Commission Directive 2013/4/EU

of 14 February 2013

amending Directive 98/8/EC of the European Parliament and of the Council to include Didecyldimethylammonium Chloride 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 market1, 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 market2 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 Didecyldimethylammonium Chloride.
(2)

Pursuant to Regulation (EC) No 1451/2007, Didecyldimethylammonium Chloride 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)

Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 August 2007 in accordance with Article 10(5) and (7) 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 21 September 2012, in an assessment report.

(5)

It appears from the evaluations that biocidal products used as wood preservatives and containing Didecyldimethylammonium Chloride may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Didecyldimethylammonium Chloride for use in product type 8 in Annex I to that Directive.

(6)

Not all potential uses and exposure scenarios have been evaluated at Union level. For example, neither use by non-professionals, nor exposure of food or feeding stuff was 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.

(7)

In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, that products are used with appropriate personal protective equipment, and that products are not applied on wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

(8)

In view of the risks identified for the environment, it is appropriate to require that industrial or professional application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of products used as wood preservatives and containing Didecyldimethylammonium Chloride are collected for reuse or disposal.

(9)
Unacceptable risks for the environment were identified for situations where wood treated with Didecyldimethylammonium Chloride was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD3), was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD4) or was in contact with fresh water (use class 4b as defined by OECD5). 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.
(10)

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 Didecyldimethylammonium Chloride 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)
In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents6, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.
(15)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DIRECTIVE: