THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 13(2) and Article 78(2) thereof,
Whereas:
(1)
In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply to active substances listed in Annex I to 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, with respect to the procedure and the conditions for approval. Imazalil is listed in Annex I to Regulation (EC) No 737/2007.
(2)
The approval of imazalil, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances, expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of imazalil in Annex I to Directive 91/414/EEC within the time period provided for in that Article.
(3)
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, prohexadione and spiroxamine, and establishing the list of the notifiers concerned.
(4)
Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with that Article together with an explanation as regards the relevance of each new study submitted.
(5)
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 active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.
(6)
The Authority communicated the assessment report to the notifier and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.
(7)
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 to the Commission on 4 March 2010. The assessment report and the conclusion of 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 17 June 2011 in the format of the Commission review report for imazalil.
(8)
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 approve imazalil.
(9)
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC.
(10)
Based on the review report which supports a lower level of purity compared to that set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, and taking into account that no toxicologically or ecotoxicologically significant impurities are present, the purity level should be modified.
(11)
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 imazalil should be approved, it is, in particular, appropriate to require further confirmatory information.
(12)
A reasonable period should be allowed to elapse before approval in order to permit Member States and interested parties to prepare themselves to meet the new requirements resulting from the approval.
(13)
Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing imazalil. Member States should, as appropriate, vary, replace or withdraw 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, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.
(14)
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.
(15)
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(16)
In the interest of clarity, 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 should be repealed.
(17)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION: