By using the tools of modern biotechnology, the enzyme industry has developed safe host organism systems for the production of many enzymes that could not otherwise be produced. These safe host systems have been used since the early 1980’s for the production of different enzymes in contained manufacturing facilities. The host organisms and their enzyme products have been tested to demonstrate that they are safe for their intended use; this includes, but isn’t restricted to, testing of the organism to demonstrate that it is not pathogenic and does not produce toxins, and testing of the product to demonstrate that it is safe for the intended use, and to determine whether it is an irritant and how likely it is to cause allergies when inhaled.

Guidelines for safety assessments of food and food ingredients developed through biotechnology have been prepared by several internationally recognized scientists and expert groups (Organization for Economic Cooperation and Development, Health Canada, Food and Agriculture Organization / World Health Organization, International Life Sciences Institute – Europe, Novel Food Task Force), and specific recommendations for microbially derived food ingredients (IFBC, 19905) and enzyme preparations (Pariza and Foster, Pariza and Johnson, EU SCF, US FDA) have also been published.