Commission Directive 2007/6/EC
of 14 February 2007
amending Council Directive 91/414/EEC to include metrafenone, Bacillus subtilis, spinosad and thiamethoxam 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 United Kingdom received on 4 June 2002 an application from BASF AG, Belgium for the inclusion of the active substance metrafenone in Annex I to Directive 91/414/EEC. Commission Decision 2003/105/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 19 April 2000 an application from AgraQuest for the inclusion of the active substance Bacillus subtilis strain QST 713 (hereafter Bacillus subtilis) in Annex I to Directive 91/414/EEC. Commission Decision 2001/6/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 19 July 1999 an application from Dow AgroSciences for the inclusion of the active substance spinosad in Annex I to Directive 91/414/EEC. Commission Decision 2000/210/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 Spain received on 17 March 1999 an application from Novartis Crop Protection AG (now Syngenta) for the inclusion of the active substance thiamethoxam in Annex I to Directive 91/414/EEC. Commission Decision 2000/181/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.
(5) 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 reports concerning the substances to the European Food Safety Authority (EFSA) on 31 October 2003 (metrafenone) and to the Commission on 15 May 2001 (Bacillus subtilis), 5 March 2001 (spinosad) and 21 January 2002 (thiamethoxam) respectively.
(6) For metrafone the assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 18 January 2005 in the format of the EFSA Scientific Report for metrafenone(6). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. For Bacillus subtilis, spinosad and thiamethoxam the draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 14 July 2006 in the format of the Commission review reports for metrafenone, Bacillus subtilis, spinosad and thiamethoxam.
(7) 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 metrafenone, Bacillus subtilis, spinosad and thiamethoxam 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.
(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 six months after inclusion to review existing provisional authorisations of plant protection products containing metrafenone, Bacillus subtilis, spinosad or thiamethoxam 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.
(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42).
EFSA Scientific Report (2006)58, 1-72, Conclusion regarding the peer review of the pesticide risk assessment of the active substance metrafenone (finalised: 13 January 2006).