(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 tolylfluanid.

(2)

Pursuant to Regulation (EC) No 1451/2007, tolylfluanid 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 98/8/EC.

(3)

Finland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 24 April 2006 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(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 15 May 2009, in an assessment report.

(5)

It appears from the examinations made that biocidal products used as wood preservatives and containing tolylfluanid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include tolylfluanid in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing tolylfluanid can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

(6)

However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, products containing tolylfluanid and used as wood preservatives should not be authorised for those uses.

(7)

In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing tolylfluanid and used as wood preservatives to ensure that risks are reduced to an acceptable level in accordance with Article 5 of Directive 98/8/EC and Annex VI thereto. In particular, it is appropriate to require that products intended for industrial or professional use be used with appropriate protective equipment unless it can be demonstrated that risks for industrial or professional users can be reduced by other means. Appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Instructions should therefore be provided to indicate that treated timber must be stored after treatment under shelter and/or on impermeable hard standing and that any losses must be collected for reuse or disposal.

(8)

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 tolylfluanid and also to facilitate the proper operation of the biocidal products market in general.

(9)

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.

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing tolylfluanid to ensure that they comply with Directive 98/8/EC.

(11)

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

(12)

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