Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance  Text with EEA relevance

21.8.2010 EN Official Journal of the European Union L 220/67
COMMISSION DIRECTIVE 2010/55/EU
of 20 August 2010
amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance
(Text with EEA relevance)
THE EUROPEAN COMMISSION
,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
Whereas:
(1) The inclusion of azoxystrobin in Annex I to Directive 91/414/EEC expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (2) for the renewal of the inclusion of azoxystrobin as active substance in Annex I to Directive 91/414/EEC within the time period provided for in that Article.
(2) That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadion-calcium and spiroxamin, and establishing the list of the notifiers concerned (3).
(3) Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with Article 6 of Regulation (EC) No 737/2007 together with an explanation as regards the relevance of each new study submitted.
(4) The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter: ‘the Authority’) and the Commission on 10 June 2009. In addition to the assessment of the substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.
(5) The Authority communicated the assessment report to the notifier and to all Member States, and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.
(6) At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority, the Authority presented its conclusion on the peer review of the risk assessment of azoxystrobin (4) to the Commission on 6 April 2010. The assessment report and the conclusion from the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 9 July 2010 in the format of the Commission review report for azoxystrobin.
(7) It has appeared from the various examinations made that plant protection products containing azoxystrobin may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to renew the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC, in order to ensure that plant protection products containing this active substance may continue to be authorised where they comply with that Directive.
(8) Moreover, the review has established that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern and therefore its presence in the technical material must not exceed the maximum level of 2 grams for kilogram.
(9) From the new data submitted, it appears that azoxystrobin may cause risks for aquatic organisms. Without prejudice to the conclusion that the inclusion of azoxystrobin is to be renewed, it is therefore appropriate to obtain further information on those specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the notifier submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the risk for groundwater contamination with respect to some minor soil transformation products and the risk for aquatic organisms.
(10) A reasonable period should be allowed to elapse before the inclusion of an active substance in Annex I to Directive 91/414/EEC is renewed in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the renewal.
(11) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of renewing the inclusion of an active substance in Annex I thereof, Member States should be allowed a period of six months after renewal to review authorisations of plant protection products containing azoxystrobin to make sure that the requirements laid down in Directive 91/414/EEC, in particular in its Article 13, and the relevant conditions set out in Annex I to that Directive, continue to be satisfied. As appropriate, Member States should renew, where appropriate with modifications, or refuse to renew authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update 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.
(12) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,