Directive 2008/116 - Amendment of Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor as active substances - Main contents

EN

Official Journal of the European Union

L 337/86

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes aclonifen, imidacloprid and metazachlor.

For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For aclonifen and imidacloprid the rapporteur Member State was Germany and all relevant information was submitted on 11 September 2006 and on 13 June 2006 respectively. For metazachlor the rapporteur Member State was United Kingdom and all relevant information was submitted on 30 September 2005.

The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 31 July 2008 for aclonifen, on 29 May 2008 for imidacloprid and on 14 April 2008 for metazachlor in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 26 September 2008 in the format of the Commission review reports for aclonifen, imidacloprid and metazachlor.

It has appeared from the various examinations made that plant protection products containing aclonifen, imidacloprid and metazachlor may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that aclonifen should be subjected to further testing for evaluation of residues in rotational crops and for the confirmation of the risk assessment for birds, mammals, aquatic organisms and non-target plants and that imidacloprid should be subjected to further testing for confirmation of the risk assessment for operators and workers and the risk to birds and mammals and such studies should be presented by the notifier. Furthermore for metazachlor it is appropriate to obtain additional information on certain specific points. Article 5(5) of Directive 91/414/EEC provides that an inclusion may be reviewed at any time if there are indications...