Commission Directive 2012/20/EU of 6 July 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto Text with EEA relevance

Published date07 July 2012
Subject MatterPlant health legislation
Official Gazette PublicationOfficial Journal of the European Union, L 177, 7 July 2012
L_2012177EN.01002501.xml
7.7.2012 EN Official Journal of the European Union L 177/25

COMMISSION DIRECTIVE 2012/20/EU

of 6 July 2012

amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 market (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 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 flufenoxuron.
(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 (3), 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 (4), 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 (5)) 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 (6)), 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
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