Considerations on COM(2011)708 - Amendment of Directive 98/8/EC to include flufenoxuron as an active substance for product-type 8 in Annex I thereto - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)708 - Amendment of Directive 98/8/EC to include flufenoxuron as an active substance for product-type 8 in Annex I thereto. |
|---|---|
| document | COM(2011)708  |
| date | November 14, 2011 |
2. Pursuant to Regulation (EC) No 1451/2007, flufenoxuron 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. France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 17 March 2009 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 22 September 2011, in an assessment report.
5. It appears from the evaluations that biocidal products used as wood preservatives and containing flufenoxuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. Therefore, and notwithstanding the fact that flufenoxuron has not been approved in certain other areas for which the use specific risk assessments gave a different result[4], it is appropriate to include flufenoxuron for use in product type 8 in Annex I to that Directive.
6. In view of its characteristics, which render it persistent, liable to bioaccumulate and toxic (PBT), as well as very persistent and very liable to bioaccumulate (vPvB), in accordance with the criteria laid down in Annex XIII 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[5], flufenoxuron should be included in Annex I for three years only and should be made 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.
7. The Union level risk assessment of flufenoxuron used in wood preservatives only addressed treatment of wood intended to be used indoors (use classes 1 and 2 as defined by OECD[6]) or outdoors not covered and not in contact with the ground and continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water (use class 3 as defined by OECD[7]), which will not be used in animal housing or come into contact with food or feed. Unacceptable risks for the environment were identified for the in situ treatment of wood outdoors, as well as in various scenarios for outdoor use of treated wood. In view of the characteristics of flufenoxuron, it is appropriate to authorise only those uses and exposure scenarios that have been representatively addressed in the Union level risk assessment, and for which no unacceptable risk was found.
8. In view of the risks identified for human health for industrial and professional use it is appropriate to require that safe operational procedures be established for products authorised for such use, and that those products be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.
9. In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that appropriate risk mitigation measures be taken to protect those compartments, in particular that freshly treated timber be stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing flufenoxuron be collected for reuse or disposal.
10. The provisions of this Directive should be applied at the same time 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 flufenoxuron 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. The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for in this Directive, and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded it to the European Parliament.