L 25/24 Official Journal of the European Union 28.1.2006 COMMISSION DIRECTIVE 2006/10/EC of 27 January 2006 amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active substances (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 (1), and in particular Article 6(1) thereof, Whereas: () O] L 230, 19.8.1991, p. 1. Commission Directive 2006/6/EC (O] L 12, 18.1.2006, p. 21). In accordance with Article 6(2) of Directive 91/414/EEC Spain received on 7 December 1998 an application from SKW Trostberg AG (on behalf of the Taskforce SKW Trosberg AG (Degussa AG) and Kyowa Hakko Kogyo Co.Ltd) for the inclusion of the active substance forchlorfenuron in Annex I to Directive 91/414/EEC. Commission Decision 2000/181/EC (%) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and infor- mation requirements of Annexes II and III to Directive 91/414/EEC. The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 October 1997 from DuPont de Nemours for the inclusion of the active substance indoxacarb in Annex I to Directive 91/414[EEC. Commission Decision 1998/398/EC (?) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive Directive as last amended by () O] L 57, 2.3.2000, p. 35. () O] L 176, 20.6.1998, p. 34. 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 2 March 2001 (forchlorfenuron) and 7 February 2000 (indoxacarb). The draft assessment reports have 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 23 September 2005 in the format of the Commission review reports for forchlor- fenuron and indoxacarb. The review of forchlorfenuron did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee. For indoxacarb, two questions were submitted to the Scientific Committee on Plants (SCP). The SCP was asked to comment on the NOEL (No observed effect level) for effects on red blood cells in rats and on the adequate basis for the derivation of an Acute Reference Dose (ARfD) for indoxacarb. In its opinion (¥) the SCP stated that the changes observed in some Red Blood Cells parameters were generally slight and not accompanied by significant reti- culocytosis, giving the overall picture of a mild haemolytic effect. While a clear NOEL could not be established, the SCP concluded on a dose up to which the effects observed are not adverse. The SCP furthermore replied that the general and non- specific signs of toxicity observed in the acute neuro- toxicity study in rats can be used as a basis for the derivation of the ARD. () Opinion of the Scientific Committee on Plants on specific questions from the Commission concerning the evaluation of indoxacarb (SCP/Indoxa/002-Final); Committee on Plants on 18 July 2002). adopted by the Scientific opinion