FDA GRAS proposed rule would make notices mandatory and widen TOR

FDA GRAS proposed rule would require notices and expand TOR

The FDA GRAS proposed rule, published on 11 August 2026, would require GRAS notices unless an exception applies. It would also expand threshold of regulation (TOR) exemptions to direct food uses, with comments due by 9 December 2026 (Federal Register, FR Doc. 2026-16296).

The proposal is not in force. Today a company "may notify" FDA of a generally recognized as safe (GRAS) conclusion. Notification is voluntary, and the use must still meet the GRAS criteria (21 CFR 170.30) (21 CFR 170.205).

The proposal at a glance

FDA announced the rule on 10 August. The Federal Register printed it the next day (FDA GRAS page). The push started on 10 March 2025, when HHS Secretary Robert F. Kennedy Jr. told FDA to explore rulemaking "to eliminate the self-affirmed GRAS pathway" (HHS release).

Mandatory GRAS notification

Proposed § 170.205(a) says that "any person introducing a substance into interstate commerce under the GRAS provision of section 201(s) of the Act must notify FDA" of the basis for the GRAS conclusion. The duty covers substances already in the food supply and first-time uses. Animal food has the parallel duty in proposed § 570.205. For a human-food use that meets the food contact substance definition, a food contact notification (FCN) is an alternative (Federal Register).

The proposal would not introduce premarket approval or bar marketing before submission. FDA says a missing notice "would be a factor" when it picks substances for post-market review. The requirement is met only when FDA files the notice. If FDA stops the evaluation, including because you asked, it is not met (proposed § 170.265). No notice is needed under proposed § 170.205(b) if any of these applies:

• a "no questions" letter already covers the use
• the use is listed or affirmed as GRAS in parts 182, 184 or 186
• the use is GRAS under § 170.30(d) or (i)(1)
• FDA reviewed the use through an established process and the public outcome does not call for a notice
• FDA granted a TOR exemption under § 170.39
• an effective FCN covers the use and the substance comes from the listed manufacturer or supplier
• the use appears on FDA's public list of subpart F submissions (see below)

Animal food has two further exceptions in proposed § 570.205(b). One covers FDA consultations, such as the Animal Food Ingredient Consultation (AFIC), whose public outcome raises no concerns. The other covers ingredients used in line with Chapter 6 of the 2024 AAFCO Official Publication, absent an FDA GRAS concern.

Human-food notices would go electronically through FDA's Centralized Online Submission Module (COSM). FDA would finish the initial filing check within 45 days, and its 180-day response could be extended. Notice data would be open to disclosure from receipt (proposed notice procedures).

Self-affirmed GRAS substances already on the market

New subpart F (§ 170.305) gives existing self-GRAS uses a one-time short-form submission instead of a full GRAS notice. It needs your name and address, the substance, the conditions of use, evidence the substance was in interstate commerce before the effective date, and any earlier GRAS notice that ended in a cease-to-evaluate letter. FDA is "not proposing to require" underlying safety data. The deadline is one year after the effective date (Federal Register).

Two limits apply. A use that got an insufficient-basis letter or an FDA not-GRAS finding cannot take this route. And a listing "does not mean that FDA has reviewed the GRAS status." FDA could still require a full notice or a food additive petition later (proposed subpart F).

The threshold of regulation expansion

The Guardian's 10 October report focuses on the TOR expansion. Qualifying direct uses could seek an FDA exemption instead of a food additive petition.

Today § 170.39 covers only substances in food-contact articles (packaging, processing equipment) that migrate into food (21 CFR 170.39). The proposal renames it "Threshold of regulation for substances used in food or as a food-contact substance." It would apply to "any substance used in food (both directly or indirectly added to food)." A granted TOR exemption would release the use from food additive regulation or from the new GRAS notice duty (Federal Register).

FDA says the new impurity test keeps the same level of protection, and it deletes "no technical effect" as a packaging-specific condition.

FDA grants a TOR exemption only on request, and it may decline if available information shows the use may pose a public health risk. So "without safety review" means no food additive petition or GRAS notice, not zero FDA involvement. Substances shown to be carcinogens stay out. FDA would keep a public list of exempted uses, without trade names.

FDA recommends the TOR process for purported GRAS uses that meet the criteria. The expansion covers human food only, because part 570 has no TOR provision (proposal, section V.D).

The Fall 2026 Regulatory Plan entry for this RIN says non-notified uses "will be presumed by FDA not to be GRAS" (Regulatory Plan). The published proposal has no such presumption. Rely on the proposal text and watch whether the final rule moves toward the agenda wording.

What it means for GRAS and food additive strategy

• Self-affirmed GRAS uses already on the market: list them now. Plan a subpart F submission within a year of the effective date, or a full GRAS notice. An insufficient-basis letter or an FDA not-GRAS finding blocks the short form.
• New ingredients: if finalized, a GRAS notice would be the default for a use marketed as GRAS. A TOR request is the alternative only when every criterion is met, not just the exposure number.
• Packaging: an FCN remains an alternative, and TOR remains available.
• Animal food: no TOR. Check the AFIC and 2024 AAFCO Chapter 6 exceptions first.

None of that is a filing duty today. FDA also wants comment on alternatives that would cut the burden, including streamlined submissions for every purported GRAS use (Federal Register).

How to comment

Submit online through regulations.gov by 11:59 p.m. Eastern Time on 9 December 2026. Late comments won't be considered. Paper comments go to Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Confidential information goes by paper only, in two copies: one marked "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" and one redacted (Federal Register). Check the docket for any extension notice before you rely on the date. FDA is also holding a webinar on 15 October 2026, from 2 to 3 p.m. ET (FDA webinar page).

RegAffairs AI's answer on the GRAS proposed rule links the cited Federal Register sections.