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Issue 18, 2006 (01 September)
 Industry News

EU to introduce new legislation on enzymes, food additives and flavourings


On 28 July 2006, the European Commission announced that it has adopted a package of legislative proposals that seeks to introduce harmonised EU legislation on food enzymes for the first time, and also clarify and update current rules for flavourings and additives. Another key feature of the proposals is the creation of a simplified common approvals procedure for food additives, flavourings and enzymes. Traders of different types of foodstuff from mainland China and Hong Kong targeting the EU market would be particularly concerned by these latest developments.

Enzymes: Under the current EU legislation - Directive 95/2/EC on food additives other than colours and sweeteners - only two enzymes are authorised as food additives: E1103 Invertase and E1105 Lysozyme. Under the legislation of the Member States, which is diverse, the remaining enzymes are not regulated at all or are regulated as "processing aids". The Commission has stated that it considers there to be a need for harmonised rules at Community level in order to promote fair trading and effective functioning of the internal market and ensure protection of human health and consumers' interests.

Under the proposed new legislation, harmonised EU rules would be laid down for the evaluation, approval and control of enzymes used in food. The draft Regulation foresees the establishment of a positive list of all food enzymes used in food for a technological purpose. Inclusion of an enzyme in this list will be considered by the Commission on the basis of a favourable scientific opinion from the European Food Safety Agency ("EFSA").

Traders of foodstuffs will be particularly concerned by the proposed labelling requirements. Enzymes used in food will be considered as ingredients similar to additives under Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs. In most cases, food enzymes are used as processing aids, i.e., are present in food in the form of a residue, if at all, and have no technological effect on the finished product. The Commission has therefore proposed that food enzymes which are used as processing aids are exempt from labelling. On the other hand, food enzymes with a technological function in the final food will have to be labelled as ingredients with their function (e.g. stabiliser) and name.

Additives: Authorisation and use of food additives in foodstuffs have been harmonised in the EU since 1995 and are laid down in Directive 89/107/EEC. However, the current procedure for the authorisation of food additives requires approval from both the Council and the European Parliament, pursuant to a proposal from the Commission, which can take some time to be furnished. Traders of foodstuffs will therefore be particularly interested to hear that the new legislation aims to simplify and streamline the food additives approval system, allowing the Commission to update and add to the EU positive list of food additives, following Member States' approval. All approvals will be based on a safety evaluation carried out by the EFSA. The new proposal also sets out a re-evaluation system for food additives currently on the EU market, based on risk assessments by the EFSA.

As regards the labelling of food additives, this is currently regulated by Directive 89/107/EC. The proposed legislation updates these rules. For example, food additives that are not intended for sale to the final consumer must be labelled with its name and/or its E-number or, in the absence of a name and/or E-number a description of the additive that is sufficiently precise to distinguish it from other products with which it may be confused. There are corresponding provisions for food additives that are intended for sale to the final consumer.

Flavourings: The general rules for flavourings, labelling requirements and maximum levels for substances present in flavourings which could pose health problems are currently laid down in Directive 88/388/EEC. The Commission has stated that new legislation is required in order to better reflect technological and scientific developments. The new rules lay down maximum levels for undesirable substances, in line with EFSA opinions. Further, the definitions of flavourings (e.g., flavouring substance, flavouring preparation, thermal process flavouring) have been clarified and stricter conditions are introduced for the use of the term "natural" when describing flavourings.

Common authorisation procedure: The final aspect of the draft legislation put forward by the Commission is the introduction of a single common procedure for the approval of food additives, flavourings and enzymes. This approval procedure includes a safety evaluation by the EFSA and is centred around the updating of a list of authorised substances that must be created and maintained by the Commission.