Evolving Regulatory Policies Regarding Food Enzymes Produced by Recombinant Microorganisms

Bio-based industries rely extensively on the use of enzymatic biocatalysts. The global market for industrial enzymes, of which approximately half is used for food applications, is estimated at $5.5 billion. Most enzymes used in food production worldwide are produced by recombinant DNA techniques. Production and use of food enzymes are regulated by three main bodies: the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives; the European Food Safety Authority; and the U.S. Food and Drug Administration. Regulation in the U.S. follows a largely product-oriented approach while the EU emphasizes production processes. Both systems have, or are developing, lists of approved enzymes to facilitate trade while protecting consumer health and welfare. This paper compares regulatory policies, and presents the growing food industry in Turkey as a case study of a national system responding to the food enzyme production and regulatory landscape.