6.6.2002 Official Journal of the European Communities L 148/19 COMMISSION DIRECTIVE 2002/48/EC of 30 May 2002 amending Council Directive 91/414/EEC to include iprovalicarb, prosulfuron and sulfosulfuron as active substances THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Commu- nity, 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/ 37[EC (3), and in particular Article 6(1) thereof, Whereas: 1 2 4 5 () O] () O] () O] () O] () O In accordance with Article 6(2) of Directive 91/414/EEC, Ireland received on 30 March 1998 an application from Bayer AG for the inclusion of the active substance ipro- valicarb in Annex I to the Directive. By Commission Decision 98/512/EC () it was confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information require- ments laid down in Annexes II and III to Directive 91/ 414/EEC. France received a similar application on 14 May 1995 from Novartis, now Syngenta, concerning prosulfuron. This application was declared complete by Commission Decision 97/137/EC (%). Ireland received a similar application on 24 April 1997 from Monsanto concerning sulfosulfuron. This applica- tion was declared complete by Commission Decision 97/ 865/EC (). For these three active substances, the effects on human health and the environment have been assessed, in accor- dance with Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 4 November 1999 (iprovalicarb), 18 January 1999 L 230, 19.8.1991, p. 1. L 117, 4.5.2002, p. 10. L 228, 15.8.1998, p. 35. L 52,22.2.1997, p. 20 L 351, 23.12.1997, p. 67. - = (prosulfuron), and 2 April 1998 (sulfosulfuron), respec- tively. 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 reviews were finalised on 26 February 2002 in the format of the Commission review reports for iprovali- carb, prosulfuron and sulfosulfuron. The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards iprovalicarb, the Committee was asked to comment on the acceptability of the risk of metabolite PMPA on earthworms and on the relevance to humans of tumours which were observed in rats after lifetime exposure to high doses. In two opinions (%) (), the Committee identified the need for further data on earth- worms, which were subsequently provided and assessed, and concluded that concerning the effects observed in rats sufficient safety margins exist to ensure protection of consumers and operators. The observations of the Scientific Committee were taken into consideration in formulating this Directive and the relevant review report. With respect to prosulfuron, the Committee was asked to comment on the acceptability of the risk of two breakdown products of the active substance to sediment dwelling organisms and on possible hormonal disruption effects observed in test animals. In its opinion (¥) the Committee concluded that certain uterine and mammary changes, which were observed in rats after lifetime expo- sure are not considered relevant for human risk assess- ment of prosulfuron in the context of its intended uses. The Committee further commented that risks of the two breakdown products to sediment-dwelling species were not yet adequately assessed and noted that other persis- tent metabolites are formed in significant quantities in sediment-water tests which also did not appear to have been assessed. The pending information and assessments were subsequently provided and the observations of the Scientific Committee were taken into consideration in formulating this Directive and the relevant review report. (®) Opinion of the Scientific Committee on Plants on the evaluation of iprovalicarb in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market (adopted 21 March 2001). Opinion of the Scientific Committee on Plants on an additional question from the Commission on the evaluation of iprovalicarb (SZX 0722) in the context of Directive 91/414/EEC (adopted 28 November 2001). Opinion of the Scientific Committee on Plants regarding the inclu- sion of prosulfuron (CGA 152005) in Annex I to Directive 91/414/ EEC concerning the lacmg of plant protection products on the market SCP/PROSULF/002-Final 21 June 2001.