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U.S. AAFCO Scientific Review of Ingredient Submissions (SRIS)

What Is the U.S. AAFCO Scientific Review of Ingredient Submissions (SRIS)?

The Scientific Review of Ingredient Submissions (SRIS) is a scientific review program for animal food ingredients jointly established by the Association of American Feed Control Officials (AAFCO) and K-State Olathe Innovation Campus. It is intended to replace the former AAFCO Ingredient Definition Request pathway and provide an independent scientific review route for new animal food ingredients.

The key value of SRIS is that, after an ingredient passes the scientific review and subsequently undergoes evaluation by the AAFCO Ingredient Definitions Committee (IDC) and approval by the AAFCO membership, it may ultimately be incorporated into the AAFCO Official Publication (OP). Because the AAFCO OP has long served as an important reference for commercial feed regulation by individual U.S. states, SRIS has significant practical value for state-level market access and interstate distribution.

What Ingredients Are Eligible for SRIS?

A proposed ingredient generally needs to meet the following eligibility criteria:

  • The proposed ingredient is not currently listed in Chapter 6 of the AAFCO Official Publication (OP).
  • The ingredient can be described through a public, generally applicable definition rather than a definition based on proprietary technology or a manufacturing process clearly associated with a single company.
  • The submission should generally concern a single ingredient, rather than a combination of multiple ingredients.
  • The intended use should be to provide nutrition, flavor, or aroma, or to perform a technical function in animal food.
  • The intended use should not be for the treatment, mitigation, or diagnosis of disease.

Therefore, SRIS is not suitable for all innovative products. For projects where the definition cannot readily be made publicly available, is highly dependent on patented or proprietary manufacturing processes, or cannot reasonably be described using an industry-wide generic definition, other regulatory pathways may need to be considered first.

What Is the SRIS Review Process?

  • Preliminary Screening and Pathway Assessment
    Confirm whether the ingredient is already listed in the AAFCO OP and assess whether it is suitable for development of a public, generally applicable ingredient definition.
  • Submission of the Intake Form
    Provide information on the intended use, target animal species, proposed definition, manufacturing overview, safety information, and publicly available scientific literature.
  • Project Complexity Assessment
    AAFCO investigators, the SRIS team, and the applicant jointly assess the complexity of the submission. The assessment is used to determine the required level of review, number of reviewers, and applicable fees.
  • Formal Dossier Submission
    The applicant prepares and submits a complete dossier in accordance with SRIS requirements.
  • Expert Scientific Review
    K-State Olathe organizes subject-matter experts to conduct the technical and scientific evaluation.
  • Responses to Questions and Submission of Additional Information
    The applicant responds to reviewer comments and provides supplementary information as needed. The review clock may be paused while additional information is being prepared.
  • AAFCO IDC Review
    Once the scientific review is successfully completed, the submission proceeds to the Ingredient Definitions Committee process.
  • AAFCO Membership Approval and Inclusion in the OP
    Following committee consideration and membership approval, the ingredient definition may be incorporated into the AAFCO Official Publication.

What Information Is Required for an SRIS Submission?

Based on the U.S. Feed Compliance Guide and publicly available SRIS guidance, the submission package generally covers the following modules:

No.

Information Module

1

Signed statements and certifications

2

Product identity, manufacturing process, specifications, and physical or technical effects

3

Target animal exposure and human exposure assessment (where food-producing animals are involved)

4

Self-limiting use levels

5

Safety assessment and supporting rationale

6

List of supporting data and information

In practice, applicants should also focus on Preparing the proposed AAFCO ingredient definition; Complete manufacturing flow chart; Representative batch data; Rationale for contaminant and impurity controls; Target animal exposure assessment; and Safety conclusions supported by publicly available scientific evidence. Where food-producing animals are involved, potential impacts on the human food chain should also be carefully evaluated.

How Does SRIS Differ from AFIC, FAP, and an FDA GRAS Notice?

Regulatory PathwayFAPFDA GRASAFICSRIS
Reviewing BodyFDA (federal)FDA (federal)FDA (federal)AAFCO and Kansas State University
Submission FeeAn application fee may applyNo FDA-level feeNo fee

Yes, and charged by AAFCO

Overall Cost & Timeline
Long timeline
High cost
Moderate timeline
Moderate cost
Shorter timeline
Relatively low to moderate cost
Generally shorter timeline
Moderate cost
Direct OutcomeInclusion in federal regulations under 21 CFRFDA “No Questions” letterCompletion of FDA consultationInclusion in AAFCO OP
RecognitionHighestHighNo federal approval; state-level acceptance may vary because the ingredient is not necessarily listed in the AAFCO OP*Broad industry recognition because inclusion in the OP is an effective tool for state-level market access, but it does not constitute federal recognition

It is important to note that although SRIS can play a significant role in state-level market access and industry acceptance, it does not constitute FDA federal approval and does not directly replace an FAP or FDA GRAS Notice.

Key Features of SRIS

  • Focuses on inclusion of an ingredient definition in the AAFCO OP, giving it significant value for state-level market access.
  • Places greater emphasis on publicly available, generally applicable, and reproducible ingredient definitions.
  • Generally applies to single, non-proprietary ingredients, with relatively strict eligibility requirements.
  • Uses an independent expert scientific review mechanism, with the technical review linked to AAFCO's internal review process.

Estimated SRIS Timeline and Cost

Step

Estimated Timeline / Cost

Data gap analysis and pathway assessment

1–2 months

Dossier preparation and internal review

3–6 months

Intake Form assessment and quotation

Several weeks to 1 month

Expert scientific review

Typically 2–3 months (review clock may be paused while additional information is provided)

AAFCO IDC review and membership approval

Subject to the AAFCO meeting schedule

Overall timeline

Typically approximately 6–12 months or longer, depending on data completeness and meeting schedules

Expert review fees

Generally approximately USD 10,000–35,000, depending on project complexity

The overall SRIS timeline depends not only on the scientific review itself, but also on the completeness of the dossier, the number of rounds of supplementary information and responses to questions, and the scheduling of AAFCO meetings and membership votes.

Why Choose CIRS

With over 450 employees, CIRS Group offers one-stop global registration and filing services for new food ingredients to support companies expanding overseas, helping them efficiently and reliably gain market access to the U.S. food ingredient market.

U.S. Local Team: CIRS USA is located in Virginia. We have full-time U.S. food regulatory experts who provide compliance services such as U.S. FDA GRAS, NDI, CAP, Animal Food GRAS, FDA Animal Food Ingredient Consultation, and AAFCO SRIS.

Team of Senior Experts: CIRS Group has 24 Chinese Certified Toxicologists (DCST), 1 European Registered Toxicologist (ERT), and 2 U.S. Certified Toxicologists (DABT). DABT experts can serve as members of the GRAS expert panel, participate in panel meetings, and sign off on GRAS submissions.

Extensive Track Record: The CIRS Food Division has over 15 years of experience in food compliance services and boasts numerous successful cases, including human milk oligosaccharides (2'-FL, LNnT, LNT, etc.), steviol glycosides, inositol, brazzein, lycopene, enzymatically converted steviol glycoside Reb M2, NMN, pasteurized AKK, fungal protein, D-allulose, glucosamine hydrochloride, N-acetylglucosamine (NAG), beta-carotene, zeaxanthin, astaxanthin, PQQ, and etc.

Cross-Regional Coverage: The CIRS Food Division provides global application services for novel food ingredients, covering more than 20 countries and regions, including China, the United States, Europe, Australia, New Zealand, Canada, South Korea, Japan, Brazil, Mexico, Singapore, Malaysia, Thailand, Vietnam, Indonesia, and China Taiwan.

End-to-End Coverage: We manage the entire process—from document organization, data gap analysis, test protocol design, expert review, and dossier preparation to submission and ongoing compliance maintenance. Our proven processes and local resources ensure shorter timelines, transparent costs, and a high first-time approval rate, reducing the costs associated with repeated revisions.

CIRS Services

  • SRIS feasibility assessment and regulatory pathway strategy;
  • Drafting and optimization of ingredient definition language;
  • Preparation and integration of the complete SRIS dossier;
  • Support for responding to expert questions and requests for additional information;
  • State-level market access support following inclusion in the AAFCO OP;
  • U.S. animal food labeling review and ongoing compliance support.

Get In Touch

CIRS Group can help you identify the correct regulatory route and build a practical approval strategy. Click to contact our food regulatory experts or get in touch with us via service@cirs-group.com.