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.

University of Nebraska Food Allergy Research and Resource Program Expert Opinion Statement

ETA’s Position Paper Enzymes and Allergens in Food Processing

ETA Allergen Position Paper – Fermentation Media

ETA Allergen Position Paper – Fermentation Media – Spanish

FDA – Food Allergen Labeling and Consumer Protection Act of 2004

Health Canada – Food Allergen Labeling