title: Use of Bacteriocins in Food: Regulatory Considerations.
abstract: The authority under which a given bacteriocin will be regulated for use in food will depend on the foods in which it is used and the purpose for which it is used. Use of (i) purified bacteriocins, (ii) cells producing bacteriocins, or (iii) genetic expression of bacteriocins in food-producing organisms to serve a preservative effect in processed foods are under the jurisdiction of the Food and Drug Administration (FDA) and are regulated as food ingredients under the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the FFDCA, those substances that are generally recognized as safe (GRAS) by qualified experts (either based on scientific principles or because they have been historically and safely present in food) are exempt from mandatory premarket approval. Substances used in processed food that are not GRAS are defined as "food additives" under the FFDCA and require premarket approval by the FDA. Bacteriocins used in meat products will require an additional suitability assessment by the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS). Bacteriocins which are used on whole fruits or vegetables (or genetically expressed in whole fruits and vegetables and intended to act in the whole food) fall within the definition of "pesticide" found in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and are therefore regulated by the Environmental Protection Agency (EPA). Bacteriocins which are genetically expressed in food-producing domestic animals may be regulated as animal drugs if they are intended for use in preventing disease in animals.
authors.affiliation: Novel Ingredients Branch, HFS-207, Division of Product Policy, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 200 C Street, S.W., Washington, D.C. 20204, USA.
authors.forename: F Owen
authors.initials: FO
authors.lastname: Fields
keywords: Bacteriocins; GRAS ingredients; U.S. government regulations; antimicrobials; food additives