THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(), and in particular Article 11(4) thereof,
Whereas:
(1) The United Kingdom received on 23 December 2005 an application from Sumitomo Chemical (UK) Plc, in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance metofluthrin in its Annex I for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC. Metofluthrin was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product.
(2) After carrying out an evaluation, the United Kingdom submitted its evaluation report, together with a recommendation, to the Commission on 19 June 2008.
(3) The report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 27 May 2010, and the findings of the review were incorporated in an assessment report.
(4) It appears from the examinations made that biocidal products used as insecticides, acaricides and products to control other arthropods and containing metofluthrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include metofluthrin in Annex I to that Directive.
(5) Not all potential uses have been evaluated at the European level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the European level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
(6) It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance metofluthrin and to facilitate the proper operation of the biocidal market in general.
(7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.
(8) Directive 98/8/EC should therefore be amended accordingly.
(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DIRECTIVE: