18.5.2005 Official Journal of the European Union L 125/5 COMMISSION DIRECTIVE 2005/34/EC of 17 May 2005 amending Council Directive 91/414/EEC to include etoxazole and tepraloxydim 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, France received on 21 April 1998 an application from Sumitomo Chemical Agro Europe SA for the inclusion of the active substance etoxazole, formerly also called ‘etoxazol, in Annex [ to Directive 91/414/EEC. Commission Decision 1999/43/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and infor- mation requirements of Annexes I and III to Directive 91/414/EEC. Spain received an application under Article 6(2) of Directive 91/414/EEC on 11 September 1997 from BASF AG for the inclusion of the active substance tepra- loxydim in Annex 1 to Directive 91/414/EEC. Commission Decision 98/512/EC (%) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and infor- mation requirements of Annexes I and III to Directive 91/414/EEC. 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 Commission on 8 October 2001 (etoxazole) and 21 January 2002 (tepraloxydim). 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 3 December 2004 in the format (") OJ L 230, 19.8.1991, p. 1. Directive as last amended by Directive 2005/25/EC (O] L 90, 8.4.2005, p. 1). () O L 14, 19.1.1999, p. 30. () O] L 228, 15.8.1998, p. 35. ) of the Commission review reports for etoxazole and tepraloxydim. The review of etoxazole and tepraloxydim did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority. 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)() 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 etoxazole and tepra- loxydim in Annex [, 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. After inclusion of etoxazole and tepraloxydim in Annex I to Directive 91/414/EEC, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing those substances and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. It is therefore appropriate to amend Directive 91/414/EEC accordingly. 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: Article 1 Annex [ to Directive 91/414/EEC is amended as set out in the Annex to this Directive.