Food Additive Petition Submission Requirements

The following information is required by the U.S. Food and Drug Administration (FDA) when a manufacturer submits a petition for a food additive approval.

1. Chemical identity
   

   The chemical name and structure of the proposed food additive, or enough information about the method of manufacture to reproduce the additive, information about its physical, chemical, and biological properties, and data showing its stability and purity must be included.

2. Purpose and amount proposed for use
   

   The petitioner must include information about how much of the additive will most likely be consumed (consumption data), recommendations for use, and specimens of proposed labelling.The level used should be no higher than the effective level.

3. Functionality
   

   Data showing that the food additive will have its intended effect, and the amount of the food additive needed to produce th effect, must be included.

4. Method of analysis in food
   

   The pettioner must provide information on how to measure the amount of the additive in food.

5. Safety Data

   Full reports of safety investigations and the methods of toxicity testing used must be provided.

These requirements are listed in detail at this Food and Drug Administration (FDA) web site: http://vm.cfsan.fda.gov/~lrd/fap-171.html

Back to Food Additive Safety Page

Prepared Summer 1997 by Bernadene Magnuson, Ph.D.
University of Idaho, Dept. of Food Science and Toxicology - EXTOXNET FAQ Team.