Commission Directive 2001/49/EC
of 28 June 2001
amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include DPX KE 459 (flupyrsulfuron-methyl) as an active substance
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), as last amended by Commission Directive 2001/236/EC(2), and in particular Article 6(1) thereof,
Whereas:
(1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") on 26 October 1995 France received an application from Du Pont de Nemours SAS, ("the applicant") for the inclusion of the active substance DPX KE 459 (flupyrsulfuron-methyl) in Annex I to the Directive.
(2) In accordance with the provisions of Article 6(3) of the Directive Commission Decision 97/164/EC(3) concluded that the dossier submitted for flupyrsulfuron-methyl could be considered as satisfying, in principle, the data and information requirements of Annex II, and for a plant protection product containing this active substance, of Annex III to the Directive.
(3) The effects of flupyrsulfuron-methyl on human and animal health and the environment have been assessed by France, acting as nominated rapporteur Member State, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant France submitted its draft assessment report concerning the substance to the Commission on 2 December 1997.
(4) The dossier and the information from the review of flupyrsulfuron-methyl were also submitted to the Scientific Committee on Plants for opinion on 15 July 1999. This Committee gave its opinion on 20 November 2000(4).
(5) In the light of these examinations, it appears that plant protection products containing flupyrsulfuron-methyl may be expected to satisfy, in general, the requirements laid down in Article 5(1) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include it in Annex I to the Directive, in order to ensure that in all Member States plant protection products containing it can be authorised in accordance with the Directive.
(6) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of this Directive and in particular to review, provisional authorisations granted for plant protection products containing flupyrsulfuron-methyl, which should be replaced by authorisations granted under Article 4 of Directive 91/414/EEC. A longer period may also be required for plant protection products containing flupyrsulfuron-methyl and other active substances included in Annex I.
(7) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive which refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested party.
(8) Should this review report be updated to take account of technical and scientific developments, the conditions for the inclusion of flupyrsulfuron-methyl in Annex I to the Directive may also need to be amended in accordance with the procedure specified in the Directive.
(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on 27 April 2001,
The table in Annex I to Directive 91/414/EEC shall be amended to include the entry in respect of DPX KE 459 (flupyrsulfuron-methyl) set out in the Annex hereto.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 December 2001. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
However, with regard to the review of provisional authorisations granted in the light of the review report and for the application of the Uniform Principles provided in Annex VI to Directive 91/414/EEC, the provisional authorisations shall be withdrawn and where appropriate, replaced by a full authorisation by 30 November 2002. However for plant protection products containing DPX KE 459 (flupyrsulfuron-methyl) together with another active substance not yet in Annex I, the period referred to above is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the other substance in the Annex.
Member States shall keep available the review report for DPX KE 459 flupyrsulfuronmethyl (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.
This Directive shall enter into force on 1 July 2001.
This Directive is addressed to the Member States.