FDA Proposes Mandatory GRAS Notification System

FDA Proposes Mandatory GRAS Notification System: What the Proposed Changes Could Mean for Ingredient Documentation, Food Safety and Regulatory Compliance

What Does GRAS Mean for Food Ingredients?

GRAS stands for Generally Recognized as Safe. Under the Federal Food, Drug, and Cosmetic Act, a substance intentionally added to food is generally considered a food additive requiring FDA premarket approval unless an exclusion or exemption applies. One of those exclusions applies when qualified experts generally recognize the substance as safe under its intended conditions of use.

A key part of the definition is under the conditions of its intended use. An ingredient is not simply "GRAS" in every formulation or at every concentration. Regulatory determination considers factors such as how much of the substance is used, how consumers or animals may be exposed to it, its technical purpose and the types of foods in which it is used.

For GRAS conclusions based on scientific procedures, FDA states that the quantity and quality of scientific evidence supporting safety should be equivalent to what would be required for approval of a food additive. The information needed to establish safety must also generally be publicly available and accepted within the scientific community.

How Does the Current GRAS Notification Process Work?

Under the current system, a company that determines an intended use of a substance is GRAS may voluntarily submit a GRAS notice to FDA. The notice provides information supporting the GRAS conclusion, allowing FDA to evaluate whether the available scientific evidence provides an adequate basis for that determination. FDA may respond that it has no questions regarding the basis of the GRAS conclusion, determine that the notice does not provide a sufficient basis for the conclusion, or stop its evaluation at the notifier's request.



Within the current voluntary process, a company can independently determine that an intended use of an ingredient is GRAS without notifying FDA. These determinations are sometimes referred to as independent GRAS determinations or informally as self-GRAS. FDA's proposed rule focuses heavily on this part of the current system.

What Would FDA's Proposed Mandatory GRAS Rule Change?

If finalized as proposed, the rule would convert FDA's voluntary GRAS notification process into a mandatory notification program. Generally, a person introducing a substance into interstate commerce based on the GRAS provision would need to notify FDA of the basis for concluding that the substance is GRAS under its intended conditions of use, unless one of the proposed exceptions applies.



This would give FDA more information about substances being introduced into human and animal food and allow the agency to evaluate whether a GRAS conclusion has an adequate scientific basis.

The proposed rule also addresses substances already marketed under independent GRAS conclusions. Rather than requiring every existing substance to immediately undergo the same process as a new ingredient, FDA has proposed a time-limited option that would allow certain substances already in interstate commerce to be submitted through a more streamlined process. This distinction will be important if a final rule is adopted.

What Information Supports GRAS Determination?

A GRAS determination is more than a statement from an ingredient supplier that a substance is safe. Depending on the ingredient and its intended use, supporting information may include the identity and composition of the substance, manufacturing methods, specifications, intended technical effect, use levels, dietary exposure and relevant safety or toxicological information. Scientific literature and other publicly available information may also be necessary to establish that qualified experts generally recognize the intended use as safe.



Changes to an ingredient can matter as well. A different manufacturing process, concentration, source or intended application may raise questions about whether an existing GRAS conclusion continues to apply. This makes accurate documentation of both the ingredient itself and its specific use an important part of assessing GRAS regulatory status.

How Could the Proposed GRAS Rule Affect Pet Food and Animal Food?

The proposed mandatory GRAS notification requirements would apply to animal food as well as human food, making the rule particularly relevant to pet food, treats, animal supplements and other products that use functional or less-established ingredients.

Examples may include botanical extracts, fermentation products, novel proteins, processing aids, flavoring ingredients and ingredients added for specific nutritional or functional purposes.

Animal food ingredients, however, have a regulatory history that differs from human food ingredients. FDA's proposal recognizes some of those differences. For example, FDA is proposing an exception for certain animal food ingredient uses that have been reviewed through an established FDA consultation process, such as the Animal Food Ingredient Consultation process, when FDA has publicly indicated that it has no questions or concerns about the safety of that intended use.



