US Market Access for Feed & Pet Food Ingredients: Compliance Q&A on the Four Major Pathways—FAP/GRAS/AFIC/SRIS

As an important feed and pet food consumption market, the United States has a complex regulatory framework for market access. With multiple submission pathways—including FAP, GRAS, AFIC, and SRIS—many exporting companies find it difficult to determine the most appropriate route. To help companies address compliance challenges when entering the U.S. market, CIRS Group provided an in-depth overview of the U.S. feed regulatory framework, requirements for each submission pathway, and a comparison of the advantages and disadvantages of the four major pathways.

Q1: What are the four compliance pathways currently available for new feed ingredients and feed additives in the United States?

Following the expiration of the 2024 Memorandum of Understanding, four major pathways are currently available:

• Food Additive Petition (FAP): A statutory FDA approval pathway under which the substance is incorporated into the 21 CFR regulations. It has the highest level of authority, but typically takes 1–3 years and involves high costs.
• FDA Generally Recognized as Safe (GRAS) Notification: A statutory pathway through which companies may obtain an FDA “no questions” letter. It currently includes Self-GRAS (which is proposed to be eliminated) and FDA GRAS notification submitted to FDA.
• Animal Food Ingredient Consultation (AFIC): A temporary voluntary consultation program introduced by FDA in 2024. Companies receive a Consultation Completion Letter. FDA exercises enforcement discretion at the federal level, but this does not constitute official FDA approval. Companies may use proprietary data.
• Substance Review & Ingredient Submission (SRIS): A third-party scientific review pathway established by AAFCO. Upon successful review, the substance can be included in the AAFCO Official Publication (OP). Expert review fees apply.

Q2: How do the four pathways compare in terms of the lead organization, fees, recognition, and outcomes?

Current status of SRIS: Applications began to be accepted in October 2025. As of publication (August 2026), no substance had yet successfully completed the SRIS process. AFIC had received eight consultations, of which one had received a completed consultation response.

Q3: How should companies choose the appropriate submission pathway?

FAP: Rarely selected by companies because of its long timeline and significant investment in safety studies. It is suitable for situations where formal federal regulatory backing is essential.

FDA GRAS: Offers the best overall balance. It has strong statutory standing, and after receiving a “no questions” letter, the substance may be included in the OP, providing both federal and state-level recognition. The main disadvantage is that most of the dossier becomes publicly available, although core manufacturing process parameters may be protected as confidential information.

Note: Self-GRAS is proposed to be eliminated under FDA's new rule.

AFIC: Suitable for companies seeking to protect proprietary data while obtaining a relatively rapid indication of FDA's position at the federal level. The risk is that, before inclusion in the OP, the regulatory position of individual U.S. states may remain uncertain. Companies are therefore advised to subsequently pursue inclusion in the OP.

SRIS: Suitable for commodity feed ingredients with broad applications. It does not provide company-specific proprietary protection. Once included in the OP, the ingredient definition can be used throughout the industry. Therefore, it is not suitable for ingredients relying on patented or proprietary manufacturing processes.

Q4: Which pathway should companies choose if they want to protect proprietary data?

AFIC: Only the substance name and conditions of use are made public. The full dossier is not publicly disclosed, allowing companies to rely extensively on proprietary data.

FDA GRAS: The dossier is generally publicly available, but core manufacturing process parameters can be kept confidential.

SRIS: Not suitable for proprietary protection because it results in a publicly available, generally applicable ingredient definition rather than company-specific rights.

Q5: What impact will the proposed elimination of Self-GRAS have on feed ingredients? Are there circumstances exempt from mandatory FDA GRAS notification?

A: The proposed rule would also cover animal feed. In the future, companies would not be able to rely solely on a Self-GRAS determination and would instead need to submit a GRAS notification to FDA.

Potential exemptions include substances that:

• Are already listed in federal regulations;
• Have already received an FDA GRAS “no questions” letter;
• Have completed an AFIC consultation and received a Consultation Completion Letter; or
• Were included as existing ingredients in the 2024 AAFCO OP.

Note: FDA recognizes the 2024 edition of the OP. FDA has not yet indicated that newly added SRIS ingredients included in the OP are federally recognized.

Q6: How are target animals classified for feed submissions, and how do the assessment requirements differ?

A: There are two major categories:

1. Food-producing animals—such as chickens, pigs, and aquatic species that are consumed by humans:
   Both the safety of the animals themselves and the potential human health risks arising from residues of the substance after consumption of the animal must be evaluated.
2. Non-food-producing animals—such as dogs, cats, and horses:
   Only the safety of the target animal itself needs to be evaluated. Human dietary exposure through consumption of the animal does not need to be assessed. However, the safety of the relevant target species must still be demonstrated.

Q7: Does inclusion in the OP through SRIS mean that FDA has approved or recognized the substance at the federal level?

A: No.

• Before the 2024 memorandum expired, the old 2024 OP had FDA backing, and FDA recognized the safety of the ingredients listed therein.
• SRIS is an independent third-party review conducted by AAFCO. FDA has not formally stated that it recognizes newly added substances approved through SRIS.
• FDA's proposed rule specifically refers to recognition of the 2024 OP, but does not mention subsequent editions of the OP, such as the 2026 edition.

The current situation is therefore that states generally recognize the OP, while FDA's position on newly added SRIS ingredients at the federal level remains unclear. This represents an important area of regulatory interaction between the industry and FDA.

Driven by a global wave of food innovation, regulatory compliance and market access for novel food ingredients and additives have become critical hurdles for companies expanding internationally. Under these circumstances, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim of helping businesses navigate the evolving global regulations and accelerate global expansion.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.