If finalized, companies introducing substances into the U.S. food supply on the basis of a GRAS conclusion would be required to notify FDA, subject to certain exceptions and transitional provisions. The proposal covers substances used in both human and animal food.
But the significance of the proposal goes beyond notification. Greater visibility of GRAS conclusions also means greater scrutiny of the scientific evidence supporting them – including the conditions of intended use and resulting dietary exposure.
How did we get here?
The GRAS concept was established under the Food Additives Amendment of 1958, which created a premarket approval system for food additives while excluding uses of substances whose safety was already generally recognized by qualified experts under their intended conditions of use.
Over time, the FDA developed a voluntary GRAS notification system. Companies could submit the scientific basis for a GRAS conclusion, but could also reach an independent conclusion without notifying the agency.
The 2026 proposal would amend 21 CFR Parts 170 and 570, with key changes including:
- moving from voluntary to mandatory GRAS notification;
- introducing certain exceptions and a time-limited streamlined pathway for eligible substances already on the market; and
- applying corresponding changes across both human and animal food.
Importantly, the reform would not turn GRAS into a conventional premarket approval process. Submission of a GRAS notice would not itself constitute FDA approval of the GRAS conclusion.
Why does this matter?
A central issue for FDA is visibility and regulatory oversight.
Under the current system, the agency may not be notified when a company reaches an independent GRAS conclusion. As a result, the FDA does not necessarily have a complete picture of which substances are entering the food supply, how they are being used, or the evidence supporting their safety.
The issue, however, is not simply whether a notification has been filed. It is whether the evidence supporting a GRAS conclusion is current, transparent and defensible.
GRAS is not simply a status attached to an ingredient; it is a safety conclusion for defined conditions of intended use.
That means food categories, use levels, relevant population groups and resulting dietary exposure all matter when determining whether a particular use is supported by the scientific evidence.
What could this mean for different stakeholders?
For ingredient manufacturers, the proposed change could mean reviewing existing GRAS conclusions and checking whether the scientific evidence, use conditions and exposure assessments supporting them remain current and complete.
For food and beverage manufacturers, a general assurance that an ingredient is “GRAS” may no longer be enough. There may be a greater need to understand whether a supplier’s conclusion actually covers the intended application, food category and concentration in the finished product.
For importers and distributors, stronger supporting documentation may need to be obtained from suppliers, particularly where ingredients originate outside the U.S.
For regulatory and food safety teams, the emphasis may increasingly shift towards demonstrating not just that a GRAS conclusion exists, but exactly what that conclusion covers and how it is supported.
Why dietary exposure is central
For many GRAS assessments, one of the critical quantitative questions is:
How much of the substance are people likely to consume under the proposed conditions of use?
Dietary exposure assessments combine proposed use levels with food consumption data to estimate intake across relevant foods and population groups.
This can be particularly important where a substance is used across multiple food categories, where use levels change, or where older assessments may no longer reflect current consumption patterns.
Dietary exposure is therefore not simply a supporting calculation. It forms an important part of the overall safety evaluation and needs to be considered alongside toxicological and other scientific evidence supporting the GRAS conclusion.
What should companies do now?
The proposal has not yet been finalized, but companies with portfolios of independently concluded GRAS substances should start identifying which conclusions, conditions of use and supporting exposure assessments would withstand regulatory scrutiny today.
That means reviewing:
- which ingredients rely on independent GRAS conclusions;
- whether intended uses and use levels are clearly documented;
- whether existing exposure assessments remain current;
- whether the GRAS conclusion still reflects how the ingredient is actually being used; and
- whether there are gaps in the supporting scientific documentation.
FDA is accepting public comments on the proposed rule until December 9, 2026.
How Creme Global can help
For many GRAS assessments, a critical quantitative question is whether the proposed conditions of use result in dietary exposures that can be supported as safe.
Creme Global helps companies answer this question quantitatively. We combine detailed U.S. food consumption data with proposed food categories and use levels to estimate dietary exposure across relevant population groups.
Our Food & Nutrition team supports organisations preparing new GRAS assessments and reviewing existing exposure evidence, helping companies develop current, transparent and defensible dietary exposure assessments that can form part of the scientific basis supporting a GRAS conclusion.
As GRAS conclusions become more visible to FDA, being able to clearly demonstrate how much of a substance consumers are likely to encounter, under which conditions, and on the basis of what evidence becomes increasingly important.
This article reflects FDA’s proposed rule published in August 2026. The proposal has not yet been finalized and its requirements may change.
