1.12.2009   

EN

Official Journal of the European Union

L 314/69

(1)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 17 March 2003 an application from Nisso Chemical Europe GmbH for the inclusion of the active substance cyflufenamid in Annex I to Directive 91/414/EEC. Commission Decision 2003/636/EC (2) 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.

(2)

For that active substance, the effects on human 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 January 2006.

(3)

The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for cyflufenamid on 8 April 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 2 October 2009 in the format of the Commission review report for cyflufenamid.

(4)

It has appeared from the various examinations made that plant protection products containing cyflufenamid 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 include cyflufenamid in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

(5)

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 six months after inclusion to review existing provisional authorisations of plant protection products containing cyflufenamid 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.

(6)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

in the case of a product containing cyflufenamid as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or

(b)

in the case of a product containing cyflufenamid as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 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.