For nearly three decades, companies introducing a new food or ingredient use into the U.S. market have had a choice: notify the FDA that they’ve concluded a substance is Generally Recognized as Safe (GRAS), or simply make that determination internally and never tell the agency at all. That second option, known as self-affirmation, may not be an option much longer. The U.S. Food and Drug Administration (FDA) has a proposed rule moving through its rulemaking agenda, tracked under RIN 0910-AJ02, that would make GRAS notification mandatory rather than voluntary.
According to the 2026 Unified Regulatory Agenda, the Notice of Proposed Rulemaking (NPRM) is targeted for publication as early as December 2026. It’s worth noting this is a projected date on a regulatory agenda, not a locked publication date. This same item first appeared in the Spring 2025 Unified Agenda, and its timeline has already shifted once. Companies should treat December as a planning target, not a certainty.
From Voluntary to Mandatory
The current voluntary notification framework has a longer history than many in the industry realize. The FDA first proposed a GRAS notification process in 1997 to replace an older, slower petition system, and operated under that proposed rule for nearly twenty years before finalizing it in 2016. Since then, companies have been able to submit a GRAS notice voluntarily, but nothing has required them to.
The FDA hasn’t published the NPRM yet, so the details below reflect the agency’s stated intentions on the rulemaking agenda rather than confirmed rule text. Based on that agenda, the proposal would amend 21 CFR Parts 170 and 570 to require a GRAS notice for certain uses of substances in human and animal food. Uses subject to that requirement would be presumed not GRAS unless a company has actually filed a notification.
The FDA also intends to maintain and update a public GRAS notice inventory, and to clarify its process for determining when a substance’s use doesn’t qualify as GRAS. A limited “streamlined submission” option is expected to be available for substances already introduced into the market before a final rule takes effect, giving companies a transition path rather than requiring every existing use to restart from scratch.
What This Means for Your Business
If your company relies on a self-affirmed GRAS conclusion for any ingredient, and has never filed a notification with the FDA, this is the moment to take a closer look at that documentation. Older self-affirmed files, especially ones built years ago for internal purposes, sometimes lack the expert panel documentation, published studies, or exposure assessments that a formal notification format expects.
The scale of this task varies by company. A business with a handful of self-affirmed ingredients has a very different task ahead than one with a large portfolio built over many years. Either way, the practical first step is the same: take stock of which ingredients are self-affirmed only, which already have a voluntary notice on file, and where the supporting science might need to be strengthened. We’d rather see companies review this now, calmly, than scramble once a final rule and its compliance window are set.
Quality Smart Solutions works with food ingredient companies to evaluate GRAS documentation and prepare compliant submissions. Contact our team to discuss your specific situation.
Frequently Asked Questions
When will the proposed rule actually be published?
The FDA’s current agenda lists the NPRM as targeted for December 2026. That’s the agency’s own projection, not a confirmed date. This item first appeared on the agenda in 2025 with an earlier target, so the timeline has already moved once and could move again.
Does this apply to ingredients already on the market?
The proposal includes a streamlined submission option for substances already in interstate commerce before a final rule’s effective date, though full transition details won’t be clear until the rule text is published.
Does mandatory notification change what counts as GRAS?
No. The proposal changes who has to notify the FDA, not the underlying legal standard for GRAS status itself.
What should we be doing before the NPRM is even published?
The most useful step right now is an honest inventory: which ingredients have a voluntary GRAS notice already on file, and which are self-affirmed only with no FDA notification. From there, it’s worth checking whether the self-affirmed files have the kind of documentation, expert panel review, published studies, exposure data, that a formal notification would expect. None of this requires waiting for the rule to be finalized.
Key Takeaways
- The FDA’s proposed rule (RIN 0910-AJ02) would end voluntary self-affirmation and require GRAS notification for certain food and animal food substances.
- The NPRM is targeted for December 2026 per the FDA’s current agenda, though this date has shifted before and isn’t guaranteed.
- Self-affirmed GRAS files should be reviewed now for completeness, ahead of any compliance deadline.
- This is a proposed rule. A comment period and final rulemaking will follow.
Preparing for What Comes Next
This proposed rule represents a meaningful shift in FDA oversight of food ingredient safety determinations, and for companies with large ingredient portfolios or long-standing self-affirmed GRAS substances, the impact of that shift could be substantial.
Early preparation, documentation audits and honest gaps analyses of existing GRAS files, is the most effective way to manage the transition smoothly, whether the NPRM lands in December 2026 or later.
Our regulatory compliance team at Quality Smart Solutions provides regulatory advisory support to food ingredient companies preparing for this kind of compliance shift. Learn more about our GRAS notification services, or speak with one of our experts to begin planning ahead of the rule’s publication.
