[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2024 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 170 to 199
Revised as of April 1, 2024
Containing a codification of documents of general
applicability and future effect
As of April 1, 2024
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services (Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 613
Alphabetical List of Agencies Appearing in the CFR...... 633
List of CFR Sections Affected........................... 643
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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.
----------------------------
[[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
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evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
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To determine whether a Code volume has been amended since its
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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
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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
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PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
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for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
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This material, like any other properly issued regulation, has the force
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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
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(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
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CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Authorities
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alphabetical list of agencies publishing in the CFR are also included in
this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
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the revision dates of the 50 CFR titles.
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INQUIRIES
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available at www.ecfr.gov.
Oliver A. Potts,
Director,
Office of the Federal Register
April 1, 2024
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299, and 1300 to end.
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services.
The ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2024.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[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
[[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: Nomenclature changes to chapter I appear at 59 FR
14366, Mar. 28, 1994, and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
Part Page
170 Food additives.............................. 5
171 Food additive petitions..................... 30
172 Food additives permitted for direct addition
to food for human consumption........... 35
173 Secondary direct food additives permitted in
food for human consumption.............. 132
174 Indirect food additives: General............ 165
175 Indirect food additives: Adhesives and
components of coatings.................. 166
176 Indirect food additives: Paper and
paperboard components................... 209
177 Indirect food additives: Polymers........... 247
178 Indirect food additives: Adjuvants,
production aids, and sanitizers......... 369
179 Irradiation in the production, processing
and handling of food.................... 463
180 Food additives permitted in food or in
contact with food on an interim basis
pending additional study................ 469
181 Prior-sanctioned food ingredients........... 475
182 Substances generally recognized as safe..... 479
184 Direct food substances affirmed as generally
recognized as safe...................... 492
186 Indirect food substances affirmed as
generally recognized as safe............ 597
189 Substances prohibited from use in human food 602
190 Dietary supplements......................... 609
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191-199
[Reserved]
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SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 170_FOOD ADDITIVES--Table of Contents
Subpart A_General Provisions
Sec.
170.3 Definitions.
170.6 Opinion letters on food additive status.
170.10 Food additives in standardized foods.
170.15 Adoption of regulation on initiative of Commissioner.
170.17 Exemption for investigational use and procedure for obtaining
authorization to market edible products from experimental
animals.
170.18 Tolerances for related food additives.
170.19 Pesticide chemicals in processed foods.
Subpart B_Food Additive Safety
170.20 General principles for evaluating the safety of food additives.
170.22 Safety factors to be considered.
170.30 Eligibility for classification as generally recognized as safe
(GRAS).
170.35 Affirmation of generally recognized as safe (GRAS) status.
170.38 Determination of food additive status.
170.39 Threshold of regulation for substances used in food-contact
articles.
Subpart C_Specific Administrative Rulings and Decisions
170.45 Fluorine-containing compounds.
170.50 Glycine (aminoacetic acid) in food for human consumption.
170.60 Nitrites and/or nitrates in curing premixes.
Subpart D_Premarket Notifications
170.100 Submission of a premarket notification for a food contact
substance (FCN) to the Food and Drug Administration (FDA).
170.101 Information in a premarket notification for a food contact
substance (FCN).
170.102 Confidentiality of information in a premarket notification for a
food contact substance (FCN).
170.103 Withdrawal without prejudice of a premarket notification for a
food contact substance (FCN).
170.104 Action on a premarket notification for a food contact substance
(FCN).
170.105 The Food and Drug Administration's (FDA's) determination that a
premarket notification for a food contact substance (FCN) is
no longer effective.
170.106 Notification for a food contact substance formulation (NFCSF).
Subpart E_Generally Recognized as Safe (GRAS) Notice
170.203 Definitions.
170.205 Opportunity to submit a GRAS notice.
170.210 How to send your GRAS notice to FDA.
170.215 Incorporation into a GRAS notice.
170.220 General requirements applicable to a GRAS notice.
170.225 Part 1 of a GRAS notice: Signed statements and certification.
170.230 Part 2 of a GRAS notice: Identity, method of manufacture,
specifications, and physical or technical effect.
170.235 Part 3 of a GRAS notice: Dietary exposure.
170.240 Part 4 of a GRAS notice: Self-limiting levels of use.
170.245 Part 5 of a GRAS notice: Experience based on common use in food
before 1958.
170.250 Part 6 of a GRAS notice: Narrative.
170.255 Part 7 of a GRAS notice: List of supporting data and information
in your GRAS notice.
170.260 Steps you may take before FDA responds to your GRAS notice.
170.265 What FDA will do with a GRAS notice.
170.270 Procedures that apply when the intended conditions of use of a
notified substance include use in a product or products
subject to regulation by the Food Safety and Inspection
Service (FSIS) of the United States Department of Agriculture.
170.275 Public disclosure of a GRAS notice.
170.280 Submission of a supplement.
170.285 Disposition of pending GRAS affirmation petitions.
Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 170 appear at 66 FR
56035, Nov. 6, 2001, and 69 FR 13717, Mar. 24, 2004.
Subpart A_General Provisions
Sec. 170.3 Definitions.
For the purposes of this subchapter, the following definitions
apply:
(a) Secretary means the Secretary of Health and Human Services.
[[Page 6]]
(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. Use
of a substance in a food contact article (e.g., food-packaging or food-
processing equipment) whereby the substance migrates, or may reasonably
be expected to migrate, into food at such levels that the use has been
exempted from regulation as a food additive under Sec. 170.39, and food
contact substances used in accordance with a notification submitted
under section 409(h) of the act that is effective.
(3) A food contact substance is any substance that is intended for
use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.
(f) Common use in food means a substantial history of consumption of
a substance for food use by a significant number of consumers.
(g) The word substance in the definition of the term ``food
additive'' includes a food or food component consisting of one or more
ingredients.
(h) Scientific procedures include the application of scientific data
(including, as appropriate, data from human, animal, analytical, or
other scientific studies), information, and methods, whether published
or unpublished, as well as the application of scientific principles,
appropriate to establish the safety of a substance under the conditions
of its intended use.
(i) Safe or safety means that there is a reasonable certainty in the
minds of competent scientists that the substance is not harmful under
the conditions of its intended 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 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
[[Page 7]]
6, 1958, by the Food and Drug Administration or the United States
Department of Agriculture pursuant to the Federal Food, Drug, and
Cosmetic Act, the Poultry Products Inspection Act, or the Meat
Inspection Act.
(m) Food includes human food, substances migrating to food from
food-contact articles, pet food, and animal feed.
(n) The following general food categories are established to group
specific related foods together for the purpose of establishing
tolerances or limitations for the use of direct human food ingredients.
Individual food products will be included within these categories
according to the detailed classifications lists contained in Exhibit 33B
of the report of the National Academy of Sciences/National Research
Council report, ``A Comprehensive Survey of Industry on the Use of Food
Chemicals Generally Recognized as Safe'' (September 1972), which is
incorporated by reference. Copies are available from the National
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(1) Baked goods and baking mixes, including all ready-to-eat and
ready-to-bake products, flours, and mixes requiring preparation before
serving.
(2) Beverages, alcoholic, including malt beverages, wines, distilled
liquors, and cocktail mix.
(3) Beverages and beverage bases, nonalcoholic, including only
special or spiced teas, soft drinks, coffee substitutes, and fruit and
vegetable flavored gelatin drinks.
(4) Breakfast cereals, including ready-to-eat and instant and
regular hot cereals.
(5) Cheeses, including curd and whey cheeses, cream, natural,
grating, processed, spread, dip, and miscellaneous cheeses.
(6) Chewing gum, including all forms.
(7) Coffee and tea, including regular, decaffeinated, and instant
types.
(8) Condiments and relishes, including plain seasoning sauces and
spreads, olives, pickles, and relishes, but not spices or herbs.
(9) Confections and frostings, including candy and flavored
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple,
powdered, and raw sugars.
(10) Dairy product analogs, including nondairy milk, frozen or
liquid creamers, coffee whiteners, toppings, and other nondairy
products.
(11) Egg products, including liquid, frozen, or dried eggs, and egg
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and
frozen multicourse egg meals, but not fresh eggs.
(12) Fats and oils, including margarine, dressings for salads,
butter, salad oils, shortenings and cooking oils.
(13) Fish products, including all prepared main dishes, salads,
appetizers, frozen multicourse meals, and spreads containing fish,
shellfish, and other aquatic animals, but not fresh fish.
(14) Fresh eggs, including cooked eggs and egg dishes made only from
fresh shell eggs.
(15) Fresh fish, including only fresh and frozen fish, shellfish,
and other aquatic animals.
(16) Fresh fruits and fruit juices, including only raw fruits,
citrus, melons, and berries, and home-prepared ``ades'' and punches made
therefrom.
(17) Fresh meats, including only fresh or home-frozen beef or veal,
pork, lamb or mutton and home-prepared fresh meat-containing dishes,
salads, appetizers, or sandwich spreads made therefrom.
(18) Fresh poultry, including only fresh or home-frozen poultry and
game birds and home-prepared fresh poultry-containing dishes, salads,
appetizers, or sandwich spreads made therefrom.
(19) Fresh vegetables, tomatoes, and potatoes, including only fresh
and home-prepared vegetables.
(20) Frozen dairy desserts and mixes, including ice cream, ice
milks, sherbets, and other frozen dairy desserts and specialties.
(21) Fruit and water ices, including all frozen fruit and water
ices.
(22) Gelatins, puddings, and fillings, including flavored gelatin
desserts,
[[Page 8]]
puddings, custards, parfaits, pie fillings, and gelatin base salads.
(23) Grain products and pastas, including macaroni and noodle
products, rice dishes, and frozen multicourse meals, without meat or
vegetables.
(24) Gravies and sauces, including all meat sauces and gravies, and
tomato, milk, buttery, and specialty sauces.
(25) Hard candy and cough drops, including all hard type candies.
(26) Herbs, seeds, spices, seasonings, blends, extracts, and
flavorings, including all natural and artificial spices, blends, and
flavors.
(27) Jams and jellies, home-prepared, including only home-prepared
jams, jellies, fruit butters, preserves, and sweet spreads.
(28) Jams and jellies, commercial, including only commercially
processed jams, jellies, fruit butters, preserves, and sweet spreads.
(29) Meat products, including all meats and meat containing dishes,
salads, appetizers, frozen multicourse meat meals, and sandwich
ingredients prepared by commercial processing or using commercially
processed meats with home preparation.
(30) Milk, whole and skim, including only whole, lowfat, and skim
fluid milks.
(31) Milk products, including flavored milks and milk drinks, dry
milks, toppings, snack dips, spreads, weight control milk beverages, and
other milk origin products.
(32) Nuts and nut products, including whole or shelled tree nuts,
peanuts, coconut, and nut and peanut spreads.
(33) Plant protein products, including the National Academy of
Sciences/National Research Council ``reconstituted vegetable protein''
category, and meat, poultry, and fish substitutes, analogs, and extender
products made from plant proteins.
(34) Poultry products, including all poultry and poultry-containing
dishes, salads, appetizers, frozen multicourse poultry meals, and
sandwich ingredients prepared by commercial processing or using
commercially processed poultry with home preparation.
(35) Processed fruits and fruit juices, including all commercially
processed fruits, citrus, berries, and mixtures; salads, juices and
juice punches, concentrates, dilutions, ``ades'', and drink substitutes
made therefrom.
(36) Processed vegetables and vegetable juices, including all
commercially processed vegetables, vegetable dishes, frozen multicourse
vegetable meals, and vegetable juices and blends.
(37) Snack foods, including chips, pretzels, and other novelty
snacks.
(38) Soft candy, including candy bars, chocolates, fudge, mints, and
other chewy or nougat candies.
(39) Soups, home-prepared, including meat, fish, poultry, vegetable,
and combination home-prepared soups.
(40) Soups and soup mixes, including commercially prepared meat,
fish, poultry, vegetable, and combination soups and soup mixes.
(41) Sugar, white, granulated, including only white granulated
sugar.
(42) Sugar substitutes, including granulated, liquid, and tablet
sugar substitutes.
(43) Sweet sauces, toppings, and syrups, including chocolate, berry,
fruit, corn syrup, and maple sweet sauces and toppings.
(o) The following terms describe the physical or technical
functional effects for which direct human food ingredients may be added
to foods. They are adopted from the National Academy of Sciences/
National Research Council national survey of food industries, reported
to the Food and Drug Administration under the contract title ``A
Comprehensive Survey of Industry on the Use of Food Chemicals Generally
Recognized as Safe'' (September 1972), which is incorporated by
reference. Copies are available from the National Technical Information
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(1) Anticaking agents and free-flow agents: Substances added to
finely powdered or crystalline food products to prevent caking, lumping,
or agglomeration.
(2) Antimicrobial agents: Substances used to preserve food by
preventing
[[Page 9]]
growth of microorganisms and subsequent spoilage, including fungistats,
mold and rope inhibitors, and the effects listed by the National Academy
of Sciences/National Research Council under ``preservatives.''
(3) Antioxidants: Substances used to preserve food by retarding
deterioration, rancidity, or discoloration due to oxidation.
(4) Colors and coloring adjuncts: Substances used to impart,
preserve, or enhance the color or shading of a food, including color
stabilizers, color fixatives, color-retention agents, etc.
(5) Curing and pickling agents: Substances imparting a unique flavor
and/or color to a food, usually producing an increase in shelf life
stability.
(6) Dough strengtheners: Substances used to modify starch and
gluten, thereby producing a more stable dough, including the applicable
effects listed by the National Academy of Sciences/National Research
Council under ``dough conditioner.''
(7) Drying agents: Substances with moisture-absorbing ability, used
to maintain an environment of low moisture.
(8) Emulsifiers and emulsifier salts: Substances which modify
surface tension in the component phase of an emulsion to establish a
uniform dispersion or emulsion.
(9) Enzymes: Enzymes used to improve food processing and the quality
of the finished food.
(10) Firming agents: Substances added to precipitate residual
pectin, thus strengthening the supporting tissue and preventing its
collapse during processing.
(11) Flavor enhancers: Substances added to supplement, enhance, or
modify the original taste and/or aroma of a food, without imparting a
characteristic taste or aroma of its own.
(12) Flavoring agents and adjuvants: Substances added to impart or
help impart a taste or aroma in food.
(13) Flour treating agents: Substances added to milled flour, at the
mill, to improve its color and/or baking qualities, including bleaching
and maturing agents.
(14) Formulation aids: Substances used to promote or produce a
desired physical state or texture in food, including carriers, binders,
fillers, plasticizers, film-formers, and tableting aids, etc.
(15) Fumigants: Volatile substances used for controlling insects or
pests.
(16) Humectants: Hygroscopic substances incorporated in food to
promote retention of moisture, including moisture-retention agents and
antidusting agents.
(17) Leavening agents: Substances used to produce or stimulate
production of carbon dioxide in baked goods to impart a light texture,
including yeast, yeast foods, and calcium salts listed by the National
Academy of Sciences/National Research Council under ``dough
conditioners.''
(18) Lubricants and release agents: Substances added to food contact
surfaces to prevent ingredients and finished products from sticking to
them.
(19) Non-nutritive sweeteners: Substances having less than 2 percent
of the caloric value of sucrose per equivalent unit of sweetening
capacity.
(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
[[Page 10]]
form a soluble metal complex, to improve the quality and stability of
products.
(27) Solvents and vehicles: Substances used to extract or dissolve
another substance.
(28) Stabilizers and thickeners: Substances used to produce viscous
solutions or dispersions, to impart body, improve consistency, or
stabilize emulsions, including suspending and bodying agents, setting
agents, jellying agents, and bulking agents, etc.
(29) Surface-active agents: Substances used to modify surface
properties of liquid food components for a variety of effects, other
than emulsifiers, but including solubilizing agents, dispersants,
detergents, wetting agents, rehydration enhancers, whipping agents,
foaming agents, and defoaming agents, etc.
(30) Surface-finishing agents: Substances used to increase
palatability, preserve gloss, and inhibit discoloration of foods,
including glazes, polishes, waxes, and protective coatings.
(31) Synergists: Substances used to act or react with another food
ingredient to produce a total effect different or greater than the sum
of the effects produced by the individual ingredients.
(32) Texturizers: Substances which affect the appearance or feel of
the food.
[42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982;
53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July
17, 1995; 67 FR 35729, May 21, 2002; 81 FR 55047, Aug. 17, 2016]
Sec. 170.6 Opinion letters on food additive status.
(a) Over the years the Food and Drug Administration has given
informal written opinions to inquiries as to the safety of articles
intended for use as components of, or in contact with, food. Prior to
the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929;
Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1)
of the Federal Food, Drug, and Cosmetic Act, which reads in part: ``A
food shall be deemed to be adulterated if it bears or contains any
poisonous or deleterious substance which may render it injurious to
health''.
(b) Since enactment of the Food Additives Amendment, the Food and
Drug Administration has advised such inquirers that an article:
(1) Is a food additive within the meaning of section 201(s) of the
act; or
(2) Is generally recognized as safe (GRAS); or
(3) Has prior sanction or approval under that amendment; or
(4) Is not a food additive under the conditions of intended use.
(c) In the interest of the public health, such articles which have
been considered in the past by the Food and Drug Administration to be
safe under the provisions of section 402(a)(1), or to be generally
recognized as safe for their intended use, or to have prior sanction or
approval, or not to be food additives under the conditions of intended
use, must be reexamined in the light of current scientific information
and current principles for evaluating the safety of food additives if
their use is to be continued.
(d) Because of the time span involved, copies of many of the letters
in which the Food and Drug Administration has expressed an informal
opinion concerning the status of such articles may no longer be in the
file of the Food and Drug Administration. In the absence of information
concerning the names and uses made of all the articles referred to in
such letters, their safety of use cannot be reexamined. For this reason
all food additive status opinions of the kind described in paragraph (c)
of this section given by the Food and Drug Administration are hereby
revoked.
(e) The prior opinions of the kind described in paragraph (c) of
this section will be replaced by qualified and current opinions if the
recipient of each such letter forwards a copy of each to the Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD
20740, along with a copy of his letter of inquiry, on or before July 23,
1970.
(f) This section does not apply to food additive status opinion
letters pertaining to articles that were considered by the Food and Drug
Administration
[[Page 11]]
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;
81 FR 49896, July 29, 2016]
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]
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:
[[Page 12]]
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 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.
[[Page 13]]
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 throughout the scientific community knowledgeable about
the safety of substances directly or indirectly added to food that there
is reasonable certainty that the substance is not harmful under the
conditions of its intended use (see Sec. 170.3(i)).
(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. General recognition of
safety through scientific procedures shall be based upon the application
of generally available and accepted scientific data, information, or
methods, which ordinarily are published, as well as the application of
scientific principles, and may be corroborated by the application of
unpublished scientific data, information, or methods.
(c)(1) General recognition of safety through experience based on
common use in food prior to January 1, 1958, may be achieved without the
quantity or quality of scientific procedures required for approval of a
food additive. 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
[[Page 14]]
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 substance is safe under the conditions of its intended use within
the meaning of section 201(u) of the Federal Food, Drug, and Cosmetic
Act (see also 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 the United States. A person who
concludes that a use of a substance is GRAS through experience based on
its common use in food outside of the United States should notify FDA of
that view in accordance with subpart E of this part.
(d) The food ingredients listed as GRAS in part 182 of this chapter
or affirmed as GRAS in part 184 or part 186 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 part 186 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 based on the view that they are
GRAS under the conditions of their intended use or subject to a prior
sanction. All affirmations of GRAS status or determinations of food
additive status or prior sanction status pursuant to this review shall
be handled pursuant to Sec. Sec. 170.35, 170.38, and 180.1 of this
chapter. Affirmation of GRAS status shall be announced in part 184 or
part 186 of this chapter.
(f) [Reserved]
(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 part 186 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 part 186 of this chapter shall comply with the specifications
therein, or in the absence of such specifications, shall be of a purity
suitable for its intended use. Copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal_register/
[[Page 15]]
code_of_federal_regulations/ibr_locations.html.
(2) It performs an appropriate function in the food or food-contact
article in which it is used.
(3) It is used at a level no higher than necessary to achieve its
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its
intended purpose in that article.
(i) If a substance is affirmed as GRAS in part 184 or part 186 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 part 186 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 part 186 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 to the GRAS status of a
food ingredient in parts 182, 184, or 186 of this chapter shall be
accomplished pursuant to Sec. 170.38.
[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53
FR 16546, May 10, 1988; 81 FR 55047, Aug. 17, 2016]
Sec. 170.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, on his own initiative, may affirm that a
substance that directly or indirectly becomes a component of food is
GRAS under the conditions of its intended use.
(b)(1) If the Commissioner proposes on his own initiative that a
substance is entitled to affirmation as GRAS under the conditions of its
intended use, he will place all of the data and information on which he
relies on public file in the office of the Dockets Management Staff 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 Staff. Copies of all
comments received shall be made available for examination in the Dockets
Management Staff's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is convincing evidence that the substance is GRAS
under the conditions of its intended use as described in Sec. 170.30,
he will publish a notice in the Federal Register listing the GRAS
conditions of use of the substance in 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 a substance is GRAS
under the conditions of its intended use and that it should be
considered a food additive subject to section 409 of the Federal Food,
Drug, and Cosmetic Act, he shall publish a notice thereof in the
[[Page 16]]
Federal Register in accordance with Sec. 170.38.
(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; 81 FR 55048, Aug. 17, 2016; 88 FR
17718, Mar. 24, 2023]
Sec. 170.38 Determination of food additive status.
(a) The Commissioner may, in accordance with Sec. 170.35(b)(4),
publish a notice in the Federal Register determining that a substance is
not GRAS under the conditions of its intended use and is a food additive
subject to section 409 of the Federal Food, Drug, and Cosmetic Act.
(b)(1) The Commissioner, on his own initiative or on the petition of
any interested person, pursuant to part 10 of this chapter, may issue a
notice in the Federal Register proposing to determine that a substance
is not GRAS and is a food additive subject to section 409 of the Act.
Any petition shall include all relevant data and information of the type
described in Sec. 171.130(b). The Commissioner will place all of the
data and information on which he relies on public file in the office of
the Dockets Management Staff 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 Staff. Copies of all
comments shall be made available for examination in the Dockets
Management Staff'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; 81 FR 55048, Aug. 17, 2016; 88 FR 17718,
Mar. 24, 2023]
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
[[Page 17]]
food-processing equipment) that migrates, or that may be expected to
migrate, into food will be exempted from regulation as a food additive
because it becomes a component of food at levels that are below the
threshold of regulation if:
(1) The substance has not been shown to be a carcinogen in humans or
animals, and there is no reason, based on the chemical structure of the
substance, to suspect that the substance is a carcinogen. The substance
must also not contain a carcinogenic impurity or, if it does, must not
contain a carcinogenic impurity with a TD50 value based on
chronic feeding studies reported in the scientific literature or
otherwise available to the Food and Drug Administration of less than
6.25 milligrams per kilogram bodyweight per day (The TD50,
for the purposes of this section, is the feeding dose that causes cancer
in 50 percent of the test animals when corrected for tumors found in
control animals. If more than one TD50 value has been
reported in the scientific literature for a substance, the Food and Drug
Administration will use the lowest appropriate TD50 value in its
review.);
(2) The substance presents no other health or safety concerns
because:
(i) The use in question has been shown to result in or may be
expected to result in dietary concentrations at or below 0.5 parts per
billion, corresponding to dietary exposure levels at or below 1.5
micrograms/person/day (based on a diet of 1,500 grams of solid food and
1,500 grams of liquid food per person per day); or
(ii) The substance is currently regulated for direct addition into
food, and the dietary exposure to the substance resulting from the
proposed use is at or below 1 percent of the acceptable daily intake as
determined by safety data in the Food and Drug Administration's files or
from other appropriate sources;
(3) The substance has no technical effect in or on the food to which
it migrates; and
(4) The substance use has no significant adverse impact on the
environment.
(b) Notwithstanding paragraph (a) of this section, the Food and Drug
Administration reserves the right to decline to grant an exemption in
those cases in which available information establishes that the proposed
use may pose a public health risk. The reasons for the agency's decision
to decline to grant an exemption will be explained in the Food and Drug
Administration's response to the requestor.
(c) A request for the Food and Drug Administration to exempt a use
of a substance from regulation as a food additive shall include three
copies of the following information (If part of the submitted material
is in a foreign language, it must be accompanied by an English
translation verified to be complete and accurate in accordance with
Sec. 10.20(c)(2) of this chapter):
(1) The chemical composition of the substance for which the request
is made, including, whenever possible, the name of the chemical in
accordance with current Chemical Abstract Service (CAS) nomenclature
guidelines and a CAS registry number, if available;
(2) Detailed information on the conditions of use of the substance
(e.g., temperature, type of food with which the substance will come into
contact, the duration of the contact, and whether the food-contact
article will be for repeated or single use applications);
(3) A clear statement as to whether the request for exemption from
regulation as a food additive is based on the fact that the use of the
substance in the food-contact article results in a dietary concentration
at or below 0.5 parts per billion, or on the fact that it involves the
use of a regulated direct food additive for which the dietary exposure
is at or below 1 percent of the acceptable dietary intake (ADI);
(4) Data that will enable the Food and Drug Administration to
estimate 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
[[Page 18]]
(iii) Information on the residual level of the substance in the
food-contact article. For repeat-use articles, an estimate of the amount
of food that contacts a specific unit of surface area over the lifetime
of the article should also be provided. (In cases where data are
provided only in the form of manufacturing use levels or residual levels
of the substance present in the food-contact article, the Food and Drug
Administration will calculate a worst-case dietary concentration level
assuming 100 percent migration.) A detailed description of the
analytical method used to quantify the substance should also be
submitted along with data used to validate the detection limit.
(iv) In cases where there is no detectable migration into food or
food simulants, or when no residual level of a substance is detected in
the food-contact article by a suitable analytical method, the Food and
Drug Administration will, for the purposes of estimating the dietary
concentration, consider the validated detection limit of the method used
to analyze for the substance.
(5) The results of an analysis of existing toxicological information
on the substance and its impurities. This information on the substance
is needed to show whether an animal carcinogen bioassay has been carried
out, or whether there is some other basis for suspecting that the
substance is a carcinogen or potent toxin. This type of information on
the impurities is needed to show whether any of them are carcinogenic,
and, if carcinogenic, whether their TD50 values are greater than 6.25
milligrams per kilogram bodyweight per day in accordance with paragraph
(a)(1) of this section.
(6) Information on the environmental impact that would result from
the proposed use of the substance. The request should contain either a
claim for categorical exclusion as specified in Sec. 25.32 of this
chapter or an environmental assessment as specified in Sec. 25.40 of
this chapter.
(d) Data to be reviewed under this section shall be submitted to the
Food and Drug Administration's Office of Food Additive Safety (HFS-200),
5001 Campus Dr., College Park, MD 20740.
(e) The Food and Drug Administration will inform the requestor by
letter whether the specific food-contact application is exempt from
regulation as a food additive or not. Although a substance that migrates
to food at a level that results in a dietary concentration at or below
the threshold of regulation will not be the subject of a regulation
published in the Federal Register and will not appear in the Code of
Federal Regulations, the Food and Drug Administration will maintain a
list of substances exempted from regulation as food additives under this
section on display at the Dockets Management Staff. 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 Food Additive
Safety (HFS-200), 5001 Campus Dr., College Park, MD 20740. For actions
requiring an environmental assessment, the agency's finding of no
significant impact and the evidence supporting that finding, contained
in the petitioner's environmental assessment, also will be available for
public inspection at the Dockets Management Staff 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
[[Page 19]]
a petition to the Food and Drug Administration for reconsideration of
the decision in accordance with the provisions of Sec. 10.33 of this
chapter.
(g) If the Food and Drug Administration receives significant new
information that raises questions about the dietary concentration or the
safety of a substance that the agency has exempted from regulation, the
Food and Drug Administration may reevaluate the substance. If the Food
and Drug Administration tentatively concludes that the information that
is available about the substance no longer supports an exemption for the
use of the food-contact material from the food additive regulations, the
agency will notify any persons that requested an exemption for the
substance of its tentative decision. The requestors will be given an
opportunity to show why the use of the substance should not be regulated
under the food additive provisions of the act. If the requestors fail to
adequately respond to the new evidence, the agency will notify them that
further use of the substance in question for the particular use will
require a food additive regulation. This notification will be placed on
public display at the Dockets Management Staff 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 Food
Additive Safety (HFS-200), 5001 Campus Dr., College Park, MD 20740.
Interested persons are encouraged to obtain specific guidance from the
Food and Drug Administration on the appropriate protocols to be used for
obtaining migration data, on the validation of the analytical methods
used to quantify migration levels, on the procedures used to relate
migration data to dietary exposures, and on any other issue not
specifically covered in the Food and Drug Administration's guidance
documents.
[60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997;
65 FR 56479, Sept. 19, 2000; 81 FR 49896, July 29, 2016; 88 FR 17718,
Mar. 24, 2023]
Subpart C_Specific Administrative Rulings and Decisions
Sec. 170.45 Fluorine-containing compounds.
The Commissioner of Food and Drugs has concluded that it is in the
interest of the public health to limit the addition of fluorine
compounds to foods (a) to that resulting from the fluoridation of public
water supplies, (b) to that resulting from the fluoridation of bottled
water within the limitation established in Sec. 165.110(d) of this
chapter, and (c) to that authorized by regulations (40 CFR part 180)
under section 408 of the Act.
[42 FR 14483, Mar. 15, 1977, as amended at 72 FR 10357 Mar. 8, 2007]
Sec. 170.50 Glycine (aminoacetic acid) in food for human consumption.
(a) Heretofore, the Food and Drug Administration has expressed the
opinion in trade correspondence that glycine is generally recognized as
safe for certain technical effects in human food when used in accordance
with good manufacturing practice; however:
(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
[[Page 20]]
for use in human food and all outstanding letters expressing sanction
for such use are rescinded.
(b) The Commissioner of Food and Drugs concludes that by May 8,
1971, manufacturers:
(1) Shall reformulate food products for human use to eliminate added
glycine and its salts; or
(2) Shall bring such products into compliance with an authorizing
food additive regulation. A food additive petition supported by toxicity
data is required to show that any proposed level of glycine or its salts
added to foods for human consumption will be safe.
(c) The status of glycine as generally recognized as safe for use in
animal feed, as prescribed in Sec. 582.5049 of this chapter, remains
unchanged because the additive is considered an essential nutrient in
certain animal feeds and is safe for such use under conditions of good
feeding practice.
Sec. 170.60 Nitrites and/or nitrates in curing premixes.
(a) Nitrites and/or nitrates are food additives when combined in
curing premixes with spices and/or other flavoring or seasoning
ingredients that contain or constitute a source of secondary or tertiary
amines, including but not limited to essential oils, disodium inosinate,
disodium guanylate, hydrolysates of animal or plant origin (such as
hydrolyzed vegetable protein), oleoresins of spices, soy products, and
spice extractives. Such food additives may be used only after the
establishment of an authorizing food additive regulation. A food
additive petition submitted pursuant to Sec. Sec. 171.1 and 171.100 of
this chapter, supported by data demonstrating that nitrosamines are not
formed in curing premixes containing such food additives, is required to
establish safety.
(b) Nitrites and/or nitrates, when packaged separately from
flavoring and seasoning in curing premixes, may continue to be used
under prior sanctions in the commercial curing of meat and meat products
and poultry products and in accordance with the provisions of Sec. Sec.
172.170 and 172.175 of this chapter that apply to meat curing
preparations for the home curing of meat and meat products, including
poultry and wild game. To assure safe use of such ingredients the
labeling of the premixes shall bear instructions to the user that such
separately packaged ingredients are not to be combined until just prior
to use. Encapsulating or coating some or all of the ingredients does not
constitute separate packaging.
Subpart D_Premarket Notifications
Source: 67 FR 35729, May 21, 2002, unless otherwise noted.
Sec. 170.100 Submission of a premarket notification for a food contact
substance (FCN) to the Food and Drug Administration (FDA).
(a) An FCN is effective for the food contact substance manufactured
or prepared by the manufacturer or supplier identified in the FCN
submission. If another manufacturer or supplier wishes to market the
same food contact substance for the same use, that manufacturer or
supplier must also submit an FCN to FDA.
(1) An FCN must contain all of the information described in Sec.
170.101.
(2) An FCN may incorporate by reference any information in FDA's
files provided that the manufacturer or supplier is authorized to
reference the information. The FCN must include information establishing
that the manufacturer or supplier is authorized to reference information
in FDA's files.
(3) Any material submitted in or referenced by an FCN that is in a
foreign language must be accompanied by an English translation verified
to be complete and accurate.
(b) FDA may choose not to accept an FCN for either of the following:
(1) A use of a food contact substance that is the subject of a
regulation in parts 173 through 189 of this chapter; or
(2) A use of a food contact substance that is the subject of an
exemption under the threshold of regulation process described in Sec.
170.39.
(c) A petition must be submitted under Sec. 171.1 of this chapter
to authorize the safe use of a food contact substance in either of the
following circumstances, unless FDA agrees to accept an FCN for the
proposed use.
[[Page 21]]
(1) The use of the food contact substance increases the cumulative
dietary concentration to a certain level. For a substance that is a
biocide (e.g., it is intended to exert microbial toxicity), this level
is equal to or greater than 200 parts per billion in the daily diet (0.6
milligram (mg)/person/day). For a substance that is not a biocide, this
level is equal to or greater than 1 part per million in the daily diet
(3 mg/person/day); or
(2) There exists a bioassay on the food contact substance, FDA has
not reviewed the bioassay, and the bioassay is not clearly negative for
carcinogenic effects.
(d) A manufacturer or supplier for which a notification is effective
must keep a current address on file with FDA.
(1) The current address may be either the manufacturer's (or
supplier's) address or the address of the manufacturer's (or supplier's)
agent.
(2) FDA will deliver correspondence to the manufacturer's or
supplier's current address.
Sec. 170.101 Information in a premarket notification for a food contact
substance (FCN).
An FCN must contain the following:
(a) A comprehensive discussion of the basis for the manufacturer's
or supplier's determination that the use of the food contact substance
is safe. This discussion must:
(1) Discuss all information and data submitted in the notification;
and
(2) Address any information and data that may appear to be
inconsistent with the determination that the proposed use of the food
contact substance is safe.
(b) All data and other information that form the basis of the
determination that the food contact substance is safe under the intended
conditions of use. Data must include primary biological data and
chemical data.
(c) A good laboratory practice statement for each nonclinical
laboratory study, as defined under Sec. 58.3(d) of this chapter, that
is submitted as part of the FCN, in the form of either:
(1) A signed statement that the study was conducted in compliance
with the good laboratory practice regulations under part 58 of this
chapter; or
(2) A brief signed statement listing the reason(s) that the study
was not conducted in compliance with part 58 of this chapter.
(3) Data from any study conducted after 1978 but not conducted in
compliance with part 58 of this chapter must be validated by an
independent third party prior to submission to the Food and Drug
Administration (FDA), and the report and signed certification of the
validating party must be submitted as part of the notification.
(d) Information to address FDA's responsibility under the National
Environmental Policy Act, in the form of either:
(1) A claim of categorical exclusion under Sec. 25.30 or Sec.
25.32 of this chapter; or
(2) An environmental assessment complying with Sec. 25.40 of this
chapter.
(e) A completed and signed FDA Form No. 3480.
Sec. 170.102 Confidentiality of information in a premarket notification
for a food contact substance (FCN).
(a) During the 120-day period of the Food and Drug Administration
(FDA) review of an FCN, FDA will not disclose publicly any information
in that FCN.
(b) FDA will not disclose publicly the information in an FCN that is
withdrawn prior to the completion of FDA's review.
(c) Once FDA completes its review of an FCN, the agency will make
its conclusion about the FCN publicly available. For example, if FDA
objects to a notification 90 days after the date of receipt, the agency
would make available its objection at that time.
(d) By submitting an FCN to FDA, the manufacturer or supplier waives
any claim to confidentiality of the information required to adequately
describe the food contact substance and the intended conditions of use
that are the subject of that FCN.
(e) The following data and information in an FCN are available for
public disclosure, unless extraordinary circumstances are shown, on the
121st day after receipt of the notification by
[[Page 22]]
FDA, except that no data or information are available for public
disclosure if the FCN is withdrawn under Sec. 170.103.
(1) All safety and functionality data and information submitted with
or incorporated by reference into the notification. Safety and
functionality data include all studies and tests of a food contact
substance on animals and humans and all studies and tests on a food
contact substance for establishing identity, stability, purity, potency,
performance, and usefulness.
(2) A protocol for a test or study, unless it is exempt from
disclosure under Sec. 20.61 of this chapter.
(3) A list of all ingredients contained in a food contact substance,
excluding information that is exempt from disclosure under Sec. 20.61
of this chapter. Where applicable, an ingredient list will be identified
as incomplete.
(4) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is exempt from disclosure under
Sec. 20.61 of this chapter.
(5) All correspondence and written summaries of oral discussions
relating to the notification, except information that is exempt for
disclosure under Sec. 20.61 of this chapter.
(6) All other information not subject to an exemption from
disclosure under subpart D of part 20 of this chapter.
Effective Date Note: At 89 FR 20315, Mar. 22, 2024, Sec. 170.102
was amended by revising the section heading and paragraphs (e)
introductory text and (e)(1) and (5), effective May 21, 2024. For the
convenience of the user, the added and revised text is set forth as
follows:
Sec. 170.102 Confidentiality of information related to premarket
notification for a food contact substance (FCN).
* * * * *
(e) The following data and information are available for public
disclosure, unless extraordinary circumstances are shown, on the 121st
day after receipt of the notification by FDA, except that no data or
information are available for public disclosure if the FCN is withdrawn
under Sec. 170.103; and on the date of publication in the Federal
Register of an FDA determination that an FCN is no longer effective.
(1) All safety and functionality data and information submitted with
or incorporated by reference into the notification, or submitted in
reference to an effective FCN. Safety and functionality data include all
studies and tests of a food contact substance on animals and humans and
all studies and tests on a food contact substance for establishing
identity, stability, purity, potency, performance, and usefulness.
* * * * *
(5) All correspondence and written summaries of oral discussions
relating to the notification or to FDA's determination that an FCN is no
longer effective, except information that is exempt under Sec. 20.61 of
this chapter.
* * * * *
Sec. 170.103 Withdrawal without prejudice of a premarket notification
for a food contact substance (FCN).
A manufacturer or supplier may withdraw an FCN without prejudice to
a future submission to the Food and Drug Administration (FDA) if FDA has
not completed review of the FCN. For the purpose of this section, FDA's
review is completed when FDA has allowed 120 days to pass without
objecting to the FCN or FDA has issued an objection letter.
Sec. 170.104 Action on a premarket notification for a food contact
substance (FCN).
(a) If the Food and Drug Administration (FDA) does not object to an
FCN within the 120-day period for FDA review, the FCN becomes effective.
(b) If an FCN is complete when received, the 120-day review period
begins on the date FDA receives the FCN.
(1) If any element required under Sec. 170.101 is missing from an
FCN, then FDA will not accept that FCN and FDA will send an FCN
nonacceptance letter to the manufacturer or supplier. If the
manufacturer or supplier submits the missing information before FDA
sends an FCN nonacceptance letter, the 120-day review period begins on
the date of receipt of the missing information.
(2) If FDA accepts an FCN, then FDA will acknowledge in writing its
receipt of that FCN.
(c) Objection to an FCN:
(1) If FDA objects to an FCN, then FDA will send an FCN objection
letter. The date of the letter will be the date of FDA's objection for
purposes of section 409(h)(2)(A) of the act.
[[Page 23]]
(2) If FDA objects to an FCN within the 120-day period for FDA
review, the FCN will not become effective.
(3) FDA may object to an FCN if any part of FDA's 120-day review
occurs during a period when this program is not funded as required in
section 409(h)(5) of the act.
(d) If FDA and a manufacturer or supplier agree that the notifier
may submit a food additive petition proposing the approval of the food
contact substance for the use in the manufacturer's or supplier's FCN,
FDA will consider that FCN to be withdrawn by the manufacturer or
supplier on the date the petition is received by FDA.
Sec. 170.105 The Food and Drug Administration's (FDA's) determination
that a premarket notification for a food contact substance (FCN) is no
longer effective.
(a) If data or other information available to FDA, including data
not submitted by the manufacturer or supplier, demonstrate that the
intended use of the food contact substance is no longer safe, FDA may
determine that the authorizing FCN is no longer effective.
(b) If FDA determines that an FCN is no longer effective, FDA will
inform the manufacturer or supplier in writing of the basis for that
determination. FDA will give the manufacturer or supplier an opportunity
to show why the FCN should continue to be effective and will specify the
time that the manufacturer or supplier will have to respond.
(c) If the manufacturer or supplier fails to respond adequately to
the safety concerns regarding the notified use, FDA will publish a
notice of its determination that the FCN is no longer effective. FDA
will publish this notice in the Federal Register, stating that a
detailed summary of the basis for FDA's determination that the FCN is no
longer effective has been placed on public display and that copies are
available upon request. The date that the notice publishes in the
Federal Register is the date on which the notification is no longer
effective.
(d) FDA's determination that an FCN is no longer effective is final
agency action subject to judicial review.
Effective Date Note: At 89 FR 20316, Mar. 22, 2024, Sec. 170.105
was revised, effective May 21, 2024. For the convenience of the user,
the added and revised text is set forth as follows:
Sec. 170.105 The Food and Drug Administration's (FDA's) determination
that a premarket notification for a food contact substance
(FCN) is no longer effective.
(a) FDA may determine that an FCN is no longer effective if:
(1) Data or other information available to FDA, including data not
submitted by the manufacturer or supplier, demonstrate that the intended
use of a food contact substance is no longer safe.
(i) FDA will inform the affected manufacturer or supplier specified
in the FCN, in writing, of FDA's concerns regarding the safety of the
intended use of the food contact substance. FDA will specify the date by
which the manufacturer or supplier must provide FDA with data or other
information to respond to FDA's safety concerns.
(ii) If the manufacturer or supplier fails, by the specified date,
to supply either the data or other information necessary to address the
safety concerns regarding the notified use or a request described in
paragraph (a)(2)(i) of this section, FDA may determine that the FCN is
no longer effective because there is no longer a basis to conclude that
the intended use is safe.
(iii) If FDA denies a request described in paragraph (a)(2)(i) of
this section, and FDA had previously informed the manufacturer or
supplier of FDA's concerns regarding the safety of the intended use of
the food contact substance as described in paragraph (a)(1)(i) of this
section, FDA may determine that an FCN is no longer effective because
there is no longer a basis to conclude that the intended use is safe.
Alternatively, FDA may provide the manufacturer or supplier with
additional time to provide FDA with data or other information to respond
to FDA's safety concerns. If the manufacturer or supplier fails, by the
specified date, to supply the data or other information necessary to
address the safety concerns regarding the notified use, FDA may
determine that the FCN is no longer effective because there is no longer
a basis to conclude that the intended use is safe.
(2) Data or other information available to FDA demonstrate that the
manufacturer or supplier specified in the FCN has ceased or intends to
cease producing, supplying, or using a food contact substance for the
intended use. Such data or other information includes, but is not
limited to:
(i) A request from the manufacturer or supplier.
(A) The manufacturer or supplier specified in the FCN may request in
writing that FDA determine that an FCN is no longer effective on the
basis that it has ceased producing,
[[Page 24]]
supplying, or using a food contact substance for the intended food
contact use in the United States or that it intends to cease producing,
supplying, or using a food contact substance for the intended food
contact use in the United States by a specified date. The request must
include information or a basis to support the estimated date for the
food contact substance, as well as food contact articles that contain
such food contact substance, produced, supplied, or used by the
manufacturer or supplier to clear the U.S. market. FDA will notify the
manufacturer or supplier whether FDA is granting the request.
(B) If FDA grants the request, FDA may determine that the FCN is no
longer effective on the basis that the manufacturer or supplier has
ceased producing, supplying, or using a food contact substance for the
intended use in the United States or that it intends to cease producing,
supplying, or using a food contact substance for the intended food
contact use in the United States by a specified date. When such a
request is based on the intent to cease producing, supplying, or using a
food contact substance for the intended food contact use in the United
States at a future date, FDA will include in the notice described in
paragraph (b) of this section the date specified in the request as the
compliance date by which the manufacturer or supplier will cease
producing, supplying, or using the food contact substance for the
intended food contact use in the United States.
(ii) Other data or information available to FDA.
(A) If other data or information available to FDA demonstrate that a
manufacturer or supplier specified in the FCN has ceased producing,
supplying, or using a food contact substance for the intended use in the
United States, FDA will inform the affected manufacturer or supplier in
writing. FDA will include a specified time period by which the
manufacturer or supplier must respond in writing indicating whether the
manufacturer or supplier continues, or intends to continue in the
future, to produce, supply, or use a food contact substance for the
intended use in the United States.
(B) If the manufacturer or supplier fails, by the specified date, to
respond in writing indicating that the manufacturer or supplier
continues, or intends to continue in the future, to produce, supply, or
use a food contact substance for the intended use in the United States;
or if the manufacturer or supplier confirms that it has ceased
producing, supplying, or using the food contact substance for the
intended food contact use in the United States, FDA may determine that
the FCN is no longer effective.
(3) The intended use of the food contact substance identified in the
FCN is authorized by a food additive regulation.
(i) FDA will inform the manufacturer or supplier specified in the
FCN in writing that the intended use of the food contact substance
identified in the FCN is authorized by a food additive regulation. FDA
will include a specified time period by which the manufacturer or
supplier must respond to FDA with data or other information about
whether the food contact substance and its intended use meet the
identity limitations and specifications authorized by the cited food
additive regulation.
(ii) If a manufacturer or supplier fails, by the specified date, to
supply data or other information that demonstrates that the intended use
of the food contact substance identified in the FCN is not authorized by
a food additive regulation, FDA may determine that the FCN is no longer
effective on the basis that the intended use of the food contact
substance is authorized under a food additive regulation.
(4) The intended use of the food contact substance identified in the
FCN is the subject of an issued threshold of regulation exemption.
(i) FDA will inform the manufacturer or supplier specified in the
authorizing FCN in writing that the intended use of the food contact
substance identified in the FCN is the subject of an issued threshold of
regulation exemption. FDA will include a specified time period by which
the manufacturer or supplier must respond to FDA with data or other
information about whether the food contact substance and its intended
use meet the identity limitations and specifications listed in the cited
threshold of regulation exemption.
(ii) If a manufacturer or supplier fails, by the specified date, to
supply data or other information that demonstrates that the intended use
of the food contact substance identified in the FCN is not exempt
through an issued threshold of regulation exemption, FDA may determine
that the FCN is no longer effective on the basis that the intended use
of the food contact substance is the subject of an issued threshold of
regulation exemption.
(b) If FDA determines that an FCN is no longer effective, FDA will
publish a notice of its determination in the Federal Register, stating
that a detailed summary of the basis for FDA's determination that the
FCN is no longer effective has been placed on public display and that
copies are available upon request. If FDA determines it would be
protective of public health, FDA may include a separate compliance date
for the use of the food contact substance in food contact articles,
including food contact substances that were produced, supplied, or used
by the manufacturer or supplier before publication of the notice in the
Federal Register or before the compliance date described in paragraph
(a)(2)(i)(B) of this section. The date
[[Page 25]]
that the notice publishes in the Federal Register is the date on which
the notification is no longer effective. FDA's determination that an FCN
is no longer effective is final Agency action subject to judicial
review.
(c) FDA's determination that an FCN is no longer effective does not
preclude any manufacturer or supplier from submitting a new FCN for the
same food contact substance, including for the same intended use, after
FDA has determined that an FCN is no longer effective, unless the
intended use of the food contact substance is authorized by a food
additive regulation or the subject of an issued threshold of regulation
exemption. The new submission must be made under Sec. Sec. 170.100 and
170.101.
Sec. 170.106 Notification for a food contact substance formulation
(NFCSF).
(a) In order for the Food and Drug Administration (FDA) to accept an
NFCSF, any food additive that is a component of the formulation must be
authorized for its intended use in that NFCSF.
(b) FDA may publish a notice in the Federal Register stating that
the agency has insufficient resources to review NFCSFs. From the date
that this notice publishes in the Federal Register, FDA will no longer
accept NFCSFs.
(c) An NFCSF must contain the following:
(1) A completed and signed FDA Form No. 3479; and
(2) Any additional documentation required to establish that each
component of the formulation already may be marketed legally for its
intended use.
Subpart E_Generally Recognized as Safe (GRAS) Notice
Source: 81 FR 55048, Aug. 17, 2016, unless otherwise noted.
Sec. 170.203 Definitions.
The definitions and interpretations of terms in Sec. 170.3 apply to
such terms when used in this subpart. The following definitions also
apply:
Amendment means any data and information that you submit regarding a
filed GRAS notice before we respond to your notice by letter in
accordance with Sec. 170.265(b)(1) or cease to evaluate your notice in
accordance with Sec. 170.265(b)(3).
GRAS means generally recognized as safe.
GRAS notice means a submission that informs us of your view that a
substance is not subject to the premarket approval requirements of the
Federal Food, Drug, and Cosmetic Act based on your conclusion that the
substance is GRAS under the conditions of its intended use in accordance
with Sec. 170.30.
Notified substance means the substance that is the subject of your
GRAS notice.
Notifier means the person (e.g., an individual, partnership,
corporation, association, or other legal entity) who is responsible for
the GRAS notice, even if another person (such as an attorney, agent, or
qualified expert) prepares or submits the notice or provides an opinion
about the basis for a conclusion of GRAS status.
Qualified expert means an individual who is qualified by scientific
training and experience to evaluate the safety of substances under the
conditions of their intended use in food.
Supplement means any data and information that you submit regarding
a filed GRAS notice after we respond to your notice by letter in
accordance with Sec. 170.265(b)(1) or cease to evaluate your notice in
accordance with Sec. 170.265(b)(3).
We, our, and us refer to the United States Food and Drug
Administration (FDA).
You and your refer to a notifier.
Sec. 170.205 Opportunity to submit a GRAS notice.
Any person may notify FDA of a view that a substance is not subject
to the premarket approval requirements of section 409 of the Federal
Food, Drug, and Cosmetic Act based on that person's conclusion that the
substance is GRAS under the conditions of its intended use.
Sec. 170.210 How to send your GRAS notice to FDA.
(a) Send your GRAS notice to the Office of Food Additive Safety
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug
Administration,
[[Page 26]]
5001 Campus Dr., College Park, MD 20740.
(b) When you submit your GRAS notice, you may do so either in an
electronic format that is accessible for our evaluation or on paper. If
you send your GRAS notice on paper, a single paper copy is sufficient.
Sec. 170.215 Incorporation into a GRAS notice.
You may incorporate into your GRAS notice either specifically
identified data and information that you previously submitted to the
Center for Food Safety and Applied Nutrition (CFSAN), or specifically
identified publicly available data and information submitted by another
party, when such data and information remain in CFSAN's records, such as
data and information contained in a previous GRAS notice or a food
additive petition.
Sec. 170.220 General requirements applicable to a GRAS notice.
(a) A GRAS notice has seven parts as required by Sec. Sec. 170.225
through 170.255. You must submit the data and information specified in
each of these parts on separate pages or sets of pages.
(b) You must include each of the seven parts in your GRAS notice. If
you do not include a part, you must include with your GRAS notice an
explanation of why that part does not apply to your GRAS notice.
Sec. 170.225 Part 1 of a GRAS notice: Signed statements and
certification.
(a) Part 1 of your GRAS notice must be dated and signed by a
responsible official of your organization, or by your attorney or agent.
(b) Except as required by paragraph (c)(8) of this section, you must
not include any information that is trade secret or confidential
commercial information in Part 1 of your GRAS notice.
(c) In Part 1 of your GRAS notice, you must:
(1) Inform us that you are submitting a GRAS notice in accordance
with this subpart;
(2) Provide the name and address of your organization;
(3) Provide the name of the notified substance, using an
appropriately descriptive term;
(4) Describe the intended conditions of use of the notified
substance, including the foods in which the substance will be used, the
levels of use in such foods, and the purposes for which the substance
will be used, including, when appropriate, a description of a
subpopulation expected to consume the notified substance;
(5) Inform us of the statutory basis for your conclusion of GRAS
status (i.e., through scientific procedures in accordance with Sec.
170.30(a) and (b) or through experience based on common use in food in
accordance with Sec. 170.30(a) and (c));
(6) State your view that the notified substance is not subject to
the premarket approval requirements of the Federal Food, Drug, and
Cosmetic Act based on your conclusion that the notified substance is
GRAS under the conditions of its intended use;
(7) State that, if we ask to see the data and information that are
the basis for your conclusion of GRAS status, either during or after our
evaluation of your notice, you will:
(i) Agree to make the data and information available to us; and
(ii) Agree to both of the following procedures for making the data
and information available to us:
(A) Upon our request, you will allow us to review and copy the data
and information during customary business hours at the address you
specify for where these data and information will be available to us;
and
(B) Upon our request, you will provide us with a complete copy of
the data and information either in an electronic format that is
accessible for our evaluation or on paper;
(8) State your view as to whether any of the data and information in
Parts 2 through 7 of your GRAS notice are exempt from disclosure under
the Freedom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or
as commercial or financial information that is privileged or
confidential).
(9) Certify that, to the best of your knowledge, your GRAS notice is
a complete, representative, and balanced submission that includes
unfavorable
[[Page 27]]
information, as well as favorable information, known to you and
pertinent to the evaluation of the safety and GRAS status of the use of
the substance;
(10) State both the name and position or title of the person who
signs the GRAS notice; and
(11) When applicable, state as required by Sec. 170.270 whether
you:
(i) Authorize us to send any trade secrets to the Food Safety and
Inspection Service (FSIS) of the U.S. Department of Agriculture; or
(ii) Ask us to exclude any trade secrets from the copy of the GRAS
notice that we will send to FSIS.
Sec. 170.230 Part 2 of a GRAS notice: Identity, method of manufacture,
specifications, and physical or technical effect.
In Part 2 of your GRAS notice, you must include:
(a) Scientific data and information that identifies the notified
substance.
(1) Examples of appropriate data and information include the
chemical name, applicable registry numbers (such as a Chemical Abstracts
Service (CAS) registry number or an Enzyme Commission (EC) number),
empirical formula, structural formula, quantitative composition, and
characteristic properties.
(2) When the source of a notified substance is a biological
material, you must include data and information sufficient to identify:
(i) The taxonomic source (e.g., genus, species) including, as
applicable, data and information at the sub-species level (e.g.,
variety, strain);
(ii) The part of any plant or animal used as the source; and
(iii) Any known toxicants that could be in the source;
(b) A description of the method of manufacture of the notified
substance in sufficient detail to evaluate the safety of the notified
substance as manufactured;
(c) Specifications for food-grade material; and
(d) When necessary to demonstrate safety, relevant data and
information bearing on the physical or other technical effect the
notified substance is intended to produce, including the quantity of the
notified substance required to produce such effect.
Sec. 170.235 Part 3 of a GRAS notice: Dietary exposure.
In part 3 of your GRAS notice, you must provide data and information
about dietary exposure (i.e., the amount of relevant substances that
consumers are likely to eat or drink as part of a total diet),
regardless of whether your conclusion of GRAS status is through
scientific procedures or through experience based on common use in food,
as follows:
(a) You must provide an estimate of dietary exposure to the notified
substance that includes exposure from its intended use and all sources
in the diet; and
(b) When applicable, you must provide an estimate of dietary
exposure to any other substance that is expected to be formed in or on
food because of the use of the notified substance (e.g., hydrolytic
products or reaction products);
(c) When applicable, you must provide an estimate of dietary
exposure to any other substance that is present with the notified
substance either naturally or due to its manufacture (e.g., contaminants
or by-products);
(d) You must describe the source of any food consumption data that
you use to estimate dietary exposure in accordance with paragraphs (a)
through (c) of this section; and
(e) You must explain any assumptions you made to estimate dietary
exposure in accordance with paragraphs (a) through (c) of this section.
Sec. 170.240 Part 4 of a GRAS notice: Self-limiting levels of use.
In circumstances where the amount of the notified substance that can
be added to food is limited because food containing levels of the
notified substance above a particular level would become unpalatable or
technologically impractical, in Part 4 of your GRAS notice you must
include data and information on such self-limiting levels of use.
Sec. 170.245 Part 5 of a GRAS notice: Experience based on common use
in food before 1958.
If the statutory basis for your conclusion of GRAS status is through
experience based on common use in food,
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in Part 5 of your GRAS notice you must include evidence of a substantial
history of consumption of the notified substance for food use by a
significant number of consumers prior to January 1, 1958.
Sec. 170.250 Part 6 of a GRAS notice: Narrative.
In Part 6 of your GRAS notice, you must include a narrative that
provides the basis for your conclusion of GRAS status, in which:
(a)(1) You must explain why the data and information in your notice
provide a basis for your view that the notified substance is safe under
the conditions of its intended use. In your explanation, you must
address the safety of the notified substance, considering all dietary
sources and taking into account any chemically or pharmacologically
related substances in such diet;
(2) In your explanation, you must identify what specific data and
information that you discuss in accordance with paragraph (a)(1) of this
section are generally available, and what specific data and information
that you discuss in accordance with paragraph (a)(1) of this section are
not generally available, by providing citations to the list of data and
information that you include in Part 7 of your GRAS notice in accordance
with Sec. 170.255;
(b) You must explain how the generally available data and
information that you rely on to establish safety in accordance with
paragraph (a) of this section provide a basis for your conclusion that
the notified substance is generally recognized, among qualified experts,
to be safe under the conditions of its intended use;
(c) You must either:
(1) Identify, discuss, and place in context, data and information
that are, or may appear to be, inconsistent with your conclusion of GRAS
status, regardless of whether those data and information are generally
available; or
(2) State that you have reviewed the available data and information
and are not aware of any data and information that are, or may appear to
be, inconsistent with your conclusion of GRAS status;
(d) If you view any of the data and information in your notice as
exempt from disclosure under the Freedom of Information Act, you must
identify the specific data and information; and
(e) For non-public, safety-related data and information considered
in reaching a conclusion of GRAS status, you must explain how there
could be a basis for a conclusion of GRAS status if qualified experts do
not have access to such data and information.
Sec. 170.255 Part 7 of a GRAS notice: List of supporting data and
information in your GRAS notice.
(a) In part 7 of your GRAS notice, you must include a list of all of
the data and information that you discuss in Part 6 of your GRAS notice
to provide a basis for your view that the notified substance is safe
under the conditions of its intended use as described in accordance with
Sec. 170.250(a)(1).
(b) You must specify which data and information that you list in
accordance with paragraph (a) of this section are generally available,
and which data and information are not generally available.
Sec. 170.260 Steps you may take before FDA responds to your GRAS notice.
(a) You may submit a timely amendment to your filed GRAS notice, to
update your GRAS notice or in response to a question from us, before we
respond to your notice by letter in accordance with Sec. 170.265(b)(1)
or cease to evaluate your notice in accordance with Sec. 170.265(b)(3).
(b) At any time before we respond to your GRAS notice in accordance
with Sec. 170.265(b)(1), you may request in writing that we cease to
evaluate your GRAS notice. Your request does not preclude you from
submitting a future GRAS notice in accordance with this subpart with
respect to the notified substance.
Sec. 170.265 What FDA will do with a GRAS notice.
(a)(1) We will conduct an initial evaluation of your submission to
determine whether to file it as a GRAS notice for evaluation of your
view that the notified substance is GRAS under the conditions of its
intended use.
[[Page 29]]
(2) If we file your submission as a GRAS notice, we will send you a
letter that informs you of the date of filing.
(3) If we do not file your submission as a GRAS notice, we will send
you a letter that informs you of that fact and provides our reasons for
not filing the submission as a GRAS notice.
(4) We will consider any timely amendment that you submit to a filed
GRAS notice, to update your GRAS notice or in response to a question
from us, before we respond to you by letter in accordance with paragraph
(b)(1) of this section, if we deem that doing so is feasible within the
timeframes established in paragraph (b) of this section. If we deem that
considering your amendment is not feasible within the timeframes
established in paragraph (b) of this section or if we have granted your
request to cease to evaluate your notice, we will inform you that we are
not considering your amendment.
(b)(1) Within 180 days of filing, we will respond to you by letter
based on our evaluation of your notice. We may extend the 180 day
timeframe by 90 days on an as needed basis.
(2) If we extend the timeframe, we will inform you in writing of the
extension as soon as practicable but no later than within 180 days of
filing.
(3) If you ask us to cease to evaluate your GRAS notice in
accordance with Sec. 170.260(b), we will send you a letter informing
you of our decision regarding your request.
(c) If circumstances warrant, we will send you a subsequent letter
about the notice.
Sec. 170.270 Procedures that apply when the intended conditions of use
of a notified substance include use in a product or products subject to
regulation by
the Food Safety and Inspection Service (FSIS) of the United
States Department of Agriculture.
If the intended conditions of use of the notified substance include
use in a product or products subject to regulation by FSIS under
statutes that it administers:
(a) When applicable, you must include in your GRAS notice a
statement as to whether you:
(1) Authorize us to send any trade secrets to FSIS; or
(2) Ask us to exclude any trade secrets from the copy of the GRAS
notice that we will send to FSIS.
(b)(1) We will forward a copy of a GRAS notice or relevant portions
thereof to FSIS;
(2) We will exclude any trade secrets unless you have authorized us
to do so in accordance with paragraph (a)(1) of this section; and
(c) We will ask FSIS to advise whether the intended conditions of
use comply with applicable statutes and regulations, or, if not, whether
the use of the substance would be permitted in products under FSIS'
jurisdiction under specified conditions or restrictions.
(d) As appropriate, we will inform you of the advice we receive from
FSIS in the letter we send you in accordance with Sec. 170.265(b)(1).
Sec. 170.275 Public disclosure of a GRAS notice.
(a) The data and information in a GRAS notice (including data and
information submitted in any amendment or supplement to your GRAS notice
or incorporated into your GRAS notice) are:
(1) Considered a mandatory, rather than voluntary, submission for
purposes of their status under the Freedom of Information Act and our
public information requirements in part 20 of this chapter; and
(2) Available for public disclosure in accordance with part 20 of
this chapter as of the date that we receive your GRAS notice.
(b) We will make the following readily accessible to the public:
(1) A list of filed GRAS notices, including the information
described in Sec. 170.225(c)(2) through (c)(5);
(2) The text of any letter that we issue under Sec. 170.265(b)(1)
or (c); and
(3) The text of any letter that we issue under Sec. 170.265(b)(3)
if we grant your request that we cease to evaluate your notice.
(c) We will disclose all remaining data and information that are not
exempt from public disclosure in accordance with part 20 of this
chapter.
[[Page 30]]
Sec. 170.280 Submission of a supplement.
If circumstances warrant, you may submit a supplement to a filed
GRAS notice after we respond to your notice by letter in accordance with
Sec. 170.265(b)(1) or cease to evaluate your notice in accordance with
Sec. 170.265(b)(3).
Sec. 170.285 Disposition of pending GRAS affirmation petitions.
Because the procedure to submit a GRAS notice is replacing the
former process to submit a GRAS affirmation petition, the following will
happen to a filed GRAS affirmation petition that is pending on October
17, 2016.
(a) On October 17, 2016, we will close the docket for any GRAS
affirmation petition that is still pending as of October 17, 2016.
(b) Any person who submitted a GRAS affirmation petition described
in this section may submit a GRAS notice as described in this subpart
and request that we incorporate the GRAS affirmation petition as
described in Sec. 170.215.
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__________________________________
________________________________________________________________________
Office of Food Additive Safety (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740.
Dear Sirs:
The undersigned, __________ submits this petition pursuant to
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with
respect to __________
(Name of the food additive and proposed use)
Attached hereto, in triplicate (quadruplicate, if intended uses
include use in meat, meat food product, or poultry product), and
constituting a part of this petition are the following:
A. The name and all pertinent information concerning the food
additive, including chemical identity and composition of the food
additive, its physical, chemical, and biological properties, and
specifications prescribing the minimum content of the desired
[[Page 31]]
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.
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;
[[Page 32]]
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 semi quan ti ta tive formulas.
(3) All correspondence and written summaries of oral discussions
relating to a food additive petition are available for public disclosure
in accordance with the provisions of part 20 of this chapter when the
food additive regulation is published in the Federal Register.
(4) For purposes of this regulation, safety and functionality data
include all studies and tests of a food additive on animals and humans
and all studies and tests on a food additive for identity, stability,
purity, potency, performance, and usefulness.
[[Page 33]]
(i)(1)(i) Within 15 days after receipt, the Food and Drug
Administration will notify the petitioner of the acceptance or
nonacceptance of a petition, and if not accepted, the reasons therefor.
If accepted, the petitioner will be sent a letter stating this and the
date of the letter shall become the date of filing for the purposes of
section 409(b)(5) of the act. In cases in which the Food and Drug
Administration agrees that a premarket notification for a food contact
substance (Food Contact Notification (FCN)) submitted under section
409(h) of the act may be converted to a petition, the withdrawal date
for the FCN will be deemed the date of receipt for the petition.
(ii) If the petitioner desires, he may supplement a deficient
petition after being notified regarding deficiencies. If the
supplementary material or explanation of the petition is deemed
acceptable, the petitioner shall be notified. The date of such
notification becomes the date of filing. If the petitioner does not wish
to supplement or explain the petition and requests in writing that it be
filed as submitted, the petition shall be filed and the petitioner so
notified.
(iii) Notwithstanding paragraph (i)(1)(ii) of this section, the
petition shall not be filed if the Food and Drug Administration
determines that the use identified in the petition should be the subject
of an FCN under section 409(h) of the act rather than a petition.
(2) The Commissioner will publish in the Federal Register within 30
days from the date of filing of such petition, a notice of the filing,
the name of the petitioner, and a brief description of the proposal in
general terms. In the case of a food additive which becomes a component
of food by migration from packaging material, the notice shall include
the name of the migratory substance, and where it is different from that
of one of the original components, the name of the parent component, the
maximum quantity of the migratory substance that is proposed for use in
food, and the physical or other technical effect which the migratory
substance or its parent component is intended to have in the packaging
material. A copy of the notice will be mailed to the petitioner when the
original is forwarded to the Federal Register for publication.
(j) The Commissioner may request a full description of the methods
used in, and the facilities and controls used for, the production of the
food additive, or a sample of the food additive, articles used as
components thereof, or of the food in which the additive is proposed to
be used, at any time while a petition is under consideration. The
Commissioner shall specify in the request for a sample of the food
additive, or articles used as components thereof, or of the food in or
on which the additive is proposed to be used, a quantity deemed adequate
to permit tests of analytical methods to determine quantities of the
food additive present in foods for which it is intended to be used or
adequate for any study or investigation reasonably required with respect
to the safety of the food additive or the physical or technical effect
it produces. The date used for computing the 90-day limit for the
purposes of section 409(c)(2) of the 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
[[Page 34]]
in part 56 of this chapter, or was not subject to such requirements in
accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted
in compliance with the requirements for informed consent set forth in
part 50 of this chapter.
(n)(1) If intended uses of the food additive include uses in meat,
meat food product, or poultry product subject to regulation by the U.S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition,
forward a copy of the petition or relevant portions thereof to the Food
Safety and Inspection Service, USDA, for simultaneous review under the
PPIA and FMIA.
(2) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA, or if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977;
46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr.
26, 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR
35731, May 21, 2002; 72 FR 10357, Mar. 8, 2007; 81 FR 49896, July 29,
2016]
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 FR 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.
(c) Any petitioner who has a food additive petition pending before
the agency and who subsequently submits a premarket notification for a
food contact substance (FCN) for a use or uses described in such
petition shall be deemed to have withdrawn the petition for such use or
uses without prejudice to a future filing on the date the FCN is
received by the Food and Drug Administration.
[42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]
Sec. 171.8 Threshold of regulation for substances used in food-contact
articles.
Substances used in food-contact articles (e.g., food-packaging or
food-processing equipment) that migrate or that may be expected to
migrate into food at negligible levels may be reviewed under Sec.
170.39 of this chapter. The Food and Drug Administration will exempt
substances whose uses it determines meet the criteria in Sec. 170.39 of
this chapter from regulation as food additives and, therefore, a food
additive petition will not be required for the exempted use.
[60 FR 36596, July 17, 1995]
[[Page 35]]
Subpart B_Administrative Actions on Applications
Sec. 171.100 Regulation based on petition.
(a) The Commissioner will forward for publication in the Federal
Register, within 90 days after filing of the petition (or within 180
days if the time is extended as provided for in section 409(c)(2) of the
Act), a regulation prescribing the conditions under which the food
additive may be safely used (including, but not limited to,
specifications as to the particular food or classes of food in or on
which such additive may be used, the maximum quantity that may be used
or permitted to remain in or on such food, the manner in which such
additive may be added to or used in or on such food, and any directions
or other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and prior to the
forwarding of the order to the Federal Register for publication shall
notify the petitioner of such order and the reasons for such action; or
by order deny the petition, and shall notify the petitioner of such
order and of the reasons for such action.
(b) The regulation shall describe the conditions under which the
substance may be safely used in any meat product, meat food product, or
poultry product subject to the Federal Meat Inspection Act (FMIA) (21
U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.).
(c) If the Commissioner determines that additional time is needed to
study and investigate the petition, he shall by written notice to the
petitioner extend the 90-day period for not more than 180 days after the
filing of the petition.
[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]
Sec. 171.102 Effective date of regulation.
A regulation published in accordance with Sec. 171.100(a) shall
become effective upon publication in the Federal Register.
Sec. 171.110 Procedure for objections and hearings.
Objections and hearings relating to food additive regulations under
section 409 (c), (d), or (h) of the Act shall be governed by part 12 of
this chapter.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]
Sec. 171.130 Procedure for amending and repealing tolerances or
exemptions from tolerances.
(a) The Commissioner, on his own initiative or on the petition of
any interested person, pursuant to part 10 of this chapter, may propose
the issuance of a regulation amending or repealing a regulation
pertaining to a food additive or granting or repealing an exception for
such additive.
(b) Any such petition shall include an assertion of facts, supported
by data, showing that new information exists with respect to the food
additive or that new uses have been developed or old uses abandoned,
that new data are available as to toxicity of the chemical, or that
experience with the existing regulation or exemption may justify its
amendment or repeal. New data shall be furnished in the form specified
in Sec. Sec. 171.1 and 171.100 for submitting petitions.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION--Table of Contents
Subpart A_General Provisions
Sec.
172.5 General provisions for direct food additives.
Subpart B_Food Preservatives
172.105 Anoxomer.
172.110 BHA.
172.115 BHT.
172.120 Calcium disodium EDTA.
172.130 Dehydroacetic acid.
172.133 Dimethyl dicarbonate.
172.135 Disodium EDTA.
172.140 Ethoxyquin.
172.145 Heptylparaben.
172.150 4-Hydroxymethyl-2,6-di-tert-butyl-phenol.
[[Page 36]]
172.155 Natamycin (pimaricin).
172.160 Potassium nitrate.
172.165 Quaternary ammonium chloride combination.
172.167 Silver nitrate and hydrogen peroxide solution.
172.170 Sodium nitrate.
172.175 Sodium nitrite.
172.177 Sodium nitrite used in processing smoked chub.
172.180 Stannous chloride.
172.185 TBHQ.
172.190 THBP.
Subpart C_Coatings, Films and Related Substances
172.210 Coatings on fresh citrus fruit.
172.215 Coumarone-indene resin.
172.225 Methyl and ethyl esters of fatty acids produced from edible fats
and oils.
172.230 Microcapsules for flavoring substances.
172.235 Morpholine.
172.250 Petroleum naphtha.
172.255 Polyacrylamide.
172.260 Oxidized polyethylene.
172.270 Sulfated butyl oleate.
172.275 Synthetic paraffin and succinic derivatives.
172.280 Terpene resin.
Subpart D_Special Dietary and Nutritional Additives
172.310 Aluminum nicotinate.
172.315 Nicotinamide-ascorbic acid complex.
172.320 Amino acids.
172.325 Bakers yeast protein.
172.330 Calcium pantothenate, calcium chloride double salt.
172.335 D-Pantothenamide.
172.340 Fish protein isolate.
172.345 Folic acid (folacin).
172.350 Fumaric acid and salts of fumaric acid.
172.365 Kelp.
172.370 Iron-choline citrate complex.
172.372 N-Acetyl-L-methionine.
172.375 Potassium iodide.
172.379 Vitamin D2.
172.380 Vitamin D3.
172.381 Vitamin D2 bakers yeast.
172.382 Vitamin D2 mushroom powder.
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 rosin.
172.736 Glycerides and polyglycides of hydrogenated vegetable oils.
172.755 Stearyl monoglyceridyl citrate.
172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770 Ethylene oxide polymer.
172.775 Methacrylic acid-divinylbenzene copolymer.
172.780 Acacia (gum arabic).
172.785 Listeria-specific bacteriophage preparation.
Subpart I_Multipurpose Additives
172.800 Acesulfame potassium.
172.802 Acetone peroxides.
172.803 Advantame.
172.804 Aspartame.
172.806 Azodicarbonamide.
172.808 Copolymer condensates of ethylene oxide and propylene oxide.
172.809 Curdlan.
172.810 Dioctyl sodium sulfosuccinate.
[[Page 37]]
172.811 Glyceryl tristearate.
172.812 Glycine.
172.814 Hydroxylated lecithin.
172.816 Methyl glucoside-coconut oil ester.
172.818 Oxystearin.
172.820 Polyethylene glycol (mean molecular weight 200-9,500).
172.822 Sodium lauryl sulfate.
172.824 Sodium mono- and dimethyl naphthalene sulfonates.
172.826 Sodium stearyl fumarate.
172.828 Acetylated monoglycerides.
172.829 Neotame.
172.830 Succinylated monoglycerides.
172.831 Sucralose.
172.832 Monoglyceride citrate.
172.833 Sucrose acetate isobutyrate (SAIB).
172.834 Ethoxylated mono- and diglycerides.
172.836 Polysorbate 60.
172.838 Polysorbate 65.
172.840 Polysorbate 80.
172.841 Polydextrose.
172.842 Sorbitan monostearate.
172.844 Calcium stearoyl-2-lactylate.
172.846 Sodium stearoyl lactylate.
172.848 Lactylic esters of fatty acids.
172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
172.852 Glyceryl-lacto esters of fatty acids.
172.854 Polyglycerol esters of fatty acids.
172.856 Propylene glycol mono- and diesters of fats and fatty acids.
172.858 Propylene glycol alginate.
172.859 Sucrose fatty acid esters.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or
both oils.
172.862 Oleic acid derived from tall oil fatty acids.
172.863 Salts of fatty acids.
172.864 Synthetic fatty alcohols.
172.866 Synthetic glycerin produced by the hydrogenolysis of
carbohydrates.
172.867 Olestra.
172.868 Ethyl cellulose.
172.869 Sucrose oligoesters.
172.870 Hydroxypropyl cellulose.
172.872 Methyl ethyl cellulose.
172.874 Hydroxypropyl methylcellulose.
172.876 Castor oil.
172.878 White mineral oil.
172.880 Petrolatum.
172.882 Synthetic isoparaffinic petroleum hydrocarbons.
172.884 Odorless light petroleum hydrocarbons.
172.886 Petroleum wax.
172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.892 Food starch-modified.
172.894 Modified cottonseed products intended for human consumption.
172.896 Dried yeasts.
172.898 Bakers yeast glycan.
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 172 appear at 61 FR
14482, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27,
2001; 68 FR 15355, Mar. 31, 2003; 70 FR 40880, July 15, 2005; 70 FR
67651, Nov. 8, 2005; 70 FR 72074, Dec. 1, 2005; and 81 FR 49896, July
29, 2016.
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
[[Page 38]]
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 Office of Food
Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-1200, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(2) Molecular weight: Total monomers, dimers and trimers below 500
not more than 1 percent as determined by a method entitled ``Low
Molecular Weight Anoxomer Analysis,'' 1982, which is incorporated by
reference. Copies are available from the Office of Food Additive Safety
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200,
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(3) Phenol content: Not less than 3.2 milliequivalent/gram and not
more than 3.8 milliequivalent/gram as determined by a method entitled
``Total Phenols,'' 1982, which is incorporated by reference. Copies are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(4) Heavy metals as lead (as Pb), not more than 10 parts per
million. Arsenic (as As), not more than 3 parts per million. Mercury (as
Hg), not more than 1 part per million.
(c) Anoxomer may be safely used as an antioxidant in food at a level
of not more than 5,000 parts per million based on fat and oil content of
the food.
[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989;
88 FR 17719, Mar. 24, 2023]
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
[[Page 39]]
from the dry mixes contain no more than 2 parts per million BHA.
Sec. 172.115 BHT.
The food additive BHT (butylated hydroxytoluene), alone or in
combination with other antioxidants permitted in this subpart B may be
safely used in or on specified foods, as follows:
(a) The BHT meets the following specification: Assay (total BHT) 99
percent minimum.
(b) The BHT is used alone or in combination with BHA, as an
antioxidant in foods, as follows:
------------------------------------------------------------------------
Limitations
(total BHA
Food and BHT)
parts per
million
------------------------------------------------------------------------
Dehydrated potato shreds................................... 50
Dry breakfast cereals...................................... 50
Emulsion stabilizers for shortenings....................... 200
Potato flakes.............................................. 50
Potato granules............................................ 10
Sweetpotato flakes......................................... 50
------------------------------------------------------------------------
(c) To assure safe use of the additive:
(1) The label of any market package of the additive shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) When the additive is marketed in a suitable carrier, in addition
to meeting the requirement of paragraph (c)(1) of this section, the
label shall declare the percentage of the additive in the mixture.
Sec. 172.120 Calcium disodium EDTA.
The food additive calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate) may be safely used in designated foods for the
purposes and in accordance with the conditions prescribed, as follows:
(a) The additive contains a minimum of 99 percent by weight of
either the dihydrate
C10H12O8N2CaNa2[mi
ddot]2H2O or the trihydrate
C10H12O8N2CaNa2[mi
ddot]3H2O, or any mixture of the two.
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as the anhydrous compound:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Cabbage, pickled.................... 220 Promote color, flavor,
and texture
retention.
Canned carbonated soft drinks....... 33 Promote flavor
retention.
Canned white potatoes............... 110 Promote color
retention.
Clams (cooked canned)............... 340 Promote color
retention.
Crabmeat (cooked canned)............ 275 Retard struvite
formation; promote
color retention.
Cucumbers pickled................... 220 Promote color, flavor,
and texture
retention.
Distilled alcoholic beverages....... 25 Promote stability of
color, flavor, and/or
product clarity.
Dressings, nonstandardized.......... 75 Preservative.
Dried lima beans (cooked canned).... 310 Promote color
retention.
Egg product that is hard-cooked and \1\ 200 Preservative.
consists, in a cylindrical shape,
of egg white with an inner core of
egg yolk.
Fermented malt beverages............ 25 Antigushing agent.
French dressing..................... 75 Preservative.
Legumes (all cooked canned, other 365 Promote color
than dried lima beans, pink beans, retention.
and red beans).
Mayonnaise.......................... 75 Do.
Mushrooms (cooked canned)........... 200 Promote color
retention.
Oleomargarine....................... 75 Preservative.
Pecan pie filling................... 100 Promote color
retention.
Pink beans (cooked canned).......... 165 Promote color
retention.
Potato salad........................ 100 Preservative.
Processed dry pinto beans........... 800 Promote color
retention.
Red beans (cooked canned)........... 165 Promote color
retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
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:
[[Page 40]]
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
(c) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraph (b) of this
section, the additives are used only in compliance with the applicable
standards of identity for such foods.
[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983;
58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug.
8, 2000]
Sec. 172.130 Dehydroacetic acid.
The food additive dehydroacetic acid and/or its sodium salt may be
safely used in accordance with the following prescribed conditions:
(a) The food additive meets the following specifications:
Dehydroacetic acid: Melting point, 109 [deg]C-111 [deg]C; assay, minimum
98 percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry
basis).
(b) It is used or intended for use as a preservative for cut or
peeled squash, and is so used that no more than 65 parts per million
expressed as dehydroacetic acid remains in or on the prepared squash.
(c) The label or labeling of any package of the additive intended
for use in food shall bear adequate directions for use to insure
compliance with this section.
Sec. 172.133 Dimethyl dicarbonate.
Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive meets the following specifications:
(1) The additive has a purity of not less than 99.8 percent as
determined by the following titration method:
principles of method
Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine
with which it reacts quantitatively. The excess amine is backtitrated
with acid.
apparatus
250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, e.g., 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,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the Office of Food Additive
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and
[[Page 41]]
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200, or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(b) The additive is used or intended for use as a microbial control
agent in the following beverages under normal circumstances of bottling,
canning, or other forms of final packaging, where the viable microbial
load has been reduced to 500 microorganisms per milliliter or less by
current good manufacturing practices such as heat treatment, filtration,
or other technologies prior to the use of dimethyl dicarbonate:
(1) In wine, dealcoholized wine, and low alcohol wine in an amount
not to exceed 200 parts per million.
(2) In ready-to-drink teas in an amount not to exceed 250 parts per
million.
(3) In carbonated or noncarbonated, nonjuice-containing (less than
or equal to 1 percent juice), flavored or unflavored beverages
containing added electrolytes (5-20 milliequivalents/liter sodium ion
(Na + ) and 3-7 milliequivalents/liter potassium ion (K + )) in an
amount not to exceed 250 parts per million.
(4) In carbonated, dilute beverages containing juice, fruit flavor,
or both, with juice content not to exceed 50 percent, in an amount not
to exceed 250 parts per million.
(c) To ensure the safe use of the food additive, the label of the
package containing the additive shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The name of the additive ``dimethyl dicarbonate.''
(2) The intended use of the additive.
(3) Adequate directions for use to ensure compliance with this
section.
[53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59
FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29,
1996; 66 FR 13653, Mar. 7, 2001; 88 FR 17719, Mar. 24, 2023]
Sec. 172.135 Disodium EDTA.
The food additive disodium EDTA (disodium ethylenediaminetetraace
tate) may be safely used in designated foods for the purposes and in
accordance with the following prescribed conditions:
(a) The additive contains a minimum of 99 percent disodium
ethylenedia-minetetraacetate dihydrate
(C10H14O8N2Na2[mid
dot]2H2O).
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as anhydrous calcium disodium EDTA:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Aqueous multivitamin preparations... 150 With iron salts as a
stabilizer for
vitamin B \12\ in
liquid multivitamin
preparations.
Canned black-eyed peas.............. 145 Promote color
retention.
Canned kidney beans................. 165 Preservative.
Canned strawberry pie filling....... 500 Promote color
retention.
Cooked sausage...................... 36 As a cure accelerator
with sodium ascorbate
or ascorbic acid.
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Frozen white potatoes including cut 100 Promote color
potatoes. retention.
Gefilte fish balls or patties in \1\ 50 Inhibit discoloration.
packing medium.
Legumes (all cooked canned, other 165 Promote color
than black-eyed peas). retention.
Mayonnaise.......................... 75 Preservative.
Ready-to-eat cereal products \2\ 315 Promote color
containing dried bananas. retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
\1\ Based on total weight of finished product including packing medium.
\2\ In dried banana component of cereal product.
(2) With calcium disodium EDTA (calcium disodium ethylenediamine
tetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the
following foods at not to exceed, in combination, the levels prescribed,
calculated as anhydrous
C10H12O8N2CaNa2:
[[Page 42]]
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
(3) Alone, as a sequestrant in the nonnutritive sweeteners that are
listed in Sec. 180.37 of this chapter and that, in addition, are
designed for aqueous solution: Provided, That the amount of the
additive, calculated as anhydrous calcium disodium EDTA, does not exceed
0.1 percent by weight of the dry nonnutritive sweetener.
(c) To assure the safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraphs (b)(1) and (2) of
this section the additives are used only in compliance with the
applicable standards of identity for such foods.
[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]
Sec. 172.140 Ethoxyquin.
(a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may
be safely used as an antioxidant for preservation of color in the
production of chili powder, paprika, and ground chili at levels not in
excess of 100 parts per million.
(b) In order to provide for the safe use of the additive in feed
prepared in accordance with Sec. Sec. 573.380 and 573.400 of this
chapter, tolerances are established for residues of ethoxyquin in or on
edible products of animals as follows:
5 parts per million in or on the uncooked fat of meat from animals
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.
Sec. 172.145 Heptylparaben.
(a) The food additive heptylparaben is the chemical n-heptyl p-
hydroxybenzoate.
(b) It may be safely used to inhibit microbiological spoilage in
accordance with the following prescribed conditions:
(1) In fermented malt beverages in amounts not to exceed 12 parts
per million.
(2) In noncarbonated soft drinks and fruit-based beverages in
amounts not to exceed 20 parts per million, when standards of identity
established under section 401 of the Act (21 U.S.C. 341) do not preclude
such use.
Sec. 172.150 4-Hydroxymethyl-2,6-di-tert-butylphenol.
The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive has a solidification point of 140 [deg]C-141
[deg]C.
(b) The additive is used as an antioxidant alone or in combination
with other permitted antioxidants.
(c) The total amount of all antioxidants added to such food shall
not exceed 0.02 percent of the oil or fat content of the food, including
the essential (volatile) oil content of the food.
Sec. 172.155 Natamycin (pimaricin).
(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is
a polyene macrolide antimycotic substance possessing an empirical
formula of C33H47NO13 and a molecular
weight of 665.7.
(b) The additive shall conform to the following specifications:
Purity: 97 percent 2 percent on an anhydrous
basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.
(c) The additive may be applied on cheese, as an antimycotic, in
amounts not to exceed 20 milligrams per kilogram (20 parts per million)
in the finished product as determined by International Dairy Federation
(IDF) Standard 140A:1992, ``Cheese and Cheese
[[Page 43]]
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 Office of
Food Additive Safety (HFS-200), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-1200, or may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63
FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb. 3,
2016; 88 FR 17719, Mar. 24, 2023]
Sec. 172.160 Potassium nitrate.
The food additive potassium nitrate may be safely used as a curing
agent in the processing of cod roe, in an amount not to exceed 200 parts
per million of the finished roe.
Sec. 172.165 Quaternary ammonium chloride combination.
The food additive, quaternary ammonium chloride combination, may be
safely used in food in accordance with the following conditions:
(a) The additive contains the following compounds: n-dodecyl
dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl
dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n-
hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n-
octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n-
tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n-
tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-
29-4).
(b) The additive meets the following specifications: pH (5 percent
active solution) 7.0-8.0; total amines, maximum 1 percent as combined
free amines and amine hydrochlorides.
(c) The additive is used as an antimicrobial agent, as defined in
Sec. 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added
prior to clarification when further processing of the sugar cane juice
must be delayed.
(d) The additive is applied to the sugar juice in the following
quantities, based on the weight of the raw cane:
------------------------------------------------------------------------
Parts per
Component million
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride................ 0.25-1.0
n-Dodecyl dimethyl ethylbenzyl ammonium chloride........... 3.4-13.5
n-Hexadecyl dimethyl benzyl ammonium chloride.............. 1.5-6.0
n-Octadecyl dimethyl benzyl ammonium chloride.............. 0.25-1.0
n-Tetradecyl dimethyl benzyl ammonium chloride............. 3.0-12.0
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride........ 1.6-6.5
------------------------------------------------------------------------
[50 FR 3890, Jan. 29, 1985]
Sec. 172.167 Silver nitrate and hydrogen peroxide solution.
An aqueous solution containing a mixture of silver nitrate and
hydrogen peroxide may be safely used in accordance with the following
prescribed conditions:
(a) The additive is used as an antimicrobial agent in bottled water.
(b) Hydrogen peroxide meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 496-497, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at
[[Page 44]]
NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-
register/cfr/ibr-locations.html.
(c) The amount of silver added will not exceed 17 micrograms per
kilogram in the treated bottled water, and the amount of hydrogen
peroxide will not exceed 23 milligrams per kilogram in the treated
bottled water. Analyses for silver and hydrogen peroxide shall be
conducted on samples of treated bottled water at the site of bottling,
using samples of the water intended for treatment for the blank
determination.
(d)(1) The amount of silver in the treated bottled water is
determined using the method for silver designated in 21 CFR
165.110(b)(4)(iii)(G)(2)(i).
(2) The amount of hydrogen peroxide in the treated bottled water is
determined using a Hydrogen Peroxide Test Kit from the HACH Co., or
equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-1,
Catalog Number 22917-00, 1991, is incorporated by reference. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies of the test kit manual from the HACH Co., P.O. Box 389,
Loveland CO, 80359 (1-800-227-4224), Model HYP-1, Catalog Number 22917-
00. Copies may be examined at the Dockets Management Staff (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday,
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030 or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(e) Substances generally recognized as safe in or on food may be
used to stabilize the additive to ensure that the additive will perform
its intended technical effect.
(f) The additive may not be added to bottled water that has been
filtered or is intended to be filtered through a silver-containing water
filter.
(g) Bottled water must meet the quality standards for bottled water
in Sec. 165.110(b)(2) through (b)(5) of this chapter, including the
limits specified for total silver and nitrate, unless the water bears a
label statement of substandard quality, as provided for under Sec.
165.110(c) of this chapter.
[74 FR 11478, Mar. 18, 2009, as amended at 78 FR 71461, Nov. 29, 2013;
81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24, 2023]
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''.
[[Page 45]]
Sec. 172.175 Sodium nitrite.
The food additive sodium nitrite may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a color fixative in smoked cured tunafish products so that
the level of sodium nitrite does not exceed 10 parts per million (0.001
percent) in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad so that the level of sodium nitrite does not exceed 200 parts
per million and the level of sodium nitrate does not exceed 500 parts
per million in the finished product.
(3) As a preservative and color fixative, with sodium nitrate, in
meat-curing preparations for the home curing of meat and meat products
(including poultry and wild game), with directions for use which limit
the amount of sodium nitrite to not more than 200 parts per million in
the finished meat product, and the amount of sodium nitrate to not more
than 500 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the
additive shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any
mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product which
complies with the limitations prescribed in paragraph (a) of this
section.
(3) If in a retail package intended for household use, the label of
the additive, or of a mixture containing the additive, shall bear the
statement ``Keep out of the reach of children''.
Sec. 172.177 Sodium nitrite used in processing smoked chub.
The food additive sodium nitrite may be safely used in combination
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation
from Clostridium botulinum type E in the commercial processing of smoked
chub in accordance with the following prescribed conditions:
(a) All fish in smoking establishments shall be clean and wholesome
and shall be expeditiously processed, packed, and stored under adequate
sanitary conditions in accordance with good manufacturing practice.
(b) The brining procedure is controlled in such a manner that the
water phase portion of the edible portion of the finished smoked product
has a salt (NaCl) content of not less than 3.5 percent, as measured in
the loin muscle, and the sodium nitrite content of the edible portion of
the finished smoked product is not less than 100 parts per million and
not greater than 200 parts per million, as measured in the loin muscle.
(c) Smoked chub shall be heated by a controlled heat process which
provides a monitoring system positioned in as many strategic locations
in the smokehouse as necessary to assure a continuous temperature
throughout each fish of at least 160 [deg]F for a minimum of 30 minutes.
(d) The finished product shall be cooled to a temperature of 50
[deg]F or below within 3 hours after smoking and further cooled to a
temperature of 38 [deg]F or below within 12 hours after smoking. A
temperature of 38 [deg]F or below shall be maintained during all
subsequent 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
[[Page 46]]
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 not less than 126.5
[deg]C.
(b) The percentage of TBHQ in the food additive is not less than
99.0 percent when tested by the assay described in the Food Chemicals
Codex, 9th ed. (2014), pp. 1192-1194, which is incorporated by
reference, or an equivalent method. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address: http://www.usp.org). Copies may
be examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(c) It is used as an antioxidant alone or in combination with BHA
and/or BHT.
(d) 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.
[42 FR 14491, Mar. 15, 1977, as amended at 80 FR 34276, June 16, 2015;
88 FR 17719, Mar. 24, 2023]
Sec. 172.190 THBP.
The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely
used in food in accordance with the following prescribed conditions:
(a) The food additive has a melting point of 149 [deg]C-153 [deg]C.
(b) It is used as an antioxidant alone or in combination with other
permitted antioxidants.
(c) The total antioxidant content of a food containing the additive
will not exceed 0.02 percent of the oil or fat content of the food,
including the essential (volatile) oil content of the food.
Subpart C_Coatings, Films and Related Substances
Sec. 172.210 Coatings on fresh citrus fruit.
Coatings may be applied to fresh citrus fruit for protection of the
fruit in accordance with the following conditions:
(a) The coating is applied in the minimum amount required to
accomplish the intended effect.
(b) The coating may be formulated from the following components,
each used in the minimum quantity required to accomplish the intended
effect:
(1) Substances generally recognized as safe for the purpose or
previously sanctioned for the purpose.
(2) One or more of the following:
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Fatty acids.................... Complying with Sec. 172.860.
Oleic acid derived from tall Complying with Sec. 172.862.
oil fatty acids.
Partially hydrogenated rosin... Catalytically hydrogenated to a maximum
refractive index of 1.5012 at 100
[deg]C. Color of WG or paler.
Pentaerythritol ester of maleic Acid number of 134-145; drop-softening
anhydride-modified wood rosin. point of 127 [deg]C-173 [deg]C;
saponification number of less than
280; and a color of M or paler.
Do............................ Acid number of 176-186; drop-softening
point of 110 [deg]C-118 [deg]C;
saponification number of less than
280; and a color of M or paler.
Polyethylene glycol............ Complying with Sec. 172.820. As a
defoamer and dispersing adjuvant.
[[Page 47]]
Polyhydric alcohol diesters of Complying with Sec. 178.3770 of this
oxidatively refined chapter and having a dropping point of
(Gersthofen process) montan 77 to 83 [deg]C (170.6 to 181.4
wax acids. [deg]F), as determined by ASTM Method
D566-76 (Reapproved 1982), ``Standard
Test Method for Dropping Point of
Lubricating Grease,'' which is
incorporated by reference (Copies are
available from the American Society
for Testing and Materials, 100 Barr
Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or at the
National Archives and Records
Administration (NARA). For information
on the availability of this material
at NARA, call 202-741-6030, or go to:
http://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.) using as a
solvent xylene-ethyl alcohol in a 2:1
ratio instead of toluene-ethyl alcohol
in a 2:1 ratio.
Sodium lauryl sulfate.......... Complying with Sec. 172.822. As a
film former.
Wood rosin..................... Color of K or paler.
------------------------------------------------------------------------
(3) In lieu of the components listed in paragraph (b)(2) and (4) of
this section, the following copolymer and one or more of the listed
adjuvants.
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Vinyl chloride-vinylidene As an aqueous dispersion containing a
chloride copolymer. minimum of 75 percent water when
applied.
Polyethylene glycol............ Complying with Sec. 172.820. As a
defoamer and dispersing adjuvant.
Polyvinylpyrrolidone........... As an adjuvant.
Potassium persulfate........... Do.
Propylene glycol alginate...... Do.
Sodium decylbenzenesulfonate... Do.
------------------------------------------------------------------------
(4) In lieu of the components listed in paragraph (b)(2) and (3) of
this section, the following rosin derivative and either or both of the
listed adjuvants:
------------------------------------------------------------------------
Component Limitations
------------------------------------------------------------------------
Calcium salt of partially Having a maximum drop-softening point
dimerized rosin. of 197 [deg]C and a color of H or
paler. It is prepared by reaction with
not more than 7 parts hydrated lime
per 100 parts of partially dimerized
rosin. The partially dimerized rosin
is rosin that has been dimerized by
sulfuric acid catalyst to a drop-
softening point of 95 [deg]C to 105
[deg]C and a color of WG or paler.
Petroleum naphtha.............. As adjuvant. Complying with Sec.
172.250.
Sperm oil...................... As adjuvant.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51
FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1,
1996]
Sec. 172.215 Coumarone-indene resin.
The food additive coumarone-indene resin may be safely used on
grapefruit, lemons, limes, oranges, tangelos, and tangerines in
accordance with the following prescribed conditions:
(a) The food additive is manufactured by the polymerization of a
crude, heavy coal-tar solvent naphtha meeting the following
specifications:
(1) It is a mixture of indene, indan (hydrindene), substituted
benzenes, and related compounds.
(2) It contains no more than 0.25 percent tar bases.
(3) 95 percent distills in the range 167 [deg]C-184 [deg]C.
(b) The food additive meets the following specifications:
(1) Softening point, ring and ball: 126 [deg]C minimum as determined
by ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or
[[Page 48]]
go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(2) Refractive index (n\25\/D) 1.63-1.64.
(c) It is used or intended for use as a protective coating for
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the
maximum amount of the resin remaining on the fruit does not exceed 200
parts per million on a fresh-weight basis.
(d) To assure safe use of the additive:
(1) The label of the market package or any intermediate premix of
the additive shall bear, in addition to the other information required
by the act:
(i) The name of the additive, coumarone-indene resin.
(ii) A statement of the concentration of the additive therein.
(2) The label or accompanying labeling shall bear adequate
directions that, if followed, will result in a finished food not in
conflict with the requirements of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]
Sec. 172.225 Methyl and ethyl esters of fatty acids produced from
edible fats and oils.
Methyl esters and ethyl esters of fatty acids produced from edible
fats and oils may be safely used in food, subject to the following
prescribed conditions:
(a) The additive consists of a mixture of either methyl or ethyl
esters of fatty acids produced from edible fats and oils and meets the
following specifications:
(1) Not less than 90 percent methyl or ethyl esters of fatty acids.
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at the level not to
exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes
to produce raisins, whereby the residue of the additive on the raisins
does not exceed 200 parts per million.
[57 FR 12711, Apr. 13, 1992]
Sec. 172.230 Microcapsules for flavoring substances.
Microcapsules may be safely used for encapsulating discrete
particles of flavoring substances that are generally recognized as safe
for their intended use or are regulated under this part, in accordance
with the following conditions:
(a) The microcapsules may be formulated from the following
components, each used in the minimum quantity required to accomplish the
intended effect:
(1) Substances generally recognized as safe for the purpose.
(2) One or more of the following components:
component and limitations
Succinylated gelatin--Not to exceed 15 percent by combined weight of the
microcapsule and flavoring oil. Succinic acid content of the gelatin is
4.5 to 5.5 percent.
Arabinogalactan--Complying with Sec. 172.610; as adjuvant.
Silicon dioxide--Complying with Sec. 172.480; as adjuvant.
(3) In lieu of the components listed in paragraph (a)(2) of this
section, the following components:
component and limitations
Glutaraldehyde--As cross-linking agent for insolubilizing a coacervate
of gum arabic and gelatin.
n-Octyl alcohol--As a defoamer.
(4) In lieu of the components listed in paragraphs (a)(2) and (3) of
this section, the following component:
component and limitations
Petroleum wax--Complying with Sec. 172.886. Not to exceed 50 percent by
combined weight of the microcapsule and spice-flavoring substance.
(b) The microcapsules produced from the components listed in
paragraphs (a)(1), (2), and (3) of this section may be used for
encapsulating authorized flavoring oils for use, in accordance with good
manufacturing practice, in foods for which standards of identity
established under section 401 of the Act do not preclude such use,
except that microcapsules formulated from components listed in paragraph
(a)(2) of this section may be used only for encapsulating lemon oil,
distilled lime oil, orange oil, peppermint oil, and spearmint oil for
use in dry mixes for puddings and gelatin desserts.
(c) The microcapsules produced from the components listed in
paragraphs
[[Page 49]]
(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 0.005 centimeter;
also for checking spectrophotometer performance only, optical path
length in the range 1,000 centimeter 0.005
centimeter. With distilled water in the cells, determine any absorbance
difference.
Spectrophotometer. Spectral range 250-400 m[micro] with spectral
slit width of 2 m[micro] or less; under instrument operating conditions
for these absorbance measurements, the spectrophotometer shall also meet
the following performance requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------
\1\ As determined by procedure using potassium chromate for
reference standard and described in National Bureau of Standards
Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949).
The accuracy is to be determined by comparison with the standard values
at 290, 345, and 400 millimicrons. The procedure is incorporated by
reference. Copies of the material incorporated by reference are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
---------------------------------------------------------------------------
[[Page 50]]
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Ultraviolet lamp. Long wavelength (3400-3800A[deg]).
reagents
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-
milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane,
insert the head assembly, allow nitrogen gas to flow into the inlet tube
and connect the outlet tube to a solvent trap and vacuum line in such a
way as to prevent any back flow of condensate into the flask. The
contents of the flask are evaporated on a steam bath until 1 milliliter
of residue remains. Dissolve the 1 milliliter of hexadecane residue in
isooctane and make up to 25 milliliters. Determine the absorbance in a
5-centimeter path length cell compared to isooctane as reference. The
absorbance should not exceed 0.01 per centimeter path length between
280-400 m[micro]. If necessary, isooctane may be purified by passage
through a column of activated silica gel (Grade 12, Davidson Chemical
Co., Baltimore, Md., or equivalent) or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed
as with isooctane. The absorbance per centimeter of path length should
be 0.00 between 280-400 m[micro]. Methyl alcohol may be purified by
simple distillation or by refluxing in the presence of potassium
hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3
hours followed by distillation.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance
in a 5-centimeter cell compared to isooctane as reference between 280-
400 m[micro]. The absorbance per centimeter path length shall not exceed
0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Sodium borohydride. 98 percent.
Water. All distilled water must be extracted with isooctane before
use. A series of three successive extracts of 1.5 liters of distilled
water with 100-milliliter portions of isooctane is satisfactory.
procedure
Determination of ultraviolet absorbance. Add a 25-milliliter aliquot
of the hydrocarbon solvent together with 1 milliliter of hexadecane to
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen,
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through
a 81-milliliter outer-diameter tube, drawn out
into a 21-centimeter long and 10.5-millimeter inner-diameter capillary tip. This is
positioned so that the capillary tip extends 4 centimeters into the
flask. The nitrogen flow rate is such that the surface of the liquid is
barely disturbed. After the volume is reduced to that of the 1
milliliter of hexadecane, the flask is left on the steam bath for 10
more minutes before removing. Add 10 milliliters of purified isooctane
to the flask and reevaporate the solution to a 1-milliliter volume in
the same manner as described above, except do not heat for an added 10
minutes. Repeat this operation twice more. Let the flask cool.
Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium
borohydride. (Minimize exposure of the borohydride to the atmosphere; a
measuring dipper may be used.) Immediately fit a water-cooled condenser
equipped with a 24/40 joint and with a drying tube into the flask, mix
until the sodium borohydride is dissolved, and allow to stand for 30
minutes at room temperature, with intermittent swirling. At the end of
this time, disconnect the flask and evaporate the methyl alcohol on the
steam bath under nitrogen until sodium borohydride begins to drop out of
solution. Remove the flask and let it cool.
Add 6 milliliters of isooctane to the flask and swirl to wash the
crystalline slurry. Carefully transfer the isooctane extract to a 250-
milliliter separatory funnel. Dissolve the crystals in the flask with
about 25 milliliters of distilled water and pour this also into the
separatory funnel. Adjust the water volume in the separatory funnel to
about 100 milliliters and shake for 1 minute. After separation of the
layers, draw off the aqueous layer into a second 250-milliliter
separatory funnel. Transfer the hydrocarbon layer in the first funnel to
a 25-milliliter volumetric flask.
Carefully wash the Erlenmeyer flask with an additional 6 milliliters
of isooctane, swirl, and transfer to the second separatory funnel. Shake
the funnel for 1 minute. After separation of the layers, draw off the
aqueous layer into the first separatory funnel. Transfer the isooctane
in the second funnel to the volumetric flask. Again wash the Erlenmeyer
flask with an additional 6 milliliters of isooctane, swirl, and transfer
to the first separatory funnel. Shake the funnel for 1 minute. After
separation of the layers, draw off the aqueous layer and discard.
Transfer the isooctane layer to the volumetric flask and adjust the
volume to 25 milliliters of isooctane. Mix the contents well, then
transfer to the first separatory funnel and wash twice with 50-
milliliter portions of distilled water. Discard the aqueous layers after
each wash.
Determine the ultraviolet absorbance of the isooctane extract in 5-
centimeter path
[[Page 51]]
length cells compared to isooctane as reference between 280-400
m[micro]. Determine a reagent blank concurrently with the sample, using
25 milliliters of purified isooctane instead of a solvent sample and
measuring the ultraviolet absorbance of the blank between 280-
400m[micro].
The reagent blank absorbance should not exceed 0.04 per centimeter
path length between 280-289 m[micro]; 0.020 between 290-359 m[micro];
and 0.010 between 360-400 m[micro].
Determination of boiling-point range. Use ASTM method D86-82,
``Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be examined at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
Determination of nonvolatile residue. For hydrocarbons boiling below
121 [deg]C, determine the nonvolatile residue by ASTM method D1353-78,
``Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;'' for those
boiling above 121 [deg]C, use ASTM method D381-80, ``Standard Test
Method for Existent Gum in Fuels by Jet Evaporation,'' which methods are
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be examined at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(c) Petroleum naphtha containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. Petroleum naphtha may contain
antioxidants authorized for use in food in an amount not to exceed that
reasonably required to accomplish the intended effect or to exceed any
prescribed limitations.
(d) Petroleum naphtha is used or intended for use as a solvent in
protective coatings on fresh citrus fruit in compliance with Sec.
172.210.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982;
49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 88 FR 17719,
Mar. 24, 2023]
Sec. 172.255 Polyacrylamide.
Polyacrylamide containing not more than 0.2 percent of acrylamide
monomer may be safely used as a film former in the imprinting of soft-
shell gelatin capsules when the amount used is not in excess of the
minimum required to produce the intended effect.
Sec. 172.260 Oxidized polyethylene.
Oxidized polyethylene may be safely used as a component of food,
subject to the following restrictions:
(a) Oxidized polyethylene is the basic resin produced by the mild
air oxidation of polyethylene. The polyethylene used in the oxidation
process conforms to the density, maximum n-hexane extractable fraction,
and maximum xylene soluble fraction specifications prescribed in item
2.3 of the table in Sec. 177.1520(c) of this chapter. The oxidized
polyethylene has a minimum number average molecular weight of 1,200, as
determined by high temperature vapor pressure osmometry; contains a
maximum of 5 percent by weight of total oxygen; and has an acid value of
9 to 19.
(b) The additive is used or intended for use as a protective coating
or component of protective coatings for fresh avocados, bananas, beets,
coconuts, eggplant, garlic, grapefruit, lemons, limes, mango,
muskmelons, onions, oranges, papaya, peas (in pods), pineapple,
plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines,
turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts,
pecans, and walnuts (all nuts in shells).
(c) The additive is used in accordance with good manufacturing
practice and in an amount not to exceed that required to produce the
intended effect.
Sec. 172.270 Sulfated butyl oleate.
Sulfate butyl oleate may be safely used in food, subject to the
following prescribed conditions:
(a) The additive is prepared by sulfation, using concentrated
sulfuric acid, of a mixture of butyl esters produced by
transesterification of an edible vegetable oil using 1-butanol.
Following sulfation, the reaction mixture is washed with water and
neutralized with aqueous sodium or potassium hydroxide. Prior to
sulfation, the butyl
[[Page 52]]
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, 100 Barr
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be
examined at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(b) It is used or intended for use as follows:
(1) As a moisture barrier on soft gelatin capsules in an amount not
to exceed 0.07 percent of the weight of the capsule.
(2) As a moisture barrier on powders of ascorbic acid or its salts
in an amount not to exceed 7 percent of the weight of the powder.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984]
Subpart D_Special Dietary and Nutritional Additives
Sec. 172.310 Aluminum nicotinate.
Aluminum nicotinate may be safely used as a source of niacin in
foods for special dietary use. A statement of the concentration of the
additive, expressed as niacin, shall appear on the label of the food
additive container or on that of any intermediate premix prepared
therefrom.
Sec. 172.315 Nicotinamide-ascorbic acid complex.
Nicotinamide-ascorbic acid complex may be safely used in accordance
with the following prescribed conditions:
(a) The additive is the product of the controlled reaction between
ascorbic
[[Page 53]]
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:
(1) L-Alanine
(2) L-Arginine
(3) L-Asparagine
(4) L-Aspartic acid
(5) L-Cysteine
(6) L-Cystine
(7) L-Glutamic acid
(8) L-Glutamine
(9) Aminoacetic acid (glycine)
(10) L-Histidine
(11) L-Isoleucine
(12) L-Leucine
(13) L-Lysine
(14) DL-Methionine (not for infant foods)
(15) L-Methionine
(16) L-Phenylalanine
(17) L-Proline
(18) L-Serine
(19) L-Threonine
(20) L-Tryptophan
(21) L-Tyrosine
(22) L-Valine
(b) The food additive meets the following specifications:
(1) As found in Food Chemicals Codex:
(i) L-Alanine, pages 28 and 29.
(ii) L-Arginine, pages 69 and 70.
(iii) L-Arginine Monohydrochloride, pages 70 and 71.
(iv) L-Cysteine Monohydrochloride, pages 269 and 270.
(v) L-Cystine, pages 270 and 271.
(vi) Aminoacetic acid (glycine), pages 457 and 458.
(vii) L-Leucine, pages 577 and 578.
(viii) DL-Methionine, pages 641 and 642.
(ix) L-Methionine, pages 642 and 643.
(x) L-Tryptophan, pages 1060 and 1061.
(xi) L-Phenylalanine, pages 794 and 795.
(xii) L-Proline, pages 864 and 865.
(xiii) L-Serine, pages 915 and 916.
(xiv) L-Threonine, pages 1031 and 1032.
(xv) L-Glutamic Acid Hydrochloride, page 440.
(xvi) L-Isoleucine, pages 544 and 545.
(xvii) L-Lysine Monohydrochloride, pages 598 and 599.
(xviii) Monopotassium L-glutamate, pages 697 and 698.
(xix) L-Tyrosine, page 1061.
(xx) L-Valine, pages 1072.
(2) As found in ``Specifications and Criteria for Biochemical
Compounds,'' NAS/NRC Publication, for the following:
(i) L-Asparagine
(ii) L-Aspartic acid
(iii) L-Glutamine
(iv) 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.
(2) The additive(s) results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) Each amino acid (or combination of the minimum number necessary
to achieve a statistically significant increase) added results in a
statistically significant increase in the PER as determined by the
method described in paragraph (d) of this section. The minimum amount of
the amino acid(s) to achieve the desired effect must be used and the
increase in PER over the primarily intact naturally occurring protein in
the food must be substantiated as a statistically significant difference
with at least a probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purposes plus the
amount naturally present in free and combined (as protein) form does not
exceed the
[[Page 54]]
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.'' 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.
(g) The standards required in this section are incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877:
(i) Sections 43.212-43.216, ``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980).
(ii) [Reserved]
(2) National Academy of Sciences, available from the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4
p.m., Monday through Friday:
(i) ``Recommended Dietary Allowances,'' NAS Publication No. 1694,
7th Ed. (1968).
(ii) ``Specifications and Criteria for Biochemical Compounds,'' NAS/
NRC Publication, 3rd Ed. (1972).
(3) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address http://www.usp.org):
[[Page 55]]
(i) Food Chemicals Codex, 7th ed. (2010), pages 28, 29, 69, 70, 71,
269, 270, 271, 440, 457, 458, 544, 545, 577, 578, 598, 599, 641, 642,
643, 697, 698, 794, 795, 864, 865, 915, 916, 1031, 1032, 1060, 1061, and
1072.
(ii) [Reserved]
[78 FR 71461, Nov. 29, 2013, as amended at 88 FR 17719, Mar. 24, 2023]
Sec. 172.325 Bakers yeast protein.
Bakers yeast protein may be safely used in food in accordance with
the following conditions:
(a) Bakers yeast protein is the insoluble proteinaceous material
remaining after the mechanical rupture of yeast cells of Saccharomyces
cerevisiae and removal of whole cell walls by centrifugation and
separation of soluble cellular materials.
(b) The additive meets the following specifications on a dry weight
basis:
(1) Zinc salts less than 500 parts per million (ppm) as zinc.
(2) Nucleic acid less than 2 percent.
(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05
ppm mercury, and 0.3 ppm selenium.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The ingredient is used in food as a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter.
Sec. 172.330 Calcium pantothenate, calcium chloride double salt.
The food additive calcium chloride double salt of calcium
pantothenate may be safely used in foods for special dietary uses in
accordance with good manufacturing practice and under the following
prescribed conditions:
(a) The food additive is of the d (dextrorotatory) or the dl
(racemic) form.
(b) To assure safe use of the additive, the label and labeling of
the food additive container, or that of any intermediate premixes
prepared therefrom, shall bear, in addition to the other information
required by the Act, the following:
(1) The name of the additive ``calcium chloride double salt of d-
calcium pantothenate'' or ``calcium chloride double salt of dl-calcium
pantothenate'', whichever is appropriate.
(2) A statement of the appropriate concentration of the additive,
expressed as pantothenic acid.
Sec. 172.335 D-Pantothenamide.
The food additive D-pantothenamide as a source of pantothenic acid
activity, may be safely used in foods for special dietary use in an
amount not in excess of that reasonably required to produce its intended
effect.
Sec. 172.340 Fish protein isolate.
(a) The food additive fish protein isolate may be safely used as a
food supplement in accordance with the following prescribed conditions:
(1) The additive shall consist principally of dried fish protein
prepared from the edible portions of fish after removal of the heads,
fins, tails, bones, scales, viscera, and intestinal contents.
(2) The additive shall be derived only from species of bony fish
that are generally recognized by qualified scientists as safe for human
consumption and that can be processed as prescribed to meet the required
specifications.
(3) Only wholesome fresh fish otherwise suitable for human
consumption may be used. The fish shall be handled expeditiously under
sanitary conditions. These conditions shall be in accordance with
recognized good manufacturing practice for fish to be used as human
food.
(4) The additive shall be prepared by extraction with hexane and
food-grade ethanol to remove fat and moisture. Solvent residues shall be
reduced by drying.
(b) The food additive meets the following specifications: (Where
methods of determination are specified, they are Association of Official
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by
reference). \1\
---------------------------------------------------------------------------
\1\ Copies are available from: AOAC INTERNATIONAL, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
---------------------------------------------------------------------------
[[Page 56]]
(1) Protein content, as N x 6.25, shall not be less than 90 percent
by weight of the final product, as determined by the method described in
section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)--
Official Final Action.
(2) Moisture content shall not be more than 10 percent by weight of
the final product, as determined by the method described in section
24.003, Air Drying (1)--Official First Action.
(3) Fat content shall not be more than 0.5 percent by weight of the
final product, as determined by the method described in section 24.005,
Crude Fat or Ether Extract--Official Final Action.
(4) Solvent residues in the final product shall not be more than 5
parts per million of hexane and 3.5 percent ethanol by weight.
[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982;
54 FR 24897, June 12, 1989]
Sec. 172.345 Folic acid (folacin).
Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate,
may be safely used in food as a nutrient in accordance with the
following prescribed conditions:
(a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
(b) Folic acid meets the specifications of the Food Chemicals Codex,
9th ed., updated through Third Supplement, effective December 1, 2015,
pp. 495-496, which is incorporated by reference. The Director of the
Office of the Federal Register approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the United States Pharmacopeial Convention, 12601 Twinbrook
Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies
may be examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(c) Folic acid may be added to foods subject to a standard of
identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act (the act) when the standard of identity specifically
provides for the addition of folic acid.
(d) Folic acid may be added, at levels not to exceed 400 micrograms
([micro]g) per serving, to breakfast cereals, as defined under Sec.
170.3(n)(4) of this chapter, and to corn grits at a level such that each
pound of corn grits contains not more than 1.0 milligram of folic acid.
(e) Folic acid may be added to infant formula in accordance with
section 412(i)(1) of the act or with regulations issued under section
412(i)(2) of the act which are codified in Sec. 107.100 of this
chapter.
(f) Folic acid may be added to a medical food, as defined in section
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to
exceed the amount necessary to meet the distinctive nutritional
requirements of the disease or condition for which the food is
formulated.
(g) Folic acid may be added to food for special dietary use at
levels not to exceed the amount necessary to meet the special dietary
needs for which the food is formulated.
(h) Folic acid may be added to foods represented as meal-replacement
products, in amounts not to exceed:
(1) Four hundred [micro]g per serving if the food is a meal-
replacement that is represented for use once per day; or
(2) Two hundred [micro]g per serving if the food is a meal-
replacement that is represented for use more than once per day.
(i) Folic acid may be added to corn masa flour at a level not to
exceed 0.7
[[Page 57]]
milligrams of folic acid per pound of corn masa flour.
[61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64
FR 1758, Jan. 12, 1999; 78 FR 71463, Nov. 29, 2013; 81 FR 22183, Apr.
15, 2016; 88 FR 17719, Mar. 24, 2023]
Sec. 172.350 Fumaric acid and salts of fumaric acid.
Fumaric acid and its calcium, ferrous, magnesium, potassium, and
sodium salts may be safely used in food in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) Fumaric acid contains a minimum of 99.5 percent by weight of
fumaric acid, calculated on the anhydrous basis.
(2) The calcium, magnesium, potassium, and sodium salts contain a
minimum of 99 percent by weight of the respective salt, calculated on
the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent
total iron and not more than 2 percent ferric iron.
(b) With the exception of ferrous fumarate, fumaric acid and the
named salts are used singly or in combination in food at a level not in
excess of the amount reasonably required to accomplish the intended
effect.
(c) Ferrous fumarate is used as a source of iron in foods for
special dietary use, when the use is consistent with good nutrition
practice.
Sec. 172.365 Kelp.
Kelp may be safely added to a food as a source of the essential
mineral iodine, provided the maximum intake of the food as may be
consumed during a period of one day, or as directed for use in the case
of a dietary supplement, will not result in daily ingestion of the
additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women. The food additive kelp is the dehydrated, ground product prepared
from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and
Laminaria cloustoni.
Sec. 172.370 Iron-choline citrate complex.
Iron-choline citrate complex made by reacting approximately
equimolecular quantities of ferric hydroxide, choline, and citric acid
may be safely used as a source of iron in foods for special dietary use.
Sec. 172.372 N-Acetyl-L-methionine.
The food additive N-acetyl-L-methionine may be safely added to food
(except infant foods and foods containing added nitrites/nitrates) as a
source of L-methionine for use as a nutrient in accordance with the
following conditions:
(a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No.
65-82-7) is the derivative of the amino acid methionine formed by
addition of an acetyl group to the alpha-amino group of methionine. It
may be in the free, hydrated or anhydrous form, or as the sodium or
potassium salts.
(b) The additive meets the following specifications:
(1) Purity assay, on a dry basis: Minimum 99 percent.
(2) Residue on ignition: Maximum 0.1 percent.
(3) Specific optical rotation [alpha]\20\D: Between -
19[deg] and -23[deg].
(4) The additive may contain residues of not more than 500 ppm ethyl
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm
acetone, when used as processing solvents.
(c) The additive is used or intended for use as a source of L-
methionine to improve significantly the biological quality of the total
protein in a food containing naturally occurring primarily intact
vegetable protein that is considered a significant dietary protein
source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes
at least 6.5 grams of naturally occurring primarily intact vegetable
protein.
(2) The additive results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method
[[Page 58]]
specified in paragraph (d) of this section.
(3) The use of the additive results in a statistically significant
increase in the PER as determined by the method described in paragraph
(d) of this section. The minimum amount of the additive to achieve the
desired effect must be used, and the increase in PER over the primarily
intact naturally occurring vegetable protein in the food must be
substantiated as a statistically significant difference with at least a
probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purpose shall not
exceed the level that will provide a total of 3.1 percent L- and DL-
methionine (expressed as the free amino acid) by weight of the total
protein of the finished food, including the amount naturally present in
free and combined (as protein) form.
(5) The additive shall not be added to infant foods or to foods
containing added nitrites/nitrates.
(d) Compliance with the limitations concerning PER under paragraph
(c) of the section shall be determined by the method described in
sections 43.212-43.216, ``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html. Each
manufacturer or person employing the additive under the provisions of
this section shall keep and maintain throughout the period of use of the
additive and for a minimum of 3 years thereafter, records of the tests
required by this paragraph and other records required to assure
effectiveness and compliance with this regulation. Those records shall
be made available upon request at all reasonable hours by any officer or
employee acting on behalf of the Secretary of Health and Human Services.
Those officers or employees shall be permitted to conduct inventories of
raw and finished materials on hand as are deemed necessary to verify the
records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the additive contained therein.
(2) The amounts of additive and each amino acid contained in any
mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) When the food additive is added as a nutrient to special dietary
foods that are intended for use solely under medical supervision to meet
nutritional requirements in specific medical conditions and these foods
comply with the requirements of part 105 of this chapter, the food
additive is exempt from the limitations in paragraphs (c)(1) through (4)
and (d) of this section and may be used in those foods at levels not to
exceed good manufacturing practices.
[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Sec. 172.375 Potassium iodide.
The food additive potassium iodide may be safely used in accordance
with the following prescribed conditions:
(a) Potassium iodide may be safely added to a food as a source of
the essential mineral iodine, provided the maximum intake of the food as
may be consumed during a period of one day, or as directed for use in
the case of a dietary supplement, will not result in daily ingestion of
the additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women.
[[Page 59]]
(b) To assure safe use of the additive, in addition to the other
information required by the Act, the label of the additive shall bear:
(1) The name of the additive.
(2) A statement of the concentration of the additive in any mixture.
Sec. 172.379 Vitamin D2.
Vitamin D2 may be used safely in foods as a nutrient
supplement defined under Sec. 170.3(o)(20) of this chapter in
accordance with the following prescribed conditions:
(a) Vitamin D2, also known as ergocalciferol, is the
chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin
D2 is produced by ultraviolet irradiation of ergosterol
isolated from yeast and is purified by crystallization.
(b) Vitamin D2 meets the specifications of the 2015 Food
Chemical Codex, 9th edition (through Third Supplement), effective
December 1, 2015, pp. 1260-1261, which is incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) The additive may be used as follows:
------------------------------------------------------------------------
Maximum Levels in Food (as
Category of Food Served)
------------------------------------------------------------------------
Edible plant-based beverages intended 84 IU/100 g.
as milk alternatives
------------------------------------------------------------------------
Edible plant-based yogurt 89 IU/100 g.
alternatives
------------------------------------------------------------------------
Soy beverage products 89 IU/100 g
------------------------------------------------------------------------
Soy-based butter substitute spreads 330 IU/100 g
------------------------------------------------------------------------
Soy-based cheese substitutes and soy- 270 IU/100 g
based cheese substitute products
------------------------------------------------------------------------
[74 FR 11022, Mar. 16, 2009, as amended at 78 FR 71463, Nov. 29, 2013;
81 FR 46581, July 18, 2016; 88 FR 17719, Mar. 24, 2023]
Sec. 172.380 Vitamin D3.
Vitamin D3 may be used safely in foods as a nutrient
supplement defined under Sec. 170.3(o)(20) of this chapter in
accordance with the following prescribed conditions:
(a) Vitamin D3, also known as cholecalciferol, is the
chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin
D3 occurs in and is isolated from fish liver oils. It also is
manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced
from cholesterol and is purified by crystallization.
(b) Vitamin D3 meets the specifications of ``Vitamin
D3,'' Food Chemicals Codex, 13th edition, effective June 1,
2022, which is incorporated by reference. The Director of the Office of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies
from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852; website: https://www.usp.org. Copies may be
examined at the FDA or the National Archives and Records Administration
(NARA). Contact FDA at: the Dockets Management Staff (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday. For
information on inspecting this material at NARA, visit www.archives.gov/
federal-register/cfr/ibr-locations.html or email [email protected].
(c) The additive may be used as follows:
[[Page 60]]
(1) At levels not to exceed 100 International Units (IU) per 240
milliliters (mL) in 100 percent fruit juices (as defined under Sec.
170.3(n)(35) of this chapter) that are fortified with greater than or
equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit
juices that are specially formulated or processed for infants.
(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks
(as defined under Sec. 170.3(n)(35) of this chapter) that are fortified
with greater than or equal to 100 mg of calcium per 240 mL, excluding
fruit juice drinks that are specially formulated or processed for
infants.
(3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in
soy-protein based meal replacement beverages (powder or liquid) that are
represented for special dietary use in reducing or maintaining body
weight in accordance with Sec. 105.66 of this chapter.
(4) At levels not to exceed 100 IU per 40 grams in meal replacement
bars or other-type bars that are represented for special dietary use in
reducing or maintaining body weight in accordance with Sec. 105.66 of
this chapter.
(5) At levels not to exceed 81 IU per 30 grams in cheese and cheese
products as defined under Sec. 170.3(n)(5) of this chapter, excluding
cottage cheese, ricotta cheese, and hard grating cheeses such as
Parmesan and Romano as defined in Sec. Sec. 133.165 and 133.183 of this
chapter, and those defined by standard of identity in Sec. 133.148 of
this chapter.
(6) At levels not to exceed 500 IU per 240 mL (prepared beverage) in
meal replacement beverages that are not intended for special dietary use
in reducing or maintaining body weight and that are represented for use
such that the total amount of Vitamin D3 provided by the
product does not exceed 1,000 IU per day.
(7) At levels not to exceed 1.0 IU per kilocalorie in foods
represented for use as a sole source of nutrition for enteral feeding.
(8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk
that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and
that meets the requirements for foods named by use of a nutrient content
claim and a standardized term in accordance with Sec. 130.10 of this
chapter.
(9) At levels not to exceed 560 IU per 100 g in breakfast cereals
(as defined under Sec. 170.3(n)(4) of this chapter).
(10) At levels not to exceed 400 IU per 100 g in grain-based bars
(e.g., breakfast bars, granola bars, rice cereal bars).
[68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70
FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463, Nov.
29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR 46582, July 18, 2016; 83 FR
47559, Sept. 20, 2018; 88 FR 749, Jan. 5, 2023; 88 FR 17719, Mar. 24,
2023]
Sec. 172.381 Vitamin D2 bakers yeast.
Vitamin D2 bakers yeast may be used safely in foods as a
source of vitamin D2 and as a leavening agent in accordance
with the following prescribed conditions:
(a) Vitamin D2 bakers yeast is the substance produced by
exposing bakers yeast (Saccharomyces cerevisiae) to ultraviolet light,
resulting in the photochemical conversion of endogenous ergosterol in
bakers yeast to vitamin D2 (also known as ergocalciferol or
(9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)).
(b) Vitamin D2 bakers yeast may be used alone as an
active dry yeast concentrate or in combination with conventional bakers
yeast.
(c) The additive may be used in yeast-leavened baked goods and
baking mixes and yeast-leavened baked snack foods at levels not to
exceed 400 International Units of vitamin D2 per 100 grams in
the finished food.
(d) To assure safe use of the additive, the label or labeling of the
food additive container shall bear, in addition to the other information
required by the Federal Food, Drug, and Cosmetic Act, adequate
directions for use to provide a final product that complies with the
limitations prescribed in paragraph (c) of this section.
(e) Labels of manufactured food products containing the additive
shall bear, in the ingredient statement, the name of the additive,
``vitamin D2 bakers yeast,'' in the proper order of
decreasing predominance in the finished food.
[77 FR 52231, Aug. 29, 2012]
[[Page 61]]
Sec. 172.382 Vitamin D2 mushroom powder.
Vitamin D2 mushroom powder may be used safely in foods as
a source of vitamin D2 in accordance with the following
prescribed conditions:
(a) Vitamin D2 mushroom powder is the substance produced
by exposing an aqueous homogenate of edible cultivars of Agaricus
bisporus mushrooms to ultraviolet (UV) light, resulting in the
photochemical conversion of endogenous ergosterol in the mushrooms to
vitamin D2 (also known as ergocalciferol or [9,10-
Seco(5Z,7E,22E)-5,7,10(19),22- ergostatetraen-3-ol]).
(b) The total dose of UV light applied to the mushroom homogenate
shall not exceed 12 Joules/square centimeter (J/cm\2\).
(c) Vitamin D2 mushroom powder meets the following
specifications:
(1) Moisture, not more than 10 percent.
(2) Negative for Salmonella, Staphylococcus aureus, and Listeria
monocytogenes, and any other recognized microbial pathogen or any
harmful microbial toxin.
(3) Standard plate count, not more than 5,000 colony forming units
per gram (CFU/g).
(4) Yeasts and molds, not more than 100 CFU/g.
(5) Lead, not more than 0.5 milligrams per kilogram (mg/kg).
(6) Arsenic, not more than 0.3 mg/kg.
(d) To assure safe use of the additive, the label or labeling of the
food additive container shall bear, in addition to the other information
required by the Federal Food, Drug, and Cosmetic Act, adequate
directions for use to provide a final product that complies with the
limitations prescribed in paragraph (f) of this section.
(e) Labels of manufactured food products containing the additive
shall bear, in the ingredient statement, the name of the additive
``vitamin D2 mushroom powder,'' in the proper order of
decreasing predominance in the finished food.
(f) Vitamin D2 mushroom powder may be used as a source of
vitamin D2 in food as follows:
Table 1 to Paragraph (f)
------------------------------------------------------------------------
Maximum level of vitamin
Category of food D2
------------------------------------------------------------------------
Breakfast cereals............................ 350 IU/100 g.
Edible plant-based beverages marketed as milk 84 IU/100 g.
alternatives.
Edible plant-based products marketed as 89 IU/100 g.
yogurt alternatives.
Extruded vegetable snacks.................... 80 IU/28 g.
Fruit smoothies.............................. 100 IU/240 mL.
100% fruit juices that are fortified with 100 IU/240 mL.
greater than or equal to 330 mg of calcium
per 240 mL, excluding fruit juices that are
specially formulated or processed for
infants.
Fruit juice drinks that are fortified with 100 IU/240 mL.
greater than or equal to 100 mg of calcium
per 240 mL, excluding fruit juice drinks
that are specially formulated or processed
for infants.
Grain products and pastas.................... 90 IU/100 g.
Meal replacement bars or other-type bars that 100 IU/40 g.
are represented for special dietary use in
reducing or maintaining body weight.
Meal replacement beverages that are not 500 IU/240 mL.
intended for special dietary use in reducing
or maintaining body weight and that are
represented for use such that the total
amount of Vitamin D provided by the product
does not exceed 1,000 IU per day.
Plant protein products....................... 80 IU/85 g.
Soups and soup mixes, except for soup and 100 IU/245 mL.
soup mixes containing meat or poultry that
are subject to regulation by the U.S.
Department of Agriculture under the Federal
Meat Inspection Act or the Poultry Products
Inspection Act.
Soy-based spreads marketed as butter 330 IU/100 g.
alternatives.
Soy-based products marketed as cheese and 270 IU/100 g.
cheese-product alternatives.
Soy beverage products........................ 89 IU/100 g.
Soy-protein based meal replacement beverages 140 IU/240 mL.
(powder or liquid) that are represented for
special dietary use in reducing or
maintaining body weight.
Vegetable juices............................. 100 IU/240 mL.
Yeast-leavened baked goods and baking mixes 400 IU/100 g.
and yeast-leavened baked snack foods.
------------------------------------------------------------------------
[[Page 62]]
[85 FR 41920, July 13, 2020]
Sec. 172.385 Whole fish protein concentrate.
The food additive whole fish protein concentrate may be safely used
as a food supplement in accordance with the following prescribed
conditions:
(a) The additive is derived from whole, wholesome hake and hakelike
fish, herring of the genera Clupea, menhaden, and anchovy of the species
Engraulis mordax, handled expeditiously and under sanitary conditions in
accordance with good manufacturing practices recognized as proper for
fish that are used in other forms for human food.
(b) The additive consists essentially of a dried fish protein
processed from the whole fish without removal of heads, fins, tails,
viscera, or intestinal contents. It is prepared by solvent extraction of
fat and moisture with isopropyl alcohol or with ethylene dichloride
followed by isopropyl alcohol, except that the additive derived from
herring, menhaden and anchovy is prepared by solvent extraction with
isopropyl alcohol alone. Solvent residues are reduced by conventional
heat drying and/or microwave radiation and there is a partial removal of
bone.
(c) The food additive meets the following specifications:
(1) Protein content (N x 6.25) shall not be less than 75 percent by
weight of the final product, as determined by the method described in
section 2.057 in ``Official Methods of Analysis of the Association of
Official Analytical Chemists'' (AOAC), 13th Ed. (1980). Protein quality
shall not be less than 100, as determined by the method described in
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by
reference, and copies may be obtained from the AOAC INTERNATIONAL, 481
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be
examined at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(2) Moisture content shall not exceed 10 percent by weight of the
final product, as determined by the method described in section 24.003
of the AOAC. See paragraph (c)(1) of this section for availability of
the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final
product, as determined by the method described in section 24.005 of the
AOAC. See paragraph (c)(1) of the this section for availability of the
material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and
ethylene dichloride not in excess of 250 parts per million and 5 parts
per million, respectively, when used as solvents in the extraction
process.
(5) Microwave radiation meeting the requirements of Sec. 179.30 of
this chapter may be used to reduce residues of the solvents used in the
extraction process.
(6) The additive shall contain not in excess of 100 parts per
million fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic
organisms, including Salmonella, and shall have a total bacterial plate
count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish
odor and taste.
(d) When the additive is used or intended for use in the household
as a protein supplement in food for regular consumption by children up
to 8 years of age, the amount of the additive from this source shall not
exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in
manufactured food, the total fluoride content (expressed as F) of the
finished food shall not exceed 8 ppm based on the dry weight of the food
product.
(f) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive
shall bear the name ``whole fish protein concentrate''.
(2) The label or labeling of containers of the additive shall bear
adequate directions for use to comply with the limitations prescribed by
paragraphs (d) and (e) of this section.
[[Page 63]]
(3) Labels of manufactured foods containing the additive shall bear,
in the ingredient statement, the name of the additive, ``whole fish
protein concentrate'' in the proper order of decreasing predominance in
the finished food.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984;
54 FR 24897, June 12, 1989]
Sec. 172.395 Xylitol.
Xylitol may be safely used in foods for special dietary uses,
provided the amount used is not greater than that required to produce
its intended effect.
Sec. 172.399 Zinc methionine sulfate.
Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used
in accordance with the following prescribed conditions:
(a) The additive is the product of the reaction between equimolar
amounts of zinc sulfate and DL-methionine in purified water.
(b) The additive meets the following specifications:
Zinc content--19 to 22 percent.
C5H11NO2S ``DL-methionine''--46 to 50
percent.
Cadmium--not more than 0.05 part per million.
(c) The additive is used in tablet form as a source of dietary zinc.
[46 FR 58297, Dec. 1, 1981]
Subpart E_Anticaking Agents
Sec. 172.410 Calcium silicate.
Calcium silicate, including synthetic calcium silicate, may be
safely used in food in accordance with the following prescribed
conditions:
(a) It is used as an anticaking agent in food in an amount not in
excess of that reasonably required to produce its intended effect.
(b) It will not exceed 2 percent by weight of the food, except that
it may be present up to 5 percent by weight of baking powder.
Sec. 172.430 Iron ammonium citrate.
Iron ammonium citrate may be safely used in food in accordance with
the following prescribed conditions:
(a) The additive is the chemical green ferric ammonium citrate.
(b) The additive is used, or intended for use as an anticaking agent
in salt for human consumption so that the level of iron ammonium citrate
does not exceed 25 parts per million (0.0025 percent) in the finished
salt.
(c) To assure safe use of the additive the label or labeling of the
additive shall bear, in addition to the other information required by
the Act:
(1) The name of the additive.
(2) Adequate directions to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
Sec. 172.480 Silicon dioxide.
The food additive silicon dioxide may be safely used in food in
accordance with the following conditions:
(a) The food additive is manufactured by vapor phase hydrolysis or
by other means whereby the particle size is such as to accomplish the
intended effect.
(b) It is used as an anticaking agent, subject to the following
conditions:
(1) It is used in only those foods in which the additive has been
demonstrated to have an anticaking effect.
(2) It is used in an amount not in excess of that reasonably
required to produce its intended effect.
(3) [Reserved]
(4) It is used in an amount not to exceed 2 percent by weight of the
food.
(c) It is used or intended for use as a stabilizer in the production
of beer, and is removed from the beer by filtration prior to final
processing.
(d) It is used or intended for use as an adsorbent for dl-a-
tocopheryl acetate and pantothenyl alcohol in tableted foods for special
dietary use, in an amount not greater than that required to accomplish
the intended physical or technical effect.
Sec. 172.490 Yellow prussiate of soda.
(a) The food additive yellow prussiate of soda (sodium ferrocyanide
decahydrate; Na4Fe(CN)6[middot]10H2O
contains a minimum of 99 percent by weight of sodium ferrocyanide
decahydrate.
(b) The additive is used or intended for use as an anticaking agent
in salt and as an adjuvant in the production of dendritic crystals of
salt in an amount
[[Page 64]]
needed to produce its intended effect but not in excess of 13 parts per
million calculated as anhydrous sodium ferrocyanide.
[42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]
Subpart F_Flavoring Agents and Related Substances
Sec. 172.510 Natural flavoring substances and natural substances used
in conjunction with flavors.
Natural flavoring substances and natural adjuvants may be safely
used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended physical or technical effect and in accordance with all the
principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts,
concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes,
and distillates) they consist of one or more of the following, used
alone or in combination with flavoring substances and adjuvants
generally recognized as safe in food, previously sanctioned for such
use, or regulated in any section of this part.
----------------------------------------------------------------------------------------------------------------
Common name Scientific name Limitations
----------------------------------------------------------------------------------------------------------------
Aloe............................................. Aloe perryi Baker, A.
barbadensis Mill., A. ferox
Mill., and hybrids of this
sp. with A. africana Mill.
and A. spicata Baker.
Althea root and flowers.......................... Althea officinalis L........
Amyris (West Indian sandalwood).................. Amyris balsamifera L........
Angola weed...................................... Roccella fuciformis Ach..... In alcoholic beverages only
Arnica flowers................................... Arnica montana L., A. Do.
fulgens Pursh, A. sororia
Greene, or A. cordifolia
Hooker.
Artemisia (wormwood)............................. Artemisia spp............... Finished food thujone free \1\
Artichoke leaves................................. Cynara scolymus L........... In alcoholic beverages only
Benzoin resin.................................... Styrax benzoin Dryander, S.
paralleloneurus Perkins, S.
tonkinensis (Pierre) Craib
ex Hartwich, or other spp.
of the Section Anthostyrax
of the genus Styrax.
Blackberry bark.................................. Rubus, Section Eubatus......
Boldus (boldo) leaves............................ Peumus boldus Mol........... Do.
Boronia flowers.................................. Boronia megastigma Nees.....
Bryonia root..................................... Bryonia alba L., or B. Do.
diocia Jacq.
Buchu leaves..................................... Barosma betulina Bartl. et
Wendl., B. crenulata (L.)
Hook. or B. serratifolia
Willd.
Buckbean leaves.................................. Menyanthes trifoliata L..... Do.
Cajeput.......................................... Melaleuca leucadendron L.
and other Melaleuca spp.
Calumba root..................................... Jateorhiza palmata (Lam.) Do.
Miers.
Camphor tree..................................... Cinnamomum camphora (L.) Safrole free
Nees et Eberm.
Cascara sagrada.................................. Rhamnus purshiana DC........
Cassie flowers................................... Acacia farnesiana (L.) Willd
Castor oil....................................... Ricinus communis L..........
Catechu, black................................... Acacia catechu Willd........
Cedar, white (aborvitae), leaves and twigs....... Thuja occidentalis L........ Finished food thujone free \1\
Centuary......................................... Centaurium umbellatum Gilib. In alcoholic beverages only
Cherry pits...................................... Prunus avium L. or P. Not to exceed 25 p.p.m. prussic
cerasus L. acid
Cherry-laurel leaves............................. Prunus laurocerasus L....... Do.
Chestnut leaves.................................. Castanea dentata (Marsh.)
Borkh.
Chirata.......................................... Swertia chirata Buch.-Ham... In alcoholic beverages only
Cinchona, red, bark.............................. Cinchona succirubra Pav. or In beverages only; not more
its hybrids. than 83 p.p.m. total cinchona
alkaloids in finished beverage
Cinchona, yellow, bark........................... Cinchona ledgeriana Moens, Do.
C. calisaya Wedd., or
hybrids of these with other
spp. of Cinchona..
Copaiba.......................................... South American spp. of
Copaifera L.
Cork, oak........................................ Quercus suber L., or Q. In alcoholic beverages only
occidentalis F. Gay.
Costmary......................................... Chrysanthemum balsamita L... Do.
[[Page 65]]
Costus root...................................... Saussurea lappa Clarke......
Cubeb............................................ Piper cubeba L. f...........
Currant, black, buds and leaves.................. Ribes nigrum L..............
Damiana leaves................................... Turnera diffusa Willd.......
Davana........................................... Artemisia pallens Wall......
Dill, Indian..................................... Anethum sowa Roxb.
(Peucedanum graveolens
Benth et Hook., Anethum
graveolens L.).
Dittany (fraxinella) roots....................... Dictamnus albus L........... Do.
Dittany of Crete................................. Origanum dictamnus L........
Dragon's blood (dracorubin)...................... Daemonorops spp.............
Elder tree leaves................................ Sambucus nigra L............ In alcoholic beverages only;
not to exceed 25 p.p.m.
prussic acid in the flavor
Elecampane rhizome and roots..................... Inula helenium L............ In alcoholic beverages only
Elemi............................................ Canarium commune L. or C.
luzonicum Miq.
Erigeron......................................... Erigeron canadensis L.......
Eucalyptus globulus leaves....................... Eucalyptus globulus Labill..
Fir (``pine'') needles and twigs................. Abies sibirica Ledeb., A.
alba Mill., A. sachalinesis
Masters or A. mayriana
Miyabe et Kudo.
Fir, balsam, needles and twigs................... Abies balsamea (L.) Mill....
Galanga, greater................................. Alpinia galanga Willd....... Do.
Galbanum......................................... Ferula galbaniflua Boiss. et
Buhse and other Ferula spp.
Gambir (catechu, pale)........................... Uncaria gambir Roxb.........
Genet flowers.................................... Spartium junceum L..........
Gentian rhizome and roots........................ Gentiana lutea L............
Gentian, stemless................................ Gentiana acaulis L.......... Do.
Germander, chamaedrys............................ Teucrium chamaedrys L....... Do.
Germander, golden................................ Teucrium polium L........... Do.
Guaiac........................................... Guaiacum officinale L., G.
santum L., Bulnesia
sarmienti Lor.
Guarana.......................................... Paullinia cupana HBK........
Haw, black, bark................................. Viburnum prunifolium L......
Hemlock needles and twigs........................ Tsuga canadensis (L.) Carr.
or T. heterophylla (Raf.)
Sarg.
Hyacinth flowers................................. Hyacinthus orientalis L.....
Iceland moss..................................... Cetraria islandica Ach...... Do.
Imperatoria...................................... Peucedanum ostruthium (L.).
Koch (Imperatoria
ostruthium L.).
Iva.............................................. Achillea moschata Jacq...... Do.
Labdanum......................................... Cistus spp..................
Lemon-verbena.................................... Lippia citriodora HBK....... Do.
Linaloe wood..................................... Bursera delpechiana Poiss.
and other Bursera spp.
Linden leaves.................................... Tillia spp.................. Do.
Lovage........................................... Levisticum officinale Koch..
Lungmoss (lungwort).............................. Sticta pulmonacea Ach.......
