COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a proposal for a European Parliament and Council Directive on the approximation of the laws of the Member States relating to food supplements

1- BACKGROUND

Date of transmission of the proposal to the EP and the Council (document COM(2000)222 final - 2000/0080COD): // 10 May 2000.

Date of the opinion of the Economic and Social Committee: // 19 October 2000.

Date of the opinion of the European Parliament, first reading: // 14 February 2001.

Date of transmission of the amended proposal: // 19 March 2001.

Date of adoption of the common position: // 3 December 2001.

2- OBJECTIVE OF THE COMMISSION PROPOSAL

The proposal aims to ensure both a high level of public health protection and the free circulation of products concerned by ensuring that food supplements are safe and bear adequate and appropriate labelling.

The most important points of the present proposal are :

* Defines food supplements as concentrated sources of nutrients and other ingredients with a nutritional or physiological effect and, as a first stage, lays down specific provisions for vitamins and minerals. Specific rules to cover other ingredients may be laid down when scientific knowledge allows.

* Sets a positive list of vitamins and minerals and their specific forms to be used in their manufacture.

* Lays down scientifically based risk analysis (safety) as the basic principle for establishing maximum amounts of vitamins and minerals in the products, through the Regulatory Committee procedure, taking into account also intakes from normal foods and fortified foods. The reference intakes for the population should also be taken into account in the case of some vitamins and minerals that have upper safe levels close (1-5 times) to these reference intakes.

* Provides for appropriate specific labelling rules.

* Enables Member States to require the notification of the marketing of these products in order to facilitate their monitoring.

3- COMMENTS ON THE COMMON POSITION

3.1. The Common Position is a carefully balanced compromise, in particular on the issue of the criteria to be used for setting maximum levels for vitamins and minerals in these products. It is in line with the basic principles of food law, namely that food should be safe and properly labelled so that consumers can make an informed choice from a wide range of safe products.

3.2. The Commission included in the modified proposal those amendments adopted in first reading by the European Parliament that were acceptable. Those amendments remain in the Common Position in a way that should be satisfactory to the EP.

There are three important differences between the modified proposal and the Common Position :

(1) In the Common Position, the issue of setting maximum limits for vitamins and minerals in food supplements is resolved by providing that scientific risk assessment and intakes from other sources will be primary factors to be taken into account for the safety of these products, and that in the overall exercise the reference intakes for the population will be given due consideration (Article 5). While this differs from the Commission proposal, supported by the Parliament, that the reference intakes be taken into account only in the case of some nutrients, the Commission can accept the Common Position because it strengthens the process of establishing safe maximum levels for vitamins and minerals in food supplements.

(2) Article 4.8 of the Common Position requires the Commission to submit to the European Parliament and the Council, within five years from the entry into force of the Directive, a report on the advisability of establishing specific rules on other nutrients or substances with a nutritional or physiological effect, accompanied by any proposals for appropriate legal measures. The Commission can accept the request to submit a report on the subject within a specified time limit while maintaining the right of initiative to propose appropriate measures.

(3) Article 4.6 of the Common Position is new. It foresees a transitional period during which vitamins and minerals and certain of their forms that are not listed in the Annexes but are currently in food supplements marketed in some Member States, may continue to be used until their evaluation by the Scientific Committee for Food and eventual insertion in the Annexes. It was introduced to give effect to an amendment of the European Parliament that was not acceptable in its original form. The Commission supports this new position.

4- CONCLUSION

For the above reasons the Commission supports the Common Position adopted by the Council on 3.12.2001.