To help industry players navigate these compliance hurdles, CIRS Group has compiled the Guide to U.S. Animal Food Ingredient Regulatory Submissions: Animal Food GRAS Notices, Food Additive Petitions, FDA Animal Food Ingredient Consultation (AFIC), and AAFCO Scientific Review of Ingredient Submissions (SRIS).

As a leading global product safety and regulatory compliance consulting agency, CIRS Group has long specialized in food, feed, pet food, synthetic biology ingredients, etc. CIRS Group has established a robust global service network covering China, the United States, the European Union, Canada, Australia, New Zealand, Japan, South Korea, and other major international markets.

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.

MEE Order 12 - the Measures for the Environmental Management Registration of New Chemical Substances (also known as China REACH) – is undergoing a new round of systematic revisions, including taking products such as pharmaceuticals, pesticides, cosmetics, food, food additives, feed, feed additives, and fertilizers that were already regulated by relevant regulations into the scope of new substances registration.

Recently, Chin’s Ministry of Agriculture and Rural Affairs (MARA) updated the Feed Materials Catalogue and the requirements for safe use. The Ministry approved one new feed material, five new feed additives, and the expanded scope of application for one feed additive.

According to Regulation (EC) No 1831/2003 (Feed Additives Regulation), feed additives refer to substances, microorganisms, or preparations—other than feed materials and premixes—that are intentionally added to feed or water to perform one or more functions. The EU has established a positive list of feed additives. To market a new feed additive not included in the positive list, an application for authorization must first be submitted to the EU authorities. Each authorization is valid for 10 years and may be renewed for an additional 10 years.

Regulation (EC) No 1831/2003 defines feed additives as substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions: satisfy the nutritional needs of animals, favourably affect: the characteristics of feed or animal products; the colour of ornamental fish and birds; the environmental consequences of animal production; animal production; performance or welfare; or have a coccidiostatic or histomonostatic effect.

“GRAS” is an acronym for Generally Recognized As Safe, which stands as an important food regulatory category in the United States. Simply speaking, if a substance is GRAS under the conditions of its intended use among qualified experts, it is excluded from the definition of a food additive and is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act.

In accordance with “Supervision and Management Measures for the Inspection and Quarantine of Import and Export Feed and Feed Additives”, GENERAL ADMINISTRATION OF CUSTOMS, P.R.CHINA (GACC) shall conduct risk analysis of the countries or regions that export feed to China for the first time, and conduct retrospective review of the countries and regions that have already exported or are exporting feed to China. According to the results of risk analysis and retrospective rev