[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.
 
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    (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
 
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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,
 
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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]