WRITTEN QUESTION E-1711/02 by Elspeth Attwooll (ELDR) to the Commission. Animal testing.
Date: 2002-06-13
Institutions: European Parliament, Provisional data
Subjects: EU research policy, animal experimentation, animal welfare, dangerous substance, evaluation method, medicinal product, pharmaceutical legislation, protection of animals

12.12.2002

EN

Official Journal of the European Communities

C 309 E/155

(2002/C 309 E/181)

WRITTEN QUESTION E-1710/02

by Elspeth Attwooll (ELDR) to the Commission

(13 June 2002)

Subject: Animal testing

Is it the case that the Commission allows the use of outdated animal tests that have never been validated to
modern standards, and even tests that have failed retrospective validation, in the hazard evaluation of
chemical substances?

(2002/C 309 E/182)

WRITTEN QUESTION E-1711/02

by Elspeth Attwooll (ELDR) to the Commission

(13 June 2002)

Subject: Animal testing

How and why do requirements for animal safety testing of drugs and chemicals differ between Member
States within the EU? Why is it not possible for alternative non-animal tests that have passed through
validation and received regulatory acceptance in one or more Member States to be used in all EU Member
States? Surely, in the interests both of animal welfare and the internal market, non-animal alternative tests
that are judged to offer a sufficient degree of hazard evaluation in one country should be in use
throughout the EU? What action is being carried out by the Commission to ensure that non-animal tests
accepted in one or more Member States receive EU-wide regulatory acceptance as soon as possible, and
certainly in time for implementation of the new EU chemicals policy?

Joint answer
to Written Questions E-1710/02 and E-1711/02
given by Mrs Wallström on behalf of the Commission

(31 July 2002)

Toxicity tests to assess the properties of chemicals which may be dangerous to human health and the
environment are included in Annex V of Directive 67/548/EEC, 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 (1), hereafter the ‘Dangerous Substances Directive’. Such
tests are harmonised throughout the Community. If properly applied, they are considered to guarantee
reliable results.

For ‘new’ chemical substances, placed on the market after September 1981, the testing requirements are
harmonised across the Community. For
the
manufacturers,
importers and distributors are required to make themselves aware of the relevant and
accessible data concerning the properties of such chemicals. They then have to classify and label the
chemicals in accordance with the Dangerous Substances Directive. Also this provision applies throughout
the Member States.

‘existing’ chemicals, marketed also before that date,

For medicinal products testing requirements are laid down in Directive 2001/83/EC of the Parliament and
the Council of 6 November 2001 on the Community code relating to medicinal products for human
use (2). The Directive requires that an application for approval of a medicinal product needs to be
accompanied by results of toxicological and pharmacological tests. Part 3 of Annex I to the Directive
contains detailed provisions on these toxicological and pharmacological tests.

Most of the test methods set out in Annex V of Directive 67/548/EEC are based on those developed and
recommended by competent international bodies, in particular the Organisation for Economic Cooperation
and Development (OECD). The quality of such methods is therefore recognised internationally. The test
methods should be performed in conformity with the principles of Good Laboratory Practice (GLP), in
order to ensure as wide as possible the mutual acceptance of data.

C 309 E/156

Official Journal of the European Communities

EN

12.12.2002

The 1998 OECD document on the ‘Validation of test methods considered for the adoption as OECD test
guidelines’ (ENV/MC/CHEM (98) 6) acknowledged that ‘… there seems to be a tendency towards being
stricter for ’alternative’ or ’replacement’ tests than for ’conventional’ animal tests, filling gaps of so far
uncovered areas.’ The general problem that double standards may be operating has thus been recognised.

The Commission is not aware of any formal retrospective validation of testing methods currently included
in Annex V of Directive 67/548/EEC. The European Centre for the Validation of Alternative Methods
(ECVAM) of the Joint Research Centre (JRC) has so far concentrated on prospective validation studies.

In the year 2000 three non-animal testing methods validated by ECVAM have been included in Annex V.
These are one method for phototoxicity and two methods for skin corrosion. The methods are since then
available for regulatory purposes in all Member States.

The Commission considers that progress in the development and validation of alternative test methods is
necessary. ECVAM has recently compiled a report, provided for publication in June 2002, on the current
status of alternative tests for human health effects required by Community chemicals legislation. The report
places the emphasis on methods that can replace existing animal tests, either entirely or partially. It makes
recommendations for the further development and validation of alternative tests and strategies.

(1) OJ P 196, 16.8.1967.
(2) OJ L 311, 28.11.2001.

(2002/C 309 E/183)

WRITTEN QUESTION E-1721/02

by Roberta Angelilli (UEN) to the Commission

(13 June 2002)

Subject: Monitoring of nuclear power stations

After 11 September and attacks by suicide bombers in Israel and Palestine, the intelligence services in both
Europe and the United States consider that nuclear power stations are potentially high-risk targets and that
therefore nuclear installations and research centres using nuclear material, such as the Ispra research centre
in Varese, are at risk of attack and hence require exceptional surveillance measures.

Can the Commission say:

1. whether steps are being taken at Community level to ensure closer monitoring of nuclear power

stations and thus to ensure the health and safety of the population;

2. what its opinion is on the subject?

Answer given by Mrs de Palacio on behalf of the Commission

(1 August 2002)

Security measures pertaining to nuclear facilities are the responsibility of the Member States. There is no
Community legislation in this area.

The authorities of the Member States have stepped up existing protective measures for all sites at risk,
particularly nuclear power stations, since 11 September 2001. The measures taken range widely, from
simple verification measures of an administrative nature to military measures. The particular arrangements
are to a great extent confidential and the competent services of the Member States ensure that they are
being properly applied.