Commission Directive 2008/108/EC

of 26 November 2008

amending Council Directive 91/414/EEC to include flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat as active substances

(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 market1, and in particular Article 6(1) thereof,

Whereas:

(1)
Commission Regulations (EC) No 451/20002 and (EC) No 1490/20023 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 flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat.
(2)

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 flutolanil the rapporteur Member State was Finland and all relevant information was submitted on 13 June 2005. For benfluralin the rapporteur Member State was Belgium and all relevant information was submitted on 16 February 2006. For fluazinam the rapporteur Member State was Austria and all relevant information was submitted on 3 January 2006. For fuberidazole and mepiquat the rapporteur Member State was the United Kingdom and all relevant information was submitted on 5 April 2005.

(3)
The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 3 March 2008 for flutolanil and benfluralin, on 26 March 2008 for fluazinam, on 14 November 2007 for fuberidazole and on 14 April 2008 for mepiquat in the format of the EFSA Scientific Reports4. 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 20 May 2008 in the format of the Commission review reports for flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat.
(4)

It has appeared from the various examinations made that plant protection products containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat 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.

(5)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that benfluralin should be subject to further testing for confirmation of the risk assessment for consumers and for aquatic organisms and that fluazinam should be subject to further testing for confirmation of the risk assessment for aquatic organisms and soil macro-organisms and such studies should be presented by the notifiers.

(6)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(7)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(8)
The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/925 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.
(9)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(10)

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: