Commission Implementing Regulation (EU) 2018/1264 of 20 September 2018 renewing the approval of the active substance pethoxamid 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) 2018/1264of 20 September 2018renewing the approval of the active substance pethoxamid 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 20(1) thereof,Whereas:(1)Commission Directive 2006/41/ECCommission Directive 2006/41/EC of 7 July 2006 amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances (OJ L 187, 8.7.2006, p. 24). included pethoxamid as an active substance in Annex I to Council Directive 91/414/EECCouncil Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1)..(2)Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of 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)..(3)The approval of the active substance pethoxamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.(4)An application for the renewal of the approval of pethoxamid was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26). within the time period provided for in that Article.(5)The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.(6)The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority ("the Authority") and the Commission on 31 August 2016.(7)The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.(8)On 30 August 2017 the Authority communicated to the Commission its conclusionEFSA Journal 2017;15(9):4981 [22 pp.] Available online: www.efsa.europa.eu. on whether pethoxamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for pethoxamid to the Standing Committee on Plants, Animals, Food and Feed on 6 October 2017.(9)The applicant was given the opportunity to submit comments on the draft renewal report.(10)It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pethoxamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.(11)It is therefore appropriate to renew the approval of pethoxamid.(12)The risk assessment for the renewal of the approval of pethoxamid is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing pethoxamid may be authorised. It is therefore appropriate to remove the restriction for use only as an herbicide.(13)In accordance with Article 14(1) 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.(14)Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.(15)Commission Implementing Regulation (EU) 2018/84Commission Implementing Regulation (EU) 2018/84 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ L 16, 20.1.2018, p. 8). extended the expiry date of pethoxamid to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 December 2018.(16)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: