Subchapter B—Food for Human Consumption (Continued)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170—FOOD ADDITIVES 170.106 Notification for a food contact substance formulation (NFCSF). Subpart A—General Provisions AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371. Sec. 170.3 Definitions. SOURCE: 42 FR 14483, Mar. 15, 1977, unless 170.6 Opinion letters on food additive sta- otherwise noted. tus. EDITORIAL NOTE: Nomenclature changes to 170.10 Food additives in standardized foods. part 170 appear at 66 FR 56035, Nov. 6, 2001 170.15 Adoption of regulation on initiative and 69 FR 13717, Mar. 24, 2004. of Commissioner. 170.17 Exemption for investigational use and procedure for obtaining authoriza- Subpart A—General Provisions tion to market edible products from ex- perimental animals. § 170.3 Definitions. 170.18 Tolerances for related food additives. For the purposes of this subchapter, 170.19 Pesticide chemicals in processed the following definitions apply: foods. (a) Secretary means the Secretary of Health and Human Services. Subpart B—Food Additive Safety (b) Department means the Department 170.20 General principles for evaluating the of Health and Human Services. safety of food additives. (c) Commissioner means the Commis- 170.22 Safety factors to be considered. sioner of Food and Drugs. 170.30 Eligibility for classification as gen- (d) As used in this part, the term act erally recognized as safe (GRAS). means the Federal Food, Drug, and 170.35 Affirmation of generally recognized as safe (GRAS) status. Cosmetic Act approved June 25, 1936, 52 170.38 Determination of food additive sta- Stat. 1040 et seq., as amended (21 U.S.C. tus. 301–392). 170.39 Threshold of regulation for sub- (e)(1) Food additives includes all substances used in food-contact articles. stances not exempted by section 201(s) of the act, the intended use of which Subpart C—Specific Administrative Rulings results or may reasonably be expected and Decisions to result, directly or indirectly, either 170.45 Fluorine-containing compounds. in their becoming a component of food 170.50 Glycine (aminoacetic acid) in food for or otherwise affecting the characteris- human consumption. tics of food. A material used in the pro- 170.60 Nitrites and/or nitrates in curing pre- duction of containers and packages is mixes. subject to the definition if it may reasonably be expected to become a com- Subpart D—Premarket Notifications ponent, or to affect the characteristics, 170.100 Submission of a premarket notifica- directly or indirectly, of food packed in tion for a food contact substance (FCN) the container. ‘‘Affecting the charac- to the Food and Drug Administration teristics of food’’ does not include such (FDA). physical effects, as protecting contents 170.101 Information in a premarket notification for a food contact substance (FCN). of packages, preserving shape, and pre- 170.102 Confidentiality of information in a venting moisture loss. If there is no premarket notification for a food contact migration of a packaging component substance (FCN). from the package to the food, it does 170.103 Withdrawal without prejudice of a not become a component of the food premarket notification for a food contact and thus is not a food additive. A sub- substance (FCN). stance that does not become a compo- 170.104 Action on a premarket notification nent of food, but that is used, for exam- for a food contact substance (FCN). 170.105 The Food and Drug Administration’s ple, in preparing an ingredient of the (FDA’s) determination that a premarket food to give a different flavor, texture, notification for a food contact substance or other characteristic in the food, (FCN) is no longer effective. may be a food additive.

