (2) The name of the new dietary ingredient that is the subject of 
the premarket notification, including the Latin binomial name (including 
the author) of any herb or other botanical;
    (3) A description of the dietary supplement or dietary supplements 
that contain the new dietary ingredient including:
    (i) The level of the new dietary ingredient in the dietary 
supplement; and
    (ii) The conditions of use recommended or suggested in the labeling 
of the dietary supplement, or if no conditions of use are recommended or 
suggested in the labeling of the dietary supplement, the ordinary 
conditions of use of the supplement;
    (4) The history of use or other evidence of safety establishing that 
the dietary ingredient, when used under the conditions recommended or 
suggested in the labeling of the dietary supplement, will reasonably be 
expected to be safe, including any citation to published articles or 
other evidence that is the basis on which the distributor or 
manufacturer of the dietary supplement that contains the new dietary 
ingredient has concluded that the new dietary supplement will reasonably 
be expected to be safe. Any reference to published information offered 
in support of the notification shall be accompanied by reprints or 
photostatic copies of such references. If any part of the material 
submitted is in a foreign language, it shall be accompanied by an 
accurate and complete English translation; and
    (5) The signature of the person designated by the manufacturer or 
distributor of the dietary supplement that contains a new dietary 
ingredient.
    (c) FDA will acknowledge its receipt of a notification made under 
section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and 
will notify the submitter of the date of receipt of such a notification. 
The date that the agency receives the notification submitted under 
paragraph (a) of this section is the filing date for the notification. 
For 75 days after the filing date, the manufacturer or distributor of a 
dietary supplement that contains a new dietary ingredient shall not 
introduce, or deliver for introduction, into interstate commerce the 
dietary supplement that contains the new dietary ingredient.
    (d) If the manufacturer or distributor of a dietary supplement that 
contains a new dietary ingredient, or of the new dietary ingredient, 
provides additional information in support of the new dietary ingredient 
notification, the agency will review all submissions pertaining to that 
notification, including responses made to inquiries from the agency, to 
determine whether they are substantive and whether they require that the 
75-day period be reset. If the agency determines that the new submission 
is a substantive amendment, FDA will assign a new filing date. FDA will 
acknowledge receipt of the additional information and, when applicable, 
notify the manufacturer of the new filing date, which is the date of 
receipt by FDA of the information that constitutes the substantive 
amendment.

[[Page 604]]

    (e) FDA will not disclose the existence of, or the information 
contained in, the new dietary ingredient notification for 90 days after 
the filing date of the notification. After the 90th day, all information 
in the notification will be placed on public display, except for any 
information that is trade secret or otherwise confidential commercial 
information.
    (f) Failure of the agency to respond to a notification does not 
constitute a finding by the agency that the new dietary ingredient or 
the dietary supplement that contains the new dietary ingredient is safe 
or is not adulterated under section 402 of the act.

[62 FR 49891, Sept. 23, 1997, as amended at 66 FR 17359, Mar. 30, 2001]

                        PARTS 191	199 [RESERVED]

[[Page 605]]



                              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.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 607]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2012)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--500)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Circulars and Guidance 
                (200--299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300-- 
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Housing and Urban Development (Parts 2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)
     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)

[[Page 608]]

       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)
        II  Recovery Accountability and Transparency Board (Parts 
                200--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)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       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 (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600-- 3699)
    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)

[[Page 609]]

    XXXIII  Overseas Private Investment Corporation (Parts 4300--
                4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)
     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
    LXXXII  Special Inspector General for Iraq Reconstruction 
                (Parts 9200--9299)

[[Page 610]]

     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--99)

                         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 Nutrition 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)
        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)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)

[[Page 611]]

       XXV  Office of Advocacy and Outreach, 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 Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     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)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 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, Department of 
                Agriculture (Parts 300--599)

[[Page 612]]

                           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)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      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)
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      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)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

[[Page 613]]

                    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  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 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 Industry and Security, 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)
      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)

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

[[Page 614]]

             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  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599)

                     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  Office of Workers' Compensation Programs, 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 Service, 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 615]]

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board (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  Millennium Challenge Corporation (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)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)

[[Page 616]]

         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, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         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)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099)
       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)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

[[Page 617]]

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       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)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            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 Standards, 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  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)

[[Page 618]]

     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 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)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      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

[[Page 619]]

       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       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)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (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)
            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 [Reserved]
        XI  National Institute for Literacy (Parts 1100--1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)

[[Page 620]]

        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)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)

[[Page 621]]

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            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 Service, Department of 
                Labor (Parts 61-1--61-999)
    62-100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
   103-104  [Reserved]
       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)
   129-200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) 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 (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--599)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

[[Page 622]]

                   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 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (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 
                (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) 
                [Reserved]
         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  Corporation for National and Community Service (Parts 
                1200--1299)
      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)

[[Page 623]]

     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 Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (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)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  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)
        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)

[[Page 624]]

        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (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)
        23  Social Security Administration (Parts 2300--2399)
        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)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        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 [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (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  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (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)

[[Page 625]]

       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)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   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 Fishing and Related Activities (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 627]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2012)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 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
  Food and Nutrition 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
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII, L
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV, L
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII, L
  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
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I

[[Page 628]]

Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Bureau of Ocean Energy Management, Regulation,    30, II
     and Enforcement
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazardous Investigation       40, VI
     Board
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Court Services and Offender Supervision Agency    5, LXX
     for the District of Columbia
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               2, XIII; 44, IV; 50, VI
  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
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  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, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      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
Commercial Space Transportation                   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 Financial Protection Bureau              12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Office                                  37, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
   for the District of Columbia
[[Page 629]]

Customs and Border Protection                     19, I
Defense Contract Audit Agency                     32, I
Defense Department                                2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
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 Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 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
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
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                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 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
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  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

[[Page 630]]

  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 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-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 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                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
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
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition 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

[[Page 631]]

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 Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  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
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A,
  Centers for Medicare & Medicaid Services        42, IV
  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
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 6, I; 8, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 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
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  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
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV

[[Page 632]]

Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
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, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department                               2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Bureau of Ocean Energy Management, Regulation,  30, II
       and Enforcement
  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, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  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, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
Iraq Reconstruction, Special Inspector General    5, LXXXVII
     for
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                                2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII

[[Page 633]]

  Employee Benefits Security Administration       29, XXV
  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 Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Office of Workers' Compensation Programs        20, VII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
  Copyright Royalty Board                         37, III
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II
National Intelligence, Office of Director of      32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          29, X

[[Page 634]]

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                       2, XXV; 5, XLIII; 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, IV
     Administration
National Transportation Safety Board              49, VIII
Natural Resources Conservation Service            7, VI
Natural Resource Revenue, Office of               30, XII
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Offices of Independent Counsel                    28, VI
Office of Workers' Compensation Programs          20, VII
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        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                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory 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 Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Procurement and Property Management, Office of    7, XXXII
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
Recovery Accountability and Transparency Board    4, II
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L

[[Page 635]]

Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Saint Lawrence Seaway Development Corporation     33, IV
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                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
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                                  2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
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                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 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
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury Department                               5, XXI; 12, XV; 17, IV; 
                                                  31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, 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

[[Page 636]]

United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the 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 637]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations that were 
made by documents published in the Federal Register since January 1, 
2001, 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, 2001, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000'' published in 
11 separate volumes.

                                  2001

21 CFR
                                                                      66
                                                                    Page
Chapter I
170 Nomenclature change............................................56034
172 Nomenclature change.....................................56034, 66742
172.133 (c)(2) redesignated as (c)(3); (b) and new (c)(3) revised; 
        new (c)(2) added...........................................13653
172.155 (c) revised................................................13847
172.615 (a) table amended..........................................38153
    (a) table corrected............................................53711
172.892 (i) introductory text revised; (i) table amended...........17509
173 Nomenclature change.....................................56034, 66742
173.115 Added......................................................27022
173.325 (b)(1)(iii), (iv) and (v) amended..........................22922
    (f) redesignated as (g); new (f) added.........................31841
173.368 Added......................................................33830
173.370 (b) and (c) revised........................................48208
175 Nomenclature change............................................56034
175.105 (c)(5) table amended.......................................13654
175.125 (a)(9) added; (b)(1) revised...............................13654
176 Nomenclature change............................................56034
176.170 (b)(2) table amended.......................................13655
176.180 (b)(2) table amended.......................................13655
177 Nomenclature change.....................................56034, 66742
178 Nomenclature change.....................................56034, 66742
178.3297 (e) table amended..........................................6469
178.3400 (c) table amended.........................................13655
179.21 (a)(4), (b)(1)(iii) and (2)(iv) added.......................18539
179.45 (b) introductory text and (d) introductory text amended.....10575
180 Nomenclature change............................................56034
181 Nomenclature change............................................56034
184 Nomenclature change.....................................56034, 66742
189 Nomenclature change............................................56034
190 Nomenclature change............................................56034
190.6 (a) amended..................................................17359

                                  2002

21 CFR
                                                                   67 FR
                                                                    Page
Chapter I
170.3 (e)(2) revised; (e)(3) added.................................35729
170.100--170.106 (Subpart D) Added.................................35729
171.1 (i)(1) revised...............................................35731
171.7 (c) added....................................................35731
171.133 (b)(2) and (3) correctly revised; CFR correction...........66045
172.829 Added......................................................45310
173.325 (g) redesignated as (h); new (g) added.....................15720
173.357 (a)(2) table amended.......................................42716
173.368 (d) corrected................................................271
173.370 (b)(1) revised.............................................61784
174.5 (d)(5) added.................................................35731
179.25 OMB number...................................................9585
    (c) revised....................................................35731

                                  2003

21 CFR
                                                                   68 FR
                                                                    Page
Chapter I
172 Nomenclature change............................................15355
    Hearing denied.................................................46403
    Technical correction....................................57799, 57957
172.380 Added.......................................................9003

