Commission Implementing Regulation (EU) No 1237/2012
of 19 December 2012
approving the active substance Zucchini Yellow Mosaic Virus — weak strain, 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,
Whereas:
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 16 March 2005 an application from Bio-Oz Biotechnologies Ltd for the inclusion of the active substance Zucchini Yellow Mosaic Virus — weak strain in Annex I to Directive 91/414/EEC. Decision 2006/586/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 30 June 2006.
It has appeared from the various examinations made that plant protection products containing Zucchini Yellow Mosaic Virus — weak strain may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Zucchini Yellow Mosaic Virus — weak strain.
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
Without prejudice to the obligations provided for in 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 six months after approval to review authorisations of plant protection products containing Zucchini Yellow Mosaic Virus — weak strain. 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.
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 1Approval of active substance
The active substance Zucchini Yellow Mosaic Virus — weak strain, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Re-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 Zucchini Yellow Mosaic Virus — weak strain as an active substance by 30 November 2013.
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 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 Zucchini Yellow Mosaic Virus — weak strain 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 May 2013 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 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 Zucchini Yellow Mosaic Virus — weak strain as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2014 at the latest; or
(b)
in the case of a product containing Zucchini Yellow Mosaic Virus — weak strain as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2014 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 the substance or substances, whichever is the latest.
Article 3Amendments 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 4Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 December 2012.
For the Commission
The President
José Manuel Barroso
ANNEX I
Common Name,Identification Numbers | IUPAC Name | Purity7 | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
Zucchini Yellow Mosaic Virus — weak strain ATCC accession number: PV-593 | Not applicable | ≥ 0,05 mg/l | 1 June 2013 | 31 May 2023 | 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 Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids. Conditions of use shall include risk mitigation measures, where appropriate. |
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name, Identification Numbers
IUPAC Name
Date of approval
Expiration of approval
Specific provisions
‘30
Zucchini Yellow Mosaic Virus — weak strain
ATCC accession number: PV-593
Not applicable
≥ 0,05 mg/l
1 June 2013
31 May 2023
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 Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids.
Conditions of use shall include risk mitigation measures, where appropriate.’