L 125/38 Official Journal of the European Union 28.4.2004 COMMISSION DIRECTIVE 2004/62[EC of 26 April 2004 amending Council Directive 91/414/EEC to include mepanipyrim as active substance (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: 1 In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 24 October 1997 an application from Kumiai Chemical Industry Co., Ltd for the inclusion of the active substance mepanipyrim (former name: KIF 3535) in Annex I to Directive 91/414/EEC. Commission Decision 98/676/EC (*) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information require- ments of Annexes II and III to Directive 91/414/EEC. For this active substance, 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 designated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 12 July 2000. 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 30 March 2004 in the format of the Commission review report for mepanipyrim. The dossier and the information from the review were also submitted to the Scientific Panel on Plant Health, Plant Protection Products and their Residues. The report of this Panel was formally adopted on 23 October 2003 (). The Panel was asked to comment on the liver tumors found in rats and mice exposed to mepanipyrim and to give its opinion on the question whether a threshold of tumor formation can be assumed. (") OJ L 230, 19.08.1991, p. 1. Directive as last amended by Commis- sion Directive 2004/30/EC (O] L 77, 13.3.2004, p. 50). () OJ L 317, 26.11.1998, p. 47. (*) Opinion of the Scientific Panel on Plant Health, Plant Protection Products and their Residues on a request from the European Commission related to the evaluation of mepanipyrim in the Context of Council Directive 91/414/EEC, The EFSA Journal (2003) 4, 1-14. In its opinion the Panel concluded that mepanipyrim induces tumors in rats and mice by a mechanism which is currently unknown but nevertheless involves a threshold below which tumors are not expected to develop and that therefore a safe level of human expo- sure can be assigned. The recommendations of the Scientific Panel were taken into account during the further review and in this Direc- tive and in the Review Report. The evaluation within the Standing Committee concluded that there would be no unacceptable human exposure under the proposed conditions of use. It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) of Directive 91/414/EEC, in par- ticular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include mepanipyrim in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provi- sions of that Directive. After inclusion, Member States should be allowed a reasonable period to implement the provisions of Direc- tive 91/414/EEC as regards plant protection products containing mepanipyrim and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisa- tions into full authorisations, to amend them or to with- draw them in accordance with the provisions of Direc- tive 91/414/EEC. It is therefore appropriate to amend Directive 91414/ EEC accordingly. The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,