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

Sweden was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 31 October 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. It follows from the report that the evaluation only covers Grade B and Grade C creosote as specified in European Standard EN 13991:2003.

A stakeholder consultation was launched on 30 April 2008. The outcome of the consultation was made public and discussed in the 30th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market.

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 December 2010 in an assessment report.

It appears from the assessment report that wood preservatives containing creosote may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, when applied on wood in some of the scenarios evaluated. Furthermore, there were strong indications in the abovementioned stakeholder consultation that there are considerable socioeconomic benefits of using creosote in certain applications. Life cycle analyses submitted and published in the context of the consultation have suggested that, in certain cases, no appropriate alternatives to creosote exist, which are less damaging to the environment. It is therefore appropriate to include creosote in Annex I.

However, for certain wood use scenarios presented in the assessment report, unacceptable risks for the environment were identified in the risk assessment.

A guidance document adopted by Decision 2009/4 of the Executive Body to the 1979 Convention on Long-Range Transboundary Air Pollution lists best available techniques to control emissions of POPs from major stationary sources. Part E of Section V of that guidance document specifically addresses emissions of PAHs associated with the preservation of wood using coal tar derived products containing PAHs, such as creosote. The techniques relate to impregnation, storage, handling and use of the wood, and include using alternatives that minimise reliance on PAH-based products. It also recommends best available techniques to be applied if treated wood is burned.

According to the second subparagraph of Article 6(2) of Regulation (EC) No 850/2004 read in conjunction with Annex III to that Regulation, Member States are required to adopt action plans including measures to promote the development and, where they deem appropriate, require the use of substitute or modified materials, products and processes to prevent the formation and release of PAHs. Pursuant to Article 3(3) of Regulation (EC) No 850/2004, Member States and the Commission shall, within the assessment and authorisation schemes for existing chemicals and pesticides under the relevant Union legislation, take appropriate measures to control existing chemicals and pesticides which exhibit characteristics of POPs.

It is therefore appropriate to limit the inclusion to 5 years only and to make it 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 I is renewed.

Furthermore, biocidal products containing creosote should be authorised only for applications where, all local and other circumstances taken into account, no appropriate alternatives are available. When an application is made for product authorisation or mutual recognition, the Member State receiving the application should therefore ask the applicant for an analysis regarding the technical and economic feasibility of substitution. Based on this analysis and any other information available to it, an authorising Member State should justify their conclusion that there are no appropriate alternatives and report the justification to the Commission at a stage when product authorisations can be expected to have been granted. In this context, to increase transparency, it is appropriate to require Member States to include in the report their information on how the development of alternatives is promoted in accordance with Article 6(2) of Regulation (EC) No 850/2004, either directly or by reference to a published action plan. To further increase transparency, it is appropriate to ensure that this information is made public.

Not all potential uses of wood treated with creosote have been evaluated at the Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to compartments and populations 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.

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 creosote and also 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 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.

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

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