The guidelines will specify the type of information that industry should provide to enable EFSA to carry out the safety assessments on enzymes. This includes the description of chemical composition, properties and toxicological tests. On the basis of the information provided, EFSA will address the safety of the source materials from which the food enzyme is produced (including the presence of possible impurities), the manufacturing process and the dietary exposure.

The request to provide guidelines arises from the new Regulation No 1331/2008, which establishes a common authorisation procedure for food additives, food enzymes and food flavourings.

In an initial phase, EFSA is requested to evaluate food enzymes which are presently on the market in the European Union. After these evaluations are complete, an EU list of authorised substances will be established by the European Commission. EFSA will then carry out the safety evaluations of new food enzymes.

EFSA is consulting on the draft guidelines in order to guarantee their completeness and clarity. Comments can be submitted until 8 June 2009 via the EFSA website and will be considered by EFSA’s Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) when finalising the document.

An enzyme is a protein that catalyses or accelerates a biochemical reaction without altering the nature of the reaction. Enzymes may be added to food to perform a technological function in the manufacturing, processing, preparation, treatment, packaging, transport or storage. As an example, food enzymes can be used in certain cases as alternatives to food additives in improving the texture, appearance or nutritional value of food, as well as helping in certain food production processes (e.g. cheese making or beer brewing).