Commission Implementing Regulation (EU) 2015/2085 of 18 November 2015 approving the active substance mandestrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2015/2085of 18 November 2015approving the active substance mandestrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EECOJ L 309, 24.11.2009, p. 1., and in particular Article 13(2) thereof,Whereas:(1)In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Austria received on 18 December 2012 an application from Sumitomo Chemical Agro EUROPE S.A.S. for the approval of the active substance mandestrobin.(2)In accordance with Article 9(3) of that Regulation, Austria, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter "the Authority") of the admissibility of the application on 31 January 2013.(3)On 31 January 2014 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.(4)The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in March 2015.(5)On 27 April 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance mandestrobin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009EFSA Journal 2014;12(12):3913. Available online: www.efsa.europa.eu.. The Authority made its conclusion available to the public.(6)On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for mandestrobin and a draft Regulation providing that mandestrobin is approved.(7)The applicant was given the possibility to submit comments on the review report.(8)It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve mandestrobin.(9)In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.(10)In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). should be amended accordingly.(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION:
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