L 196/18 Official Journal of the European Union 19.7.2013 DIRECTIVES COMMISSION DIRECTIVE 2013/41/EU of 18 July 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include 1R-trans phenothrin 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) 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 d-phenothrin. Pursuant to Regulation (EC) No 1451/2007, d- phenothrin has been evaluated in accordance with Article 11(2) of Directive 988/EC for use in product- type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. The data submitted for the purpse of the evaluation allowed conclusions to be drawn only regarding a certain form of d-phenothrin, i.e. a substance containing at least 89 % w/w of 1R-trans phenothrin. In accordance with current practice for naming of substances (%), that substance should be considered as mono-constituent and named 1R-trans phenothrin. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of d-phenothrin in the abovementioned list of active substances in Regu- lation (EC) No 1451/2007. Therefore, only 1R-trans phenothrin should be included in Annex I to Directive 98/8/EC based on the existing evaluation. () OJ L 123, 24.4.1998, p. 1. () OJ L 325, 11.12.2007, p. 3. (}) See in particular Guidance for identification and naming of substances under REACH and CLP, ECHA-11-G-10.1-EN, p. 19 f. S Ireland was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 29 July 2010 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 1 March 2013, in an assessment report. It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing 1R-trans phenothrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appro- priate to include 1R-trans phenothrin for use in product- type 18 in Annex I to that Directive. Not all potential uses and exposure scenarios have been evaluated at Union level. 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 for ultra low volume (ULV) application, and that products are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means. In view of the risks identified for the environment, it is appropriate to require that product authorisations are subject to appropriate risk mitigation measures for the protection of honey bees.