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Commission Directive 2006/5/EC of 17 January 2006 amending Council Directive 91/414/EEC to include warfarin as active substance (Text with EEA relevance)
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Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall adopt and publish by 31 March 2007, at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 April 2007.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
1.Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing warfarin as an active substance by 31 March 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive, relating to warfarin, 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.
2.By derogation from paragraph 1, for each authorised plant protection product containing warfarin 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 30 September 2006 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 warfarin. 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 warfarin as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2010 at the latest; or
(b)in the case of a product containing warfarin as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2010 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.
This Directive shall enter into force on 1 October 2006.
This Directive is addressed to the Member States.
Done at Brussels, 17 January 2006.
For the Commission
Markos Kyprianou
Member of the Commission
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