
Article 1 
Annex I to Directive 91/414/EEC is amended in accordance with the Annex to this Directive.
Article 2 
Member States shall adopt and publish by 31 January 2012 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 February 2012.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3 

1. Member States shall in accordance with Directive 91/414/EEC, where necessary amend or withdraw existing authorisations for plant protection products containing imazalil as an active substance by 31 January 2012.By that date they shall in particular verify that the conditions in Annex I to that Directive relating to imazalil are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
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 Annex I to Directive 91/414/EEC by 31 July 2011 at the latest, Member States shall, where necessary, re-evaluate the products, to take into account developments occurred in the scientific and technical knowledge and in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning imazalil. On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall, where necessary, amend or withdraw the authorisation by 31 July 2015.
3. By way of derogation from paragraphs 1 and 2, for each authorised plant protection product containing imazalil as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2011 at the latest, and at least one of which was included in Annex I to Directive 91/414/EEC between 1 January 2009 and 31 July 2011, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning imazalil. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.Following that determination Member States shall, where necessary, amend or withdraw the authorisation by 31 July 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
Article 4 
This Directive shall enter into force on 1 August 2011.
Article 5 
This Directive is addressed to the Member States.
Done at Brussels, 26 August 2010.
For the Commission
The President
José Manuel BARROSO
ANNEX

In Annex I to Directive 91/414/EEC, row No 1 is replaced by the following:

No Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions
‘1 imazalilCAS No 35554-44-073790-28-0 (replaced)CIPAC No 335 (RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazoleorallyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether ≥ 950 g/kg 1 August 2011 31 July 2021 
PART A Only uses as fungicide may be authorised.

PART B For the implementation of the uniform principles of Annex VI, 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 9 July 2010 shall be taken into account.
In this overall assessment Member States must pay particular attention to:

— 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,
— the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,
— 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,
— 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,
— risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate.
The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular confirmatory data on:

— route of degradation of imazalil in soil and surface water systems,
— environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible,
— a hydrolysis study to investigate the nature of residues in processed commodities.
They shall ensure that the notifier provides such information to the Commission by 31 October 2012.’