Maidenhair fern.................................. Adiantum capillus-veneris L. Do.
Maple, mountain.................................. Acer spicatum Lam...........
Mimosa (black wattle) flowers.................... Acacia decurrens Willd. var.
dealbata.
Mullein flowers.................................. Verbascum phlomoides L. or Do.
V. thapsiforme Schrad.
Myrrh............................................ Commiphora molmol Engl., C.
abyssinica (Berg) Engl., or
other Commiphora spp.
Myrtle leaves.................................... Myrtus communis L........... Do.
Oak, English, wood............................... Quercus robur L............. Do.
Oak, white, chips................................ Quercus alba L..............
Oak moss......................................... Evernia prunastri (L.) Ach., Finished food thujone free \1\
E. furfuracea (L.) Mann,
and other lichens.
Olibanum......................................... Boswellia carteri Birdw. and
other Boswellia spp.
Opopanax (bisabolmyrrh).......................... Opopanax chironium Koch
(true opopanax) of
Commiphora erythraea Engl.
var. Llabrescens.
Orris root....................................... Iris germanica L. (including
its variety florentina
Dykes) and I. pallida Lam.
Pansy............................................ Viola tricolor L............ In alcoholic beverages only
Passion flower................................... Passiflora incarnata L......
Patchouly........................................ Pogostemon cablin Benth. and
P. heyneanus Benth.
Peach leaves..................................... Prunus persica (L.) Batsch.. In alcoholic beverages only;
not to exceed 25 p.p.m.
prussic acid in the flavor
Pennyroyal, American............................. Hedeoma pulegioides (L.)
Pers.
Pennyroyal, European............................. Mentha pulegium L...........
[[Page 66]]
Pine, dwarf, needles and twigs................... Pinus mugo Turra var.
pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs.................. Pinus sylvestris L..........
Pine, white, bark................................ Pinus strobus L............. In alcoholic beverages only
Pine, white oil.................................. Pinus palustris Mill., and
other Pinus spp.
Poplar buds...................................... Populus balsamifera L. (P. Do.
tacamahacca Mill.), P.
candicans Ait., or P. nigra
L.
Quassia.......................................... Picrasma excelsa (Sw.)
Planch, or Quassia amara L.
Quebracho bark................................... Aspidosperma quebracho- Schinopsis lorentzii (Griseb.)
blanco Schlecht, or Engl.
(Quebrachia lorentzii
(Griseb)).
Quillaia (soapbark).............................. Quillaja saponaria Mol......
Red saunders (red sandalwood).................... Pterocarpus san alinus L.... In alcoholic beverages only
Rhatany root..................................... Krameria triandra Ruiz et
Pav. or K. argentea Mart.
Rhubarb, garden root............................. Rheum rhaponticum L......... Do.
Rhubarb root..................................... Rheum officinale Baill., R.
palmatum L., or other spp.
(excepting R. rhaponticum
L.) or hybrids of Rheum
grown in China.
Roselle.......................................... Hibiscus sabdariffa L....... Do.
Rosin (colophony)................................ Pinus palustris Mill., and Do.
other Pinus spp.
St. Johnswort leaves, flowers, and caulis........ Hypericum perforatum L...... Hypericin-free alcohol
distillate form only; in
alcoholic beverages only
Sandalwood, white (yellow, or East Indian)....... Santalum album L............
Sandarac......................................... Tetraclinis articulata In alcoholic beverages only
(Vahl.), Mast.
Sarsaparilla..................................... Smilax aristolochiaefolia
Mill., (Mexican
sarsaparilla), S. regelii
Killip et Morton (Honduras
sarsaparilla), S. febrifuga
Kunth (Ecuadorean
sarsaparilla), or
undetermined Smilax spp.
(Ecuadorean or Central
American sarsaparilla).
Sassafras leaves................................. Sassafras albidum (Nutt.) Safrole free
Nees.
Senna, Alexandria................................ Cassia acutifolia Delile....
Serpentaria (Virginia snakeroot)................. Aristolochia serpentaria L.. In alcoholic beverages only
Simaruba bark.................................... Simaruba amara Aubl......... Do.
Snakeroot, Canadian (wild ginger)................ Asarum canadense L..........
Spruce needles and twigs......................... Picea glauca (Moench) Voss
or P. mariana (Mill.) BSP.
Storax (styrax).................................. Liquidambar orientalis Mill.
or L. styraciflua L.
Tagetes (marigold)............................... Tagetes patula L., T. erecta As oil only
L., or T. minuta L. (T.
glandulifera Schrank).
Tansy............................................ Tanacetum vulgare L......... In alcoholic beverages only;
finished alcoholic beverage
thujone free \1\
Thistle, blessed (holy thistle).................. Onicus benedictus L......... In alcoholic beverages only
Thymus capitatus (Spanish ``origanum'').......... Thymus capitatus Hoffmg. et
Link.
Tolu............................................. Myroxylon balsamum (L.)
Harms.
Turpentine....................................... Pinus palustris Mill. and
other Pinus spp. which
yield terpene oils
exclusively.
Valerian rhizome and roots....................... Valeriana officinalis L.....
Veronica......................................... Veronica officinalis L...... Do.
Vervain, European................................ Verbena officinalis L....... Do.
Vetiver.......................................... Vetiveria zizanioides Stapf. Do.
Violet, Swiss.................................... Viola calcarata L...........
Walnut husks (hulls), leaves, and green nuts..... Juglans nigra L. or J. regia
L.
Woodruff, sweet.................................. Asperula odorata L.......... In alcoholic beverages only
Yarrow........................................... Achillea millefolium L...... In beverages only; finished
beverage thujone free \1\
Yerba santa...................................... Eriodictyon californicum
(Hook, et Arn.) Torr.
Yucca, Joshua-tree............................... Yucca brevifolia Engelm.....
Yucca, Mohave.................................... Yucca schidigera Roezl ex
Ortgies (Y. mohavensis
Sarg.).
----------------------------------------------------------------------------------------------------------------
\1\ As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in
section 9.129 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
[[Page 67]]
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 69 FR 24511, May 4,
2004; 72 FR 10357, Mar. 8, 2007]
Sec. 172.515 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants may be safely used in
food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended effect, and otherwise in accordance with all the principles of
good manufacturing practice.
(b) They consist of one or more of the following, used alone or in
combination with flavoring substances and adjuvants generally recognized
as safe in food, prior-sanctioned for such use, or regulated by an
appropriate section in this part.
Acetal; acetaldehyde diethyl acetal.
Acetaldehyde phenethyl propyl acetal.
Acetanisole; 4'-methoxyacetophenone.
Acetophenone; methyl phenyl ketone.
Allyl anthranilate.
Allyl butyrate.
Allyl cinnamate.
Allyl cyclohexaneacetate.
Allyl cyclohexanebutyrate.
Allyl cyclohexanehexanoate.
Allyl cyclohexaneproprionate.
Allyl cyclohexanevalerate.
Allyl disulfide.
Allyl 2-ethylbutyrate.
Allyl hexanoate; allyl caproate.
Allyl [alpha]-ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-
heptadiene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
[alpha]-Amylcinnamaldehyde.
[alpha]-Amylcinnamaldehyde dimethyl acetal.
[alpha]-Amylcinnamyl acetate.
[alpha]-Amylcinnamyl alcohol.
[alpha]-Amylcinnamyl formate.
[alpha]-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; [alpha]-toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl [beta]-methoxyethyl
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
[beta]-Bourbonene; 1,2,3,3a,3b[beta],4,5,6,6a[beta],6b[alpha]-deca-
hydro-l[alpha]-isopropyl-3aa-methyl-6-methylene-cyclobuta
[1,2:3,4] dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
[alpha]-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
[[Page 68]]
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
[beta]-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
[beta]-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-oxatricylo
[8.2.0.0 \4 6\] dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit ronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
[gamma]-Decalactone; 4-hydroxy-decanoic acid, [gamma]-lactone.
[gamma]-Decalactone; 5-hydroxy-decanoic acid, [delta]-lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl-[gamma]-butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid,
[gamma]-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
[alpha],[alpha]-Dimethylbenzyl isobutyrate; phenyldi methylcarbinyl
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
[alpha],[alpha]-Dimethylphenethyl acetate; benzylpropyl acetate;
benzyldimethylcarbinyl acetate.
[alpha],[alpha]-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
[alpha],[alpha]-Dimethylphenethyl butyrate; benzyldimethylcarbinyl
butyrate.
[alpha],[alpha]-Dimethylphenethyl formate; benzyldi methylcarbinyl
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
[gamma]-Dodecalactone; 4-hydroxydodecanoic acid [gamma]-lactone.
2-Dodecenal.
Estragole.
[rho]-Ethoxybenzaldehyde.
Ethyl acetoacetate.
[[Page 69]]
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl [rho]-anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
[alpha]-Ethylbenzyl butyrate; [alpha]-phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol diester;
cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.
Ethyl heptanoate.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein.
Ethyl hexanoate.
Ethyl isobutyrate.
Ethyl isovalerate.
Ethyl lactate.
Ethyl laurate.
Ethyl levulinate.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4-one.
Ethyl 2-methylbutyrate.
Ethyl myristate.
Ethyl nitrite.
Ethyl nonanoate.
Ethyl 2-nonynoate; ethyl octyne carbonate.
Ethyl octanoate.
Ethyl oleate.
Ethyl phenylacetate.
Ethyl 4-phenylbutyrate.
Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; [mu]-methoxyphenol.
Guaiacyl acetate; [mu]-methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-[Delta]9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-([alpha]-hydroxy-isopropyl)-[delta]9,10-
octahydroazulene acetate.
[gamma]-Heptalactone; 4-hydroxyheptanoic acid, [gamma]-lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
[omega]-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, [omega]-
lactone; ambrettolide.
[gamma]-Hexalactone; 4-hydroxyhexanoic acid, [gamma]-lactone; tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
[alpha]-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
[[Page 70]]
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellol; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hy dro xy ben zyl acetone.
Indole.
[alpha]-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
[beta]-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
[alpha]-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-one;
6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; [alpha]-isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; [alpha]-isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.
Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
[alpha]-Isobutylphenethyl alcohol; isobutyl benzyl carbinol; 4-methyl-1-
phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and 2-hexyl-2-
cyclopenten-1-one.
[alpha]-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-methyl-
3-buten-2-one; methyl [gamma]-ionone.
Isopropyl acetate.
[rho]-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
[rho]-Isopropylbenzyl alcohol; cuminic alcohol; [rho]-cymen-7-ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
[rho]-Isopropylphenylacetaldehyde; [rho]-cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-([rho]-Isopropylphenyl)-propionaldehyde; [rho]-
isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-
methylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
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.
[[Page 71]]
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p-menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p-Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; [alpha]-methylanisylidene acetone;
ethone.
1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
[alpha]-Methylbenzyl acetate; styralyl acetate.
[alpha]-Methylbenzyl alcohol; styralyl alcohol.
[alpha]-Methylbenzyl butyrate; styralyl butyrate.
[alpha]-Methylbenzyl isobutyrate; styralyl isobutyrate.
[alpha]-Methylbenzyl formate; styralyl formate.
[alpha]-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
[alpha]-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methyl cy clo pen tane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in Sec.
172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl [alpha]-ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [beta]-ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [Delta]-ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-penten-
3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; [alpha]-methyl-p-
isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl-3-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl [beta]-naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
[beta]-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; [alpha]-isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
[[Page 72]]
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
[gamma]-Nonalactone; 4-hydroxynonanoic acid, [gamma]-lactone; aldehyde
C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.
Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo[4,4,0]-dec-1-en-3-one.
Ocimene; trans-[beta]-ocimene; 3,7-dimethyl-1,3,6-octatriene.
[gamma]-Octalactone; 4-hydroxyoctanoic acid, [gamma]-lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.
Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
[omega]-Pentadecalactone; 15-hydroxypentadeca-noic acid, [omega]-
lactone; pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;p-mentha-
1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
[alpha]-Phellandrene; [rho]-mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; [beta]-phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; [alpha]-toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; [alpha]-toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde dimethyl
acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
[alpha]-Pinene; 2-pinene.
[beta]-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
[[Page 73]]
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
[alpha]-Propylphenethyl alcohol.
Propyl phenylacetate.
Propyl propionate.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol, [alpha] and [beta].
Santalyl acetate.
Santalyl phenylacetate.
Skatole.
Sorbitan monostearate.
Sucrose octaacetate.
[alpha]-Terpinene.
[gamma]-Terpinene.
[alpha]-Terpineol; p-menth-1-en-8-ol.
[beta]-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-
2-cyclohexen-1-one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methyl benzy la ce tone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methyl hy dra tro pic al de hyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
[gamma]-Undecalactone; 4-hydroxyundecanoic acid [gamma]-lactone; peach
aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.
(c) [Delta]-Decalactone and [Delta]-dodecalactone when used
separately or in combination in oleomargarine are used at levels not to
exceed 10 parts per million and 20 parts per million, respectively, in
accordance with Sec. 166.110 of this chapter.
(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in
flavoring substances whereby the additive does not exceed 0.5 percent of
the essential (volatile) oil content of the flavoring substance.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43
FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25,
1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR
5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21,
1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511, May 4, 2004; 83 FR 50490,
50503, Oct. 9, 2018]
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
[[Page 74]]
bear adequate directions to assure use in compliance with this section.
Sec. 172.530 Disodium guanylate.
Disodium guanylate may be safely used as a flavor enhancer in foods,
at a level not in excess of that reasonably required to produce the
intended effect.
Sec. 172.535 Disodium inosinate.
The food additive disodium inosinate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the disodium salt of inosinic acid,
manufactured and purified so as to contain no more than 150 parts per
million of soluble barium in the compound disodium inosinate with seven
and one-half molecules of water of crystallization.
(b) The food additive is used as a flavoring adjuvant in food.
Sec. 172.540 DL-Alanine.
DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-
72-7) may be safely used as a flavor enhancer for sweeteners in pickling
mixtures at a level not to exceed 1 percent of the pickling spice that
is added to the pickling brine.
[56 FR 6968, Feb. 21, 1991]
Sec. 172.560 Modified hop extract.
The food additive modified hop extract may be safely used in beer in
accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring
agent in the brewing of beer.
(b) The food additive is manufactured by one of the following
processes:
(1) The additive is manufactured from a hexane extract of hops by
simultaneous isomerization and selective reduction in an alkaline
aqueous medium with sodium borohydride, whereby the additive meets the
following specifications:
(i) A solution of the food additive solids is made up in
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This
absorbance is obtained by approximately 0.03 milligram solids
permilliliter.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
millimicrons; no absorption peak at 325 to 330 millimicrons; the
absorbance at 268 millimicrons does not exceed the absorbance at 272
millimicrons.
(ii) The boron content of the food additive does not exceed 310
parts per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
and methyl alcohol as solvents, followed by isomerization by potassium
carbonate treatment. Residues of solvents in the modified hop extract
shall not exceed 1.0 part per million of benzene, 1.0 part per million
of light petroleum spirits, and 250 parts per million of methyl alcohol.
The light petroleum spirits and benzene solvents shall comply with the
specifications in Sec. 172.250 except that the boiling point range for
light petroleum spirits is 150 [deg]F-300 [deg]F.
(3) The additive is manufactured from hops by a sequence of
extractions and fractionations, using methylene chloride, hexane, and
methyl alcohol as solvents, followed by isomerization by sodium
hydroxide treatment. Residues of the solvents in the modified hop
extract shall not exceed 5 parts per million of methylene chloride, 25
parts per million of hexane, and 100 parts per million of methyl
alcohol.
(4) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed
by isomerization by potassium carbonate treatment. Residues of solvents
in the modified hop extract shall not exceed 1.0 part per million of
benzene, 1.0 part per million of light petroleum spirits, 50 parts per
million of methyl alcohol, 50 parts per million 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.
[[Page 75]]
(5) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the following solvents: Ethylene
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene
chloride, trichloroethylene, and water; followed by isomerization by
calcium chloride or magnesium chloride treatment in ethylene dichloride,
methylene chloride, or trichloroethylene and a further sequence of
extractions and fractionations using one or more of the solvents set
forth in this paragraph. Residues of the solvents in the modified hop
extract shall not exceed 125 parts per million of hexane; 150 parts per
million of ethylene dichloride, methylene chloride, or
trichloroethylene; or 250 parts per million of isopropyl alcohol or
methyl alcohol.
(6) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the solvents listed in paragraph
(b)(5) of this section followed by: Hydrogenation using palladium as a
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol
acidified with hydrochloric or sulfuric acid; oxidation with peracetic
acid; isomerization by calcium chloride or magnesium chloride treatment
in ethylene dichloride, methylene chloride, or trichloroethylene
(alternatively, the hydrogenation and isomerization steps may be
performed in reverse order); and a further sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph
(b)(6) of this section followed by reduction with sodium borohydride in
aqueous alkaline methyl alcohol, and a sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section, and a boron content
level not in excess of 300 parts per million (0.0300 percent),
calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable
nonvolatile hop resin by an initial extraction and fractionation using
one or more of the solvents listed in paragraph (b)(5) of this section
followed by a sequence of aqueous extractions and removal of nonaqueous
solvents to less than 0.5 percent. The additive is added to the wort
before or during cooking in the manufacture of beer.
Sec. 172.575 Quinine.
Quinine, as the hydrochloride salt or sulfate salt, may be safely
used in food in accordance with the following conditions:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
In carbonated beverages as a flavor..... Not to exceed 83 parts per
million, as quinine. Label
shall bear a prominent
declaration of the presence
of quinine either by the use
of the word ``quinine'' in
the name of the article or
through a separate
declaration.
------------------------------------------------------------------------
Sec. 172.580 Safrole-free extract of sassafras.
The food additive safrole-free extract of sassafras may be safely
used in accordance with the following prescribed conditions:
(a) The additive is the aqueous extract obtained from the root bark
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
(b) It is obtained by extracting the bark with dilute alcohol, first
concentrating the alcoholic solution by vacuum distillation, then
diluting the concentrate with water and discarding the oily fraction.
(c) The purified aqueous extract is safrole-free.
(d) It is used as a flavoring in food.
Sec. 172.585 Sugar beet extract flavor base.
Sugar beet extract flavor base may be safely used in food in
accordance with the provisions of this section.
(a) Sugar beet extract flavor base is the concentrated residue of
soluble sugar beet extractives from which 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.
[[Page 76]]
Sec. 172.590 Yeast-malt sprout extract.
Yeast-malt sprout extract, as described in this section, may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive is produced by partial hydrolysis of yeast extract
(derived from Saccharomyces cereviseae, Saccharomyces fragilis, or
Candida utilis) using the sprout portion of malt barley as the source of
enzymes. The additive contains a maximum of 6 percent 5' nucleotides by
weight.
(b) The additive may be used as a flavor enhancer in food at a level
not in excess of that reasonably required to produce the intended
effect.
Subpart G_Gums, Chewing Gum Bases and Related Substances
Sec. 172.610 Arabinogalactan.
Arabinogalactan may be safely used in food in accordance with the
following conditions:
(a) Arabinogalactan is a polysaccharide extracted by water from
Western larch wood, having galactose units and arabinose units in the
approximate ratio of six to one.
(b) It is used in the following foods in the minimum quantity
required to produce its intended effect as an emulsifier, stabilizer,
binder, or bodying agent: Essential oils, nonnutritive sweeteners,
flavor bases, nonstandardized dressings, and pudding mixes.
Sec. 172.615 Chewing gum base.
The food additive chewing gum base may be safely used in the
manufacture of chewing gum in accordance with the following prescribed
conditions:
(a) The food additive consists of one or more of the following
substances that meet the specifications and limitations prescribed in
this paragraph, used in amounts not to exceed those required to produce
the intended physical or other technical effect.
Masticatory Substances
natural (coagulated or concentrated latices) of vegetable origin
------------------------------------------------------------------------
Family Genus and species
------------------------------------------------------------------------
Sapotaceae:
Chicle....................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Chiquibul.................... Manilkara zapotilla Gilly.
Crown gum.................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Gutta hang kang.............. Palaquium leiocarpum Boerl. and
Palaquium oblongifolium Burck.
Massaranduba balata (and the Manilkara huberi (Ducke) Chevalier.
solvent-free resin extract
of Massaranduba balata).
Massaranduba chocolate....... Manilkara solimoesensis Gilly.
Nispero...................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Rosidinha (rosadinha)........ Micropholis (also known as Sideroxylon)
spp.
Venezuelan chicle............ Manilkara williamsii Standley and
related spp.
Apocynaceae:
Jelutong..................... Dyera costulata Hook, F. and Dyera
lowii Hook, F.
Leche caspi (sorva).......... Couma macrocarpa Barb. Rodr.
Pendare...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Perillo...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca................ Brosimum utile (H.B.K.) Pittier and
Poulsenia spp.; also Lacmellea
standleyi (Woodson), Monachino
(Apocynaceae).
Niger gutta.................. Ficus platyphylla Del.
Tunu (tuno).................. Castilla fallax Cook.
Euphorbiaceae:
Chilte....................... Cnidoscolus (also known as Jatropha)
elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet Hevea brasiliensis.
and latex solids).
------------------------------------------------------------------------
Synthetic Specifications
------------------------------------------------------------------------
Butadiene-styrene rubber..... Basic polymer.
Isobutylene-isoprene Do.
copolymer (butyl rubber).
[[Page 77]]
Paraffin....................... Synthesized by Fischer-Tropsch process
from carbon monoxide and hydrogen
which are catalytically converted to a
mixture of paraffin hydrocarbon. Lower
molecular weight fractions are removed
by distillation. The residue is
hydrogenated and further treated by
percolation through activated
charcoal. The product has a congealing
point of 93[deg]-99 [deg]C as
determined by ASTM method D938-71
(Reapproved 1981), ``Standard Test
Method for Congealing Point of
Petroleum Waxes, Including
Petrolatum,'' a maximum oil content of
0.5 percent as determined by ASTM
method D721-56T, ``Tentative Method of
Test for Oil Content of Petroleum
Waxes,'' and an absorptivity of less
than 0.01 at 290 millimicrons in
decahydronaphthalene at 88 [deg]C as
determined by ASTM method D2008-80,
``Standard Test Method for Ultraviolet
Absorbance and Absorptivity of
Petroleum Products,'' which are
incorporated by reference. Copies may
be obtained from the American Society
for Testing Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia,
PA 19428-2959, or may be examined at
the National Archives and Records
Administration (NARA). For information
on the availability of this material
at NARA, call 202-741-6030, or go to:
http://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
Petroleum wax................ Complying with Sec. 172.886.
Petroleum wax synthetic...... Complying with Sec. 172.888.
Polyethylene................. Molecular weight 2,000-21,000.
Polyisobutylene.............. Minimum molecular weight 37,000
(Flory).
Polyvinyl acetate............ Molecular weight, minimum 2,000.
------------------------------------------------------------------------
Plasticizing Materials (Softeners)
------------------------------------------------------------------------
Glycerol ester of partially Having an acid number of 3-8, a minimum
dimerized rosin. drop-softening point of 109 [deg]C,
and a color of M or paler.
Glycerol ester of partially Having an acid number of 3-10, a
hydrogenated gum or wood rosin. minimum drop-softening point of 79
[deg]C, and a color of N or paler.
Glycerol ester of polymerized Having an acid number of 3-12, a
rosin. minimum melting-point of 80 [deg]C,
and a color of M or paler.
Glycerol ester of gum rosin.... Having an acid number of 5-9, a minimum
drop-softening point of 88 [deg]C, and
a color of N or paler. The ester is
purified by steam stripping.
Glycerol ester of tall oil Having an acid number of 2-12, a
rosin. softening point (ring and ball) of
80[deg]-88 [deg]C, and a color of N or
paler. The ester is purified by steam
stripping.
Glycerol ester of wood rosin... Having an acid number of 3-9, a drop-
softening point of 88 [deg]C-96
[deg]C, and a color of N or paler. The
ester is purified by steam stripping.
Lanolin........................ .......................................
Methyl ester of rosin, Having an acid number of 4-8, a
partially hydrogenated. refractive index of 1.5170-1.5205 at
20 [deg]C, and a viscosity of 23-66
poises at 25 [deg]C. The ester is
purified by steam stripping.
Pentaerythritol ester of Having an acid number of 7-18, a
partially hydrogenated gum or minimum drop-softening point of 102
wood rosin. [deg]C, and a color of K or paler.
Pentaerythritol ester of gum or Having an acid number of 6-16, a
wood rosin. minimum drop-softening point of 109
[deg]C, and a color of M or paler.
Rice bran wax.................. Complying with Sec. 172.890.
Stearic acid................... Complying with Sec. 172.860.
Sodium and potassium stearates. Complying with Sec. 172.863.
------------------------------------------------------------------------
Terpene Resins
------------------------------------------------------------------------
Synthetic resin................ Consisting of polymers of
[alpha]pinene, [beta]pinene, and/or
dipentene; acid value less than 5,
saponification number less than 5, and
color less than 4 on the Gardner scale
as measured in 50 percent mineral
spirit solution.
Natural resin.................. Consisting of polymers of [alpha]-
pinene; softening point minimum 155
[deg]C, determined by U.S.P. closed-
capillary method, United States
Pharmacopeia XX (1980) (page 961).
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
[[Page 78]]
(b) In addition to the substances listed in paragraph (a) of this
section, chewing gum base may also include substances generally
recognized as safe in food.
(c) To assure safe use of the additive, in addition to the other
information required by the act, the label and labeling of the food
additive shall bear the name of the additive, ``chewing gum base.'' As
used in this paragraph, the term ``chewing gum base'' means the
manufactured or partially manufactured nonnutritive masticatory
substance comprised of one or more of the ingredients named and so
defined in paragraph (a) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980;
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July
23, 2001; 66 FR 53711, Oct. 24, 2001]
Sec. 172.620 Carrageenan.
The food additive carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by
aqueous extraction from the following members of the families
Gigartinaceae and Solieriaceae of the class Rodophyceae (red seaweed):
Chondrus crispus.
Chondrus ocellatus.
Eucheuma cottonii.
Eucheuma spinosum.
Gigartina acicularis.
Gigartina pistillata.
Gigartina radula.
Gigartina stellata.
(b) The food additive conforms to the following conditions:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 20 percent to 40 percent on a dry-
weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, carrageenan.
Sec. 172.623 Carrageenan with polysorbate 80.
Carrageenan otherwise meeting the definition and specifications of
Sec. 172.620 (a) and (b) and salts of carrageenan otherwise meeting the
definition of Sec. 172.626(a) may be safely produced with the use of
polysorbate 80 meeting the specifications and requirements of Sec.
172.840 (a) and (b) in accordance with the following prescribed
conditions:
(a) The polysorbate 80 is used only to facilitate separation of
sheeted carrageenan and salts of carrageenan from drying rolls.
(b) The carrageenan and salts of carrageenan contain not more than 5
percent by weight of polysorbate 80, and the final food containing the
additives contains polysorbate 80 in an amount not to exceed 500 parts
per million.
(c) The carrageenan and salts of carrageenan so produced are used
only in producing foods in gel form and only for the purposes defined in
Sec. Sec. 172.620(c) and 172.626(b), respectively.
(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
[[Page 79]]
for an emulsifier, stabilizer, or thickener in foods, except for those
standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the salt of carrageenan that
dominates the mixture by reason of the modification, e.g., ``sodium
carrageenan'', ``potassium carrageenan'', etc.
Sec. 172.655 Furcelleran.
The food additive furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by
aqueous extraction of furcellaria fastigiata of the class Rodophyceae
(red seaweed).
(b) The food additive conforms to the following:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 8 percent to 19 percent, on a dry-
weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the additive, furcelleran.
Sec. 172.660 Salts of furcelleran.
The food additive salts of furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of furcelleran, meeting the
provisions of Sec. 172.655, modified by increasing the concentration of
one of the naturally occurring salts (ammonium, calcium, potassium, or
sodium) of furcelleran to the level that it is the dominant salt in the
additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of
the additive shall bear the name of the salt of furcelleran that
dominates the mixture by reason of the modification, e.g., ``sodium
furcelleran'', ``potassium furcelleran'', etc.
Sec. 172.665 Gellan gum.
The food additive gellan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a high molecular weight polysaccharide gum
produced from Pseudomonas elodea by a pure culture fermentation process
and purified by recovery with isopropyl alcohol. It is composed of
tetrasaccharide repeat units, each containing one molecule of rhamnose
and glucuronic acid, and two molecules of glucose. The glucuronic acid
is neutralized to a mixed potassium, sodium, calcium, and magnesium
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups
as the O-glycosidically linked esters.
(b) The strain of P. elodea is nonpathogenic and nontoxic in man and
animals.
(c) The additive is produced by a process that renders it free of
viable cells of P. elodea.
(d) The additive meets the following specifications:
(1) Positive for gellan gum when subjected to the following
identification tests:
(i) A 1-percent solution is made by hydrating 1 gram of gellan gum
in 99 milliliters of distilled water. The mixture is stirred for about 2
hours, using a motorized stirrer and a propeller-type stirring blade. A
small amount of the above solution is drawn into a wide 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
[[Page 80]]
the ``Gellan gum'' monograph in the Food Chemicals Codex, 7th ed.
(2010), pp. 425-426, which is incorporated by reference. The Director of
the Office of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the United States Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://
www.usp.org). Copies may be examined at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.
(e) The additive is used or intended for use in accordance with
current good manufacturing practice as a stabilizer and thickener as
defined in Sec. 170.3(o)(28) of this chapter. The additive may be used
in foods where standards of identity established under section 401 of
the Federal Food, Drug, and Cosmetic Act do not preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act, the
name of the additive and the designation ``food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992;
64 FR 1758, Jan. 12, 1999; 78 FR 71463, Nov. 29, 2013; 88 FR 17719, Mar.
24, 2023]
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:
[[Page 81]]
Pyruvic Acid Test
Pipet 10 milliliters of an 0.6 percent solution of the
polysaccharide in distilled water (60 milligrams of water-soluble gum)
into a 50-milliliter flask equipped with a standard taper glass joint.
Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux
the mixture for 3 hours. Take precautions to avoid loss of vapor during
the refluxing. Cool the solution to room temperature. Add distilled
water to make up any weight loss from the flask contents.
Pipet 1 milliliter of a 2,4-dinitro phenyl hydrazine reagent (0.5
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum)
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to
stand at room temperature for 5 minutes. Extract the mixture with 5
milliliters of ethyl acetate. Discard the aqueous layer.
Extract the hydrazone from the ethyl acetate with three 5 milliliter
portions of 10 percent sodium carbonate solution. Dilute the combined
sodium carbonate extracts to 100 milliliters with additional 10 percent
sodium carbonate in a 10-milliliter volumetric flask. Measure the
optical density of the sodium carbonate solution at 375 millimicrons.
Compare the results with a curve of the optical density versus
concentration of an authentic sample of pyruvic acid that has been run
through the procedure starting with the preparation of the hydrazone.
Record the percent by weight of pyruvic acid in the test
polysaccharide. Note ``positive'' for xanthan gum if the sample contains
more than 1.5 percent of pyruvic acid and ``negative'' for xanthan gum
if the sample contains less than 1.5 percent of pyruvic acid by weight.
(e) The additive is used or intended for use in accordance with good
manufacturing practice as a stabilizer, emulsifier, thickener,
suspending agent, bodying agent, or foam enhancer in foods for which
standards of identity established under section 401 of the Act do not
preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Act, the name of the additive and the
designation ``food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
Subpart H_Other Specific Usage Additives
Sec. 172.710 Adjuvants for pesticide use dilutions.
The following surfactants and related adjuvants may be safely added
to pesticide use dilutions by a grower or applicant prior to application
to the growing crop:
n-Alkyl (C8-C18) amine acetate, where the
alkyl groups (C8-C18) are derived from coconut
oil, as a surfactant in emulsifier blends at levels not in excess of 5
percent by weight of the emulsifier blends that are added to herbicides
for application to corn and sorghum.
Di-n-alkyl (C8-C18) dimethyl ammonium
chloride, where the alkyl groups (C8-C18) are
derived from coconut oil, as surfactants in emulsifier blends at levels
not in excess of 5 percent by weight of emulsifier blends that are added
to herbicides for application to corn or sorghum.
Diethanolamide condensate based on a mixture of saturated and
unsaturated soybean oil fatty acids (C16-C18) as a
surfactant in emulsifier blends that are added to the herbicide atrazine
for application to corn.
Diethanolamide condensate based on stripped coconut fatty acids
(C10 C18) as a surfactant in emulsifier blends
that are added to the herbicide atrazine for application to corn.
[alpha]-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of dodecylphenol (dodecyl group is a
proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of
ethylene oxide; if a blend of products is used, the average number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
Ethylene dichloride.
Polyglyceryl phthalate ester of coconut oil fatty acids.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles
of ethylene oxide; if a blend of products is used, the average number of
moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene oxide.
Sodium acrylate and acrylamide copolymer with a minimum average
molecular weight of 10,000,000 in which 30 percent of the
[[Page 82]]
polymer is comprised of acrylate units and 70 percent acrylamide units,
for use as a drift control agent in herbicide formulations applied to
crops at a level not to exceed 0.5 ounces of the additive per acre.
Sec. 172.712 1,3-Butylene glycol.
The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be
safely used in food in accordance with the following prescribed
conditions:
(a) It is prepared by the aldol condensation of acetaldehyde
followed by catalytic hydrogenation.
(b) The food additive shall conform to the identity and
specifications of the Food Chemicals Codex, 7th ed. (2010), p. 126,
which is incorporated by reference. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be
examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(c) It is used in the manufacture of sausage casings as a
formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as
a processing aid as defined in Sec. 170.3(o)(24) of this chapter.
[62 FR 26228, May 13, 1997, as amended at 78 FR 14664, Mar. 7, 2013; 78
FR 71463, Nov. 29, 2013; 88 FR 17719, Mar. 24, 2023]
Sec. 172.715 Calcium lignosulfonate.
Calcium lignosulfonate may be safely used in or on food, subject to
the provisions of this section.
(a) Calcium lignosulfonate consists of sulfonated lignin, primarily
as calcium and sodium salts.
(b) It is used in an amount not to exceed that reasonably required
to accomplish the intended physical or technical effect when added as a
dispersing agent and stabilizer in pesticides for preharvest or
postharvest application to bananas.
Sec. 172.720 Calcium lactobionate.
The food additive calcium lactobionate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the calcium salt of lactobionic acid (4-
([beta],D-galactosido)-D-gluconic acid) produced by the oxidation of
lactose.
(b) It is used or intended for use as a firming agent in dry pudding
mixes at a level not greater than that required to accomplish the
intended effect.
Sec. 172.723 Epoxidized soybean oil.
Epoxidized soybean oil may be safely used in accordance with the
following prescribed conditions:
(a) The additive is prepared by reacting soybean oil in toluene with
hydrogen peroxide and formic acid.
(b) It meets the following specifications:
(1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and
8.0 percent, as determined by the American Oil Chemists' Society
(A.O.C.S.) method Cd 9-57, ``Oxirane Oxygen,'' reapproved 1989, which is
incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR
part 51. Copies are available from the American Oil Chemists' Society,
P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9
a.m. and 4 p.m., Monday through Friday, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(2) The maximum iodine value is 3.0, as determined by A.O.C.S.
method Cd 1-25, ``Iodine Value of Fats and Oils Wijs Method,'' revised
1993, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. The availability of this incorporation by
reference is given in paragraph (b)(1) of this section.
[[Page 83]]
(3) The heavy metals (as Pb) content cannot be more than 10 parts
per million, as determined by the ``Heavy Metals Test,'' of the ``Food
Chemicals Codex,'' 4th ed. (1996), pp. 760-761, Method II (with a 2-gram
sample and 20 microgram of lead ion in the control), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Academy Press, Box 285,
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address
http://www.nap.edu), or may be examined at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(c) The additive is used as a halogen stabilizer in brominated
soybean oil at a level not to exceed 1 percent.
[60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999; 78
FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24,
2023]
Sec. 172.725 Gibberellic acid and its potassium salt.
The food additives gibberellic acid and its potassium salt may be
used in the malting of barley in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) The gibberellic acid is produced by deep-culture fermentation of
a suitable nutrient medium by a strain of Fusarium moniliforme or a
selection of this culture.
(2) The gibberellic acid produced is of 80 percent purity or better.
(3) The empirical formula of gibberellic acid is represented by
C19H22O6.
(4) Potassium gibberellate is the potassium salt of the specified
gibberellic acid.
(5) The potassium gibberellate is of 80 percent purity or better.
(6) The gibberellic acid or potassium gibberellate may be diluted
with substances generally recognized as safe in foods or with salts of
fatty acids conforming to Sec. 172.863.
(b) They are used or intended for use in the malting of barley under
conditions whereby the amount of either or both additives present in the
malt is not in excess of 2 parts per million expressed as gibberellic
acid, and the treated malt is to be used in the production of fermented
malt beverages or distilled spirits only, whereby the finished distilled
spirits contain none and the finished malt beverage contains not more
than 0.5 part per million of gibberellic acid.
(c) To insure the safe use of the food additives the label of the
package shall bear, in addition to the other information required by the
Act:
(1) The name of the additive, ``gibberellic acid'' or ``potassium
gibberellate'', whichever is appropriate.
(2) An accurate statement of the concentration of the additive
contained in the package.
(3) Adequate use directions to provide not more than 2 parts per
million of gibberellic acid in the finished malt.
(4) Adequate labeling directions to provide that the final malt is
properly labeled as described in paragraph (d) of this section.
(d) To insure the safe use of the additive the label of the treated
malt shall bear, in addition to the other information required by the
Act, the statements:
(1) ``Contains not more than 2 parts per million ______'', the blank
being filled in with the words ``gibberellic acid'' or ``potassium
gibberellate'', whichever is appropriate; and
(2) ``Brewer's malt--To be used in the production of fermented malt
beverages only'' or ``Distiller's malt--To be used in the production of
distilled spirits only'', whichever is appropriate.
Sec. 172.730 Potassium bromate.
The food additive potassium bromate may be safely used in the
malting of barley under the following prescribed conditions:
(a)(1) It is used or intended for use in the malting of barley under
conditions
[[Page 84]]
whereby the amount of the additive present in the malt from the
treatment does not exceed 75 parts per million of bromate (calculated as
Br), and the treated malt is used only in the production of fermented
malt beverages or distilled spirits.
(2) The total residue of inorganic bromides in fermented malt
beverages, resulting from the use of the treated malt plus additional
residues of inorganic bromides that may be present from uses in
accordance with other regulations in this chapter promulgated under
sections 408 and/or 409 of the act, does not exceed 25 parts per million
of bromide (calculated as Br). No tolerance is established for bromide
in distilled spirits because there is evidence that inorganic bromides
do not pass over in the distillation process.
(b) To assure safe use of the additive, the label or labeling of the
food additive shall bear, in addition to the other information required
by the Act, the following:
(1) The name of the additive.
(2) Adequate directions for use.
(c) To assure safe use of the additive, the label or labeling of the
treated malt shall bear, in addition to other information required by
the Act, the statement, ``Brewer's Malt--To be used in the production of
fermented malt beverages only'', or ``Distiller's Malt--To be used in
the production of distilled spirits only'', whichever is the case.
Sec. 172.735 Glycerol ester of rosin.
Glycerol ester of wood rosin, gum rosin, or tall oil rosin may be
safely used in food in accordance with the following prescribed
conditions:
(a) It has an acid number of 3 to 9, a drop-softening point of 88 to
96 [deg]C; and a color of N or paler as determined in accordance with
Official Naval Stores Standards of the United States. It is purified by
countercurrent steam distillation or steam stripping.
(b) It is used to adjust the density of citrus oils used in the
preparation of beverages whereby the amount of the additive does not
exceed 100 parts per million of the finished beverage.
[42 FR 14491, Mar. 15, 1977, as amended at 70 FR 15758, Mar. 29, 2005;
72 FR 46896, Aug. 22, 2007]
Sec. 172.736 Glycerides and polyglycides of hydrogenated vegetable oils.
The food additive glycerides and polyglycides of hydrogenated
vegetable oils may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is manufactured by heating a mixture of
hydrogenated oils of vegetable origin and polyethylene glycol in the
presence of an alkaline catalyst followed by neutralization with any
acid that is approved or is generally recognized as safe for this use to
yield the finished product.
(b) The additive consists of a mixture of mono-, di- and tri-
glycerides and polyethylene glycol mono- and di-esters of fatty acids
(polyglycides) of hydrogenated vegetable oils and meets the following
specifications:
(1) Total ester content, greater than 90 percent as determined by a
method entitled ``Determination of Esterified Glycerides and
Polyoxyethylene Glycols,'' approved November 16, 2001, printed by
Gattefosse S.A.S., and incorporated by reference. The Director of the
Office of the Federal Register approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a
copy from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1200 or you may examine a copy at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(2) Acid value, not greater than 2, and hydroxyl value, not greater
than 56, as determined by the methods entitled ``Acid Value,'' p. 1220
and ``Hydroxyl Value,'' p. 1223, respectively, in the Food Chemicals
Codex, 7th ed. (2010), which is incorporated by reference. The Director
of the Office of
[[Page 85]]
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies
from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be
examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(3) Lead, not greater than 0.1 mg/kg as determined by the American
Oil Chemists' Society (A.O.C.S.) method Ca 18c-91, ``Determination of
Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,''
updated 1995, and incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from American Oil
Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be
examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(4) 1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/
kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a
gas chromatographic method entitled ``Determination of Ethylene Oxide
and 1,4-Dioxane by Headspace Gas Chromatography,'' approved November 5,
1998, printed by Gattefosse S.A.S., and incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1)
of this section for availability of the incorporation by reference.
(c) The additive is used or intended for use as an excipient in
dietary supplement tablets, capsules, and liquid formulations that are
intended for ingestion in daily quantities measured in drops or similar
small units of measure.
[71 FR 12620, Mar. 13, 2006, as amended at 78 FR 71463, Nov. 29, 2013;
81 FR 5591, Feb. 3, 2016; 88 FR 17720, Mar. 24, 2023]
Sec. 172.755 Stearyl monoglyceridyl citrate.
The food additive stearyl monoglyceridyl citrate may be safely used
in food in accordance with the following provisions:
(a) The additive is prepared by controlled chemical reaction of the
following:
------------------------------------------------------------------------
Reactant Limitations
------------------------------------------------------------------------
Citric acid.............................. .............................
Monoglycerides of fatty acids............ Prepared by the glycerolysis
of edible fats and oils or
derived from fatty acids
conforming with Sec.
172.860.
Stearyl alcohol.......................... Derived from fatty acids
conforming with Sec.
172.860, or derived
synthetically in conformity
with Sec. 172.864.
------------------------------------------------------------------------
(b) The additive stearyl monoglyceridyl citrate, produced as
described under paragraph (a) of this section, meets the following
specifications:
Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Saponification number 215-255.
(c) The additive is used or intended for use as an emulsion
stabilizer in or with shortenings containing emulsifiers.
Sec. 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
The food additive succistearin (stearoyl propylene glycol hydrogen
succinate) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive is the reaction product of succinic anhydride,
fully hydrogenated vegetable oil (predominantly C16 or
C18 fatty acid chain length), and propylene glycol.
(b) The additive meets the following specifications:
Acid number 50-150.
Hydroxyl number 15-50.
Succinated ester content 45-75 percent.
[[Page 86]]
(c) The additive is used or intended for use as an emulsifier in or
with shortenings and edible oils intended for use in cakes, cake mixes,
fillings, icings, pastries, and toppings, in accordance with good
manufacturing practice.
Sec. 172.770 Ethylene oxide polymer.
The polymer of ethylene oxide may be safely used as a foam
stabilizer in fermented malt beverages in accordance with the following
conditions.
(a) It is the polymer of ethylene oxide having a minimum viscosity
of 1,500 centipoises in a 1 percent aqueous solution at 25 [deg]C.
(b) It is used at a level not to exceed 300 parts per million by
weight of the fermented malt beverage.
(c) The label of the additive bears directions for use to insure
compliance with paragraph (b) of this section.
Sec. 172.775 Methacrylic acid-divinylbenzene copolymer.
Methacrylic acid-divinylbenzene copolymer may be safely used in food
in accordance with the following prescribed conditions:
(a) The additive is produced by the polymerization of methacrylic
acid and divinylbenzene. The divinylbenzene functions as a cross-linking
agent and constitutes a minimum of 4 percent of the polymer.
(b) Aqueous extractives from the additive do not exceed 2 percent
(dry basis) after 24 hours at 25 [deg]C.
(c) The additive is used as a carrier of vitamin B12 in
foods for special dietary use.
Sec. 172.780 Acacia (gum arabic).
The food additive may be safely used in food in accordance with the
following prescribed conditions:
(a) Acacia (gum arabic) is the dried gummy exudate from stems and
branches of trees of various species of the genus Acacia, family
Leguminosae.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 8th ed. (2012), p. 516, which is incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address: http://www.usp.org). Copies may be examined at the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4
p.m., Monday through Friday. For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) The ingredient is used in food in accordance with good
manufacturing practices under the following conditions:
Maximum Usage Levels Permitted
------------------------------------------------------------------------
Food (as served) Percent Function
------------------------------------------------------------------------
Beverages, alcoholic.......... 20.0............. Thickener,
emulsifier, or
stabilizer.
Breakfast cereals, Sec. 6.0.............. Dietary fiber;
170.3(n)(4) of this chapter. emulsifier and
emulsifier salt;
flavoring agent and
adjuvant;
formulation aid;
processing aid;
stabilizer and
thickener; surface-
finishing agent;
texturizer.
Cakes, brownies, pastries, 3.0.............. Do.
biscuits, muffins, and
cookies.
Grain-based bars (e.g., 35.0............. Do.
breakfast bars, granola bars,
rice cereal bars).
Soups and soup mixes, Sec. 2.5.............. Do.
170.3(n)(40) of this chapter,
except for soups and soup
mixes containing meat or
poultry that are subject to
regulation by the U.S.
Department of Agriculture
under the Federal Meat
Inspection Act or the Poultry
Products Inspection Act.
Food categories listed in Sec. Levels prescribed Dietary fiber.
184.1330 of this chapter, in Sec.
except for meat, poultry, and 184.1330 of this
foods for which standards of chapter.
identity established under
section 401 of the Federal
Food, Drug, and Cosmetic Act
preclude the use of acacia.
------------------------------------------------------------------------
[[Page 87]]
[70 FR 8034, Feb. 17, 2005, as amended at 78 FR 71464, Nov. 29, 2013; 78
FR 73437, Dec. 6, 2013; 88 FR 17720, Mar. 24, 2023]
Sec. 172.785 Listeria-specific bacteriophage preparation.
The additive may be safely used as an antimicrobial agent specific
for Listeria monocytogenes (L. monocytogenes) in accordance with the
following conditions:
(a) Identity. (1) The additive consists of a mixture of equal
proportions of six different individually purified lytic-type (lacking
lysogenic activity) bacteriophages (phages) specific against L.
monocytogenes.
(2) Each phage is deposited at, and assigned an identifying code by,
a scientifically-recognized culture collection center, and is made
available to FDA upon request.
(3) The additive is produced from one or more cell cultures of L.
monocytogenes in a safe and suitable nutrient medium.
(b) Specifications. (1) The additive achieves a positive lytic
result (OD600 <=0.06) when tested against any of the
following L. monocytogenes isolates available from American Type Culture
Collection (ATCC): ATCC 35152 (serogroup 1/2a), ATCC 19118 (serogroup
4b), and ATCC 15313 (serogroup 1/2b). The analytical method for
determining the potency of the additive entitled ``Determination of
Potency of LMP-102 \TM\,'' dated October 9, 2003, and printed by
Intralytix, Inc., is incorporated by reference. The Director of the
Office of the Federal Register approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a
copy from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(2) The mean phage titer of each monophage in the additive is 1 x
10\9\ plaque forming units (PFU)/ml. The analytical method for
determining phage titer entitled ``Method to Determine Lytic Activity/
Phage Titer,'' dated November 6, 2001, and printed by Intralytix, Inc.,
is incorporated by reference. Copies are available at locations cited in
paragraph (b)(1) of this section.
(3) The phages present in the preparation must not contain a
functional portion of any of the toxin-encoding sequences described in
40 CFR 725.421(d). No sequences derived from genes encoding bacterial
16S ribosomal RNA are present in the complete genomic sequence of the
phages.
(4) L. monocytogenes toxin, listeriolysin O (LLO), is not greater
than 5 hemolytic units (HU)/ml. The analytical method for determining
LLO entitled ``Quantitation of Listeriolysin O Levels in LMP-102 \TM\,''
dated September 27, 2004, and printed by Intralytix, Inc., is
incorporated by reference. Copies are available at locations cited in
paragraph (b)(1) of this section.
(5) The additive is negative for L. monocytogenes. The modified
version of the U.S. Department of Agriculture's method for determining
L. monocytogenes entitled ``LMP-102 \TM\ Listeria monocytogenes
Sterility Testing,'' dated May 24, 2004, and printed by Intralytix,
Inc., is incorporated by reference. Copies are available at locations
cited in paragraph (b)(1) of this section.
(6) The additive is negative for gram-positive and gram-negative
bacteria capable of growing in commonly used microbiological media
(e.g., Luria-Bertani (LB) medium), including Escherichia coli,
Salmonella species and coagulase-positive Staphylococci, as determined
by the ``Method to Determine Microbial Contamination,'' dated July 11,
2003, and printed by Intralytix, Inc., is incorporated by reference.
Copies are available at locations cited in paragraph (b)(1) of this
section.
[[Page 88]]
(7) Total organic carbon (TOC) is less than or equal to 36 mg/kg.
The analytical method for determining TOC entitled ``Determination of
Total Organic Carbon by Automated Analyzer,'' dated March 30, 2001, and
printed by Intralytix, Inc., is incorporated by reference. Copies are
available at locations cited in paragraph (b)(1) of this section.
(c) Conditions of use. The additive is used in accordance with
current good manufacturing practice to control L. monocytogenes by
direct application to meat and poultry products that comply with the
ready-to-eat definition in 9 CFR 430.1. Current good manufacturing
practice is consistent with direct spray application of the additive at
a rate of approximately 1 mL of the additive per 500 cm\2\ product
surface area.
[71 FR 47731, Aug. 18, 2006, as amended at 81 FR v5591, Feb. 3, 2016; 88
FR 17720, Mar. 24, 2023]
Subpart I_Multipurpose Additives
Sec. 172.800 Acesulfame potassium.
Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as
acesulfame K, may be safely used as a general-purpose sweetener and
flavor enhancer in foods generally, except in meat and poultry, in
accordance with current good manufacturing practice and in an amount not
to exceed that reasonably required to accomplish the intended technical
effect in foods for which standards of identity established under
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude
such use, under the following conditions:
(a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-
oxathiazine-4(3H)-one-2,2-dioxide.
(b) The additive meets the following specifications:
(1) Purity is not less than 99 percent on a dry basis. The purity
shall be determined by a method titled ``Acesulfame Potassium Assay,''
which is incorporated by reference. Copies are available from the Office
of Food Additive Safety (HFS-200), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-1200, or available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(2) Fluoride content is not more than 30 milligrams per kilogram, as
determined by method III of the Fluoride Limit Test of the Food
Chemicals Codex, 7th ed. (2010), p. 1151, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) If the food containing the additive is represented to be for
special dietary uses, it shall be labeled in compliance with part 105 of
this chapter.
[53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59
FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR
36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003; 78 FR 71464, Nov. 29,
2013; 88 FR 17720, Mar. 24, 2023]
Sec. 172.802 Acetone peroxides.
The food additive acetone peroxides may be safely used in flour, and
in bread and rolls where standards of identity do not preclude its use,
in accordance with the following prescribed conditions:
(a) The additive is a mixture of monomeric and linear dimeric
acetone peroxide, with minor proportions of higher polymers,
manufactured by reaction of hydrogen peroxide and acetone.
[[Page 89]]
(b) The additive may be mixed with an edible carrier to give a
concentration of: (1) 3 grams to 10 grams of hydrogen peroxide
equivalent per 100 grams of the additive, plus carrier, for use in flour
maturing and bleaching; or (2) approximately 0.75 gram of hydrogen
peroxide equivalent per 100 grams of the additive, plus carrier, for use
in dough conditioning.
(c) It is used or intended for use: (1) In maturing and bleaching of
flour in a quantity not more than sufficient for such effect; and (2) as
a dough-conditioning agent in bread and roll production at not to exceed
the quantity of hydrogen peroxide equivalent necessary for the
artificial maturing effect.
(d) To insure safe use of the additive, the label of the food
additive container and any intermediate premix thereof shall bear, in
addition to the other information required by the act:
(1) The name of the additive, ``acetone peroxides''.
(2) The concentration of the additive expressed in hydrogen peroxide
equivalents per 100 grams.
(3) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (c) of this section.
Sec. 172.803 Advantame.
(a) Advantame is the chemical N-[N-[3-(3-hydroxy-4-
methoxyphenyl)propyl]-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester,
monohydrate (CAS Reg. No. 714229-20-6).
(b) Advantame meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled ``Specifications and Analytical Methods for Advantame'' dated
April 1, 2009, by the Ajinomoto Co. Inc., Sweetener Department 15-1,
Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315, Japan. 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 Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200. Copies may be examined
at the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030 or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) Assay for advantame, not less than 97.0 percent and not more
than 102.0 percent on a dry basis.
(2) Free N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-[alpha]-
aspartyl]-L-phenylalanine, not more than 1.0 percent.
(3) Total other related substances, not more than 1.5 percent.
(4) Lead, not more than 1.0 milligram per kilogram.
(5) Water, not more than 5.0 percent.
(6) Residue on ignition, not more than 0.2 percent.
(7) Specific rotation, determined at20 [deg]C [[alpha]]D:
-45.0 to -38.0[deg] calculated on a dry basis.
(c) The food additive advantame may be safely used as a sweetening
agent and flavor enhancer in foods generally, except in meat and
poultry, in accordance with current good manufacturing practice, in an
amount not to exceed that reasonably required to achieve the intended
technical effect, in foods for which standards of identity established
under section 401 of the Federal Food, Drug, and Cosmetic Act do not
preclude such use.
(d) If the food containing the additive purports to be or is
represented to be for special dietary use, it must be labeled in
compliance with part 105 of this chapter.
[79 FR 29085, May 21, 2014, as amended at 88 FR 17720, Mar. 24, 2023]
Sec. 172.804 Aspartame.
The food additive aspartame may be safely used in food in accordance
with good manufacturing practice as a sweetening agent and a flavor
enhancer in foods for which standards of identity established under
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude
such use under the following conditions:
[[Page 90]]
(a) Aspartame is the chemical 1-methyl N-l-[alpha]-aspartyl-l-
phenylalanine (C14H18N2O5).
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 73-74, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c)(1) When aspartame is used as a sugar substitute tablet for
sweetening hot beverages, including coffee and tea, L-leucine may be
used as a lubricant in the manufacture of such tablets at a level not to
exceed 3.5 percent of the weight of the tablet.
(2) When aspartame is used in baked goods and baking mixes, the
amount of the additive is not to exceed 0.5 percent by weight of ready-
to-bake products or of finished formulations prior to baking. Generally
recognized as safe (GRAS) ingredients or food additives approved for use
in baked goods shall be used in combination with aspartame to ensure its
functionality as a sweetener in the final baked product. The level of
aspartame used in these products is determined by an analytical method
entitled ``Analytical Method for the Determination of Aspartame and
Diketopiperazine in Baked Goods and Baking Mixes,'' October 8, 1992,
which was developed by the Nutrasweet Co. Copies are available from the
Office of Food Additive Safety (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1200, or are available for inspection at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, and at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The principal display panel of any intermediate mix of the
additive for manufacturing purposes shall bear a statement of the
concentration of the additive contained therein;
(2) The label of any food containing the additive shall bear, either
on the principal display panel or on the information panel, the
following statement:
PHENYLKETONURICS: CONTAINS PHENYLALANINE
The statement shall appear in the labeling prominently and conspicuously
as compared to other words, statements, designs or devices and in bold
type and on clear contrasting background in order to render it likely to
be read and understood by the ordinary individual under customary
conditions of purchase and use.
(3) When the additive is used in a sugar substitute for table use,
its label shall bear instructions not to use in cooking or baking.
(4) Packages of the dry, free-flowing additive shall prominently
display the sweetening equivalence in teaspoons of sugar.
(e) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
[39 FR 27319, July 26, 1974]
Editorial Note: For Federal Register citations affecting Sec.
172.804, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
[[Page 91]]
Sec. 172.806 Azodicarbonamide.
The food additive azodicarbonamide may be safely used in food in
accordance with the following prescribed conditions:
(a) It is used or intended for use:
(1) As an aging and bleaching ingredient in cereal flour in an
amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent;
45 parts per million).
(2) As a dough conditioner in bread baking in a total amount not to
exceed 0.0045 percent (45 parts per million) by weight of the flour
used, including any quantity of azodicarbonamide added to flour in
accordance with paragraph (a)(1) of this section.
(b) To assure safe use of the additive:
(1) The label and labeling of the additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the Act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or the strength of the
additive in any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions for use.
Sec. 172.808 Copolymer condensates of ethylene oxide and propylene oxide.
Copolymer condensates of ethylene oxide and propylene oxide may be
safely used in food under the following prescribed conditions:
(a) The additive consists of one of the following:
(1) [alpha]-Hydro-omega-hydroxy-poly (oxyethylene)
poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer,
having a molecular weight range of 9,760-13,200 and a cloud point above
100 [deg]C in 1 percent aqueous solution.
(2) [alpha]-Hydro-omega-hydroxy-poly (oxy
ethylene)poly(oxypropylene)-(53-59 moles)poly(oxyethylene)(14-16 moles)
block copolymer, having a molecular weight range of 3,500-4,125 and a
cloud point of 9 [deg]C-12 [deg]C in 10 percent aqueous solution.
(3) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene)/
poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer,
having a minimum average molecular weight of 1900 and a minimum cloud
point of 9 [deg]C-12 [deg]C in 10 percent aqueous solution.
(4) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene) poly
(oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having
an average molecular weight of 14,000 and a cloud point above 100 [deg]C
in 1 percent aqueous solution.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used in practice as a solubilizing and stabilizing agent in flavor
concentrates (containing authorized flavoring oils) for use in foods for
which standards of identity established under section 401 of the Act do
not preclude such use, provided that the weight of the additive does not
exceed the weight of the flavoring oils in the flavor concentrate.
(2) The additive identified in paragraph (a)(2) of this section is
used as a processing aid and wetting agent in combination with dioctyl
sodium sulfosuccinate for fumaric acid as prescribed in Sec. 172.810.
(3) The additive identified in paragraph (a)(3) of this section is
used:
(i) As a surfactant and defoaming agent, at levels not to exceed
0.05 percent by weight, in scald baths for poultry defeathering,
followed by potable water rinse. The temperatures of the scald baths
shall be not less than 125 [deg]F.
(ii) As a foam control and rinse adjuvant in hog dehairing machines
at a use level of not more than 5 grams per hog.
(4) The additive identified in paragraph (a)(4) of this section is
used as a dough conditioner in yeast-leavened bakery products for which
standards of identity established under section 401 of the Act do not
preclude such use, provided that the amount of the additive dose not
exceed 0.5 percent by weight of the flour used.
[42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24, 1981]
Sec. 172.809 Curdlan.
Curdlan may be safely used in accordance with the following
conditions:
(a) Curdlan is a high molecular weight polymer of glucose ([beta]-
1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture
fermentation
[[Page 92]]
from the nonpathogenic and nontoxicogenic bacterium Alcaligenes faecalis
var. myxogenes.
(b) Curdlan meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled ``Analytical Methods for Specification Tests for Curdlan,'' by
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku,
Tokyo, 103, Japan, 1996, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1200, or may be examined at the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9
a.m. and 4 p.m., Monday through Friday, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(1) Positive for curdlan.
(2) Assay for curdlan (calculated as anhydrous glucose), not less
than 80 percent.
(3) pH of 1 percent aqueous suspension, 6.0-7.5.
(4) Lead, not more than 0.5 mg/kg.
(5) Heavy metals (as Pb), not more than 0.002 percent.
(6) Total nitrogen, not more than 0.2 percent.
(7) Loss on drying, not more than 10 percent.
(8) Residue on ignition, not more than 6 percent.
(9) Gel strength of 2 percent aqueous suspension, not less than 600
x 10\3\ dyne per square centimeter.
(10) Aerobic plate count, not more than 10\3\ per gram.
(11) Coliform bacteria, not more than 3 per gram.
(c) Curdlan is used or intended for use in accordance with good
manufacturing practice as a formulation aid, processing aid, stabilizer
and thickener, and texturizer in foods for which standards of identity
established under section 401 of the act do not preclude such use.
[61 FR 65941, Dec. 16, 1996, as amended at 78 FR 14665, Mar. 7, 2013; 81
FR 5591, Feb. 3, 2016; 88 FR 17720, Mar. 24, 2023]
Sec. 172.810 Dioctyl sodium sulfosuccinate.
The food additive, dioctyl sodium sulfosuccinate, meets the
specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 313-314,
which is incorporated by reference. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be
examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html). The
food additive, dioctyl sodium sulfosuccinate, may be safely used in food
in accordance with the following prescribed conditions:
(a) As a wetting agent in the following fumaric acid-acidulated
foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks,
when standards of identity do not preclude such use. The labeling of the
dry gelatin dessert and dry beverage base shall bear adequate directions
for use, and the additive shall be used in such an amount that the
finished gelatin dessert will contain not in excess of 15 parts per
million of the additive and the finished beverage or fruit juice drink
will contain not in excess of 10 parts per million of the additive.
(b) As a processing aid in sugar factories in the production of
unrefined cane sugar, in an amount not in excess of 0.5 part per million
of the additive per percentage point of sucrose in the
[[Page 93]]
juice, syrup, or massecuite being processed, and so used that the final
molasses will contain no more than 25 parts per million of the additive.
(c) As a solubilizing agent on gums and hydrophilic colloids to be
used in food as stabilizing and thickening agents, when standards of
identity do not preclude such use. The additive is used in an amount not
to exceed 0.5 percent by weight of the gums or hydrophilic colloids.
(d) As an emulsifying agent for cocoa fat in noncarbonated beverages
containing cocoa, whereby the amount of the additive does not exceed 25
parts per million of the finished beverage.
(e) As a dispersing agent in ``cocoa with dioctyl sodium
sulfosuccinate for manufacturing'' that conforms to the provisions of
Sec. 163.117 of this chapter and the use limitations prescribed in
Sec. 172.520, in an amount not to exceed 0.4 percent by weight thereof.
(f) As a processing aid and wetting agent in combination with
[alpha]-hydro-omega -hydroxy - poly(oxyethylene) - poly-(oxypropylene)
(53-59 moles) poly(oxyethylene) (14-16 moles) block copolymer, having a
molecular weight range of 3,500-4,125 and a cloud point of 9 [deg]C-12
[deg]C in 10 percent aqueous solution, for fumaric acid used in fumaric
acid-acidulated dry beverage base and in fumaric acid-acidulated fruit
juice drinks, when standards of identity do not preclude such use. The
labeling of the dry beverage base shall bear adequate directions for
use, and the additives shall be used in such an amount that the finished
beverage or fruit juice drink will contain not in excess of a total of
10 parts per million of the dioctyl sodium sulfosuccinate-block
copolymer combination.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984;
78 FR 71464, Nov. 29, 2013; 88 FR 17720, Mar. 24, 2023]
Sec. 172.811 Glyceryl tristearate.
The food additive glyceryl tristearate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive (CAS Reg. No. 555-43-1) is prepared by
reacting stearic acid with glycerol in the presence of a suitable
catalyst.
(b) The food additive meets the following specifications:
Acid number: Not to exceed 1.0.
Iodine number: Not to exceed 1.0.
Saponification number: 186-192.
Hydroxyl number: Not to exceed 5.0.
Free glycerol content: Not to exceed 0.5 percent.
Unsaponifiable matter: Not to exceed 0.5 percent.
Melting point (Class II): 69 [deg]C-73 [deg]C.
(c) The additive is used or intended for use as follows when
standards of identity established under section 401 of the Act do not
preclude such use:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
1. As a crystallization accelerator Not to exceed 1 percent of the
in cocoa products, in imitation combined weight of the
chocolate, and in compound coatings. formulation.
2. As a formulation aid as defined in Not to exceed 0.5 percent.
Sec. 170.3(o)(14) of this chapter,
lubricant and release agent as
defined in Sec. 170.3(o)(18) of
this chapter, and surface-finishing
agent as defined in Sec.
170.3(o)(30) of this chapter in food.
3. As a formulation aid as defined in Not to exceed 3.0 percent of the
Sec. 170.3(o)(14) of this chapter combined weight of the
in confections. formulation.
4. As a formulation aid as defined in Not to exceed 1.0 percent of the
Sec. 170.3(o)(14) of this chapter combined weight of the
in fats and oils as defined in Sec. formulation.
170.3 (n)(12) of this chapter.
5. As a winterization and Not to exceed 0.5 percent by
fractionation aid in fat and oil weight of the processed fat or
processing. oil.
------------------------------------------------------------------------
(d) To assure safe use of the additive:
(1) In addition to the other information required by the act, the
label or labeling of the additive shall bear the name of the additive.
(2) The label of the additive shall bear adequate directions to
provide a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994]
Sec. 172.812 Glycine.
The food additive glycine may be safely used for technological
purposes in food in accordance with the following prescribed conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 457-458, which is incorporated by reference.
The Director of
[[Page 94]]
the Office of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the United States Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://
www.usp.org). Copies may be examined at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html.
(b) The additive is used or intended for use as follows:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
As a masking agent for the bitter Not to exceed 0.2 percent in
aftertaste of saccharin used in the finished beverage.
manufactured beverages and beverage bases.
As a stabilizer in mono- and diglycerides Not to exceed 0.02 percent
prepared by the glycerolysis of edible of the mono- and
fats or oils. diglycerides.
------------------------------------------------------------------------
(c) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The labeling of the additive shall bear adequate directions for
use of the additive in compliance with the provisions of this section.
(2) The labeling of beverage bases containing the additive shall
bear adequate directions for use to provide that beverages prepared
therefrom shall contain no more than 0.2 percent glycine.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984;
78 FR 71464, Nov. 29, 2013; 88 FR 17720, Mar. 24, 2023]
Sec. 172.814 Hydroxylated lecithin.
The food additive hydroxylated lecithin may be safely used as an
emulsifier in foods in accordance with the following conditions:
(a) The additive is obtained by the treatment of lecithin in one of
the following ways, under controlled conditions whereby the separated
fatty acid fraction of the resultant product has an acetyl value of 30
to 38:
(1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and
sodium hydroxide.
(2) With hydrogen peroxide, acetic acid, and sodium hydroxide.
(b) It is used or intended for use, in accordance with good
manufacturing practice, as an emulsifier in foods, except for those
standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, ``hydroxylated lecithin''.
(2) Adequate directions for its use.
Sec. 172.816 Methyl glucoside-coconut oil ester.
Methyl glucoside-coconut oil ester may be safely used in food in
accordance with the following conditions:
(a) It is the methyl glucoside-coconut oil ester having the
following specifications:
Acid number: 10-20
Hydroxyl number: 200-300
pH (5% aqueous): 4.8-5.0
Saponification number: 178-190
(b) It is used or intended for use as follows:
(1) As an aid in crystallization of sucrose and dextrose at a level
not to exceed the minimum quantity required to produce its intended
effect.
(2) As a surfactant in molasses at a level not to exceed 320 parts
per million in the molasses.
Sec. 172.818 Oxystearin.
The food additive oxystearin may be safely used in foods, when such
use is not precluded by standards of identity in accordance with the
following conditions:
(a) The additive is a mixture of the glycerides of partially
oxidized stearic and other fatty acids obtained by heating hydrogenated
cottonseed or soybean oil under controlled conditions, in the presence
of air and a suitable catalyst which is not a food additive as so
defined. The resultant product meets the following specifications:
Acid number: Maximum 15.
[[Page 95]]
Iodine number: Maximum 15.
Saponification number: 225-240.
Hydroxyl number: 30-45.
Unsaponifiable material: Maximum 0.8 percent.
Refractive index (butyro): 601 at 48 [deg]C.
(b) It is used or intended for use as a crystallization inhibitor in
vegetable oils and as a release agent in vegetable oils and vegetable
shortenings, whereby the additive does not exceed 0.125 percent of the
combined weight of the oil or shortening.
(c) To insure safe use of the additive, the label and labeling of
the additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive.
(2) Adequate directions to provide an oil or shortening that
complies with the limitations prescribed in paragraph (b) of this
section.
Sec. 172.820 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a) Identity. (1) The additive is an addition polymer of ethylene
oxide and water with a mean molecular weight of 200 to 9,500.
(2) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols when tested by the analytical methods prescribed
in paragraph (b) of this section.
(b) Analytical method. (1) The analytical method prescribed in the
National Formulary XV (1980), page 1244, for polyethylene glycol 400
shall be used to determine the total ethylene and diethylene glycol
content of polyethylene glycols having mean molecular weights of 450 or
higher.
(2) The following analytical method shall be used to determine the
total ethylene and diethylene glycol content of polyethylene glycols
having mean molecular weights below 450.
Analytical Method
ethylene glycol and diethylene glycol content of polyethylene glycols
The analytical method for determining ethylene glycol and diethylene
glycol is as follows:
apparatus
Gas chromatograph with hydrogen flame ionization detector (Varian
Aerograph 600 D or equivalent). The following conditions shall be
employed with the Varian Aerograph 600 D gas chromatograph:
Column temperature: 165 [deg]C.
Inlet temperature: 260 [deg]C.
Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
Hydrogen and air flow to burner: Optimize to give maximum
sensitivity.
Sample size: 2 microliters.
Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5
minutes.
Recorder: -0.5 to + 1.05 millivolt, full span, 1 second full
response time.
Syringe: 10-microliter (Hamilton 710 N or equivalent).
Chromatograph column: 5 feet x \1/8\ inch. I.D. stainless steel tube
packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, or
equivalent) 12 percent in H2O by weight on 60-80 mesh nonacid
washed diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent).
reagents and materials
Carrier gas, nitrogen: Commercial grade in cylinder equipped with
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
Ethylene glycol: Commercial grade. Purify if necessary, by
distillation.
Diethylene glycol: Commercial grade. Purify, if necessary, by
distillation.
Glycol standards: Prepare chromatographic standards by dissolving
known amounts of ethylene glycol and diethylene glycol in water.
Suitable concentrations for standardization range from 1 to 6 milligrams
of each component per milliliter (for example 10 milligrams diluted to
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram
per milliliter).
standardization
Inject a 2-microliter aliquot of the glycol standard into the gas
chromatograph employing the conditions described above. Measure the net
peak heights for the ethylene glycol and for the diethylene glycol.
Record the values as follows:
A = Peak height in millimeters of the ethylene glycol peak.
B = milligrams of ethylene glycol per milliliter of standard
solution.
C = Peak height in millimeters of the diethylene glycol peak.
D = Milligrams of diethylene glycol per milliliter of standard
solution.
procedure
Weigh approximately 4 grams of polyethylene glycol sample accurately
into a 10-milliliter volumetric flask. Dilute to volume with water. Mix
the solution thoroughly and
[[Page 96]]
inject a 2-microliter aliquot into the gas chromatograph. Measure the
heights, in millimeters, of the ethylene glycol peak and of the
diethylene glycol peak and record as E and F, respectively.
Percent ethylene glycol = (E x B) / (A x sample weight in grams)
Percent diethylene glycol = (F x D) / (C x sample weight in grams)
(c) Uses. It may be used, except in milk or preparations intended
for addition to milk, as follows:
(1) As a coating, binder, plasticizing agent, and/or lubricant in
tablets used for food.
