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| HHS/FDA | RIN: 0910-AJ02 | Publication ID: Spring 2025 |
| Title: ●Substances Generally Recognized as Safe | |
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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. |
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| 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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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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 |
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