FDA is also proposing an exception for animal food ingredients listed and used in accordance with Chapter 6 of the 2024 AAFCO Official Publication, provided FDA has not publicly expressed a concern about the GRAS status of that use. As a result, determining whether an animal food or pet food ingredient would require a GRAS notification may involve reviewing several possible regulatory pathways rather than looking at GRAS status alone.

Which Ingredients May Need a Closer Regulatory Review?

The proposed rule provides a reason to take a closer look at ingredient regulatory documentation, particularly for ingredients that do not have a straightforward regulatory history.

Areas that may deserve additional review include:

• Novel food or pet food ingredients
• Concentrated botanical extracts
• Proprietary ingredients or blends
• New processing aids
• Fermentation-derived ingredients
• Ingredients used at concentrations different from established uses
• Ingredients used for a new technical or functional purpose
• Ingredients supported primarily by an independent GRAS conclusion
• Ingredients with limited publicly available safety information



Established ingredients may still require attention if the current application differs substantially from the conditions under which their safety was originally evaluated.

What Is a GRAS Readiness Review?

Because the FDA proposal is not yet final, preparing for possible GRAS changes does not necessarily mean submitting new notifications now. A more practical first step is understanding the regulatory basis for ingredients already being used or considered for future formulations.

A GRAS readiness review can begin with an inventory of ingredients and their intended uses. For each ingredient, the regulatory basis can then be documented, which may include an FDA regulation, GRAS notice, independent GRAS conclusion, food additive regulation, AAFCO ingredient definition, FDA animal food consultation or another applicable regulatory pathway. From there, documentation can be compared with the actual product formulation. 

Questions to consider include:

• Does the documented use cover the current concentration?
• Is the ingredient being used for the same technical purpose?
• Does the documentation apply to the appropriate food category or target animal species?
• Have manufacturing methods or specifications changed?
• Is sufficient safety and exposure information available?
• Is the formulation relying primarily on a supplier's GRAS statement without access to the underlying regulatory basis?

This type of review can identify documentation gaps before they become an issue during product development, formulation changes, label review or a future FDA submission.

Does the Proposed Rule Require Companies to Submit GRAS Notices Now?

No. FDA's August 2026 rule is still a proposed rule, and the current GRAS notification program remains in effect. Comments on the proposal are due December 9, 2026. If FDA ultimately publishes a final rule, the agency is currently proposing that it become effective 60 days after publication, with an 18-month compliance period for the primary mandatory notification requirements. FDA has also proposed a one-year window following the effective date for certain streamlined submissions involving substances already in interstate commerce. Those dates and requirements could change before a final rule is issued.

What Should Food and Pet Food Companies Watch Next?

The final shape of FDA's GRAS reform is still uncertain. FDA is specifically requesting comments on possible alternatives that could reduce regulatory burden while still increasing transparency and improving oversight of food ingredient safety. 

For now, one of the most useful steps is simply knowing what is in a formulation and why each ingredient can legally be used under its specific conditions of use. For common ingredients with well-established regulatory pathways, that review may be straightforward. Novel ingredients, functional ingredients, proprietary extracts and substances supported through independent GRAS conclusions may require a closer look.

Regardless of how the final GRAS rule changes, maintaining clear records of ingredient identity, regulatory status, intended use and supporting scientific documentation can make future formulation, labeling and regulatory reviews easier to navigate.

References and Resources

U.S. Food and Drug Administration, Proposed Rule: Substances Generally Recognized as Safe, August 11, 2026

View the FDA proposed GRAS rule in the Federal Register

U.S. Food and Drug Administration, Generally Recognized as Safe (GRAS)

FDA GRAS information and resources

U.S. Food and Drug Administration, GRAS Notification Program for Animal Food

FDA animal food GRAS notification information