L 349/32 Official Journal of the European Union 12.12.2006 COMMISSION DIRECTIVE 2006/ 1 34/EC of 11 December 2006 amending Council Directive 91/414[EEC to include fenarimol 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: () 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 fenarimol. For fenarimol 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 (}), the United Kingdom was designated as Rapporteur Member State. The United Kingdom submitted the relevant assessment report and recommendations to the Commission on 30 April 1996 in accordance with Article 7(1)(c) of Regu- lation (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 fenarimol two questions were submitted to the Scientific Committee on Plants (the Scientific Committee). The Scientific Committee was asked to comment on the interpretation of the multi-generation studies and to consider the aromatase inhibition effects of fenarimol. In addition its opinion was sought on the establishment of a reliable acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) (). The Scientific Committee concluded that the effects of fenarimol on male fertility seen in rats had to be considered relevant for human risk assessment although man is less sensitive than rats to the effects of aromatase inhibition. It also concluded that the effects of fenarimol on parturition in rats could be considered as not relevant for human risk assessment. It was further concluded that, apart from male-mediated reduced fertility and effects associated with delayed parturition, there was no convincing evidence for other adverse reproductive effects associated with aromatase inhibition by fenarimol. Finally, the Scientific Committee agreed that the toxicological studies submitted permitted the estab- lishment of a reliable ADI and AOEL. A second opinion (°) addressed the question whether the approach taken to calculate the Predicted Environmental Concentrations (PEC) in soil was adequate. The Committee proposed a combination of field dissipation and laboratory degradation data to calculate an accu- mulated soil PEC. This opinion has been examined by the rapporteur Member State who considered never- theless that this procedure was no more scientifically justified than relying on field dissipation measurements alone. Therefore it was decided to await the outcome of the field dissipation studies that were ongoing. The interim results from these studies are consistent with the results of the model calculation and consequently the issue was considered to be adequately addressed. It is therefore concluded that in all cases, the recommen- dations from 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 fenarimol 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 (*) Opinion of the Scientific Committee on Plants regarding the possible inclusion of fenarimol in Annex 1 to Directive 91/414/EEC concerning the placing of plant protection products on the market (SCP/FENARI/005 — Final) (Opinion adopted by the Scientific Committee on Plants on 18 May 1999). (*) Opinion of the Scientific Committee on Plants on a specific question from the Commission concerning the evaluation of Fenarimol in the context of Council Directive 91/414/EEC (Opinion adopted by the Scientific Committee on Plants on 8 November 2001).