17.3.2009 Official Journal of the European Union L 71/59 COMMISSION DECISION of 16 March 2009 concerning the non-inclusion of triflumuron in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2009) 1681) (Text with EEA relevance) (2009/241EC) 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: 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 triflumuron. For triflumuron 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 triflumuron the rapporteur Member State was Italy and all relevant information was submitted on 15 July 2005. 230, 19.8.1991, p. 1. oJL 0J L 55, 29.2.2000, p. 25. oL 224, 21.8.2002, p. 23. S ) 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 30 September 2008 in the format of the EFSA conclusion regarding the peer review of the pesticide risk assessment of the active substance triflumuron (¥). 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 2 December 2008 in the format of the Commission review report for triflumuron. During the evaluation of this active substance, a number of concerns have been identified. In particular, based on the available information, it has not been demonstrated that the consumer exposure is acceptable due to lack of data in terms of nature and level of the relevant residues. In fact, it was not possible to perform an acute risk assessment for the metabolite M0O7, because data was not sufficient to allocate an acute reference dose for this metabolite. Moreover, data were missing to determine an appropriate residue definition and to estimate the level of residues in processed fruit commodities. In addition, a high risk to aquatic organisms has been identified. Consequently, it was not possible to conclude on the basis of the information available that triflumuron 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 triflumuron satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Triflumuron should therefore not be included in Annex I to Directive 91/414/EEC. () EFSA Scientific Report (2008) 194, Conclusion on the peer review of triflumuron, finalised 30 September 2008.