This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170]
[Page 5]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec.
170.3 Definitions.
170.6 Opinion letters on food additive status.
170.10 Food additives in standardized foods.
170.15 Adoption of regulation on initiative of Commissioner.
170.17 Exemption for investigational use and procedure for obtaining
authorization to market edible products from experimental
animals.
170.18 Tolerances for related food additives.
170.19 Pesticide chemicals in processed foods.
Subpart B--Food Additive Safety
170.20 General principles for evaluating the safety of food additives.
170.22 Safety factors to be considered.
170.30 Eligibility for classification as generally recognized as safe
(GRAS).
170.35 Affirmation of generally recognized as safe (GRAS) status.
170.38 Determination of food additive status.
170.39 Threshold of regulation for substances used in food-contact
articles.
Subpart C--Specific Administrative Rulings and Decisions
170.45 Fluorine-containing compounds.
170.50 Glycine (aminoacetic acid) in food for human consumption.
170.60 Nitrites and/or nitrates in curing premixes.
Subpart D--Premarket Notifications
170.100 Submission of a premarket notification for a food contact
substance (FCN) to the Food and Drug Administration (FDA).
170.101 Information in a premarket notification for a food contact
substance (FCN).
170.102 Confidentiality of information in a premarket notification for
a food contact substance (FCN).
170.103 Withdrawal without prejudice of a premarket notification for a
food contact substance (FCN).
170.104 Action on a premarket notification for a food contact substance
(FCN).
170.105 The Food and Drug Administration's (FDA's) determination that a
premarket notification for a food contact substance (FCN) is
no longer effective.
170.106 Notification for a food contact substance formulation (NFCSF).
Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.
Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 170 appear at 66 FR
56035, Nov. 6, 2001.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.3]
[Page 5-9]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 170.3 Definitions.
For the purposes of this subchapter, the following definitions
apply:
(a) Secretary means the Secretary of Health and Human Services.
(b) Department means the Department of Health and Human Services.
(c) Commissioner means the Commissioner of Food and Drugs.
(d) As used in this part, the term act means the Federal Food, Drug,
and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as
amended (21 U.S.C. 301-392).
(e)(1) Food additives includes all substances not exempted by
section 201(s) of the act, the intended use of which results or may
reasonably be expected to result, directly or indirectly, either in
their becoming a component of food or otherwise affecting the
characteristics of food. A material used in the production of containers
and packages is subject to the definition if it may reasonably be
expected to become a component, or to affect the characteristics,
directly or indirectly, of food packed in the container. "Affecting the
characteristics of food" does not include such physical effects, as
protecting contents of packages, preserving shape, and preventing
moisture loss. If there is no migration of a packaging component from
the package to the food, it does not become a component of the food and
thus is not a food additive. A substance that does not become a
component of food, but that is used, for example, in preparing an
ingredient of the food to give a different flavor, texture, or other
characteristic in the food, may be a food additive.
[[Page 6]]
(2) Uses of food additives not requiring a listing regulation. Use
of a substance in a food contact article (e.g., food-packaging or food-
processing equipment) whereby the substance migrates, or may reasonably
be expected to migrate, into food at such levels that the use has been
exempted from regulation as a food additive under Sec. 170.39, and food
contact substances used in accordance with a notification submitted
under section 409(h) of the act that is effective.
(3) A food contact substance is any substance that is intended for
use as a component of materials used in manufacturing, packing,
packaging, transporting, or holding food if such use is not intended to
have any technical effect in such food.
(f) Common use in food means a substantial history of consumption of
a substance for food use by a significant number of consumers.
(g) The word substance in the definition of the term "food
additive" includes a food or food component consisting of one or more
ingredients.
(h) Scientific procedures include those human, animal, analytical,
and other scientific studies, whether published or unpublished,
appropriate to establish the safety of a substance.
(i) Safe or safety means that there is a reasonable certainty in the
minds of competent scientists that the substance is not harmful under
the intended conditions of use. It is impossible in the present state of
scientific knowledge to establish with complete certainty the absolute
harmlessness of the use of any substance. Safety may be determined by
scientific procedures or by general recognition of safety. In
determining safety, the following factors shall be considered:
(1) The probable consumption of the substance and of any substance
formed in or on food because of its use.
(2) The cumulative effect of the substance in the diet, taking into
account any chemically or pharmacologically related substance or
substances in such diet.
(3) Safety factors which, in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food and
food ingredients, are generally recognized as appropriate.
(j) The term nonperishable processed food means any processed food
not subject to rapid decay or deterioration that would render it unfit
for consumption. Examples are flour, sugar, cereals, packaged cookies,
and crackers. Not included are hermetically sealed foods or manufactured
dairy products and other processed foods requiring refrigeration.
(k) General recognition of safety shall be determined in accordance
with Sec. 170.30.
(l) Prior sanction means an explicit approval granted with respect
to use of a substance in food prior to September 6, 1958, by the Food
and Drug Administration or the United States Department of Agriculture
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry
Products Inspection Act, or the Meat Inspection Act.
(m) Food includes human food, substances migrating to food from
food-contact articles, pet food, and animal feed.
(n) The following general food categories are established to group
specific related foods together for the purpose of establishing
tolerances or limitations for the use of direct human food ingredients.
Individual food products will be included within these categories
according to the detailed classifications lists contained in Exhibit 33B
of the report of the National Academy of Sciences/National Research
Council report, "A Comprehensive Survey of Industry on the Use of Food
Chemicals Generally Recognized as Safe" (September 1972), which is
incorporated by reference. Copies are available from the National
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408:
(1) Baked goods and baking mixes, including all ready-to-eat and
ready-to-bake products, flours, and mixes requiring preparation before
serving.
(2) Beverages, alcoholic, including malt beverages, wines, distilled
liquors, and cocktail mix.
(3) Beverages and beverage bases, nonalcoholic, including only
special or
[[Page 7]]
spiced teas, soft drinks, coffee substitutes, and fruit and vegetable
flavored gelatin drinks.
(4) Breakfast cereals, including ready-to-eat and instant and
regular hot cereals.
(5) Cheeses, including curd and whey cheeses, cream, natural,
grating, processed, spread, dip, and miscellaneous cheeses.
(6) Chewing gum, including all forms.
(7) Coffee and tea, including regular, decaffeinated, and instant
types.
(8) Condiments and relishes, including plain seasoning sauces and
spreads, olives, pickles, and relishes, but not spices or herbs.
(9) Confections and frostings, including candy and flavored
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple,
powdered, and raw sugars.
(10) Dairy product analogs, including nondairy milk, frozen or
liquid creamers, coffee whiteners, toppings, and other nondairy
products.
(11) Egg products, including liquid, frozen, or dried eggs, and egg
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and
frozen multicourse egg meals, but not fresh eggs.
(12) Fats and oils, including margarine, dressings for salads,
butter, salad oils, shortenings and cooking oils.
(13) Fish products, including all prepared main dishes, salads,
appetizers, frozen multicourse meals, and spreads containing fish,
shellfish, and other aquatic animals, but not fresh fish.
(14) Fresh eggs, including cooked eggs and egg dishes made only from
fresh shell eggs.
(15) Fresh fish, including only fresh and frozen fish, shellfish,
and other aquatic animals.
(16) Fresh fruits and fruit juices, including only raw fruits,
citrus, melons, and berries, and home-prepared "ades" and punches made
therefrom.
(17) Fresh meats, including only fresh or home-frozen beef or veal,
pork, lamb or mutton and home-prepared fresh meat-containing dishes,
salads, appetizers, or sandwich spreads made therefrom.
(18) Fresh poultry, including only fresh or home-frozen poultry and
game birds and home-prepared fresh poultry-containing dishes, salads,
appetizers, or sandwich spreads made therefrom.
(19) Fresh vegetables, tomatoes, and potatoes, including only fresh
and home-prepared vegetables.
(20) Frozen dairy desserts and mixes, including ice cream, ice
milks, sherbets, and other frozen dairy desserts and specialties.
(21) Fruit and water ices, including all frozen fruit and water
ices.
(22) Gelatins, puddings, and fillings, including flavored gelatin
desserts, puddings, custards, parfaits, pie fillings, and gelatin base
salads.
(23) Grain products and pastas, including macaroni and noodle
products, rice dishes, and frozen multicourse meals, without meat or
vegetables.
(24) Gravies and sauces, including all meat sauces and gravies, and
tomato, milk, buttery, and specialty sauces.
(25) Hard candy and cough drops, including all hard type candies.
(26) Herbs, seeds, spices, seasonings, blends, extracts, and
flavorings, including all natural and artificial spices, blends, and
flavors.
(27) Jams and jellies, home-prepared, including only home-prepared
jams, jellies, fruit butters, preserves, and sweet spreads.
(28) Jams and jellies, commercial, including only commercially
processed jams, jellies, fruit butters, preserves, and sweet spreads.
(29) Meat products, including all meats and meat containing dishes,
salads, appetizers, frozen multicourse meat meals, and sandwich
ingredients prepared by commercial processing or using commercially
processed meats with home preparation.
(30) Milk, whole and skim, including only whole, lowfat, and skim
fluid milks.
(31) Milk products, including flavored milks and milk drinks, dry
milks, toppings, snack dips, spreads, weight control milk beverages, and
other milk origin products.
(32) Nuts and nut products, including whole or shelled tree nuts,
peanuts, coconut, and nut and peanut spreads.
(33) Plant protein products, including the National Academy of
Sciences/National Research Council "reconstituted vegetable protein"
category, and meat, poultry, and fish substitutes, analogs,
[[Page 8]]
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 available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408:
(1) "Anticaking agents and free-flow agents": Substances added to
finely powdered or crystalline food products to prevent caking, lumping,
or agglomeration.
(2) "Antimicrobial agents": Substances used to preserve food by
preventing growth of microorganisms and subsequent spoilage, including
fungistats, mold and rope inhibitors, and the effects listed by the
National Academy of Sciences/National Research Council under
"preservatives."
(3) "Antioxidants": Substances used to preserve food by retarding
deterioration, rancidity, or discoloration due to oxidation.
(4) "Colors and coloring adjuncts": Substances used to impart,
preserve, or enhance the color or shading of a food, including color
stabilizers, color fixatives, color-retention agents, etc.
(5) "Curing and pickling agents": Substances imparting a unique
flavor and/or color to a food, usually producing an increase in shelf
life stability.
(6) "Dough strengtheners": Substances used to modify starch and
gluten, thereby producing a more stable dough, including the applicable
effects listed by the National Academy of Sciences/National Research
Council under "dough conditioner."
(7) "Drying agents": Substances with moisture-absorbing ability,
used to maintain an environment of low moisture.
(8) "Emulsifiers and emulsifier salts": Substances which modify
surface tension in the component phase of an emulsion to establish a
uniform dispersion or emulsion.
(9) "Enzymes": Enzymes used to improve food processing and the
quality of the finished food.
(10) "Firming agents": Substances added to precipitate residual
pectin, thus strengthening the supporting tissue and preventing its
collapse during processing.
(11) "Flavor enhancers": Substances added to supplement, enhance,
or modify the original taste and/or aroma of a food, without imparting a
characteristic taste or aroma of its own.
[[Page 9]]
(12) "Flavoring agents and adjuvants": Substances added to impart
or help impart a taste or aroma in food.
(13) "Flour treating agents": Substances added to milled flour, at
the mill, to improve its color and/or baking qualities, including
bleaching and maturing agents.
(14) "Formulation aids": Substances used to promote or produce a
desired physical state or texture in food, including carriers, binders,
fillers, plasticizers, film-formers, and tableting aids, etc.
(15) "Fumigants": Volatile substances used for controlling insects
or pests.
(16) "Humectants": Hygroscopic substances incorporated in food to
promote retention of moisture, including moisture-retention agents and
antidusting agents.
(17) "Leavening agents": Substances used to produce or stimulate
production of carbon dioxide in baked goods to impart a light texture,
including yeast, yeast foods, and calcium salts listed by the National
Academy of Sciences/National Research Council under "dough
conditioners."
(18) "Lubricants and release agents": Substances added to food
contact surfaces to prevent ingredients and finished products from
sticking to them.
(19) "Non-nutritive sweeteners": Substances having less than 2
percent of the caloric value of sucrose per equivalent unit of
sweetening capacity.
(20) "Nutrient supplements": Substances which are necessary for
the body's nutritional and metabolic processes.
(21) "Nutritive sweeteners": Substances having greater than 2
percent of the caloric value of sucrose per equivalent unit of
sweetening capacity.
(22) "Oxidizing and reducing agents": Substances which chemically
oxidize or reduce another food ingredient, thereby producing a more
stable product, including the applicable effect listed by the National
Academy of Sciences/National Research Council under "dough
conditioners."
(23) "pH control agents": Substances added to change or maintain
active acidity or basicity, including buffers, acids, alkalies, and
neutralizing agents.
(24) "Processing aids": Substances used as manufacturing aids to
enhance the appeal or utility of a food or food component, including
clarifying agents, clouding agents, catalysts, flocculents, filter aids,
and crystallization inhibitors, etc.
(25) "Propellants, aerating agents, and gases": Gases used to
supply force to expel a product or used to reduce the amount of oxygen
in contact with the food in packaging.
(26) "Sequestrants": Substances which combine with polyvalent
metal ions to form a soluble metal complex, to improve the quality and
stability of products.
(27) "Solvents and vehicles": Substances used to extract or
dissolve another substance.
(28) "Stabilizers and thickeners": Substances used to produce
viscous solutions or dispersions, to impart body, improve consistency,
or stabilize emulsions, including suspending and bodying agents, setting
agents, jellying agents, and bulking agents, etc.
(29) "Surface-active agents": Substances used to modify surface
properties of liquid food components for a variety of effects, other
than emulsifiers, but including solubilizing agents, dispersants,
detergents, wetting agents, rehydration enhancers, whipping agents,
foaming agents, and defoaming agents, etc.
(30) "Surface-finishing agents": Substances used to increase
palatability, preserve gloss, and inhibit discoloration of foods,
including glazes, polishes, waxes, and protective coatings.
(31) "Synergists": Substances used to act or react with another
food ingredient to produce a total effect different or greater than the
sum of the effects produced by the individual ingredients.
(32) "Texturizers": Substances which affect the appearance or feel
of the food.
[42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982;
53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July
17, 1995; 67 FR 35729, May 21, 2002]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.6]
[Page 9-10]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
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
[[Page 10]]
safety of articles intended for use as components of, or in contact
with, food. Prior to the enactment of the Food Additives Amendment of
1958 (Pub. L. 85-929; Sept. 6, 1958), these opinions were given pursuant
to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which
reads in part: "A food shall be deemed to be adulterated if it bears or
contains any poisonous or deleterious substance which may render it
injurious to health".
(b) Since enactment of the Food Additives Amendment, the Food and
Drug Administration has advised such inquirers that an article:
(1) Is a food additive within the meaning of section 201(s) of the
act; or
(2) Is generally recognized as safe (GRAS); or
(3) Has prior sanction or approval under that amendment; or
(4) Is not a food additive under the conditions of intended use.
(c) In the interest of the public health, such articles which have
been considered in the past by the Food and Drug Administration to be
safe under the provisions of section 402(a)(1), or to be generally
recognized as safe for their intended use, or to have prior sanction or
approval, or not to be food additives under the conditions of intended
use, must be reexamined in the light of current scientific information
and current principles for evaluating the safety of food additives if
their use is to be continued.
(d) Because of the time span involved, copies of many of the letters
in which the Food and Drug Administration has expressed an informal
opinion concerning the status of such articles may no longer be in the
file of the Food and Drug Administration. In the absence of information
concerning the names and uses made of all the articles referred to in
such letters, their safety of use cannot be reexamined. For this reason
all food additive status opinions of the kind described in paragraph (c)
of this section given by the Food and Drug Administration are hereby
revoked.
(e) The prior opinions of the kind described in paragraph (c) of
this section will be replaced by qualified and current opinions if the
recipient of each such letter forwards a copy of each to the Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College
Park, MD 20740, along with a copy of his letter of inquiry, on or before
July 23, 1970.
(f) This section does not apply to food additive status opinion
letters pertaining to articles that were considered by the Food and Drug
Administration to be food additives nor to articles included in
regulations in parts 170 through 189 of this chapter if the articles are
used in accordance with the requirements of such regulations.
[42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.10]
[Page 10-11]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
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
[[Page 11]]
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.15]
[Page 11]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.17]
[Page 11]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
Sec. 170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for
investigational use by qualified experts shall be exempt from the
requirements of section 409 of the Act under the following conditions:
(a) If intended for investigational use in vitro or in laboratory
research animals, it bears a label which states prominently, in addition
to the other information required by the act, the warning:
Caution. Contains a new food additive for investigational use only
in laboratory research animals or for tests in vitro. Not for use in
humans.
(b) If intended for use in animals other than laboratory research
animals and if the edible products of the animals are to be marketed as
food, permission for the marketing of the edible products as food has
been requested by the sponsor, and authorization has been granted by the
Food and Drug Administration in accordance with Sec. 511.1 of this
chapter or by the Department of Agriculture in accordance with 9 CFR
309.17, and it bears a label which states prominently, in addition to
the other information required by the Act, the warning:
Caution. Contains a new food additive for use only in
investigational animals. Not for use in humans.
Edible products of investigational animals are not to be used for
food unless authorization has been granted by the U.S. Food and Drug
Administration or by the U.S. Department of Agriculture.
(c) If intended for nonclinical laboratory studies in food-producing
animals, the study is conducted in compliance with the regulations set
forth in part 58 of this chapter.
[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.18]
[Page 11-12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
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.
[[Page 12]]
(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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.19]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart A--General Provisions
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.20]
[Page 12]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.22]
[Page 12-13]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart B--Food Additive Safety
Sec. 170.22 Safety factors to be considered.
In accordance with section 409(c)(5)(C) of the Act, the following
[[Page 13]]
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.30]
[Page 13-15]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart B--Food Additive Safety
Sec. 170.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of
experts qualified by scientific training and experience to evaluate the
safety of substances directly or indirectly added to food. The basis of
such views may be either (1) scientific procedures or (2) in the case of
a substance used in food prior to January 1, 1958, through experience
based on common use in food. General recognition of safety requires
common knowledge about the substance throughout the scientific community
knowledgeable about the safety of substances directly or indirectly
added to food.
(b) General recognition of safety based upon scientific procedures
shall require the same quantity and quality of scientific evidence as is
required to obtain approval of a food additive regulation for the
ingredient. General recognition of safety through scientific procedures
shall ordinarily be based upon published studies which may be
corroborated by unpublished studies and other data and information.
(c)(1) General recognition of safety through experience based on
common use in food prior to January 1, 1958, may be determined without
the quantity or quality of scientific procedures required for approval
of a food additive regulation. General recognition of safety through
experience based on common use in food prior to January 1, 1958, shall
be based solely on food use of the substance prior to January 1, 1958,
and shall ordinarily be based upon generally available data and
information. An ingredient not in common use in food prior to January 1,
1958, may achieve general recognition of safety only through scientific
procedures.
(2) A substance used in food prior to January 1, 1958, may be
generally recognized as safe through experience based on its common use
in food when that use occurred exclusively or primarily outside of the
United States if the information about the experience establishes that
the use of the substance is safe within the meaning of the act (see
Sec. 170.3(i)). Common use in food prior to January 1, 1958, that
occurred outside of the United States shall be documented by published
or other information and shall be corroborated by information from a
second, independent source that confirms the history and circumstances
of use of the substance. The information used to document and to
corroborate the history and circumstances of use of the substance must
be generally available; that is, it must be widely available in the
country in which the history of use has occurred and readily available
to interested qualified experts in this country. Persons claiming GRAS
status for a substance based on its common use in food outside of the
United States should obtain FDA concurrence that the use of the
substance is GRAS.
(d) The food ingredients listed as GRAS in part 182 of this chapter
or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter do not
include all substances that are generally recognized as safe for their
intended use in food. Because of the large number of substances the
intended use of which results or may reasonably be expected to result,
directly or indirectly, in their becoming a component or otherwise
affecting the characteristics of food, it is impracticable to list all
such substances that are GRAS. A food ingredient of natural biological
origin that has been widely consumed for its nutrient properties in the
United States prior to January 1, 1958, without known detrimental
effects, which is subject only to conventional processing as practiced
prior to January 1, 1958, and for which no known safety hazard exists,
will ordinarily be regarded as GRAS without specific inclusion in part
182, part 184 or Sec. 186.1 of this chapter.
[[Page 14]]
(e) Food ingredients were listed as GRAS in part 182 of this chapter
during 1958-1962 without a detailed scientific review of all available
data and information relating to their safety. Beginning in 1969, the
Food and Drug Administration has undertaken a systematic review of the
status of all ingredients used in food on the determination that they
are GRAS or subject to a prior sanction. All determinations of GRAS
status or food additive status or prior sanction status pursuant to this
review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of
this chapter. Affirmation of GRAS status shall be announced in part 184
or Sec. 186.1 of this chapter.
(f) The status of the following food ingredients will be reviewed
and affirmed as GRAS or determined to be a food additive or subject to a
prior sanction pursuant to Sec. 170.35, Sec. 170.38, or Sec. 180.1 of
this chapter:
(1) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, and which has been modified by processes first
introduced into commercial use after January 1, 1958, which may
reasonably be expected significantly to alter the composition of the
substance.
(2) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, that has had significant alteration of composition by
breeding or selection after January 1, 1958, where the change may be
reasonably expected to alter the nutritive value or the concentration of
toxic constituents.
(3) Distillates, isolates, extracts, and concentration of extracts
of GRAS substances.
(4) Reaction products of GRAS substances.
(5) Substances not of a natural biological origin, including those
for which evidence is offered that they are identical to a GRAS
counterpart of natural biological origin.
(6) Substances of natural biological origin intended for consumption
for other than their nutrient properties.
(g) A food ingredient that is not GRAS or subject to a prior
sanction requires a food additive regulation promulgated under section
409 of the act before it may be directly or indirectly added to food.
(h) A food ingredient that is listed as GRAS in part 182 of this
chapter or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter
shall be regarded as GRAS only if, in addition to all the requirements
in the applicable regulation, it also meets all of the following
requirements:
(1) It complies with any applicable food grade specifications of the
Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in
the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed.
(1981), which are incorporated by reference, except that any substance
used as a component of articles that contact food and affirmed as GRAS
in Sec. 186.1 of this chapter shall comply with the specifications
therein, or in the absence of such specifications, shall be of a purity
suitable for its intended use. Copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) It performs an appropriate function in the food or food-contact
article in which it is used.
(3) It is used at a level no higher than necessary to achieve its
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its
intended purpose in that article.
(i) If a substance is affirmed as GRAS in part 184 or Sec. 186.1 of
this chapter with no limitation other than good manufacturing practice,
it shall be regarded as GRAS if its conditions of use are not
significantly different from those reported in the regulation as the
basis on which the GRAS status of the substance was affirmed. If the
conditions of use are significantly different, such use of the substance
may not be GRAS. In such a case a manufacturer may not
[[Page 15]]
rely on the regulation as authorizing the use but must independently
establish that the use is GRAS or must use the substance in accordance
with a food additive regulation.
(j) If an ingredient is affirmed as GRAS in part 184 or Sec. 186.1
of this chapter with specific limitation(s), it may be used in food only
within such limitation(s) (including the category of food(s), the
functional use(s) of the ingredient, and the level(s) of use). Any use
of such an ingredient not in full compliance with each such established
limitation shall require a food additive regulation.
(k) Pursuant to Sec. 170.35, a food ingredient may be affirmed as
GRAS in part 184 or Sec. 186.1 of this chapter for a specific use(s)
without a general evaluation of use of the ingredient. In addition to
the use(s) specified in the regulation, other uses of such an ingredient
may also be GRAS. Any affirmation of GRAS status for a specific use(s),
without a general evaluation of use of the ingredient, is subject to
reconsideration upon such evaluation.
(l) New information may at any time require reconsideration of the
GRAS status of a food ingredient. Any change in part 182, part 184, or
Sec. 186.1 of this chapter shall be accomplished pursuant to
Sec. 170.38.
[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53
FR 16546, May 10, 1988]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.35]
[Page 15-17]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart B--Food Additive Safety
Sec. 170.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, either on his initiative or on the petition of
an interested person, may affirm the GRAS status of substances that
directly or indirectly become components of food.
(b)(1) If the Commissioner proposes on his own initiative that a
substance is entitled to affirmation as GRAS, he will place all of the
data and information on which he relies on public file in the office of
the Dockets Management Branch and will publish in the Federal Register a
notice giving the name of the substance, its proposed uses, and any
limitations proposed for purposes other than safety.
(2) The Federal Register notice will allow a period of 60 days
during which any interested person may review the data and information
and/or file comments with the Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is convincing evidence that the substance is GRAS
as described in Sec. 170.30, he will publish a notice in the Federal
Register listing the substance as GRAS in part 182, part 184, or part
186 of this chapter, as appropriate.
(4) If, after evaluation of the comments, the Commissioner concludes
that there is a lack of convincing evidence that the substance is GRAS
and that it should be considered a food additive subject to section 409
of the Act, he shall publish a notice thereof in the Federal Register in
accordance with Sec. 170.38.
(c)(1) Persons seeking the affirmation of GRAS status of substances
as provided in Sec. 170.30(e), except those subject to the NAS/NRC GRAS
list survey (36 FR 20546; October 23, 1971), shall submit a petition for
GRAS affirmation pursuant to part 10 of this chapter. Such petition
shall contain information to establish that the GRAS criteria as set
forth in Sec. 170.30 (b) or (c) have been met, in the following form:
(i) Description of the substance, including:
(a) Common or usual name.
(b) Chemical name.
(c) Chemical Abstract Service (CAS) registry number.
(d) Empirical formula.
(e) Structural formula.
(f) Specifications for food grade material, including arsenic and
heavy metals. (Recommendation for any change in the Food Chemicals Codex
monograph should be included where applicable.)
(g) Quantitative compositions.
(h) Manufacturing process (excluding any trade secrets).
(ii) Use of the substance, including:
(a) Date when use began.
(b) Information and reports or other data on past uses in food.
(c) Foods in which used, and levels of use in such foods, and for
what purposes.
[[Page 16]]
(iii) Methods for detecting the substance in food, including:
(a) References to qualitative and quantitative methods for
determining the substance(s) in food, including the type of analytical
procedures used.
(b) Sensitivity and reproducibility of such method(s).
(iv) Information to establish the safety and functionality of the
substance in food. Published scientific literature, evidence that the
substance is identical to a GRAS counterpart of natural biological
origin, and other data may be submitted to support safety. Any adverse
information or consumer complaints shall be included. Complete
bibliographic references shall be provided where a copy of the article
is not provided.
(v) A statement signed by the person responsible for the petition
that to the best of his knowledge it is a representative and balanced
submission that includes unfavorable information, as well as favorable
information, known to him pertinent to the evaluation of the safety and
functionality of the substance.
(vi) If nonclinical laboratory studies are involved, additional
information and data submitted in support of filed petitions shall
include, with respect to each nonclinical study, either a statement that
the study was conducted in compliance with the requirements set forth in
part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a brief statement of the reason for
the noncompliance.
(vii) [Reserved]
(viii) A claim for categorical exclusion under Sec. 25.30 or
Sec. 25.32 of this chapter or an environmental assessment under
Sec. 25.40 of this chapter.
(2) Within 30 days after the date of filing the petition, the
Commissioner will place the petition on public file in the office of the
Dockets Management Branch and will publish a notice of filing in the
Federal Register giving the name of the petitioner and a brief
description of the petition including the name of the substance, its
proposed use, and any limitations proposed for reasons other than
safety. A copy of the notice will be mailed to the petitioner at the
time the original is sent to the Federal Register.
(3)(i) If intended uses of the substance include uses in meat, meat
food product, or poultry product subject to regulation by the U.S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act (FMIA)
(21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward
a copy of the petition or relevant portions thereof to the Food Safety
and Inspection Service, USDA, for simultaneous review under the PPIA and
FMIA.
(ii) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA or, if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
(4) The notice of filing in the Federal Register will allow a period
of 60 days during which any interested person may review the petition
and/or file comments with the Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch's office.
(5) The Commissioner will evaluate the petition and all available
information including all comments received. If the petition and such
information provide convincing evidence that the substance is GRAS as
described in Sec. 170.30 he will publish an order in the Federal
Register listing the substance as GRAS in part 182, part 184, or part
186 of this chapter, as appropriate.
(6) If, after evaluation of the petition and all available
information, the Commissioner concludes that there is a lack of
convincing evidence that the substance is GRAS and that it should be
considered a food additive subject to section 409 of the Act, he shall
publish a notice thereof in the Federal Register in accordance with
Sec. 170.38.
(7) The notice of filing in the Federal Register will request
submission of proof of any applicable prior sanction for use of the
ingredient under conditions different from those proposed to be
determined to be GRAS. The failure of any person to come forward with
proof of such an applicable
[[Page 17]]
prior sanction in response to the notice of filing will constitute a
waiver of the right to assert or rely on such sanction at any later
time. The notice of filing will also constitute a proposal to establish
a regulation under part 181 of this chapter, incorporating the same
provisions, in the event that such a regulation is determined to be
appropriate as a result of submission of proof of such an applicable
prior sanction in response to the notice of filing.
(Information collection requirements were approved by the Office of
Management and Budget under control number 0910-0132)
[42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50
FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, July
29, 1997; 65 FR 51762, Aug. 25, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.38]
[Page 17-18]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart B--Food Additive Safety
Sec. 170.38 Determination of food additive status.
(a) The Commissioner may, in accordance with Sec. 170.35(b)(4) or
(c)(5), publish a notice in the Federal Register determining that a
substance is not GRAS and is a food additive subject to section 409 of
the Act.
(b)(1) The Commissioner, on his own initiative or on the petition of
any interested person, pursuant to part 10 of this chapter, may issue a
notice in the Federal Register proposing to determine that a substance
is not GRAS and is a food additive subject to section 409 of the Act.
Any petition shall include all relevant data and information of the type
described in Sec. 171.130(b). The Commissioner will place all of the
data and information on which he relies on public file in the office of
the Dockets Management Branch and will include in the Federal Register
notice the name of the substance, its known uses, and a summary of the
basis for the determination.
(2) The Federal Register notice will allow a period of 60 days
during which any interested person may review the data and information
and/or file comments with the Dockets Management Branch. Copies of all
comments shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is a lack of convincing evidence that the substance
is GRAS or is otherwise exempt from the definition of a food additive in
section 201(s) of the Act, he will publish a notice thereof in the
Federal Register. If he concludes that there is convincing evidence that
the substance is GRAS, he will publish an order in the Federal Register
listing the substance as GRAS in part 182, part 184, or part 186 of this
chapter, as appropriate.
(c) A Federal Register notice determining that a substance is a food
additive shall provide for the use of the additive in food or food
contact surfaces as follows:
(1) It may promulgate a food additive regulation governing use of
the additive.
(2) It may promulgate an interim food additive regulation governing
use of the additive.
(3) It may require discontinuation of the use of the additive.
(4) It may adopt any combination of the above three approaches for
different uses or levels of use of the additive.
(d) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of the substance, he will concurrently propose a
separate regulation covering such use of the ingredient under part 181
of this chapter. If the Commissioner is unaware of any such applicable
prior sanction, the proposed regulation will so state and will require
any person who intends to assert or rely on such sanction to submit
proof of its existence. Any regulation promulgated pursuant to this
section constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof
[[Page 18]]
of such an applicable prior sanction in response to the proposal.
[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
54 FR 24896, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.39]
[Page 18-20]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart B--Food Additive Safety
Sec. 170.39 Threshold of regulation for substances used in food-contact articles.
(a) A substance used in a food-contact article (e.g., food-packaging
or food-processing equipment) that migrates, or that may be expected to
migrate, into food will be exempted from regulation as a food additive
because it becomes a component of food at levels that are below the
threshold of regulation if:
(1) The substance has not been shown to be a carcinogen in humans or
animals, and there is no reason, based on the chemical structure of the
substance, to suspect that the substance is a carcinogen. The substance
must also not contain a carcinogenic impurity or, if it does, must not
contain a carcinogenic impurity with a TD50 value based on
chronic feeding studies reported in the scientific literature or
otherwise available to the Food and Drug Administration of less than
6.25 milligrams per kilogram bodyweight per day (The TD50,
for the purposes of this section, is the feeding dose that causes cancer
in 50 percent of the test animals when corrected for tumors found in
control animals. If more than one TD50 value has been
reported in the scientific literature for a substance, the Food and Drug
Administration will use the lowest appropriate TD50 value in its
review.);
(2) The substance presents no other health or safety concerns
because:
(i) The use in question has been shown to result in or may be
expected to result in dietary concentrations at or below 0.5 parts per
billion, corresponding to dietary exposure levels at or below 1.5
micrograms/person/day (based on a diet of 1,500 grams of solid food and
1,500 grams of liquid food per person per day); or
(ii) The substance is currently regulated for direct addition into
food, and the dietary exposure to the substance resulting from the
proposed use is at or below 1 percent of the acceptable daily intake as
determined by safety data in the Food and Drug Administration's files or
from other appropriate sources;
(3) The substance has no technical effect in or on the food to which
it migrates; and
(4) The substance use has no significant adverse impact on the
environment.
(b) Notwithstanding paragraph (a) of this section, the Food and Drug
Administration reserves the right to decline to grant an exemption in
those cases in which available information establishes that the proposed
use may pose a public health risk. The reasons for the agency's decision
to decline to grant an exemption will be explained in the Food and Drug
Administration's response to the requestor.
(c) A request for the Food and Drug Administration to exempt a use
of a substance from regulation as a food additive shall include three
copies of the following information (If part of the submitted material
is in a foreign language, it must be accompanied by an English
translation verified to be complete and accurate in accordance with
Sec. 10.20(c)(2) of this chapter):
(1) The chemical composition of the substance for which the request
is made, including, whenever possible, the name of the chemical in
accordance with current Chemical Abstract Service (CAS) nomenclature
guidelines and a CAS registry number, if available;
(2) Detailed information on the conditions of use of the substance
(e.g., temperature, type of food with which the substance will come into
contact, the duration of the contact, and whether the food-contact
article will be for repeated or single use applications);
(3) A clear statement as to whether the request for exemption from
regulation as a food additive is based on the fact that the use of the
substance in the food-contact article results in a dietary concentration
at or below 0.5 parts per billion, or on the fact that it involves the
use of a regulated direct food additive for which the dietary exposure
is at or below 1 percent of the acceptable dietary intake (ADI);
(4) Data that will enable the Food and Drug Administration to
estimate
[[Page 19]]
the daily dietary concentration resulting from the proposed use of the
substance. These data should be in the form of:
(i) Validated migration data obtained under worst-case (time/
temperature) intended use conditions utilizing appropriate food
simulating solvents;
(ii) Information on the amount of the substance used in the
manufacture of the food-contact article; or
(iii) Information on the residual level of the substance in the
food-contact article. For repeat-use articles, an estimate of the amount
of food that contacts a specific unit of surface area over the lifetime
of the article should also be provided. (In cases where data are
provided only in the form of manufacturing use levels or residual levels
of the substance present in the food-contact article, the Food and Drug
Administration will calculate a worst-case dietary concentration level
assuming 100 percent migration.) A detailed description of the
analytical method used to quantify the substance should also be
submitted along with data used to validate the detection limit.
(iv) In cases where there is no detectable migration into food or
food simulants, or when no residual level of a substance is detected in
the food-contact article by a suitable analytical method, the Food and
Drug Administration will, for the purposes of estimating the dietary
concentration, consider the validated detection limit of the method used
to analyze for the substance.
(5) The results of an analysis of existing toxicological information
on the substance and its impurities. This information on the substance
is needed to show whether an animal carcinogen bioassay has been carried
out, or whether there is some other basis for suspecting that the
substance is a carcinogen or potent toxin. This type of information on
the impurities is needed to show whether any of them are carcinogenic,
and, if carcinogenic, whether their TD50 values are greater than 6.25
milligrams per kilogram bodyweight per day in accordance with paragraph
(a)(1) of this section.
(6) Information on the environmental impact that would result from
the proposed use of the substance. The request should contain either a
claim for categorical exclusion as specified in Sec. 25.32 of this
chapter or an environmental assessment as specified in Sec. 25.40 of
this chapter.
(d) Data to be reviewed under this section shall be submitted to the
Food and Drug Administration's Office of Premarket Approval (HFS-200),
5100 Paint Branch Pkwy., College Park, MD 20740.
(e) The Food and Drug Administration will inform the requestor by
letter whether the specific food-contact application is exempt from
regulation as a food additive or not. Although a substance that migrates
to food at a level that results in a dietary concentration at or below
the threshold of regulation will not be the subject of a regulation
published in the Federal Register and will not appear in the Code of
Federal Regulations, the Food and Drug Administration will maintain a
list of substances exempted from regulation as food additives under this
section on display at the Dockets Management Branch. This list will
include the name of the company that made the request, the chemical name
of the substance, the specific use for which it has received an
exemption from regulation as a food additive, and any appropriate
limitations on its use. The list will not include any trade names. This
list will enable interested persons to see the types of uses of food-
contact materials being exempted under the regulation. Interested
persons may also obtain a copy of the list of exempted substances by
contacting the Food and Drug Administration's Office of Premarket
Approval (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740. For
actions requiring an environmental assessment, the agency's finding of
no significant impact and the evidence supporting that finding,
contained in the petitioner's environmental assessment, also will be
available for public inspection at the Dockets Management Branch in
accordance with Sec. 25.51(b)(2) of this chapter. Requests for copies of
releasable information contained in submissions requesting exemptions
from the food additive regulations will be handled in accordance with
the Food and Drug Administration's Freedom of
[[Page 20]]
Information Act procedures, as described in part 20 of this chapter. In
particular, data and information that fall within the definitions of a
trade secret or confidential commercial or financial information are not
available for public disclosure in accordance with Sec. 20.61(c) of this
chapter.
(f) If the request for an exemption from regulation as a food
additive is not granted, the requestor may submit a petition to the Food
and Drug Administration for reconsideration of the decision in
accordance with the provisions of Sec. 10.33 of this chapter.
(g) If the Food and Drug Administration receives significant new
information that raises questions about the dietary concentration or the
safety of a substance that the agency has exempted from regulation, the
Food and Drug Administration may reevaluate the substance. If the Food
and Drug Administration tentatively concludes that the information that
is available about the substance no longer supports an exemption for the
use of the food-contact material from the food additive regulations, the
agency will notify any persons that requested an exemption for the
substance of its tentative decision. The requestors will be given an
opportunity to show why the use of the substance should not be regulated
under the food additive provisions of the act. If the requestors fail to
adequately respond to the new evidence, the agency will notify them that
further use of the substance in question for the particular use will
require a food additive regulation. This notification will be placed on
public display at the Dockets Management Branch as part of the file of
uses of substances exempted from regulation as food additives. The Food
and Drug Administration recognizes that manufacturers other than those
that actually made a request for exemption may also be using exempted
substances in food-contact articles under conditions of use (e.g., use
levels, temperature, type of food contacted, etc.) that are similar to
those for which the exemption was issued. Because only requestors will
be notified as part of the revocation process described in this section,
the Food and Drug Administration plans to notify other manufacturers by
means of a notice published in the Federal Register of its decision to
revoke an exemption issued for a specific use of a substance in a food
contact article.
(h) Guidance documents to assist requestors in the preparation of
submissions seeking exemptions from the food additive regulations are
available from the Food and Drug Administration's Office of Premarket
Approval (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740.
Interested persons are encouraged to obtain specific guidance from the
Food and Drug Administration on the appropriate protocols to be used for
obtaining migration data, on the validation of the analytical methods
used to quantify migration levels, on the procedures used to relate
migration data to dietary exposures, and on any other issue not
specifically covered in the Food and Drug Administration's guidance
documents.
[60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997;
65 FR 56479, Sept. 19, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.45]
[Page 20]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart C--Specific Administrative Rulings and Decisions
Sec. 170.45 Fluorine-containing compounds.
The Commissioner of Food and Drugs has concluded that it is in the
interest of the public health to limit the addition of fluorine
compounds to foods (a) to that resulting from the fluoridation of public
water supplies as stated in Sec. 250.203 of this chapter, (b) to that
resulting from the fluoridation of bottled water within the limitation
established in Sec. 103.35(d) of this chapter, and (c) to that
authorized by regulations (40 CFR part 180) under section 408 of the
Act.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.50]
[Page 20-21]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart C--Specific Administrative Rulings and Decisions
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.
[[Page 21]]
(2) Current usage information indicates that the daily dietary
intake of glycine by humans may be substantially increasing due to
changing use patterns in food technology.
Therefore, the Food and Drug Administration no longer regards glycine
and its salts as generally recognized as safe for use in human food and
all outstanding letters expressing sanction for such use are rescinded.
(b) The Commissioner of Food and Drugs concludes that by May 8,
1971, manufacturers:
(1) Shall reformulate food products for human use to eliminate added
glycine and its salts; or
(2) Shall bring such products into compliance with an authorizing
food additive regulation. A food additive petition supported by toxicity
data is required to show that any proposed level of glycine or its salts
added to foods for human consumption will be safe.
(c) The status of glycine as generally recognized as safe for use in
animal feed, as prescribed in Sec. 582.5049 of this chapter, remains
unchanged because the additive is considered an essential nutrient in
certain animal feeds and is safe for such use under conditions of good
feeding practice.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.60]
[Page 21]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart C--Specific Administrative Rulings and Decisions
Sec. 170.60 Nitrites and/or nitrates in curing premixes.
(a) Nitrites and/or nitrates are food additives when combined in
curing premixes with spices and/or other flavoring or seasoning
ingredients that contain or constitute a source of secondary or tertiary
amines, including but not limited to essential oils, disodium inosinate,
disodium guanylate, hydrolysates of animal or plant origin (such as
hydrolyzed vegetable protein), oleoresins of spices, soy products, and
spice extractives. Such food additives may be used only after the
establishment of an authorizing food additive regulation. A food
additive petition submitted pursuant to Secs. 171.1 and 171.100 of this
chapter, supported by data demonstrating that nitrosamines are not
formed in curing premixes containing such food additives, is required to
establish safety.
(b) Nitrites and/or nitrates, when packaged separately from
flavoring and seasoning in curing premixes, may continue to be used
under prior sanctions in the commercial curing of meat and meat products
and poultry products and in accordance with the provisions of
Secs. 172.170 and 172.175 of this chapter that apply to meat curing
preparations for the home curing of 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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.100]
[Page 21-22]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
Sec. 170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).
Source: 67 FR 35729, May 21, 2002, unless otherwise noted.
(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
[[Page 22]]
under the threshold of regulation process described in Sec. 170.39.
(c) A petition must be submitted under Sec. 171.1 of this chapter to
authorize the safe use of a food contact substance in either of the
following circumstances, unless FDA agrees to accept an FCN for the
proposed use.
(1) The use of the food contact substance increases the cumulative
dietary concentration to a certain level. For a substance that is a
biocide (e.g., it is intended to exert microbial toxicity), this level
is equal to or greater than 200 parts per billion in the daily diet (0.6
milligram (mg)/person/day). For a substance that is not a biocide, this
level is equal to or greater than 1 part per million in the daily diet
(3 mg/person/day); or
(2) There exists a bioassay on the food contact substance, FDA has
not reviewed the bioassay, and the bioassay is not clearly negative for
carcinogenic effects.
(d) A manufacturer or supplier for which a notification is effective
must keep a current address on file with FDA.
(1) The current address may be either the manufacturer's (or
supplier's) address or the address of the manufacturer's (or supplier's)
agent.
(2) FDA will deliver correspondence to the manufacturer's or
supplier's current address.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.101]
[Page 22]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.102]
[Page 22-23]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
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.
[[Page 23]]
(e) The following data and information in an FCN are available for
public disclosure, unless extraordinary circumstances are shown, on the
121st day after receipt of the notification by FDA, except that no data
or information are available for public disclosure if the FCN is
withdrawn under Sec. 170.103.
(1) All safety and functionality data and information submitted with
or incorporated by reference into the notification. Safety and
functionality data include all studies and tests of a food contact
substance on animals and humans and all studies and tests on a food
contact substance for establishing identity, stability, purity, potency,
performance, and usefulness.
(2) A protocol for a test or study, unless it is exempt from
disclosure under Sec. 20.61 of this chapter.
(3) A list of all ingredients contained in a food contact substance,
excluding information that is exempt from disclosure under Sec. 20.61 of
this chapter. Where applicable, an ingredient list will be identified as
incomplete.
(4) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is exempt from disclosure under
Sec. 20.61 of this chapter.
(5) All correspondence and written summaries of oral discussions
relating to the notification, except information that is exempt for
disclosure under Sec. 20.61 of this chapter.
(6) All other information not subject to an exemption from
disclosure under subpart D of part 20 of this chapter.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.103]
[Page 23]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.104]
[Page 23]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
Sec. 170.104 Action on a premarket notification for a food contact substance (FCN).
(a) If the Food and Drug Administration (FDA) does not object to an
FCN within the 120-day period for FDA review, the FCN becomes effective.
(b) If an FCN is complete when received, the 120-day review period
begins on the date FDA receives the FCN.
(1) If any element required under Sec. 170.101 is missing from an
FCN, then FDA will not accept that FCN and FDA will send an FCN
nonacceptance letter to the manufacturer or supplier. If the
manufacturer or supplier submits the missing information before FDA
sends an FCN nonacceptance letter, the 120-day review period begins on
the date of receipt of the missing information.
(2) If FDA accepts an FCN, then FDA will acknowledge in writing its
receipt of that FCN.
(c) Objection to an FCN:
(1) If FDA objects to an FCN, then FDA will send an FCN objection
letter. The date of the letter will be the date of FDA's objection for
purposes of section 409(h)(2)(A) of the act.
(2) If FDA objects to an FCN within the 120-day period for FDA
review, the FCN will not become effective.
(3) FDA may object to an FCN if any part of FDA's 120-day review
occurs during a period when this program is not funded as required in
section 409(h)(5) of the act.
(d) If FDA and a manufacturer or supplier agree that the notifier
may submit a food additive petition proposing the approval of the food
contact substance for the use in the manufacturer's or supplier's FCN,
FDA will consider that FCN to be withdrawn by the manufacturer or
supplier on the date the petition is received by FDA.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.105]
[Page 23-24]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
Sec. 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.
(a) If data or other information available to FDA, including data
not submitted by the manufacturer or supplier, demonstrate that the
intended use of the food contact substance is no
[[Page 24]]
longer safe, FDA may determine that the authorizing FCN is no longer
effective.
(b) If FDA determines that an FCN is no longer effective, FDA will
inform the manufacturer or supplier in writing of the basis for that
determination. FDA will give the manufacturer or supplier an opportunity
to show why the FCN should continue to be effective and will specify the
time that the manufacturer or supplier will have to respond.
(c) If the manufacturer or supplier fails to respond adequately to
the safety concerns regarding the notified use, FDA will publish a
notice of its determination that the FCN is no longer effective. FDA
will publish this notice in the Federal Register, stating that a
detailed summary of the basis for FDA's determination that the FCN is no
longer effective has been placed on public display and that copies are
available upon request. The date that the notice publishes in the
Federal Register is the date on which the notification is no longer
effective.
(d) FDA's determination that an FCN is no longer effective is final
agency action subject to judicial review.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.106]
[Page 24]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 170--FOOD ADDITIVES--Table of Contents
Subpart D--Premarket Notifications
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.
