Commission Decision

of 26 April 2004

allowing Member States to extend provisional authorisations granted for the new active substance profoxydim

(notified under document number C(2004) 1512)

(Text with EEA relevance)

(2004/400/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular the fourth subparagraph of Article 8(1) thereof,

Whereas:

(1) In accordance with Article 6(2) of Directive 91/414/EEC, in March 1998 Spain received an application from BASF AG for the inclusion of the active substance profoxydim (former names: clefoxydim, BAS 625H) in Annex I to Directive 91/414/EEC. Decision 1999/43/EC(2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to the Directive.

(2) Confirmation of the completeness of the dossier was necessary in order to allow it to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods up to three years, for plant protection products containing profoxydim, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the condition relating to the detailed assessment of the active substance and the plant protection product in the light of the requirements laid down by that Directive.

(3) For profoxydim, 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 rapporteur Member State submitted the draft assessment report to the Commission on 28 March 2001.

(4) The examination of the dossier is still ongoing after submission of the draft assessment reports by the rapporteur Member State and it will not be possible to complete the evaluation within the timeframe foreseen by Directive 91/414/EEC.

(5) As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing profoxydim for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossier to continue. It is expected that the evaluation and decision-making process with respect to a decision on possible Annex I inclusion for profoxydim will have been completed within 24 months.

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

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant protection products containing profoxydim for a period not exceeding 24 months from the date of adoption of this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 26 April 2004.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 230, 19.08.1991, p. 1. Directive as last amended by Commission Directive 2004/30/EC (OJ L 77, 13.3.2004, p. 50).

(2) OJ L 14, 19.1.1999, p. 30.