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 Article 6(1) thereof,
Whereas:
(1) In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 27 June 1996 an application from Spiess-Urania Chemicals GmbH for the inclusion of the active substance imazosulfuron in Annex I to Directive 91/414/EEC. Commission Decision 97/865/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) Belgium received an application under Article 6(2) of Directive 91/414/EEC on 29 March 2001 from Goëmar SA for the inclusion of the active substance laminarin in Annex I to Directive 91/414/EEC. Commission Decision 2001/861/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) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 21 February 2000 from Rohm and Haas France SA (now Dow AgroSciences) for the inclusion of the active substance methoxyfenozide in Annex I to Directive 91/414/EEC. Commission Decision 2001/385/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) Belgium received an application under Article 6(2) of Directive 91/414/EEC on 1 August 1997 from Novartis NV (now Syngenta) for the inclusion of the active substance s-metolachlor in Annex I to Directive 91/414/EEC. Commission Decision 98/512/EC(5) 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.
(5) 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 draft assessment reports concerning the substances to the Commission on 17 June 1998 (imazosulfuron), on 2 June 2003 (laminarin), on 2 August 2002 (methoxyfenozide) and 3 May 1999 (s-metolachlor).
(6) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 8 October 2004 in the format of the Commission review reports for imazosulfuron, laminarin, methoxyfenozide and s-metolachlor.
(7) For imazosulfuron, the dossier and the information from the review were also submitted to the Scientific Committee on Plants. The report of this Committee was formally adopted on 25 April 2001(6).
(8) The Committee was asked to comment on the relevance of the metabolite IPSN due to its presence in soil and water. In its opinion the Committee concluded that there is no significant health risk arising from IPSN in the groundwater, and that the risk to soil micro-organisms, aquatic invertebrates, fish and the acute risk to earthworms are sufficiently addressed. The Committee also concluded that on the basis of worst-case exposure estimates further information is required to assess some other risks from IPSN. The Committee finally concluded that the risk to the environment and the toxicological risk to human health from the parent substance and/or metabolites other than IPSN, in some studies formed at levels comparable to IPSN, have not been fully assessed and therefore should be addressed during the further evaluation.
(9) The recommendations of the Scientific Committee were taken into account during the further review, in this Directive and in the Review Report.
(10) With respect to IPSN, additional data on the risk based on worst-case exposure estimates and identified by the Scientific Committee have been delivered by the notifier and assessed. The evaluation within the Standing Committee concluded that in the light of the additional data submitted by the notifier, and under the proposed conditions of use, there would be no harmful effect on humans from IPSN.
(11) With respect to imazosulfuron and other metabolites than IPSN, no other metabolites than IPSN occur in levels that are considered as ‘relevant’ in the sense of the provisions of Directive 91/414/EEC. Therefore the evaluation within the Standing Committee concluded that the risk can be assessed with the data available.
(12) Following this assessment, the evaluation within the Standing Committee furthermore concluded that under the proposed conditions of use, in particular the maximum dose rate of 0,05 kg active substance/ha, and when appropriate risk mitigation measures are applied, there would be no harmful effect on humans and no unacceptable risk to the environment from imazosulfuron and its metabolites.
(13) The review of laminarin, methoxyfenozide and s-metolachlor did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority.
(14) 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 imazosulfuron, laminarin, methoxyfenozide and s-metolachlor in Annex I, 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.
(15) After inclusion of imazosulfuron, laminarin, methoxyfenozide and s-metolachlor in Annex I to Directive 91/414/EEC, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing those substances and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
(16) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(17) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/99/EC (OJ L 309, 6.10.2004, p. 6).
Opinion of the Scientific Committee on Plants regarding the inclusion of imazosulfuron in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market — SCP/IMAZO/002-Final, published 21 May 2001.