Official Journal of the European Union
of 31 August 2004
allowing Member States to extend provisional authorisations granted for the new active substances etoxazole and carvone
(notified under document number C(2004) 3136)
(Text with EEA relevance)
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,
In accordance with Article 6(2) of Directive 91/414/EEC, in April 1998 Spain received an application from Sumitomo Chemical Agro Europe SA for the inclusion of the active etoxazole in Annex I to Directive 91/414/EEC. Commission 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 that Directive.
In March 1997 the Netherlands received an application from Luxan BV concerning carvone (former name: L 91105D). Commission Decision 1999/610/EC (3) 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 that Directive.
Confirmation of the completeness of the dossiers was necessary in order to allow them 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 the active substances concerned, 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.
For these 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 respective applicants. The rapporteur Member States submitted the draft assessment reports to the Commission on 12 October 2001 (etoxazole) and 16 October 2000 (carvone).
Following submission of the draft assessment reports by the rapporteur Member States, it has been necessary to request further information from the applicants and to have the rapporteur Member State examine that information and submit their assessments. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluation within the time-frame provided for in Directive 91/414/EEC.
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 the active substances concerned 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 dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on possible Annex I inclusion for each of the active substances concerned will have been completed within 24 months.
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:
Member States may extend provisional authorisations for plant protection products containing etoxazole or carvone for a period not exceeding 24 months from the date of adoption of this Decision.
This Decision is addressed to the Member States.
Done at Brussels, 31 August 2004.
For the Commission
Member of the Commission
(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71 (OJ L 127, 29.4.2004, p. 104).
(2) OJ L 14, 19.1.1999, p. 30.
(3) OJ L 242, 14.9.1999, p. 29.