Draft statement of the Council's reasons: Common Position for a Directive concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of be

February 13, 2003

Brussels, 12 Feb 2003

Full text of Document 14502/02

[...]

III. ANALYSIS OF THE COMMON POSITION

There is no difference of opinion between the Council, the European Parliament and the Commission regarding the essential elements of the proposed directive and in particular on the need for maintaining a prohibition on the use of oestradiol 17 and its ester-like derivatives for growth promotion purposes and to introduce a temporary precautionary prohibition on the use of other hormones while additional scientific information, necessary for a fuller assessment of the risk, is gathered.

In deciding such measures the Council has taken into account the latest scientific evidence and risk assessments, in particular the opinion of the SCVMPH of April 2002, together with other possible consequences, in particular environmental, of the large scale use of hormones in stockfarming. The recitals of the proposed directive have been modified accordingly.

Contrary to the Commission's proposal, but in accordance with amendments 4, 5, 6, 7, 9, 12, 13 et 14, which have been followed in substance even if using a different drafting, the Council considered preferable to let the Parliament and the Council take future risk management decisions concerning the updates of the directive's provisions in the light of the new evidence which the Commission is required to gather taking into account recent scientific data from all possible sources and present to them.

The Council, in agreement with the Commission and Parliament, has decided to maintain the use of certain of the substances, where this is strictly necessary, for therapeutic purposes or zootechnical treatment as this is not likely to constitute an unacceptable hazard for public health due to the nature and the limited duration of the treatments, the limited quantities administered and the strict conditions under which their administration can take place, laid down in Directive 96/22/EC in order to prevent any possible misuse. The Council has, however, considered appropriate, in the light of the existing information to limit as far as reasonably achievable the exposure to oestradiol 17 and only authorise those very few treatments (foetus maceration or mummification, pyometra in cattle and oestrus induction in cattle, horses, sheep or goats) for which no viable and effective alternatives seem presently to be available. Such treatments are not likely to present an unacceptable risk to public health, especially in the light of the new very stringent conditions required to be taken to avoid any possible abusive use. The Council has equally provided for a timely review of the provisions concerning treatments of farm animals with oestradiol 17 .

The Council incorporated amendments 8 and 10 which present useful clarifications but did not incorporate amendments 1, 2, 3, 10 et 11 the content of which is already largely reflected in the proposed directive which the Council, like the Commission, considered would have been made redundant by those additions.

For the sake of clarity the Council added some minor drafting improvements to directive 96/22/EC , in particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 1.

IV. CONCLUSIONS

The Council feels that the fact that it has to a very large extent taken account of the European Parliament's position ought to lead to an early adoption of the Directive.

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