Commission Decision
of 12 July 2001
making it possible for Member States to extend provisional authorisations granted for the new active substances benzoic acid and BAS 615H (cinidon-ethyl)
(notified under document number C(2001) 1861)
(Text with EEA relevance)
(2001/529/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), as last amended by Commission Directive 2001/36/EC(2) and in particular Article 8(1), fourth subparagraph, thereof,
Whereas:
(1) Directive 91/414/EEC (hereinafter "the Directive") has provided for the development of a Community list of active substances authorised for use in plant-protection products.
(2) The applicant Menno Chemie Vertriebs-Ges. submitted a dossier for the new active substance benzoic acid to Germany on 25 May 1998.
(3) The applicant BASF Plc submitted a dossier for the new active substance BAS 615H to the United Kingdom on 28 April 1997.
(4) In accordance with the provisions of Article 6(3) of the Directive, the Commission confirmed in its Decision 98/676/EC(3) that the dossier submitted for benzoic acid could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive.
(5) In accordance with the provisions of Article 6(3) of the Directive, the Commission confirmed in its Decision 98/398/EC(4) that the dossier submitted for BAS 615H (cinidon-ethyl) could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant-protection product containing this active substance, of Annex III to the Directive.
(6) Such confirmation of data and information is necessary to permit a detailed examination of the dossier and to allow Member States the possibility of granting provisional authorisations, for a period up to three years, for plant-protection products containing the active substance concerned, while complying with the conditions laid down in Article 8(1) of the Directive 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 the Directive.
(7) For benzoic acid the effects on human health and the environment are being assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant. Germany acting as nominated rapporteur Member State submitted to the Commission on 12 December 2000 the draft assessment report concerned. The submitted report is being reviewed by the Member States and the Commission within the framework of the Standing Committee on Plant Health and in Working Groups thereof.
(8) For BAS 615H (cinidon-ethyl) the effects on human health and the environment are being assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant. The United Kingdom acting as nominated rapporteur Member State submitted to the Commission on 2 November 1998 the draft assessment report concerned. The submitted report is being reviewed by the Member States and the Commission within the framework of the Standing Committee on Plant Health and in working groups thereof.
(9) It will not be possible to complete the evaluation of the dossiers within three years of the adoption of the Decisions on completeness referred to above because the examination of the dossiers after submission of the draft assessment reports by the respective rapporteur Member States has taken longer than three years.
(10) Member States should be given the possibility of prolonging provisional authorisations granted of plant protection products containing these active substances for a period of 12 months in accordance with the provisions of Article 8 of the Directive so as to enable examination of the dossiers to continue. It is expected that within 12 months the completion of 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.
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DECISION:
Article 1
Member States may extend provisional authorisations for plant-protection products containing benzoic acid or BAS 615H (cinidon-ethyl) for a period not exceeding 12 months from the date of adoption of this Decision.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 12 July 2001.