22.1.2005 Official Journal of the European Union L 20/15 COMMISSION DIRECTIVE 2005/2/EC of 19 January 2005 amending Council Directive 91/414/EEC to include Ampelomyces quisqualis and Gliocladium catenulatum 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 ('), and in particular Article 6(1) thereof, Whereas: () O] L 230, 19.8.1991, p. 1. Commission Decision 2004/99/EC (O] L 309, 6.10.2004, p. 6). In accordance with Article 6(2) of Directive 91/414/EEC the French authorities received on 12 April 1996 an application from JSC International Ltd for the inclusion of the active substance Ampelomyces quisqualis in Annex I to the Directive. Commission Decision 97/591/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 Il and III to Directive 91/414/EEC. Finland received an application under Article 6(2) of Directive 91/414/EEC on 19 May 1998 from Kemira Agro Oy (now: Verdera Oy) for the inclusion of the active substance Gliocladium catenulatum in Annex I to the Directive. Commission Decision 1999/392/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 Il 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 91/414/[EEC, for the uses proposed by the applicants. The nominated rapporteur Member States submitted draft Directive as last amended by () O] L 239, 30.8.1997, p. 48. () O] L 148, 15.6.1999, p. 44. assessment reports concerning the substances to the Commission on 28 October 1997 (Ampelomyces quis- qualis) and on 15 June 2000 (Gliocladium catenulatum). The draft assessment reports were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 8 October 2004 in the format of the Commission review reports for Ampe- lomyces quisqualis and Gliocladium catenulatum. The dossier and the information from the review of Ampelomyces  quisqualis were also submitted to the Scientific Committee on Plants. The report of this Committee was formally adopted on 7 March 2001 (¥). In its opinion the Committee concluded that in the absence of a satisfactory pulmonary study, the risk of operators had not been adequately addressed. The Committee further concluded that repeated dosing should in general be part of the primary data set, but it could be omitted provided that adequate justification is provided. In the specific case of Ampelomyces quisqualis the Committee was unable to comment on the necessity of repeated dosing due to absence of a satis- factory pulmonary study. The Committee finally concluded that although no allergic reactions against Ampelomyces quisqualis had been observed, the possibility of occurrence of allergic reactions resulting from agricultural exposure to this organism could not be excluded. The Committee recom- mended monitoring the health of producers and users as a prudent post authorisation measure and making these results available for future re-assessment. The recommendations of the Scientific Committee were taken into account during the further review, in this Directive and in the Review Report. (%) Opinion of the scientific Committee on Plants regarding the evaluation of Ampelomyces quisqualis in the context of Council Directive 91/414/EEC concerning the placing of plant protection products on the market — Opinion adopted by the Scientific Committee on Plants on 7 March 2001.