On 11 August 2026, the U.S. Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register titled, "Substances Generally Recognized as Safe". If finalised, this rule would end the ability to market food and food-contact substances based on a self-determined GRAS conclusion without notifying the FDA. Companies could still reach their own GRAS conclusions, but would now be required to report the basis for that conclusion to the agency. This affects food manufacturers, ingredient suppliers, and food-contact material producers alike. The proposed rule converts the current voluntary GRAS notification procedure into a mandatory notification framework, mandates electronic filings, expands the Threshold of Regulation (TOR) exemption, and provides a time-limited streamlined submission pathway for substances currently on the market.
This is a Proposed Rule, not a final rule. Current voluntary GRAS regulations remain fully in effect. If finalised, the FDA proposes a mandatory compliance date of 18 months after the effective date of the final rule. Public comments are due 9 December, 2026.
Under Section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), substances added to food are defined as food additives requiring premarket review and approval unless they are Generally Recognized as Safe (GRAS) under their intended conditions of use.
Since 1997, the FDA has operated a voluntary GRAS notification program. Under the voluntary framework, industry has been able to voluntarily notify the FDA of a GRAS conclusion, or reach that conclusion independently and market the substance without ever notifying the agency.
The proposed rule would require any person introducing a substance into interstate commerce under the GRAS provision to notify the FDA of the basis for their conclusion, subject to limited exceptions. Non-compliance would become a factor the FDA weighs when prioritizing substances for post-market review.
The proposed rule applies to all human and animal food substances introduced into U.S. interstate commerce under the GRAS provision of Section 201(s) of the FD&C Act. Focusing on the food contact substances, the mandatory notification requirement would apply to any food-contact substance whose market entry currently or in future relies on a company's own conclusion of GRAS status, including materials already on the market. It would not apply to substance categories already excluded from the “food additive” definition under section 201(s)(1)–(6) of the FD&C Act (e.g., pesticide chemical residues, color additives, pre-1958 sanctioned substances, new animal drugs, dietary supplement ingredients), since those cannot be the subject of a GRAS notice in the first place.
| Regulatory area | Current voluntary rule | Proposed mandatory rule |
| Notification Requirement | Voluntary submission to FDA. | Mandatory, but not premarket-gated. Filing may occur before or after market entry, the rule sets no specific deadline tied to launch. |
| Independent / Self-Affirmed GRAS | Permitted without FDA filing. | Independent conclusions remain permitted but must now be reported to FDA. Failure to notify becomes a factor the FDA weighs when prioritizing substances for post-market review — not an automatic prohibition. |
| Submission Method | Paper or electronic. | Mandatory electronic via COSM for human food (waiver available for paper). Animal food: notifier must first email CVM's Division of Animal Food Ingredients for current submission instructions. |
| FDA Filing Assessment | No regulatory deadline. | 45-day deadline for the FDA to complete initial filing evaluation; submitter notified within 2 business days of that decision. |
| FDA Review Timeline | 180 days, extendable once by 90 days. | 180 days, extendable by 90 days up to two times (360 days maximum). |
| Cease to Evaluate Requests | Submitter could withdraw notice and market independently. | If the FDA grants a cease-to-evaluate request, the mandatory notification requirement is deemed NOT met. |
A new Subpart F (proposed §170.305 / §570.305) would create a one-time, lighter-weight submission option for food contact substance (FCS) already marketed under an independent, non-notified GRAS conclusion before the rule's effective date. Required content is limited to submitter identity, substance identity, conditions of intended use, and evidence of pre-rule market presence. Full underlying safety data is not required. This window would be open for one year after the effective date of the final rule and would close permanently thereafter; substances not addressed within that window would need a full GRAS notice or food additive petition. FDA may still require a full GRAS notice if it has questions about a streamlined submission.
The TOR exemption under §170.39, previously limited to substances used in “food-contact articles,” would be broadened to cover any substance used in food or as a food-contact substance generally. The exposure assessment would also change, from a flat 0.5 parts-per-billion dietary concentration standard to a bodyweight-normalized 0.025 micrograms/kilogram/day standard intended to more consistently protect different age groups. A granted TOR exemption would also except a substance from the mandatory GRAS notice requirement (proposed §170.205(b)(5)).
Companies with food-contact substances in their U.S. supply chain should:
For questions and additional information, please contact Dr. Pratik Ichhaporia (pratikichhaporia@eurofinsus.com, +1-669-837-2257) or David Hong (david.Hong@cpt.eurofinscn.com).
Notice of Proposed Rulemaking: https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf