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Commission Implementing Directive 2011/48/EUDangos y teitl llawn
Commission Implementing Directive 2011/48/EU of 15 April 2011 amending Council Directive 91/414/EEC to include bromadiolone as active substance and amending Commission Decision 2008/941/EC (Text with EEA relevance)
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Article 4
1.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing bromadiolone as an active substance by 30 November 2011.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to bromadiolone are met, with the exception of those identified in Part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
2.By way of derogation from paragraph 1, for each authorised plant protection product containing bromadiolone as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account Part B of the entry in Annex I to that Directive concerning bromadiolone. On the basis of that evaluation, they shall determine whether the product 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 bromadiolone as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
(b)in the case of a product containing bromadiolone as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
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