10.2.2010 Official Journal of the European Union L 37/37 COMMISSION DIRECTIVE 2010/8/EU of 9 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto (Text with EEA relevance) 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 the second subparagraph of Article 16(2) thereof, Whereas: () ) 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 (%) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, A or IB to Directive 98/8/EC. That list includes warfarin sodium. Pursuant to Regulation (EC) No 1451/2007, warfarin sodium 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. Ireland was designated as Rapporteur Member State and submitted its report, together with a recommendation, to the Commission on 3 October 2005 in accordance with Article 14(4) and 14(6) of Regulation (EC) No 1451/200 7. 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 17 September 2009, in an assessment report. L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. () It appears from the examinations made that biocidal products used as rodenticides and containing warfarin sodium may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals. However, warfarin sodium is for the time being considered essential for reasons of public health and hygiene. It is therefore appropriate to include warfarin sodium in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing warfarin sodium can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. 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 warfarin sodium and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals. To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed for all rodenticides containing warfarin sodium, while other conditions should be imposed by the Member States on a case by case basis. In view of the identified risks, warfarin sodium 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 [ is renewed. 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 warfarin sodium and 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 to bring into force the laws, regu- lations and administrative provisions necessary to comply with this Directive.