L 203/58 Official Journal of the European Union 5.8.2009 COMMISSION DIRECTIVE 2009/98/EC of 4 August 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include boric oxide 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 (!), 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 Annex I, TA or IB to Directive 98/8/EC. That list includes boric oxide. Pursuant to Regulation (EC) No 1451/2007, boric oxide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 988 /EC. The Netherlands was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 7 July 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. 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 20 February 2009, in an assessment report. It appears from the examinations made that biocidal products used as wood preservatives and containing boric oxide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include boric oxide in Annex I, L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. in order to ensure that in all Member States authori- sations for biocidal products used as wood preservatives and containing boric oxide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98)8[EC. However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment. 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 appro- priate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels. 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 boric oxide and used as wood preservatives. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products should also be used with appropriate protective equipment if the risk identified for professional and industrial users cannot be reduced by other means. 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 boric oxide and also to facilitate the proper operation of the biocidal products market in general. 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.