WRITTEN QUESTION E-3395/01

by Peter Liese (PPE-DE) to the Commission

(21 December 2001)

Subject: Classification of chromates under the Biocides Directive

Hexavalent chromium compounds (chromates) have been used for about 70 years in industrial timber preservation as an anti-corrosive and fixative, mainly in conjunction with copper compounds. Chromium compounds, which are present in treated timber as insoluble and non-toxic chromium (III) compounds, do not themselves have any biocidal effect. Lasting protection of timber, pylons, vine stakes, etc. is possible without using such chromium-copper preparations, but durability and stability would inevitably be substantially reduced. Under the Biocides Directive (98/8/EC(1)), adjuvants which do not have proven biocidal effects do not have to be notified or identified. For reasons which have to do with competition policy, an attempt is now being made to designate chromium compounds as biocides in order to prevent or greatly restrict their continued use in timber preservation.

What is the Commission's position as regards the classification of the above-mentioned chromium compounds under the Biocides Directive? Is the Commission aware that incorrect classification is bound to have serious consequences in terms of distortion of competition and barriers to trade, to the detriment of timber preservation methods with a long proven track record and the use of European timber varieties?

(1) OJ L 123, 24.4.1998, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(14 February 2002)

The Commission would like to inform the Honourable Member that Directive 98/8/EC of the Parliament and of the Council of 16 February 1998, concerning the placing of biocidal products on the market does not establish a system of classification of substances.

According to Article 2 the following definitions apply:

Biocidal Product: Active substance and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organisms by chemical or biological means.

Active substance: A substance or micro-organism including a virus or a fungus having general or specific action on or against harmful organisms.

Substance of concern: Any substance, other than the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentrations to create such an effect. Such a substance would be normally a substance classified as dangerous according to Directive 67/548/EEC and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Directive 1999/45/EC.

According to Article 5, biocidal products can only be authorised if the active substance(s) contained therein are listed in Annex I or IA and it is established on the basis of a very thorough evaluation of the risks to human health and the environment that the biocidal product is sufficiently effective and has no unacceptable effects on the target organism nor on human health or the environment.

For inclusion of an active substance into Annex I or IA, applicants have to submit dossiers containing data as defined in the Annexes to the Directive, with information on the active substance and at least one biocidal product. Efficiency and absence of unacceptable effects are again important criteria for decision-making. According to Annex IIB, the dossier regarding the biocidal product must contain data on the toxicological and ecotoxicological effects of all substances of concern contained in the product. This requirement applies also for the dossiers to be submitted for the authorisation of individual biocidal products.

Neither the Directive nor Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the Parliament and of the Council on biocidal products(1) define lists of active substances for use in biocidal products. Quite on the contrary, according to Article 3 of the Regulation, active substances placed on the market before 14 May 2000 must be identified by producers before 28 March 2002. Formulators may also identify such existing active substances. According to Article 4 of the same Regulation, producers, formulators or associations wishing to apply for the inclusion in Annex I or IA to the Directive of an existing active substance, must submit a notification by 28 March 2002. It is therefore the task of the producers or formulators to decide, based on the definitions and criteria established by the Directive, whether they consider a substance to be an active substance and whether they want to apply for an inclusion into Annex I or IA.

If chromium compounds used by themselves do not meet the definition of an active substance, they do not have to be notified or identified. However, if a producer or formulator considers that they do meet the definitions, he can notify such compounds for inclusion into Annex I or IA, and will then have to provide all necessary data (including on efficacy) at the latest by 28 March 2004.

In any case, a biocidal product for the preservation of wood containing chromium compounds will have to be authorised in the light of the criteria established by Article 5 of Directive 98/8/EC. In principle, chromium containing biocidal products for wood preservation contain the chromium compounds in hexavalent form, which are classified as dangerous according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2) and hence meet the definition of substances of concern. These are reduced to chromium (III) compounds only during the fixation process. The dossiers for such biocidal products will, therefore, have to contain all required information on the chromium compounds, even if they are not considered to be active substances.

The Commission considers that a correct application of Directive 98/8/EC will avoid distortion of competition and barriers to trade for wood preservatives containing chromium compounds, because it will guarantee an improved harmonisation of the different authorisations, which currently exist in various Member States.

(1) OJ L 228, 8.9.2000.

(2) OJ P 196, 16.8.1967.