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Animal Food Additive Petitions

Food Additives

The Federal Food, Drug, and Cosmetic Act (FD&C Act) in section 201(f) states: “The term ‘food’ means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Animal food means food for animals other than man and includes pet food, animal feed, and raw materials and ingredients. The term “food additive” is also defined in the FD&C Act (section 201(s)) as any substance that directly or indirectly becomes a component of a food or that affects a food’s characteristics. Substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use (GRAS) are not food additives. Food additives must be approved by the Food and Drug Administration (FDA) prior to their use in foods and, after approval, they must be used in accordance with a specific food additive regulation.

Substances in animal food are regulated as food additives based on their composition and intended use. An animal food additive is generally intended to supply nutrients, add aroma or flavor, or aid stability. Food additives can also be substances that alter a food’s properties, including substances such as emulsifiers, sequestrants, anti-caking agents, or enzymes. Substances used in the processing, packaging, packing, or transporting of animal food may also be food additives based on indirect or incidental contact with animal food. Food additives that are approved for use in animal food are listed in Title 21 of the Code of Federal Regulations Part 573 (21 CFR 573).

Approval Process

A manufacturer or other sponsor may petition the FDA for approval of a new animal food additive, or for a new use of an already-approved animal food additive by submitting a food additive petition (FAP). The FAP must include sufficient information to establish that the food additive is safe and accomplishes its intended use under the conditions of use specified in the petition. When FDA determines that safety and effectiveness have been established, a listing in the CFR is created approving the food additive and its use. The listing may specify the types of animal food that may contain the additive, the amount of the additive that may be used in an animal food, and the requirements for labeling the additive or for labeling the animal food containing the additive. Once approved, an animal food additive must be used within the constraints of its established specifications in the listing.

Information that is required for an FAP submission is described in 21 CFR 571.

Below is a list of the general information that should be included in the FAP.

  1. Identity and composition of the additive including manufacturing methods and controls;
  2. Intended use, use level, and labeling (cautions, warnings, shelf life, directions for use);
  3. Data establishing the intended effect (physical, nutritional, or other technical effect);
  4. Analytical methods (for the additive and for animal foods containing the additive);
  5. Safety evaluation (target animal and human food);
  6. Proposed tolerances for the food additive;
  7. Proposed regulation; and
  8. Environmental assessment.

To obtain additional information on how to submit a FAP for a substance to be used in animal food, please contact the Division of Animal Food Ingredients at: Animalfood-premarket@fda.hhs.gov or Center for Veterinary Medicine, Division of Animal Food Ingredients, CPK1, Room 1B068, 5001 Campus Drive, College Park, Maryland 20740-3835. 

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