Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto (Text with EEA relevance)
Commission Directive 2008/86/ECof 5 September 2008amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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 marketOJ L 123, 24.4.1998, p. 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 marketOJ L 325, 11.12.2007, p. 3. 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 tebuconazole.(2)Pursuant to Regulation (EC) No 1451/2007, tebuconazole 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)Denmark was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 January 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 29 November 2007, in an assessment report.(5)The review of tebuconazole did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.(6)It appears from the examinations made that biocidal products used as wood preservatives and containing tebuconazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include tebuconazole in Annex I for product type 8, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing tebuconazole can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood in continuous contact with water. Authorisation of these uses will require the submission of data demonstrating that the products can be used without unacceptable risks to the environment.(7)In the light of the findings of the assessment report, it is appropriate to require that instructions are provided to indicate that treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and allow losses to be collected for re-use or disposal, in accordance with Article 10(2)(i)(d) of Directive 98/8/EC.(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 tebuconazole 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 tebuconazole 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,HAS ADOPTED THIS DIRECTIVE:
Article 1Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2Transposition1.Member States shall adopt and publish, by 31 March 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 April 2010.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4This Directive is addressed to the Member States.
Done at Brussels, 5 September 2008.For the CommissionStavros DimasMember of the CommissionANNEXThe following entry "No 6" is inserted in Annex I to Directive 98/8/EC:
For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
NoCommon NameIUPAC nameIdentification numbersMinimum purity of the active substance in the biocidal product as placed on the marketDate of inclusionDeadline for compliance with Article 16(3)(except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)Expiry date of inclusionProduct typeSpecific provisions
"6tebuconazole1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-olEC No: 403-640-2CAS No: 107534-96-3950 g/kg1 April 201031 March 201231 March 20208Member States shall ensure that authorisations are subject to the following conditions:In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.In addition, products cannot be authorised for the in situ treatment of wood outdoors or for wood that will be in continuous contact with water unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures."
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For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm