Introductory text

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market^f1, and in particular Article 6(1) thereof,

Whereas:

In accordance with Article 6(2) of Directive 91/414/EEC, the Netherlands received on 3 July 2001 an application from Crompton Europe Ltd. for the inclusion of the active substance bifenazate in Annex I to Directive 91/414/EEC. Commission Decision 2002/268/EC^f2 confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 March 2000 from Sankyo Company Ltd. for the inclusion of the active substance milbemectin in Annex I to Directive 91/414/EEC. Commission Decision 2000/540/EC^f3 confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 3 April 2003 (bifenazate) and 16 June 2001 (milbemectin).

The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 June 2005 in the format of the Commission review reports for bifenazate and milbemectin.

The review of bifenazate and milbemectin did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.

It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include bifenazate and milbemectin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing bifenazate or milbemectin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

The inclusion of bifenazate in Annex I is based on a dossier covering the use of this active substance on ornamental plants in greenhouses. Other uses are currently not adequately supported by data from the notifier and not all of the risks from such uses have shown to be adequately addressed under the criteria required by Annex VI. If Member States are to grant authorisations for other uses, they should therefore require the data and information necessary to prove that the uses are compatible with the criteria in Directive 91/414/EEC, in particular concerning the effect on human consumers and the environment.

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE: