WRITTEN QUESTION E-3256/02 by Caroline Lucas (Verts/ALE) to the Commission. Chemical testing on animals.
Date: 2002-11-19
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, chemical product, drafting of EU law, epidemiology, public health, research method, scientific research

C 155 E/120

Official Journal of the European Union

EN

3.7.2003

In order to study the possibility for further action, the Commission launched the Clean Air For Europe
(CAFE) programme in May 2001. PM has been identified as one of the key issues to be considered. As well
as the WHO review, several other initiatives have been taken up by the CAFE programme so far also with
regard to the PM issue,

for instance:

(cid:1) a baseline scenario and integrated assessment modelling showing different options of possible

measures to control air pollutants and thus providing a basis for the final policy advice;

(cid:1) a CAFE working group on PM comprising experts from different stakeholders which will give

recommendations on possible future targets for PM.

(1) Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen dioxide and

oxides of nitrogen, particulate matter and lead in ambient air (cid:1) OJ L 163, 29.6.1999.

(2003/C 155 E/132)

WRITTEN QUESTION E-3256/02

by Caroline Lucas (Verts/ALE) to the Commission

(19 November 2002)

Subject: Chemical testing on animals

Data obtained from animal tests can be misleading due to difficulties extrapolating results from animals to
people and from laboratory doses to realistic levels of human exposure. The use of human exposure data
could drastically reduce the need for animal-based toxicity testing during implementation of the proposed
EU chemicals policy, and would ensure that data used for the evaluation of existing substances is directly
relevant to effects in human beings.

What efforts are being made by the Commission to ensure that human exposure data is used to evaluate
the toxicological effects of existing substances? Will a systematic evaluation of human exposure data be
incorporated into the REACH system, and will such data be made publicly available?

Furthermore, does the Commission agree that it is unsatisfactory to use data from animal tests that have
never been validated to modern standards to validate new non-animal test methods? Are there plans to use
human data generated from ethical human studies (such as skin allergy testing results), as well as from
occupational information, hospital records, epidemiology and accidental poisoning records, to assess and
validate non-animal test methods?

Answer given by Mrs Wallström on behalf of the Commission

(8 January 2003)

The Commission is currently preparing a legislative proposal, which will be based on the White Paper on
the ‘Strategy for a Future Chemicals Policy’. One of the approaches proposed in the White Paper to limit
the need for animal testing was that ‘existing information on the toxicity and ecotoxicity of substances,
including epidemiological studies, will be taken into account’. Accordingly,
the proposal will make
appropriate provisions for the use of data from human epidemiology.

3.7.2003

EN

Official Journal of the European Union

C 155 E/121

The White Paper also proposed that the general public should have access to non-confidential information
from the REACH system. Much human exposure data is expected to be non-confidential and so would be
publicly available.

Any test method, be it animal or non-animal, cannot predict with certainty the response in humans.
Validation is therefore a process of establishing the level of uncertainty associated with a given method.
While the data from animal tests are not perfect models for human responses, they have been successfully
used for decades to predict human responses to pharmaceuticals and other chemical substances. They can
therefore contribute to the validation of non-animal test methods.

While the Commission does not, a priori, exclude the use of human exposure data for the validation of
non-animal test methods, experience shows that it is rarely possible to obtain a sufficiently large and
diverse human data set of the quality needed for use in a validation study.

(2003/C 155 E/133)

WRITTEN QUESTION E-3262/02

by Erik Meijer (GUE/NGL) to the Commission

(19 November 2002)

Subject: Increase in the extent of

the area where groundwater is seriously polluted as a result of

bombardments around the town of Pancevo on the Danube in Serbia

Is the Commission aware that, as a result of the series of bombardments of the industrial town of
in April 1999, chemical and petrochemical

1.
Panèevo, on the Danube in Serbia north-east of Belgrade,
plants were damaged or destroyed and that oil and chemicals leaked into the ground as a result?

2.
Is the Commission furthermore aware that, since the time of the leaks referred to in paragraph 1,
worrying changes have occurred in the health of people and animals, taking the form both of a higher
incidence of various types of cancer (lung cancer, skin cancer and leukaemia) and of reproductive problems
(miscarriages)?

Does the Commission consider it adequate that, although the soil has been studied in recent years
3.
with support from various sources, ranging from the municipalities of Amsterdam and Zaanstad in the
Netherlands to the United Nations, and a number of measures have been taken to clean up the industrial
sites concerned, the relevant work is now being terminated despite the fact that the serious pollution of
groundwater outside the sites persists and is now spreading ever wider?

4.
Is it right to accept lasting and ever wider pollution of groundwater with dangerous substances near
the River Danube, which will affect not only Serbia but also the Iron Gate (Derdap, Portile de Fier)
reservoir on the border with Romania and the downstream applicant countries Romania and Bulgaria?

5. What will the Commission do to ensure that the remaining pollution of groundwater around
Panèevo is completely eliminated, so that it cannot continue to spread?

Source: Netwerk (TV programme), TV Nederland 1, 3 November 2002.

Answer given by Mrs Wallström on behalf of the Commission

(17 December 2002)

The Commission is aware of the situation in Panèevo in the Federal Republic of Yugoslavia (FRY) referred
to by the Honourable Member, and that there were problems in the area even before the NATO bombing.
The Commission is, however, unable to comment on the accuracy of the claims made by the television
programme on the health problems in the town.

The Commission would also not wish to pass comment on the actions undertaken by other bilateral
donors, particularly as it is unaware of the reasons behind such alleged decisions.