29.10.2008 Official Journal of the European Union L 285/15 COMMISSION COMMISSION DECISION of 20 October 2008 concerning the non-inclusion of butralin 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(2008) 6066) (Text with EEA relevance) (2008/819/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: 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 230, 19.8.1991, p. 1. oJL 0J L 55, 29.2.2000, p. 25. oL 224, 21.8.2002, p. 23. with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes butralin. For butralin the effects on human health and the en- vironment 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 8(1) of Regulation (EC) No 451/2000. For butralin the rapporteur Member State was France and all relevant information was submitted on 20 February 2006. The Commission examined butralin in accordance with Article 11a of Regulation (EC) No 1490/2002. A draft review report for that substance was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 20 May 2008 in the format of the Commission review report. During the examination of this active substance by the Committee, it was concluded, taking into account comments received from Member States, that there are clear indications that it may be expected that it has harmful effects on human health and in particular on operators, because the exposure is greater than 100 % of the AOEL. Moreover, other concerns which were iden- tified by the rapporteur Member States in its assessment report are included in the review report for the substance.