The Association of American Feed Control Officials (AAFCO) maintains a list of feed ingredient names and the definitions in the AAFCO Official Publication. This list is central to harmonizing inter-state trade for animal feed and is referenced by international organizations. In late 2024, it was announced that the AAFCO “ingredient definition” process was going to change when the memorandum of understanding between AAFCO and the FDA came to an end. The FDA quickly put forward a draft guidance that has since been finalized for Animal Food Ingredient Consultation (AFIC) process as an alternative pathway, complementing the Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) notifications that exist currently. Similarly, AAFCO released a draft proposal from Kansas State University (KSU) for a new AAFCO ingredient definition process that does not involve the FDA.
On January 21, the AAFCO Committee representatives voted to accept the proposal from KSU for a modified review process for AAFCO Ingredient definitions. The information required in the proposal is based on the CVM-GRAS pathway. The KSU proposal provides an Expert Panel review before submission to AAFCO for acceptance. Past critiques of the GRAS process include a lack of transparency for independent GRAS conclusions because even though the data is required to be publicly available, it can be difficult to decipher what a company has considered to be pivotal safety information. By bringing the review process into the public sphere, could the AAFCO ingredient definition serve to address this concern without resorting to the lengthy notified CVM-GRAS pathway?
How does this fit in the US Animal Feed regulatory landscape?
Feed ingredients for use in animal feed (including pet food) have legacy pathways available:
- Food Additive Petition where success equals a new regulation listed in the CFR identifying the ingredient and any limitations on intended use
- A notified GRAS conclusion that is submitted to FDA-CVM for review and if successful, a “no questions letter” posted publicly on the GRAS inventory
- An independent (non-notified) GRAS that is kept on file by the company and is only required to be provided to the FDA if requested
The AFIC with the FDA or the revised AAFCO Ingredient Definition review process add two new pathways in replace of the AAFCO definition process that has now ended.
Why do (almost) all roads lead to AAFCO?
When any of the the FAP, notified GRAS, or AFIC pathways are followed, these definitions will be incorporated into the AAFCO OP. By its nature, an independent GRAS conclusion is kept confidential to the company. So, novel ingredients are in a position where 4 out of 5 pathways to market will be incorporated into the AAFCO OP. Why one path is more appealing than another is largely a business decision for the company and based on the risk profile of the ingredient, however, there are commonalities to the data set requirements for all paths.
Clear and Consistent Manufacturing:
The substance in the final product must be clearly identified, including all compositional details as relevant to the material type. The manufacturing process needs to be in compliance with Good Manufacturing Practice and enough manufacturing information needs to be provided in a dossier to allow experts to assess the safety. The ability to produce a consistent product needs to be provided in the form of batch analyses that are in compliance with a comprehensive product specification. If you are early in your product development process, this can be a good opportunity to get feedback from experienced consultants on your specifications and manufacturing process to avoid issues down the line.
Adequate Safety Data:
Once your manufacturing process is ironed out, safety studies will need to be performed on your product. There are a range of studies that may be needed depending on the substance and can include in silico, in vitro, and in vivo study methods. Additionally, the substance needs to be shown to be safe for its intended use in the target species. Edible animal tissues from the target species may need to be tested for residues of the substance (including any byproducts or associated substances) and demonstrate that these residues are safe for human consumption. It is important that these studies are conducted with the material made according to the manufacturing and specifications that will be presented in the dossier.
Defined Indications For Use:
A material used in feed has to have a function such as taste, aroma, nutrition, or technical effect, and this utility needs to be demonstrated with supportive data. The use level, delivery method, mixability, and directions for handling need to be safe for the intended species and life stage and this needs to be clearly demonstrated through a comprehensive body of evidence.
Conclusion
It can be a challenge to bring all of these elements together, so working with an experienced partner may help the process move more smoothly from data compilation to dossier submission. The team at SGS Nutrasource/GRAS Associates can help, whether it’s a one-off review of a study protocol or bottom to top support for a new product to reach market. Contact us today to learn more.
About Kaiti Valm, MBA, MSc
Program Manager, Nonclinical and Animal Health Services
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Kaiti Valm is Program Manager, Nonclinical and Animal Health Services with SGS Nutrasource/GRAS Associates. She supports clients with GRAS and other regulatory filings, as well as safety and efficacy studies and brings over seven years of experience in nonclinical research and education in business, zoology, and veterinary medicine. |
