On August 11, 2026, the U.S. Food and Drug Administration published a proposed rule that would fundamentally change how companies use the Generally Recognized as Safe—or GRAS—pathway for substances added to human and animal food.
Under the proposal, companies generally would be required to notify FDA when introducing a substance into interstate commerce based on a conclusion that the substance is GRAS under its intended conditions of use. The requirement would apply to direct food ingredients as well as indirectly added substances, including substances that may migrate into food from packaging, processing equipment and other food-contact materials.
The proposal would convert FDA’s existing voluntary GRAS notification program into a mandatory program. Comments on the proposed rule are due December 9, 2026. Importantly, this is only a proposed rule; the current voluntary notification framework remains in effect unless and until FDA issues a final rule. Read the FDA proposed rule.
How Does the Current GRAS Process Work?
Under the current regulatory framework, a company may independently conclude that a substance is GRAS under its intended conditions of use. This is commonly called a “self-GRAS” or “independent GRAS” conclusion.
A GRAS conclusion must be supported by generally available and accepted scientific information. For GRAS conclusions based on scientific procedures, FDA states that the quantity and quality of evidence must be equivalent to the evidence required to obtain approval of a food additive. The safety conclusion must also be generally recognized among qualified experts.
Although companies must possess an adequate scientific basis for their GRAS conclusions, they are not currently required to submit those conclusions to FDA. A company may voluntarily submit a GRAS notice and receive one of several FDA responses, including a letter stating that the agency has “no questions” regarding the notifier’s GRAS conclusion.
Because notification is voluntary, FDA may not know about substances marketed exclusively through independent GRAS conclusions. This lack of visibility is one of the primary issues the proposed rule is intended to address.
What Would the Proposed Rule Change?
The proposal would require a person introducing a substance into interstate commerce under the GRAS provision to notify FDA of the basis for concluding that the substance is GRAS under its intended conditions of use, unless a specified exception applies.
FDA would generally require GRAS notices to be submitted electronically through its Centralized Online Submission Module. The agency proposes to complete its initial assessment of whether a submission can be filed as a GRAS notice within 45 days.
Once a notice is filed, FDA would evaluate its scientific basis. The proposal would allow FDA 180 days to respond, with the possibility of as many as two additional 90-day extensions when necessary.
The information contained in a GRAS notice would also be subject to public disclosure in accordance with applicable disclosure requirements. Consequently, manufacturers would need to carefully distinguish confidential commercial information from the safety evidence needed to demonstrate general recognition.
Would the Proposal Eliminate Self-GRAS?
Not entirely.
The proposal would preserve a company’s ability to reach its own GRAS conclusion. It would not convert GRAS notification into a traditional premarket approval process, and FDA expressly states that a company could market a purported GRAS substance before submitting a notice or while FDA is evaluating it.
However, the proposal would largely eliminate the ability to rely on an undisclosed independent GRAS conclusion indefinitely. The notification requirement would be considered satisfied when FDA files the submission as a GRAS notice—not merely when the company sends materials to the agency.
Failure to meet the notification requirement could become a factor in FDA’s prioritization of substances for post-market review. If FDA ultimately determines that the evidence does not support GRAS status, the use could be considered an unapproved food additive.
In practical terms, self-GRAS would remain a scientific and legal conclusion, but it generally would no longer remain exclusively within a company’s files.
Which Substances Would Be Affected?
The proposed requirement would apply broadly to substances used in human and animal food, including:
- Direct food ingredients
- Processing aids
- Enzymes and microbial-derived ingredients
- Flavoring and formulation components
- Animal food ingredients
- Substances that migrate or may be expected to migrate from food packaging
- Components of coatings, adhesives, polymers, paper, processing equipment and other food-contact materials
The regulatory status of a substance depends on its identity, manufacturing process, specifications, intended technical effect, use level, food categories and resulting dietary exposure. A prior GRAS conclusion or FDA response may not cover a materially different manufacturing process or condition of use.
Are There Exceptions to Mandatory GRAS Notification?
FDA has proposed several exceptions. A new GRAS notice generally would not be required when, among other circumstances:
- An existing FDA “no questions” letter covers the substance and its conditions of use.
- The substance is listed or affirmed as GRAS for the intended use under 21 CFR Parts 182, 184 or 186.
- The intended use qualifies under certain common-use or established FDA provisions.
- FDA has already evaluated the intended use through an applicable regulatory process.
- FDA has granted a Threshold of Regulation exemption for the intended use.
- An effective Food Contact Notification covers the food-contact substance, its intended use and the applicable manufacturer or supplier.
- A qualifying substance already in commerce is included through the proposed time-limited streamlined submission process.
Whether an exception applies must be evaluated against the precise identity and conditions of use. A superficially similar authorization may not cover differences in purity, manufacturing, migration, food type, temperature, duration of contact or exposure.
Special Considerations for Food Packaging and Food-Contact Materials
The proposed rule expressly covers substances added indirectly to food, including substances migrating from packaging.
Manufacturers and suppliers of food-contact substances would need to determine which regulatory pathway is most appropriate:
| Pathway | When it may be appropriate |
|---|---|
| GRAS Notice | The substance is generally recognized as safe under the specific food-contact conditions of use. |
| Food Contact Notification | The substance is used as a food-contact substance and the safety data support the proposed use. |
| Food Additive Petition | The use does not qualify as GRAS and requires a food additive regulation, or FDA determines that a petition is necessary. |
| Threshold of Regulation Exemption | Expected dietary exposure is sufficiently low and the use meets FDA’s applicable criteria. |
| Existing Authorization | An existing regulation, prior sanction, GRAS listing, effective FCN or other authorization fully covers the use. |
FDA indicates that manufacturers or suppliers could submit either a GRAS notice or an FCN for a food-contact substance purported to be GRAS. However, the agency recommends the FCN process because it is specifically designed for food-contact substances.
An important distinction is that an effective FCN generally applies only to the manufacturer or supplier identified in the notification. A GRAS conclusion, by contrast, is not inherently manufacturer-specific, although another manufacturer must ensure that its substance and conditions of use are adequately covered by the supporting safety conclusion. Learn more about FDA’s Food Contact Substance Notification Program.
What Would Happen to Existing Self-GRAS Substances?
FDA is proposing a transition mechanism for certain substances that entered interstate commerce under an independent GRAS conclusion before the effective date of a final rule.
For qualifying existing uses, companies could make a streamlined submission containing information such as:
- The identity of the submitter
- The identity of the substance
- The intended conditions of use
- The foods in which the substance is used or with which it comes into contact
- Use levels and technical purpose
- Evidence that the substance was in interstate commerce before the final rule’s effective date
The streamlined option would be available for one year after the effective date of a final rule. Inclusion on FDA’s public list would not constitute an FDA determination that the substance is GRAS. FDA could subsequently require a complete GRAS notice or Food Additive Petition.
FDA proposes that a final rule would become effective 60 days after publication, with an 18-month compliance period for the mandatory notification provisions.
How Could the Proposal Affect Manufacturers?
If finalized, the proposal could have several significant consequences.
Increased FDA and Public Scrutiny
GRAS conclusions previously maintained as internal company records would become visible to FDA and, subject to applicable protections, the public. Weaknesses in exposure calculations, toxicological data, expert consensus or manufacturing specifications could receive greater attention.
Greater Documentation Expectations
Companies would need submission-ready documentation supporting substance identity, specifications, manufacturing, intended use, dietary exposure and safety. A short internal memorandum may not be sufficient.
More Careful Regulatory Pathway Selection
For some substances—particularly food-contact substances—an FCN, Food Additive Petition or Threshold of Regulation submission may be more appropriate than a GRAS notice.
Longer Product-Development Timelines
Although the proposal would not formally establish GRAS as a premarket approval pathway, customers, investors and internal risk-management teams may prefer to wait for an FDA response. Companies should therefore incorporate regulatory strategy into product development at an earlier stage.
Review of Legacy Products
Manufacturers relying on older self-GRAS determinations would need to identify those uses, determine whether an exception applies and prepare either a complete GRAS notice or a streamlined legacy submission.
What Should Companies Do Now?
Food ingredient and food-contact material manufacturers should consider taking the following steps:
- Inventory existing GRAS conclusions. Identify every substance and condition of use currently supported by an independent GRAS determination.
- Confirm the scope of each conclusion. Compare the supporting assessment with current manufacturing processes, specifications, food categories, use levels and exposure.
- Evaluate existing authorizations. Determine whether an FDA regulation, no-questions letter, FCN, Threshold of Regulation exemption or other authorization already covers the intended use.
- Conduct a scientific data-gap assessment. Review chemistry, migration, dietary exposure, toxicology and general-recognition evidence for potential weaknesses.
- Consider public-disclosure implications. Identify confidential commercial information while ensuring that sufficient publicly available evidence exists to support general recognition of safety.
- Select the appropriate regulatory pathway. Compare the advantages and limitations of a GRAS notice, FCN, Food Additive Petition and Threshold of Regulation exemption.
- Monitor the rulemaking. Companies should follow the docket, evaluate the potential operational impact and consider submitting comments before the December 9, 2026 deadline.
Frequently Asked Questions
Has FDA already made GRAS notification mandatory?
No. FDA has issued a proposed rule. The existing voluntary GRAS notification framework remains in effect unless FDA publishes a final rule.
Would companies still be able to make their own GRAS conclusions?
Yes. The proposal would preserve the ability to reach an independent GRAS conclusion, but companies generally would be required to notify FDA of the conclusion and its supporting basis.
Does the proposal cover substances that migrate from food packaging?
Yes. FDA expressly states that covered food substances include indirectly added substances, such as substances migrating from food packaging.
Would FDA have to approve a GRAS notice before marketing?
No. The proposal would not establish a traditional premarket approval requirement for GRAS substances. However, marketing without meeting the notification requirement could increase post-market regulatory risk.
Are Food Additive Petitions and FCNs the only alternatives?
No. Depending on the substance and intended use, available pathways may include a mandatory GRAS notice, an FCN, a Food Additive Petition, a Threshold of Regulation exemption or reliance on an existing applicable authorization.
Preparing for a More Transparent GRAS Process
FDA’s proposal represents a significant shift toward greater transparency and federal oversight of food ingredients and food-contact substances. Although it would not formally eliminate independent GRAS conclusions, it would substantially reduce the ability to rely on such conclusions without FDA awareness.
Manufacturers should begin evaluating their existing GRAS portfolio, identifying scientific and regulatory gaps and determining the most appropriate pathway for each substance and intended use.
Experien Health Sciences can assist food ingredient, packaging and food-contact material companies with regulatory pathway assessments, GRAS evaluations and notices, Food Contact Notifications, Food Additive Petitions, exposure assessments and toxicological data-gap analyses.
Contact us to discuss how the proposed requirements may affect your products and regulatory strategy.
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