[[Page 638]]

172.615 (a) table corrected; CFR correction........................17277
172.800 Introductory text and (c) revised; (d) and (e) removed.....75413
172.867 (e) revised................................................46402
172.869 Added......................................................50072
173 Nomenclature change............................................15355
177 Nomenclature change............................................15355
178 Nomenclature change............................................15355
184 Nomenclature change............................................24879

                                  2004

21 CFR
                                                                   69 FR
                                                                    Page
Chapter I
170 Nomenclature change............................................13717
172 Technical correction...........................................40765
172.510 (b) table amended..........................................24511
172.515 (b) amended................................................24511
172.867 (b) and (c) revised; (f) removed...........................29432
173.325 (d) redesignated as (d)(1); (d)(2) added...................78304
173.375 Added......................................................17298
175.105 (c)(5) table amended.......................................24512
176.170 (b)(2) table correctly amended; CFR correction.............77897
176.180 (b)(2) table amended.......................................24512
    (b)(2) table correctly amended; CFR correction.................77897
176.300 (c) table amended..........................................24512
177.1390 (c)(1)(i)(g) added........................................15668
177.1500 (a) and (b) table amended.................................24512
177.1520 (b) table amended.........................................16481
177.1632 (b)(2) table amended......................................24512
178.1010 (b)(36) amended...........................................24512
178.2010 (b) table amended.........................................24512
178.3400 (c) table amended.........................................24512
178.3770 (c)(1) amended............................................24512
178.3910 (a)(2) table amended......................................24512
179.21 (a)(5), (b)(1)(iv) and (2)(v) added.........................76404
179.26 (a)(3) revised; (a)(4) added................................76846
180.25 (a)(3) added................................................65542
184 Nomenclature change............................................13717
184.1034 (a) amended...............................................24512
184.1090 (a) amended...............................................24512
184.1307a (a) amended..............................................24512
184.1434 (a) amended...............................................24512
186.1374 (a) amended...............................................24512
189.5 (Subpart B) Added; interim...................................42273
189.110--189.191 (Subpart B) Redesignated as Subpart C; interim....42273
189.220--189.301 (Subpart C) Redesignated as Subpart D; interim....42273

                                  2005

21 CFR
                                                                   70 FR
                                                                    Page
Chapter I
172 Policy statement...............................................21619
    Nomenclature change..............................40880, 67651, 72074
172.735 Heading and introductory text revised......................15758
172.380 Introductory text, (c) and (d) correctly revised...........36025
    (b) and (c) revised; (d) removed...............................37257
    (c)(5) added...................................................69438
172.780 Added.......................................................8034
172.864 (a)(3) added...............................................72908
173 Nomenclature change.....................................40880, 67651
173.300 (a) and (b) revised.........................................7396
175 Nomenclature change............................................72074
176 Nomenclature change..............................40880, 67651, 72074
177 Nomenclature change..............................40880, 67651, 72074
178 Nomenclature change..............................40880, 67651, 72074
179 Nomenclature change............................................72074
179 Technical correction...........................................15583
179.26 (b) table amended...........................................48072
184 Nomenclature change.....................................40880, 67651
184.1472 (a)(2)(iii) and (3) revised; (a)(4) added.................14531
189 Nomenclature change.....................................40880, 67651
189.5 Revised; interim.............................................53068

                                  2006

21 CFR
                                                                   71 FR
                                                                    Page
Chapter I
172.736 Added......................................................12620
172.785 Added......................................................47731
189 Authority citation revised.....................................59668
189.5 (c) revised..................................................59668

[[Page 639]]

                                  2007

21 CFR
                                                                   72 FR
                                                                    Page
Chapter I
170.45 Amended.....................................................10357
171.1 Regulation at 65 FR 51763 confirmed...........................8111
    (c) amended....................................................10357
172.510 (b) amended................................................10357
172.735 Heading, introductory text and (a) revised.................46896
172.841 (b) and (c) revised........................................46564
173.375 Revised....................................................67576
179 Actions on petitions...........................................17394
    Policy statement...............................................39557
180.37 (f)(2)(iii) amended.........................................10357
184.1769a (c)(2) amended...........................................10357

                                  2008

21 CFR
                                                                   73 FR
                                                                    Page
Chapter I
179.26 (b) table amended...........................................49603
184.1065 (b) revised................................................8606
184.1140 (b) revised................................................8606
184.1155 (b) revised................................................8606
184.1165 (b) revised................................................8607
184.1240 (b) revised................................................8607
184.1261 (b) revised................................................8607
184.1262 (b) revised................................................8607
184.1265 (b) revised................................................8607
184.1287 (b) revised................................................8607
184.1297 (b) revised................................................8607
184.1298 (b) revised................................................8607
184.1307 (b) revised................................................8607
184.1307a (b) revised...............................................8607
184.1307b (b) revised...............................................8607
184.1307c (b) revised...............................................8607
184.1321 (b) revised................................................8607
184.1322 (b) revised...............