September 11, 2013
The U.S. Food and Drug Administration announced today the availability of a draft document describing the type of information it recommends that companies provide when they submit a food additive petition for substances intended for use in animal food.
Under the Federal Food, Drug, and Cosmetic Act, FDA must approve food additives before they can be used in animal food.
The draft Guidance for Industry #221, titled “Recommendations for Preparation and Submission of Animal Food Additive Petitions,” recommends that petitioners submit to FDA:
- Information to identify and characterize the food additive;
- Information about the manufacturing methods and controls;
- Data to show the food additive will have its intended effect and the amount of the food additive needed to achieve the intended effect;
- The proposed labeling;
- A description of the method or methods used to determine the strength, purity and quality of the food additive;
- A safety evaluation of the food additive (this includes evaluating the safety to people who eat edible products of animals fed the food additive and the safety to the target animal species);
- Proposed tolerances for the food additive (this represents the maximum concentration of the additive allowed in edible tissues, for example, in meat, milk and eggs);
- Proposed food additive regulation describing the conditions under which the additive can be safely used in animal food; and
- Information to allow FDA to assess the environmental impact from the manufacture, use and disposal of the food additive.
The draft guidance is open for public comment for 60 days, starting on Sept. 11, 2013. Although you can comment on any guidance at any time, to ensure that FDA considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by Nov. 12, 2013.
To submit comments electronically, go to www.regulations.gov and enter docket number FDA-2013-D-0928. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and include docket number FDA-2013-D-0928 on each page.