Commission Directive 2010/38/EU of 18 June 2010 amending Council Directive 91/414/EEC to include sulfuryl fluoride as active substance (Text with EEA relevance )
Commission Directive 2010/38/EUof 18 June 2010amending Council Directive 91/414/EEC to include sulfuryl fluoride 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 29 July 2002 an application from Dow AgroScience for the inclusion of the active substance sulfuryl fluoride in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/ECOJ L 37, 10.2.2004, p. 34. 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 rapporteur Member State submitted a draft assessment report on 29 October 2004.(3)The assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) and presented to the Commission on 17 December 2009The EFSA Journal 2010; 8(1):1441. [66 pp.], Conclusion on the peer review of the pesticide risk assessment of the active substance sulfuryl fluoride (finalised: 17 December 2009).. The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for sulfuryl fluoride.(4)It has appeared from the various examinations made that plant protection products containing sulfuryl fluoride 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 sulfuryl fluoride 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 sulfuryl fluoride, to require that the notifier submit further information on milling processing conditions necessary to ensure that residues of fluoride ion in cereals do not exceed the natural background levels, on tropospheric concentrations of sulfuryl fluoride and on estimates of sulfuryl fluoride atmospheric lifetime.(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 6 months after inclusion to review existing provisional authorisations of plant protection products containing sulfuryl fluoride 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: