Food Law News - EU - 2009

EFSA News Story, 12 August 2009

ADDITIVES - EFSA publishes guidance on the safety evaluation of food enzymes

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 Details of EFSA’s data requirements for assessing the safety of additives were published on August 3rd and draft guidance relating to flavourings is due to be published in the autumn.

The following is a summary of the published document

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 [1]

Question number: EFSA-Q-2007-080

Adopted: 23 July 2009

According to Regulation (EC) No 1332/2008 [2] 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.

The purpose of this document is to provide guidance to applicants and other interested parties in providing a dossier for safety evaluation of food enzymes. It gives guidance on the format of a formal application for the safety assessment of a food enzyme, on the administrative and technical data required, and on the range of toxicological tests generally required.

Applicants should note that the Commission will make available to competent authorities in Member States in full form any dossier submitted to the Authority for a safety assessment. Confidentiality of information provided by the applicant will be treated in accordance with Article 12 of the Regulation (EC) No 1331/2008 [3]. Therefore applicants should mark clearly which of the information provided they wish to be treated as confidential and provide verifiable justification in such case.

Applications shall be submitted in accordance with Regulation (EC) 1331/2008 and its implementing measures referred to in Article 9 of this Regulation. All the information necessary to enable EFSA to conduct a safety assessment of a food enzyme must be provided by the applicants in the dossier. Applicants wishing to make a submission are advised to consult this Guidance.

Note: For full details, please consult the Guidance document available on the EFSA web site at:


[1] For citation purposes: Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, 1-26.

[2] Regulation (EC) No 1332/2008 of the European Parliament and of the Council on Food Enzymes and Amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/199, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97. Official Journal L354/7, p7, 31/12/2008.

[3] Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Official Journal L354/1, p1, 31/12/2008.

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