22.1.2005 Official Journal of the European Union L 20/19 COMMISSION DIRECTIVE 2005/3/EC of 19 January 2005 amending Council Directive 91/414/EEC to include imazosulfuron, laminarin, methoxyfenozide and s-metolachlor 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) (4) () O L 230, 19.8.1991, p. 1. Commission Directive 2004/99/EC (O] L 309, 6.10.2004, p. 6). In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 27 June 1996 an application from Spiess-Urania Chemicals GmbH for the inclusion of the active substance imazosulfuron in Annex I to Directive 91/414[/EEC. Commission Decision 97/865/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 Directive 91/414/EEC. Belgium received an application under Article 6(2) of Directive 91/414/EEC on 29 March 2001 from Goémar SA for the inclusion of the active substance laminarin in Annex [ to Directive 91/414/EEC. Commission Decision 2001/861/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. The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 21 February 2000 from Rohm and Haas France SA (now Dow AgroS- ciences) for the inclusion of the active substance meth- oxyfenozide in Annex I to Directive 91/414/EEC. Commission Decision 2001/385/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. Belgium received an application under Article 6(2) of Directive 91/414/EEC on 1 August 1997 from Novartis Directive as last amended by () O] L 351, 23.12.1997, p. 67. () O] L 321, 6.12.2001, p. 34. (% O] L 137, 19.5.2001, p. 30. NV (now Syngenta) for the inclusion of the active substance s-metolachlor in Annex I 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 information requirements of Annexes II and IIl 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 17 June 1998 (imazosulfuron), on 2 June 2003 (laminarin), on 2 August 2002 (methoxyfe- nozide) and 3 May 1999 (s-metolachlor). 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 8 October 2004 in the format of the Commission review reports for imazosulfuron, laminarin, methoxyfenozide and s-metolachlor. For imazosulfuron, the dossier and the information from the review were also submitted to the Scientific Committee on Plants. The report of this Committee was formally adopted on 25 April 2001 (9). The Committee was asked to comment on the relevance of the metabolite IPSN due to its presence in soil and water. In its opinion the Committee concluded that there is no significant health risk arising from IPSN in the groundwater, and that the risk to soil micro-organisms, aquatic invertebrates, fish and the acute risk to earthworms are sufficiently addressed. The Committee also concluded that on the basis of worst-case exposure estimates further information is required to assess some other risks from IPSN. The Committee finally concluded that the risk to the environment and the toxicological risk to human health from the parent substance and/or metabolites other than IPSN, in some studies formed at levels comparable to IPSN, have not been fully assessed and therefore should be addressed during the further evaluation. () OJ L 228, 15.8.1998, p. 35. (6) Opinion of the Scientific Committee on Plants regarding the inclusion of imazosulfuron in Annex I to Council Directive 91/414[EEC concerning the placing of plant protection products on the market — SCP/IMAZO/002-Final, published 21 May 2001.