L 133/40 Official Journal of the European Union 25.5.2007 COMMISSION DECISION of 21 May 2007 concerning the non-inclusion of carbaryl 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(2007) 2093) (Text with EEA relevance) (2007/355/EC) 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 of 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 (3 and (EC) No 703/2001 () lay down the detailed rules for the implementation of the second 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 carbaryl. (3)  For carbaryl the effects on human health and the envi- ronment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 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 () O] L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/25/EC (O] L 106, 24.04.2007, p. 34). (®» OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regu- lation (EC) No 1044/2003 (O] L 151, 19.6.2003, p. 32). () O] L 98, 7.4.2001, p. 6. with Article 8(1) of Regulation (EC) No 451/2000. For carbaryl the rapporteur Member State was Spain and all relevant information was submitted on 29 April 2004. (4)  The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission on 12 May 2006 in the format of the EFSA conclusion regarding the peer review of the pesticide risk assessment of the active substance carbaryl (*). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 29 September 2006 in the format of the Commission review report for carbaryl. (5)  During the evaluation of this active substance, a number of concerns were identified. In particular based on the available data it has not been demonstrated that the consumer exposure is acceptable. The information available indicates concerns for metabolites which are at the same level of toxicity as the active substance, and their presence at levels which might be of toxico- logical concerns can not be excluded. Moreover there are concerns on potential carcinogenic properties of the active substance. There is also a high long-term risk for insectivorous birds and a high acute risk to herbivorous mammals, a high acute and long-term risk to aquatic organisms and a high risk for beneficial arthropods. (6)  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 advanced, the above concerns remained unsolved, 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 carbaryl satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. (7) Carbaryl should therefore not be included in Annex I to Directive 91/414/EEC. (*) EFSA Scientific Report (2006) 80, 1-71, Conclusion regarding the peer review of pesticide risk assessment of carbaryl.