COMMISSION DIRECTIVE 2011/10/EU
of 8 February 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include bifenthrin as an active substance 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 bifenthrin.
(2)
Pursuant to Regulation (EC) No 1451/2007, bifenthrin 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 3 January 2008 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 24 September 2010, in an assessment report.
(5)
It appears from the evaluations that biocidal products used as wood preservatives and containing bifenthrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include bifenthrin in Annex I to that Directive.
(6)
Not all potential uses have been evaluated at the Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to environmental compartments and populations that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
(7)
Unacceptable risks were identified for non-professional users. It is therefore appropriate to require that product authorisations are limited to industrial or professional use, unless it is demonstrated in the application for product authorisation that risks to non-professional users can be reduced to acceptable levels in accordance with Article 5 of, and Annex VI to, Directive 98/8/EC.
(8)
In view of the assumptions made during the risk assessment, it is appropriate to require that products authorised for industrial or professional use are 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 soil and aquatic compartments, appropriate measures should be taken to protect those compartments. It is therefore appropriate to require that instructions are provided to indicate that freshly treated timber is stored after treatment under shelter or on impermeable hardstanding, or both, and that any losses from the application of products used as wood preservatives and containing bifenthrin are collected for reuse or disposal. Furthermore, it is appropriate to require that products are not authorised for the in situ treatment of wood outdoors, or for treatment of wood that will be either continually exposed to the weather or protected from the weather but subject to frequent wetting (use class 3 as defined by OECD (3), unless data is submitted demonstrating that the product will meet the requirements of Article 5 of, and Annex VI to, Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.
(10)
It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance bifenthrin 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 measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2
Transposition
1. Member States shall adopt and publish, by 31 January 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
They shall apply those provisions from 1 February 2013.
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 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 8 February 2011.