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Commission Directive 2004/99/EC

of 1 October 2004

amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances

(Text with EEA relevance)

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(1), and in particular Article 6(1) thereof,

Whereas:

(1) In accordance with Article 6(2) of Directive 91/414/EEC Greece received on 22 October 1999 an application from Nisso Chemical Europe GmbH for the inclusion of the active substance acetamiprid in Annex I to Directive 91/414/EEC. Commission Decision 2000/390/EC(2) 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.

(2) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 11 September 1998 from Bayer plc. (now Bayer CropScience AG) concerning thiacloprid. Commission Decision 2000/181/EC(3) 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.

(3) 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 19 March 2001 (acetamiprid) and 22 November 2000 (thiacloprid).

(4) 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 29 June 2004 in the format of the Commission review reports for acetamiprid and thiacloprid.

(5) The review of acetamiprid and thiacloprid did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants.

(6) 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 acetamiprid and thiacloprid in Annex I to that Directive, 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.

(7) After the inclusion of acetamiprid and thiacloprid in Annex I to Directive 91/414/EEC, Member States should be allowed a reasonable period to implement the provisions of that Directive as regards plant protection products containing those substances and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.

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

(9) 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:

(1)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 104).