19.3.2010   

EN

Official Journal of the European Union

L 69/11

(1)

In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 29 November 2002 an application from Dow AgroScience for the inclusion of the active substance penoxsulam in Annex I to Directive 91/414/EEC. Commission Decision 2004/131/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)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 9 January 2004 an application from DuPont Ltd for the inclusion of the active substance proquinazid in Annex I to Directive 91/414/EEC. Commission Decision 2004/686/EC (3) 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.

(3)

In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 23 August 2001 an application from Bayer CropScience for the inclusion of the active substance spirodiclofen in Annex I to Directive 91/414/EEC. Commission Decision 2002/593/EC (4) 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.

(4)

For those active substances, 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 applicants. The designated rapporteur Member States submitted a draft assessment report on 10 February 2005 (penoxsulam), 14 March 2006 (proquinazid) and 21 April 2004 (spirodiclofen).

(5)

The assessment reports were peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission in the format of the EFSA Scientific Reports on 31 August 2009 for penoxsulam (5), on 13 October 2009 (6) for proquinazid and on 27 July 2009 (7) for spirodiclofen. These reports and the draft assessment reports were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2010 in the format of the Commission review reports for penoxsulam, proquinazid and spirodiclofen.

(6)

It has appeared from the various examinations made that plant protection products containing the active substances concerned 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 penoxsulam, proquinazid and spirodiclofen in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards penoxsulam, to require that the notifier submits further information on the off-field risk to higher aquatic plants.

(8)

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 penoxsulam, proquinazid or spirodiclofen 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.

(9)

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

(10)

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 penoxsulam, proquinazid or spirodiclofen as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2012 at the latest; or

(b)

in the case of a product containing penoxsulam, proquinazid or spirodiclofen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2012 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.