EFSA Publishes Guidance on the Safety Evaluation of Food Enzymes

The guidance specifies that industry should provide details of the physico-chemical characteristics of the food enzyme in question as well as the toxicological tests which have been carried out.

13 Aug 2009 The European Food Safety Authority (EFSA) has published a guidance document specifying the type of information that industry should provide to enable EFSA to carry out the safety assessments on food enzymes. The guidance takes into account the outcome of a public consultation which ended on 8 June.

An enzyme is a protein that promotes or accelerates a biochemical reaction. Enzymes may be added to food to perform a technological function in 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 order to improve the texture, appearance or nutritional value of food, as well as helping in certain food production processes (e.g. cheese making or beer brewing).

The guidance specifies that industry should provide details of the physico-chemical characteristics of the food enzyme in question as well as the toxicological tests which have been carried out. 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 dietary exposure.

With regard to the safety evaluation of food enzymes, EFSA will first evaluate those which are currently on the market in the EU. After these evaluations are complete, an EU list of authorised substances will be established by the European Commission. EFSA will then carry out safety evaluations of new food enzymes.

The need to provide this guidance arises from new EU legislation (Regulation No 1331/2008), which establishes a common authorisation procedure for food additives, enzymes and flavourings. Details of EFSA’s data requirements for assessing the safety of additives were published on August 3rd and draft guidance relating to flavourings is due to be published in the autumn.

According to Regulation (EC) No 1332/2008 food enzymes shall be subject to safety evaluation by the European Food Safety Authority (EFSA) and approval via a Community list. The inclusion of a food enzyme in the Community list will be considered by the Commission on the basis of the opinion from EFSA, taking into account also other general criteria such as technological need and consumer aspects.