New approaches to improve predictive human safety testing

Topic description

Scope:

Specific challenge: Current approaches assessing the safety of chemical substances in humans are expensive and time consuming, and may be of limited relevance as a predictor of adverse effects. Better approaches are needed both to improve the efficiency of predictive toxicological testing to address key areas of concern for human health and to meet regulatory requirements (e.g. EU legislations on REACH, cosmetics, biocides). Safety testing is of worldwide concern and therefore international cooperation may be an important element in addressing the challenge.

Scope: Proposals should capitalise on advances in all relevant fields of science to understand complex biological pathways of toxicological relevance and to identify early markers predictive of toxicological effects in humans with the objectives of developing and validating routine, non-animal approaches for toxicity testing of chemical substances (excluding radio-chemicals). The research may include the development of methodologies for confirmatory testing of mechanistic hypotheses to improve understanding of toxicity mechanisms.

Proposals should involve, amongst others, research communities, SMEs, industry and regulatory agencies as appropriate. Proposals should demonstrate efficient mechanisms for the co-ordination of activities and exchange of information, and should include a timeline for delivery of test methods.

In line with the Union’s strategy for international cooperation[1] in research and innovation, cooperation is encouraged with similar initiatives in the USA and elsewhere, and would be highly beneficial from scientific and economic standpoints.

 Proposals could consider the involvement of the European Commission Joint Research Centre (JRC) as an added value in order to provide an effective interface between the research activities and regulatory aspects and/or to translate the research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will collaborate with any successful proposal.

Applicants are encouraged to seek during the life-time of the project additional support from various sectors in order to facilitate translational aspects.

The Commission considers that proposals requesting a contribution from the EU of between EUR 10 and 30 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:

• More effective, faster, cheaper toxicological testing to better predict human risk and meet regulatory needs.
• Improved toxicological knowledge to encourage ‘read across’ between chemical substances for use in different research and regulatory domains.
• Commercial exploitation of the developed toxicological testing methods and assessment approaches, products and services.
• Advancement of international co-operation in the field of predictive toxicology and human safety testing.
• Reduced use of laboratory animals in safety testing.

Form of funding: Research and innovation actions

[1] COM(2012)497

International cooperation