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Published by: eurolex on Nov 29, 2010
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COMMISSION DIRECTIVE 2009/154/ECof 30 November 2009amending Council Directive 91/414/EEC to include cyflufenamid as active substance
 (Text with EEA relevance)
 Having regard to the Treaty establishing the EuropeanCommunity,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products onthe market (
 ), and in particular Article 6(1) thereof,Whereas:
In accordance with Article 6(2) of Directive 91/414/EECthe United Kingdom received on 17 March 2003 anapplication from Nisso Chemical Europe GmbH for theinclusion of the active substance cyflufenamid in Annex Ito Directive 91/414/EEC. Commission Decision2003/636/EC (
 ) confirmed that the dossier wascomplete in the sense that it could be considered assatisfying, in principle, the data and informationrequirements of Annexes II and III to Directive91/414/EEC.
For that active substance, the effects on human healthand the environment have been assessed, in accordancewith the provisions of Article 6(2) and (4) of Directive91/414/EEC, for the uses proposed by the applicant. Thedesignated rapporteur Member State submitted a draftassessment report on 30 January 2006.
The assessment report was peer reviewed by the MemberStates and the EFSA and presented to the Commission inthe format of the EFSA Scientific Report for cyflufenamidon 8 April 2009 (
 ). This report was reviewed by theMember States and the Commission within theStanding Committee on the Food Chain and AnimalHealth and finalised on 2 October 2009 in the formatof the Commission review report for cyflufenamid.
It has appeared from the various examinations made thatplant protection products containing cyflufenamid may be expected to satisfy, in general, the requirements laiddown in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to theuses which were examined and detailed in theCommission review report. It is therefore appropriateto include cyflufenamid in Annex I to that Directive, inorder to ensure that in all Member States the authori
sations of plant protection products containing thisactive substance may be granted in accordance with theprovisions of that Directive.
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 six months after inclusion toreview existing provisional authorisations of plantprotection products containing cyflufenamid to ensurethat the requirements laid down by Directive91/414/EEC, in particular in its Article 13 and therelevant conditions set out in Annex I, are satisfied.Member States should transform existing provisionalauthorisations into full authorisations, amend them orwithdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the abovedeadline, a longer period should be provided for thesubmission and assessment of the complete Annex IIIdossier of each plant protection product for eachintended use in accordance with the uniform principleslaid down in Directive 91/414/EEC.
It is therefore appropriate to amend Directive91/414/EEC accordingly.
The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
 Article 1
 Annex I to Directive 91/414/EEC is amended as set out in theAnnex to this Directive.
 Article 2
 Member States shall adopt and publish by 30 September 2010at 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.They shall apply those provisions from 1 October 2010.When Member States adopt those provisions, they shall containa reference to this Directive or shall be accompanied by such areference on the occasion of their official publication. MemberStates shall determine how such reference is to be made.
 1.12.2009 Official Journal of the European Union L 314/69
 ) OJ L 230, 19.8.1991, p. 1.(
 ) OJ L 221, 4.9.2003, p. 42.(
 ) Conclusion on pesticide peer review regarding the risk assessment of the active substance cyflufenamid. EFSA Scientific Report (2009)258, pp. 1-99.
Article 3
 1. Member States shall in accordance with Directive91/414/EEC, where necessary, amend or withdraw existingauthorisations for plant protection products containingcyflufenamid as active substance by 30 September 2010. By that date, they shall in particular verify that the conditions inAnnex I to that Directive relating to cyflufenamid are met, withthe exception of those identified in part B of the entry concerning the active substance, and that the holder of theauthorisation has, or has access to, a dossier satisfying therequirements of Annex II to that Directive in accordance withthe conditions of Article 13(2) of that Directive.2. By way of derogation from paragraph 1, for each au-thorised plant protection product containing cyflufenamid 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 March 2010 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 entry in Annex I to that Directive concerning cyflufenamid. On thebasis of that evaluation, they shall determine whether theproduct satisfies the conditions set out in Article 4(1)(b), (c),(d) and (e) of Directive 91/414/EEC.Following that determination Member States shall:(a) in the case of a product containing cyflufenamid as the only active substance, where necessary, amend or withdraw theauthorisation by 30 September 2011 at the latest; or(b) in the case of a product containing cyflufenamid as one of several active substances, where necessary, amend orwithdraw the authorisation by 30 September 2011 or by the date 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.
 Article 4
 This Directive shall enter into force on 1 April 2010.
 Article 5
 This Directive is addressed to the Member States.Done at Brussels, 30 November 2009.
 For the Commission
 Androulla VASSILIOU
 Member of the Commission
 L 314/70 Official Journal of the European Union 1.12.2009

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