Getting New Animal Food Ingredients Into the U.S. Market
Emerging Developments in U.S. Animal Food Regulatory Acceptance
23 February 2016
Navigating the route to animal food ingredient approval and marketing in the U.S. can present numerous challenges, especially with the ambiguity of the 3 different feed approval processes. Conventionally, the animal food additive petition is the most accepted authorisation process under the regulatory oversight of the FDA’s Center for Veterinary Medicine (CVM); however, other options such as the Association of American Feed Control Officials (AAFCO) ingredient definition process and the Generally Recognized as Safe (GRAS) route can provide alternative routes to market depending on a company’s overall business strategy. Each of these routes presents their own issues, which relate to the data requirements, the time to market, and the regulatory acceptance by State officials. Although the GRAS route to authorisation is well established in the marketing of human food ingredients in the U.S., GRAS determinations and notifications for animal food ingredients are often overlooked as a less utilized option.
At the recent mid-year AAFCO meeting held in January in Isle of Palms, South Carolina there was discussion on the inclusion of GRAS Notices in the AAFCO Official Publication (OP), which provides regulatory guidance for State-to-State acceptability of feed ingredients. This is anticipated to mirror the adoption of authorised animal food additives that have been approved through the petition process and included in Title 21 of the Code of Federal Regulations (CFR). Questions regarding State acceptance, the usefulness of inclusion into the OP, and the propriety nature of GRAS Notices were considered and still need to be evaluated. These discussions suggest the possible role that GRAS-notified substances may play in the future and highlight the importance of a well-thought out regulatory strategy when seeking feed product approval in the U.S.. Ultimately, the underlying strategy depends on the specific marketing needs for your ingredient and the limitations of each of the food additive, AAFCO and GRAS processes. Appropriate guidance is critical at this stage.
Other developments of the AAFCO meeting, included the revision of the terms “feed grade” and “suitable for use in animals”, which are in essence synonymous with each other. A new “human grade” handling standard has also been accepted, which opens the door for human grade claims in areas such as pet foods. Similarly, a new Section for human food by-products was also accepted for inclusion in the OP. These developments will prompt new considerations for animal feed ingredients and the type of claims that companies should consider to grow their animal food business.
Intertek has extensive experience in the regulatory approval of feed ingredients and with offices world-wide, our feed experts can assist you with a global regulatory strategy and jurisdiction-specific approvals for expanding your products into markets in the U.S. EU, China, and Canada.
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Today’s expert blogger is Dr. Winnie Ng, Scientific and Regulatory Consultant, within Intertek’s Health and Environmental Regulatory Services Group. As part of a team that is responsible for critical review, evaluation, and interpretation of scientific literature, Winnie has prepared submissions and notifications for both human and animal food ingredients for review by global regulatory agencies and organizations including the U.S. Food and Drug Administration (FDA), the Canadian Food Inspection Agency (CFIA), and the European Food Safety Agency (EFSA) including, food additive petitions, Generally Recognized as Safe (GRAS), New Dietary Ingredient (NDI), Novel Foods, and product registration notifications.