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Title 21—Food and Drugs

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Title 21—Food and Drugs Title 21—Food and Drugs (This book contains parts 170 to 199) Part CHAPTER I—Food and Drug Administration, Department of Health and Human Services (Continued) ........................... 170 CROSS REFERENCES: Food Safety and Inspection Service, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chap- ter I. Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, To- bacco Products and Firearms, 27 CFR chapter I. 1 VerDate Apr<19>2002 13:38 Apr 27, 2002 Jkt 197064 PO 00000 Frm 00001 Fmt 8008 Sfmt 8008 Y:\SGML\197064T.XXX pfrm13 PsN: 197064T VerDate Apr<19>2002 13:38 Apr 27, 2002 Jkt 197064 PO 00000 Frm 00002 Fmt 8008 Sfmt 8008 Y:\SGML\197064T.XXX pfrm13 PsN: 197064T CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) (Parts 170 to 199) EDITORIAL NOTE: The Food and Drug Administration published a document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform effective date for compliance for regula- tions affecting the labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 1, 1989 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after July 1, 1986, and before January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective date for compliance. The new uniform effective date will apply only to final FDA food labeling regulations published after January 1, 1990 and before January 1, 1992. EDITORIAL NOTE: For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994. SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (Con’t.) Part Page 170 Food additives ......................................................... 5 171 Food additive petitions ........................................... 21 172 Food additives permitted for direct addition to food for human consumption ................................ 26 173 Secondary direct food additives permitted in food for human consumption ....................................... 112 174 Indirect food additives: General .............................. 142 175 Indirect food additives: Adhesives and components of coatings ............................................................ 143 176 Indirect food additives: Paper and paperboard com- ponents ................................................................. 185 177 Indirect food additives: Polymers ........................... 223 178 Indirect food additives: Adjuvants, production aids, and sanitizers ............................................... 342 179 Irradiation in the production, processing and han- dling of food ......................................................... 434 180 Food additives permitted in food or in contact with food on an interim basis pending additional study .................................................................... 440 181 Prior-sanctioned food ingredients ........................... 445 182 Substances generally recognized as safe ................. 449 3 VerDate Apr<19>2002 13:38 Apr 27, 2002 Jkt 197064 PO 00000 Frm 00003 Fmt 8008 Sfmt 8008 Y:\SGML\197064T.XXX pfrm13 PsN: 197064T 21 CFR Ch. I (4–1–02 Edition) Part Page 184 Direct food substances affirmed as generally recog- nized as safe ......................................................... 463 186 Indirect food substances affirmed as generally rec- ognized as safe ...................................................... 561 189 Substances prohibited from use in human food ...... 566 190 Dietary supplements ............................................... 571 191–199 [Reserved] 4 VerDate Apr<19>2002 13:44 Apr 27, 2002 Jkt 197064 PO 00000 Frm 00004 Fmt 8008 Sfmt 8008 Y:\SGML\197064T.XXX pfrm13 PsN: 197064T SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION PART 170—FOOD ADDITIVES (d) As used in this part, the term act means the Federal Food, Drug, and Subpart A—General Provisions Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as amended (21 U.S.C. Sec. 301–392). 170.3 Definitions. (e)(1) Food additives includes all sub- 170.6 Opinion letters on food additive sta- tus. stances not exempted by section 201(s) 170.10 Food additives in standardized foods. of the act, the intended use of which 170.15 Adoption of regulation on initiative results or may reasonably be expected of Commissioner. to result, directly or indirectly, either 170.17 Exemption for investigational use in their becoming a component of food and procedure for obtaining authoriza- or otherwise affecting the characteris- tion to market edible products from ex- tics of food. A material used in the pro- perimental animals. duction of containers and packages is 170.18 Tolerances for related food additives. 170.19 Pesticide chemicals in processed subject to the definition if it may rea- foods. sonably be expected to become a com- ponent, or to affect the characteristics, Subpart B—Food Additive Safety directly or indirectly, of food packed in the container. ‘‘Affecting the charac- 170.20 General principles for evaluating the safety of food additives. teristics of food’’ does not include such 170.22 Safety factors to be considered. physical effects, as protecting contents 170.30 Eligibility for classification as gen- of packages, preserving shape, and pre- erally recognized as safe (GRAS). venting moisture loss. If there is no 170.35 Affirmation of generally recognized migration of a packaging component as safe (GRAS) status. from the package to the food, it does 170.38 Determination of food additive sta- not become a component of the food tus. and thus is not a food additive. A sub- 170.39 Threshold of regulation for sub- stance that does not become a compo- stances used in food-contact articles. nent of food, but that is used, for exam- Subpart C—Specific Administrative Rulings ple, in preparing an ingredient of the and Decisions food to give a different flavor, texture, or other characteristic in the food, 170.45 Fluorine-containing compounds. may be a food additive. 170.50 Glycine (aminoacetic acid) in food for (2) Uses of food additives not requiring human consumption. 170.60 Nitrites and/or nitrates in curing pre- a listing regulation. Substances used in mixes. food-contact articles (e.g., food-pack- aging and food-processing equipment) AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, that migrate, or may be expected to 371. migrate, into food at such negligible SOURCE: 42 FR 14483, Mar. 15, 1977, unless levels that they have been exempted otherwise noted. from regulation as food additives under EDITORIAL NOTE: Nomenclature changes to § 170.39. part 170 appear at 66 FR 56035, Nov. 6, 2001. (f) Common use in food means a sub- stantial history of consumption of a Subpart A—General Provisions substance for food use by a significant number of consumers. § 170.3 Definitions. (g) The word substance in the defini- For the purposes of this subchapter, tion of the term ‘‘food additive’’ in- the following definitions apply: cludes a food or food component con- (a) Secretary means the Secretary of sisting of one or more ingredients. Health and Human Services. (h) Scientific procedures include those (b) Department means the Department human, animal, analytical, and other of Health and Human Services. scientific studies, whether published or (c) Commissioner means the Commis- unpublished, appropriate to establish sioner of Food and Drugs. the safety of a substance. 5 VerDate Mar<13>2002 11:39 Apr 17, 2002 Jkt 197064 PO 00000 Frm 00005 Fmt 8010 Sfmt 8010 Y:\SGML\197064T.XXX pfrm03 PsN: 197064T § 170.3 21 CFR Ch. I (4–1–02 Edition) (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 available tors shall be considered: for inspection at the Office of the Fed- (1) The probable consumption of the eral Register, 800 North Capitol Street, substance and of any substance formed NW., suite 700, Washington, DC 20408: in or on food because of its use. (1) Baked goods and baking mixes, in- (2) The cumulative effect of the sub- cluding all ready-to-eat and ready-to- stance in the diet, taking into account bake products, flours, and mixes re- any chemically or pharmacologically quiring preparation before serving. related substance or substances in such (2) Beverages, alcoholic, including diet. malt beverages, wines, distilled liq- (3) Safety factors which, in the opin- uors, and cocktail mix. ion of experts qualified by scientific (3) Beverages and beverage bases,
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