Regulatory Process for Food Additives Used in Animal Foods

Tuesday, July 22, 2014
Exhibit Hall AB (Kansas City Convention Center)
Sharon A. Benz , Center for Veterinary Medicine, FDA, Woodbine, MD
Rial Christensen , Nutrition & Labeling Team, Center for Veterinary Medicine, FDA, Rockville, MD
Michaela G. Alewynse , Nutrition & Labeling Team, Center for Veterinary Medicine, FDA, Rockville, MD
Abstract Text: Animal food, both livestock feed and companion animal food, is composed of many different ingredients. With recent changes in ingredient availability, there is increasing interest in the use of novel ingredients in animal food.  These ingredients may be intended to be a source of nutrients or, like enzymes, may affect the characteristics of the food itself. Under Federal law, ingredients that are not generally recognized as safe (GRAS) for an intended use are considered food additives that must be approved by the Food and Drug Administration (FDA) before they can be used in animal food.  The food additive petition (FAP) process is the means to get approval of food additives and it is described in Title 21 of the Code of Federal Regulations Part 571 (21 CFR 571). Within FDA, the Center for Veterinary Medicine (CVM) approves animal FAPs when a firm demonstrates that the ingredient is safe and achieves its intended purpose. In a petition, the safety of the substance at the intended use rate must be addressed for both the animal and the environment. For food producing species, the safety of human food obtained from the animals must also be addressed. When FDA approves a FAP, a regulation in 21 CFR 573 is established addressing the safe use of the substance in animal food. In September 2013, FDA published Guidance for Industry #221 on the Recommendations for the Preparation and Submission of Animal Food Additive Petitions. This draft guidance describes the types of information to be included in a petition, including: the name and all pertinent information concerning the food additive itself; chemical identity and composition of the additive; manufacturing methods and controls; intended use, use level and labeling; data establishing the intended effect (physical, nutritional, or other technical effect); a description of validated analytical methods to determine the amount of the food additive in the food; safety evaluations for the animal and humans consuming animal products; proposed tolerances for the food additive; proposed regulation; and environmental assessment.  With the guidance, CVM seeks to provide the animal industry with knowledge of the types of information that are required to establish the safety of the use of an ingredient to help to ensure a safe animal food supply.

Keywords: FDA, food additive, guidance