Food enzymes

PURPOSE: to authorise the use of food enzymes at Community level.

LEGISLATIVE ACT: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 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97.

CONTENT: the Council adopted a Regulation on food enzymes following agreement reached with the Parliament at second reading. Previously, Community legislation only covered enzymes used as food additives. The remaining enzymes were not regulated at all or were regulated as processing aids under the legislation of the Member States, which is diverse. With respect to safety, there was neither safety evaluation nor authorisation of food enzymes at Community level, except for those that were considered as food additives. This Regulation aims to establish harmonised rules for food enzymes at Community level, in order to promote fair trading and effective functioning of the internal market and to ensure protection of human health and consumers' interests.

The Regulation provides for:

• a Community list of approved food enzymes;
• conditions of use of food enzymes in foods;
• rules on the labelling of food enzymes sold as such.

A food enzyme may be included in the Community list only if it meets the following conditions and, where relevant, other legitimate factors:

• it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed;
• there is a reasonable technological need, and
• its use does not mislead the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness and quality of the ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.

The Regulation applies to enzymes which are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food.

The Commission will consider whether a food enzyme should be included on the positive list on the basis of a scientific assessment by the European Food Safety Authority.

Parliament’s amendments at second reading mainly concerned the clarification of the interplay between the Regulation and Regulation (EC) No 1829/2003 on genetically modified food and feed.

A food enzyme which falls within the scope of Regulation (EC) No 1829/2003 on genetically modified food and feed should be authorised in accordance with that Regulation as well as under this Regulation.

The approval of food enzymes should also take into account societal, economic, traditional, ethical and environmental factors and the feasibility of controls.

It should be noted that the Regulation forms part of the package of proposals on 'food improvement agents'. This package of proposals refers to food flavourings, and food additives. It contributes to the Commission’s simplification programme and also provides for harmonisation not only in their respective fields but also promotes consistency between the three related areas. An additional fourth act within the package will establish a single common authorisation procedure for the evaluation and approval of these substances (COD/2006/0143.)

ENTRY INTO FORCE: 20/01/2009.

APPLICATION: the provision regarding the Community list of food enzymes will apply from the date of application of the Community list. Until that date, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes shall continue to apply in the Member States.

The Chapter on Labelling will apply from 20/01/2010.