COMMISSION DIRECTIVE 2012/22/EU
of 22 August 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include DDACarbonate 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 Article 11(4) thereof,
Whereas:
(1)
The United Kingdom received on 17 January 2007 an application from Lonza, in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance DDACarbonate in Annex I to that Directive for use in product type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. DDACarbonate was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product.
(2)
After carrying out an evaluation, the United Kingdom submitted its report, together with a recommendation, to the Commission on 11 November 2010.
(3)
The report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 2 March 2012, and the findings of the review were incorporated in an assessment report.
(4)
It appears from the evaluations that biocidal products used as wood preservatives and containing DDACarbonate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include DDACarbonate for use in product type 8 in Annex I to that Directive.
(5)
Not all potential uses have been evaluated at Union level. For example, use by non-professional users was not assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments 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.
(6)
In view of the risks identified for human health, for industrial users it is appropriate to require that safe operational procedures are established, and that products are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.
(7)
In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that industrial application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is 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 DDACarbonate are collected for reuse or disposal.
(8)
Unacceptable risks for the environment were identified for situations where wood treated by dipping with DDACarbonate was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD (2)), and where wood treated with DDACarbonate was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (3)) or was in contact with fresh water (use class 4b as defined by OECD (4)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.
(9)
The provisions of this Directive should be applied simultaneously 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 DDACarbonate and also to facilitate the proper operation of the biocidal products market in general.
(10)
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 to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.
(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 1
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 January 2013 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 twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 22 August 2012.