[Code of Federal Regulations]

[Title 21, Volume 3, Parts 170 to 199]

[Revised as of April 1, 1999]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR170.3]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN

SERVICES (CONTINUED)

Subpart A--General Provisions

Sec. 170.3 Definitions.

For the purposes of this subchapter, the following definitions

apply:

(a) Secretary means the Secretary of Health and Human Services.

(b) Department means the Department of Health and Human Services.

(c) Commissioner means the Commissioner of Food and Drugs.

(d) As used in this part, the term act means the Federal Food, Drug,

and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as

amended (21 U.S.C. 301-392).

(e)(1) Food additives includes all substances not exempted by

section 201(s) of the act, the intended use of which results or may

reasonably be expected to result, directly or indirectly, either in

their becoming a component of food or otherwise affecting the

characteristics of food. A material used in the production of containers

and packages is subject to the definition if it may reasonably be

expected to become a component, or to affect the characteristics,

directly or indirectly, of food packed in the container. ``Affecting the

characteristics of food'' does not include such physical effects, as

protecting contents of packages, preserving shape, and preventing

moisture loss. If there is no migration of a packaging component from

the package to the food, it does not become a component of the food and

thus is not a food additive. A substance that does not become a

component of food, but that is used, for example, in preparing an

ingredient of the food to give a different flavor, texture, or other

characteristic in the food, may be a food additive.

(2) Uses of food additives not requiring a listing regulation.

Substances used in food-contact articles (e.g., food-packaging and food-

processing equipment) that migrate, or may be expected to migrate, into

food at such negligible levels that they have been exempted from

regulation as food additives under Sec. 170.39.

(f) Common use in food means a substantial history of consumption of

a substance for food use by a significant number of consumers.

(g) The word substance in the definition of the term ``food

additive'' includes a food or food component consisting of one or more

ingredients.

(h) Scientific procedures include those human, animal, analytical,

and other scientific studies, whether published or unpublished,

appropriate to establish the safety of a substance.

(i) Safe or safety means that there is a reasonable certainty in the

minds of competent scientists that the substance is not harmful under the

intended conditions of use. It is impossible in the present state of

scientific knowledge to establish with complete certainty the absolute

harmlessness of the use of any substance. Safety may be determined by

scientific procedures or by general recognition of safety. In

determining safety, the following factors shall be considered:

(1) The probable consumption of the substance and of any substance

formed in or on food because of its use.

(2) The cumulative effect of the substance in the diet, taking into

account any chemically or pharmacologically related substance or

substances in such diet.

(3) Safety factors which, in the opinion of experts qualified by

scientific training and experience to evaluate the safety of food and

food ingredients, are generally recognized as appropriate.

(j) The term nonperishable processed food means any processed food

not subject to rapid decay or deterioration that would render it unfit

for consumption. Examples are flour, sugar, cereals, packaged cookies,

and crackers. Not included are hermetically sealed foods or manufactured

dairy products and other processed foods requiring refrigeration.

(k) General recognition of safety shall be determined in accordance

with Sec. 170.30.

(l) Prior sanction means an explicit approval granted with respect

to use of a substance in food prior to September 6, 1958, by the Food

and Drug Administration or the United States Department of Agriculture

pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry

Products Inspection Act, or the Meat Inspection Act.

(m) Food includes human food, substances migrating to food from

food-contact articles, pet food, and animal feed.

(n) The following general food categories are established to group

specific related foods together for the purpose of establishing

tolerances or limitations for the use of direct human food ingredients.

Individual food products will be included within these categories

according to the detailed classifications lists contained in Exhibit 33B

of the report of the National Academy of Sciences/National Research

Council report, ``A Comprehensive Survey of Industry on the Use of Food

Chemicals Generally Recognized as Safe'' (September 1972), which is

incorporated by reference. Copies are available from the National

Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,

VA 22161, or available for inspection at the Office of the Federal

Register, 800 North Capitol Street, NW., suite 700, Washington, DC

20408:

(1) Baked goods and baking mixes, including all ready-to-eat and

ready-to-bake products, flours, and mixes requiring preparation before

serving.

(2) Beverages, alcoholic, including malt beverages, wines, distilled

liquors, and cocktail mix.

