L 349/22 Official Journal of the European Union 12.12.2006 COMMISSION DIRECTIVE 2006/132/EC of 11 December 2006 amending Council Directive 91/414[EEC to include procymidone 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 (1), and in particular Article 6(1) thereof, Whereas: 4 () 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 procymidone. For procymidone 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 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 (3), France was designated as Rapporteur Member State. France submitted the relevant assessment report and recommendations to the Commission on 15 January 2001 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. It has appeared from the various examinations made that plant protection products containing procymidone may 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). 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 procy- midone is a hazardous substance, its use should not be unrestricted. In particular there are concerns about its intrinsic toxic effects, including potential endocrine disrupting properties. 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 procymidone. 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 procymidone 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, which were not or only partially covered by this assessment, had first to be subject to a complete assessment, before their inclusion in Annex 1 of Directive 91/414/EEC could be considered. Finally, due to the hazardous nature of procymidone, it was considered necessary to provide for a minimum harmo- nisation at Community level of certain risk mitigation measures that were to be applied by Member States when granting authorisations. Under the procedures laid down by Directive 91/414[EEC, the approval of active substances, including the definition of risk management measures, is decided by the Commission. Member States bear the responsibility for the implementation, application and control of the measures intended to mitigate the risks generated by plant protection products. Concerns expressed by several Member States reflect their judgment that additional restrictions are necessary to reduce the risk to a level that can be considered acceptable and consistent with the high level of