L 49/66 Official Journal of the European Union 22.2.2013 DIRECTIVES COMMISSION DIRECTIVE 2013/7/EU of 21 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include Alkyl (Cy;.1¢) dimethylbenzyl ammonium chloride 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: (1) ( ( ( b %) ’) O] O] 0] 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 (3 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 Quaternary ammonium compounds, benzyl- Cy.1¢-alkyldimethyl, chlorides, which is synonymous with Alkyl (Cy,.4) dimethylbenzyl ammonium chloride. Pursuant to Regulation (EC) No 1451/2007, Alkyl (Cq2.16) dimethylbenzyl ammonium chloride 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 that Directive. Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 August 2007 in accordance with Article 10(5) and (7) of 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 (). L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. L 307, 24.11.2003, p. 1. S 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 September 2012, in an assessment report. It appears from the evaluations that biocidal products used as wood preservatives and containing Alkyl (Ci5.1¢) dimethylbenzyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Alkyl (C;,.1¢) dimethylbenzyl ammonium chloride for use in product type 8 in Annex I to that Directive. Not all potential uses and exposure scenarios have been evaluated at Union level. For example, neither use by non-professionals, nor exposure of food or feeding stuff were assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, that products are used with appropriate personal protective equipment, and that products are not applied on wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level. In view of the risks identified for the environment, it is appropriate to require that industrial or professional application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of products used as wood preservatives and containing Alkyl (Cyy4) dimethylbenzyl ammonium chloride are collected for reuse or disposal.