11.5.2011 [ EN | Official Journal of the European Union L 12271 DIRECTIVES COMMISSION DIRECTIVE 2011/58/EU of 10 May 2011 amending Council Directive 91/414/EEC to renew the inclusion of carbendazim 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 market ('), and in particular Article 6(1) thereof, Whereas: 1 The inclusion of carbendazim in Annex I to Directive 91/414[EEC expires on 13 June 2011. On request the inclusion of an active substance may be renewed for a period not exceeding ten years. On 6 August 2007 the Commission received such a request from the applicant regarding the renewal of the inclusion for this substance. On 10 January 2008, the applicant submitted to the rapporteur Member State Germany data in support of its request for renewal of the inclusion of carbendazim. The rapporteur Member State prepared a draft re- assessment report which was commented by the applicant on 13 May 2009 and after its finalisation was submitted to the applicant and the Commission on 24 July 2009. In addition to the assessment of the substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment. The Commission communicated the draft re-assessment report to the European Food Safety Authority (here- inafter: ‘the Authority) and to the Member States on 28 July 2009 for comments. At the request of the Commission, the draft re- assessment report was peer reviewed by the Member States and the Authority and commented by the (") OJ L 230, 19.8.1991, p. 1. applicant on 14 December 2009. The Authority presented its conclusion on the peer review of the risk assessment of carbendazim () to the Commission on 30 April 2010. After the applicant had been given the possibility to comment and taking into account its comments delivered on 31 May 2010, the draft re- assessment report and the conclusion from the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 November 2010 in the format of the Commission review report for carbendazim. It has appeared from the various examinations made that plant protection products containing carbendazim may be expected to continue to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to renew the inclusion of carbendazim in Annex I to Directive 91/414/EEC, in order to ensure that plant protection products containing this active substance may continue to be authorised where they comply with that Directive. In addition to the uses supported for the first inclusion, the applicant supports in its renewal dossier the use on fodder beet. Taking into consideration the additional data submitted by the applicant, the use on fodder beet should be added to the list of uses that may be authorised. Article 5(4) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to restrictions. In order to correctly reflect the high level of protection of human and animal health and the environment sought in the Union, it is necessary to limit the uses of carbendazim to those that have actually been assessed and which are considered to comply with the conditions of Article 5(1) of Directive 91/414/EEC. This implies that uses which are not part of the list of uses set out in Annex I to that Directive may not be authorised unless they are first added to that list. It is appropriate to set maximum limits for the presence of two relevant impurities 2-amino-3-hydroxyphenazine (AHP) and 2,3-diaminophenazine (DAP) in commercially manufactured carbendazim. (%) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance carbendazim EFSA Journal 2010; 8(5):1598.