(2) As an adjuvant to improve flavor and as a bodying agent in
nonnutritive sweeteners identified in Sec. 180.37 of this chapter.
(3) As an adjuvant in dispersing vitamin and/or mineral
preparations.
(4) As a coating on sodium nitrite to inhibit hygroscopic
properties.
(d) Limitations. (1) It is used in an amount not greater than that
required to produce the intended physical or technical effect.
(2) A tolerance of zero is established for residues of polyethylene
glycol in milk.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
Sec. 172.822 Sodium lauryl sulfate.
The food additive sodium lauryl sulfate may be safely used in food
in accordance with the following conditions:
(a) The additive meets the following specifications:
(1) It is a mixture of sodium alkyl sulfates consisting chiefly of
sodium lauryl sulfate
[CH2(CH2)10CH2OSO2
Na].
(2) It has a minimum content of 90 percent sodium alkyl sulfates.
(b) It is used or intended for use:
(1) As an emulsifier in or with egg whites whereby the additive does
not exceed the following limits:
Egg white solids, 1,000 parts per million.
Frozen egg whites, 125 parts per million.
Liquid egg whites, 125 parts per million.
(2) As a whipping agent at a level not to exceed 0.5 percent by
weight of gelatine used in the preparation of marshmallows.
(3) As a surfactant in:
(i) Fumaric acid-acidulated dry beverage base whereby the additive
does not exceed 25 parts per million of the finished beverage and such
beverage base is not for use in a food for which a standard of identity
established under section 401 of the Act precludes such use.
(ii) Fumaric acid-acidulated fruit juice drinks whereby the additive
does not exceed 25 parts per million of the finished fruit juice drink
and it is not used in a fruit juice drink for which a standard of
identity established under section 401 of the Act precludes such use.
(4) As a wetting agent at a level not to exceed 10 parts per million
in the partition of high and low melting fractions of crude vegetable
oils and animal fats, provided that the partition step is followed by a
conventional refining process that includes alkali neutralization and
deodorization of the fats and oils.
(c) To insure the safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, sodium lauryl sulfate.
(2) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978]
Sec. 172.824 Sodium mono- and dimethyl naphthalene sulfonates.
The food additive sodium mono- and dimethyl naphthalene sulfonates
may be safely used in accordance with the following prescribed
conditions:
(a) The additive has a molecular weight range of 245-260.
(b) The additive is used or intended for use:
(1) In the crystallization of sodium carbonate in an amount not to
exceed 250 parts per million of the sodium carbonate. Such sodium
carbonate is used or intended for use in potable water systems to reduce
hardness and aid in sedimentation and coagulation by raising the pH for
the efficient utilization of other coagulation materials.
(2) As an anticaking agent in sodium nitrite at a level not in
excess of 0.1 percent by weight thereof for authorized uses in cured
fish and meat.
[[Page 97]]
(c) In addition to the general labeling requirements of the Act:
(1) Sodium carbonate produced in accordance with paragraph (b)(1) of
this section shall be labeled to show the presence of the additive and
its label or labeling shall bear adequate directions for use.
(2) Sodium nitrite produced in accordance with paragraph (b)(2) of
this section shall bear the labeling required by Sec. 172.175 and a
statement declaring the presence of sodium mono- and dimethyl
naphthalene sulfonates.
[42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998]
Sec. 172.826 Sodium stearyl fumarate.
Sodium stearyl fumarate may be safely used in food in accordance
with the following conditions:
(a) It contains not less than 99 percent sodium stearyl fumarate
calculated on the anhydrous basis, and not more than 0.25 percent sodium
stearyl maleate.
(b) The additive is used or intended for use:
(1) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(2) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 1 percent by weight thereof.
(3) As a stabilizing agent in nonyeast-leavened bakery products in
an amount not to exceed 1 percent by weight of the flour used.
(4) As a conditioning agent in processed cereals for cooking in an
amount not to exceed 1 percent by weight of the dry cereal, except for
foods for which standards of identity preclude such use.
(5) As a conditioning agent in starch-thickened or flour-thickened
foods in an amount not to exceed 0.2 percent by weight of the food.
Sec. 172.828 Acetylated monoglycerides.
The food additive acetylated monoglycerides may be safely used in or
on food in accordance with the following prescribed conditions:
(a) The additive is manufactured by:
(1) The interesterification of edible fats with triacetin and in the
presence of catalytic agents that are not food additives or are
authorized by regulation, followed by a molecular distillation or by
steam stripping; or
(2) The direct acetylation of edible monoglycerides with acetic
anhydride without the use of catalyst or molecular distillation, and
with the removal by vacuum distillation, if necessary, of the acetic
acid, acetic anhydride, and triacetin.
(b) The food additive has a Reichert-Meissl value of 75-200 and an
acid value of less than 6.
(c) The food additive is used at a level not in excess of the amount
reasonably required to produce its intended effect in food, or in food-
processing, food-packing, or food-storage equipment.
[42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985]
Sec. 172.829 Neotame.
(a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).
(b) Neotame meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled ``Specifications and Analytical Methods for Neotame'' dated
April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount
Prospect, IL 60056. The Director of the Office of the Federal Register
has approved the incorporation by reference of this material in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1200. Copies may be examined at the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9
a.m. and 4 p.m., Monday through Friday, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
[[Page 98]]
(1) Assay for neotame, not less than 97.0 percent and not more than
102.0 percent on a dry basis.
(2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine), not more than 1.5 percent.
(3) Other related substances, not more than 2.0 percent.
(4) Lead, not more than 2.0 milligrams per kilogram.
(5) Water, not more than 5.0 percent.
(6) Residue on ignition, not more than 0.2 percent
(7) Specific rotation, determined at 20 [deg]C
[[alpha]]D: -40.0[deg] to 43.4[deg] calculated on a dry
basis.
(c) The food additive neotame may be safely used as a sweetening
agent and flavor enhancer in foods generally, except in meat and
poultry, in accordance with current good manufacturing practice, in an
amount not to exceed that reasonably required to accomplish the intended
technical effect, in foods for which standards of identity established
under section 401 of the Federal Food, Drug, and Cosmetic Act do not
preclude such use.
(d) When neotame is used as a sugar substitute tablet, L-leucine may
be used as a lubricant in the manufacture of tablets at a level not to
exceed 3.5 percent of the weight of the tablet.
(e) If the food containing the additive purports to be or is
represented to be for special dietary use, it shall be labeled in
compliance with part 105 of this chapter.
[67 FR 45310, July 9, 2002, as amended at 81 FR 5591, Feb. 3, 2016; 88
FR 17721, Mar. 24, 2023]
Sec. 172.830 Succinylated monoglycerides.
The food additive succinylated monoglycerides may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is a mixture of semi-and neutral succinic acid
esters of mono- and diglycerides produced by the succinylation of a
product obtained by the glycerolysis of edible fats and oils, or by the
direct esterification of glycerol with edible fat-forming fatty acids.
(b) The additive meets the following specifications:
Succinic acid content: 14.8%-25.6%
Melting point: 50 [deg]C-60 [deg]C.
Acid number: 70-120
(c) The additive is used or intended for use in the following foods:
(1) As an emulsifier in liquid and plastic shortenings at a level
not to exceed 3 percent by weight of the shortening.
(2) As a dough conditioner in bread baking, when such use is
permitted by an appropriate food standard, at a level not to exceed 0.5
percent by weight of the flour used.
Sec. 172.831 Sucralose.
(a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-[beta]-D-
fructofuranosyl-4-chloro-4-deoxy-[alpha]-D-galactopyranoside (CAS Reg.
No. 56038-13-2).
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 993-995, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) The additive may be used as a sweetener in foods generally, in
accordance with current good manufacturing practice in an amount not to
exceed that reasonably required to accomplish the intended effect.
(d) If the food containing the additive purports to be or is
represented to be for special dietary use, it shall be labeled in
compliance with part 105 of this chapter.
[63 FR 16433, Apr. 3, 1998, as amended at 64 FR 43909, Aug. 12, 1999; 78
FR 14665, Mar. 7, 2013; 78 FR 71464, Nov. 29, 2013; 88 FR 17721, Mar.
24, 2023]
[[Page 99]]
Sec. 172.832 Monoglyceride citrate.
A food additive that is a mixture of glyceryl monooleate and its
citric acid monoester manufactured by the reaction of glyceryl
monooleate with citric acid under controlled conditions may be safely
used as a synergist and solubilizer for antioxidants in oils and fats,
when used in accordance with the conditions prescribed in this section.
(a) The food additive meets the following specifications:
Acid number, 70-100.
Total citric acid (free and combined), 14 percent-17 percent.
(b) It is used, or intended for use, in antioxidant formulations for
addition to oils and fats whereby the additive does not exceed 200 parts
per million of the combined weight of the oil or fat and the additive.
(c) To assure safe use of the additive:
(1) The container label shall bear, in addition to the other
information required by the Act, the name of the additive.
(2) The label or accompanying labeling shall bear adequate
directions for the use of the additive which, if followed, will result
in a food that complies with the requirements of this section.
Sec. 172.833 Sucrose acetate isobutyrate (SAIB).
Sucrose acetate isobutyrate may be safely used in foods in
accordance with the following prescribed conditions:
(a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB,
is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-
oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).
(b) SAIB, a pale, straw-colored liquid, meets the following
specifications: (1) Assay: Not less than 98.8 percent and not more than
101.9 percent, based on the following formula:
Assay = ((SV 0.10586) / 56.1) x 100
Where SV = Saponification value
(2) Saponification value: 524-540 determined using 1 gram of sample
by the ``Guide to Specifications for General Notices, General Analytical
Techniques, Identification Tests, Test Solutions, and Other Reference
Materials,'' in the ``Compendium of Food Additive Specifications,
Addendum 4, Food and Agriculture Organization of the United Nations
(FAO), Food and Nutrition Paper 5, Revision 2'' (1991), pp. 203 and 204,
which is incorporated by reference, in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Office of Food Additive
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200, or may be examined at the Dockets Management Staff (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday,
or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(3) Acid value: Not to exceed 0.20 determined using 50 grams of
sample by the ``Guide to Specifications for General Notices, General
Analytical Techniques, Identification Tests, Test Solutions, and Other
Reference Materials,'' in the ``Compendium of Food Additive
Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision
2,'' p. 189 (1991), which is incorporated by reference; see paragraph
(b)(2) of this section for availability of the incorporation by
reference.
(4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the
``Atomic Absorption Spectrophotometric Graphite Furnace Method, Method
I,'' in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 763 and 764,
with an attached modification to the sample digestion section in
Appendix III.B (July 1996), which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may
be examined at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the
National Archives and Records
[[Page 100]]
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
(5) Triacetin: Not to exceed 0.10 percent determined by gas
chromatography as described in the ``Guide to Specifications for General
Notices, General Analytical Techniques, Identification Tests, Test
Solutions, and Other Reference Materials,'' in the ``Compendium of Food
Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5,
Revision 2,'' (1991), pp. 13-26, which is incorporated by reference; see
paragraph (b)(2) of this section for availability of the incorporation
by reference.
(c) The food additive is used as a stabilizer (as defined in Sec.
170.3(o)(28) of this chapter) of emulsions of flavoring oils in
nonalcoholic beverages.
(d) The total SAIB content of a beverage containing the additive
does not exceed 300 milligrams/kilogram of the finished beverage.
[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999, as amended at 78
FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17721, Mar. 24,
2023]
Sec. 172.834 Ethoxylated mono- and diglycerides.
The food additive ethoxylated mono-and diglycerides (polyoxyethylene
(20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be
safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by:
(1) Glycerolysis of edible fats primarily composed of stearic,
palmitic, and myristic acids; or
(2) Direct esterification of glycerol with a mixture of primarily
stearic, palmitic, and myristic acids;
to yield a product with less than 0.3 acid number and less than 0.2
percent water, which is then reacted with ethylene oxide.
(b) The additive meets the following specifications:
Saponification number, 65-75.
Acid number, 0-2.
Hydroxyl number, 65-80.
Oxyethylene content, 60.5-65.0 percent.
(c) The additive is used or intended for use in the following foods
when standards of identity established under section 401 of the Act do
not preclude such use:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
1. As an emulsifier in pan-release agents Not to exceed levels
for and as a dough conditioner in yeast- required to produce the
leavened bakery products. intended effects, total not
to exceed 0.5 percent by
weight of the flour used.
2. As an emulsifier in cakes and cake Not to exceed 0.5 percent by
mixes. weight of the dry
ingredients.
3. As an emulsifier in whipped vegetable Not to exceed 0.45 percent
oil toppings and topping mixes. by weight of the finished
whipped vegetable oil
toppings.
4. As an emulsifier in icings and icing Not to exceed 0.5 percent by
mixes. weight of the finished
icings.
5. As an emulsifier in frozen desserts.... Not to exceed 0.2 percent by
weight of the finished
frozen desserts.
6. As an emulsifier in edible vegetable Not to exceed 0.4 percent by
fat-water emulsions intended for use as weight of the finished
substitutes for milk or cream in beverage vegetable fat-water
coffee. emulsions.
------------------------------------------------------------------------
(d) When the name ``polyglycerate 60'' is used in labeling it shall
be followed by either ``polyoxyethylene (20) mono-and diglycerides of
fatty acids'' or ``ethoxylated mono- and diglycerides'' in parentheses.
[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26, 1977;
50 FR 49536, Dec. 3, 1985]
Sec. 172.836 Polysorbate 60.
The food additive polysorbate 60 (polyoxyethylene (20) sorbitan
monostearate) which is a mixture of polyoxyethylene ethers of mixed
partial stearic and palmitic acid esters of sorbitol anhydrides and
related compounds, may be safely used in food in accordance with the
following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 10 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
[[Page 101]]
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.
(c) It is used or intended for use as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with sorbitan
monostearate may be used in excess of 0.4 percent, provided that the
amount of the additive does not exceed 0.77 percent and the amount of
sorbitan monostearate does not exceed 0.27 percent of the weight of the
finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the cake or cake mix, on a dry-weight basis. When used
with polysorbate 65 and/or sorbitan monostearate, it shall not exceed
0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the
sorbitan monostearate exceed 0.61 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with sorbitan
monostearate, in nonstandardized confectionery coatings and standardized
cacao products specified in Sec. Sec. 163.123, 163.130, 163.135,
163.140, 163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 0.5 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with sorbitan monostearate in any combination of up
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan
monostearate: Provided, That the total combination does not exceed 1
percent of the weight of the finished nonstandardized confectionery
coating or standardized cacao product.
(4) [Reserved]
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed
0.46 percent of the weight of the cake icings and cake fillings. When
used with polysorbate 65 and/or sorbitan monostearate, it shall not
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or
the sorbitan monostearate exceed 0.7 percent, and no combination of
these emulsifiers shall exceed 1 percent of the weight of the cake icing
or cake filling.
(6) To impart greater opacity to sugar-type confection coatings
whereby the maximum amount of the additive does not exceed 0.2 percent
of the weight of the finished sugar coating.
(7) As an emulsifier in nonstandardized dressings whereby the
maximum amount of the additive does not exceed 0.3 percent of the weight
of the finished dressings.
(8) As an emulsifier, alone or in combination with polysorbate 80,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 80 in any combination providing no
more than 1 percent of polysorbate 60 and no more than 1 percent of
polysorbate 80, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8)(i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or
[[Page 102]]
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(10) As a foaming agent in nonalcoholic mixes, to be added to
alcoholic beverages in the preparation of mixed alcoholic drinks, at a
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
(11) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(12) As an emulsifier, alone or in combination with sorbitan
monostearate, in the minimum quantity required to accomplish the
intended effect, in formulations of white mineral oil conforming with
Sec. 172.878 and/or petroleum wax conforming with Sec. 172.886 for use
as protective coatings on raw fruits and vegetables.
(13) As a dispersing agent in artificially sweetened gelatin
desserts and in artificially sweetened gelatin dessert mixes, whereby
the amount of the additive does not exceed 0.5 percent on a dry-weight
basis.
(14) As an emulsifier in chocolate flavored syrups, whereby the
maximum amount of the additive does not exceed 0.05 percent in the
finished product.
(15) As a surfactant and wetting agent for natural and artificial
colors in food as follows:
(i) In powdered soft drink mixes in an amount not to exceed 4.5
percent by weight of the mix.
(ii) In sugar-based gelatin dessert mixes in an amount not to exceed
0.5 percent by weight of the mix.
(iii) In artificially sweetened gelatin dessert mixes in an amount
not to exceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in an amount not to exceed 0.5
percent by weight of the mix.
(v) In artificially sweetened pudding mixes in an amount not to
exceed 0.5 percent by weight of the mix.
(16) As an emulsifier in ice cream, frozen custard, fruit sherbet,
and nonstandardized frozen desserts when used alone or in combination
with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of
the additives, alone or in combination, does not exceed 0.1 percent of
the finished frozen dessert.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45
FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct.
28, 1999]
Sec. 172.838 Polysorbate 65.
The food additive polysorbate 65 (polyoxyethylene (20) sorbitan
tristearate), which is a mixture of polyoxyethylene ethers of mixed
stearic acid esters of sorbitol anhydrides and related compounds, may be
safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 15 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 88-98.
Acid number 0-2.
Hydroxyl number 44-60.
Oxyethylene content 46 percent-50 percent.
(c) The additive is used, or intended for use, as follows:
(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet and nonstandardized frozen desserts when used alone or in
combination with polysorbate 80, whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
[[Page 103]]
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the cake or cake mix, on a dry-weight basis. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(4) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not exceed
0.32 percent of the weight of the cake icing or cake filling. When used
with sorbitan monostearate and/or polysorbate 60, it shall not exceed
0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or
the polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]
Sec. 172.840 Polysorbate 80.
The food additive polysorbate 80 (polyoxyethylene (20) sorbitan
monooleate), which is a mixture of polyoxyethylene ethers of mixed
partial oleic acid esters of sorbitol anhydrides and related compounds,
may be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting oleic acid
(usually containing associated fatty acids) with sorbitol to yield a
product with a maximum acid number of 7.5 and a maximum water content of
0.5 percent, which is then reacted with ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.
(c) The additive is used or intended for use as follows:
(1) An emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet, and nonstandardized frozen desserts, when used alone or in
combination with polysorbate 65 whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) In yeast-defoamer formulations whereby the maximum amount of the
additive does not exceed 4 percent of the finished yeast defoamer and
the maximum amount of the additive in the yeast from such use does not
exceed 4 parts per million.
[[Page 104]]
(3) As a solubilizing and dispersing agent in pickles and pickle
products, whereby the maximum amount of the additive does not exceed 500
parts per million.
(4) As a solubilizing and dispersing agent in:
(i) Vitamin-mineral preparations containing calcium caseinate in the
absence of fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 175 milligrams from the recommended
daily dose of the preparations.
(ii) Fat-soluble vitamins in vitamin and vitamin-mineral
preparations containing no calcium caseinate, whereby the maximum intake
of polysorbate 80 shall not exceed 300 milligrams from the recommended
daily dose of the preparations.
(iii) In vitamin-mineral preparations containing both calcium
caseinate and fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 475 milligrams from the recommended
daily dose of the preparations.
(5) As a surfactant in the production of coarse crystal sodium
chloride whereby the maximum amount of the additive in the finished
sodium chloride does not exceed 10 parts per million.
(6) In special dietary foods, as an emulsifier for edible fats and
oils, with directions for use which provide for the ingestion of not
more than 360 milligrams of polysorbate 80 per day.
(7) As a solubilizing and dispersing agent for dill oil in canned
spiced green beans, not to exceed 30 parts per million.
(8) As an emulsifier, alone or in combination with polysorbate 60,
in shortenings and edible oils intended for use in foods as follows,
when standards of identity established under section 401 of the act do
not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 60 in any combination providing no
more than 1 percent of polysorbate 80 and no more than 1 percent of
polysorbate 60, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8)(i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 65;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(10) It is used as a wetting agent in scald water for poultry
defeathering, followed by potable water rinse. The concentration of the
additive in the scald water does not exceed 0.0175 percent.
(11) As a dispersing agent in gelatin desserts and in gelatin
dessert mixes, whereby the amount of the additive does not exceed 0.082
percent on a dry-weight basis.
(12) As an adjuvant added to herbicide use and plant-growth
regulator use dilutions by a grower or applicator prior to application
of such dilutions to the growing crop. Residues resulting from such use
are exempt from the requirement of a tolerance. When so used or intended
for use, the additive shall be exempt from the requirements of paragraph
(d)(1) of this section.
(13) As a defoaming agent in the preparation of the creaming mixture
for cottage cheese as identified in Sec. 133.128 of this chapter,
whereby the amount of the additive does not exceed .008 percent by
weight of the finished product.
(14) As a surfactant and wetting agent for natural and artificial
colors for use in barbecue sauce where the level of the additive does
not exceed 0.005 percent by weight of the barbecue sauce.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
[[Page 105]]
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45
FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 85 FR 72907, Nov.
16, 2020]
Sec. 172.841 Polydextrose.
Polydextrose as identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially
metabolizable water-soluble polymer prepared by the condensation of a
melt which consists either of approximately 89 percent D-glucose, 10
percent sorbitol, and 1 percent citric acid or of approximately 90
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid,
on a weight basis.
(2) Polydextrose may be partially neutralized with potassium
hydroxide, or partially reduced by transition metal catalytic
hydrogenation in aqueous solution.
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 811-814, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) When standards of identity established under section 401 of the
act do not preclude such use, polydextrose may be used in accordance
with current good manufacturing practices as a bulking agent,
formulation aid, humectant, and texturizer in all foods, except meat and
poultry, baby food, and infant formula.
(d) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
(e) The label and labeling of food a single serving of which would
be expected to exceed 15 grams of the additive shall bear the statement:
``Sensitive individuals may experience a laxative effect from excessive
consumption of this product''.
[46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60
FR 54425, Oct. 24, 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, June 6,
1997; 63 FR 57597, Oct. 28, 1998; 65 FR 64605, Oct. 30, 2000; 65 FR
79719, Dec. 20, 2000; 72 FR 46564, Aug. 21, 2007; 78 FR 71464, Nov. 29,
2013; 88 FR 17721, Mar. 24, 2023]
Sec. 172.842 Sorbitan monostearate.
The food additive sorbitan monostearate, which is a mixture of
partial stearic and palmitic acid esters of sorbitol anhydrides, may be
safely used in or on food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield essentially a mixture of esters.
(b) The food additive meets the following specifications:
Saponification number, 147-157
Acid number, 5-10
Hydroxyl number, 235-260
(c) It is used or intended for use, alone or in combination with
polysorbate 60 as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Polysorbate 60;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with polysorbate 60
may be used in excess of 0.4 percent: Provided, That the amount of the
additive does not exceed
[[Page 106]]
0.27 percent and the amount of polysorbate 60 does not exceed 0.77
percent of the weight of the finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall not
exceed 0.61 percent of the cake or cake mix, on a dry-weight basis. When
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.61
percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of the
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake
mix, calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with polysorbate 60 in
nonstandardized confectionery coatings and standardized cacao products
specified in Sec. Sec. 163.123, 163.130, 163.135, 163.140, 163.145, and
163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with polysorbate 60 in any combination of up to 1
percent sorbitan monostearate and up to 0.5 percent polysorbate 60
provided that the total combination does not exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(4) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall not
exceed 0.7 percent of the weight of the cake icing or cake filling. When
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.7
percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(5) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 60.
(ii) Polysorbate 65.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(6) It is used alone as a rehydration aid in the production of
active dry yeast in an amount not to exceed 1 percent by weight of the
dry yeast.
(7) As an emulsifier, alone or in combination with polysorbate 60,
in the minimum quantity required to accomplish the intended effect, in
formulations of white mineral oil conforming with Sec. 172.878 and/or
petroleum wax conforming with Sec. 172.886 for use as protective
coatings on raw fruits and vegetables.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide
a final product that complies with the limitations prescribed in
paragraph (c) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]
Sec. 172.844 Calcium stearoyl-2-lactylate.
The food additive calcium stearoyl-2-lactylate may be safely used in
or on food in accordance with the following prescribed conditions:
(a) The additive, which is a mixture of calcium salts of stearoyl
lactylic acids and minor proportions of other calcium salts of related
acids, is manufactured by the reaction of stearic acid and lactic acid
and conversion to the calcium salts.
(b) The additive meets the following specifications:
Acid number, 50-86.
Calcium content, 4.2-5.2 percent.
[[Page 107]]
Lactic acid content, 32-38 percent.
Ester number, 125-164.
(c) It is used or intended for use as follows:
(1) As a dough conditioner in yeast-leavened bakery products and
prepared mixes for yeast-leavened bakery products in an amount not to
exceed 0.5 part for each 100 parts by weight of flour used.
(2) As a whipping agent in:
(i) Liquid and frozen egg white at a level not to exceed 0.05
percent.
(ii) Dried egg white at a level not to exceed 0.5 percent.
(iii) Whipped vegetable oil topping at a level not to exceed 0.3
percent of the weight of the finished whipped vegetable oil topping.
(3) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 0.5 percent by weight thereof.
(d) To assure safe use of the additive:
(1) The label and labeling of the food additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions of use to provide a finished food that complies with
the limitations prescribed in paragraph (c) of this section.
Sec. 172.846 Sodium stearoyl lactylate.
The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-
997) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive, which is a mixture of sodium salts of stearoyl
lactylic acids and minor proportions of sodium salts of related acids,
is manufactured by the reaction of stearic acid and lactic acid and
conversion to the sodium salts.
(b) The additive meets the specifications of the ``Food Chemicals
Codex,'' 3d Ed. (1981), pp. 300-301, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(c) It is used or intended for use as follows when standards of
identity established under section 401 of the Act do not preclude such
use:
(1) As a dough strengthener, emulsifier, or processing aid in baked
products, pancakes, and waffles, in an amount not to exceed 0.5 part for
each 100 parts by weight of flour used.
(2) As a surface-active agent, emulsifier, or stabilizer in icings,
fillings, puddings, and toppings, at a level not to exceed 0.2 percent
by weight of the finished food.
(3) As an emulsifier or stabilizer in liquid and solid edible fat-
water emulsions intended for use as substitutes for milk or cream in
beverage coffee, at a level not to exceed 0.3 percent by weight of the
finished edible fat-water emulsion.
(4) As a formulation aid, processing aid, or surface-active agent in
dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry
weight of the food.
(5) As an emulsifier, stabilizer, or texturizer in snack dips, at a
level not to exceed 0.2 percent by weight of the finished product.
(6) As an emulsifier, stabilizer, or texturizer in cheese
substitutes and imitations and cheese product substitutes and
imitations, at a level not to exceed 0.2 percent by weight of the
finished food.
(7) As an emulsifier, stabilizer, or texturizer in sauces or
gravies, and the products containing the same, in an amount not to
exceed 0.25 percent by weight of the finished food.
(8) In prepared mixes for each of the foods listed in paragraphs
(c)(1) through (7) of this section, provided the additive is used only
as specified in each of those paragraphs.
(9) As an emulsifier, stabilizer, or texturizer in cream liqueur
drinks, at a
[[Page 108]]
level not to exceed 0.5 percent by weight of the finished product.
[45 FR 51767, Aug. 5, 1980, as amended at 49 FR 10105, Mar. 19, 1984; 50
FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. 27,
1986; 65 FR 60859, Oct. 13, 2000]
Sec. 172.848 Lactylic esters of fatty acids.
Lactylic esters of fatty acids may be safely used in food in
accordance with the following prescribed conditions:
(a) They are prepared from lactic acid and fatty acids meeting the
requirements of Sec. 172.860(b) and/or oleic acid derived from tall oil
fatty acids meeting the requirements of Sec. 172.862.
(b) They are used as emulsifiers, plasticizers, or surface-active
agents in the following foods, when standards of identity do not
preclude their use:
------------------------------------------------------------------------
Foods Limitations
------------------------------------------------------------------------
Bakery mixes.............................. ............................
Baked products............................ ............................
Cake icings, fillings, and toppings....... ............................
Dehydrated fruits and vegetables.......... ............................
Dehydrated fruit and vegetable juices..... ............................
Edible vegetable fat-water emulsions...... As substitutes for milk or
cream in beverage coffee.
Frozen desserts........................... ............................
Liquid shortening......................... For household use.
Pancake mixes............................. ............................
Precooked instant rice.................... ............................
Pudding mixes............................. ............................
------------------------------------------------------------------------
(c) They are used in an amount not greater than required to produce
the intended physical or technical effect, and they may be used with
shortening and edible fats and oils when such are required in the foods
identified in paragraph (b) of this section.
Sec. 172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
The food additive lactylated fatty acid esters of glycerol and
propylene glycol may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is a mixture of esters produced by the lactylation
of a product obtained by reacting edible fats or oils with propylene
glycol.
(b) The additive meets the following specifications: Water insoluble
combined lactic acid, 14-18 percent; and acid number, 12 maximum.
(c) It is used in amounts not in excess of that reasonably required
to produce the intended physical effect as an emulsifier, plasticizer,
or surface-active agent in food.
Sec. 172.852 Glyceryl-lacto esters of fatty acids.
Glyceryl-lacto esters of fatty acids (the lactic acid esters of
mono- and diglycerides) may be safely used in food in accordance with
the following prescribed conditions:
(a) They are manufactured from glycerin, lactic acid, and fatty
acids conforming with Sec. 172.860 and/or oleic acid derived from tall
oil fatty acids conforming with Sec. 172.862 and/or edible fats and
oils.
(b) They are used in amounts not in excess of those reasonably
required to accomplish their intended physical or technical effect as
emulsifiers and plasticizers in food.
Sec. 172.854 Polyglycerol esters of fatty acids.
Polyglycerol esters of fatty acids, up to and including the
decaglycerol esters, may be safely used in food in accordance with the
following prescribed conditions:
(a) They are prepared from corn oil, cottonseed oil, lard, palm oil
from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and
tallow and the fatty acids derived from these substances (hydrogenated
and nonhydrogenated) meeting the requirements of Sec. 172.860(b) and/or
oleic acid derived from tall oil fatty acids meeting the requirements of
Sec. 172.862.
(b) They are used as emulsifiers in food, in amounts not greater
than that required to produce the intended physical or technical effect.
(c) Polyglycerol esters of a mixture of stearic, oleic, and coconut
fatty acids are used as a cloud inhibitor in vegetable and salad oils
when use is not precluded by standards of identity. The fatty acids used
in the production of the polyglycerol esters meet the requirements of
Sec. 172.860(b), and the polyglycerol esters are used at a level not in
excess of the amount required to perform its cloud-inhibiting effect.
Oleic acid derived from tall oil fatty acids conforming with Sec.
172.862 may be used as a substitute for or together
[[Page 109]]
with the oleic acid permitted by this paragraph.
(d) Polyglycerol esters of butter oil fatty acids are used as
emulsifiers in combination with other approved emulsifiers in dry,
whipped topping base. The fatty acids used in the production of the
polyglycerol esters meet the requirements of Sec. 172.860(b), and the
polyglycerol esters are used at a level not in excess of the amount
required to perform their emulsifying effect.
Sec. 172.856 Propylene glycol mono- and diesters of fats and fatty acids.
Propylene glycol mono- and diesters of fats and fatty acids may be
safely used in food, subject to the following prescribed conditions:
(a) They are produced from edible fats and/or fatty acids in
compliance with Sec. 172.860 and/or oleic acid derived from tall oil
fatty acids in compliance with Sec. 172.862.
(b) They are used in food in amounts not in excess of that
reasonably required to produce their intended effect.
Sec. 172.858 Propylene glycol alginate.
The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2)
may be used as an emulsifier, flavoring adjuvant, formulation aid,
stabilizer, surfactant, or thickener in foods in accordance with the
following prescribed conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.), and the additional specification that it shall
have up to 85 percent of the carboxylic acid groups esterified with the
remaining groups either free or neutralized.
(b) The additive is used or intended for use in the following foods
as defined in Sec. 170.3(n) of this chapter, when standards of identity
established under section 401 of the act do not preclude such use:
(1) As a stabilizer in frozen dairy desserts, in fruit and water
ices, and in confections and frostings at a level not to exceed 0.5
percent by weight of the finished product.
(2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener
in baked goods at a level not to exceed 0.5 percent by weight of the
finished product.
(3) As an emulsifier, stabilizer, or thickener in cheeses at a level
not to exceed 0.9 percent by weight of the finished product.
(4) As an emulsifier, stabilizer, or thickener in fats and oils at a
level not to exceed 1.1 percent by weight of the finished product.
(5) As an emulsifier, stabilizer, or thickener in gelatins and
puddings at a level not to exceed 0.6 percent by weight of the finished
product.
(6) As a stabilizer or thickener in gravies and in sweet sauces at a
level not to exceed 0.5 percent by weight of the finished product.
(7) As a stabilizer in jams and jellies at a level not to exceed 0.4
percent by weight of the finished product.
(8) As an emulsifier, stabilizer, or thickener in condiments and
relishes at a level not to exceed 0.6 percent by weight of the finished
product.
(9) As a flavoring adjunct or adjuvant in seasonings and flavors at
a level not to exceed 1.7 percent by weight of the finished product.
(10) As an emulsifier, flavoring adjuvant, formulation aid,
stabilizer or thickener, or surface active agent in other foods, where
applicable, at a level not to exceed 0.3 percent by weight of the
finished product.
(c) To ensure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the act:
(1) The name of the additive, ``propylene glycol alginate'' or
``propylene glycol ester of alginic acid''.
(2) Adequate directions for use.
[47 FR 29950, July 9, 1982]
Sec. 172.859 Sucrose fatty acid esters.
Sucrose fatty acid esters identified in this section may be safely
used in accordance with the following prescribed conditions:
[[Page 110]]
(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of
sucrose with fatty acids and are derived from sucrose and edible tallow
or hydrogenated edible tallow or edible vegetable oils. The only
solvents which may be used in the preparation of sucrose fatty acid
esters are those generally recognized as safe in food or regulated for
such use by an appropriate section in this part. Ethyl acetate or methyl
ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-
propanol) may be used in the preparation of sucrose fatty acid esters.
(b) Sucrose fatty acid esters meet the following specifications:
(1) The total content of mono-, di-, and tri-esters is not less than
80 percent as determined by a method title ``Sucrose Fatty Acid Esters,
Method of Assay,'' which is incorporated by reference. Copies are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(2) The free sucrose content is not more than 5 percent as
determined by Test S.2 in the method titled ``Sucrose Fatty Acid Esters,
Method of Assay,'' which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (b)(1) of this
section.
(3) The acid value is not more than 6.
(4) The residue on ignition (sulfated ash) is not more than 2
percent.
(5) The total ethyl acetate content is not more than 350 parts per
million as determined by a method titled ``Determination of Ethyl
Acetate,'' which is incorporated by reference. Copies are available from
the Office of Food Additive Safety (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1200, or available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(6) Arsenic is not more than 3 parts per million.
(7) Total heavy metal content (as Pb) is not more than 50 parts per
million.
(8) Lead is not more than 10 parts per million.
(9) The total content of methyl ethyl ketone or of methanol shall
not be more than 10 parts per million as determined by a method titled
``Methyl Ethyl Ketone Test; Methyl Alcohol Test,'' which is incorporated
by reference. Copies are available from the Office of Food Additive
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200, or available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
(10) The total dimethyl sulfoxide content is not more than 2 parts
per million as determined by a method entitled ``Determination of
Dimethyl Sulfoxide,'' which is incorporated by reference. Copies are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not
more than 10 parts per million as determined by a method entitled
``Determination of Isobutyl Alcohol,'' which is incorporated by
reference. Copies are available from the Office of Food Additive
[[Page 111]]
Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
1200, or available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
(c) Sucrose fatty acid esters may be used as follows when standards
of identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter,
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter,
in coffee and tea beverages with added dairy ingredients and/or dairy
product analogues, in confections and frostings as defined in Sec.
170.3(n)(9) of this chapter, in dairy product analogues as defined in
Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes
as defined in Sec. 170.3(n)(20) of this chapter, and in whipped milk
products.
(2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of
this chapter, and in surimi-based fabricated seafood products.
