EC to include flufenoxuron as an active substance for product-type 8 in Annex I thereto - Main contents

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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

ANNEX

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

No | Common Name | IUPAC Name Identification Numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline 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 inclusion | Product type | Specific provisions (*) |

"(**) [OPOCE: please insert substance number] | flufenoxuron | 1-[4-(2-chloro-alpha, alpha,alpha-trifluoro-para-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea EC No: 417-680-3 CAS No: 101463-69-8 | 960 g/kg | 1 February 2014 | 31 January 2016 | 31 January 2017 | 8 | Flufenoxuron shall be 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 this Annex is renewed. The Union level risk assessment addressed treatment of wood which will not be used in animal housing or come into contact with food or feed. Products shall not be authorised for uses or exposure scenarios that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions: Products shall only be used for treatment of wood intended for indoor use. For products authorised for industrial or professional use safe operational procedures shall be established, and products shall 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. Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of authorised products shall indicate that freshly treated timber shall 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 from the application of the product shall be collected for reuse or disposal." |

(*) 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

[1] OJ L 123, 24.4.1998, p. 1

[2] OJ L 123, 24.4.1998, p. 1.

[3] OJ L 325, 11.12.2007, p. 3.

[4] Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Decision 2008/934/EC, OJ L 246 of 23.9.2011, p. 13. See also Draft Commission Decision concerning the non-inclusion of flufenoxuron for product type 18 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, to which the Standing Committee for Biocidal Products gave a favourable opinion on 22 September 2011.

[5] OJ L 396, 30.12.2006, p. 1.

[6] OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.

[7] Ibid.