17.9.2005 Official Journal of the European Union L 241/51 COMMISSION DIRECTIVE 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl 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: Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414[EEC concerning the placing of plant protection products on the market (?), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92 (}), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recom- mendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For chlorothalonil the rapporteur Member State was the Netherlands, and all relevant information was submitted on 31 January 2000. For chlorotoluron, the rapporteur Member State was Spain and all relevant information was submitted on 7 May 1999. For cypermethrin the rapporteur Member State was Belgium and all relevant information was submitted on 25 October 1999. For (") OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1) (® OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu- lation (EC) No 22662000 (O] L 259, 13.10.2000, p. 27). () OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu- lation (EC) No 2230/95 (O] L 225, 22.9.1995, p. 1). daminozide the rapporteur Member State was the Neth- erlands and all relevant information was submitted on 30 July 1999. For thiophanate-methyl, the rapporteur Member State was Germany and all relevant information was submitted on 21 November 1997. The 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 of all active substances were finalised on 15 February 2005 in the format of the Commission review reports for chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. The review of chlorothalonil, chlorotoluron and cyper- methrin did not reveal any open questions to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of the latter. The review of daminozide revealed a number of open questions which were addressed by the EFSA. The Scientific Panel on Plant Health, Plant Protection Products and their Residues (PPR Panel) of the EFSA was asked to comment on the mechanism of action of the carcinogenic response of rodents to 1,1-dimethylhy- drazide (UDMH) and to indicate whether or not a threshold could be derived for this effect. If yes, it was requested to indicate this value. The PPR Panel, having regard to the submitted questions, concluded (%) that, on the basis of the available data, it is not possible to identify the mechanism responsible for the carcinogenic action of UDMH in rodents. There is no in vitro evidence of genotoxicity of pure and oxidation-protected UDMH and in vivo studies are not available. In addition, the PPR Panel noted an apparent discrepancy in that daminozide long-term studies did not give rise to carcinogenicity in rats and mice at doses that should have produced internal doses of metabolically-formed UDMH at least one order of magnitude higher than those proven to be effective on direct testing. In addition, methylation () Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the Commission related to the evaluation of daminozide in the context of Council Directive 91/414/EEC (The EFSA Journal (2004), 61, 1-27), adopted on 11 May 2004.