Brussels, 23 June 2004
the presence of H.R.H. Prince Laurent of Belgium, President of the
Prince Laurent Foundation for Animal Welfare, European Research
Commissioner Philippe Busquin will today present in Brussels ongoing
European research to replace, reduce and refine animal tests. The
research is funded through the European Union’s Sixth Research
Framework Programme (FP6, 2002-2006). In particular, two new EU
research integrated projects, ReProTect and A-Cute-Tox, will be
on display. Advances in bio-medical research for new treatments
and drugs, the European Union’s new chemicals policy (REACH)
and the testing requirements of the amended cosmetics directive
will be discussed at the briefing.
“The newly developed alternative
test methods supported by the EU will substantially contribute to
the three Rs of reduction, refinement and replacement of animal
experimentation and testing, also guaranteeing the highest safety
standards for consumers and patients, respect for the environment
and animal welfare,” says Commissioner Busquin. “Fostering
the Three Rs can only be achieved if there is a joint effort between
scientists, national administrations, industry, NGOs and European
The on-site media briefing at the
Scientific Institute of Public Health (IPH, Rue Wytsmanstraat 14,
B-1050 Brussels, 14:30-18:00), project partner in EU funded research
projects, will give journalists the opportunity to visit laboratories
and learn about two new EU research projects to develop alternative
What are the “three
Advantages of modern alternative testing methods developed within
the new research projects presented today are that 1) the same experiments
can be used for drugs, chemicals and cosmetics without using animals
and 2) the tests compare toxicity directly between cell or tissue
experiments (“in vitro”) and the effects on humans (“in
vivo”), thus not requiring any animal experiments.
- “Reduction” aims to obtain reliable information
by using fewer animals, or more information from the same number
- “Refinement” alternatives focus on methods that
alleviate or minimise pain, suffering and distress.
- “Replacement” alternatives aim to gather equivalent
scientific results without conducting experiments on animals.
For the thematic priority on life sciences, genomics and
biotechnology for health in the EU Sixth Research Framework
Programme (FP6) see also: http://cordis.europa.eu/lifescihealth/home.html.
The web site of the Scientific
Institute of Public Health (IPH) can be found at: http://www.iph.fgov.be.
In Vitro Testing Industrial Platform
Prince Laurent Foundation
for the welfare of domestic and wild animals:
European Centre for the Validation
of Alternative Methods (ECVAM), Joint Research
Centre, European Commission, Ispra (Italy) http://ecvam.jrc.it/index.htm.
23 June 2004
Location: IPH, Rue Wytsmanstraat 14,
Bus shuttle leaving from main European Commission
(BREYDEL, Avenue d’Auderghem 45, 1040 Brussels; near
metro station “Schuman”)
14:30 Welcome coffee (and sandwiches)
Introduction to laboratory visits for journalists
Dr. Paul Dierickx, IPH
Visit to Laboratory for Biochemical Toxicology, IPH
European Research for the development of alternative
Philippe Busquin, Commissioner for Research,
European research for in vitro
testing methods: the view and role of an industrial platform
Joan-Albert Vericat1, 2 (ES),
Director Preclinical Development, NeuroPharma S.A. Tres Cantos
(Madrid) and Representative of IVTIP (In Vitro Testing Industrial
Development and validation projects
for alternatives in a new dimension - ECVAM's response to
the challenge of chemicals and cosmetics legislation
Dr. Thomas Hartung1, 2, European
Centre for the Validation of Alternative Methods (ECVAM, JRC)
Alternative in vitro testings
for human reproductive health"
Dr. Rita Georgette Cortvrindt1,
EggCentris nv, Zellik (Brussels)
In vitro toxicity assays for the
prediction of acute human toxicity
Dr. Paul Dierickx2, Scientific
Institute of Public Health (IPH), Brussels
In the presence of H.R.H.
Prince Laurent of Belgium,
President of Prince Laurent Foundation for Animal Welfare
Discussion (Question time for journalists)
Reception & Interview opportunities
Bus shuttle leaving for airport and/or for BREYDEL
building and press centre
(depending on demand)
1 project partner in EU project ReProTect (FP6, 1st call
2 project partner in EU project A-Cute-Tox (FP6, 2nd call
- 1. Philippe Busquin, European Commissioner
points (PDF 108 Kb)
- 2. Joan-Albert Vericat, NeuroPharma, IVTIP
(PDF 553 Kb)
- 3. Thomas Hartung, JRC/ECVAM - Presentation (PDF 966 Kb)
- 4. Rita Georgette Cortvrindt, EggCentris -
Presentation (PDF 1490 Kb)
- 5. Paul Dierickx, IPH - Presentation (PDF 1520 Kb)
European research –
selected integrated projects on alternative testing
Development of a novel
approach in hazard and risk assessment or reproductive toxicity
by a combination and application of in vitro, tissue and sensor
Budget: €13.9 million, EU
contribution: €9.1 million, Duration: 5 years
Coordinator: University of Tuebingen, Germany (Contact: Dr.
M. Schwarz, firstname.lastname@example.org)
The Integrated Project ReProTect will develop testing strategies
through novel in vitro and in silico (sensor) alternatives to
animal testing. It will strive to develop a substantial number
of alternative test methods making use of advanced technologies.
Studies in reproductive toxicity within ReProTect will enable
scientists to substantially reduce the number of animals that
are currently required in “in vivo” tests; use a
number of pioneering alternatives that have already been developed;
and carry out the same experiments for drugs, chemicals and
cosmetics without using animals.
The European Centre for the Validation of Alternative Methods
(ECVAM) is leading the project to validate a conceptual framework
in the area of reproductive toxicity. Key stakeholders, including
the European Consensus Platform on Alternatives (ECOPA), European
regulators, OECD, and industry, are involved in the project.
Countries involved: Austria, Belgium, Bulgaria, Denmark, France,
Germany, Italy, the Netherlands, Sweden, Switzerland, and the
Optimisation and pre-validation
of an in vitro test strategy for predicting human acute toxicity
Budget: €15.65 million,
EU contribution: approx. €9 million, Duration: 5 years
Coordinator: University of Oulu, Finland (Contact: Dr. Leila
Validated alternative test methods are urgently required for
safe toxicology of drugs, chemicals and cosmetics. The EU's
new chemicals policy (REACH) and the 7th amendment of the cosmetics
directive call for the broad replacement of animal experiments
for a short-term period. The aim of the EU Integrated Project,
A-Cute-Tox, is to develop a simple and robust in vitro testing
strategy to predict human acute systemic toxicity, which could
replace the animal acute toxicity tests currently used for regulatory
purposes. The scientific objectives of the project are to:
- Compile, critically evaluate and generate high quality in vitro
and in vivo data for comparative analysis.
- Identify factors that influence the correlation between in
vitro toxicity (concentration) and in vivo toxicity (dosage),
and define an algorithm that accounts for this.
- Explore innovative tools and cellular systems to identify new
end-points and strategies to better anticipate animal and human
- Design a simple, robust and reliable in vitro test strategy
to be used for robotic testing, associated with the prediction
model for acute toxicity.
Countries involved: Belgium, the
Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands,
Poland, Spain, Sweden, Switzerland, and the United Kingdom.
acute toxicity - an adverse effect occurring within
24 hours after a single or multiple dose of a substance is given.
alternatives - testing methods which refine existing
ones by minimizing animal distress, reducing the number of animals
needed for an experiment, or replacing whole-animal tests with in
vitro or other tests.
assay - a qualitative or quantitative test, an
chronic toxicity - effects of repeated or long-term
exposure to a substance.
cell culture - growth of living cells in an artificial,
cytotoxicity - the ability of a chemical to damage
or kill cells.
genomics - the investigation of the way the genetic
make-up, or the genome, translates into biological functions.
in silico - computer-based simulations or mathematical
models relating to animal biochemistry, behaviour and environment.
in vitro testing - studies done with cells or
tissues cultured in Petri dishes or test tubes. "In vitro"
means "in glass" in Latin.
in vivo testing - studies done in the living animal.
"In vivo" means "in that which is alive" in
QSARs - Quantitative Structure/Activity Relationships
REACH - Registration, Evaluation and Authorisation
of new and existing Chemicals (draft EU directive).
reproductive toxicity - refers to the adverse
effects of a substance on any aspect of the reproductive cycle,
including the impairment of the reproductive function, the induction
of adverse effects in the embryo, such as growth retardation, malformations,
risk assessment - the process of calculating the
toxic effects of exposure to a chemical substance and determining
the potential uses of the substance.
test battery - a group of tests.
toxicity testing - In vivo or in vitro experiments
designed to reveal a chemical's toxic potential in order to determine
the potential uses (or danger of use) for the substance.
toxicology - science which studies how chemicals
interact with and affect people, animals, and the environment.
toxicology endpoint - a quantifiable biological
change or effect caused by a toxic process.
Beatrice Lucaroni, Scientific officer
Unit Biotechnology and Applied Genomics, DG Research, European
Tel: +32.2.296 22 29
Michael H. Wappelhorst, Press and information officer, Research
Tel.: +32.2.298 75 75, Fax: +32.2.295 82 20
E-mail: Michael.Wappelhorst @ cec.eu.int.
Commissioner Philippe Busquin’s
Spokesman for Research Commissioner Philippe Busquin, Press
Tel. +32.2.296 41 74, Fax +32.2.296 30 03
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