THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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(1), and in particular Article 11(4) thereof,
Whereas:
(1) The United Kingdom (UK) has received on 12 December 2005 an application from DuPont de Nemours S.A., in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance indoxacarb in its Annex I or IA for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC. Indoxacarb 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 UK submitted a competent authority report, together with a recommendation, to the Commission on 5 March 2007.
(3) The competent authority report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 28 May 2008, 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 or to control other arthropods and containing indoxacarb may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include indoxacarb in Annex I.
(5) Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels.
(6) In the light of the findings of the assessment report, it is also appropriate to require that risk mitigation measures are applied at product authorisation level to products containing indoxacarb and used as insecticides, acaricides or to control other arthropods.
(7) Such measures should be aimed at limiting the risks to non-target species and the aquatic environment. To this end, certain conditions such as ensuring that products are not placed in areas accessible to infants, children and companion animals and do not enter into contact with water should be imposed.
(8) 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.
(9) Directive 98/8/EC should therefore be amended accordingly.
(10) The Standing Committee on Biocidal Products was consulted on 30 May 2008 and delivered a positive opinion on the draft Commission Directive amending Annex I of Directive 98/8/EC to include indoxacarb as an active substance. On 11 June 2008 the Commission submitted the said draft for scrutiny by the European Parliament and the Council. The European Parliament did not oppose the draft measures within the set deadline. The Council opposed the adoption by the Commission indicating that the proposed measures exceeded the implementing powers provided for in Directive 98/8/EC. As a consequence, the Commission did not adopt the draft measures and submitted an amended draft of the concerned Directive to the Standing Committee on Biocidal Products. The Standing Committee was consulted on the said draft on 20 February 2009.
(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DIRECTIVE: