12.12.2006 Official Journal of the European Union L 349[37 COMMISSION DIRECTIVE 2006/135/EC of 11 December 2006 amending Council Directive 91/414/EEC to include carbendazim 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 carbendazim. For carbendazim 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 (), Germany was designated as Rapporteur Member State. Germany submitted the relevant assessment report and recommen- dations to the Commission on 10 February 1998 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 The review of carbendazim revealed a number of open questions which were addressed by the Scientific Committee on Plants. The Scientific Committee was asked to comment on the advisability of establishing an Acceptable Daily Intake (ADI) and Acceptable Operator Exposure Level (AOEL) having regard parti- cularly to the results of mutagenicity, carcinogenicity and reproductive studies for benomyl, carbendazim and thiophanate-methyl. The Committee (¥} noted that carbendazim is the biologically active substance common to these three substances. Benomyl in particular, but also thiophanate-methyl, is metabolised to carbendazim and all three substances produce numerical chromosomal aberrations (aneuploidy) in mammalian cells, exposed in vivo. There is no evidence that any other form of damage to genetic material is induced by any of these substances. Carcinogenicity is not a concern. The known effects of these fungicides upon reproduction are explicable by interaction with the microtubules of the spindle apparatus. The mechanism of aneuploidy induction is well understood and consists of inhibition of polymerisation of tubulin, the protein that is essential for the segregation of chro- mosomes during cell division: it does not involve any interaction with DNA. Since multiple copies of tubulin molecules are present in proliferating cells, in the presence of low concentration of the fungicides a limited number of tubulin molecules will be affected and consequently no toxicologically adverse effects will ensue. Consequently, a clear no adverse effect level is recognisable and both an ADI and an AOEL can be established. 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 carbendazim. 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 carbendazim that have been actually assessed within the () Opinion of the Scientific Committee on Plants (SCP/[BENOMY/002 — final, SCP/CARBEN/002 — final, SCP/THIOPHAN/002 — final 002) dated 23 March 2001 regarding the evaluation of benomyl, carbendazim and thiophanate-methyl in the context of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Opinion adopted by the Scientific Committee on Plants on 7 March 2001).