EVALUATING FOOD-CONTACT MATERIALS

The use of articles in contact with food involves both regulatory and scientific considerations when establishing the status of the components under the laws administered by the Food and Drug Administration (FDA). This paper focuses on these considerations by discussing the definition of a food additive, the FDA's regulatory framework for substances used in food-contact articles, and the parameters used for testing the materials to establish their FDA status. The paper also examines emerging regulatory concepts being developed at the FDA, and presents an overview of the data necessary to support a Food Additive Petition submitted to clear a new food-contact material. The evaluation of food-contact materials involves legal, regulatory and scientific considerations, this paper concentrates on the scientific and technical considerations. Although legal definitions and regulatory concepts are discussed these will receive only a cursory treatment. A more exhaustive discussion of the pertinent legal concepts can be found elsewhere (1).