[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2001 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
21
Part 170 to 199
Revised as of April 1, 2001
Food and Drugs
Containing a codification of documents
of general applicability and future effect
As of April 1, 2001
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2001
For sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: (202) 512-1800 Fax: (202) 512-2250
Mail Stop: SSOP, Washington, DC 20402-0001
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Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services (Continued) 3
Finding Aids:
Material Approved for Incorporation by Reference........ 573
Table of CFR Titles and Chapters........................ 587
Alphabetical List of Agencies Appearing in the CFR...... 605
Redesignation Table..................................... 615
List of CFR Sections Affected........................... 617
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 170.3 refers
to title 21, part 170,
section 3.
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[[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
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To determine whether a Code volume has been amended since its
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Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
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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
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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, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For
the period beginning January 1, 1986, a ``List of CFR Sections
Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
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This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you find
the material is not available, please notify the Director of the Federal
Register, National Archives and Records Administration, Washington DC
20408, or call (202) 523-4534.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I). A list of CFR titles, chapters,
and parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
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REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
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Raymond A. Mosley,
Director,
Office of the Federal Register.
April 1, 2001.
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THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The
first eight volumes, containing parts 1-1299, comprise Chapter I--Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2001.
Redesignation tables for Chapter I--Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.
[[Page x]]
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 170 to 199)
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Part
chapter i--Food and Drug Administration, Department of
Health and Human Services (Continued)..................... 170
Cross References: Food Safety and Inspection Service, Department of
Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.
Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.
United States Customs Service, Department of the Treasury: See Customs
Duties, 19 CFR chapter I.
Internal Revenue Service, Department of the Treasury: See Internal
Revenue, 26 CFR chapter I.
Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury:
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
(Parts 170 to 199)
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Editorial Note: The Food and Drug Administration published a document
at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform
effective date for compliance for regulations affecting the labeling of
food products. At 51 FR 34085, Sept. 25, 1986, FDA established January
1, 1989 as a new uniform effective date for compliance. The new uniform
effective date will apply only to final FDA food labeling regulations
published after July 1, 1986, and before January 1, 1988. At 55 FR 276,
Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective
date for compliance. The new uniform effective date will apply only to
final FDA food labeling regulations published after January 1, 1990 and
before January 1, 1992.
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (Con't.)
Part Page
170 Food additives.............................. 5
171 Food additive petitions..................... 21
172 Food additives permitted for direct addition
to food for human consumption........... 26
173 Secondary direct food additives permitted in
food for human consumption.............. 111
174 Indirect food additives: General............ 140
175 Indirect food additives: Adhesives and
components of coatings.................. 141
176 Indirect food additives: Paper and
paperboard components................... 183
177 Indirect food additives: Polymers........... 221
178 Indirect food additives: Adjuvants,
production aids, and sanitizers......... 340
179 Irradiation in the production, processing
and handling of food.................... 432
180 Food additives permitted in food or in
contact with food on an interim basis
pending additional study................ 438
181 Prior-sanctioned food ingredients........... 443
182 Substances generally recognized as safe..... 447
184 Direct food substances affirmed as generally
recognized as safe...................... 461
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186 Indirect food substances affirmed as
generally recognized as safe............ 559
189 Substances prohibited from use in human food 564
190 Dietary supplements......................... 569
191-199 [Reserved]
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SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec.
170.3 Definitions.
170.6 Opinion letters on food additive status.
170.10 Food additives in standardized foods.
170.15 Adoption of regulation on initiative of Commissioner.
170.17 Exemption for investigational use and procedure for obtaining
authorization to market edible products from experimental
animals.
170.18 Tolerances for related food additives.
170.19 Pesticide chemicals in processed foods.
Subpart B--Food Additive Safety
170.20 General principles for evaluating the safety of food additives.
170.22 Safety factors to be considered.
170.30 Eligibility for classification as generally recognized as safe
(GRAS).
170.35 Affirmation of generally recognized as safe (GRAS) status.
170.38 Determination of food additive status.
170.39 Threshold of regulation for substances used in food-contact
articles.
Subpart C--Specific Administrative Rulings and Decisions
170.45 Fluorine-containing compounds.
170.50 Glycine (aminoacetic acid) in food for human consumption.
170.60 Nitrites and/or nitrates in curing premixes.
Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 170.3 Definitions.
For the purposes of this subchapter, the following definitions
apply:
(a) Secretary means the Secretary of Health and Human Services.
(b) Department means the Department of Health and Human Services.
(c) Commissioner means the Commissioner of Food and Drugs.
(d) As used in this part, the term act means the Federal Food, Drug,
and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as
amended (21 U.S.C. 301-392).
(e)(1) Food additives includes all substances not exempted by
section 201(s) of the act, the intended use of which results or may
reasonably be expected to result, directly or indirectly, either in
their becoming a component of food or otherwise affecting the
characteristics of food. A material used in the production of containers
and packages is subject to the definition if it may reasonably be
expected to become a component, or to affect the characteristics,
directly or indirectly, of food packed in the container. ``Affecting the
characteristics of food'' does not include such physical effects, as
protecting contents of packages, preserving shape, and preventing
moisture loss. If there is no migration of a packaging component from
the package to the food, it does not become a component of the food and
thus is not a food additive. A substance that does not become a
component of food, but that is used, for example, in preparing an
ingredient of the food to give a different flavor, texture, or other
characteristic in the food, may be a food additive.
(2) Uses of food additives not requiring a listing regulation.
Substances used in food-contact articles (e.g., food-packaging and food-
processing equipment) that migrate, or may be expected to migrate, into
food at such negligible levels that they have been exempted from
regulation as food additives under Sec. 170.39.
(f) Common use in food means a substantial history of consumption of
a substance for food use by a significant number of consumers.
(g) The word substance in the definition of the term ``food
additive'' includes a food or food component consisting of one or more
ingredients.
(h) Scientific procedures include those human, animal, analytical,
and other scientific studies, whether published or unpublished,
appropriate to establish the safety of a substance.
(i) Safe or safety means that there is a reasonable certainty in the
minds of
[[Page 6]]
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 available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408:
(1) Baked goods and baking mixes, including all ready-to-eat and
ready-to-bake products, flours, and mixes requiring preparation before
serving.
(2) Beverages, alcoholic, including malt beverages, wines, distilled
liquors, and cocktail mix.
(3) Beverages and beverage bases, nonalcoholic, including only
special or spiced teas, soft drinks, coffee substitutes, and fruit and
vegetable flavored gelatin drinks.
(4) Breakfast cereals, including ready-to-eat and instant and
regular hot cereals.
(5) Cheeses, including curd and whey cheeses, cream, natural,
grating, processed, spread, dip, and miscellaneous cheeses.
(6) Chewing gum, including all forms.
(7) Coffee and tea, including regular, decaffeinated, and instant
types.
(8) Condiments and relishes, including plain seasoning sauces and
spreads, olives, pickles, and relishes, but not spices or herbs.
(9) Confections and frostings, including candy and flavored
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple,
powdered, and raw sugars.
(10) Dairy product analogs, including nondairy milk, frozen or
liquid creamers, coffee whiteners, toppings, and other nondairy
products.
(11) Egg products, including liquid, frozen, or dried eggs, and egg
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and
frozen multicourse egg meals, but not fresh eggs.
(12) Fats and oils, including margarine, dressings for salads,
butter, salad oils, shortenings and cooking oils.
(13) Fish products, including all prepared main dishes, salads,
appetizers,
[[Page 7]]
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.
(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.
[[Page 8]]
(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 available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408:
(1) ``Anticaking agents and free-flow agents'': Substances added to
finely powdered or crystalline food products to prevent caking, lumping,
or agglomeration.
(2) ``Antimicrobial agents'': Substances used to preserve food by
preventing growth of microorganisms and subsequent spoilage, including
fungistats, mold and rope inhibitors, and the effects listed by the
National Academy of Sciences/National Research Council under
``preservatives.''
(3) ``Antioxidants'': Substances used to preserve food by retarding
deterioration, rancidity, or discoloration due to oxidation.
(4) ``Colors and coloring adjuncts'': Substances used to impart,
preserve, or enhance the color or shading of a food, including color
stabilizers, color fixatives, color-retention agents, etc.
(5) ``Curing and pickling agents'': Substances imparting a unique
flavor and/or color to a food, usually producing an increase in shelf
life stability.
(6) ``Dough strengtheners'': Substances used to modify starch and
gluten, thereby producing a more stable dough, including the applicable
effects listed by the National Academy of Sciences/National Research
Council under ``dough conditioner.''
(7) ``Drying agents'': Substances with moisture-absorbing ability,
used to maintain an environment of low moisture.
(8) ``Emulsifiers and emulsifier salts'': Substances which modify
surface tension in the component phase of an emulsion to establish a
uniform dispersion or emulsion.
(9) ``Enzymes'': Enzymes used to improve food processing and the
quality of the finished food.
(10) ``Firming agents'': Substances added to precipitate residual
pectin, thus strengthening the supporting tissue and preventing its
collapse during processing.
(11) ``Flavor enhancers'': Substances added to supplement, enhance,
or modify the original taste and/or aroma of a food, without imparting a
characteristic taste or aroma of its own.
(12) ``Flavoring agents and adjuvants'': Substances added to impart
or help impart a taste or aroma in food.
(13) ``Flour treating agents'': Substances added to milled flour, at
the mill, to improve its color and/or baking qualities, including
bleaching and maturing agents.
(14) ``Formulation aids'': Substances used to promote or produce a
desired physical state or texture in food, including carriers, binders,
fillers, plasticizers, film-formers, and tableting aids, etc.
(15) ``Fumigants'': Volatile substances used for controlling insects
or pests.
(16) ``Humectants'': Hygroscopic substances incorporated in food to
promote retention of moisture, including moisture-retention agents and
antidusting agents.
(17) ``Leavening agents'': Substances used to produce or stimulate
production of carbon dioxide in baked goods to impart a light texture,
including yeast, yeast foods, and calcium salts listed by the National
Academy of Sciences/National Research Council under ``dough
conditioners.''
(18) ``Lubricants and release agents'': Substances added to food
contact surfaces to prevent ingredients and finished products from
sticking to them.
[[Page 9]]
(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]
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
[[Page 10]]
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, 200 C Street SW., Washington, DC
20204, along with a copy of his letter of inquiry, on or before July 23,
1970.
(f) This section does not apply to food additive status opinion
letters pertaining to articles that were considered by the Food and Drug
Administration to be food additives nor to articles included in
regulations in parts 170 through 189 of this chapter if the articles are
used in accordance with the requirements of such regulations.
[42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989]
Sec. 170.10 Food additives in standardized foods.
(a) The inclusion of food ingredients in parts 170 through 189 of
this chapter does not imply that these ingredients may be used in
standardized foods unless they are recognized as optional ingredients in
applicable food standards. Where a petition is received for the issuance
or amendment of a regulation establishing a definition and standard of
identity for a food under section 401 of the Act, which proposes the
inclusion of a food additive in such definition and standard of
identity, the provisions of the regulations in this part shall apply
with respect to the information that must be submitted with respect to
the food additive. Since section 409(b)(5) of the Act requires that the
Secretary publish notice of a petition for the establishment of a food-
additive regulation within 30 days after filing, notice of a petition
relating to a definition and standard of identity shall also be
published within that time limitation if it includes a request, so
designated, for the establishment of a regulation pertaining to a food
additive.
(b) If a petition for a definition and standard of identity contains
a proposal for a food-additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a food-additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in this part.
(c) A regulation will not be issued allowing the use of a food
additive in a food for which a definition and standard of identity is
established, unless its issuance is in conformity with section 401 of
the Act or with the terms of a temporary permit issued under Sec. 130.17
of this chapter. When the contemplated use of such additive complies
with the terms of a temporary permit, the food additive regulation will
be conditioned on such compliance and will expire with the expiration of
the temporary permit.
Sec. 170.15 Adoption of regulation on initiative of Commissioner.
(a) The Commissioner upon his own initiative may propose the
issuance of a regulation prescribing, with respect to any particular use
of a food additive, the conditions under which such additive may be
safely used. Notice of such proposal shall be published in the Federal
Register and shall state the reasons for the proposal.
(b) Action upon a proposal made by the Commissioner shall proceed as
provided in part 10 of this chapter.
[42 FR 14486, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
[[Page 11]]
Sec. 170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for
investigational use by qualified experts shall be exempt from the
requirements of section 409 of the Act under the following conditions:
(a) If intended for investigational use in vitro or in laboratory
research animals, it bears a label which states prominently, in addition
to the other information required by the act, the warning:
Caution. Contains a new food additive for investigational use only
in laboratory research animals or for tests in vitro. Not for use in
humans.
(b) If intended for use in animals other than laboratory research
animals and if the edible products of the animals are to be marketed as
food, permission for the marketing of the edible products as food has
been requested by the sponsor, and authorization has been granted by the
Food and Drug Administration in accordance with Sec. 511.1 of this
chapter or by the Department of Agriculture in accordance with 9 CFR
309.17, and it bears a label which states prominently, in addition to
the other information required by the Act, the warning:
Caution. Contains a new food additive for use only in
investigational animals. Not for use in humans.
Edible products of investigational animals are not to be used for
food unless authorization has been granted by the U.S. Food and Drug
Administration or by the U.S. Department of Agriculture.
(c) If intended for nonclinical laboratory studies in food-producing
animals, the study is conducted in compliance with the regulations set
forth in part 58 of this chapter.
[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]
Sec. 170.18 Tolerances for related food additives.
(a) Food additives that cause similar or related pharmacological
effects will be regarded as a class, and in the absence of evidence to
the contrary, as having additive toxic effects and will be considered as
related food additives.
(b) Tolerances established for such related food additives may limit
the amount of a common component that may be present, or may limit the
amount of biological activity (such as cholinesterase inhibition) that
may be present or may limit the total amount of related food additives
that may be present.
(c) Where food additives from two or more chemicals in the same
class are present in or on a food, the tolerance for the total of such
additives shall be the same as that for the additive having the lowest
numerical tolerance in this class, unless there are available methods
that permit quantitative determination of the amount of each food
additive present or unless it is shown that a higher tolerance is
reasonably required for the combined additives to accomplish the
physical or technical effect for which such combined additives are
intended and that the higher tolerance will be safe.
(d) Where residues from two or more additives in the same class are
present in or on a food and there are available methods that permit
quantitative determination of each residue, the quantity of combined
residues that are within the tolerance may be determined as follows:
(1) Determine the quantity of each residue present.
(2) Divide the quantity of each residue by the tolerance that would
apply if it occurred alone, and multiply by 100 to determine the
percentage of the permitted amount of residue present.
(3) Add the percentages so obtained for all residues present.
(4) The sum of the percentage shall not exceed 100 percent.
Sec. 170.19 Pesticide chemicals in processed foods.
When pesticide chemical residues occur in processed foods due to the
use of raw agricultural commodities that bore or contained a pesticide
chemical in conformity with an exemption granted or a tolerance
prescribed under section 408 of the Act, the processed food will not be
regarded as adulterated so long as good manufacturing practice has been
followed in removing
[[Page 12]]
any residue from the raw agricultural commodity in the processing (such
as by peeling or washing) and so long as the concentration of the
residue in the processed food when ready to eat is not greater than the
tolerance prescribed for the raw agricultural commodity. But when the
concentration of residue in the processed food when ready to eat is
higher than the tolerance prescribed for the raw agricultural commodity,
the processed food is adulterated unless the higher concentration is
permitted by a tolerance obtained under section 409 of the Act. For
example, if fruit bearing a residue of 7 parts per million of DDT
permitted on the raw agricultural commodity is dried and a residue in
excess of 7 parts per million of DDT results on the dried fruit, the
dehydrated fruit is adulterated unless the higher tolerance for DDT is
authorized by the regulations in this part. Food that is itself ready to
eat, and which contains a higher residue than allowed for the raw
agricultural commodity, may not be legalized by blending or mixing with
other foods to reduce the residue in the mixed food below the tolerance
prescribed for the raw agricultural commodity.
Subpart B--Food Additive Safety
Sec. 170.20 General principles for evaluating the safety of food additives.
(a) In reaching a decision on any petition filed under section 409
of the Act, the Commissioner will give full consideration to the
specific biological properties of the compound and the adequacy of the
methods employed to demonstrate safety for the proposed use, and the
Commissioner will be guided by the principles and procedures for
establishing the safety of food additives stated in current publications
of the National Academy of Sciences-National Research Council. A
petition will not be denied, however, by reason of the petitioner's
having followed procedures other than those outlined in the publications
of the National Academy of Sciences-National Research Council if, from
available evidence, the Commissioner finds that the procedures used give
results as reliable as, or more reliable than, those reasonably to be
expected from the use of the outlined procedures. In reaching a
decision, the Commissioner will give due weight to the anticipated
levels and patterns of consumption of the additive specified or
reasonably inferrable. For the purposes of this section, the principles
for evaluating safety of additives set forth in the abovementioned
publications will apply to any substance that may properly be classified
as a food additive as defined in section 201(s) of the Act.
(b) Upon written request describing the proposed use of an additive
and the proposed experiments to determine its safety, the Commissioner
will advise a person who wishes to establish the safety of a food
additive whether he believes the experiments planned will yield data
adequate for an evaluation of the safety of the additive.
Sec. 170.22 Safety factors to be considered.
In accordance with section 409(c)(5)(C) of the Act, the following
safety factors will be applied in determining whether the proposed use
of a food additive will be safe: Except where evidence is submitted
which justifies use of a different safety factor, a safety factor in
applying animal experimentation data to man of 100 to 1, will be used;
that is, a food additive for use by man will not be granted a tolerance
that will exceed \1/100\th of the maximum amount demonstrated to be
without harm to experimental animals.
Sec. 170.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of
experts qualified by scientific training and experience to evaluate the
safety of substances directly or indirectly added to food. The basis of
such views may be either (1) scientific procedures or (2) in the case of
a substance used in food prior to January 1, 1958, through experience
based on common use in food. General recognition of safety requires
common knowledge about the substance throughout the scientific community
knowledgeable about the safety of substances directly or indirectly
added to food.
[[Page 13]]
(b) General recognition of safety based upon scientific procedures
shall require the same quantity and quality of scientific evidence as is
required to obtain approval of a food additive regulation for the
ingredient. General recognition of safety through scientific procedures
shall ordinarily be based upon published studies which may be
corroborated by unpublished studies and other data and information.
(c)(1) General recognition of safety through experience based on
common use in food prior to January 1, 1958, may be determined without
the quantity or quality of scientific procedures required for approval
of a food additive regulation. General recognition of safety through
experience based on common use in food prior to January 1, 1958, shall
be based solely on food use of the substance prior to January 1, 1958,
and shall ordinarily be based upon generally available data and
information. An ingredient not in common use in food prior to January 1,
1958, may achieve general recognition of safety only through scientific
procedures.
(2) A substance used in food prior to January 1, 1958, may be
generally recognized as safe through experience based on its common use
in food when that use occurred exclusively or primarily outside of the
United States if the information about the experience establishes that
the use of the substance is safe within the meaning of the act (see
Sec. 170.3(i)). Common use in food prior to January 1, 1958, that
occurred outside of the United States shall be documented by published
or other information and shall be corroborated by information from a
second, independent source that confirms the history and circumstances
of use of the substance. The information used to document and to
corroborate the history and circumstances of use of the substance must
be generally available; that is, it must be widely available in the
country in which the history of use has occurred and readily available
to interested qualified experts in this country. Persons claiming GRAS
status for a substance based on its common use in food outside of the
United States should obtain FDA concurrence that the use of the
substance is GRAS.
(d) The food ingredients listed as GRAS in part 182 of this chapter
or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter do not
include all substances that are generally recognized as safe for their
intended use in food. Because of the large number of substances the
intended use of which results or may reasonably be expected to result,
directly or indirectly, in their becoming a component or otherwise
affecting the characteristics of food, it is impracticable to list all
such substances that are GRAS. A food ingredient of natural biological
origin that has been widely consumed for its nutrient properties in the
United States prior to January 1, 1958, without known detrimental
effects, which is subject only to conventional processing as practiced
prior to January 1, 1958, and for which no known safety hazard exists,
will ordinarily be regarded as GRAS without specific inclusion in part
182, part 184 or Sec. 186.1 of this chapter.
(e) Food ingredients were listed as GRAS in part 182 of this chapter
during 1958-1962 without a detailed scientific review of all available
data and information relating to their safety. Beginning in 1969, the
Food and Drug Administration has undertaken a systematic review of the
status of all ingredients used in food on the determination that they
are GRAS or subject to a prior sanction. All determinations of GRAS
status or food additive status or prior sanction status pursuant to this
review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of
this chapter. Affirmation of GRAS status shall be announced in part 184
or Sec. 186.1 of this chapter.
(f) The status of the following food ingredients will be reviewed
and affirmed as GRAS or determined to be a food additive or subject to a
prior sanction pursuant to Sec. 170.35, Sec. 170.38, or Sec. 180.1 of
this chapter:
(1) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, and which has been modified by processes first
introduced into commercial use
[[Page 14]]
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 may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) It performs an appropriate function in the food or food-contact
article in which it is used.
(3) It is used at a level no higher than necessary to achieve its
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its
intended purpose in that article.
(i) If a substance is affirmed as GRAS in part 184 or Sec. 186.1 of
this chapter with no limitation other than good manufacturing practice,
it shall be regarded as GRAS if its conditions of use are not
significantly different from those reported in the regulation as the
basis on which the GRAS status of the substance was affirmed. If the
conditions of use are significantly different, such use of the substance
may not be GRAS. In such a case a manufacturer may not rely on the
regulation as authorizing the use but must independently establish that
the use is GRAS or must use the substance in accordance with a food
additive regulation.
(j) If an ingredient is affirmed as GRAS in part 184 or Sec. 186.1
of this chapter with specific limitation(s), it may be used in food only
within such limitation(s) (including the category of food(s), the
functional use(s) of the ingredient, and the level(s) of use). Any use
of such an ingredient not in full compliance with each such established
limitation shall require a food additive regulation.
(k) Pursuant to Sec. 170.35, a food ingredient may be affirmed as
GRAS in part 184 or Sec. 186.1 of this chapter for a specific use(s)
without a general evaluation of use of the ingredient. In addition to
the use(s) specified in the regulation, other uses of such an ingredient
may also be GRAS. Any affirmation of GRAS status for a specific use(s),
without a general evaluation of use of the ingredient, is subject to
reconsideration upon such evaluation.
(l) New information may at any time require reconsideration of the
GRAS status of a food ingredient. Any change in part 182, part 184, or
Sec. 186.1 of this
[[Page 15]]
chapter shall be accomplished pursuant to Sec. 170.38.
[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53
FR 16546, May 10, 1988]
Sec. 170.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, either on his initiative or on the petition of
an interested person, may affirm the GRAS status of substances that
directly or indirectly become components of food.
(b)(1) If the Commissioner proposes on his own initiative that a
substance is entitled to affirmation as GRAS, he will place all of the
data and information on which he relies on public file in the office of
the Dockets Management Branch and will publish in the Federal Register a
notice giving the name of the substance, its proposed uses, and any
limitations proposed for purposes other than safety.
(2) The Federal Register notice will allow a period of 60 days
during which any interested person may review the data and information
and/or file comments with the Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is convincing evidence that the substance is GRAS
as described in Sec. 170.30, he will publish a notice in the Federal
Register listing the substance as GRAS in part 182, part 184, or part
186 of this chapter, as appropriate.
(4) If, after evaluation of the comments, the Commissioner concludes
that there is a lack of convincing evidence that the substance is GRAS
and that it should be considered a food additive subject to section 409
of the Act, he shall publish a notice thereof in the Federal Register in
accordance with Sec. 170.38.
(c)(1) Persons seeking the affirmation of GRAS status of substances
as provided in Sec. 170.30(e), except those subject to the NAS/NRC GRAS
list survey (36 FR 20546; October 23, 1971), shall submit a petition for
GRAS affirmation pursuant to part 10 of this chapter. Such petition
shall contain information to establish that the GRAS criteria as set
forth in Sec. 170.30 (b) or (c) have been met, in the following form:
(i) Description of the substance, including:
(a) Common or usual name.
(b) Chemical name.
(c) Chemical Abstract Service (CAS) registry number.
(d) Empirical formula.
(e) Structural formula.
(f) Specifications for food grade material, including arsenic and
heavy metals. (Recommendation for any change in the Food Chemicals Codex
monograph should be included where applicable.)
(g) Quantitative compositions.
(h) Manufacturing process (excluding any trade secrets).
(ii) Use of the substance, including:
(a) Date when use began.
(b) Information and reports or other data on past uses in food.
(c) Foods in which used, and levels of use in such foods, and for
what purposes.
(iii) Methods for detecting the substance in food, including:
(a) References to qualitative and quantitative methods for
determining the substance(s) in food, including the type of analytical
procedures used.
(b) Sensitivity and reproducibility of such method(s).
(iv) Information to establish the safety and functionality of the
substance in food. Published scientific literature, evidence that the
substance is identical to a GRAS counterpart of natural biological
origin, and other data may be submitted to support safety. Any adverse
information or consumer complaints shall be included. Complete
bibliographic references shall be provided where a copy of the article
is not provided.
(v) A statement signed by the person responsible for the petition
that to the best of his knowledge it is a representative and balanced
submission that includes unfavorable information, as well as favorable
information, known to him pertinent to the evaluation of the safety and
functionality of the substance.
(vi) If nonclinical laboratory studies are involved, additional
information and data submitted in support of filed petitions shall
include, with respect to
[[Page 16]]
each nonclinical study, either a statement that the study was conducted
in compliance with the requirements set forth in part 58 of this
chapter, or, if the study was not conducted in compliance with such
regulations, a brief statement of the reason for the noncompliance.
(vii) [Reserved]
(viii) A claim for categorical exclusion under Sec. 25.30 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
Dockets Management Branch and will publish a notice of filing in the
Federal Register giving the name of the petitioner and a brief
description of the petition including the name of the substance, its
proposed use, and any limitations proposed for reasons other than
safety. A copy of the notice will be mailed to the petitioner at the
time the original is sent to the Federal Register.
(3)(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 Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch'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 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
[[Page 17]]
is a food additive subject to section 409 of the Act. Any petition shall
include all relevant data and information of the type described in
Sec. 171.130(b). The Commissioner will place all of the data and
information on which he relies on public file in the office of the
Dockets Management Branch and will include in the Federal Register
notice the name of the substance, its known uses, and a summary of the
basis for the determination.
(2) The Federal Register notice will allow a period of 60 days
during which any interested person may review the data and information
and/or file comments with the Dockets Management Branch. Copies of all
comments shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is a lack of convincing evidence that the substance
is GRAS or is otherwise exempt from the definition of a food additive in
section 201(s) of the Act, he will publish a notice thereof in the
Federal Register. If he concludes that there is convincing evidence that
the substance is GRAS, he will publish an order in the Federal Register
listing the substance as GRAS in part 182, part 184, or part 186 of this
chapter, as appropriate.
(c) A Federal Register notice determining that a substance is a food
additive shall provide for the use of the additive in food or food
contact surfaces as follows:
(1) It may promulgate a food additive regulation governing use of
the additive.
(2) It may promulgate an interim food additive regulation governing
use of the additive.
(3) It may require discontinuation of the use of the additive.
(4) It may adopt any combination of the above three approaches for
different uses or levels of use of the additive.
(d) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of the substance, he will concurrently propose a
separate regulation covering such use of the ingredient under part 181
of this chapter. If the Commissioner is unaware of any such applicable
prior sanction, the proposed regulation will so state and will require
any person who intends to assert or rely on such sanction to submit
proof of its existence. Any regulation promulgated pursuant to this
section constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof of such an applicable prior sanction in response
to the proposal.
[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
54 FR 24896, June 12, 1989]
Sec. 170.39 Threshold of regulation for substances used in food-contact articles.
(a) A substance used in a food-contact article (e.g., food-packaging
or food-processing equipment) that migrates, or that may be expected to
migrate, into food will be exempted from regulation as a food additive
because it becomes a component of food at levels that are below the
threshold of regulation if:
(1) The substance has not been shown to be a carcinogen in humans or
animals, and there is no reason, based on the chemical structure of the
substance, to suspect that the substance is a carcinogen. The substance
must also not contain a carcinogenic impurity or, if it does, must not
contain a carcinogenic impurity with a TD50 value based on
chronic feeding studies reported in the scientific literature or
otherwise available to the Food and Drug Administration of less than
6.25 milligrams per kilogram bodyweight per day (The TD50,
for the purposes of this section, is the feeding dose that causes cancer
in 50 percent of the test animals when corrected for tumors found in
control animals. If more than one TD50 value
[[Page 18]]
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 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
[[Page 19]]
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),
200 C St. SW., Washington, DC 20204.
(e) The Food and Drug Administration will inform the requestor by
letter whether the specific food-contact application is exempt from
regulation as a food additive or not. Although a substance that migrates
to food at a level that results in a dietary concentration at or below
the threshold of regulation will not be the subject of a regulation
published in the Federal Register and will not appear in the Code of
Federal Regulations, the Food and Drug Administration will maintain a
list of substances exempted from regulation as food additives under this
section on display at the Dockets Management Branch. This list will
include the name of the company that made the request, the chemical name
of the substance, the specific use for which it has received an
exemption from regulation as a food additive, and any appropriate
limitations on its use. The list will not include any trade names. This
list will enable interested persons to see the types of uses of food-
contact materials being exempted under the regulation. Interested
persons may also obtain a copy of the list of exempted substances by
contacting the Food and Drug Administration's Office of Premarket
Approval (HFS-200), 200 C St. SW., Washington, DC 20204. 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 Dockets Management Branch 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 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
[[Page 20]]
food additive regulation. This notification will be placed on public
display at the Dockets Management Branch as part of the file of uses of
substances exempted from regulation as food additives. The Food and Drug
Administration recognizes that manufacturers other than those that
actually made a request for exemption may also be using exempted
substances in food-contact articles under conditions of use (e.g., use
levels, temperature, type of food contacted, etc.) that are similar to
those for which the exemption was issued. Because only requestors will
be notified as part of the revocation process described in this section,
the Food and Drug Administration plans to notify other manufacturers by
means of a notice published in the Federal Register of its decision to
revoke an exemption issued for a specific use of a substance in a food
contact article.
(h) 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), 200 C St. SW., Washington, DC 20204. Interested
persons are encouraged to obtain specific guidance from the Food and
Drug Administration on the appropriate protocols to be used for
obtaining migration data, on the validation of the analytical methods
used to quantify migration levels, on the procedures used to relate
migration data to dietary exposures, and on any other issue not
specifically covered in the Food and Drug Administration's 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 as stated in Sec. 250.203 of this chapter, (b) to that
resulting from the fluoridation of bottled water within the limitation
established in Sec. 103.35(d) of this chapter, and (c) to that
authorized by regulations (40 CFR part 180) under section 408 of the
Act.
Sec. 170.50 Glycine (aminoacetic acid) in food for human consumption.
(a) Heretofore, the Food and Drug Administration has expressed the
opinion in trade correspondence that glycine is generally recognized as
safe for certain technical effects in human food when used in accordance
with good manufacturing practice; however:
(1) Reports in scientific literature indicate that adverse effects
were found in cases where high levels of glycine were administered in
diets of experimental animals.
(2) Current usage information indicates that the daily dietary
intake of glycine by humans may be substantially increasing due to
changing use patterns in food technology.
Therefore, the Food and Drug Administration no longer regards glycine
and its salts as generally recognized as safe for use in human food and
all outstanding letters expressing sanction for such use are rescinded.
(b) The Commissioner of Food and Drugs concludes that by May 8,
1971, manufacturers:
(1) Shall reformulate food products for human use to eliminate added
glycine and its salts; or
(2) Shall bring such products into compliance with an authorizing
food additive regulation. A food additive petition supported by toxicity
data is required to show that any proposed level of glycine or its salts
added to foods for human consumption will be safe.
(c) The status of glycine as generally recognized as safe for use in
animal feed, as prescribed in Sec. 582.5049 of this chapter, remains
unchanged because the additive is considered an essential nutrient in
certain animal feeds and is safe for such use under conditions of good
feeding practice.
Sec. 170.60 Nitrites and/or nitrates in curing premixes.
(a) Nitrites and/or nitrates are food additives when combined in
curing premixes with spices and/or other flavoring or seasoning
ingredients that
[[Page 21]]
contain or constitute a source of secondary or tertiary amines,
including but not limited to essential oils, disodium inosinate,
disodium guanylate, hydrolysates of animal or plant origin (such as
hydrolyzed vegetable protein), oleoresins of spices, soy products, and
spice extractives. Such food additives may be used only after the
establishment of an authorizing food additive regulation. A food
additive petition submitted pursuant to Secs. 171.1 and 171.100 of this
chapter, supported by data demonstrating that nitrosamines are not
formed in curing premixes containing such food additives, is required to
establish safety.
(b) Nitrites and/or nitrates, when packaged separately from
flavoring and seasoning in curing premixes, may continue to be used
under prior sanctions in the commercial curing of meat and meat products
and poultry products and in accordance with the provisions of
Secs. 172.170 and 172.175 of this chapter that apply to meat curing
preparations for the home curing of meat and meat products, including
poultry and wild game. To assure safe use of such ingredients the
labeling of the premixes shall bear instructions to the user that such
separately packaged ingredients are not to be combined until just prior
to use. Encapsulating or coating some or all of the ingredients does not
constitute separate packaging.
PART 171--FOOD ADDITIVE PETITIONS--Table of Contents
Subpart A--General Provisions
Sec.
171.1 Petitions.
171.6 Amendment of petition.
171.7 Withdrawal of petition without prejudice.
171.8 Threshold of regulation for substances used in 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 additive petition should be
accompanied by reprints or photostatic copies of such references.
(c) Petitions shall include the following data and be submitted in
the following form:
(Date)
Name of petitioner______________________________________________________
Post-office address_____________________________________________________
Date____________________________________________________________________
Name of food additive and proposed use__________________________________
_______________________________________________________________________
Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.
Dear Sirs:
The undersigned, __________ submits this petition pursuant to
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with
respect to __________
(Name of the food additive and proposed use)
[[Page 22]]
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 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.
[[Page 23]]
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 and they no
longer represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.61 of this chapter:
(i) Manufacturing methods or processes, including quality control
procedures.
(ii) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
(iii) Quantitative or semiquantitative formulas.
(3) All correspondence and written summaries of oral discussions
relating
[[Page 24]]
to a food additive petition are available for public disclosure in
accordance with the provisions of part 20 of this chapter when the food
additive regulation is published in the Federal Register.
(4) For purposes of this regulation, safety and functionality data
include all studies and tests of a food additive on animals and humans
and all studies and tests on a food additive for identity, stability,
purity, potency, performance, and usefulness.
(i)(1) Within 15 days after receipt, the Commissioner will notify
the petitioner of acceptance or nonacceptance of a petition, and if not
accepted the reasons therefor. If accepted, the date of the notification
letter sent to petitioner becomes the date of filing for the purposes of
section 409(b)(5) of the Act. If the petitioner desires, he may
supplement a deficient petition after being notified regarding
deficiencies. If the supplementary material or explanation of the
petition is deemed acceptable, petitioner shall be notified. The date of
such notification becomes the date of filing. If the petitioner does not
wish to supplement or explain the petition and requests in writing that
it be filed as submitted, the petition shall be filed and the petitioner
so notified. The date of such notification becomes the date of filing.
(2) The Commissioner will publish in the Federal Register within 30
days from the date of filing of such petition, a notice of the filing,
the name of the petitioner, and a brief description of the proposal in
general terms. In the case of a food additive which becomes a component
of food by migration from packaging material, the notice shall include
the name of the migratory substance, and where it is different from that
of one of the original components, the name of the parent component, the
maximum quantity of the migratory substance that is proposed for use in
food, and the physical or other technical effect which the migratory
substance or its parent component is intended to have in the packaging
material. A copy of the notice will be mailed to the petitioner when the
original is forwarded to the Federal Register for publication.
(j) The Commissioner may request a full description of the methods
used in, and the facilities and controls used for, the production of the
food additive, or a sample of the food additive, articles used as
components thereof, or of the food in which the additive is proposed to
be used, at any time while a petition is under consideration. The
Commissioner shall specify in the request for a sample of the food
additive, or articles used as components thereof, or of the food in or
on which the additive is proposed to be used, a quantity deemed adequate
to permit tests of analytical methods to determine quantities of the
food additive present in foods for which it is intended to be used or
adequate for any study or investigation reasonably required with respect
to the safety of the food additive or the physical or technical effect
it produces. The date used for computing the 90-day limit for the
purposes of section 409(c)(2) of the Act shall be moved forward 1 day
for each day after the mailing date of the request taken by the
petitioner to submit the sample. If the information or sample is
requested a reasonable time in advance of the 180 days, but is not
submitted within such 180 days after filing of the petition, the
petition will be considered withdrawn without prejudice.
(k) If nonclinical laboratory studies are involved, petitions filed
with the Commissioner under section 409(b) of the act shall include,
with respect to each nonclinical study contained in the petition, either
a statement that the study has been, or will be, conducted in compliance
with the good laboratory practice regulations as set forth in part 58 of
this chapter, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the noncompliance.
(l) [Reserved]
(m) If clinical investigations involving human subjects are
involved, petitions filed with the Commissioner under section 409(b) of
the Act shall include statements regarding each such clinical
investigation relied upon in the petition that it either was conducted
in compliance with the requirements for institutional review set forth
in part 56 of this chapter, or was not
[[Page 25]]
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]
Effective Date Note: At 65 FR 51763, Aug. 25, 2000, Sec. 171.1 was
amended in paragraph (a) by revising the first sentence, in paragraph
(c) in the petition by revising the introductory paragraph preceding
paragraph A., and by adding paragraph (n). The revised and added text
contains information collection and recordkeeping requirements and will
not become effective until approval has been given by the Office of
Management and Budget.
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.
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
[[Page 26]]
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 shall be furnished in the form specified
in Secs. 171.1 and 171.100 for submitting petitions.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION--Table of Contents
Subpart A--General Provisions
Sec.
172.5 General provisions for direct food additives.
Subpart B--Food Preservatives
172.105 Anoxomer.
172.110 BHA.
172.115 BHT.
172.120 Calcium disodium EDTA.
172.130 Dehydroacetic acid.
172.133 Dimethyl dicarbonate.
172.135 Disodium EDTA.
172.140 Ethoxyquin.
172.145 Heptylparaben.
172.150 4-Hydroxymethyl-2,6-di-tert-butyl-phenol.
172.155 Natamycin (pimaricin).
172.160 Potassium nitrate.
172.165 Quaternary ammonium chloride combination.
172.170 Sodium nitrate.
172.175 Sodium nitrite.
172.177 Sodium nitrite used in processing smoked chub.
172.180 Stannous chloride.
172.185 TBHQ.
172.190 THBP.
[[Page 27]]
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.
172.385 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.
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 wood rosin.
172.755 Stearyl monoglyceridyl citrate.
172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770 Ethylene oxide polymer.
172.775 Methacrylic acid-divinylbenzene copolymer.
Subpart I--Multipurpose Additives
172.800 Acesulfame potassium.
172.802 Acetone peroxides.
172.804 Aspartame.
172.806 Azodicarbonamide.
172.808 Copolymer condensates of ethylene oxide and propylene oxide.
172.809 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.
172.830 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.
[[Page 28]]
172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
172.852 Glyceryl-lacto esters of fatty acids.
172.854 Polyglycerol esters of fatty acids.
172.856 Propylene glycol mono- and diesters of fats and fatty acids.
172.858 Propylene glycol alginate.
172.859 Sucrose fatty acid esters.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or
both oils.
172.862 Oleic acid derived from tall oil fatty acids.
172.863 Salts of fatty acids.
172.864 Synthetic fatty alcohols.
172.866 Synthetic glycerin produced by the hydrogenolysis of
carbohydrates.
172.867 Olestra.
172.868 Ethyl cellulose.
172.870 Hydroxypropyl cellulose.
172.872 Methyl ethyl cellulose.
172.874 Hydroxypropyl methylcellulose.
172.876 Castor oil.
172.878 White mineral oil.
172.880 Petrolatum.
172.882 Synthetic isoparaffinic petroleum hydrocarbons.
172.884 Odorless light petroleum hydrocarbons.
172.886 Petroleum wax.
172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.892 Food starch-modified.
172.894 Modified cottonseed products intended for human consumption.
172.896 Dried yeasts.
172.898 Bakers yeast glycan.
Authority: 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.
Subpart A--General Provisions
Sec. 172.5 General provisions for direct food additives.
(a) Regulations prescribing conditions under which food additive
substances may be safely used predicate usage under conditions of good
manufacturing practice. For the purposes of this part, good
manufacturing practice shall be defined to include the following
restrictions.
(1) The quantity of the substance added to food does not exceed the
amount reasonably required to accomplish its intended physical,
nutritive, or other technical effect in food.
(2) Any substance intended for use in or on food is of appropriate
food grade and is prepared and handled as a food ingredient.
(b) The existence of a regulation prescribing safe conditions of use
for a food additive shall not be construed to relieve the use of the
substance from compliance with any other provision of the Act.
(c) The existence of any regulation prescribing safe conditions of
use for a nutrient substance does not constitute a finding that the
substance is useful or required as a supplement to the diet of humans.
Subpart B--Food Preservatives
Sec. 172.105 Anoxomer.
Anoxomer as identified in this section may be safely used in
accordance with the following conditions:
(a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-
(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-
57-2) prepared by condensation polymerization of divinylbenzene (m- and
p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-
cresol and 4,4'-isopropylidenediphenol.
(b) The polymeric antioxidant meets the following specifications:
(1) Polymer, not less than 98.0 percent as determined by an
ultraviolet method entitled ``Ultraviolet Assay, ``1982, which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(2) Molecular weight: Total monomers, dimers and trimers below 500
not more than 1 percent as determined by a method entitled ``Low
Molecular Weight Anoxomer Analysis,'' 1982, which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or available for inspection at the Office of
the Federal Register, 800
[[Page 29]]
North Capitol Street, NW., suite 700, Washington, DC 20408.
(3) Phenol content: Not less than 3.2 milliequivalent/gram and not
more than 3.8 milliequivalent/gram as determined by a method entitled
``Total Phenols,'' 1982, which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204,
or available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(4) Heavy metals as lead (as Pb), not more than 10 parts per
million. Arsenic (as As), not more than 3 parts per million. Mercury (as
Hg), not more than 1 part per million.
(c) Anoxomer may be safely used as an antioxidant in food at a level
of not more than 5,000 parts per million based on fat and oil content of
the food.
[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]
Sec. 172.110 BHA.
The food additive BHA (butylated hydroxyanisole) alone or in
combination with other antioxidants permitted in food for human
consumption in this subpart B may be safely used in or on specified
foods, as follows:
(a) The BHA meets the following specification:
Assay (total BHA), 98.5 percent minimum. Melting point 48 deg.C
minimum.
(b) The BHA is used alone or in combination with BHT, as an
antioxidant in foods, as follows:
------------------------------------------------------------------------
Limitations
(total BHA
Food and BHT)
parts per
million
------------------------------------------------------------------------
Dehydrated potato shreds................................... 50
Active dry yeast........................................... \1\ 1,000
Beverages and desserts prepared from dry mixes............. \1\ 2
Dry breakfast cereals...................................... 50
Dry diced glazed fruit..................................... \1\ 32
Dry mixes for beverages and desserts....................... \1\ 90
Emulsion stabilizers for shortenings....................... 200
Potato flakes.............................................. 50
Potato granules............................................ 10
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:
[[Page 30]]
(a) The additive contains a minimum of 99 percent by weight of
either the dihydrate
C10H12O8N2CaNa2
2H2O or the trihydrate
C10H12O8N2CaNa2
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.
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.
[[Page 31]]
Sec. 172.133 Dimethyl dicarbonate.
Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive meets the following specifications:
(1) The additive has a purity of not less than 99.8 percent as
determined by the following titration method:
principles of method
Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine
with which it reacts quantitatively. The excess amine is backtitrated
with acid.
apparatus
250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, eg., Metrohm burette)
Stirrer
Device for potentiometric titration
Reference electrode
Glass electrode
reagents
Acetone, analytical-grade
Solution of 1 N diisobutylamine in chlorobenzene, distilled
1 N Acetic Acid
procedure
Accurately weigh in about 2 grams of the sample (W) and dissolve in
100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution
by pipette and allow to stand for 5 minutes. Subsequently, titrate the
reaction mixture potentiometrically with 1 N hydrochloric acid
(consumption=a mL) while stirring. For determining the blank
consumption, carry out the analysis without a sample (consumption=b mL).
calculation
[GRAPHIC] [TIFF OMITTED] 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,'' whichis incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), 200 C Street SW., Washington, DC 20204, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(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. 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
ethylenediaminetetraacetate) may be safely used in designated foods for
the purposes and in accordance with the following prescribed conditions:
[[Page 32]]
(a) The additive contains a minimum of 99 percent disodium
ethylenedia-minetetraacetate dihydrate
(C10H14O8N2Na2
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.
Ready-to-eat cereal products \2\ 315 Promote color
containing dried bananas. retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
\1\ Based on total weight of finished product including packing medium.
\2\ In dried banana component of cereal product.
(2) With calcium disodium EDTA (calcium disodium
ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo)
tetraacetate), in the following foods at not to exceed, in combination,
the levels prescribed, calculated as anhydrous
C10H12O8N2CaNa2:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
(3) Alone, as a sequestrant in the nonnutritive sweeteners that are
listed in Sec. 180.37 of this chapter and that, in addition, are
designed for aqueous solution: Provided, That the amount of the
additive, calculated as anhydrous 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 Secs. 573.380 and 573.400 of this chapter,
tolerances are established for residues of ethoxyquin in or on edible
products of animals as follows:
5 parts per million in or on the uncooked fat of meat from animals
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.
Sec. 172.145 Heptylparaben.
(a) The food additive heptylparaben is the chemical n-heptyl p-
hydroxybenzoate.
(b) It may be safely used to inhibit microbiological spoilage in
accordance with the following prescribed conditions:
[[Page 33]]
(1) In fermented malt beverages in amounts not to exceed 12 parts
per million.
(2) In noncarbonated soft drinks and fruit-based beverages in
amounts not to exceed 20 parts per million, when standards of identity
established under section 401 of the Act (21 U.S.C. 341) do not preclude
such use.
Sec. 172.150 4-Hydroxymethyl-2,6-di-tert-butylphenol.
The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive has a solidification point of 140 deg.C-141
deg.C.
(b) The additive is used as an antioxidant alone or in combination
with other permitted antioxidants.
(c) The total amount of all antioxidants added to such food shall
not exceed 0.02 percent of the oil or fat content of the food, including
the essential (volatile) oil content of the food.
Sec. 172.155 Natamycin (pimaricin).
(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is
a polyene macrolide antimycotic substance possessing an empirical
formula of C33H47NO13 and a molecular
weight of 665.7.
(b) The additive shall conform to the following specifications:
Purity: 97 percent plus-minus2 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, 200 C St. SW., Washington, DC 20204, or may be examined
at the Center for Food Safety and Applied Nutrition's Library, 200 C St.
SW., rm. 3321, Washington, DC, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
[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
[[Page 34]]
n-Hexadecyl dimethyl benzyl ammonium chloride.............. 1.5-6.0
n-Octadecyl dimethyl benzyl ammonium chloride.............. 0.25-1.0
n-Tetradecyl dimethyl benzyl ammonium chloride............. 3.0-12.0
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride........ 1.6-6.5
------------------------------------------------------------------------
[50 FR 3890, Jan. 29, 1985]
Sec. 172.170 Sodium nitrate.
The food additive sodium nitrate may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a preservative and color fixative, with or without sodium
nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad, so that the level of sodium nitrate does not exceed 500
parts per million and the level of sodium nitrite does not exceed 200
parts per million in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrite, in meat-curing preparations for the home curing of meat and
meat products (including poultry and wild game), with directions for use
which limit the amount of sodium nitrate to not more than 500 parts per
million in the finished meat product and the amount of sodium nitrite to
not more than 200 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the
additive shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any
mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product that
complies with the limitations prescribed in paragraph (a) of this
section.
(3) If in a retail package intended for household use, the label of
the additive or of a mixture containing the additive, shall bear the
statement ``Keep out of the reach of children''.
Sec. 172.175 Sodium nitrite.
The food additive sodium nitrite may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a color fixative in smoked cured tunafish products so that
the level of sodium nitrite does not exceed 10 parts per million (0.001
percent) in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad so that the level of sodium nitrite does not exceed 200 parts
per million and the 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''.
[[Page 35]]
Sec. 172.177 Sodium nitrite used in processing smoked chub.
The food additive sodium nitrite may be safely used in combination
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation
from Clostridium botulinum type E in the commercial processing of smoked
chub in accordance with the following prescribed conditions:
(a) All fish in smoking establishments shall be clean and wholesome
and shall be expeditiously processed, packed, and stored under adequate
sanitary conditions in accordance with good manufacturing practice.
(b) The brining procedure is controlled in such a manner that the
water phase portion of the edible portion of the finished smoked product
has a salt (NaCl) content of not less than 3.5 percent, as measured in
the loin muscle, and the sodium nitrite content of the edible portion of
the finished smoked product is not less than 100 parts per million and
not greater than 200 parts per million, as measured in the loin muscle.
(c) Smoked chub shall be heated by a controlled heat process which
provides a monitoring system positioned in as many strategic locations
in the smokehouse as necessary to assure a continuous temperature
throughout each fish of at least 160 deg.F for a minimum of 30 minutes.
(d) The finished product shall be cooled to a temperature of 50
deg.F or below within 3 hours after smoking and further cooled to a
temperature of 38 deg.F or below within 12 hours after smoking. A
temperature of 38 deg.F or below shall be maintained during all
subsequent storage and distribution. All shipping containers, retail
packages, and shipping records shall indicate with appropriate notice
the perishable nature of the product and specify that the product shall
be held under refrigeration (38 deg.F or below) until consumed.
(e) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate directions to assure use in compliance with the provisions of
this section.
Sec. 172.180 Stannous chloride.
The food additive stannous chloride may be safely used for color
retention in asparagus packed in glass, with lids lined with an inert
material, in an amount not to exceed 20 parts per million calculated as
tin (Sn).
Sec. 172.185 TBHQ.
The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-
1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0),
also known as tertiary butylhydroquinone, may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive has a melting point of 126.5 deg.C-128.5
deg.C.
(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:
[[Page 36]]
(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, 1916 Race
St., Philadelphia, PA 19103, or
available for inspection at the Office
of the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC 20408) using as a
solvent xylene-ethyl alcohol in a 2:1
ratio instead of toluene-ethyl alcohol
in a 2:1 ratio.
Sodium lauryl sulfate.......... Complying with Sec. 172.822. As a film
former.
Wood rosin..................... Color of K or paler.
------------------------------------------------------------------------
(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.
[[Page 37]]
(b) The food additive meets the following specifications:
(1) Softening point, ring and ball: 126 deg.C minimum as determined
by ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(2) Refractive index (n25/D) 1.63-1.64.
(c) It is used or intended for use as a protective coating for
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the
maximum amount of the resin remaining on the fruit does not exceed 200
parts per million on a fresh-weight basis.
(d) To assure safe use of the additive:
(1) The label of the market package or any intermediate premix of
the additive shall bear, in addition to the other information required
by the act:
(i) The name of the additive, coumarone-indene resin.
(ii) A statement of the concentration of the additive therein.
(2) The label or accompanying labeling shall bear adequate
directions that, if followed, will result in a finished food not in
conflict with the requirements of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]
Sec. 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.
Methyl esters and ethyl esters of fatty acids produced from edible
fats and oils may be safely used in food, subject to the following
prescribed conditions:
(a) The additive consists of a mixture of either methyl or ethyl
esters of fatty acids produced from edible fats and oils and meets the
following specifications:
(1) Not less than 90 percent methyl or ethyl esters of fatty acids.
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at the level not to
exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes
to produce raisins, whereby the residue of the additive on the raisins
does not exceed 200 parts per million.
[57 FR 12711, Apr. 13, 1992]
Sec. 172.230 Microcapsules for flavoring substances.
Microcapsules may be safely used for encapsulating discrete
particles of flavoring substances that are generally recognized as safe
for their intended use or are regulated under this part, in accordance
with the following conditions:
(a) The microcapsules may be formulated from the following
components, 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
[[Page 38]]
good manufacturing practice, in foods for which standards of identity
established under section 401 of the Act do not preclude such use,
except that microcapsules formulated from components listed in paragraph
(a)(2) of this section may be used only for encapsulating lemon oil,
distilled lime oil, orange oil, peppermint oil, and spearmint oil for
use in dry mixes for puddings and gelatin desserts.
(c) The microcapsules produced from the components listed in
paragraphs (a) (1) and (4) of this section may be used only for
encapsulating authorized spice-flavoring substances for use, in
accordance with good manufacturing practice, in frozen pizzas which are
to be further processed by heat. Such pizzas shall bear labels or
labeling including adequate directions for use to ensure heating to
temperatures which will melt the wax to release the spice-flavoring
substances.
[45 FR 48123, July 18, 1980]
Sec. 172.235 Morpholine.
Morpholine may be safely used as a component of food, subject to the
following restrictions.
(a) It is used as the salt(s) of one or more of the fatty acids
meeting the requirements of Sec. 172.860, as a component of protective
coatings applied to fresh fruits and vegetables.
(b) It is used at a level not in excess of that reasonably required
to produce its intended effect.
Sec. 172.250 Petroleum naphtha.
Petroleum naphtha may be safely used in food in accordance with the
following conditions:
(a) The additive is a mixture of liquid hydrocarbons, essentially
paraffinic and naphthenic in nature obtained from petroleum,
(b) The additive is refined to meet the following specifications
when subjected to the procedures described in this paragraph.
(1) Boiling-point range: 175 deg.F-300 deg.F.
(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.
(3) Ultraviolet absorbance limits, as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (milli-microns) centimeter
optical
pathlength
------------------------------------------------------------------------
280-289..................................................... 0.15
290-299..................................................... .13
300-359..................................................... .08
360-400..................................................... .02
------------------------------------------------------------------------
Analytical Specification for Petroleum Naphtha
general instructions
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care to avoid contamination of petroleum naphtha
samples in handling and to assure absence of any extraneous material
arising from inadequate packaging is essential. Because some of the
polynuclear hydrocarbons sought in this test are very susceptible to
photo-oxidation, the entire procedure is to be carried out under subdued
light.
apparatus
Separatory funnels. 250-milliliter, and 2,000-milliliter capacity,
equipped with tetrafluoroethylene polymer stopcocks.
Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.
Evaporation flask. 250-milliliter capacity all-glass flask equipped
with 24/40 standard taper stopper having inlet and outlet tubes to
permit passage of nitrogen across the surface of the container liquid to
be evaporated.
Condenser. 24/40 joints, fitted with drying tube, length optional.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeters plus-minus0.005 centimeter;
also for checking spectrophotometer performance only, optical path
length in the range 1,000 centimeter plus-minus0.005
centimeter. With distilled water in the cells, determine any absorbance
difference.
Spectrophotometer. Spectral range 250-400 m with spectral
slit width of 2 m or less; under instrument operating
conditions for these absorbance measurements, the spectrophotometer
shall also meet the following performance requirements:
Absorbance repeatability, plus-minus0.01 at 0.4 absorbance.
[[Page 39]]
Absorbance accuracy, \1\ plus-minus0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949).
The accuracy is to be determined by comparison with the standard values
at 290, 345, and 400 millimicrons. The procedure is incorporated by
reference. Copies of the material incorporated by reference are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204,
or available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
---------------------------------------------------------------------------
Wavelength repeatability, plus-minus0.2 millimicron.
Wavelength accuracy, plus-minus1.0 millimicron.
Ultraviolet lamp. Long wavelength (3400-3800A deg.).
reagents
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-
milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane,
insert the head assembly, allow nitrogen gas to flow into the inlet tube
and connect the outlet tube to a solvent trap and vacuum line in such a
way as to prevent any back flow of condensate into the flask. The
contents of the flask are evaporated on a steam bath until 1 milliliter
of residue remains. Dissolve the 1 milliliter of hexadecane residue in
isooctane and make up to 25 milliliters. Determine the absorbance in a
5-centimeter path length cell compared to isooctane as reference. The
absorbance should not exceed 0.01 per centimeter path length between
280-400 m. If necessary, isooctane may be purified by passage
through a column of activated silica gel (Grade 12, Davidson Chemical
Co., Baltimore, Md., or equivalent) or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed
as with isooctane. The absorbance per centimeter of path length should
be 0.00 between 280-400 m. Methyl alcohol may be purified by
simple distillation or by refluxing in the presence of potassium
hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3
hours followed by distillation.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference between 280-
400 m. The absorbance per centimeter path length shall not
exceed 0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Sodium borohydride. 98 percent.
Water. All distilled water must be extracted with isooctane before
use. A series of three successive extracts of 1.5 liters of distilled
water with 100-milliliter portions of isooctane is satisfactory.
procedure
Determination of ultraviolet absorbance. Add a 25-milliliter aliquot
of the hydrocarbon solvent together with 1 milliliter of hexadecane to
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen,
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through
a 8plus-minus1-milliliter outer-diameter tube, drawn out into
a 2plus-minus1-centimeter long and 1plus-minus0.5-
millimeter inner-diameter capillary tip. This is positioned so that the
capillary tip extends 4 centimeters into the flask. The nitrogen flow
rate is such that the surface of the liquid is barely disturbed. After
the volume is reduced to that of the 1 milliliter of hexadecane, the
flask is left on the steam bath for 10 more minutes before removing. Add
10 milliliters of purified isooctane to the flask and reevaporate the
solution to a 1-milliliter volume in the same manner as described above,
except do not heat for an added 10 minutes. Repeat this operation twice
more. Let the flask cool.
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
[[Page 40]]
flask with an additional 6 milliliters of isooctane, swirl, and transfer
to the first separatory funnel. Shake the funnel for 1 minute. After
separation of the layers, draw off the aqueous layer and discard.
Transfer the isooctane layer to the volumetric flask and adjust the
volume to 25 milliliters of isooctane. Mix the contents well, then
transfer to the first separatory funnel and wash twice with 50-
milliliter portions of distilled water. Discard the aqueous layers after
each wash.
Determine the ultraviolet absorbance of the isooctane extract in 5-
centimeter path length cells compared to isooctane as reference between
280-400 m. Determine a reagent blank concurrently with the
sample, using 25 milliliters of purified isooctane instead of a solvent
sample and measuring the ultraviolet absorbance of the blank between
280-400m.
The reagent blank absorbance should not exceed 0.04 per centimeter
path length between 280-289 m; 0.020 between 290-359
m; and 0.010 between 360-400 m.
Determination of boiling-point range. Use ASTM method D86-82,
``Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
Determination of nonvolatile residue. For hydrocarbons boiling below
121 deg.C, determine the nonvolatile residue by ASTM method D1353-78,
``Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;'' for those
boiling above 121 deg.C, use ASTM method D381-80, ``Standard Test
Method for Existent Gum in Fuels by Jet Evaporation,'' which methods are
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) Petroleum naphtha containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. Petroleum naphtha may contain
antioxidants authorized for use in food in an amount not to exceed that
reasonably required to accomplish the intended effect or to exceed any
prescribed limitations.
(d) Petroleum naphtha is used or intended for use as a solvent in
protective coatings on fresh citrus fruit in compliance with
Sec. 172.210.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982;
49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989]
Sec. 172.255 Polyacrylamide.
Polyacrylamide containing not more than 0.2 percent of acrylamide
monomer may be safely used as a film former in the imprinting of soft-
shell gelatin capsules when the amount used is not in excess of the
minimum required to produce the intended effect.
Sec. 172.260 Oxidized polyethylene.
Oxidized polyethylene may be safely used as a component of food,
subject to the following restrictions:
(a) Oxidized polyethylene is the basic resin produced by the mild
air oxidation of polyethylene. The polyethylene used in the oxidation
process conforms to the density, maximum n-hexane extractable fraction,
and maximum xylene soluble fraction specifications prescribed in item
2.3 of the table in Sec. 177.1520(c) of this chapter. The 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
[[Page 41]]
acid, of a mixture of butyl esters produced by transesterification of an
edible vegetable oil using 1-butanol. Following sulfation, the reaction
mixture is washed with water and neutralized with aqueous sodium or
potassium hydroxide. Prior to sulfation, the butyl oleate reaction
mixture meets the following specifications:
(1) Not less than 90 percent butyl oleate.
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at a level not to
exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes
to produce raisins, whereby the residue of the additive on the raisins
does not exceed 100 parts per million.
[57 FR 12711, Apr. 13, 1992]
Sec. 172.275 Synthetic paraffin and succinic derivatives.
Synthetic paraffin and succinic derivatives identified in this
section may be safely used as a component of food, subject to the
following restrictions:
(a) The additive is prepared with 50 percent Fischer-Tropsch process
synthetic paraffin, meeting the definition and specifications of
Sec. 172.615, and 50 percent of such synthetic paraffin to which is
bonded succinic anhydride and succinic acid derivatives of isopropyl
alcohol, polyethylene glycol, and polypropylene glycol. It consists of a
mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic
anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl
succinic anhydride polyethylene glycol half ester, and dialkyl succinic
anhydride polypropylene glycol half ester, where the alkane (alkyl) has
a chain length of 30-70 carbon atoms and the polyethylene and
polypropylene glycols have molecular weights of 600 and 260,
respectively.
(b) The additive meets the following specifications: Molecular
weight, 880-930; melting point, 215 deg.-217 deg.F; acid number, 43-47;
and saponification number, 75-78.
(c) It is used or intended for use as a protective coating or
component of protective coatings for fresh grapefruit, lemons, limes,
muskmelons, oranges, sweetpotatoes, and tangerines.
(d) It is used in an amount not to exceed that required to produce
the intended effect.
Sec. 172.280 Terpene resin.
The food additive terpene resin may be safely used in accordance
with the following prescribed conditions:
(a) The food additive is the betapinene polymer obtained by
polymerizing terpene hydrocarbons derived from wood. It has a softening
point of 112 deg.C-118 deg.C, as determined by ASTM method E28-67
(Reapproved 1982), ``Standard Test Method for Softening Point By Ring-
and-Ball Apparatus,'' which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(b) It is used or intended for use as follows:
(1) As a moisture barrier on soft gelatin capsules in an amount not
to 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
[[Page 42]]
acid and nicotinamide, melting in the range 141 deg.C to 145 deg.C.
(b) It is used as a source of ascorbic acid and nicotinamide in
multivitamin preparations.
Sec. 172.320 Amino acids.
The food additive amino acids may be safely used as nutrients added
to foods in accordance with the following conditions:
(a) The food additive consists of one or more of the following
individual amino acids in the free, hydrated or anhydrous form or as the
hydrochloride, sodium or potassium salts:
L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
(b) The food additive meets the following specifications:
(1) As found in ``Food Chemicals Codex,'' National Academy of
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), which is
incorporated by reference (copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) for the following:
L-Alanine
L-Arginine
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
DL-Methionine
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine
(2) As found in ``Specifications and Criteria for Biochemical
Compounds,'' NAS/NRC Publication, 3rd Ed. (1972), which is incorporated
by reference (copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408) for the following:
L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine
(c) The additive(s) is used or intended for use to significantly
improve the biological quality of the total protein in a food containing
naturally occurring primarily-intact protein that is considered a
significant dietary protein source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes
at least 6.5 grams of naturally occurring primarily intact protein
(based upon 10 percent of the daily allowance for the ``reference''
adult male recommended by the National Academy of Sciences in
``Recommended Dietary Allowances,'' NAS Publication No. 1694, 7th Ed.
(1968), which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 200 C St. SW., Washington, DC 20204, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) The additive(s) results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
[[Page 43]]
(3) Each amino acid (or combination of the minimum number necessary
to achieve a statistically significant increase) added results in a
statistically significant increase in the PER as determined by the
method described in paragraph (d) of this section. The minimum amount of
the amino acid(s) to achieve the desired effect must be used and the
increase in PER over the primarily-intact naturally occurring protein in
the food must be substantiated as a statistically significant difference
with at least a probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purposes plus the
amount naturally present in free and combined (as protein) form does not
exceed the following levels of amino acids expressed as percent by
weight of the total protein of the finished food:
------------------------------------------------------------------------
Percent by
weight of
total
protein
(expressed
as free
amino
acid)
------------------------------------------------------------------------
L-Alanine................................................... 6.1
L-Arginine.................................................. 6.6
L-Aspartic acid (including L-asparagine).................... 7.0
L-Cystine (including L-cysteine)............................ 2.3
L-Glutamic acid (including L-glutamine)..................... 12.4
Aminoacetic acid (glycine).................................. 3.5
L-Histidine................................................. 2.4
L-Isoleucine................................................ 6.6
L-Leucine................................................... 8.8
L-Lysine.................................................... 6.4
L- and DL-Methionine........................................ 3.1
L-Phenylalanine............................................. 5.8
L-Proline................................................... 4.2
L-Serine.................................................... 8.4
L-Threonine................................................. 5.0
L-Tryptophan................................................ 1.6
L-Tyrosine.................................................. 4.3
L-Valine.................................................... 7.4
------------------------------------------------------------------------
(d) Compliance with the limitations concerning PER under paragraph
(c) of this section shall be determined by the method described in
sections 43.212-43.216, ``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408. Each manufacturer or person employing the
additive(s) under the provisions of this section shall keep and maintain
throughout the period of his use of the additive(s) and for a minimum of
3 years thereafter, records of the tests required by this paragraph and
other records required to assure effectiveness and compliance with this
regulation and shall make such records available upon request at all
reasonable hours by any officer or employee of the Food and Drug
Administration, or any other officer or employee acting on behalf of the
Secretary of Health and Human Services and shall permit such officer or
employee to conduct such inventories of raw and finished materials on
hand as he deems necessary and otherwise to check the correctness of
such records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(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
[[Page 44]]
cells of Saccharomyces cerevisiae and removal of whole cell walls by
centrifugation and separation of soluble cellular materials.
(b) The additive meets the following specifications on a dry weight
basis:
(1) Zinc salts less than 500 parts per million (ppm) as zinc.
(2) Nucleic acid less than 2 percent.
(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05
ppm mercury, and 0.3 ppm selenium.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The ingredient is used in food as a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter.
Sec. 172.330 Calcium pantothenate, calcium chloride double salt.
The food additive calcium chloride double salt of calcium
pantothenate may be safely used in foods for special dietary uses in
accordance with good manufacturing practice and under the following
prescribed conditions:
(a) The food additive is of the d (dextrorotatory) or the dl
(racemic) form.
(b) To assure safe use of the additive, the label and labeling of
the food additive container, or that of any intermediate premixes
prepared therefrom, shall bear, in addition to the other information
required by the Act, the following:
(1) The name of the additive ``calcium chloride double salt of d-
calcium pantothenate'' or ``calcium chloride double salt of dl-calcium
pantothenate'', whichever is appropriate.
(2) A statement of the appropriate concentration of the additive,
expressed as pantothenic acid.
Sec. 172.335 D-Pantothenamide.
The food additive D-pantothenamide as a source of pantothenic acid
activity, may be safely used in foods for special dietary use in an
amount not in excess of that reasonably required to produce its intended
effect.
Sec. 172.340 Fish protein isolate.
(a) The food additive fish protein isolate may be safely used as a
food supplement in accordance with the following prescribed conditions:
(1) The additive shall consist principally of dried fish protein
prepared from the edible portions of fish after removal of the heads,
fins, tails, bones, scales, viscera, and intestinal contents.
(2) The additive shall be derived only from species of bony fish
that are generally recognized by qualified scientists as safe for human
consumption and that can be processed as prescribed to meet the required
specifications.
(3) Only wholesome fresh fish otherwise suitable for human
consumption may be used. The fish shall be handled expeditiously under
sanitary conditions. These conditions shall be in accordance with
recognized good manufacturing practice for fish to be used as human
food.
(4) The additive shall be prepared by extraction with hexane and
food-grade ethanol to remove fat and moisture. Solvent residues shall be
reduced by drying.
(b) The food additive meets the following specifications: (Where
methods of determination are specified, they are Association of Official
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by
reference). \1\
---------------------------------------------------------------------------
\1\ Copies are available from: Association of Official Analytical
Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
---------------------------------------------------------------------------
(1) Protein content, as N x 6.25, shall not be less than 90
percent by weight of the final product, as determined by the method
described in section 2.057, Improved Kjeldahl Method for Nitrate-Free
Samples (20)--Official Final Action.
(2) Moisture content shall not be more than 10 percent by weight of
the final product, as determined by the method described in section
24.003, Air Drying (1)--Official First Action.
(3) Fat content shall not be more than 0.5 percent by weight of the
final
[[Page 45]]
product, as determined by the method described in section 24.005, Crude
Fat or Ether Extract--Official Final Action.
(4) Solvent residues in the final product shall not be more than 5
parts per million of hexane and 3.5 percent ethanol by weight.
[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982;
54 FR 24897, June 12, 1989]
Sec. 172.345 Folic acid (folacin).
Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate,
may be safely used in food as a nutrient in accordance with the
following prescribed conditions:
(a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
(b) Folic acid meets the specifications of the ``Food Chemicals
Codex,'' 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, 200 C St.
SW., rm. 3321, Washington, DC, or at the Office of the Federal Register,
800 North Capitol St. NW., suite 700, Washington, DC.
(c) Folic acid may be added to foods subject to a standard of
identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act (the act) when the standard of identity specifically
provides for the addition of folic acid.
(d) Folic acid may be added, at levels not to exceed 400 micrograms
(g) per serving, to breakfast cereals, as defined under
Sec. 170.3(n)(4) of this chapter, 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 g per serving if the food is a meal-
replacement that is represented for use once per day; or
(2) Two hundred g per serving if the food is a meal-
replacement that is represented for use more than once per day.
[61 FR 8807, Mar. 5, 1996, 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 46]]
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]20D:
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 Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal
[[Page 47]]
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408. Each manufacturer or person employing the additive under the
provisions of this section shall keep and maintain throughout the period
of use of the additive and for a minimum of 3 years thereafter, records
of the tests required by this paragraph and other records required to
assure effectiveness and compliance with this regulation. Those records
shall be made available upon request at all reasonable hours by any
officer or employee acting on behalf of the Secretary of Health and
Human Services. Those officers or employees shall be permitted to
conduct inventories of raw and finished materials on hand as are deemed
necessary to verify the records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the additive contained therein.
(2) The amounts of additive and each amino acid contained in any
mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) When the food additive is added as a nutrient to special dietary
foods that are intended for use solely under medical supervision to meet
nutritional requirements in specific medical conditions and these foods
comply with the requirements of part 105 of this chapter, the food
additive is exempt from the limitations in paragraphs (c)(1) through (4)
and (d) of this section and may be used in those foods at levels not to
exceed good manufacturing practices.
[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Sec. 172.375 Potassium iodide.
The food additive potassium iodide may be safely used in accordance
with the following prescribed conditions:
(a) Potassium iodide may be safely added to a food as a source of
the essential mineral iodine, provided the maximum intake of the food as
may be consumed during a period of one day, or as directed for use in
the case of a dietary supplement, will not result in daily ingestion of
the additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women.
(b) To assure safe use of the additive, in addition to the other
information required by the Act, the label of the additive shall bear:
(1) The name of the additive.
(2) A statement of the concentration of the additive in any mixture.
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
[[Page 48]]
``Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980). Protein quality shall not be less
than 100, as determined by the method described in sections 43.212-
43.216 of the AOAC. The 13th Ed. is incorporated by reference, and
copies may be obtained from the Association of Official Analytical
Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or may be examined at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(2) Moisture content shall not exceed 10 percent by weight of the
final product, as determined by the method described in section 24.003
of the AOAC. See paragraph (c)(1) of this section for availability of
the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final
product, as determined by the method described in section 24.005 of the
AOAC. See paragraph (c)(1) of the this section for availability of the
material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and
ethylene dichloride not in excess of 250 parts per million and 5 parts
per million, respectively, when used as solvents in the extraction
process.
