Commission Directive 2010/85/EU
of 2 December 2010
amending Council Directive 91/414/EEC to include zinc phosphide as active substance and amending Decision 2008/941/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
The application was submitted to Germany, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/941/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
It has appeared from the various examinations made that plant protection products containing zinc phosphide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include zinc phosphide in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing zinc phosphide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment 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.
It is therefore appropriate to amend Directive 91/414/EEC accordingly.
Decision 2008/941/EC concerning the non-inclusion of certain active substances in Annex I to Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances provides for the non-inclusion of zinc phosphide and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning zinc phosphide in the Annex to that Decision.
It is therefore appropriate to amend Decision 2008/941/EC accordingly.
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:
Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2
The line concerning zinc phosphide in the Annex to Decision 2008/941/EC is deleted.
Article 3
Member States shall adopt and publish by 31 October 2011 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 November 2011.
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 4
1.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing zinc phosphide as an active substance by 1 November 2011.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to zinc phosphide 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 zinc phosphide 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 30 April 2011 at the latest, 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 zinc phosphide. 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:
(a)
in the case of a product containing zinc phosphide as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or
(b)
in the case of a product containing zinc phosphide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 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 5
This Directive shall enter into force on 1 May 2011.
Article 6
This Directive is addressed to the Member States.
Done at Brussels, 2 December 2010.
For the Commission
The President
José Manuel Barroso
ANNEX
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:
No
Common Name, Identification Numbers
IUPAC Name
Entry into force
Expiration of inclusion
Specific provisions
‘319
Zinc phosphide
CAS No: 1314-84-7
CIPAC No: 69
Trizinc diphosphide
≥ 800 g/kg
1 May 2011
30 April 2021
PART A
Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.
In this overall assessment Member States should pay particular attention to:
the protection of non-target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.’