4.12.2009 Official Journal of the European Union L 318/41 COMMISSION DECISION of 30 November 2009 concerning the non-inclusion of bifenthrin in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document C(2009) 9196) (Text with EEA relevance) (2009/887EC) 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 the fourth subparagraph of Article 8(2) thereof, Whereas: 1) Article 8(2) of Directive 91/414[EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work. Commission Regulations (EC) No 451/2000 (?) and (EC) No 1490/2002 (}) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish 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 bifenthrin. For bifenthrin the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For bifenthrin the rapporteur Member State was France and all relevant information was submitted on 15 December 2005. The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 230, 19.8.1991, p. 1. 0] L 0J L 55, 29.2.2000, p. 25. 0J L 224, 21.8.2002, p. 23. 30 September 2008 in the format of the EFSA conclusion regarding the peer review of the pesticide risk assessment of the active substance bifenthrin (). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 12 March 2009 in the format of the Commission review report for bifenthrin. During the evaluation of this active substance, a number of concerns have been identified. In particular, based on the data lodged by the notifier within the legal deadlines, it was not possible to assess the potential contamination of groundwater by a major soil degradation product (TFP acid). Furthermore, concerns have been raised as regards a possible underestimation of the risk to consumers, due to the limited number of residue data made available and the lack of investigation on the metabolism pattern of the two isomers constituting bifenthrin. As regards eco- toxicology, the risk to aquatic vertebrates has not shown to generate acceptable uses, while there is a remaining uncertainty as regards the effects of the experienced bioaccumulation in fish of the active substance. Furthermore, high risks have been identified for mammals (long-term risk and secondary poisoning), earthworms (long-term risk) and non-target arthropods (in-field), while the risk to non-target plants and non- target soil macro-organisms has not been sufficiently addressed. Consequently, it was not possible to conclude, on the basis of the information made available within the legal deadlines, that bifenthrin met the criteria for inclusion in Annex I to Directive 91/414/EEC. The Commission invited the notifier to submit its comments on the results of the peer review and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing bifenthrin satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. (*) EFSA Scientific Report (2008) 186, Conclusion regarding the peer review of the pesticide risk assessment of the active substance bifenthrin, finalised 30 September 2008.