Commission Directive 2010/15/EU of 8 March 2010 amending Council Directive 91/414/EEC to include fluopicolide as active substance (Text with EEA relevance)
Commission Directive 2010/15/EUof 8 March 2010amending Council Directive 91/414/EEC to include fluopicolide as active substance(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the marketOJ L 230, 19.8.1991, p. 1., and in particular Article 6(1) thereof,Whereas:(1)In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/ECOJ L 293, 9.11.2005, p. 26. 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)For that active substance, 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 applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.(3)The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009EFSA Scientific Report (2009) 299, 1-158, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fluopicolide (finalised: 4 June 2009).. This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.(4)It has appeared from the various examinations made that plant protection products containing fluopicolide 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 fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.(5)Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.(6)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 fluopicolide 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.(7)It is therefore appropriate to amend Directive 91/414/EEC accordingly.(8)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: