Enzymes have long been used in food production. Until 2009 food enzymes, other than those used as food additives, were not regulated at EU level. New legislation came into force in 2009 to harmonise the use of food enzymes across the EU ((EC) No 1332/2008). The law applies to enzymes that perform any technological function in the manufacture, processing, preparation, treatment, packaging, transport and storage of food. It includes food enzymes used as processing aids but not food enzymes intended for human consumption, such as those added for nutritional purposes.
EFSA will carry out safety evaluations of the food enzyme dossiers before they can be considered for inclusion on the list of approved food enzymes by EU decision-makers. The establishment of this list by the European Commission will take place in a single step after EFSA has delivered opinions on all food enzyme applications received by the 2015 deadline. Current national rules on the use and marketing of food enzymes will apply until a full EU list is established.
As a first step, producers need to submit applications for the authorisation of new and existing enzymes used in foods – including those previously assessed by authorities in France and Denmark. The European Commission has set a deadline of 11 March 2015 to receive these applications. EFSA has developed a guidance document and accompanying explanatory notes that specify the type of data and studies that industry should provide for the safety assessment of a food enzyme application. This includes the description of chemical composition, properties, uses and use levels, as well as toxicological tests. EFSA's Contact Material, Enzymes, Flavourings and Processing Aids (CEF) Panel will carry out safety assessments on around 300 food enzyme applications in the coming years.
It is important to notice that enzymes that have been produced using genetically modified microorganisms (GMMs) require risk assessment of EFSA Panel on Genetically Modified Organisms (GMO) in addition to CEF panel evaluation. EFSA has published a guidance document describing the scientific information required in applications for authorisation to be evaluated by EFSA GMO Panel.
Guidance of the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation
Explanatory Note for the Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes
Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use