21 C.F.R. § 170.35 Affirmation of generally recognized as safe (GRAS) status.
Title 21 - Food and Drugs
(a) The Commissioner, either on his initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly become components of food. (b)(1) If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS, he will place all of the data and information on which he relies on public file in the office of the Division of Dockets Management and will publish in the (2) The (3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS as described in §170.30, he will publish a notice in the (4) If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that the substance is GRAS and that it should be considered a food additive subject to section 409 of the Act, he shall publish a notice thereof in the (c)(1) Persons seeking the affirmation of GRAS status of substances as provided in §170.30(e), except those subject to the NAS/NRC GRAS list survey (36 FR 20546; October 23, 1971), shall submit a petition for GRAS affirmation pursuant to part 10 of this chapter. Such petition shall contain information to establish that the GRAS criteria as set forth in §170.30 (b) or (c) have been met, in the following form: (i) Description of the substance, including: (a) Common or usual name. (b) Chemical name. (c) Chemical Abstract Service (CAS) registry number. (d) Empirical formula. (e) Structural formula. (f) Specifications for food grade material, including arsenic and heavy metals. (Recommendation for any change in the Food Chemicals Codex monograph should be included where applicable.) (g) Quantitative compositions. (h) Manufacturing process (excluding any trade secrets). (ii) Use of the substance, including: (a) Date when use began. (b) Information and reports or other data on past uses in food. (c) Foods in which used, and levels of use in such foods, and for what purposes. (iii) Methods for detecting the substance in food, including: (a) References to qualitative and quantitative methods for determining the substance(s) in food, including the type of analytical procedures used. (b) Sensitivity and reproducibility of such method(s). (iv) Information to establish the safety and functionality of the substance in food. Published scientific literature, evidence that the substance is identical to a GRAS counterpart of natural biological origin, and other data may be submitted to support safety. Any adverse information or consumer complaints shall be included. Complete bibliographic references shall be provided where a copy of the article is not provided. (v) A statement signed by the person responsible for the petition that to the best of his knowledge it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him pertinent to the evaluation of the safety and functionality of the substance. (vi) If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (vii) [Reserved] (viii) A claim for categorical exclusion under §25.30 or §25.32 of this chapter or an environmental assessment under §25.40 of this chapter. (2) Within 30 days after the date of filing the petition, the Commissioner will place the petition on public file in the office of the Division of Dockets Management and will publish a notice of filing in the (3)(i) If intended uses of the substance include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA. (ii) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA or, if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions. (4) The notice of filing in the (5) The Commissioner will evaluate the petition and all available information including all comments received. If the petition and such information provide convincing evidence that the substance is GRAS as described in §170.30 he will publish an order in the (6) If, after evaluation of the petition and all available information, the Commissioner concludes that there is a lack of convincing evidence that the substance is GRAS and that it should be considered a food additive subject to section 409 of the Act, he shall publish a notice thereof in the (7) The notice of filing in the [42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, July 29, 1997; 65 FR 51762, Aug. 25, 2000]
Title 21: Food and Drugs
PART 170—FOOD ADDITIVES
Subpart B—Food Additive Safety
§ 170.35 Affirmation of generally recognized as safe (GRAS) status.