L 321/32 Official Journal of the European Union 6.12.2003 COMMISSION DIRECTIVE 2003/1 12/EC of 1 December 2003 amending Council Directive 91/414/EEC to include paraquat as an 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 ('), as last amended by Commission Directive 2003/84/EC (%), and in particular Article 6(1) thereof, Whereas: (1)  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 Regulation (EC) No 2266/2000 (*), establishes a list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes paraquat. (2)  For paraquat, 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. Pursuant to Commission Regulation (EC) No 93394 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 (), as last amended by Regulation (EC) No 2230/95 (%), the United Kingdom was designated as rapporteur Member State. The United Kingdom submitted the relevant assessment reports and recommendations to the Commission on 31 October 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3)  This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 October 2003 in the format of the Commission review report for paraquat. (4)  The report on paraquat and further information were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the relevance for consumers and operators of the ocular and pulmonary changes, which were observed in the long-term rat study, on the risk for operators, taking into particular account potential inhalatory and dermal exposure, on potential long-term effects to soil-dwelling organisms, and on the risks the intended uses might pose to repro- ducing birds and hares. In its opinion (), the Scientific Committee concluded that neither the pulmonary lesions observed in animals after oral administration of paraquat nor the systemic effects on the eye, observed in rats and not in other species, are relevant to the risk assessment for opera- tors and consumers. Based on the field exposure studies, corroborated by information on health surveys on operators, the Committee found that when paraquat is used as a plant protection product as recommended under prescribed good working practices, its use does not pose any significant health risk for the operators. The Committee also noted that uses at recommended field rates are unlikely to pose a significant risk to soil-dwelling organisms. However, a more detailed appraisal of the likely effects of paraquat on the rate of degradation of organic material in soil was requested in view of remaining uncertainty. This information was subsequently delivered and evaluated by the rapporteur Member State. Furthermore, the Scientific Committee concluded that available studies J L 230, 19.8.1991, p. 1. ] L 247, 30.9.2003, p. 20. J L 366,15.12.1992, p. 10. ] L 259, 13.10.2000, p. 27. ] L 107, 28.4.1994, p. 8. J L 225,22.9.1995, p. 1. fpinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of paraquat in the context of Council Directive 91/414/EEC; SCPJPARA/002 adopted on 20 December 2001.