Annexes to COM(2011)50 - Amendment of Directive 98/8/EC to include creosote as an active substance in Annex I thereto

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dossier COM(2011)50 - Amendment of Directive 98/8/EC to include creosote as an active substance in Annex I thereto.
document COM(2011)50 EN
date July 26, 2011
ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

‘45CreosoteCreosote

EC No: 232-287-5

CAS No: 8001-58-9
Grade B or Grade C creosote as specified in European Standard EN 13991:20031 May 201330 April 201530 April 20188Biocidal products containing creosote may only be authorised for uses where the authorising Member State, based on an analysis regarding the technical and economic feasibility of substitution which it shall request from the applicant, as well as on any other information available to it, concludes that no appropriate alternatives are available. Those Member States authorising such products in their territory shall no later than 31 July 2016 submit a report to the Commission justifying their conclusion that there are no appropriate alternatives and indicating how the development of alternatives is promoted. The Commission will make these reports publicly available.

The active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) before its inclusion in this Annex is renewed.

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed at the Union level risk assessment.

Member States shall ensure that authorisations are subject to the following conditions:

(1)Creosote may only be used under the conditions mentioned in point 2 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1).

(2)Creosote shall not be used for the treatment of wood intended for those uses referred to in point 3 of the second column of entry No 31 in Annex XVII to Regulation (EC) No 1907/2006.

(3)Appropriate risk mitigation measures shall be taken to protect workers, including down-stream users, from exposure during treatment and handling of treated wood in compliance with Regulation (EC) No 1907/2006 and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (2).

(4)Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.


(1) OJ L 396, 30.12.2006, p. 1.

(2) OJ L 158, 30.4.2004, p. 50.’