United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-08-11 article Part II Proposed Rules D09002ee1e6944966 D09002ee1e6944a15 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act). 91 FR 51834 https://www.govinfo.gov/app/details/FR-2026-08-11/2026-16296 2026-16296 fr11au26-26 RIN 0910-AJ02 4164-01-P Docket No. FDA-2025-N-3262 https://www.govinfo.gov/app/details/FR-2026-08-11/2026-16296 https://www.govinfo.gov/content/pkg/FR-2026-08-11/html/2026-16296.htm https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf Administrative Practice and Procedure Food Additives Reporting and Recordkeeping Requirements Animal Feeds Animal Foods Incorporation by Reference 48 p. 51834 51881 91 FR 51834 Title 21 Part 170 21 CFR Part 170 Title 21 Part 570 21 CFR Part 570 RIN 0910-AJ02 Substances Generally Recognized as Safe; Federal Register Vol. 91, Issue PRORULE 2026-16296 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-12-09 Docket No. FDA-2025-N-3262 4164-01-P 2026-16296 Proposed rule.

The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by December 9, 2026. With regard to substances that would be used in human food: Paulette Gaynor or Christopher Kampmeyer, Office of Pre-Market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200; Carrol Bascus or Alexandra Beliveau, Office of Policy and International Engagement, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. 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Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-08-11 P0b002ee1e6943eb0 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11au26 https://www.govinfo.gov/app/details/FR-2026-08-11 https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/FR-2026-08-11.pdf https://www.govinfo.gov/content/pkg/FR-2026-08-11/xml/FR-2026-08-11.xml fdlp 51549 51995 DGPO 2026-08-11 2026-08-11 FR-2026-08-11 machine generated eng FR FR-2026-08-11 91 153