27.7.2006 Official Journal of the European Union L 206/107 COMMISSION DIRECTIVE 2006/64/CE of 18 July 2006 amending Council Directive 91/414/EEC to include clopyralid, cyprodinil, fosetyl and trinexapac 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 mar- ket (1), and in particular Article 6(1) thereof, Whereas: Commission Regulations (EC) No 451/2000 () and (EC) No 703/2001 () lay down the detailed rules for the imple- mentation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish 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 clopyralid, cyprodinil, fos- etyl and trinexapac. For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations des- ignate the rapporteur Member States which have to sub- mit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accor- dance with Article 8(1) of Regulation (EC) No 451/2000. For clopyralid the rapporteur Member State was Finland and all relevant information was submitted on 2 Decem- ber 2003. For cyprodinil and fosetyl the rapporteur Mem- ber State was France and all relevant information was submitted on 16 January 2004 and 20 October 2003 respectively. For trinexapac the rapporteur Member State was The Netherlands and all relevant information was sub- mitted on 7 November 2003. (1) OJL 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/45/EC (O] L 130, 18.5.2006, p. 27). (3 OJL55,29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 10442003 (O] L 151, 19.6.2003, p. 32). () OJ L 98, 7.4.2001, p. 6. 6) The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Com- mission on 14 December 2005 in the format of the EFSA Scientific Reports for clopyralid, cyprodinil, fosetyl and trinexapac (*). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 4 April 2006 in the format of the Commis- sion review reports for clopyralid, cyprodinil, fosetyl and trinexapac. It has appeared from the various examinations made that plant protection products containing clopyralid, cyprodi- nil, fosetyl and trinexapac may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Com- mission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points con- cerning clopyralid, cyprodinil and fosetyl. Article 6(1) of Directive 91/414/EC provides that inclusion of a sub- stance in Annex I may be subject to conditions. Therefore it is appropriate to require that clopyralid, cyprodinil and fosetyl should be subjected to further testing for confirma- tion of the risk assessment for some issues and that such studies should be presented by the notifiers. (*) EFSA Scientific Report (2005) 50, 1-65, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance clopyralid (finalised: 14 December 2005). EFSA Scientific Report (2005) 51, 1-78, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance cyprodinil (finalised: 14 December 2005). EFSA Scientific Report (2005) 54, 1-79, Conclusion regarding the Peer review of the pesticide risk assessment of the active substance fosethyl (finalised: 14 December 2005). EFSA Scientific Report (2005) 57, 1-70, Conclusion regarding the peer review of the pesticide risk assessment of the active substance trinexapac (finalised: 14 December 2005).