CFR Subpart B

CFR Subpart B
in effect

21 C.F.R. § 570.20 General principles for evaluating the safety of food additives.

(a) In reaching a decision on any petition filed under section 409 of the act, the Commissioner will give full consideration to the specific biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures. In reaching a decision, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferable. For the purposes of this section, the principles for evaluating safety of additives set forth in the above-mentioned publications will apply to any substance that may properly be classified as a food additive as defined in section 201(s) of the act. (b) Upon written request describing the proposed use of an additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive.

21 C.F.R. § 570.30 Eligibility for classification as generally recognized as safe (GRAS).

(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful to either the target animal or to humans consuming human food derived from food-producing animals under the conditions of its intended use (see § 570.3(i)). (b) General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive. General recognition of safety through scientific procedures shall address safety for both the target animal and for humans consuming human food derived from food-producing animals and shall be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods. (c)(1) General recognition of safety through experience based on common use in food prior to January 1, 1958, shall address safety for both the target animal and for humans consuming human food derived from food-producing animals and may be achieved without the quantity or quality of scientific procedures required for approval of a food additive. General recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance in the same animal species prior to January 1, 1958, and shall ordinarily be based upon generally available data and information. An ingredient not in common use in food prior to January 1, 1958, may achieve general recognition of safety only through scientific procedures. (2) A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the substance is safe under the conditions of its intended use within the meaning of section 201(u) of the Federal Food, Drug, and Cosmetic Act (see also § 570.3(i)) for both the target animal and for humans consuming human food derived from food-producing animals. Common use in food prior to January 1, 1958, that occurred outside of the United States shall be documented by published or other information and shall be corroborated by information from a second, independent source that confirms the history and circumstances of use of the substance. The information used to document and to corroborate the history and circumstances of use of the substance must be generally available; that is, it must be widely available in the country in which the history of use has occurred and readily available to interested qualified experts in the United States. A person who concludes that a use of a substance is GRAS through experience based on its common use in food outside of the United States should notify FDA of that view in accordance with subpart E of this part. (d) The food ingredients listed as GRAS in part 582 of this chapter or affirmed as GRAS in part 584 of this chapter do not include all substances that are generally recognized as safe for their intended use in food. Because of the large number of substances the intended use of which results or may reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of food, it is impracticable to list all such substances that are GRAS. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS without specific inclusion in part 582 or part 584 of this chapter. (e) A food ingredient that is not GRAS or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the act before it may be directly or indirectly added to food. (f) A food ingredient that is listed as GRAS in part 582 of this chapter shall be regarded as GRAS only if, in addition to all the requirements in the applicable regulation, it also meets all of the following requirements: (1) It complies with any applicable specifications, or in the absence of such specifications, shall be of a purity suitable for its intended use. (2) It performs an appropriate function in the food or food-contact article in which it is used. (3) It is used at a level no higher than necessary to achieve its intended purpose in that food or, if used as a component of a food-contact article, at a level no higher than necessary to achieve its intended purpose in that article. (g) New information may at any time require reconsideration of the GRAS status of a food ingredient. Any change in status shall be accomplished pursuant to § 570.38. (h) If a substance is affirmed as GRAS pursuant to § 570.35 and listed in a regulation with no limitation other than good manufacturing practice, it shall be regarded as GRAS if its conditions of use are not significantly different from those reported in the regulation as the basis on which the GRAS status of the substance was affirmed. If the conditions of use are significantly different, such use of the substance may not be GRAS. In such case a manufacturer may not rely on the regulation as authorizing the use but must independently establish that the use is GRAS or must use the substance in accordance with a food additive regulation. (i) If an ingredient is affirmed as GRAS pursuant to § 570.35 and listed in a regulation with specific limitation(s), it may be used in food only within such limitation(s) (including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use). Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation. (j) Pursuant to § 570.35, a food ingredient may be affirmed as GRAS and listed in a regulation for a specific use(s) without a general evaluation of use of the ingredient. In addition to the use(s) specified in the regulation, other uses of such an ingredient may also be GRAS. Any affirmation of GRAS status for a specific use(s), without a general evaluation of use of the ingredient, is subject to reconsideration upon such evaluation.

21 C.F.R. § 570.35 Affirmation of generally recognized as safe (GRAS) status.

(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use. (b)(1) If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS under the conditions of its intended use, he will place all of the data and information on which he relies on public file in the office of the Dockets Management Staff and will publish in the Federal Register a notice giving the name of the substance, its proposed uses, and any limitations proposed for purposes other than safety. (2) The Federal Register notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Dockets Management Staff. Copies of all comments received shall be made available for examination in the Dockets Management Staff's office. (3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS under the conditions of its intended use as described in § 570.30, he will publish a notice in the Federal Register listing the GRAS conditions of use in this subchapter E. (4) If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that the substance is GRAS under the conditions of its intended use and that it should be considered a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act, he shall publish a notice thereof in the Federal Register in accordance with § 570.38.

21 C.F.R. § 570.38 Determination of food additive status.

(a) The Commissioner may, in accordance with § 570.35(b)(4), publish a notice in the Federal Register determining that a substance is not GRAS under the conditions of its intended use and is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act. (b)(1) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may issue a notice in the Federal Register proposing to determine that a substance is not GRAS and is a food additive subject to section 409 of the act. Any petition shall include all relevant data and information of the type described in § 571.130(b) of this chapter. The Commissioner will place all of the data and information on which he relies on public file in the Dockets Management Staff and will include in the Federal Register notice the name of the substance, its known uses, and a summary of the basis for the determination. (2) The Federal Register notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Dockets Management Staff. Copies of all comments shall be made available for examination in the Dockets Management Staff. (3) The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evidence that the substance is GRAS or is otherwise exempt from the definition of a food additive in section 201(s) of the act, he will publish a notice thereof in the Federal Register. If he concludes that there is convincing evidence that the substance is GRAS, he will publish an order in the Federal Register listing the substance in this subchapter E as GRAS. (c) A Federal Register notice determining that a substance is a food additive shall provide for the use of the additive in food or food-contact surfaces as follows: (1) It may promulgate a food additive regulation governing use of the additive. (2) It may promulgate an interim food additive regulation governing use of the additive. (3) It may require discontinuation of the use of the additive. (4) It may adopt any combination of the above three approaches for different uses or levels of use of the additive. (d) If the Commissioner of Food and Drugs is aware of any prior sanction for use of the substance, he will concurrently propose a separate regulation covering such use of the ingredient under this subchapter E. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under this subchapter E., incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.

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