Food Additive Petitions

In its broadest sense, a food additive is any substance added to food that does not meet the criteria to be considered generally recognized as safe (GRAS). Legally, the term refers to any substance the intended use of which results or may reasonable be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of animal feed, including pet food. Food additives have a premarket approval requirement and they, must be used in accordance with a food additive regulation. Substances that may affect the characteristics of an animal feed or feed ingredientmay also be food additives, including any substances used in producing, manufacturing, packing, processing, preparing, treating, packaging, and transporting. The definition for a food additiveand the criteria for GRAS use of substances aredetailed in Section 201(s) of the Federal Food, Drug, and Cosmetic Act.

The basis of a food additive regulation is an approved food additive petition. A manufacturer or other sponsor must first petition FDA for approvalof a new food additive or a new use of an already approved food additive. The food additive petition should include an adequate factual basis to establish that the food additive is safe for its intended use, under the conditions of use specified in the petition. If the petitioner meets this burden of proof, the food additive can be approved for use in animal feed. The FDA then issues a regulation that may include the types of animal feed which the additive can be used in, how much may be used, and labeling information for the additive and feeds containing the additive.

There are several types of food additives based on its composition and intended use. A food additive generally provides one or more of the following, i.e., nutrient, aroma/flavor, taste, soluble or insoluble fiber, stabilizer, emulsifier, sequestrant, chemical preservative, anti-oxidant, anti-caking agent, etc.

Section 571 of Part 21 of the Code of Federal Regulations (CFR) prescribes the kinds of data that must be submitted by the petitioner and the format which the food additive petition must follow when sent to FDA. While the actual content may vary from petition to petition, depending primarily on the food additive's composition and intended use, each of the following subject areas must be addressed:

1. human food safety,
2. target animal safety,
3. environmental impact,
4. utility,
5. labeling,
6. proposed regulation,
7. assay methodology, and
8. manufacturing process and controls.

Subsequently, when the FDA concludes that the available data for a food additive are sufficient to meet current criteria, the FDA issues a regulation permitting the petitioned use of the additive.The list of approved food additives is found in 21 CFR 573.

To obtain further information on how to submit a food additive petition for an substance to be used in animal feed, please contact the Division of Animal Feeds.