Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances Text with EEA relevance
Modified by
Commission Implementing Regulation (EU) No 380/2013of 25 April 2013amending Regulation (EU) No 1141/2010 as regards the submission of the supplementary complete dossier to the Authority, the other Member States and the Commission, 32013R0380, April 26, 2013
Commission Regulation (EU) No 1141/2010of 7 December 2010laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances(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(5) thereof,Whereas:(1)Directive 91/414/EEC provides that, on request, the inclusion of an active substance may be renewed.(2)The Commission has received letters from several producers requesting a renewal for active substances included in Annex I to Directive 91/414/EEC and for which the inclusion period is to expire in 2011 and 2012.(3)It is necessary to provide for a procedure for the submission and appraisal of applications for the renewal of the inclusion in Annex I to Directive 91/414/EEC of those active substances.(4)Periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.(5)Producers wishing to secure the renewal of active substances covered by this Regulation should be required to apply to the relevant rapporteur Member State.(6)Where two or more applications for the same active substance have been submitted separately and fulfil the requirements, the rapporteur Member States should communicate the updated contact details of each applicant to the other applicants to facilitate the submission of joint dossiers and to avoid, whenever possible, duplication of studies involving vertebrate animals.(7)In order to ensure the efficiency of renewal procedures, rapporteur Member States should organise, prior to the submission of the dossiers, a meeting to discuss the state of the art of the active substance and consider whether and, if necessary, how the dossiers submitted for the first inclusion are to be updated.(8)The dossiers submitted for renewal should include new data relevant to the active substance and new risk assessments to reflect any changes in data requirements and any changes in scientific or technical knowledge since the active substance was first included in Annex I to Directive 91/414/EEC, as reflected in guidance documents published by the Commission and in relevant opinions from the Scientific Committee on Plants or the European Food Safety Authority (hereinafter "the Authority"). The range of uses submitted should reflect the representative uses. The applicant should demonstrate, on the basis of the data submitted, that for one or more preparations the requirements of Article 5 of Directive 91/414/EEC will be fulfilled.(9)The applicants should list separately vertebrate studies to be submitted with the dossier and the rapporteur Member States should make such lists available on request to promote early discussions on the sharing of vertebrates data to avoid duplication of vertebrate studies.(10)Technical or scientific information about an active substance, in particular with regard to potentially dangerous effects, submitted within the relevant period by third parties should be taken into consideration in the evaluations. The applicants should be given the opportunity to comment on such information.(11)The renewal assessment reports prepared by the rapporteur Member States may, where necessary, be the subject of a consultation of experts organised by the Authority on request of the Commission before they are submitted to the Standing Committee on the Food Chain and Animal Health.(12)The rules on data protection of Article 13 of Directive 91/414/EEC are intended to provide an incentive to applicants to assemble the detailed studies required under Annexes II and III to that Directive. However, data protection should not be extended artificially by the production of new studies which are not needed to decide on the renewal of an active substance. To this end, applicants should be required to identify explicitly which studies are new compared to the original dossier used for the first inclusion of the substance in Annex I to Directive 91/414/EC and to provide justification for their submission.(13)In view of the particular situation, where parts of the renewal procedure still take place while Directive 91/414/EEC applies while the decisions on the renewals will be taken under 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., applicants are encouraged, as regards the format of the updating statement and the format and content of the dossier, to pay particular attention to the specific guidance documents published by the Commission.(14)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION: