WRITTEN QUESTION E-3395/01 by Peter Liese (PPE-DE) to the Commission. Classification of chromates under the Biocides Directive.
Date: 2001-12-21
Institutions: European Parliament, Provisional data
Subjects: chemical product, dangerous substance, environmental protection, environmental risk prevention, marketing, public health, wood industry

C 147 E/166

Official Journal of the European Communities

EN

20.6.2002

harmonization of the laws of Member States relating to electrical equipment designed for use within
certain voltage limits, the Commission would like to draw the Honourable Member’s attention to the fact
that a first set of standards, covering mobile telephones, low power radio transmitters and radio frequency
identification devices (e.g. anti-theft ports) have been published. Standards for the antennas are in the final
stage of development. Their publication is foreseen for the middle of 2002.
Information on these
harmonised standards is available on the Europa website (2).

(1) http://europa.eu.int/comm/food/fs/sc/sct/outcome_en.html.
(2) http://europa.eu.int/comm/enterprise/rtte.

(2002/C 147 E/173)

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.

is the Commission’s position as regards the classification of

the above-mentioned chromium
What
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.

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Official Journal of the European Communities

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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
is sufficiently effective and has no
unacceptable effects on the target organism nor on human health or the environment.

the biocidal product

that

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.

(2002/C 147 E/174)

WRITTEN QUESTION P-3402/01

by Alexandros Alavanos (GUE/NGL) to the Commission

Subject: Closure of subsidised company Typopoiitiria Thivas

(5 December 2001)

Typopoiitiria Thivas, a company founded pursuant to Regulations (EEC) 355/77 (1) and 866/90 (2), and
jointly funded by the Greek State (Ministry for Agriculture) and the Commission (Commission decisions
156/28.6.1989 and 2742/24.11.1992), has announced that it is suspending operations less than a decade
since it started up.