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(2) Uses of food additives not requiring (j) The term nonperishable processed a listing regulation. Use of a substance food means any processed food not sub- in a food contact article (e.g., food- ject to rapid decay or deterioration packaging or food-processing equip- that would render it unfit for consump- ment) whereby the substance migrates, tion. Examples are flour, sugar, cere- or may reasonably be expected to mi- als, packaged cookies, and crackers. grate, into food at such levels that the Not included are hermetically sealed use has been exempted from regulation foods or manufactured dairy products as a food additive under § 170.39, and and other processed foods requiring re- food contact substances used in accord- frigeration. ance with a notification submitted (k) General recognition of safety shall under section 409(h) of the act that is be determined in accordance with effective. § 170.30. (3) A food contact substance is any sub- (l) Prior sanction means an explicit stance that is intended for use as a approval granted with respect to use of component of materials used in manu- a substance in food prior to September facturing, packing, packaging, trans- 6, 1958, by the Food and Drug Adminis- porting, or holding food if such use is tration or the United States Depart- not intended to have any technical ef- ment of Agriculture pursuant to the fect in such food. Federal Food, Drug, and Cosmetic Act, (f) Common use in food means a sub- the Poultry Products Inspection Act, stantial history of consumption of a or the Meat Inspection Act. substance for food use by a significant (m) Food includes human food, sub- number of consumers. stances migrating to food from food- (g) The word substance in the defini- contact articles, pet food, and animal tion of the term ‘‘food additive’’ in- feed. cludes a food or food component con- (n) The following general food cat- sisting of one or more ingredients. egories are established to group spe- (h) Scientific procedures include those cific related foods together for the pur- human, animal, analytical, and other pose of establishing tolerances or limi- scientific studies, whether published or tations for the use of direct human unpublished, appropriate to establish food ingredients. Individual food prod- the safety of a substance. ucts will be included within these cat- (i) Safe or safety means that there is egories according to the detailed clas- a reasonable certainty in the minds of sifications lists contained in Exhibit competent scientists that the sub- 33B of the report of the National Acad- stance is not harmful under the in- emy of Sciences/National Research tended conditions of use. It is impos- Council report, ‘‘A Comprehensive Sur- sible in the present state of scientific vey of Industry on the Use of Food knowledge to establish with complete Chemicals Generally Recognized as certainty the absolute harmlessness of Safe’’ (September 1972), which is incor- the use of any substance. Safety may porated by reference. Copies are avail- be determined by scientific procedures able from the National Technical Infor- or by general recognition of safety. In mation Service (NTIS), 5285 Port Royal determining safety, the following fac- Rd., Springfield, VA 22161, or at the Na- tors shall be considered: tional Archives and Records Adminis- (1) The probable consumption of the tration (NARA). For information on substance and of any substance formed the availability of this material at in or on food because of its use. NARA, call 202–741–6030, or go to: http:// (2) The cumulative effect of the sub- www.archives.gov/federallregister/ stance in the diet, taking into account codeloflfederallregulations/ any chemically or pharmacologically ibrllocations.html. related substance or substances in such (1) Baked goods and baking mixes, in- diet. cluding all ready-to-eat and ready-to- (3) Safety factors which, in the opin- bake products, flours, and mixes re- ion of experts qualified by scientific quiring preparation before serving. training and experience to evaluate the (2) Beverages, alcoholic, including safety of food and food ingredients, are malt beverages, wines, distilled liq- generally recognized as appropriate. uors, and cocktail mix.

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(3) Beverages and beverage bases, (18) Fresh poultry, including only nonalcoholic, including only special or fresh or home-frozen poultry and game spiced teas, soft drinks, coffee sub- birds and home-prepared fresh poultry- stitutes, and fruit and vegetable fla- containing dishes, salads, appetizers, or vored gelatin drinks. sandwich spreads made therefrom. (4) Breakfast cereals, including (19) Fresh vegetables, tomatoes, and ready-to-eat and instant and regular potatoes, including only fresh and hot cereals. home-prepared vegetables. (5) Cheeses, including curd and whey (20) Frozen dairy desserts and mixes, cheeses, cream, natural, grating, proc- including ice cream, ice milks, sher- essed, spread, dip, and miscellaneous bets, and other frozen dairy desserts cheeses. and specialties. (6) Chewing gum, including all forms. (21) Fruit and water ices, including (7) Coffee and tea, including regular, all frozen fruit and water ices. decaffeinated, and instant types. (22) Gelatins, puddings, and fillings, (8) Condiments and relishes, includ- including flavored gelatin desserts, ing plain seasoning sauces and spreads, puddings, custards, parfaits, pie fill- olives, pickles, and relishes, but not ings, and gelatin base salads. spices or herbs. (23) Grain products and pastas, in- (9) Confections and frostings, includ- cluding macaroni and noodle products, ing candy and flavored frostings, rice dishes, and frozen multicourse marshmallows, baking chocolate, and meals, without meat or vegetables. brown, lump, rock, maple, powdered, (24) Gravies and sauces, including all and raw sugars. meat sauces and gravies, and tomato, (10) Dairy product analogs, including milk, buttery, and specialty sauces. nondairy milk, frozen or liquid cream- (25) Hard candy and cough drops, in- ers, coffee whiteners, toppings, and cluding all hard type candies. other nondairy products. (26) Herbs, seeds, spices, seasonings, (11) Egg products, including liquid, frozen, or dried eggs, and egg dishes blends, extracts, and flavorings, includ- made therefrom, i.e., egg roll, egg foo ing all natural and artificial spices, young, egg salad, and frozen multi- blends, and flavors. course egg meals, but not fresh eggs. (27) Jams and jellies, home-prepared, (12) Fats and oils, including mar- including only home-prepared jams, garine, dressings for salads, butter, jellies, fruit butters, preserves, and salad oils, shortenings and cooking sweet spreads. oils. (28) Jams and jellies, commercial, in- (13) Fish products, including all pre- cluding only commercially processed pared main dishes, salads, appetizers, jams, jellies, fruit butters, preserves, frozen multicourse meals, and spreads and sweet spreads. containing fish, shellfish, and other (29) Meat products, including all aquatic animals, but not fresh fish. meats and meat containing dishes, sal- (14) Fresh eggs, including cooked ads, appetizers, frozen multicourse eggs and egg dishes made only from meat meals, and sandwich ingredients fresh shell eggs. prepared by commercial processing or (15) Fresh fish, including only fresh using commercially processed meats and frozen fish, shellfish, and other with home preparation. aquatic animals. (30) Milk, whole and skim, including (16) Fresh fruits and fruit juices, in- only whole, lowfat, and skim fluid cluding only raw fruits, citrus, melons, milks. and berries, and home-prepared ‘‘ades’’ (31) Milk products, including flavored and punches made therefrom. milks and milk drinks, dry milks, top- (17) Fresh meats, including only fresh pings, snack dips, spreads, weight con- or home-frozen beef or veal, pork, lamb trol milk beverages, and other milk or- or mutton and home-prepared fresh igin products. meat-containing dishes, salads, appe- (32) Nuts and nut products, including tizers, or sandwich spreads made there- whole or shelled tree nuts, peanuts, co- from. conut, and nut and peanut spreads.

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(33) Plant protein products, including Copies are available from the National the National Academy of Sciences/Na- Technical Information Service (NTIS), tional Research Council ‘‘reconstituted 5285 Port Royal Rd., Springfield, VA vegetable protein’’ category, and meat, 22161, or at the National Archives and poultry, and fish substitutes, analogs, Records Administration (NARA). For and extender products made from plant information on the availability of this proteins. material at NARA, call 202–741–6030, or (34) Poultry products, including all go to: http://www.archives.gov/ poultry and poultry-containing dishes, federallregister/ salads, appetizers, frozen multicourse codeloflfederallregulations/ poultry meals, and sandwich ingredi- ibrllocations.html. ents prepared by commercial proc- (1) Anticaking agents and free-flow essing or using commercially processed agents: Substances added to finely pow- poultry with home preparation. dered or crystalline food products to (35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer- including all commercially processed ation. fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances salads, juices and juice punches, con- used to preserve food by preventing centrates, dilutions, ‘‘ades’’, and drink growth of microorganisms and subse- substitutes made therefrom. quent spoilage, including fungistats, (36) Processed vegetables and vege- mold and rope inhibitors, and the ef- table juices, including all commer- fects listed by the National Academy of cially processed vegetables, vegetable Sciences/National Research Council dishes, frozen multicourse vegetable under ‘‘preservatives.’’ meals, and vegetable juices and blends. (3) Antioxidants: Substances used to (37) Snack foods, including chips, preserve food by retarding deteriora- pretzels, and other novelty snacks. tion, rancidity, or discoloration due to (38) Soft candy, including candy bars, oxidation. chocolates, fudge, mints, and other (4) Colors and coloring adjuncts: Sub- chewy or nougat candies. stances used to impart, preserve, or en- (39) Soups, home-prepared, including hance the color or shading of a food, in- meat, fish, poultry, vegetable, and cluding color stabilizers, color fixa- combination home-prepared soups. tives, color-retention agents, etc. (40) Soups and soup mixes, including (5) Curing and pickling agents: Sub- commercially prepared meat, fish, stances imparting a unique flavor and/ poultry, vegetable, and combination or color to a food, usually producing an soups and soup mixes. increase in shelf life stability. (41) Sugar, white, granulated, includ- (6) Dough strengtheners: Substances ing only white granulated sugar. used to modify starch and gluten, (42) Sugar substitutes, including thereby producing a more stable dough, granulated, liquid, and tablet sugar including the applicable effects listed substitutes. by the National Academy of Sciences/ (43) Sweet sauces, toppings, and syr- National Research Council under ups, including chocolate, berry, fruit, ‘‘dough conditioner.’’ corn syrup, and maple sweet sauces and (7) Drying agents: Substances with toppings. moisture-absorbing ability, used to (o) The following terms describe the maintain an environment of low mois- physical or technical functional effects ture. for which direct human food ingredi- (8) Emulsifiers and emulsifier salts: ents may be added to foods. They are Substances which modify surface ten- adopted from the National Academy of sion in the component phase of an Sciences/National Research Council na- emulsion to establish a uniform disper- tional survey of food industries, re- sion or emulsion. ported to the Food and Drug Adminis- (9) Enzymes: Enzymes used to im- tration under the contract title ‘‘A prove food processing and the quality Comprehensive Survey of Industry on of the finished food. the Use of Food Chemicals Generally (10) Firming agents: Substances added Recognized as Safe’’ (September 1972), to precipitate residual pectin, thus which is incorporated by reference. strengthening the supporting tissue

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and preventing its collapse during (23) pH control agents: Substances processing. added to change or maintain active (11) Flavor enhancers: Substances acidity or basicity, including buffers, added to supplement, enhance, or mod- acids, alkalies, and neutralizing ify the original taste and/or aroma of a agents. food, without imparting a char- (24) Processing aids: Substances used acteristic taste or aroma of its own. as manufacturing aids to enhance the (12) Flavoring agents and adjuvants: appeal or utility of a food or food com- Substances added to impart or help im- ponent, including clarifying agents, part a taste or aroma in food. clouding agents, catalysts, flocculents, (13) Flour treating agents: Substances filter aids, and crystallization inhibi- added to milled flour, at the mill, to tors, etc. improve its color and/or baking quali- (25) Propellants, aerating agents, and ties, including bleaching and maturing gases: Gases used to supply force to agents. expel a product or used to reduce the (14) Formulation aids: Substances used amount of oxygen in contact with the to promote or produce a desired phys- food in packaging. ical state or texture in food, including (26) Sequestrants: Substances which carriers, binders, fillers, plasticizers, combine with polyvalent metal ions to film-formers, and tableting aids, etc. form a soluble metal complex, to im- (15) Fumigants: Volatile substances prove the quality and stability of prod- used for controlling insects or pests. ucts. (16) Humectants: Hygroscopic sub- (27) Solvents and vehicles: Substances stances incorporated in food to pro- used to extract or dissolve another sub- mote retention of moisture, including stance. moisture-retention agents and anti- (28) Stabilizers and thickeners: Sub- dusting agents. stances used to produce viscous solu- (17) Leavening agents: Substances tions or dispersions, to impart body, used to produce or stimulate produc- improve consistency, or stabilize emul- tion of carbon dioxide in baked goods sions, including suspending and body- to impart a light texture, including ing agents, setting agents, jellying yeast, yeast foods, and calcium salts agents, and bulking agents, etc. listed by the National Academy of (29) Surface-active agents: Substances Sciences/National Research Council used to modify surface properties of under ‘‘dough conditioners.’’ liquid food components for a variety of (18) Lubricants and release agents: Sub- effects, other than emulsifiers, but in- stances added to food contact surfaces cluding solubilizing agents, to prevent ingredients and finished dispersants, detergents, wetting products from sticking to them. agents, rehydration enhancers, whip- (19) Non-nutritive sweeteners: Sub- ping agents, foaming agents, and de- stances having less than 2 percent of foaming agents, etc. the caloric value of sucrose per equivalent unit of sweetening capacity. (30) Surface-finishing agents: Sub- stances used to increase palatability, (20) Nutrient supplements: Substances which are necessary for the body’s nu- preserve gloss, and inhibit discolora- tritional and metabolic processes. tion of foods, including glazes, polishes, waxes, and protective coatings. (21) Nutritive sweeteners: Substances having greater than 2 percent of the ca- (31) Synergists: Substances used to act loric value of sucrose per equivalent or react with another food ingredient unit of sweetening capacity. to produce a total effect different or (22) Oxidizing and reducing agents: greater than the sum of the effects pro- Substances which chemically oxidize duced by the individual ingredients. or reduce another food ingredient, (32) Texturizers: Substances which af- thereby producing a more stable prod- fect the appearance or feel of the food. uct, including the applicable effect list- [42 FR 14483, Mar. 15, 1977, as amended at 47 ed by the National Academy of FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, Sciences/National Research Council 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, under ‘‘dough conditioners.’’ July 17, 1995; 67 FR 35729, May 21, 2002]

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