Commission Directive 2009/77/EC
of 1 July 2009
amending Council Directive 91/414/EEC to include chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron as active substances
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Whereas:
For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For chlorsulfuron and cyromazine the rapporteur Member State was Greece and all relevant information was submitted on 27 July 2007 and on 31 August 2007. For dimethachlor and penconazole the rapporteur Member State was Germany and all relevant information was submitted on 2 May 2007 and on 19 June 2007 respectively. For etofenprox the rapporteur Member State was Italy and all relevant information was submitted on 15 July 2005. For lufenuron the rapporteur Member State was Portugal and all relevant information was submitted on 20 September 2006. For tri-allate the rapporteur Member State was the United Kingdom and all relevant information was submitted on 6 August 2007. For triflusulfuron the rapporteur Member State was France and all relevant information was submitted on 26 July 2007.
It has appeared from the various examinations made that plant protection products containing chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.
Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, for lufenuron, dimethachlor and chlorsulfuron the notifiers should be required to submit further information on the chemical specification of the active substances as manufactured. Furthermore, for cyromazine and penconazole it is appropriate to require that the notifiers submit further information on the fate and behaviour of the soil metabolite NOA 435343 (for cyromazine) and U1 (for penconazole) and on the risk to aquatic organisms. Moreover, it is appropriate as regards tri-allate, to require that the notifier submit further information on the primary plant metabolism, the fate and behaviour of the soil metabolite diisopropylamine, the potential for biomagnification in aquatic food chains, the risk to fish-eating mammals and the long-term risk to earthworms. In addition, it is appropriate for the etofenprox to require that the notifier submit further information on the risk to aquatic organisms, including the risk to sediment dwellers, further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study) and biomagnification. Finally, for dimethachlor, chlorsulfuron and triflusulfuron, the notifiers should be required to submit further information on the toxicological relevance of metabolites in case the substance is classified as carcinogenic category 3.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
It is therefore appropriate to amend Directive 91/414/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,
HAS ADOPTED THIS DIRECTIVE: