WRITTEN QUESTION E-2775/01 by Chris Davies (ELDR) to the Commission. Funding of Non-Animal Tests.
Date: 2001-10-09
Institutions: European Parliament, Provisional data
Subjects: EU aid, EU office or agency, EU programme, animal experimentation, chemical product, cosmetic product, protection of animals, research and development

6.6.2002

EN

Official Journal of the European Communities

C 134 E/97

(2002/C 134 E/100)

WRITTEN QUESTION E-2775/01

by Chris Davies (ELDR) to the Commission

(9 October 2001)

Subject: Funding of Non-Animal Tests

‘Strategy for a future Chemicals Policy’ COM(2001) 88 final. and
The Commission’s White Paper:
Parliament’s option on the proposed seventh amendment to the Cosmetics Directive both call for the
development of new non-animal test methods. Animal Welfare Campaigners claim that animal based
toxicity testing is scientifically outdated, that new non-animal tests under development offer scientific
benefits, and are frequently quicker and cheaper to perform than animal tests. Their use could prevent the
suffering of millions of animals.

Article 23.1 of Directive 86/609/EEC (1) states that: ‘The Commission and Member States should encourage
research into the development and validation of alternative techniques which could provide the same level
of information as that obtained in experiments using animals but which involve fewer animals or which
entail less painful procedures, and shall take such steps as they consider appropriate to encourage research
in this field’.

What action has been taken by the Commission to ensure such work is encouraged? In particular, what
levels of funding have been provided by the Commission and by each Member State for the development
of alternative non-animal test methods in all areas of research, and specifically in the development of
alternatives to toxicity testing?

(1) OJ L 358, 18.12.1986, p. 1.

Answer given by Mr Busquin on behalf of the Commission

(20 November 2001)

To date, in the current Fifth Framework Programme for research, technological development (RTD) and
demonstration activities 1998 to 2002 (1), more than 30 projects specifically addressing in vitro
alternatives to animal testing are being funded under the Quality of Life and Management of Living
Resources Programme, representing a Community contribution of more than € 27 million. Of these, € 24
million are devoted to the support of alternatives to toxicity testing. Information on the contracts can be
obtained through the Cordis Web service at http://www. cordis. lu/life.

As far as the new RTD Framework Programme 2002-2006 is concerned, the Commission has adopted, on
30 May 2001, proposals for the Specific Programmes (2) that can be downloaded at the Web site: http://
www. cordis. lu/rtd2002/fp-debate/cec. htm. This text clearly mentions the development of new in vitro
tests to replace animal experimentation in the research priority (ii) of the thematic priority 1.1.1 ‘Genomics
and biotechnology for health’ (see page 20 of the text). Furthermore, it includes several general statements
regarding the respect of animal welfare, which concern all activities of the new Framework Programme
(see footnote 14, page 18 of the text).

flexibility for policy-related research is offered under

Additionally,
the heading ‘Anticipating the
Community’s scientific and technological needs’ which covers policy-orientated research and could include
non-animal testing.

Many non-animal methods are in the course of development. However, such methods must be subject to
independent validation, before they can be formally accepted into the regulatory process. In order to fulfil
its obligations under Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws,
regulations and administrative provisions of the Member States regarding the protection of animals used
for experimental and other scientific purposes (3), the Commission, in 1991, set up the European Centre
for the validation of alternative methods, (ECVAM), as a unit of its Joint Research Centre, located at Ispra,
Italy. ECVAM’s principal duty is to specifically co-ordinate the validation of advanced, non-animal test
methods at the Community level.

C 134 E/98

Official Journal of the European Communities

EN

6.6.2002

In 2000, the first three validated in vitro methods were introduced (4) into Annex V of 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 (5). The Commission attaches
great importance to this work and is actively promoting the acceptance of these methods also in the
framework of the Organisation for economic cooperation and development (OECD) Test Guidelines
in order to secure their worldwide application. A number of other scientifically-validated
Programme,
methods are to be put forward for regulatory acceptance in the near future.

Furthermore,
in consultation with other Commission services and with external experts, ECVAM is
preparing a comprehensive review of the current status of non-animal test methods and their future
potential,
in the light of the challenges and opportunities provided by the White Paper on a future
chemicals policy as well as a detailed review on the current status of non-animal test methods for cosmetic
ingredients and products.

The total support for ECVAM in the Fifth Framework Programme is € 26,5 million.

The Commission has no information on financial support by the Member States for the replacement
alternative tests.

(1) OJ L 26, 1.2.1999.
(2) OJ C 240 E, 28.8.2001.
(3) OJ L 358, 18.12.1986.
(4) OJ L 136, 8.6.2000.
(5) OJ B 196, 16.8.1967.

(2002/C 134 E/101)

WRITTEN QUESTION E-2776/01

by Chris Davies (ELDR) to the Commission

(9 October 2001)

Subject: Enforcement of environmental legislation (Greece)

What is the total amount paid by the Greek Government in settlement of the fine imposed by the
European Court of Justice for the failure to prevent pollution resulting from inadequate storage of waste
on Crete, and is any payment outstanding?

What work has been carried out to prevent the recurrence of the problem, and is the Commission satisfied
with what has been done?

When did the Commission first commence enforcement measures in a bid to ensure that the work was
undertaken, and is it able to provide an estimate of the cost, in terms of the time spent by its officials,
involved in this exercise over many years?

What lessons have been learnt by the Commission from this exercise which may assist its future work in
enforcing environmental legislation?

How many cases of a similar nature to this are now being pursued by the Commission, and does any EU
Member State NOT have any enforcement action being taken against it?

Answer given by Mrs Wallström on behalf of the Commission

(3 December 2001)

In its judgement (1) delivered on 4 July 2000 (second judgement under article 228 (ex Article 171) of the
EC Treaty) the European Court of Justice declared that by failing to take the measures necessary to ensure
that waste is disposed of in the area of Chania without endangering human health and without harming
the environment in accordance with Article 4 of Council Directive 75/442/EEC (2) and by failing to draw
up for that area plans for the disposal of waste, pursuant to Article 6 of Directive 75/442/EEC, and of toxic
to Article 12 of Council Directive 78/319/EEC (3), Greece has not
and dangerous waste, pursuant