(5) Microwave radiation meeting the requirements of Sec. 179.30 of
this chapter may be used to reduce residues of the solvents used in the
extraction process.
(6) The additive shall contain not in excess of 100 parts per
million fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic
organisms, including Salmonella, and shall have a total bacterial plate
count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish
odor and taste.
(d) When the additive is used or intended for use in the household
as a protein supplement in food for regular consumption by children up
to 8 years of age, the amount of the additive from this source shall not
exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in
manufactured food, the total fluoride content (expressed as F) of the
finished food shall not exceed 8 ppm based on the dry weight of the food
product.
(f) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive
shall bear the name ``whole fish protein concentrate''.
(2) The label or labeling of containers of the additive shall bear
adequate directions for use to comply with the limitations prescribed by
paragraphs (d) and (e) of this section.
(3) Labels of manufactured foods containing the additive shall bear,
in the ingredient statement, the name of the 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]
[[Page 49]]
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)610H2O
contains a minimum of 99 percent by weight of sodium ferrocyanide
decahydrate.
(b) The additive is used or intended for use as an anticaking agent
in salt and as an adjuvant in the production of dendritic crystals of
salt in an amount needed to produce its intended effect but not in
excess of 13 parts per million calculated as anhydrous sodium
ferrocyanide.
[42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]
Subpart F--Flavoring Agents and Related Substances
Sec. 172.510 Natural flavoring substances and natural substances used in conjunction with flavors.
Natural flavoring substances and natural adjuvants may be safely
used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended physical or technical effect and in accordance with all the
principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts,
concretes, absolutes, oils, gums, balsams, resins, oleoresins, waxes,
and distillates) they consist of one or more of the following, used
alone or in combination with flavoring substances and adjuvants
generally recognized as safe in food, previously sanctioned for such
use, or regulated in any section of this part.
[[Page 50]]
----------------------------------------------------------------------------------------------------------------
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.
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.
[[Page 51]]
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
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...........
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
[[Page 52]]
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 Association of Official
Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Sec. 172.515 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants may be safely used in
food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended effect, and otherwise in accordance with all the principles of
good manufacturing practice.
(b) They consist of one or more of the following, used alone or in
combination 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.
[[Page 53]]
Allyl hexanoate; allyl caproate.
Allyl -ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-
heptadiene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
-Amylcinnamaldehyde.
-Amylcinnamaldehyde dimethyl acetal.
-Amylcinnamyl acetate.
-Amylcinnamyl alcohol.
-Amylcinnamyl formate.
-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzophenone; diphenylketone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; -toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl -methoxyethyl
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
-Bourbonene;
1,2,3,3a,3b,4,5,6,6a,6b-deca-hydro-
l-isopropyl-3aa-methyl-6-methylene-cyclobuta
[1,2:3,4] dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-
oxatricylo [8.2.0.04, 6] dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
[[Page 54]]
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-citronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
-Decalactone; 4-hydroxy-decanoic acid, -lactone.
-Decalactone; 5-hydroxy-decanoic acid, -lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl--butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid,
-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
,-Dimethylbenzyl isobutyrate; phenyldimethylcarbinyl
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
,-Dimethylphenethyl acetate; benzylpropyl acetate;
benzyldimethylcarbinyl acetate.
,-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
,-Dimethylphenethyl butyrate; benzyldimethylcarbinyl
butyrate.
,-Dimethylphenethyl formate; benzyldimethylcarbinyl
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
-Dodecalactone; 4-hydroxydodecanoic acid -lactone.
2-Dodecenal.
Estragole.
-Ethoxybenzaldehyde.
Ethyl acetoacetate.
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl -anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
-Ethylbenzyl butyrate; -phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol diester;
cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.
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.
[[Page 55]]
Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Eugenyl methyl ether; 4-allylveratrole; methyl eugenol.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; -methoxyphenol.
Guaiacyl acetate; -methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-(-hydroxy-isopropyl)-
9,10-octahydroazulene acetate.
-Heptalactone; 4-hydroxyheptanoic acid, -lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid,
-lactone; ambrettolide.
-Hexalactone; 4-hydroxyhexanoic acid, -lactone;
tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellal; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxybenzyl acetone.
Indole.
-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-
one; 6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; -isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; -isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.
[[Page 56]]
Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
-Isobutylphenethyl alcohol; isobutyl benzyl carbinol; 4-methyl-
1-phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and 2-hexyl-2-
cyclopenten-1-one.
-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-
methyl-3-buten-2-one; methyl -ionone.
Isopropyl acetate.
-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
-Isopropylbenzyl alcohol; cuminic alcohol; -cymen-7-
ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
-Isopropylphenylacetaldehyde; -cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-(-Isopropylphenyl)-propionaldehyde; -
isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-
methylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.
Menthadienol; p-mentha-1,8(10)-dien-9-ol.
p-Mentha-1,8-dien-7-ol; perillyl alcohol.
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p-menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p-Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; -methylanisylidene acetone;
ethone.
1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
-Methylbenzyl acetate; styralyl acetate.
-Methylbenzyl alcohol; styralyl alcohol.
-Methylbenzyl butyrate; styralyl butyrate.
-Methylbenzyl isobutyrate; styralyl isobutyrate.
-Methylbenzyl formate; styralyl formate.
[[Page 57]]
-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methylcyclopentane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in
Sec. 172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl -ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-
3-one.
Methyl -ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-
3-one.
Methyl -ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-
penten-3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; -methyl-p-
isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl-3-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl -naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; -isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myrcene; 7-methyl-3-methylene-1,6-octadiene.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
-Nonalactone; 4-hydroxynonanoic acid, -lactone;
aldehyde C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.
Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo[4,4,0]-dec-1-en-3-one.
Ocimene; trans--ocimene; 3,7-dimethyl-1,3,6-octatriene.
-Octalactone; 4-hydroxyoctanoic acid, -lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.
[[Page 58]]
Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
-Pentadecalactone; 15-hydroxypentadeca-noic acid, -
lactone; pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;p-mentha-
1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
-Phellandrene; -mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; -phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; -toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; -toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde dimethyl
acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
-Pinene; 2-pinene.
-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
-Propylphenethyl alcohol.
Propyl phenylacetate.
Propyl propionate.
Pulegone; p-menth-4(8)-en-3-one.
Pyridine.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol, and .
Santalyl acetate.
Santalyl phenylacetate.
[[Page 59]]
Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
-Terpinene.
-Terpinene.
-Terpineol; p-menth-1-en-8-ol.
-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-
2-cyclohexen-1-one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methylbenzylacetone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methylhydratropic aldehyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
-Undecalactone; 4-hydroxyundecanoic acid -lactone;
peach aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.
(c) -Decalactone and -dodecalactone when used
separately or in combination in oleomargarine are used at levels not to
exceed 10 parts per million and 20 parts per million, respectively, in
accordance with Sec. 166.110 of this chapter.
(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in
flavoring substances whereby the additive does not exceed 0.5 percent of
the essential (volatile) oil content of the flavoring substance.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43
FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25,
1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR
5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21,
1989; 61 FR 14245, Apr. 1, 1996]
Sec. 172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
The food additive ``cocoa with dioctyl sodium sulfosuccinate for
manufacturing,'' conforming to Sec. 163.117 of this chapter and
Sec. 172.810, is used or intended for use as a flavoring substance in
dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate
does not exceed 75 parts per million of the finished beverage. The
labeling of the dry beverage mix shall bear adequate directions to
assure use in compliance with this section.
Sec. 172.530 Disodium guanylate.
Disodium guanylate may be safely used as a flavor enhancer in foods,
at a level not in excess of that reasonably required to produce the
intended effect.
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
[[Page 60]]
pickling spice that is added to the pickling brine.
[56 FR 6968, Feb. 21, 1991]
Sec. 172.560 Modified hop extract.
The food additive modified hop extract may be safely used in beer in
accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring
agent in the brewing of beer.
(b) The food additive is manufactured by one of the following
processes:
(1) The additive is manufactured from a hexane extract of hops by
simultaneous isomerization and selective reduction in an alkaline
aqueous medium with sodium borohydride, whereby the additive meets the
following specifications:
(i) A solution of the food additive solids is made up in
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This
absorbance is obtained by approximately 0.03 milligram solids
permilliliter.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
millimicrons; no absorption peak at 325 to 330 millimicrons; the
absorbance at 268 millimicrons does not exceed the absorbance at 272
millimicrons.
(ii) The boron content of the food additive does not exceed 310
parts per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
and methyl alcohol as solvents, followed by isomerization by potassium
carbonate treatment. Residues of solvents in the modified hop extract
shall not exceed 1.0 part per million of benzene, 1.0 part per million
of light petroleum spirits, and 250 parts per million of methyl alcohol.
The light petroleum spirits and benzene solvents shall comply with the
specifications in Sec. 172.250 except that the boiling point range for
light petroleum spirits is 150 deg.F-300 deg.F.
(3) The additive is manufactured from hops by a sequence of
extractions and fractionations, using methylene chloride, hexane, and
methyl alcohol as solvents, followed by isomerization by sodium
hydroxide treatment. Residues of the solvents in the modified hop
extract shall not exceed 5 parts per million of methylene chloride, 25
parts per million of hexane, and 100 parts per million of methyl
alcohol.
(4) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed
by isomerization by potassium carbonate treatment. Residues of solvents
in the modified hop extract shall not exceed 1.0 part per million of
benzene, 1.0 part per million of light petroleum spirits, 50 parts per
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and
1 part per million of ethyl acetate. The light petroleum spirits and
benzene solvents shall comply with the specifications in Sec. 172.250
except that the boiling point range for light petroleum spirits is 150
deg.F to 300 deg.F.
(5) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the following solvents: Ethylene
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene
chloride, trichloroethylene, and water; followed 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
[[Page 61]]
peracetic acid; isomerization by calcium chloride or magnesium chloride
treatment in ethylene dichloride, methylene chloride, or
trichloroethylene (alternatively, the hydrogenation and isomerization
steps may be performed in reverse order); and a further sequence of
extractions and fractionations using one or more of the solvents listed
in paragraph (b)(5) of this section. The additive shall meet the residue
limitations as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph
(b)(6) of this section followed by reduction with sodium borohydride in
aqueous alkaline methyl alcohol, and a sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section, and a boron content
level not in excess of 300 parts per million (0.0300 percent),
calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable
nonvolatile hop resin by an initial extraction and fractionation using
one or more of the solvents listed in paragraph (b)(5) of this section
followed by a sequence of aqueous extractions and removal of nonaqueous
solvents to less than 0.5 percent. The additive is added to the wort
before or during cooking in the manufacture of beer.
Sec. 172.575 Quinine.
Quinine, as the hydrochloride salt or sulfate salt, may be safely
used in food in accordance with the following conditions:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
In carbonated beverages as a flavor..... Not to exceed 83 parts per
million, as quinine. Label
shall bear a prominent
declaration of the presence
of quinine either by the use
of the word ``quinine'' in
the name of the article or
through a separate
declaration.
------------------------------------------------------------------------
Sec. 172.580 Safrole-free extract of sassafras.
The food additive safrole-free extract of sassafras may be safely
used in accordance with the following prescribed conditions:
(a) The additive is the aqueous extract obtained from the root bark
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
(b) It is obtained by extracting the bark with dilute alcohol, first
concentrating the alcoholic solution by vacuum distillation, then
diluting the concentrate with water and discarding the oily fraction.
(c) The purified aqueous extract is safrole-free.
(d) It is used as a flavoring in food.
Sec. 172.585 Sugar beet extract flavor base.
Sugar beet extract flavor base may be safely used in food in
accordance with the provisions of this section.
(a) Sugar beet extract flavor base is the concentrated residue of
soluble sugar beet extractives from which sugar and glutamic acid have
been recovered, and which has been subjected to ion exchange to minimize
the concentration of naturally occurring trace minerals.
(b) It is used as a flavor in food.
Sec. 172.590 Yeast-malt sprout extract.
Yeast-malt sprout extract, as described in this section, may be
safely used in food in accordance with the following prescribed
conditions:
(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.
[[Page 62]]
(b) It is used in the following foods in the minimum quantity
required to produce its intended effect as an emulsifier, stabilizer,
binder, or bodying agent: Essential oils, nonnutritive sweeteners,
flavor bases, nonstandardized dressings, and pudding mixes.
Sec. 172.615 Chewing gum base.
The food additive chewing gum base may be safely used in the
manufacture of chewing gum in accordance with the following prescribed
conditions:
(a) The food additive consists of one or more of the following
substances that meet the specifications and limitations prescribed in
this paragraph, used in amounts not to exceed those required to produce
the intended physical or other technical effect.
Masticatory Substances
natural (coagulated or concentrated latices) of vegetable origin
------------------------------------------------------------------------
Family Genus and species
------------------------------------------------------------------------
Sapotaceae:
Chicle....................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Chiquibul.................... Manilkara zapotilla Gilly.
Crown gum.................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Gutta hang kang.............. Palaquium leiocarpum Boerl. and
Palaquium oblongifolium Burck.
Massaranduba balata (and the Manilkara huberi (Ducke) Chevalier.
solvent-free resin extract
of Massaranduba balata).
Massaranduba chocolate....... Manilkara solimoesensis Gilly.
Nispero...................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Rosidinha (rosadinha)........ Micropholis (also known as Sideroxylon)
spp.
Venezuelan chicle............ Manilkara williamsii Standley and
related spp.
Apocynaceae:
Jelutong..................... Dyera costulata Hook, F. and Dyera
lowii Hook, F.
Leche caspi (sorva).......... Couma macrocarpa Barb. Rodr.
Pendare...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Perillo...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca................ Brosimum utile (H.B.K.) Pittier and
Poulsenia spp.; also Lacmellea
standleyi (Woodson), Monachino
(Apocynaceae).
Niger gutta.................. Ficus platyphylla Del.
Tunu (tuno).................. Castilla fallax Cook.
Euphorbiaceae:
Chilte....................... Cnidoscolus (also known as Jatropha)
elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet Hevea brasiliensis.
and latex solids).
------------------------------------------------------------------------
Synthetic Specifications
------------------------------------------------------------------------
Butadiene-styrene rubber..... Basic polymer.
Isobutylene-isoprene Do.
copolymer (butyl rubber).
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, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408.
Petroleum wax................ Complying with Sec. 172.886.
Petroleum wax synthetic...... Complying with Sec. 172.888.
Polyethylene................. Molecular weight 2,000-21,000.
Polyisobutylene.............. Minimum molecular weight 37,000
(Flory).
Polyvinyl acetate............ Molecular weight, minimum 2,000.
------------------------------------------------------------------------
[[Page 63]]
Plasticizing Materials (Softeners)
------------------------------------------------------------------------
Glycerol ester of partially Having an acid number of 3-8, a drop-
dimerized rosin. softening point of 109 deg.C-119
deg.C, and a color of M or paler.
Glycerol ester of partially Having an acid number of 3-10, a drop-
hydrogenated gum or wood rosin. softening point of 79 deg.C-88
deg.C, and a color of N or paler.
Glycerol ester of polymerized Having an acid number of 3-12, a
rosin. melting-point range 80 deg.C-126
deg.C, and a color of M or paler.
Glycerol ester of gum rosin.... Having an acid number of 5-9, a drop-
softening point of 88 deg.C-96
deg.C, and a color of N or paler. The
ester is purified by steam stripping.
Glycerol ester of tall oil Having an acid number of 2-12, a
rosin. softening point (ring and ball) of 80
deg.-88 deg.C, and a color of N or
paler. The ester is purified by steam
stripping.
Glycerol ester of wood rosin... Having an acid number of 3-9, a drop-
softening point of 88 deg.C-96
deg.C, and a color of N or paler. The
ester is purified by steam stripping.
Lanolin........................ .......................................
Methyl ester of rosin, Having an acid number of 4-8, a
partially hydrogenated. refractive index of 1.5170-1.5205 at
20 deg.C, and a viscosity of 23-66
poises at 25 deg.C. The ester is
purified by steam stripping.
Pentaerythritol ester of Having an acid number of 7-18, a drop-
partially hydrogenated gum or softening point of 102 deg.C-110
wood resin. deg.C, and a color of K or paler.
Pentaerythritol ester of gum or Having an acid number of 6-16, a drop-
wood rosin. softening point of 109 deg.C-116
deg.C, and a color of M or paler.
Rice bran wax.................. Complying with Sec. 172.890.
Stearic acid................... Complying with Sec. 172.860.
Sodium and potassium stearates. Complying with Sec. 172.863.
------------------------------------------------------------------------
Terpene Resins
------------------------------------------------------------------------
Synthetic resin................ Consisting of polymers of pinene, pinene, and/or
dipentene; acid value less than 5,
saponification number less than 5, and
color less than 4 on the Gardner scale
as measured in 50 percent mineral
spirit solution.
Natural resin.................. Consisting of polymers of -
pinene; softening point minimum 155
deg.C, determined by U.S.P. closed-
capillary method, United States
Pharmacopeia XX (1980) (page 961).
------------------------------------------------------------------------
Antioxidants
------------------------------------------------------------------------
Butylated hydroxyanisole....... Not to exceed antioxidant content of
0.1% when used alone or in any
combination.
Butylated hydroxytoluene....... Do.
Propyl gallate................. Do.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
Sodium sulfate................. .......................................
Sodium sulfide................. Reaction-control agent in synthetic
polymer production.
------------------------------------------------------------------------
(b) In addition to the substances listed in paragraph (a) of this
section, chewing gum base may also include substances generally
recognized as safe in food.
(c) To assure safe use of the additive, in addition to the other
information required by the act, the label and labeling of the food
additive shall bear the name of the additive, ``chewing gum base.'' As
used in this paragraph, the term ``chewing gum base'' means the
manufactured or partially manufactured nonnutritive masticatory
substance comprised of one or more of the ingredients named and so
defined in paragraph (a) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980;
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984]
Sec. 172.620 Carrageenan.
The food additive carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by
aqueous extraction from the following members of
[[Page 64]]
the families Gigartinaceae and Solieriaceae of the class Rodophyceae
(red seaweed):
Chondrus crispus.
Chondrus ocellatus.
Eucheuma cottonii.
Eucheuma spinosum.
Gigartina acicularis.
Gigartina pistillata.
Gigartina radula.
Gigartina stellata.
(b) The food additive conforms to the following conditions:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 20 percent to 40 percent on a dry-
weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, carrageenan.
Sec. 172.623 Carrageenan with polysorbate 80.
Carrageenan otherwise meeting the definition and specifications of
Sec. 172.620 (a) and (b) and salts of carrageenan otherwise meeting the
definition of Sec. 172.626(a) may be safely produced with the use of
polysorbate 80 meeting the specifications and requirements of
Sec. 172.840 (a) and (b) in accordance with the following prescribed
conditions:
(a) The polysorbate 80 is used only to facilitate separation of
sheeted carrageenan and salts of carrageenan from drying rolls.
(b) The carrageenan and salts of carrageenan contain not more than 5
percent by weight of polysorbate 80, and the final food containing the
additives contains polysorbate 80 in an amount not to exceed 500 parts
per million.
(c) The carrageenan and salts of carrageenan so produced are used
only in producing foods in gel form and only for the purposes defined in
Secs. 172.620(c) and 172.626(b), respectively.
(d) The carrageenan and salts of carrageenan so produced are not
used in foods for which standards of identity exist unless the standards
provide for the use of carrageenan, or salts of carrageenan, combined
with polysorbate 80.
(e) The carrageenan and salts of carrageenan produced in accordance
with this section, and foods containing the same, in addition to the
other requirements of the Act, are labeled to show the presence of
polysorbate 80, and the label or labeling of the carrageenan and salts
of carrageenan so produced bear adequate directions for use.
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
[[Page 65]]
for an emulsifier, stabilizer, or thickener in foods, except for those
standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, furcelleran.
Sec. 172.660 Salts of furcelleran.
The food additive salts of furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of furcelleran, meeting the
provisions of Sec. 172.655, modified by increasing the concentration of
one of the naturally occurring salts (ammonium, calcium, potassium, or
sodium) of furcelleran to the level that it is the dominant salt in the
additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the salt of furcelleran that
dominates the mixture by reason of the modification, e.g., ``sodium
furcelleran'', ``potassium furcelleran'', etc.
Sec. 172.665 Gellan gum.
The food additive gellan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a high molecular weight polysaccharide gum
produced from Pseudomonas elodea by a pure culture fermentation process
and purified by recovery with isopropyl alcohol. It is composed of
tetrasaccharide repeat units, each containing one molecule of rhamnose
and glucuronic acid, and two molecules of glucose. The glucuronic acid
is neutralized to a mixed potassium, sodium, calcium, and magnesium
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups
as the O-glycosidically linked esters.
(b) The strain of P. elodea is nonpathogenic and nontoxic in man and
animals.
(c) The additive is produced by a process that renders it free of
viable cells of P. elodea.
(d) The additive meets the following specifications:
(1) Positive for gellan gum when subjected to the following
identification tests:
(i) A 1-percent solution is made by hydrating 1 gram of gellan gum
in 99 milliliters of distilled water. The mixture is stirred for about 2
hours, using a motorized stirrer and a propeller-type stirring blade. A
small amount of the above solution is drawn into a wide 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,
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(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,
[[Page 66]]
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 to be
tested. Add the blend slowly (approximately \1/2\ minute) at the point
of maximum agitation to a stirred solution of 200 milliliters of
distilled water previously heated to 80 deg.C in a 400-milliliter
beaker. Continue mechanical stirring until the mixture is in solution,
but stir for a minimum time of 30 minutes. Do not allow the water
temperature to drop below 60 deg.C.
Set the beaker and its contents aside to cool in the absence of
agitation. Allow a minimum time of 2 hours for cooling. Examine the
cooled beaker contents for a firm rubbery gel formation after the
temperature drops below 40 deg.C.
In the event that a gel is obtained, make up a 1 percent solution of
the polysaccharide to be tested in 200 milliliters of distilled water
previously heated to 80 deg.C (omit the locust bean gum). Allow the
solution to cool without agitation as before. Formation of a gel on
cooling indicates that the sample is a gelling polysaccharide and not
xanthan gum.
Record the sample as ``positive'' for xanthan gum if a firm, rubbery
gel forms in the presence of locust bean gum but not in its absence.
Record the sample as ``negative'' for xanthan gum if no gel forms or if
a soft or brittle gel forms both with locust bean gum and in a 1 percent
solution of the sample (containing no locust bean gum).
(4) Positive for xanthan gum when subjected to the following
procedure:
Pyruvic Acid Test
Pipet 10 milliliters of an 0.6 percent solution of the
polysaccharide in distilled water (60 milligrams of water-soluble gum)
into a 50-milliliter flask equipped with a standard taper glass joint.
Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux
the mixture for 3 hours. Take precautions to avoid loss of vapor during
the refluxing. Cool the solution to room temperature. Add distilled
water to make up any weight loss from the flask contents.
Pipet 1 milliliter of a 2,4-dinitrophenylhydrazine reagent (0.5
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum)
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to
stand at room temperature for 5 minutes. Extract the mixture with 5
milliliters of ethyl acetate. Discard the aqueous layer.
Extract the hydrazone from the ethyl acetate with three 5 milliliter
portions of 10 percent sodium carbonate solution. Dilute the combined
sodium carbonate extracts to 100 milliliters with additional 10 percent
sodium carbonate in a 10-milliliter volumetric flask. Measure the
optical density of the sodium carbonate solution at 375 millimicrons.
Compare the results with a curve of the optical density versus
concentration of an authentic sample of pyruvic acid that has been run
through the procedure starting with the preparation of the hydrazone.
Record the percent by weight of pyruvic acid in the test
polysaccharide. Note ``positive'' for xanthan gum if the sample contains
more than 1.5 percent of pyruvic acid and ``negative'' for xanthan gum
if the sample
[[Page 67]]
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 added to the herbicide atrazine for application to corn.
-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of dodecylphenol (dodecyl group is a
proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of
ethylene oxide; if a blend of products is used, the average number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
Ethylene dichloride.
Polyglyceryl phthalate ester of coconut oil fatty acids.