42 - EUR-Lex - Europa

EN12.4.2011 Official Journal of the European Union L 97/43(8) A reasonable period should be allowed to elapse beforean active substance is included in Annex I in order topermit Member States and the interested parties toprepare themselves to meet the new requirementswhich will result from the inclusion.(9) Without prejudice to the obligations defined by Directive91/414/EEC as a consequence of including an activesubstance in Annex I, Member States should beallowed a period of 6 months after inclusion to reviewexisting authorisations of plant protection productscontaining flutriafol to ensure that the requirementslaid down by Directive 91/414/EEC, in particular in itsArticle 13 and the relevant conditions set out in Annex I,are satisfied. Member States should vary, replace orwithdraw, as appropriate, existing authorisations, inaccordance with the provisions of Directive 91/414/EEC.By derogation from the above deadline, a longer periodshould be provided for the submission and assessment ofthe complete Annex III dossier of each plant protectionproduct for each intended use in accordance with theuniform principles laid down in Directive 91/414/EEC.HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in theAnnex to this Directive.Article 2The line concerning flutriafol in the Annex to Decision2008/934/EC is deleted.Article 3Member States shall adopt and publish by 30 November 2011at the latest the laws, regulations and administrative provisionsnecessary to comply with this Directive. They shall forthwithcommunicate to the Commission the text of those provisionsand a correlation table between those provisions and thisDirective.(10) The experience gained from previous inclusions in AnnexI to Directive 91/414/EEC of active substances assessedin the framework of Commission Regulation (EEC) No3600/92 of 11 December 1992 laying down the detailedrules for the implementation of the first stage of theprogramme of work referred to in Article 8(2) ofCouncil Directive 91/414/EEC concerning the placingof plant protection products on the market ( 1 ) hasshown that difficulties can arise in interpreting theduties of holders of existing authorisations in relationto access to data. In order to avoid further difficultiesit therefore appears necessary to clarify the duties ofthe Member States, especially the duty to verify thatthe holder of an authorisation demonstrates access to adossier satisfying the requirements of Annex II to thatDirective. However, this clarification does not impose anynew obligations on Member States or holders of authorisationscompared to the directives which havebeen adopted until now amending Annex I.(11) It is therefore appropriate to amend Directive91/414/EEC accordingly.(12) Decision 2008/934/EC provides for the non-inclusion offlutriafol and the withdrawal of authorisations for plantprotection products containing that substance by31 December 2011. It is necessary to delete the lineconcerning flutriafol in the Annex to that Decision.(13) It is therefore appropriate to amend Decision2008/934/EC accordingly.(14) The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,( 1 ) OJ L 366, 15.12.1992, p. 10.They shall apply those provisions from 1 December 2011.When Member States adopt those provisions, they shall containa reference to this Directive or be accompanied by such areference on the occasion of their official publication. MemberStates shall determine how such reference is to be made.Article 41. Member States shall in accordance with Directive91/414/EEC, where necessary, amend or withdraw existingauthorisations for plant protection products containing flutriafolas an active substance by 30 November 2011.By that date they shall in particular verify that the conditions inAnnex I to that Directive relating to flutriafol are met, with theexception of those identified in Part B of the entry concerningthat active substance, and that the holder of the authorisationhas, or has access to, a dossier satisfying the requirements ofAnnex II to that Directive in accordance with the conditions ofArticle 13 of that Directive.2. By way of derogation from paragraph 1, for each authorisedplant protection product containing flutriafol aseither the only active substance or as one of several activesubstances all of which were listed in Annex I to Directive91/414/EEC by 31 May 2011 at the latest, Member Statesshall re-evaluate the product in accordance with the uniformprinciples provided for in Annex VI to Directive 91/414/EEC,on the basis of a dossier satisfying the requirements of AnnexIII to that Directive and taking into account Part B of the entryin Annex I to that Directive concerning flutriafol. On the basisof that evaluation, they shall determine whether the productsatisfies the conditions set out in Article 4(1)(b), (c), (d) and(e) of Directive 91/414/EEC.

ENL 97/44 Official Journal of the European Union 12.4.2011Following that determination Member States shall:(a) in the case of a product containing flutriafol as the onlyactive substance, where necessary, amend or withdraw theauthorisation by 31 May 2015 at the latest; orArticle 5This Directive shall enter into force on 1 June 2011.Article 6This Directive is addressed to the Member States.(b) in the case of a product containing flutriafol as one ofseveral active substances, where necessary, amend orwithdraw the authorisation by 31 May 2015 or by thedate fixed for such an amendment or withdrawal in therespective Directive or Directives which added the relevantsubstance or substances to Annex I to Directive91/414/EEC, whichever is the latest.Done at Brussels, 11 April 2011.For the CommissionThe PresidentJosé Manuel BARROSO