CHAPTER 11 - Regulatory Aspects of Bacteriocin Use

Abstract

This chapter provides an overview on the kind of issues regulatory agencies consider for ensuring the safety of bacteriocins or bacteriocin-producing organisms in foods. Purified bacteriocins to be added to foods as preservatives would be regulated by Food and Drug Administration (FDA) as either food additives or generally recognized as safe (GRAS) substances. The chapter also discusses factors affecting regulatory approval of naturally occurring bacteriocin-producing strains. Microorganisms added to foods such as yeast in bread, wine and beer making, and bacteria used for the production of fermented dairy, meat, and vegetable products, have been safely consumed by humans for hundreds of years. The microorganisms are generally recognized as safe by the FDA and are sanctioned for specific applications. The organisms, however, are not evaluated as GRAS substances. The agency considers them to be an integral constituent of fermented foods and even though they are safely used for one purpose, safety must be documented if they are to be used for a different purpose. Applications for approval of genetically engineered bacteriocin-producing strains are handled on a case-by-case basis applying regulations already in use.