L 206/16 Official Journal of the European Communities 5.8.1999 COMMISSION DIRECTIVE 1999/73[EC of 19 July 1999 including an active substance (spiroxamine) 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 Council Directive 99/1/EC (%), hereafter referred to as the Directive, and in partic- ular Article 6(1); 1) Whereas in accordance with Article 6(2) of Directive 91/414/EEC Germany received on 13 October 1995 an application from Bayer AG, hereafter referred to as the applicant, for the inclusion of the active substance spir- oxamine in Annex I to the Directive; Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in Decision 96/522[EC of 29 July 1996 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of spiroxamine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (}) that the dossier submitted for spiroxamine could be considered as satisfying, in prin- ciple, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive; Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in 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 environment; Whereas for spiroxamine, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant; whereas Germany acting as nominated rapporteur Member State, has submitted to the Commission on 5 February 1997 the assessment report concerned; 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 L 230, 19.8.1991, p. 1. L 21, 28.1.1999, p. 21. L 220, 30.8.1996, p. 23. been finalised on 12 May 1999 in the format of the Commission review report for spiroxamine; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of spiroxa- mine in Annex [ to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive; Whereas the dossier and the information from the review have also been submitted to the Scientific Committee on Plants for opinion; whereas this Committee has given its opinion on 18 December 1998 (%); whereas this Committee identified potential risks to algae, sediment - dwelling organisms and possibly plants; whereas therefore, where appropriate, risk mitigation measures must be taken; whereas for operator exposure, this Committee concluded that with the use of personal protective equipment (PPE), the esti- mated operator exposure was acceptable; whereas there- fore appropriate protective measures will need to be taken in order to ensure operator safety; whereas these conclusions are also consistent with the issues high- lighted in the review carried out within the framework of the Standing Committee on Plant Health; Whereas 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), (b) and (3) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is neces- sary to include the active substance concerned in Annex [, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accord- ance with the provisions of the said Directive; Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing spiroxamine and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive; whereas a longer period may also be required for plant protection products containing spiroxamine and other active substances included in Annex I (*) SCP[Spirox/004-final dated 18 January 1999.