L 353/26 Official Journal of the European Communities 24. 12. 97 COMMISSION DIRECTIVE 97/73/EC of 15 December 1997 including an active substance (imazalil) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (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 ('), as last amended by Directive 97/57/EC (%, and in particular Article 6 (1) and the fourth subparagraph of Article 8 (2) thereof, Whereas Commission Regulation (EEC) No 3600/92 (), as last amended by Regulation (EC) No 1199/97 (*), has laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC (hereinafter referred to as ‘the Directive’); whereas, pursuant to that Regulation, Commission Regulation (EC) No 933/94(%), as last amended by Regulation (EC) No 2230/95 (), laid down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive; Whereas those active substances should be included in that Annex when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the en- vironment; Whereas such inclusion should be made for a period not exceeding 10 years; Whereas the Directive, at Article 8 (2), provides that after inclusion of an active substance in Annex I to the Dir- ective, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorizations of the plant protection products containing the active substance; whereas, in particular, Articles 4 (1) and 13 (1) of the Directive require that plant protection products are not authorized unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data require- ments laid down in Article 13; Whereas for imazalil the effects on human health and the environment have been assessed in accordance with the L 230, 19. 8. 1991, p. 1. L 265, 27. 9. 1997, p. 87. L 366, 15. 12. 1992, p. 10. L 170, 28. 6. 1997, p. 19. L 107, 28. 4. 1994, p. 8. L 225, 22. 9. 1995, p. 1. provisions laid down in Regulation (EEC) No 3600/92, for a number of uses proposed by the notifiers; whereas Belgium, acting on behalf of Luxembourg as designated rapporteur Member State pursuant to Regulation (EC) No 933/94, has submitted to the Commission on 15 July 1996 the relevant assessment report; Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalized on 11 July 1997 in the format of the Commis- sion review report for imazalil, in accordance with the provisions of Article 7 (6) of Regulation (EEC) No 3600/92; whereas it may be necessary to update this report from time to time to take into account technical and scientific developments; whereas in such case the conditions for the inclusion of imazalil in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6 (1) of that Directive; Whereas it has appeared from the assessments 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) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that, in all Member States, the granting, varying or with- drawing, as appropriate, of the authorizations of plant protection products containing the active substance concerned can be organized in accordance with the provi- sions of the Directive, and to ensure that this activity is not further delayed; Whereas before inclusion a reasonable deadline is neces- sary to permit Member States and the interested parties to prepare themselves to the new requirements which will result from the inclusion; whereas moreover after inclu- sion a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorizations or grant new authorizations in accordance with the provi- sions of Directive 91/414/EEC; whereas a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive; whereas, however, for plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive;