COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011

of 20 July 2011

approving the active substance imazalil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

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(1), 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(2) 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(3), 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(4), 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(5).

(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(6) 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(7) 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(8) 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:

Article 1

Approval of active substance

The active substance imazalil, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Re-evaluation of plant protection products

1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing imazalil as an active substance by 30 June 2012.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2. By way of derogation from paragraph 1, for each authorised plant protection product containing imazalil as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

(a) in the case of a product containing imazalil as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

(b) in the case of a product containing imazalil as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

Article 3

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 4

Repeal

Directive 2010/57/EU is repealed.

Article 5

Entry into force and date of application

This Regulation shall enter into force on the 20th day following its publication in the

Official Journal of the European Union

It shall apply from 1 January 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 July 2011.

For the Commission

The President

José Manuel BARROSO

(1)

OJ L 309, 24.11.2009, p. 1

(2)

OJ L 230, 19.8.1991, p. 1

(3)

OJ L 169, 29.6.2007, p. 10

(4)

OJ L 153, 11.6.2011, p. 1

(5)

OJ L 214, 9.8.2008, p. 70

(6) 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.

(7)

OJ L 366, 15.12.1992, p. 10

(8)

OJ L 225, 27.8.2010, p. 5

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity(1)

Date of approval

Expiration of approval

Specific provisions

Imazalil

CAS No 35554-44-0

73790-28-0 (replaced)

CIPAC No 335

(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole

allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

≥ 950 g/kg

1 January 2012

31 December 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States shall:

(1)

pay particular attention to the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

(2)	pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;

(3)	pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

(4)

ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;

(5)	pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)	route of degradation of imazalil in soil and surface water systems;

(b)	environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;

(c)	a hydrolysis study to investigate the nature of residues in processed commodities.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

(1) Further details on identity and specification of active substance are provided in the review report.

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1) in Part A, the entry relating to imazalil is deleted;

(2) in Part B, the following entry is added: