Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto (Text with EEA relevance)

30.11.2007 EN Official Journal of the European Union L 312/23
COMMISSION DIRECTIVE 2007/69/EC
of 29 November 2007
amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto
(Text with EEA relevance)
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 the second subparagraph of Article 16(2) thereof,
Whereas:
(1) Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes difethialone.
(2) Pursuant to Regulation (EC) No 2032/2003, difethialone has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
(3) Norway was designated as Rapporteur and submitted the competent authority report, together with a recommendation, to the Commission on 11 October 2005 in accordance with Article 10(5) and (7) of Regulation (EC) No 2032/2003.
(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 June 2007, in an assessment report.
(5) The review of difethialone did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.
(6) It appears from the examinations made that biocidal products used as rodenticides and containing difethialone may be expected not to present a risk to humans except for accidental incidents with children. Regarding non-target animals and the environment a risk has been identified. However, difethialone is for the time being considered essential for reasons of public health and hygiene. It is therefore justified to include difethialone in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing difethialone can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
(7) In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing difethialone and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals as well as the long term effects of the substance on the environment.
(8) Because of the identified risks and its characteristics, which render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate difethialone should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.
(9) 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 difethialone and also to facilitate the proper operation of the biocidal products market in general.
(10) 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 entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
(11) After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing difethialone to ensure that they comply with Directive 98/8/EC.
(12) Directive 98/8/EC should therefore be amended accordingly.
(13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,