12.12.2006 Official Journal of the European Union L 349/27 COMMISSION DIRECTIVE 2006/133/EC of 11 December 2006 amending Council Directive 91/414/EEC to include flusilazole as active substance (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 ('), and in particular Article 6(1) thereof, Whereas: () O] L 230, 19.8.1991, p. 1. Commission Directive 2006/85/EC (O] L 293, 24.10.2006, p. 3). 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 flusilazole. For flusilazole the effects on human health and the envir- onment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifier. 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 Commission Regulation (EEC) No 3600/92 (%), Ireland was designated as Rapporteur Member State. Ireland submitted the relevant assessment report and recommendations to the Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. Directive as last amended by (®» 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. 10). () 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). 4 As regards flusilazole two questions were submitted to the Scientific Committee on Plants (the Scientific Committee). The first concerned the adequacy of the proposed NOEC (No Observed Effect Concentration) for ensuring a sufficient protection from adverse effects on reproduction and, more generally, the comparative sensi- tivity of the early life stage test compared to the full fish life cycle study. The second question related to the potential impact on organic matter decomposition. In both cases, the recommendations of the Scientific Committee (¥) have been taken into consideration in formulating this Directive and the relevant review report. It has appeared from the various examinations made that plant protection products containing flusilazole may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard to the uses which were examined and detailed in the Commission review report, provided that adequate risk mitigation measures are applied. As flusilazole is a hazardous substance, its use should not be unrestricted. In particular there are concerns about its intrinsic toxic effects, including potential endocrine disrupting prop- erties. There is at present no scientific consensus on the exact extent of the risk. Applying the precautionary principle, and taking into account the current state of scientific knowledge, risk mitigation measures should be imposed in order to achieve the high level of protection of human and animal health and the environment chosen in the Community. Articles 5(4) and 6(1) of Directive 91/414/EEC provide that inclusion of a substance in Annex I may be subject to restrictions and conditions. In this case, restrictions on the inclusion period and on the authorised crops are deemed necessary. The original measures presented to the Standing Committee on the Food Chain and Animal Health, proposed the restriction of the inclusion period to seven years, so that Member States would give priority to reviewing plant protection products already on the market containing flusilazole. In order to avoid discrepancies in the high level of protection sought, the inclusion in Annex I to Directive 91/414/EEC was intended to be limited to the uses of flusilazole that have been actually assessed within the Community evaluation and for which the proposed uses were considered to comply with the conditions of Directive 91/414/EEC. This implies that other uses, () Opinion of the Scientific Committee on Plants on specific questions from the Commission concerning the evaluation of flusilazole in the context of Council Directive 91/414/EEC (Opinion adopted by the Scientific Committee on Plants on 18 July 2002).