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HHS/FDA RIN: 0910-AJ02 Publication ID: Spring 2025 
Title: ●Substances Generally Recognized as Safe 
Abstract:

This proposed rule, if finalized, would amend the Generally Recognized as Safe (GRAS) regulations in 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS. Food substances include both ingredients and substances added indirectly (such as from food packing). Food substances that are listed or affirmed as GRAS for the intended use by regulation, or for which FDA has already issued a no questions letter” on its GRAS notice inventory, would be exempted. The proposed rule would clarify that FDA maintain and update the a public-facing GRAS notice inventory for all substances that are the subject of mandatory GRAS notice for its conditions of intended use. The proposed rule would also clarify the process under which FDA would determine that a substance is not GRAS.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 14192 Designation: Regulatory 
CFR Citation: 21 CFR part 170    21 CFR part 570     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 342    21 U.S.C. 348    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2025 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
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, 4300 River Road Room 2053 (HFS-255),
College Park, MD 20740-3835
Phone:240 402-1192
Fax:301 436-2965
Email: paulette.gaynor@fda.hhs.gov