ABSTRACT
The safety assessment of a microorganism is a multifaceted task that involves thoroughly reviewing the history and properties of the organism of interest, testing the products manufactured for the presence of any harmful metabolites, and validation or accreditation of the production process. The guidelines and recommendations for safe use of microbial products in applications such as food and feed processing or biocontrol may vary in different countries. However, the tests and the methods used in a safety evaluation of, for example, enzyme products are in general based on the guidelines formulated by recognised authorities such as the Organisation for Economic Cooperation and Development (OECD), Joint FAO/WHO Expert Committee on Food Additives (JECFA), European Economic Community (EEC) and the Food and Drug Administration of the USA (FDA). Regulations concerning genetically modified microorganisms are documented in international agreements, directives and recommendations, EC directives and decrees and, at the national level, by legislation or guidelines concerning such aspects as the labelling of recombinant products.
