OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendment to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approximation of the laws of the Member States relating to food supplements AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

2000/0080 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendment to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approximation of the laws of the Member States relating to food supplements

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendment proposed by the European Parliament at second reading. The Commission sets out its opinion below on the one amendment proposed by Parliament.

2. Background

Harmonisation became necessary due to the great diversity of national rules. The proposal was announced in the White Paper on Food Safety (Action N° 60). The course of the proposal was as follows :

- Adoption of the proposal by the Commission : 08 May 2000 [1]

[1] COM(2000)222 2000/0080 (COD) of 08.05.2000, OJ C/2000/311 of 31.10.2000, p.207

- Opinion of the Economic and Social Committee : 19 October 2000 [2]

[2] OJ C/2000/14 of 16.01.2001, p. 42

- Opinion of the European Parliament at first reading : 14 February 2001 [3]

[3] A5-0025/2001 of 14.02.2001, OJ C/2001/276 of 01.10.2001, p.126

- Date of political agreement in Council : 27 September 2001

- Date of transmission of the amended proposal : 19 March 2001 [4]

[4] 0J C/2001/180/E of 26.06.2001, p. 248

- Date of adoption of the common position : 03 December 2001 [5]

[5] OJ C

- Communication from the Commission concerning the common position : 07 December 2001 [6]

[6] SEC(2001)1975 final of 07.12.2001

- Adoption by Parliament of the Recommandation for a second reading : 13 March 2002

3. Purpose of the 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 proposal laid down the definitions and specific labelling requirements for food supplements as well as the possibility for Member States to require the notification of the marketing of these products in order to facilitate their monitoring. As a first stage it laid down more specific provisions for vitamins and minerals as ingredients of those products such as a positive list of vitamins and minerals and their specific forms to be used in their manufacture and the criteria for setting maximum levels for these nutrients. It foresaw the adoption of provisions for other ingredients at a later stage.

Common position

The Common Position built on the amended proposal of the Commission that included many amendments proposed by the European Parliament in first reading. It is in line with the objectives of the proposal and 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.

The Common Position introduced a provision to give effect to an amendment of the European Parliament that was not acceptable in its original form. 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, following a derogation to be granted by Member States, until their evaluation by the Scientific Committee for Food and eventual insertion in the Annexes.

The Common Position also 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 ingredients of food supplements, accompanied by any proposals for appropriate legal measures and provides a carefully balanced compromise on the issue of the criteria to be used for setting maximum levels for vitamins and minerals in food supplements.

The Commission supported the Common Position.

4. Opinion of the Commission on the amendment by the European Parliament

4.1. Amendment accepted by the Commission

* The European Parliament adopted one amendment in second reading. That amendment proposes to increase the maximum time period allowed for the submission to the Commission of dossiers for scientific evaluation, in the context of Article 4.6.b, from 18 to 36 months. It has been argued that this would facilitate the task of preparing these dossiers by the companies concerned, in particular small and medium enterprises.

* The Commission can accept the amendment.

5. Conclusion

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out above.