Commission Directive 2010/28/EU of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as active substance (Text with EEA relevance)

24.4.2010 EN Official Journal of the European Union L 104/57
COMMISSION DIRECTIVE 2010/28/EU
of 23 April 2010
amending Council Directive 91/414/EEC to include metalaxyl as active substance
(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 market (1), and in particular Article 6(1) thereof,
Whereas:
(1) Metalaxyl is one of the substances listed in Annex I to Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2).
(2) As a consequence of the judgment of the Court of Justice of 18 July 2007 in Case C-326/05 P Industrias Químicas del Vallés v Commission
 (3), which annulled Commission Decision 2003/308/EC (4) concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC, the Commission adopted Regulation (EC) No 1313/2007 of 8 November 2007 amending Regulations (EC) No 2076/2002 as regards the extension of the time period referred to in Article 8(2) of Council Directive 91/414/EEC with respect to metalaxyl and (EC) No 2024/2006 as regards the deletion of the derogation concerning metalaxyl (5) and Regulation (EC) No 416/2008 of 8 May 2008 amending Regulation (EEC) No 3600/92 as regards the assessment of the active substance metalaxyl in the framework of Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (6).
(3) Article 266 TFEU requires the institution whose act has been declared void to take the necessary measures to comply with the judgment of the Court of Justice. It is therefore necessary to assess metalaxyl once more taking into account the additional information submitted.
(4) An additional assessment report has been submitted by the rapporteur Member State Portugal, which has been peer reviewed by the Member States and the Commission and finalised within the Standing Committee on the Food Chain and Animal Health on 12 March 2010 in the format of the Commission review report for metalaxyl.
(5) The review of metalaxyl did not reveal any open questions to be addressed by the European Food Safety Authority which has taken over the role of the Scientific Committee on Plants.
(6) It has appeared from the various examinations made that plant protection products containing metalaxyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include metalaxyl in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing metalaxyl can be granted in accordance with the provisions of that Directive.
(7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
(8) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing metalaxyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(9) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.
(10) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,