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 In this section:

                Development & Approval Process

Development & Approval Process

                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight of Products for Animals Regulated as Pesticides or New Animal Drugs
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees Home
          Animal & Veterinary
          Development & Approval Process
          Food Additive Petitions for Animal FoodDevelopment & Approval Process Food Additive Petitions for Animal Food
  
  	
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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.” Thus, animal food includes both livestock feed and pet (companion) animal food. 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 as safe (GRAS) by qualified experts for a specific use in 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.

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).

Approval Process

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 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.

Information that is required in a submitted FAP is described in 21 CFR 571.

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.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, MPN4, Room 176, 12225 Wilkins Avenue, Rockville, Maryland 20852.

Additional Information

CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions
	Ingredients & Additives

                                                                                  Content current as of:
      02/03/2023Development & Approval Process

          
                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight for Animal Products
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees
 
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