US FDA Consults on Proposed Mandatory GRAS Notification Requirements

SafeGuardSHardgoodsAugust 26, 2026

SG 117/26

US Food and Drug Administration (FDA) seeks greater transparency into substances marketed under generally recognized as safe (GRAS) determinations.

In the US, 21 CFR Part 170 (Food Additives) establishes the FDA’s regulatory framework for food additives, food contact substances (FCSs) and GRAS substances. The regulation outlines procedures for evaluating substances intended for direct or indirect food use, including food contact notifications (FCNs), exemptions for certain low-risk food contact uses and the current voluntary GRAS notification program to ensure food safety and consumer protection.

On August 11, 2026, the FDA opened a 120-day consultation on a proposed rule (91 FR 51834) that would amend 21 CFR Parts 170 and 570 (Food Additives) by requiring the submission of GRAS notices for human and animal food substances that are claimed to be GRAS under the Federal Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 321(s)).

Key proposed changes in the proposed rule include:

Replacing the current voluntary GRAS notification program with a mandatory GRAS notification system, helping FDA verify that GRAS conclusions are supported by adequate scientific evidence and documentation. This would require any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act to notify FDA on the basis for their conclusion that the substance is GRAS under the conditions of its intended use
Specifying circumstances under which a GRAS notice is not required, including a time-limited option for streamlined submission of information to FDA for certain substances already in interstate commerce
Identifying uses of substances that are ineligible for GRAS notice submission
Updating 21 CFR Part 170 to reflect the transition to a mandatory GRAS notification program, revising the threshold of regulation (TOR) exemption framework to incorporate current scientific approaches and guidance, and expanding its scope to cover uses of substances in food and FCSs, in addition to FCSs used in food contact articles (FCAs) (see Table 1 below for selected proposed changes)
Amending 21 CFR Part 570 for substances used in animal food and incorporation by reference provisions to align with the proposed changes to the human food regulations in 21 CFR Part 170, as both parts implement the same statutory provisions

Current Section (§) to 21 CFR Part 170 ‘Food Additives’	Highlights of proposed changes
21 CFR Part 170 ‘Food Additives’	Renaming header to ‘Part 170 ‘Food Additives and Generally Recognized as Safe (GRAS)’
§ 170.3 ‘Definitions’	Updating the definition of ‘food’ to ‘Food includes human food, substances migrating to food from FCAs, and animal feed’
§ 170.39 ‘Threshold of regulation (TOR) for substances used in food contact articles’	Renaming the section to ‘Threshold of regulation for substances used in food or as an FCS’ Revising §170.39(a): To exempt substances directly or indirectly added to food from food additive regulation and GRAS notification requirement under §170.205, provided they meet the TOR criteria To update scientific terminology and incorporating updated approaches for assessing cancer risk of carcinogenic compounds Updating §170.39(a)(2)(i) to reflect updated exposure assessment methodologies that account for differences in total dietary consumption and body weight among subpopulations. The current dietary concentration threshold of 0.5 ppb would be replaced with an estimated daily intake (EDI) of 0.025 µg/kg bodyweight/day to provide a consistent level of safety across all subpopulations
§ 170.203 ‘GRAS notices: Definitions’	Updating definitions and associated cross-references Introducing definitions for ‘Inventory’ and ‘No questions letter’
§ 170.205 ‘GRAS notices: Opportunity to submit a GRAS notice’	Creating a mandatory GRAS notification program that requires any person introducing a substance into interstate commerce under the GRAS provision of § 201(s) of the FD&C Act to notify FDA of the basis for concluding that the substance is GRAS under the conditions of its intended use. These rules would replace the current voluntary GRAS notification program with this mandatory framework Specifying circumstances under which a GRAS notice would not be required, including: A no questions letter covering the substance under the conditions of its intended use The substance is listed or affirmed as GRAS under specified conditions of intended use The substance is considered GRAS under defined conditions of its intended use The use of the substance has been established by an FDA process The use of the substance is subject to a TOR exemption There is an effective premarket notification for an FCS (FCN) Information on the substance’s condition of use has been submitted in accordance with § 170.305 and the submission is included on an FDA-maintained public list
§ 170.210 ‘GRAS notices: How to send your GRAS notice to FDA’	Mandating electronic submission of GRAS notices through the Human Foods Program’s (HFP) Centralized Online Submission Module (COSM), unless a waiver permitted for paper submission is granted
§ 170.220 ‘GRAS notices: General requirements applicable to a GRAS notice’	Requiring English translations for foreign-language materials submitted in, or referenced by, a GRAS notice
§ 170.265 ‘GRAS notices: What FDA will do with a GRAS notice’	Setting a 45-day period for FDA’s initial evaluation of a submission to determine whether it should be filed as a GRAS notice Extending the current review timeline from ‘within 180 days of filing plus one additional 90-day extension if needed’ to ‘within 180 days of filing plus up to two additional 90-day extensions, if required’ to complete timely reviews
Subpart F ‘Submissions for substances introduced into interstate commerce under the GRAS provision of section 201(s) of the Act before [effective date of the final rule] (new section)	Adding new subpart governing substances introduced into interstate commerce before the effective date of the final rule Introducing several new terms and their definitions applicable only to this subpart: a) cease to evaluate letter, b) GRAS, c) GRAS notice, d) Insufficient basis letter and e) submitter Permitting a person to submit information on a substance and its conditions of use in lieu of submitting a GRAS notice under § 170.205: Unless a paper submission waiver is granted, electronic submission through COSM within one year after the effective date of the final rule. The required information includes a) submitter’s name and address, b) substance name, c) intended conditions of use, d) evidence that the substance was in interstate commerce before the effective date of the final rule and e) any FDA cease to evaluate letter issued in response to a previous GRAS notice

Table 1

Who is impacted?

The proposal would affect stakeholders throughout the food contact materials and articles supply chain, including manufacturers, importers, retailers and other intermediaries operating in the US.

When is the deadline for submitting comments?

Comments will be accepted until December 9, 2026.

When does it apply?

Except for § 170.205 (Submission of a GRAS Notice) and § 570.205 (Submission of a GRAS Notice), which would apply 18 months after the effective date of the final rule, the final rule is proposed to take effect 60 days after publication in the Federal Register.

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