Since ancient times, enzymes have played an important part in food production. One of the earliest examples of an industrial enzyme use was in the production of whiskey. Today, nearly all commercially prepared foods contain at least one ingredient that has been made with enzymes. Some of the typical applications include enzyme use in the production of sweeteners, chocolate syrups, bakery products, alcoholic beverages, precooked cereals, infant foods, fish meal, cheese and dairy products, egg products, fruit juice, soft drinks, vegetable oil and puree, candy, spice and flavor extracts, and liquid coffee, as well as for dough conditioning, chill proofing of beer, flavor development, and meat tenderizing.


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.

Allergen Information

  • The regulatory agencies in the EU and Japan have determined that enzyme preparations are not required to have allergen labeling for the raw materials used in the fermentation process. Indeed, the European Commission’s Health & Consumer Protection Directorate General has clearly stated that enzymes are outside the scope of the Directive 2003/89/EC which amended the EU Food Labelling Regulations.
  •  Enzyme broths are normally processed to separate biomass and fermentation materials from the enzyme, to concentrate the enzymatic activity, and formulated to achieve a uniform and stable enzyme product.
  • The unique role of enzymes in food processing is as a catalyst. Due to the specific nature of enzymes, only small amounts are required to make desired modifications to the property of a food.
  • Many enzymes do not become a component of the food ingredient or final food.  Some enzymes are used in an immobilized form or are denatured during processing. Further, processing of the food ingredient after the enzyme catalyst has performed the expected function often reduces or eliminates the enzyme from the product.
  •  ETA has made an extensive review of the published scientific literature and has found no reports that even suggest there has been an allergenic reaction to a component of the fermentation media which was used to feed the microorganism that produced the enzyme.