Identity and Safety of Food Additive Petitions (for conventional foods and dietary supplements)
What is a food?
The Federal Food, Drug, and Cosmetic Act (section 201(f)) states that “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.” Thus, animal food includes both livestock feed and pet (companion) animal food. The term food additive is also defined in the Federal Food, Drug, and Cosmetic 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 as safe (GRAS) for a specific use within an animal food are not considered 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.
Any substance that is reasonably expected to become a component of food is a food additive that is subject to premarket approval by FDA, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Any food additive that is intended to have a technical effect in the food is deemed unsafe unless it either conforms to the terms of a regulation prescribing its use or to an exemption for investigational use. Otherwise, in accordance with section 409 of the Act, the substance is deemed an unsafe food additive. Any food that contains an unsafe food additive is adulterated under section 402(a)(2)(C) of the FFDCA.
Food additives used in animal food are usually characterized based on their composition and intended use. An animal food additive is generally intended to supply nutrients, add aroma/flavor, aid stability, or alter a food’s characteristics. Substances that alter the characteristics of a food may include emulsifiers, sequestrants, anti-caking agents, or enzymes. Also, substances used in the processing, packaging, packing, or transporting of animal food may be food additives based on indirect or incidental contact with animal food. A list of food additives that are approved for use in animal food is described in Title 21 of the Code of Federal Regulations Part 573 (21 CFR 573).
Do you need Approval?
A manufacturer or other sponsor may petition the FDA for approval of a new animal food additive or they may petition for a new use of an already approved animal food additive. To demonstrate that the additive is safe for the proposed use in an animal food, the sponsor submits 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; and once this has been demonstrated, FDA can issue a regulation addressing the food additive and its use. The regulation 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/or 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 regulation.
What do you need to include in a Food Additive Petition?
Below is a list of the general information that should be included in a FAP.
- Identity and composition of the additive including manufacturing methods and controls;
- Intended use, use level, and labeling (cautions, warnings, shelf life, directions for use);
- Data establishing the intended effect (physical, nutritional, or other technical effect);
- Analytical methods (for the additive and for animal foods containing the additive);
- Safety evaluation (target animal and human food)
- Proposed tolerances for the food additive;
- Proposed regulation; and
- Environmental assessment
Information that is required in a Food Additive Petitions is found in 21 CFR 571.
Food Additive Petitions Under Review (active as of 2015)
Determining the Regulatory Status of a Food Ingredient
Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety
Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives
Guidance for Industry: Food Additive Petition Expedited Review
Guidance for Industry: Questions and Answers About the Petition Process
Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
Guidance for Industry: Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices
Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food
Guidance for Industry: Estimating Dietary Intake of Substances in Food
Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
Redbook 2000 (Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients)
Redbook II 1993 (Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food)
Everything Added to Food in the U.S. (EAFUS Database) – Searchable Database
Probiotic and Live Microbial Food Additive Guidance
Guidance for Industry: Antimicrobial Food Additives
Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions