174 INDIRECT FOOD ADDITIVES------ GENERAL.doc

Code of Federal Regulations Title 21, Volume 3 Revised as of April 1, 2006 CITE: 21CFR174 TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B-FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 174 INDIRECT FOOD ADDITIVES: GENERAL Sec. 174.5 General provisions applicable to indirect food additives. (a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing practice shall be defined to include the following restrictions:(1) The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required to accomplish the intended physical or technical effect in the food-contact article; shall not exceed any prescribed limitations; and shall not be intended to accomplish any physical or technical effect in the food itself, except as such may be permitted by regulations in parts 170 through 189 of this chapter.(2) Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.(b) The existence in the subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed to relieve such use of the substance or article from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-packaging material were found on appropriate test to impart odor or taste to a specific food product such as to render it unfit within the meaning of section 402(a)(3) of the Act, the regulation would not be construed to relieve such use from compliance with section 402(a)(3).(c) The existence in this subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed as implying that such substance may be safely used as a direct additive in food.(d) Substances that under conditions of good manufacturing practice may be safely used as components of articles that contact food include the following, subject to any prescribed limitations:(1) Substances generally recognized as safe in or on food.(2) Substances generally recognized as safe for their intended use in food packaging.(3) Substances used in accordance with a prior sanction or approval.(4) Substances permitted for use by regulations in this part and parts 175, 176, 177, 178 and 179.45 of this chapter.(5) Food contact substances used in accordance with an effective premarket notification for a food contact substance (FCN) submitted under section 409(h) of the act.42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002 Sec. 174.6 Threshold of regulation for substances used in food-contact articles. Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed under 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.60 FR 36596, July 17, 1995 Authority: 21 U.S.C. 321, 342, 348, 371.