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HHS/FDA | RIN: 0910-AH15 | Publication ID: Fall 2015 |
Title: Substances Generally Recognized as Safe | |
Abstract:
This final rule relates to the process for informing FDA of a determination that the use of a substance in human food or in animal feed is not subject to the food additive premarket approval requirements because such use is generally recognized as safe (GRAS). FDA has proposed to replace the voluntary GRAS affirmation petition process, under which FDA issues a regulation affirming the use of a substance as GRAS, with a voluntary process to notify FDA of a determination that a particular use of a substance is GRAS. FDA also proposed to clarify when use of a substance is GRAS. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 170.3 21 CFR 170.30 21 CFR 170.35 21 CFR 170.36 21 CFR 170.38 21 CFR 184.1 21 CFR186.1 21 CFR 570.3 21 CFR 570.30 21 CFR 570.35 21 CFR 570.36 21 CFR 570.38 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 348 21 U.S.C. 371 |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: No | |
Agency Contact: Paulette Gaynor Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Humans Foods Program, 5001 Campus Drive, College Park, MD 20740-3835 Phone:240 402-1192 Fax:301 436-2965 Email: paulette.gaynor@fda.hhs.gov |