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HHS/FDA RIN: 0910-AH15 Publication ID: Fall 2015 
Title: Substances Generally Recognized as Safe 

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.

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:
Action Source Description Date
Final  Judicial  Under consent decree, FDA to submit final rule for publication.  08/31/2016 
Action Date FR Cite
NPRM  04/17/1997  62 FR 18938   
Comment Period End  07/16/1997 
Final Action  08/00/2016 
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 M. Gaynor
Senior Regulatory Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-255), 5100 Paint Branch Parkway,
College Park, MD 20740-3835
Phone:240 402-1192
Fax:301 436-2965