23.4.2003 Official Journal of the European Union L 101/3 COMMISSION DIRECTIVE 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin 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 market ('), as last amended by Commission Directive 2003/ 23[EC (3, and in particular Article 6(1) thereof, Whereas: 1 1 2 3 5 6 () O] () O () O] () O] () O] () O 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 (}), as last amended by Regula- tion (EC) No 2266/2000 (*), 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 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin. For these active substances 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 notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protec- tion products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 (), as last amended by Regulation (EC) No 2230/95 (), the following rapporteur Member States were designated and submitted the relevant assess- ment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: 2,4-DB: rapporteur Member State Greece, all relevant information was submitted on 30 April 1996; beta-cyfluthrin:  rapporteur Member State Germany, all relevant information was submitted on 4 November 1996; cyfluthrin: rapporteur Member State Germany, all relevant information was submitted on 4 November 1996; iprodione: rapporteur Member State France, all relevant information was submitted on 18 July 1996; linuron: rapporteur Member State United Kingdom, all relevant information was submitted on 31 October 1996; maleic hydrazide: rapporteur Member State Denmark, all relevant information was submitted on 5 September 1997; pendimethalin: rapporteur Member State Spain, all relevant information was submitted on 20 May 1998. L 230, 19.8.1991, p. 1. L 81, 28.3.2003, p. 39. L 366, 15.12.1992, p. 10. L 259, 13.10.2000, p. 27. L 107, 28.4.1994, p. 8. L 225,22.9.1995, p. 1. 3) These assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for 2,4- DB and for pendimethalin the Commission organised tripartite meetings with the main data submitter and the rapporteur Member State on 7 May 1998 and on 4 June 1999. For both substances the main data submitter provided further data in order to meet the initial concerns. The reviews of all active substances were finalised on 3 December 2002 in the format of the Commission review report for 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin. The reviews of 2,4-DB, linuron, maleic hydrazide and pendimethalin did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. The report on beta-cyfluthrin and on cyfluthrin and further information concerning both substances were also submitted to the Scientific Committee on Plants for separate consultations. The Committee was asked to comment on the appropriate dietary risk assessment to be used and to confirm that the available ecotoxicolo- gical data supports uses only in glasshouses and for seed treatment. In its opinions (') (%), the Committee suggested that in addition to a long-term dietary intake risk assess- ment, as routinely carried out for plant protection products, beta-cyfluthrin and cyfluthrin should also undergo a short-term acute dietary risk assessment to evaluate their potential neurotoxicity properties. The Committee confirmed that uses as seed dressing and in greenhouses (except where beneficial arthropods are used) can be considered safe for non-target terrestrial and aquatic organisms, due to the specific circumstances of these applications and the immobility of beta-cyflu- thrin and cyfluthrin in soil. The Committee furthermore supports the conclusions reached during the evaluation by the Member States that field spray applications of beta-cyfluthrin and cyfluthrin have not shown to be sufficiently safe under the criteria required by Annex VI to Directive 91/414/EEC. Following the opinion of the Scientific Committee on Plants the short term dietary risk assessment was subsequently provided and discussed () Opinion of the Scientific Committee on Plants regarding the inclu- sion of beta-cyfluthrin in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market. (Opinion expressed January 2000). y the Scientific Committee on Plants, 28 (®) Opinion of the scientific Committee on Plants regarding the inclu- sion of cyfluthrin in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market. (Opinion expressed January 2000). y the Scientific Committee on Plants, 28