Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (Text with EEA relevance)

5.4.2008 EN Official Journal of the European Union L 94/13
COMMISSION DIRECTIVE 2008/44/EC
of 4 April 2008
amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
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) In accordance with Article 6(2) of Directive 91/414/EEC Belgium received on 19 April 2002 an application from Kumiai Chemicals Industry Co. Ltd for the inclusion of the active substance benthiavalicarb in Annex I to Directive 91/414/EEC. Commission Decision 2003/35/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 26 April 2001 an application from BASF AG for the inclusion of the active substance boscalid in Annex I to Directive 91/414/EEC. Commission Decision 2002/268/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(3) In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 26 March 1997 an application from Luxan B.V. for the inclusion of the active substance carvone in Annex I to Directive 91/414/EEC. Commission Decision 1999/610/EC (4) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(4) In accordance with Article 6(2) of Directive 91/414/EEC United Kingdom received on 25 March 2002 an application from Bayer AG for the inclusion of the active substance fluoxastrobin in Annex I to Directive 91/414/EEC. Decision 2003/35/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(5) In accordance with Article 6(2) of Directive 91/414/EEC Belgium received on 15 September 2002 an application from Prophyta for the inclusion of the active substance Paecilomyces lilacinus strain 251 (hereafter Paecilomyces lilacinus) in Annex I to Directive 91/414/EEC. Commission Decision 2003/305/EC (5) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(6) In accordance with Article 6(2) of Directive 91/414/EEC United Kingdom received on 25 March 2002 an application from Bayer CropScience for the inclusion of the active substance prothioconazole in Annex I to Directive 91/414/EEC. Decision 2003/35/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(7) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment report on 13 April 2004 (benthiavalicarb), 22 November 2002 (boscalid), 16 October 2000 (carvone), 2 September 2003 (fluoxastrobin), 3 November 2004 (Paecilomyces lilacinus) and 18 October 2004 (prothioconazole).
(8) The assessment reports were peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission in the format of the EFSA Scientific Reports on 15 June 2007 for fluoxastrobin (6) and Paecilomyces lilacinus
 (7) and on 12 July for benthiavalicarb (8) and prothioconazole (9). These reports and the draft assessment reports for boscalid and carvone were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the review was finalised on 22 January 2008 in the format of the Commission review reports for benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole.
(9) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) 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 benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.
(10) Without prejudice to the above conclusion, for fluoxastrobin and prothioconazole it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that fluoxastrobin should be subjected to further testing for confirmation of the risk assessment for surface water and for non-rat metabolites and that prothioconazole should be subjected to further testing for confirmation of the risk assessment as regards the triazole metabolite derivatives and the risk to granivorous birds and mammals and that such studies should be presented by the notifiers.
(11) 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 six months after inclusion to review existing provisional authorisations of plant protection products containing benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus or prothioconazole 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.
(12) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,