SRIS GRAS Readiness Intake Form

Purpose: The SRIS program evaluates animal feed ingredients supported by evidence sufficient to establish safety under a Generally Recognized as Safe (GRAS) framework. Firms should ensure that relevant safety data and publicly available scientific literature exist prior to requesting a consultation. Incomplete responses may result in SRIS declining further consultation.

1. Firm Information

Company Name *

Contact Name *

Title

Email *

Phone *

Regulatory Consultant(if applicable)

2. Ingredient Identity

Proposed Ingredient Name (common name) *

Proposed Ingredient Definition (written in AAFCO Official Publication format) *The definition should describe the ingredient name, source material, manufacturing description, composition or functional properties, and intended use in animal feed.

3. Composition and Manufacturing Overview

Brief Description *Provide a brief description of the ingredient’s composition and manufacturing process (source materials, general manufacturing steps, key components, and known impurities).

4. Intended Use in Animal Feed

Functional Purpose in Feed *Nutritional ingredientFlavoring agentAroma aidTechnical additive

Technical EffectIf technical additive, specify the technical effect (e.g., acidifier, antioxidant, pellet binder, etc.)

Target Animal Species *

Proposed Maximum Use Level *(e.g., mg/kg feed or % of diet)

5. Estimated Animal Exposure

Expected Intake *Provide an estimate of expected intake (e.g., mg/kg body weight/day).

6. Existing Regulatory Status

Existing Regulatory Status *Indicate whether the ingredient currently has any regulatory statusAAFCO ingredient definition existsGRAS Notice (FDA AGRN)Self-affirmed GRASFood Additive Petition (21 CFR)Approved outside the United States (specify jurisdiction)No existing regulatory status

CitationIf applicable, provide citation (e.g., AAFCO definition number, AGRN number, or 21 CFR reference)

Notes

Important Regulatory Note: GRAS Notices listed in the AAFCO Official Publication (Table 101.1 AGRN) are firm‑specific and cannot be modified by AAFCO. Food Additive Petitions (FAPs) codified in 21 CFR cannot be modified through the AAFCO ingredient definition process because they are federal regulatory approvals established through FDA rulemaking.

When reviewing ingredient definitions in the AAFCO Official Publication, please refer to the parenthetical citation at the end of the definition. If the definition includes a citation such as “(21 CFR …)”, this indicates the ingredient is based on a Food Additive Petition and is codified in the U.S. Code of Federal Regulations. These ingredients cannot be modified through the AAFCO ingredient definition process. Any changes to ingredients established through Food Additive Petitions must be addressed through the appropriate FDA regulatory pathway.

7. Safety Summary

Safety Summary *Briefly describe the basis for concluding the ingredient is safe for the intended use and target species at the proposed use level. Include relevant information such as target animal tolerance studies, feeding trials, toxicology studies, metabolism data, or other supporting evidence.

8. Publicly Available Safety Evidence

Publicly Available Safety Evidence *List key studies or literature supporting safety (target animal tolerance studies, feeding trials, toxicology studies, metabolism studies). Provide citations. Pivotal safety studies should be peer‑reviewed and publicly available in the scientific literature.

9. Submission Readiness

Submission Readiness *Early concept stageSome safety data availableGRAS dossier in preparationGRAS dossier largely complete

10. Required Confirmation

Required Confirmation *Please check each statement to indicate confirmed understanding of the following requirements for SRIS submissions.Our firm understands that a GRAS conclusion requires publicly available scientific evidence supporting safety.Our firm has access to scientific data or literature supporting safety of the ingredient.Our firm understands that SRIS reviews ingredients supported by a GRAS‑level safety framework.

Is there sufficient publicly available evidence existing to support a GRAS conclusion for the intended use of this ingredient in animal feed? *YesNoUncertain