SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub- stance 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 sub- stances 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 rea- sonably 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 notifica- tion 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. 5 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR § 170.3 21 CFR Ch. I (4–1–12 Edition) (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. 6 VerDate Mar<15>2010 10:14 May 14, 2012 Jkt 226069 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Y:\SGML\226069.XXX 226069 erowe on DSK2VPTVN1PROD with CFR Food and Drug Administration, HHS § 170.3 (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.