21 CFR 170.35 - Affirmation of generally recognized as safe (GRAS) status.

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There are 2 Updates appearing in the Federal Register for 21 CFR Part 170. View below or at eCFR (GPOAccess)
§ 170.35 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 Division of Dockets Management 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 Division of Dockets Management. Copies of all comments received shall be made available for examination in the Division of Dockets Management'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 § 170.30, he will publish a notice in the Federal Register listing the GRAS conditions of use of the substance in part 184 or part 186 of this chapter, as appropriate.

(4) If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that a 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 § 170.38.

(Information collection requirements were approved by the Office of Management and Budget under control number 0910-0132)
[ 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; 81 FR 55048, Aug. 17, 2016]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 170 after this date.

  • 2016-09-08; vol. 81 # 174 - Thursday, September 8, 2016
    1. 81 FR - Substances Generally Recognized as Safe
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      21 CFR Parts 20, 25, 170, 184, 186, and 570

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-09-08; vol. 81 # 174 - Thursday, September 8, 2016
    1. 81 FR - Substances Generally Recognized as Safe
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      21 CFR Parts 20, 25, 170, 184, 186, and 570