(3) As components of protective coatings applied to fresh apples,
avocados, bananas, banana plantains, limes, melons (honeydew and
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard
ripening and spoiling.
(d) Sucrose fatty acid esters are used in accordance with current
good manufacturing practice and in an amount not to exceed that
reasonably required to accomplish the intended effect.
[47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23, 1983;
52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995; 88 FR 17721, Mar. 24,
2023]
Sec. 172.860 Fatty acids.
The food additive fatty acids may be safely used in food and in the
manufacture of food components in accordance with the following
prescribed conditions:
(a) The food additive consists of one or any mixture of the
following straight-chain monobasic carboxylic acids and their associated
fatty acids manufactured from fats and oils derived from edible sources:
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid,
palmitic acid, and stearic acid.
(b) The food additive meets the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) It is free of chick-edema factor:
(i) As evidenced during the bioassay method for determining the
chick-edema factor as prescribed in paragraph (c)(2) of this section; or
(ii) As evidenced by the absence of chromatographic peaks with a
retention time relative to aldrin (RA) between 10 and 25, using the gas
chromatographic-electron capture method prescribed in paragraph (c)(3)
of this section. If chromatographic peaks are found with RA values
between 10 and 25, the food additive shall meet the requirements of the
bioassay method prescribed in paragraph (c)(2) of this section for
determining chick-edema factor.
(c) For the purposes of this section:
(1) Unsaponifiable matter shall be determined by the method
described in the 13th Ed. (1980) of the ``Official Methods of Analysis
of the Association of Official Analytical Chemists,'' which is
incorporated by reference. Copies are available from the AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
[[Page 112]]
(2) Chick-edema factor shall be determined by the bioassay method
described in ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), sections 28.127-28.130,
which is incorporated by reference. Copies may be obtained from the AOAC
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
(3) The gas chromatographic-electron capture method for testing
fatty acids for chick-edema shall be the method described in the
``Journal of the Association of Official Analytical Chemists,'' Volume
50 (No. 1), pages 216-218 (1967), or the modified method using a
sulfuric acid clean-up procedure, as described in the ``Journal of the
Association of the Official Analytical Chemists,'' Volume 51 (No. 2),
pages 489-490 (1968), which are incorporated by reference. See paragraph
(c)(2) of this section for availability of these references.
(d) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and as a defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the act, the following:
(1) The common or usual name of the acid or acids contained therein.
(2) The words ``food grade,'' in juxtaposition with and equally as
prominent as the name of the acid.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982;
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]
Sec. 172.861 Cocoa butter substitute from coconut oil,
palm kernel oil, or both oils.
The food additive, cocoa butter substitute from coconut oil, palm
kernel oil, or both oils, may be safely used in food in accordance with
the following conditions:
(a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS
Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is
manufactured by esterification of glycerol with food-grade fatty acids
(complying with Sec. 172.860) derived from edible coconut oil, edible
palm kernel oil, or both oils.
(b) The ingredient meets the following specifications:
Acid number: Not to exceed 0.5.
Saponification number: 220 to 260.
Iodine number: Not to exceed 3.
Melting range: 30 to 44 [deg]C.
(c) The ingredient is used or intended for use as follows:
(1) As coating material for sugar, table salt, vitamins, citric
acid, succinic acid, and spices; and
(2) In compound coatings, cocoa creams, cocoa-based sweets, toffees,
caramel masses, and chewing sweets as defined in Sec. 170.3 (n)(9) and
(n)(38) of this chapter, except that the ingredient may not be used in a
standardized food unless permitted by the standard of identity.
(d) The ingredient is used in accordance with current good
manufacturing practice and in an amount not to exceed that reasonably
required to accomplish the intended effect.
[56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992]
Sec. 172.862 Oleic acid derived from tall oil fatty acids.
The food additive oleic acid derived from tall oil fatty acids may
be safely used in food and as a component in the manufacture of food-
grade additives in accordance with the following prescribed conditions:
(a) The additive consists of purified oleic acid separated from
refined tall oil fatty acids.
(b) The additive meets the following specifications:
(1) Specifications for oleic acid prescribed in the Food Chemicals
Codex, 7th ed. (2010), pp. 743-744, which is incorporated by reference,
except that titer (solidification point) shall not exceed 13.5 [deg]C
and unsaponifiable matter
[[Page 113]]
shall not exceed 0.5 percent. The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United
States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD
20852 (Internet address http://www.usp.org). Copies may be examined at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030 or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.
(2) The resin acid content does not exceed 0.01 as determined by
ASTM method D1240-82, ``Standard Test Method for Rosin Acids in Fatty
Acids,'' which is incorporated by reference. Copies may be obtained from
the American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(3) The requirements for absence of chick-edema factor as prescribed
in Sec. 172.860.
(c) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(d) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the acid.
(2) The words ``food grade'' in juxtaposition with and equally as
prominent as the name of the acid.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984;
78 FR 71465, Nov. 29, 2013; 88 FR 17721, Mar. 24, 2023]
Sec. 172.863 Salts of fatty acids.
The food additive salts of fatty acids may be safely used in food
and in the manufacture of food components in accordance with the
following prescribed conditions:
(a) The additive consists of one or any mixture of two or more of
the aluminum, calcium, magnesium, potassium, and sodium salts of the
fatty acids conforming with Sec. 172.860 and/or oleic acid derived from
tall oil fatty acids conforming with Sec. 172.862.
(b) The food additive is used or intended for use as a binder,
emulsifier, and anticaking agent in food in accordance with good
manufacturing practice.
(c) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the fatty acid salt or salts
contained therein.
(2) The words ``food grade,'' in juxtaposition with and equally as
prominent as the name of the salt.
Sec. 172.864 Synthetic fatty alcohols.
Synthetic fatty alcohols may be safely used in food and in the
synthesis of food components in accordance with the following prescribed
conditions:
(a) The food additive consists of any one of the following fatty
alcohols:
(1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl;
manufactured by fractional distillation of alcohols obtained by a
sequence of oxidation and hydrolysis of organo-aluminums generated by
the controlled reaction of low molecular weight trialkylaluminum with
purified ethylene (minimum 99 percent by volume
C2H4), and utilizing the hydrocarbon solvent as
defined in paragraph (b) of this section, such that:
(i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not
less than 99 percent of total alcohols and not less
[[Page 114]]
than 96 percent of straight chain alcohols. Any nonalcoholic impurities
are primarily paraffins.
(ii) Cetyl and stearyl alcohols contain not less than 98 percent of
total alcohols and not less than 94 percent of straight chain alcohols.
Any nonalcoholic impurities are primarily paraffins.
(iii) The synthetic fatty alcohols contain no more than 0.1 weight
percent of total diols as determined by a method available upon request
from the Commissioner of Food and Drugs.
(2) Hexyl, octyl, and decyl; manufactured by fractional distillation
of alcohols obtained by a sequence of oxidation, hydrolysis, and
catalytic hydrogenation (catalyst consists of copper, chromium, and
nickel) of organo-aluminums generated by the controlled reaction of low
molecular weight trialkylaluminum with purified ethylene (minimum 99
percent by volume C2H4), and utilizing an external
coolant such that these alcohols meet the specifications prescribed in
paragraph (a)(1)(i) and (iii) of this section.
(3) n-Octyl; manufactured by the hydrodimerization of 1,3-butadiene,
followed by catalytic hydrogenation of the resulting dienol, and
distillation to produce n-octyl alcohol with a minimum purity of 99
percent. The analytical method for n-octyl alcohol entitled ``Test
Method [Normal-octanol]'' dated October 2003, and printed by Kuraray
Co., Ltd., is incorporated by reference. The Director of the Office of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy
from the Office of Food Additive Safety (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between
9 a.m. and 4 p.m., Monday through Friday, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(b) The hydrocarbon solvent used in the process described in
paragraph (a)(1) of this section is a mixture of liquid hydrocarbons
essentially paraffinic in nature, derived from petroleum and refined to
meet the specifications described in paragraph (b)(1) of this section
when subjected to the procedures described in paragraph (b)(2) and (3)
of this section.
(1) The hydrocarbon solvent meets the following specifications:
(i) Boiling-point range: 175 [deg]C-275 [deg]C.
(ii) Ultraviolet absorbance limits as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength (millicrons) centimeter
optical
path
length
------------------------------------------------------------------------
280-289..................................................... 0.15
290-299..................................................... .12
300-359..................................................... .05
360-400..................................................... .02
------------------------------------------------------------------------
(2) Use ASTM method D86-82, ``Standard Method for Distillation of
Petroleum Products,'' which is incorporated by reference, to determine
boiling point range. Copies of the material incorporated by reference
may be obtained from the American Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may
be examined at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(3) The analytical method for determining ultraviolet absorbance
limits is as follows:
General Instructions
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care
[[Page 115]]
to avoid contamination of hydrocarbon solvent samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
Apparatus
Chromatographic tube. 450 millimeters in length (packing section),
inside diameter 19 millimeters 1 millimeter,
equipped with a wad of clean Pyrex brand filtering wool (Corning Glass
Works Catalog No. 3950 or equivalent). The tube shall contain a 250-
milliliter reservoir and a 2-millimeter tetrafluoroethylene polymer
stopcock at the opposite end. Overall length of the tube is 670
millimeters.
Stainless steel rod. 2 feet in length, 2 to 4 millimeters in
diameter.
Vacuum oven. Similar to Labline No. 3610 but modified as follows: A
copper tube one-fourth inch in diameter and 13 inches in length is bent
to a right angle at the 4-inch point and plugged at the opposite end;
eight copper tubes one-eighth inch in diameter and 5 inches in length
are silver soldered in drilled holes (one-eighth inch in diameter) to
the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and
12.5-inch points; the one-eighth-inch copper tubes are bent to conform
with the inner periphery of the oven.
Beakers. 250-milliliter and 500-milliliter capacity.
Graduated cylinders. 25-milliliter, 50-milliliter, and 150-
milliliter capacity.
Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge
needle.
Volumetric flask. 5-milliliter capacity.
Spectrophotometric cells. Fused quartz ground glass stoppered cells,
optical path length in the range of 1.000 centimeter 0.005 centimeter. With distilled water in the cells,
determine any absorbance difference.
Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons
with spectral slit width of 2 millimicrons or less: under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4
absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4
absorbance.
---------------------------------------------------------------------------
\1\ As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
---------------------------------------------------------------------------
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Reagents and Materials
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, hexane, and 1,2-dichloroethane designated in the
list following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter beaker, add
1 milliliter of purified n-hexadecane and evaporate in the vacuum oven
under a stream of nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. (To the residue from benzene add a 5-
milliliter portion of purified isooctane, reevaporate, and repeat once
to insure complete removal of benzene.)
Dissolve the 1 milliliter of hexadecane residue in isooctane and
make to 5 milliliters volume. Determine the absorbance in the 1-
centimeter path length cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue shall not exceed 0.02
per centimeter path length between 280 and 300 m[micro] and shall not
exceed 0.01 per centimeter path length between 300 and 400 m[micro].
Isooctane (2,2,4-trimethylpentane). Use 10 milliliters for the test
described in the preceding paragraph. If necessary, isooctane may be
purified by passage through a column of activated silica gel (Grade 12,
Davison Chemical Co., Baltimore, Md., or equivalent).
Benzene, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If
necessary, benzene may be purified by distillation or otherwise.
Hexane, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 650 milliliters for the test. If
necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East
Rutherford, N.J., or
[[Page 116]]
equivalent). Use 20 milliliters for test. If necessary, 1,2-
dichloroethane may be purified by distillation.
Eluting mixtures:
1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of
1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and
adjust to volume with hexane, with mixing.
2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene
into a 1-liter glass-stoppered volumetric flask and adjust to volume
with hexane, with mixing.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 5 milliliters with isooctane and determine the absorbance
in a 1-centimeter cell compared to isooctane as reference between 280
m[micro]-400m[micro]. The absorbance per centimeter path length shall
not exceed 0.00 in this range. If necessary, n-hexadecane may be
purified by percolation through activated silica gel or by distillation.
Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore,
Md., or equivalent). Activate as follows: Weigh about 900 grams into a
1-gallon bottle, add 100 milliliters of de-ionized water, seal the
bottle and shake and roll at intervals for 1 hour. Allow to equilibrate
overnight in the sealed bottle. Activate the gel at 150 [deg]C for 16
hours, in a 2-inch x 7-inch x 12-inch porcelain pan loosely covered with
aluminum foil, cool in a dessicator, transfer to a bottle and seal.
Procedure
Determination of ultraviolet absorbance. Before proceeding with the
analysis of a sample determine the absorbance in a 1-centimeter path
cell for the reagent blank by carrying out the procedure without a
sample. Record the absorbance in the wavelength range of 280 to 400
millimicrons. Typical reagent blank absorbance in this range should not
exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359
millimicron range, and 0.01 in the 360 to 400 millimicron range. If the
characteristic benzene peaks in the 250 to 260 millimicron region are
present, remove the benzene by the procedure described above under
``Reagents and Materials,'' ``Organic Solvents,'' and record absorbance
again.
Transfer 50 grams of silica gel to the chromatographic tube for
sample analysis. Raise and drop the column on a semisoft, clean surface
for about 1 minute to settle the gel. Pour 100 milliliters of hexane
into the column with the stopcock open and allow to drain to about one-
half inch above the gel. Turn off the stopcock and allow the column to
cool for 30 minutes. After cooling, vibrate the column to eliminate air
and stir the top 1 to 2 inches with a small diameter stainless steel
rod. Take care not to get the gel above the liquid and onto the sides of
the column.
Weigh out 40 grams 0.1 gram of the hydrocarbon
solvent sample into a 250-milliliter beaker, add 50 milliliters of
hexane, and pour the solution into the column. Rinse the beaker with 50
milliliters of hexane and add this to the column. Allow the hexane
sample solution to elute into a 500-milliliter beaker until the solution
is about one-half inch above the gel. Rinse the column three times with
50-milliliter portions of hexane. Allow each hexane rinse to separately
elute to about one-half inch above the gel. Replace the eluate beaker
(discard the hexane eluate) with a 250-milliliter beaker. Add two
separate 25-milliliter portions of 10 percent 1,2-dichloroethane and
allow each to separately elute as before. Finally, add 150 milliliters
of 10 percent 1,2-dichloroethane for a total of 200 milliliters. When
the final 10 percent 1,2-dichloroethane fraction is about one-half inch
above the top of the gel bed, replace the receiving beaker (discard the
1,2-dichloroethane eluate) with a 250-milliliter beaker containing 1
milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters
per minute, add two 25-milliliter portions of 40 percent benzene and
allow each to separately elute as before to within about one-half inch
of the gel bed. Finally, add 150 milliliters of 40 percent benzene for a
total of 200 milliliters. Evaporate the benzene in the oven with vacuum
and sufficient nitrogen flow to just ripple the top of the benzene
solution. When the benzene is removed (as determined by a constant
volume of hexadecane) add 5 milliliters of isooctane and evaporate.
Repeat once to insure complete removal of benzene. Remove the beaker and
cover with aluminum foil (previously rinsed with hexane) until cool.
Quantitatively transfer the hexadecane residue to a 5-milliliter
volumetric flask and dilute to volume with isooctane. Determine the
absorbance of the solution in 1-centimeter path length cells between 280
and 400 millimicrons using isooctane as a reference. Correct the
absorbance values for any absorbance derived from reagents as determined
by carrying out the procedure without a sample. If the corrected
absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii)
of this section, the sample meets the ultraviolet absorbance
specifications for hydrocarbon solvent.
(c) Synthetic fatty alcohols may be used as follows:
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted in food by existing regulations in this part or part
173 of this chapter provided that the use is in compliance with any
prescribed limitations.
[[Page 117]]
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted in food.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982;
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 70 FR 72908,
Dec. 8, 2005; 81 FR 5591, Feb. 3, 2016; 88 FR 17721, Mar. 24, 2023]
Sec. 172.866 Synthetic glycerin produced by the hydrogenolysis of
carbohydrates.
Synthetic glycerin produced by the hydrogenolysis of carbohydrates
may be safely used in food, subject to the provisions of this section:
(a) It shall contain not in excess of 0.2 percent by weight of a
mixture of butanetriols.
(b) It is used or intended for use in an amount not to exceed that
reasonably required to produce its intended effect.
Sec. 172.867 Olestra.
Olestra, as identified in this section, may be safely used in
accordance with the following conditions:
(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of
sucrose with fatty acids derived from edible fats and oils or fatty acid
sources that are generally recognized as safe or approved for use as
food ingredients. The chain lengths of the fatty acids are no less than
12 carbon atoms.
(b) Olestra meets the specifications of the Food Chemicals Codex,
7th ed. (2010), pp. 744-746, which is incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address
http://www.usp.org). Copies may be examined at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) Olestra may be used in place of fats and oils in prepackaged
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and
prepackaged, unpopped popcorn kernels that are ready-to-heat. In such
foods, the additive may be used in place of fats and oils for frying or
baking, in dough conditioners, in sprays, in filling ingredients, or in
flavors.
(d) To compensate for any interference with absorption of fat
soluble vitamins, the following vitamins shall be added to foods
containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram
olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or
retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 [micro]g
vitamin K1 per gram olestra.
(e)(1) Vitamins A, D, E, and K present in foods as a result of the
requirement in paragraph (d) of this section shall be declared in the
listing of ingredients. Such vitamins shall not be considered in
determining nutrient content for the nutritional label or for any
nutrient claims, express or implied.
(i) An asterisk shall follow vitamins A, D, E, and K in the listing
of ingredients;
(ii) The asterisk shall appear as a superscript following each
vitamin;
(iii) Immediately following the ingredient list an asterisk and
statement, ``Dietarily insignificant'' shall appear prominently and
conspicuously as specified in Sec. 101.2(c) of this chapter;
(2) Olestra shall not be considered as a source of fat or calories
for purposes of Sec. Sec. 101.9 and 101.13 of this chapter.
[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996, as amended at 68
FR 46402, Aug. 5, 2003; 69 FR 29432, May 24, 2004; 78 FR 71465, Nov. 29,
2013; 88 FR 17721, Mar. 24, 2023]
Sec. 172.868 Ethyl cellulose.
The food additive ethyl cellulose may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is a cellulose ether containing ethoxy
(OC2H5) groups attached by an ether linkage and
containing on an anhydrous basis not more than 2.6 ethoxy groups per
anhydroglucose unit.
[[Page 118]]
(b) It is used or intended for use as follows:
(1) As a binder and filler in dry vitamin preparations.
(2) As a component of protective coatings for vitamin and mineral
tablets.
(3) As a fixative in flavoring compounds.
Sec. 172.869 Sucrose oligoesters.
Sucrose oligoesters, as identified in this section, may be safely
used in accordance with the following conditions:
(a) Sucrose oligoesters consist of mixtures of sucrose fatty acid
esters with an average degree of esterification ranging from four to
seven. It is produced by interesterification of sucrose with methyl
esters of fatty acids derived from edible fats and oils (including
hydrogenated fats and oils). The only solvents which may be used in the
preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl
alcohol, and those solvents generally recognized as safe in food.
(b) Sucrose oligoesters meet the specifications in the methods
listed in the table in this paragraph. The methods for determining
compliance with each specification are incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be examined at the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: http://www.archives.gov/federal-register/
cfr/ibr-locations.html. Copies of the methods are available from the
sources listed in the table in this paragraph:
----------------------------------------------------------------------------------------------------------------
Source for Obtaining
Specification Limit Method Cited Method
----------------------------------------------------------------------------------------------------------------
(1) Sucrose esters.................. Not less than 90%...... ``Method for Analyzing Office of Food
the Purity of Sucrose Additive Safety (HFS-
Fatty Acid Esters,'' 200), Center for Food
Chemical Corp., June 17, Safety and Applied
1998 Nutrition, Food and
Drug Administration,
5001 Campus Dr.,
College Park, MD
20740, 240-402-1200.
----------------------------------------------------------------------------------------------------------------
(2) Mono-, di-, and tri-esters...... Not more than 45%...... ``Method for Measuring Do.
the Ester Distribution
of Sucrose
Oligoesters,'' issued by
Mitsubishi Chemical
Corp., June 17, 1998.
----------------------------------------------------------------------------------------------------------------
(3) Tetra-, penta-, hexa-, and hepta- Not less than 50%...... Do. Do.
esters.
----------------------------------------------------------------------------------------------------------------
(4) Octa-esters..................... Not more than 40%...... Do. Do.
----------------------------------------------------------------------------------------------------------------
(5) Free Sucrose.................... Not more than 0.5%..... ``Free Sucrose Method,'' Do.
issued by Mitsubishi
Chemical Corp., June 17,
1998.
----------------------------------------------------------------------------------------------------------------
(6) Acid Value...................... Not more than 4.0...... ``Acid Value,'' Appendix United States
VII, Method I Pharmacopeial
(Commercial Fatty Convention, 12601
Acids), in the Food Twinbrook Pkwy.,
Chemicals Codex, 7th ed. Rockville, MD 20852
(2010), p. 1220. (Internet address
http://www.usp.org)
----------------------------------------------------------------------------------------------------------------
(7) Residue on Ignition............. Not more than 0.7%..... ``Residue on Ignition,'' Do.
Appendix IIC, Method I,
in the Food Chemicals
Codex, 7th ed. (2010),
pp. 1141-1142 (using a 1-
gram sample).
----------------------------------------------------------------------------------------------------------------
[[Page 119]]
(8) Residual Methanol............... Not more than 10 Method listed in the Do
milligrams/kilogram. monograph for ``Sucrose
Fatty Acid Esters'' in
the Food Chemicals
Codex, 7th ed. (2010),
pp. 998-1000.
----------------------------------------------------------------------------------------------------------------
(9) Residual Dimethyl Sulfoxide..... Not more than 2.0 ......do Do.
milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(10) Residual Isobutyl Alcohol...... Not more than 10 ......do Do.
milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(11) Lead........................... Not more than 1.0 ``Atomic Absorption Do.
milligram/kilogram. Spectrophometric
Graphite Furnace
Method,'' Method I in
the Food Chemicals
Codex, 7th ed. (2010),
p. 1154-1155
----------------------------------------------------------------------------------------------------------------
(c) The additive is used as an emulsifier (as defined in Sec.
170.3(o)(8) of this chapter) or stabilizer (as defined in Sec.
170.3(o)(28) of this chapter) in chocolate and in butter-substitute
spreads, at a level not to exceed 2.0 percent; except that the additive
may not be used in a standardized food unless permitted by the standard
of identity.
[68 FR 50072, Aug. 20, 2003, as amended at 78 FR 71465, Nov. 29, 2013;
88 FR 17721, Mar. 24, 2023]
Sec. 172.870 Hydroxypropyl cellulose.
The food additive hydroxypropyl cellulose may be safely used in
food, except standardized foods that do not provide for such use, in
accordance with the following prescribed conditions:
(a) The additive consists of one of the following:
(1) A cellulose ether containing propylene glycol groups attached by
an ether linkage that contains, on an anhydrous basis, not more than 4.6
hydroxypropyl groups per anhydroglucose unit. The additive has a minimum
viscosity of 10 centipoises for a 10 percent by weight aqueous solution
at 25 degrees C.
(2) A cellulose ether containing propylene glycol groups attached by
an ether linkage having a hydroxypropoxy (OC3H6OH)
content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis,
i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The
common name for this form of the additive is low substituted
hydroxypropyl cellulose.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used or intended for use as an emulsifier, film former, protective
colloid, stabilizer, suspending agent, or thickener in food, in
accordance with good manufacturing practice. The additive also may be
used as a binder in dietary supplements, in accordance with good
manufacturing practice.
(2) The additive identified in paragraph (a)(2) of this section is
used or intended for use as a binder and disintegrator in tablets or
wafers containing dietary supplements of vitamins and/or minerals. The
additive is used in accordance with good manufacturing practice.
[46 FR 50065, Oct. 9, 1981, as amended at 76 FR 41689, July 15, 2011]
Sec. 172.872 Methyl ethyl cellulose.
The food additive methyl ethyl cellulose may be safely used in food
in accordance with the following prescribed conditions.
(a) The additive is a cellulose ether having the general formula
[C6H(10-x-
y)O5(CH3)x(C2H5)y]n, where x
is the number of methyl groups and y is the number of ethyl groups. The
average value of x is 0.3 and the average value of y is 0.7.
(b) The additive meets the following specifications:
(1) The methoxy content shall be not less than 3.5 percent and not
more than 6.5 percent, calculated as OCH3, and the ethoxy
content shall be not less than
[[Page 120]]
14.5 percent and not more than 19 percent, calculated as
OC2H5, both measured on the dry sample.
(2) The viscosity of an aqueous solution, 2.5 grams of the material
in 100 milliliters of water, at 20 [deg]C, is 20 to 60 centipoises.
(3) The ash content on a dry basis has a maximum of 0.6 percent.
(c) The food additive is used as an aerating, emulsifying, and
foaming agent, in an amount not in excess of that reasonably required to
produce its intended effect.
Sec. 172.874 Hydroxypropyl methylcellulose.
The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-
65-3) may be safely used in food, except in standardized foods which do
not provide for such use if:
(a) The additive complies with the definition and specifications
prescribed in the National Formulary, 12th edition.
(b) It is used or intended for use as an emulsifier, film former,
protective colloid, stabilizer, suspending agent, or thickener, in
accordance with good manufacturing practice.
(c) To insure safe use of the additive, the container of the
additive, in addition to being labeled as required by the general
provisions of the act, shall be accompanied by labeling which contains
adequate directions for use to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 38273, Aug. 31, 1982]
Sec. 172.876 Castor oil.
The food additive castor oil may be safely used in accordance with
the following conditions:
(a) The additive meets the specifications of the United States
Pharmacopeia XX (1980).
(b) The additive is used or intended for use as follows:
Use and Limitations
Hard candy production--As a release agent and antisticking agent,
not to exceed 500 parts per million in hard candy.
Vitamin and mineral tablets--As a component of protective coatings.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
Sec. 172.878 White mineral oil.
White mineral oil may be safely used in food in accordance with the
following conditions:
(a) White mineral oil is a mixture of liquid hydrocarbons,
essentially paraffinic and naphthenic in nature obtained from petroleum.
It is refined to meet the following specifications:
(1) It meets the test requirements of the United States Pharmacopeia
XX (1980) for readily carbonizable substances (page 532).
(2) It meets the test requirements of U.S.P. XVII for sulfur
compounds (page 400).
(3) It meets the specifications prescribed in the ``Journal of the
Association of Official Analytical Chemists,'' Volume 45, page 66
(1962), which is incorporated by reference, after correction of the
ultraviolet absorbance for any absorbance due to added antioxidants.
Copies of the material incorporated by reference are available from the
Office of Food Additive Safety (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1200, or available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(b) White mineral oil may contain any antioxidant permitted in food
by regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
(c) White mineral oil is used or intended for use as follows:
[[Page 121]]
------------------------------------------------------------------------
Limitation (inclusive of
all petroleum hydrocarbons
Use that may be used in
combination with white
mineral oil)
------------------------------------------------------------------------
1. As a release agent, binder, and lubricant Not to exceed 0.6% of the
in or on capsules and tablets containing capsule or tablet.
concentrates of flavoring, spices,
condiments, and nutrients intended for
addition to food, excluding confectionery.
2. As a release agent, binder, and lubricant Not to exceed 0.6% of the
in or on capsules and tablets containing capsule or tablet.
food for special dietary use.
3. As a float on fermentation fluids in the In an amount not to exceed
manufacture of vinegar and wine to prevent good manufacturing
or retard access of air, evaporation, and practice.
wild yeast contamination during
fermentation.
4. As a defoamer in food.................... In accordance with Sec.
173.340 of this chapter.
5. In bakery products, as a release agent Not to exceed 0.15% of
and lubricant. bakery products.
6. In dehydrated fruits and vegetables, as a Not to exceed 0.02% of
release agent. dehydrated fruits and
vegetables.
7. In egg white solids, as a release agent.. Not to exceed 0.1% of egg
white solids.
8. On raw fruits and vegetables, as a In an amount not to exceed
protective coating. good manufacturing
practice.
9. In frozen meat, as a component of hot- Not to exceed 0.095% of
melt coating. meat.
10. As a protective float on brine used in In an amount not to exceed
the curing of pickles. good manufacturing
practice.
11. In molding starch used in the Not to exceed 0.3 percent
manufacture of confectionery. in the molding starch.
12. As a release agent, binder, and Not to exceed 0.15 percent
lubricant in the manufacture of yeast. of yeast.
13. As an antidusting agent in sorbic acid Not to exceed 0.25 percent
for food use. in the sorbic acid.
14. As release agent and as sealing and Not to exceed 0.2 percent
polishing agent in the manufacture of of confectionery.
confectionery.
15. As a dust control agent for wheat, corn, Applied at a level of no
soybean, barley, rice, rye, oats, and more than 0.02 percent by
sorghum. weight of grain.
16. As a dust control agent for rice........ ISO 100 oil viscosity (100
centistokes (cSt) at 100
[deg]F) applied at a
level of no more than
0.08 percent by weight of
the rice grain.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47
FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar.
19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998; 88 FR
17722, Mar. 24, 2023]
Sec. 172.880 Petrolatum.
Petrolatum may be safely used in food, subject to the provisions of
this section.
(a) Petrolatum complies with the specifications set forth in the
United States Pharmacopeia XX (1980) for white petrolatum or in the
National Formulary XV (1980) for petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in Sec.
172.886(b):
Ultraviolet absorbance per centimeter path length:
------------------------------------------------------------------------
Millimicrons Maximum
------------------------------------------------------------------------
280-289..................................................... 0.25
290-299..................................................... .20
300-359..................................................... .14
360-400..................................................... .04
------------------------------------------------------------------------
(c) Petrolatum is used or intended for use as follows:
------------------------------------------------------------------------
Limitation (inclusive of all
petroleum hydrocarbons that may
Use be used in combination with
petrolatum)
------------------------------------------------------------------------
In bakery products; as release agent With white mineral oil, not to
and lubricant. exceed 0.15 percent of bakery
product.
In confectionery; as release agent and Not to exceed 0.2 percent of
as sealing and polishing agent. confectionery.
In dehydrated fruits and vegetables; as Not to exceed 0.02 percent of
release agent. dehydrated fruits and
vegetables.
In egg white solids; as release agent.. Not to exceed 0.1 percent of
egg white solids.
On raw fruits and vegetables; as In an amount not to exceed good
protective coating. manufacturing practice.
In beet sugar and yeast; as defoaming As prescribed in Sec. 173.340
agent. of this chapter.
------------------------------------------------------------------------
[[Page 122]]
(d) Petrolatum may contain any antioxidant permitted in food by
regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]
Sec. 172.882 Synthetic isoparaffinic petroleum hydrocarbons.
Synthetic isoparaffinic petroleum hydrocarbons may be safely used in
food, in accordance with the following conditions:
(a) They are produced by synthesis from petroleum gases and consist
of a mixture of liquid hydrocarbons meeting the following
specifications:
Boiling point 93-260 [deg]C as determined by ASTM method D86-82,
``Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be examined at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
Ultraviolet absorbance:
260-319 millimicrons--1.5 maximum.
320-329 millimicrons--0.08 maximum.
330-350 millimicrons--0.05 maximum.
Nonvolatile residual: 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing
antioxidants shall meet the specified ultraviolet absorbance limits
after correction for any absorbance due to the antioxidants. The
ultraviolet absorbance shall be determined by the procedure described
for application of mineral oil, disregarding the last sentence of the
procedure, under ``Specifications'' on page 66 of the ``Journal of the
Association of Official Analytical Chemists,'' Volume 45 (February
1962), which is incorporated by reference. Copies are available from the
Office of Food Additive Safety (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1200, or available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. For hydrocarbons boiling below 250 [deg]F, the
nonvolatile residue shall be determined by ASTM method D1353-78,
``Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;'' for those
boiling above 121 [deg]C, ASTM method D381-80, ``Standard Test Method
for Existent Gum in Fuels by Jet Evaporation'' shall be used. These
methods are incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants
authorized for use in food in an amount not to exceed that reasonably
required to accomplish the intended technical effect nor to exceed any
prescribed limitations.
(c) Synthetic isoparaffinic petroleum hydrocarbons are used or
intended for use as follows:
------------------------------------------------------------------------
Uses Limitations
------------------------------------------------------------------------
1. In the froth-flotation cleaning of In an amount not to exceed
vegetables. good manufacturing
practice.
2. As a component of insecticide Do.
formulations for use on processed foods.
3. As a component of coatings on fruits Do.
and vegetables.
4. As a coating on shell eggs............. Do.
5. As a float on fermentation fluids in Do.
the manufacture of vinegar and wine and
on brine used in curing pickles, to
prevent or retard access of air,
evaporation, and contamination with wild
organisms during fermentation.
------------------------------------------------------------------------
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982;
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 88 FR 17722,
Mar. 24, 2023]
Sec. 172.884 Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used in food, in
accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from
petroleum or synthesized from petroleum gases. The additive is chiefly
paraffinic, isoparaffinic, or naphthenic in nature.
[[Page 123]]
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 [deg]F minimum.
(3) Final boiling point is 650 [deg]F maximum.
(4) Ultraviolet absorbance limits determined by method specified in
Sec. 178.3620(b)(1)(ii) of this chapter, as follows:
------------------------------------------------------------------------
Maximum
absorbance
per
Wavelength m[micro] centimeter
optical
pathlength
------------------------------------------------------------------------
280-289..................................................... 4.0
290-299..................................................... 3.3
300-329..................................................... 2.3
330-360..................................................... .8
------------------------------------------------------------------------
(c) The additive is used as follows:
------------------------------------------------------------------------
Use Limitations
------------------------------------------------------------------------
As a coating on shell eggs................ In an amount not to exceed
good manufacturing
practice.
As a defoamer in processing beet sugar and Complying with Sec.
yeast. 173.340 of this chapter.
As a float on fermentation fluids in the In an amount not to exceed
manufacture of vinegar and wine to good manufacturing
prevent or retard access of air, practice.
evaporation, and wild yeast contamination
during fermentation.
In the froth-flotation cleaning of Do.
vegetables.
As a component of insecticide formulations Do.
used in compliance with regulations
issued in parts 170 through 189 of this
chapter.
------------------------------------------------------------------------
Sec. 172.886 Petroleum wax.
Petroleum wax may be safely used in or on food, in accordance with
the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in
nature, derived from petroleum, and refined to meet the specifications
prescribed by this section.
(b) Petroleum wax meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in this paragraph.
------------------------------------------------------------------------
Maximum
ultraviolet
absorbance
per
centimeter
path length
------------------------------------------------------------------------
280-289 millimicrons....................................... 0.15
290-299 millimicrons....................................... 0.12
300-359 millimicrons....................................... 0.08
360-400 millimicrons....................................... 0.02
------------------------------------------------------------------------
Analytical Specification for Petroleum Wax
general instructions
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of wax samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
apparatus
Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable ball-joint at the top
for connecting to the nitrogen supply. The male fitting should be
equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to
be 15.7 millimeters 0.1 millimeter, equipped with
a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock,
and a female 24/40 standard tapered fitting at the opposite end.
(Overall length of the column with the female joint is 235 millimeters.)
The female fitting should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately
\3/16\-inch thick with a hole bored in the center to closely fit the
stem of the chromatographic tube.
Heating jacket. Conical, for 500-milliliter separatory funnel. (Used
with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
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Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of
dimethyl sulfoxide); 2-liter distillation flask with heating mantle;
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters
in length and distilling head with separable cold finger condenser. Use
of tetrafluoroethylene polymer sleeves on the glass joints will prevent
freezing. Do not use grease on stopcocks or joints.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5.000 centimeters 0.005 centimeter;
also for checking spectrophotometer performance only, optical path
length in the range 1.000 centimeter 0.005
centimeter. With distilled water in the cells, determine any absorbance
differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons
with spectral slit width of 2 millimicrons or less, under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4
absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4
absorbance.
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\1\ As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies are
available from the Office of Food Additive Safety (HFS-200), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1200, or available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
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Wavelength repeatability,