L 247)20 Official Journal of the European Union 30.9.2003 COMMISSION DIRECTIVE 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethe- namid-p, picoxystrobin, fosthiazate and silthiofam 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 (), as last amended by Commission Directive 2003/ 79[EC (3), and in particular Article 6(1) thereof, Whereas: 1 In accordance with Article 6(2) of Directive 91/414/EEC the authorities of France received on 15 February 1994 an application from Rhone-Poulenc Agro France (now Bayer CropScience) for the inclusion of the active substance flurtamone in Annex I to Directive 91/414/ EEC. Commission Decision 1996/341/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 Il and III to Direc- tive 91/414/EEC. France received an application under Article 6(2) of Directive 91/414/EEC on 1 February 1996 an applica- tion from Bayer AG (now Bayer CropScience) concerning flufenacet (former name: fluthiamide). This application was declared complete by Commission Deci- sion 97/362[EC (%). Germany received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Hoechst  Schering AgrEvo GmbH (now  Bayer CropScience) concerning iodosulfuron (as parent substance of iodosulfuron-methyl-sodium). This applica- tion was declared complete by Commission Decision 1999/392/EC (). Germany received an application under Article 6(2) of Directive 91/414/EEC on 16 April 1999 from BASF AG concerning  dimethenamid-p. This application was declared complete by Commission Decision 1999/555/ EC (9. Ireland received an application under Article 6(2) of Directive 91/414/EEC on 26 May 1999 from Zeneca Agrochemicals (now Syngenta) concerning picoxy- strobin. This application was declared complete also by Commission Decision 1999/555/EC. L 230, 19.8.1991, p. 1. L 228,12.9.2003, p. 11. L 130, 31.5.1996, p. 20. L 152,11.6.1997, p. 31. L 148, 15.6.1999, p. 44. L 210, 10.8.1999, p. 22. (6) (10) (11) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 5 March 1996 from ISK Biosciences Europe SA concerning fosthiazate. This application was declared complete by Commission Decision 97/362/EC. Ireland received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Monsanto Crop Protection concerning silthiofam (former name: silthiopham). This application was declared complete by Commission Decision 1999/392/EC. 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 nominated rapporteur Member States submitted a draft assessment report concerning the substance to the Commission on 21 May 1997 (flurtamone), 6 January 1998 (flufenacet), 30 May 2000 (iodosulfuron), 26 September 2000 (dimethenamid-p), 11 June 2001 (picoxystrobin), 18 March 1998 (fosthiazate), and 2 October 2000 (silthiofam). 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 4 July 2003 in the format of the Commission review report for flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam. The review of iodosulfuron, dimethenamid-p, picoxy- strobin and silthiofam did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. For flurtamone, the documents and information were also submitted to the Scientific Committee for Plants for separate consultation. The Scientific Committee for Plants was consulted twice, mainly to assess the potential leaching of two metabolites of the active substance, 3- trifluoromethylbenzoic acid (TFMBA) and trifluoroacetic acid (TFAA). In a first opinion (), the Scientific Committee recommended with respect to TFMBA the inclusion of soils with pH values between 7 and 8 in the sorption studies with this metabolite. As regards the () Opinion of the Scientific Committee on Plants regarding the inclu- sion of flurtamone in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/FLURT/ 004-Final, adopted on 18 December 1998).