28.3.2003 Official Journal of the European Union L 81/39 COMMISSION DIRECTIVE 2003/23EC of 25 March 2003 amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid 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 2002/ 81/EC (%), and in particular Article 6(1) thereof, Whereas: 1 1 2 3 4 6 8 () O] () O () O] () O] () O] () O] () O] () O In accordance with Article 6(2) of Directive 91/414/EEC France received on 2 December 1997 an application from Cyanamid NV/SA (now BASF AG) for the inclusion of the active substance imazamox in Annex I to Direc- tive 91/414/EEC. Commission Decision 1998/676/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. Italy received a similar application on 29 May 1998 from Novartis Protezione Piante SpA (now Syngenta) concerning oxasulfuron. This application was declared complete by Commission Decision 1999/237[EC (¥). Italy received a similar application on 3 July 1996 from Hoechst Schering AgrEvo GmbH (now Bayer Crop Science concerning ethoxysulfuron. This application was declared complete by Commission Decision 97/591/ EC (). Germany received a similar application on 30 March 2000 from Aventis Crop Science (now Bayer Crop Science) concerning foramsulfuron. This application was declared complete by Commission Decision 2000/540/ EC (). Italy received a similar application on 16 June 1997 from Rhone-Poulenc Agro SA (now Bayer Crop Science) concerning oxadiargyl. This application was declared complete by Commission Decision 98/398/EC (). France received a similar application on 16 December 1999 from Ishira Sangyo Kaisha Ltd concerning cyazo- famid. This application was declared complete by Commission Decision 2000/412[EC (¥). L 230, 19.8.1991, p. 1. L 276,12.10.2002, p. 28. L 317,26.11.1998, p. 47. L 87,31.3.1999, p. 15. L 239, 30.8.1997, p. 48. L 230, 12.9.2000, p. 14. L 176, 20.6.1998, p. 34. L 155, 28.6.2000, p. 62. ) For these 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 9 September 1999 (imazamox), 10 May 2000 (oxasulfuron), 20 May 1998 (ethoxysulfuron), 1 June 2001 (foramsulfuron), 20 July 1999 (oxadiargyl) and 27 August 2001 (cyazofamid). 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 2002 in the format of the Commission review reports for imazamox, oxadiargyl, oxasulfuron, ethoxysulfuron, foramsulfuron and cyazofamid. The reviews of imazamox, oxasulfuron foramsulfuron, oxadiargyl and cyazofamid did not reveal any open ques- tions or concern, which would have required a consulta- tion of the Scientific Committee on Plants. The documents and information on ethoxysulfuron were also submitted to the Scientific Committee for Plants for separate consultation. In a first consultation the Scien- tific Committee was invited to comment on the occur- rence of uterine tumours in rats. In its opinion (°) the Committee considered the increase in uterine tumour incidence in rats of no relevance to human risk as it occurred only at a high dose causing marked general toxicity. No additional mechanistic studies were deemed necessary. An additional consultation was made on the potential risk to aquatic organisms. In its second opinion (*°) the Committee concluded that assessment of the risk of ethoxysulfuron to aquatic organisms was lacking in several respects, in particular with respect to sediment-dwelling organisms. Also assessment of the risk to aquatic plants and algae from the metabolite Hoe 136086 of ethoxysulfuron was considered incomplete. (°) Opinion of the Scientific Committee on Plants regarding the evalua- tion of ethoxysulfuron in the context of Council Directive 91/414/ EEC concerning the placing of plant protection products on the market SCP/ETHOXY/002-Final — adopted 22 September 2000. (1 Opinion on the evaluation of ethoxysulfuron (AE F095404) in the context of Council Directive 91/414/EEC concerning the placing of plant protection products on the market — SCP/ETHOXY-Bis/002 adopted 7 June 2001.