Commission Directive 2008/75/EC of 24 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex I thereto (Text with EEA relevance)

25.7.2008 EN Official Journal of the European Union L 197/54
COMMISSION DIRECTIVE 2008/75/EC
of 24 July 2008
amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide 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 1451/2007 of 4 December 2007 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 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annexes I, IA or IB to Directive 98/8/EC. That list includes carbon dioxide.
(2) Pursuant to Regulation (EC) No 1451/2007, carbon dioxide 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) France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 15 May 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 June 2007, in an assessment report, with a proposal to include carbon dioxide in Annex IA to Directive 98/8/EC, only for use in ready-for-use gas canisters functioning together with a trapping device.
(5) An active substance listed in Annex IA should normally also be listed in Annex I. Inclusion in Annex I would cover those uses for which products may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, but not those of low-risk products. Such is the case of certain biocidal products used as rodenticides and containing carbon dioxide. It is therefore appropriate to include carbon dioxide in Annex I for product-type 14, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing carbon dioxide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
(6) The assessment report was modified accordingly, and was reviewed by the Standing Committee on Biocidal Products on 29 November 2007.
(7) The review of carbon dioxide did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.
(8) The evaluation at the Community level was carried out for one specific use. In addition, in accordance with Article 8(5) of the Directive, some information was not submitted, and thus not assessed. 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.
(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 carbon dioxide 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 carbon dioxide 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,