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 Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta-agonists

2000/0132 (COD)

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 Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta-agonists

1. BACKGROUND

Date of transmission of the proposal to the EP and the Council 2000/0132(COD) // 03.07.2000

Date of the opinion of the European Economic and Social Committee: // 19.10.2000

Date of the opinion of the European Parliament, first reading: // 01.02.2001

Date of transmission of the a modified proposal (2001/C 180 E/15) COM(2001) 131 final // 06.03.2001

Date of adoption of the common position: // 20.02.2003

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The main aims of the proposed amendment of the Directive are to protect consumer health and to reach compliance with World Trade Organisation (WTO) requirements by basing the proposal on sound scientific evaluation. In consequence the Commission proposal prohibits the use of oestradiol-17-beta and provisionally allows to continue to apply the prohibition on five further hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) based on the conclusion of the Scientific Committee on Veterinary Measures relating to Public Health.

3. COMMENTS ON THE COMMON POSITION

The Common Position is based on a modified Commission proposal that already includes several amendments proposed by the European Parliament into account. As adopted by the Council by qualified majority, it does not alter the basic objectives of the proposed Directive: to protect consumer health and reach WTO compliance.

After its first reading the European Parliament had agreed to the proposed complete prohibition of the use of oestradiol-17-ß. The Common Position does not propose an immediate complete prohibition of the use oestradiol-17-ß. Nevertheless, it still drastically reduces the circumstances in which this hormonal substance can be administered to farm animals. Only three indications remain on a transitional basis under strict veterinary control to ensure that these conditions are respected.

In detail Council has introduced the following major changes:

Further provisional use of oestradiol-17-ß

Recitals 6 and 8 have been modified to justify the further provisional use of oestradiol-17-ß for purposes other than growth promotion. To this end relevant paragraphs of the reports of the Committee for Veterinary Medicinal Products (CVMP) and the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) have been cited.

Articles 3 and 8 have been modified to cater for the introduction of Article 5a, which lists the conditions under which oestradiol-17- ß may be used in the future. The introduction of this article was central for the establishment of the Common Position, as the majority of Member States could not agree to the immediate and complete prohibition of the use of the substance in food producing animals. The use is now limited to three distinct uses (the treatment of foetus maceration or mummification in cattle, pyometra in cattle and oestrus induction in cattle, horses, sheep or goats) under explicit conditions (distinctively registered treatment effected directly by veterinarian to clearly identified animals).

The new version of Article 11a ensures that measures are taken in order to guarantee that even the strictly limited use of oestradiol-17-ß is kept under review and therefore is to be considered temporary. This idea is supported by the attached declaration of the Council and the Commission emphasising that the aim pursued in Article 11a is to ban in five years' time the use of oestradiol 17â and its ester-like derivatives for treating farm animals and replace it with equally effective substances.

Amendments due to changes in Community legislation

Recitals 10 and Articles 4, 5 and 6 have been amended due to respective changes in Community legislation (Directive 2001/82/EC and Regulation 2002/178/EC) adopted while the present proposal was on the agenda of Council.

Procedural issues

The modification of Article 11a and the deletion of Article 11b remove the Comitology procedure established in Articles 5 and 7 of Decision 1999/468/EC from the proposal. The Commission proposed the 'Standing Committee Procedure' to allow the modification of the Annexes to the Directive at short-term. Council and Parliament, however, opposed the introduction of this procedure and preferred the amendment of the Annexes of the Directive under the Co-Decision Procedure (Article 251 of the Treaty).

4. CONCLUSION

The Commission supports the Common Position adopted by the Council as the best compromise that could be reached and has made a relevant declaration during the Council of Agriculture of 16 December 2002.

5. DECLARATION

At the Council of Agriculture of 16 December 2002 the Commission agreed to the attached declaration.

ANNEX

DECLARATION

Re Article 11a

"The Council and the Commission emphasise that the aim pursued in Article 11a is to ban in five years' time the use of oestradiol 17â and its ester-like derivatives for treating farm animals and replace it with equally effective substances."