WRITTEN QUESTION P-2562/02 by Professor Sir Neil MacCormick (Verts/ALE) to the Commission. REACH system.
Date: 2002-09-10
Institutions: European Parliament, Provisional data
Subjects: EU policy, animal experimentation, animal welfare, chemical product, data collection, environmental protection, health control, health risk, public health

6.3.2003

EN

Official Journal of the European Union

C 52 E/185

(2003/C 52 E/204)

WRITTEN QUESTION P-2562/02

by Professor Sir Neil MacCormick (Verts/ALE) to the Commission

(10 September 2002)

Subject: REACH system

Is the Commission aware of the concern held by many people concerning aspects of the REACH system
proposed for the testing and registering of chemicals? In particular, will the Commission reconsider those
elements of the REACH system which will radically increase the amount of animal testing in ways which
are deeply repugnant to many European citizens? Will the Commission also indicate its opinion on the
relevance of the REACH system to chemicals which are bonded elements of the final products and which
therefore exhibit none of the chemical properties in their pure state?

Answer given by Mrs Wallström on behalf of the Commission

(3 October 2002)

The REACH system was proposed by the Commission in the White Paper on the Strategy for a future
Chemicals Policy (1) in order to strengthen the protection of human health and the environment from the
potential risks of chemicals. For a very high proportion of the chemical substances on the Community
market, available knowledge about dangerous properties and uses is not sufficient to ensure the required
high level of protection.

To increase the knowledge, and therefore improve the management and control of chemicals, the White
Paper does not simply propose a testing programme but rather the collection of information about
chemicals. Appropriate information may come from any source in the Community and world-wide.
Testing on laboratory animals should only be the last resort.

Indeed one of the political objectives of the Strategy is the promotion of non-animal testing.

The following elements of REACH will be proposed with a view to keep animal testing to a minimum:

(cid:1) for substances produced/imported in quantities between 1-10 tonnes per year, testing should generally
be limited to in vitro methods. 20 000 out of the estimated 30 000 ‘existing’ substances on the
Community market fall into this category;

(cid:1) existing information on the toxicity and ecotoxicity of substances, including epidemiological studies,

will be taken into account;

(cid:1) the general
appropriate;

testing requirements will be modified to incorporate exposure-driven testing where

(cid:1) tailor-made testing programmes for substances will be developed under the control of authorities for

testing of higher production volume chemicals;

(cid:1) efforts will be made to develop further alternative testing methods using fewer or no animals;

(cid:1) substances will be grouped to minimise testing, where appropriate;

(cid:1) data-sharing on animal test data among companies submitting registrations will be made mandatory,

with very limited exceptions to respect confidentiality.

The Commission held meetings with eight Working Groups from October 2001 to February 2002 to seek
technical expert advice on specific aspects of the White Paper. This included testing aspects and their
relation to animal welfare. Experts, including from animal welfare organisations, were invited to provide
their suggestions.

C 52 E/186

Official Journal of the European Union

EN

6.3.2003

The Commission is aware that chemical substances, when bonded within polymers, may change their
properties significantly. However, also those properties should also be known to ensure a safe use. The
Commission will therefore develop an appropriate and proportionate scheme that provides the necessary
information.

In conclusion, the Commission is seeking to balance animal welfare considerations against the potentially
serious threats to human health and the environment presented by chemicals when their properties and
uses are not sufficiently known.

(1) COM(2001) 88final, available on the Internet http://europa.eu.int/comm/environment/chemicals/0188_en.pdf.

(2003/C 52 E/205)

WRITTEN QUESTION E-2572/02

by Kathleen Van Brempt (PSE) to the Commission

(16 September 2002)

Subject: Cyclamate in ‘light’ soft drinks

The Voedingscentrum (Nutrition Centre) in the Netherlands recently gave a warning about the use of
cyclamate in ‘light’ drinks. A written question on this subject (E-0051/02 (1)) has been posed by Alexander
de Roo (Verts/ALE). In its reply of 22 February 2002, the Commission stated that it did not intend to
introduce a ban on cyclamate. It also said that it did not regard additional
labelling requirements as
justified.

If the Commission takes the view that additional warnings on labels are unnecessary, how does it intend to
warn the public against excessive consumption of cyclamate?

The Commission is looking at how to ensure that intake of cyclamate does not exceed the new ADI, for
example by amending authorised limits for its use and authorising alternatives. Could it give further
details?

What is the Commission’s objective in amending authorised limits for the use of cyclamate?

What are the alternatives to cyclamate to which the Commission refers in its answer to written question E-
0051/02? How does it intend to promote their use?

(1) OJ C 147 E, 20.6.2002, p. 236.

Answer given by Mr Byrne on behalf of the Commission

(16 October 2002)

As indicated in its reply to Written Question E-0051/02 by Mr De Roo, the Commission has examined
how to ensure that the intake of cyclamate does not exceed the new Acceptable Daily Intake (ADI) for this
substance, for example by amendments to authorised limits for its use and the authorisation of alternatives.

Consequently, the Commission adopted on 11 July 2002 a proposal for the amendment of Parliament and
Council Directive 94/35/EC on sweeteners for use in foodstuffs (1). This proposal foresees to lower the
amount of cyclamate that may be used in light soft drinks. Furthermore, it is proposed to ban the use of
cyclamate in confectionery, chewing gum and ice cream with no added sugar.

As an alternative to cyclamate, all other authorised sweeteners may be used. With the proposed
amendment of the above-mentioned Directive, sucralose, a new sweetener, is proposed for authorisation
and could therefore become available as an additional alternative. The Parliament and the Council are
currently examining the proposal.