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An Integrated European ‘Flagship’ Program Driving Mechanism-based
Toxicity Testing and Risk Assessment for the 21st Century

In a large (30 Million €) H2020-supported collaborative project, academia joins forces with small and medium-sized enterprises (SMEs), large industry, contract research organisations (CROs) and regulatory bodies to achievea paradigm shift in toxicologytowards a more efficient and animal-free chemical safety assessment.

Gödöllő, 21 October 2015

An international consortium of 39 partner organisations will be funded by the European Commission to work on the integration of new concepts for regulatory chemical safety assessment. These new concepts involve cutting-edge human-relevant in vitro non-animal methods and in silico computational technologies to translate molecular mechanistic understanding of toxicity into safety testing strategies. The ultimate goal is to deliver reliable, animal-free hazard and risk assessment of chemicals.

Coordinated by Bob van de Water, Professor of Toxicology at Leiden University (The Netherlands), EU-ToxRisk intends to become the European flagship for animal-free chemical safety assessment. The project will integrate advancementsin cell biology, omics technologies, systems biology and computational modelling to define the complex chains of events that link chemical exposure to toxic outcome. The consortium will provide proof of concept for a new mechanism-based chemical safety testing strategy with a focus on repeated-dose systemic toxicity as well as developmental and reproductive toxicity. Importantly, novel mechanism-based test methods will be integrated in fit-for-purpose testing batteries that are in line with the regulatory framework and will meet industrial implementation. EU-ToxRisk will develop new quantitative risk assessment approaches based on understanding of so-called “Adverse Outcome Pathways” incorporating all mechanistic toxicity data available in the public domain. It will also achieve a rapid improvement of so-called “read across” approaches as the most important data-gap filling and hence animal-saving alternative method at present. Thus, the project strives towards faster safety evaluation of the many chemicals used by industry and society.

“BioTalentum Ltd as the only Hungarian partner, is proud,  to be part of such a European flagship project and to provide our combined expertise in human pluripotent stem cells and molecular biology to generate novel fluorescent reporter cell lines to assess neurotoxicity in two and three dimensional neuronal networks” said Biotalentum General Director Prof Andras Dinnyes. “We have high expectations that this project will boost BioTalentum’s portfolio in neuronal assays for chemical and drug toxicity and further strengthen our ties with chemical, cosmetics and pharma industry profiting from the new platforms.”

The EU-ToxRisk project will kick-off in January 2016 and will run for six years.

For further information on EU-ToxRisk and the project partners see:

For more information on the H2020 programme, visit:

Press contacts

Prof. Bob van de Water

Division of Toxicology

Leiden Academic Centre for Drug Research (LACDR)

Leiden University

Einsteinweg 55 / P.O. Box 9502 / 2300 RA  LEIDEN / The Netherlands

Office: +31-71-5276223 / Secretariat: +31-71-5276270 / E-mail:


Prof. Andras Dinnyes, General Director

BioTalentum Ltd, Aulich L u 26, Godollo, 2100, Hungary Email:





Notes to editors 

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 681002 — EU-ToxRisk.

Full document available here: /uploaded_files/files/EU-ToxRisk_press%20release_en_long_BIOT%281%29.docx

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