WRITTEN QUESTION E-3471/01 by Cristiana Muscardini (UEN) to the Commission. Alternative methods of evaluating acute toxicity.
Date: 2002-01-04
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, chemical product, cooperation policy, scientific discovery, scientific research, testing, toxic substance

C 160 E/120

Official Journal of the European Communities

EN

4.7.2002

Based on the opinion published on 30 October 2001 by the Scientific Committee for Toxicity, Ecotoxicity
and the Environment, the Commission currently has no plans to change the recommended exposure limits.

(1) See page 115.
(2) OJ L 199, 30.7.1999.

(2002/C 160 E/155)

WRITTEN QUESTION E-3471/01

by Cristiana Muscardini (UEN) to the Commission

Subject: Alternative methods of evaluating acute toxicity

(4 January 2002)

The MEIC (Multicenter Evaluation of In Vitro Cytotoxicity) research programme has examined over sixty of
the most promising alternative methods of evaluating the acute toxicity of chemical substances and has
compared the data obtained from human exposure, by animal testing and by means of alternative
methods.

The results appear to demonstrate that a series of three human cell tests can provide a more accurate
assessment of the acute toxicity of chemical substances and, consequently, a safer and faster means of
protecting public health, than the corresponding animal tests currently practised.

This being so:

1.

Is the European Centre for the Validation of Alternative Methods aware of this series of studies?

2. Has the study and validation procedure required for official recognition of the relevant alternative

methods begun, or is it due to begin?

3.

If not, what does the Commission intend to do to ensure that awareness of these new methods does
not continue to be restricted to a few groups of specialists?

Answer given by Mr Busquin on behalf of the Commission

(14 February 2002)

The European Centre for the validation of alternative methods (ECVAM) is fully aware of the Multi-center
evaluation of in vitro cytotoxicity (MEIC) research programme. The Head of ECVAM laboratory Unit
participated in the programme.

ECVAM was also involved in the international workshop on in vitro methods for assessing acute systemic
toxicity, organised by the United States Interagency Co-ordinating Committee on the validation of
alternative methods (ICCVAM), and held in Arlington, Virginia, United States, on 16-20 October 2000.
The MEIC programme was one of the main focuses of attention at this workshop.

One of the main recommendations of the ICCVAM workshop was that there should be a validation study
on the use of in vitro cytotoxicity assays for predicting rodent oral
lethal doses and human lethal
concentrations, since the MEIC programme was not designed to represent a formal validation study
conducted according to currently-accepted international criteria.

This study is now being planned as an ICCVAM/ECVAM collaborative project, which will involve the
testing of 60 coded chemicals in two assays, in three or four laboratories in the United States and in
Europe. It is expected that the results will be available by the end of 2002.

4.7.2002

EN

Official Journal of the European Communities

C 160 E/121

In vitro methods for predicting basal cytotoxicity have been widely used in many parts of the world for
several years, and have already contributed to a reduction in the need for animal experimentation.
However, the purpose of the ICCVAM/ECVAM study is to provide independent advice on their formal use
for regulatory purposes, initially to predict starting doses for mandatory in vivo testing, in order to reduce
animal suffering and to reduce the number of animals required. The longer term aim is to do away with
the use of animals.

(2002/C 160 E/156)

WRITTEN QUESTION P-3477/01

by Bart Staes (Verts/ALE) to the Commission

(10 December 2001)

Subject: Investigation into Wallonia Region subsidy to Ryanair

In answer to my Written Question P-1767/01 (1), the Commission indicated that it could see nothing
wrong with the aid provided by the Wallonia Region to the Ryanair airline company for its use of
Charleroi airport. The Commission nevertheless stated that it intended ‘to check whether the information it
obtained earlier [was] still valid’.

New information about Ryanair has become available. In December and January it is giving away 300 000
free tickets in Europe. 50 000 of those will be for flights out of Charleroi. A so-called ‘master agreement’
has been concluded between Ryanair and that airport for a period of 15 years. During that period, Ryanair
will enjoy a number of advantages (see also Written Question P-1767/01). Over and above those subsidies,
the Wallonia Region government is also providing € 250 000 in hotel and restaurant costs for Ryanair
crews. Every new destination out of Charleroi will also be good for an extra € 160 000. And the Region is
contributing € 768 000 to training, in particular for pilots, is making office accommodation available free
of charge and spending some € 4 000 on so-called ‘miscellaneous expenses’. Yet the amount Ryanair
charges would-be pilots for their training is no less than € 24 170.

Has the Commission meanwhile checked whether the information it obtained earlier about possible aid
from the Wallonia Region to Ryanair is still accurate? Is that information compatible with Community
competition law? Will the Commission investigate further?

Does the Commission think that Charleroi and the surrounding region can be described as a ‘backward
area’, which would allow the authorities to provide financial assistance for infrastructural development?

Does the Commission consider the subsidies from the Wallonia Region for a period of 15 years, as
described above and in question P-1767/01, as being compatible with the provisions governing backward
regions?

(1) OJ C 350 E, 11.12.2001, p. 222.

Answer given by Mrs de Palacio on behalf of the Commission

(21 January 2002)

Following press reports at the start of the summer about possible advantages conferred on Ryanair for
operating at Charleroi airport, in September 2001 the Commission asked the Belgian authorities for certain
details so that it could appraise the nature of any advantages enjoyed by Ryanair in the light of the rules
on State aid in the EC Treaty.

This information was recently supplied by the Belgian authorities and is now being assessed by the
Commission.