Commission Directive 2013/27/EU of 17 May 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include chlorfenapyr 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⁽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 Annex I, IA or IB to Directive 98/8/EC. That list includes chlorfenapyr.

2. Pursuant to Regulation (EC) No 1451/2007, chlorfenapyr 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.

3. Portugal was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission in August 2006 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⁽³⁾.

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 14 December 2012, in an assessment report.

5. It appears from the evaluations that biocidal products used as wood preservatives and containing chlorfenapyr may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include chlorfenapyr for use in product-type 8 in Annex I to that Directive.

6. 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.

7. In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, and that products are used with appropriate personal protective equipment, and that products are only authorised for industrial or professional users, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

8. 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 chlorfenapyr are collected for reuse or disposal.

9. Unacceptable risks for the environment were identified for situations where wood treated with chlorfenapyr was used outdoors. It is therefore appropriate to require that products are not authorised for the treatment of wood intended for outdoor use, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

10. The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 8 containing the active substance chlorfenapyr and also to facilitate the proper operation of the biocidal products market in general.

11. A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and 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.

12. After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

13. Directive 98/8/EC should therefore be amended accordingly.

14. In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents⁽⁴⁾, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

15. The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE: