Commission Directive 2010/57/EU (repealed)Show full title

Commission Directive 2010/57/EU

of 26 August 2010

amending Annex I to Council Directive 91/414/EEC to renew the inclusion of imazalil as active substance

(Text with EEA relevance) (repealed)

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 imazalil 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 imazalil 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 9 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 the Member States and forwarded the comments received to the Commission. The Authority also makes available the assessment report available for 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 imazalil(4) to the Commission on 4 March 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 imazalil.

(7) It has appeared from the various examinations made that plant protection products containing imazalil 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 imazalil 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) Based on the review report which supports a lower level of purity compared to the level of inclusion of imazalil in Annex I to Directive 91/414/EEC and taking into account that no toxicologically or ecotoxicologically significant impurities are present, the purity level should be modified.

(9) It is necessary to include specific provisions requiring Member States, when authorising plant protection products containing imazalil, to pay particular attention to certain points or to ensure that appropriate risk mitigation measures are taken. In particular, the Member States should ensure that: the test materials used in the toxicity dossiers will be compared and verified against the specification of the technical material as commercially manufactured; the acute dietary exposure situation will pose no risk to the consumers, when reviewing maximum residue levels.

(10) From the new data submitted, it appears that imazalil and its degradation products in soil and surface water systems may cause risks for soil micro-organisms and aquatic organisms; negligible groundwater exposure needs to be confirmed; further investigation is needed on the nature of residues in processed commodities. Without prejudice to the conclusion that the inclusion of imazalil 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 as regards the route of degradation of imazalil in soil and surface water systems, environmental data to ensure that groundwater exposure is negligible and a hydrolysis study to investigate the nature of residues in processed commodities.

(11) 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.

(12) 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 imazalil 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.

(13) It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(14) 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:

(1)

OJ L 230, 19.8.1991, p. 1.

(2)

OJ L 169, 29.6.2007, p. 10.

(3)

OJ L 214, 9.8.2008, p. 70.

(4)

European Food Safety Authority: ‘Conclusion on the peer review of the pesticide risk assessment of the active substance imazalil’ on request from the European Commission, EFSA Journal 2010, 8(3):1526.