0910-AJ02 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Substances Generally Recognized as Safe

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.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 21 CFR part 170 21 CFR part 570 21 U.S.C. 321 21 U.S.C. 342 21 U.S.C. 348 21 U.S.C. 371 No NPRM 10/00/2025 Undetermined No None No No No Paulette Gaynor Senior Policy Advisor 0910 Food and Drug Administration FDA 240 402-1192 301 436-2965 paulette.gaynor@fda.hhs.gov Humans Foods Program, 4300 River Road Room 2053 (HFS-255), College Park MD 20740-3835