(3) Beverages and beverage bases, nonalcoholic, including only

special or spiced teas, soft drinks, coffee substitutes, and fruit and

vegetable flavored gelatin drinks.

(4) Breakfast cereals, including ready-to-eat and instant and

regular hot cereals.

(5) Cheeses, including curd and whey cheeses, cream, natural,

grating, processed, spread, dip, and miscellaneous cheeses.

(6) Chewing gum, including all forms.

(7) Coffee and tea, including regular, decaffeinated, and instant

types.

(8) Condiments and relishes, including plain seasoning sauces and

spreads, olives, pickles, and relishes, but not spices or herbs.

(9) Confections and frostings, including candy and flavored

frostings, marshmallows, baking chocolate, and brown, lump, rock, maple,

powdered, and raw sugars.

(10) Dairy product analogs, including nondairy milk, frozen or

liquid creamers, coffee whiteners, toppings, and other nondairy

products.

(11) Egg products, including liquid, frozen, or dried eggs, and egg

dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and

frozen multicourse egg meals, but not fresh eggs.

(12) Fats and oils, including margarine, dressings for salads,

butter, salad oils, shortenings and cooking oils.

(13) Fish products, including all prepared main dishes, salads,

appetizers, frozen multicourse meals, and spreads containing fish, shellfish, and

other aquatic animals, but not fresh fish.

(14) Fresh eggs, including cooked eggs and egg dishes made only from

fresh shell eggs.

(15) Fresh fish, including only fresh and frozen fish, shellfish,

and other aquatic animals.

(16) Fresh fruits and fruit juices, including only raw fruits,

citrus, melons, and berries, and home-prepared ``ades'' and punches made

therefrom.

(17) Fresh meats, including only fresh or home-frozen beef or veal,

pork, lamb or mutton and home-prepared fresh meat-containing dishes,

salads, appetizers, or sandwich spreads made therefrom.

(18) Fresh poultry, including only fresh or home-frozen poultry and

game birds and home-prepared fresh poultry-containing dishes, salads,

appetizers, or sandwich spreads made therefrom.

(19) Fresh vegetables, tomatoes, and potatoes, including only fresh

and home-prepared vegetables.

(20) Frozen dairy desserts and mixes, including ice cream, ice

milks, sherbets, and other frozen dairy desserts and specialties.

(21) Fruit and water ices, including all frozen fruit and water

ices.

(22) Gelatins, puddings, and fillings, including flavored gelatin

desserts, puddings, custards, parfaits, pie fillings, and gelatin base

salads.

(23) Grain products and pastas, including macaroni and noodle

products, rice dishes, and frozen multicourse meals, without meat or

vegetables.

(24) Gravies and sauces, including all meat sauces and gravies, and

tomato, milk, buttery, and specialty sauces.

(25) Hard candy and cough drops, including all hard type candies.

(26) Herbs, seeds, spices, seasonings, blends, extracts, and

flavorings, including all natural and artificial spices, blends, and

flavors.

(27) Jams and jellies, home-prepared, including only home-prepared

jams, jellies, fruit butters, preserves, and sweet spreads.

(28) Jams and jellies, commercial, including only commercially

processed jams, jellies, fruit butters, preserves, and sweet spreads.

(29) Meat products, including all meats and meat containing dishes,

salads, appetizers, frozen multicourse meat meals, and sandwich

ingredients prepared by commercial processing or using commercially

processed meats with home preparation.

(30) Milk, whole and skim, including only whole, lowfat, and skim

fluid milks.

(31) Milk products, including flavored milks and milk drinks, dry

milks, toppings, snack dips, spreads, weight control milk beverages, and

other milk origin products.

(32) Nuts and nut products, including whole or shelled tree nuts,

peanuts, coconut, and nut and peanut spreads.

(33) Plant protein products, including the National Academy of

Sciences/National Research Council ``reconstituted vegetable protein''

category, and meat, poultry, and fish substitutes, analogs, and extender

products made from plant proteins.

(34) Poultry products, including all poultry and poultry-containing

dishes, salads, appetizers, frozen multicourse poultry meals, and

sandwich ingredients prepared by commercial processing or using

commercially processed poultry with home preparation.

(35) Processed fruits and fruit juices, including all commercially

processed fruits, citrus, berries, and mixtures; salads, juices and

juice punches, concentrates, dilutions, ``ades'', and drink substitutes

made therefrom.

(36) Processed vegetables and vegetable juices, including all

commercially processed vegetables, vegetable dishes, frozen multicourse

vegetable meals, and vegetable juices and blends.

(37) Snack foods, including chips, pretzels, and other novelty

snacks.

(38) Soft candy, including candy bars, chocolates, fudge, mints, and

other chewy or nougat candies.

(39) Soups, home-prepared, including meat, fish, poultry, vegetable,

and combination home-prepared soups.

(40) Soups and soup mixes, including commercially prepared meat,

fish, poultry, vegetable, and combination soups and soup mixes.

(41) Sugar, white, granulated, including only white granulated

sugar.

(42) Sugar substitutes, including granulated, liquid, and tablet

sugar substitutes.

(43) Sweet sauces, toppings, and syrups, including chocolate, berry,

fruit, corn syrup, and maple sweet sauces and toppings.

(o) The following terms describe the physical or technical

functional effects for which direct human food ingredients may be added

to foods. They are adopted from the National Academy of Sciences/

National Research Council national survey of food industries, reported

to the Food and Drug Administration under the contract title ``A

Comprehensive Survey of Industry on the Use of Food Chemicals Generally

Recognized as Safe'' (September 1972), which is incorporated by

reference. Copies are available from the National Technical Information

Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or available

for inspection at the Office of the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC 20408:

(1) ``Anticaking agents and free-flow agents'': Substances added to

finely powdered or crystalline food products to prevent caking, lumping,

or agglomeration.

(2) ``Antimicrobial agents'': Substances used to preserve food by

preventing growth of microorganisms and subsequent spoilage, including

fungistats, mold and rope inhibitors, and the effects listed by the

National Academy of Sciences/National Research Council under

``preservatives.''

(3) ``Antioxidants'': Substances used to preserve food by retarding

deterioration, rancidity, or discoloration due to oxidation.

(4) ``Colors and coloring adjuncts'': Substances used to impart,

preserve, or enhance the color or shading of a food, including color

stabilizers, color fixatives, color-retention agents, etc.

(5) ``Curing and pickling agents'': Substances imparting a unique

flavor and/or color to a food, usually producing an increase in shelf

life stability.

(6) ``Dough strengtheners'': Substances used to modify starch and

gluten, thereby producing a more stable dough, including the applicable

effects listed by the National Academy of Sciences/National Research

Council under ``dough conditioner.''

(7) ``Drying agents'': Substances with moisture-absorbing ability,

used to maintain an environment of low moisture.

(8) ``Emulsifiers and emulsifier salts'': Substances which modify

surface tension in the component phase of an emulsion to establish a

uniform dispersion or emulsion.

(9) ``Enzymes'': Enzymes used to improve food processing and the

quality of the finished food.

(10) ``Firming agents'': Substances added to precipitate residual

pectin, thus strengthening the supporting tissue and preventing its

collapse during processing.

(11) ``Flavor enhancers'': Substances added to supplement, enhance,

or modify the original taste and/or aroma of a food, without imparting a

characteristic taste or aroma of its own.

(12) ``Flavoring agents and adjuvants'': Substances added to impart

or help impart a taste or aroma in food.

(13) ``Flour treating agents'': Substances added to milled flour, at

the mill, to improve its color and/or baking qualities, including

bleaching and maturing agents.

(14) ``Formulation aids'': Substances used to promote or produce a

desired physical state or texture in food, including carriers, binders,

fillers, plasticizers, film-formers, and tableting aids, etc.

(15) ``Fumigants'': Volatile substances used for controlling insects

or pests.

(16) ``Humectants'': Hygroscopic substances incorporated in food to

promote retention of moisture, including moisture-retention agents and

antidusting agents.

(17) ``Leavening agents'': Substances used to produce or stimulate

production of carbon dioxide in baked goods to impart a light texture,

including yeast, yeast foods, and calcium salts listed by the National

Academy of Sciences/National Research Council under ``dough

conditioners.''

(18) ``Lubricants and release agents'': Substances added to food

contact surfaces to prevent ingredients and finished products from

sticking to them.

(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]