Food enzymes

European legislation will regulate all enzymes intended for use in food. With certain exceptions, these have so far only been regulated at national level. The objective is to lay down the conditions governing the use of food enzymes, to create a list of authorised enzymes and to define the rules governing enzyme labelling.

PROPOSAL

Proposal for a Regulation of the European Parliament and of the Council of 28 July 2006 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC and Council Directive 2001/112/EC.

SUMMARY

A food enzyme is a product obtained by extraction from plants or animals or by a fermentation process using micro-organisms and which is added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of foods, including enzymes used as processing aids *.

The proposed Regulation calls for the creation of a list harmonising at European level all food enzymes, including those at present authorised as food additives, namely invertase (E 1103) and lysozyme (E 1105); see under "Context" below. At present, only a few Member States have any regulations on enzymes.

Harmonising food enzymes in a positive list will benefit consumers, since it will establish uniform rules for the evaluation and authorisation of these products.

The future list of enzymes must include:

• the name of the enzyme;
• the enzyme's specifications (including its origin, purity criteria, etc.);
• the foods to which it may be added;
• the conditions under which it may be used;
• any restrictions on its sale;
• specific requirements in respect of labelling.

Labelling

Food enzymes will not be mentioned on food labels, with the exception of those enzymes that have a technological function (additive, stabiliser, etc.) in the final product.

At present, only two enzymes which have a technological function in the final product are labelled, namely lysozyme and invertase, which are used as additives. The labelling must include the general information requirements for food plus, in accordance with the proposed Regulation, the function of the food enzyme (e.g. preservative) followed by its specific name (e.g. lysozyme).

According to the Commission, the number of labelled enzymes will be limited, since most of them are used as processing aids in food manufacture.

In addition, the information must be written in a language easily understandable to purchasers.

For more information, see the sheet on the use of languages for informing consumers.

GMO enzymes

All enzymes are covered by the Regulation, including those which are genetically modified organisms (GMO). Enzymes already covered by the Regulation on genetically modified food and feed must be authorised under that Regulation before they can be authorised under the new Regulation.

Applications for authorisation

The Commission has proposed a Regulation establishing a common authorisation procedure for food additives, food enzymes and food flavourings [COM(2006) 423]. This forms part of a package of legislative measures launched on 28 July 2006 (see under "Context" below).

This harmonisation will entail simplifying the existing legislation. In particular, it will enable manufacturers of enzymes to lodge an application for authorisation directly. In addition, the time lag between the lodging of the application and the granting of the authorisation will be substantially reduced.

The European Food Safety Authority (EFSA) will evaluate the enzymes for their safety.

Community list of enzymes

The proposed Regulation provides for the establishment of a list of authorised enzymes. It will include all enzymes, including those authorised by other Regulations.

Transition period

The Commission will have a period of two years to establish, via an implementing Regulation, the implementing measures for this proposed Regulation, concerning in particular: the content, drafting and presentation of the application; the arrangements for checking the validity of the application; and the type of information that must be included in the Authority's opinion. The proposal therefore establishes a transitional period of two years after the entry into force of the implementing Regulation for the industry to submit all the enzyme authorisation applications.

Background

The new legislation on enzymes has three objectives: to ensure protection of human health, to protect consumers' interests and to eliminate barriers to the single market.

It ties in with the reform launched by the European Commission to simplify the existing legislation on food additives, food flavourings and food enzymes with three proposals launched on 18 July 2006 :

• food enzymes [COM(2006) 425 final];
• additives [COM(2006) 428 final];
• the common authorisation procedure for food additives, food enzymes and food flavourings [COM(2006) 423 final.

The existing European regulations concerning enzymes are based on four legislative acts:

• Directive 89/107/EEC, which regulates additives such as invertase and lysozyme ;
• Directive 2001/112/EC, which regulates fruit juices and similar products, but also the enzymes used in these drinks;
• Directive 83/417/EEC, which regulates caseins and caseinates;
• Regulation (EC) No 1493/1999 on the common organisation of the market in wine. It defines the conditions under which lysozyme, urease and betaglucanase may be used in the production of wine.

With the exception of the examples mentioned above, enzymes have so far only been regulated at national level. The Commission considers that the regulation of enzymes at national level only may give rise to problems of free movement within the single market and may engender a lack of clarity for consumers. The idea of creating a harmonised list of enzymes was one of the driving forces behind the new Regulation.

The future legislation concerning enzymes, additives and the new authorisation procedure also meets the wishes of the BEUC (the European Consumers' Organisation), which had requested a European list of all authorised enzymes in light of the increasing use being made of enzymes by the food industry. The BEUC also recommended that consumers be informed about the use of enzymes.

Last updated: 09.02.2007