For decades a company could decide on its own that a food ingredient was "generally recognized as safe" (GRAS), use it in food sold in the United States, and never tell FDA. That practice, usually called self-affirmed GRAS, is the target of a proposed rule FDA published in the Federal Register on August 11, 2026. If it is finalized, anyone who relies on GRAS status for a substance in human or animal food would have to submit a GRAS notice to FDA. Foreign companies are directly affected. FDA itself notes that of the more than 1,200 GRAS notices filed so far, 617 came from foreign firms.
What the proposed rule would change
Today the GRAS notification program is voluntary. The proposal would make it mandatory by adding a notice requirement for human food at proposed 21 CFR 170.205 and a parallel requirement for animal food at proposed 21 CFR 570.205. A substance used under a GRAS conclusion, without a filed notice and without fitting one of the listed exceptions, would no longer have a lawful GRAS pathway once the compliance date passes. The rule does not change the legal definition of GRAS. It changes who has to see the evidence: FDA, not only the company's own experts.
The proposal also tightens how notices are submitted. Under proposed 21 CFR 170.220, any material in a GRAS notice that is written in a language other than English must come with a complete and accurate English translation. For suppliers whose safety studies, specifications or manufacturing records are in Turkish, Chinese, Spanish or another language, that translation work should be planned early.
The proposed timeline
- August 11, 2026: proposed rule published (docket FDA-2025-N-3262).
- December 9, 2026: last day to submit comments. Regulations.gov accepts electronic comments until 11:59 p.m. Eastern Time.
- Final rule: FDA proposes that it take effect 60 days after publication in the Federal Register.
- Compliance date: FDA proposes 18 months after the effective date for the new notice requirements.
- Streamlined window: one year after the effective date for certain substances already on the US market (explained below).
None of these later dates is fixed yet, because a final rule has not been published. What is certain is the comment deadline, and that the current voluntary GRAS rules stay in force until a final rule says otherwise.
The one-year option for ingredients already on the market
FDA recognizes that many self-affirmed GRAS substances are already in US food. Proposed 21 CFR 170.305 would give these a time-limited, streamlined submission. The company would send FDA basic information, including its name and contact details, the substance, its conditions of intended use, evidence that it was in interstate commerce before the final rule's effective date, and the GRAS notice file. These submissions would go electronically through FDA's online submission system, COSM, and FDA would not accept them more than one year after the effective date. FDA would publish the information on a public list. The streamlined route is not available for conditions of use that already received an FDA "insufficient basis" response.
For a foreign supplier, the practical message is that evidence of past US sales will matter. Commercial invoices, US customer records, import entries and product specifications that show the substance was sold into the United States under the same conditions of use should be gathered and kept together now, while they are easy to find.
Who should pay attention
- Ingredient manufacturers that sell extracts, fibers, proteins, sweeteners, flavors with GRAS components, probiotics or processing aids to US food makers.
- Food exporters whose finished products contain a novel ingredient that their supplier described as "self-GRAS".
- Animal food and pet food producers, because the proposal covers animal food in parallel under 21 CFR Part 570.
- Makers of food-contact materials whose substances rely on a GRAS conclusion rather than a food contact notification.
Dietary supplement ingredients follow a separate framework, including new dietary ingredient notifications, but a GRAS conclusion is sometimes used to support an ingredient in conventional food versions of the same product. If you sell both, check each product against the right pathway. Our guide to exporting dietary supplements to the United States explains where those lines fall.
GRAS, food additive petition or food contact notification?
GRAS is one of three common routes for a substance in food. A substance that is not GRAS for its intended use is a food additive and needs a regulation issued through a food additive petition, which we describe in our food additive petition guide. Packaging and other food-contact substances often use the food contact notification program instead, covered in our food contact substance notification guide. Choosing the right route for each use matters more under the proposed rule, because an unsupported GRAS claim would become easier for FDA and US buyers to see.
What to do before December 9, 2026
- List every ingredient in your US products and note the legal basis you rely on for each: a food additive regulation, a prior sanction, an FDA-acknowledged GRAS notice, a self-affirmed GRAS conclusion, or a food contact notification.
- For each self-affirmed GRAS substance, locate the expert panel report or safety dossier and confirm that the conditions of use in your US products match it.
- Gather proof of US sales before the eventual effective date, so a streamlined submission would be possible.
- Plan English translations of any foreign-language studies or specifications.
- Decide whether to comment on docket FDA-2025-N-3262, for example on the length of the compliance period or on how foreign suppliers can show prior US use.
- Ask your US importer or customer which ingredient documents they will now expect, because buyers often update supplier questionnaires long before a rule takes effect.
How this connects to registration and labeling
GRAS status does not replace the basics. A foreign facility that manufactures, processes, packs or holds food for the US still needs FDA food facility registration and a US Agent, and every ingredient must be declared correctly on the label. If you change or rename an ingredient because of a GRAS review, have the new ingredient list checked. FDABridge's food label review compares your label with FDA's labeling rules before you print.
Sources
- FDA proposed rule, Substances Generally Recognized as Safe (FR Doc. 2026-16296): https://public-inspection.federalregister.gov/2026-16296.pdf
- FDA, Generally Recognized as Safe (GRAS): https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras