31.12.2008 Official Journal of the European Union L 354/7 REGULATION (EC) No 1332/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- PEAN UNION, Having regard to the Treaty establishing the European Commu- nity, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (%), Whereas: The free movement of safe and wholesome food is an essential aspect of the internal market and contributes sig- nificantly to the health and well-being of citizens, and to their social and economic interests. A high level of protection of human life and health should be assured in the pursuit of Community policies. Food enzymes other than those used as food additives are not currently regulated or are regulated as processing aids under the legislation of the Member States. Differences between national laws, regulations and administrative pro- visions concerning the assessment and authorisation of food enzymes may hinder their free movement, creating conditions for unequal and unfair competition. It is there- fore necessary to adopt Community rules harmonising national provisions relating to the use of enzymes in foods. () OJ C 168, 20.7.2007, p. 34. (?) Opinion of the European Parliament of 10 July 2007 (O] C 175 E, 10.7.2008, p. 162), Council Common Position of 10 March 2008 (OJ C111E, 6.5.2008, p. 32), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008. 4 This Regulation should only cover enzymes that are added to food to perform a technological function in the manu- facture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids (hereinafter referred to as food enzymes). The scope of this Regulation should therefore not extend to enzymes that are not added to food to perform a tech- nological function but are intended for human consump- tion, such as enzymes for nutritional or digestive purposes. Microbial cultures traditionally used in the production of food such as cheese and wine, and which may incidentally produce enzymes but are not specifically used to produce them, should not be considered food enzymes. Food enzymes used exclusively in the production of food additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (*) should be excluded from the scope of this Regulation, since the safety of these foods is already assessed and regulated. However, when these food enzymes are used as such in food, they are covered by this Regulation. Food enzymes should be approved and used only if they fulfil the criteria laid down in this Regulation. Food enzymes must be safe when used, there must be a techno- logical need for their use and their use must not mislead the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, qual- ity of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. The approval of food enzymes should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary prin- ciple and the feasibility of controls. Some food enzymes are permitted for specific uses, such as in fruit juices and certain similar products and certain lac- toproteins intended for human consumption, and for cer- tain authorised oenological practices and processes. The use of such food enzymes should comply with this (?) See page 16 of this Official Journal.