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European Test and Risk Assessment Strategies for Mixtures (EuroMix)
Project
Project code: BfR-LMS-08-1342-506
Contract period: 01.05.2015
- 31.05.2019
Budget: 7,999,097 Euro
Purpose of research: Applied research
The central aim of Euromix is to develop an experimentally verified, tiered strategy for the risk assessment of mixtures of multiple chemicals, which can be derived from multiple sources across different life stages. The project takes due account of the gender dimension and balances the risk of chemicals present in foods against the benefits of those foods. Important concepts for the new strategy to be developed in Euromix are prioritisation criteria for chemicals based on their exposure and hazard characteristics and evaluation of the role of mode of action and their key events in grouping chemicals into cumulative assessment groups. To this end, in‐silico and in‐vitro tools will be developed and verified against in‐vivo experiments. To be able to provide a full proof‐of‐principle, the project will focus in detail on hepatic, developmental and endocrine effects. In addition, more limited studies on immune toxicity will be undertaken. The EuroMix project will result in an innovative platform of bioassays for mixture testing and refined categorisation of chemicals in cumulative assessment groups. New hazard and exposure models will be embedded in the EuroMix model toolbox, which will be made available for stakeholders through an openly accessible web‐based platform. Access to the web‐based tools will be facilitated by training. Criteria will be set and guidance will be written on how to use and implement the tiered test strategy. Dissemination and harmonisation, to the extent possible, of the approach within EU, Codex Alimentarius, and WHO will be achieved by involving a.o. WHO and US‐EPA in the project and by the participation of experts who play a key role in helping establish international food safety policies.
The “Euro-Mix” project was funded in the frame of the EU research and innovation programme “Horizon 2020” with a total of 8 million Euro and was coordinated by the Dutch Institute for Public Health and the Environment (RIVM). With the goal to improve future risk assessment of mixtures, the cooperation of 26 scientific institutions developed a laboratory animal-free testing strategy, which enables the examination of interactions of substances in mixtures. The BfR was involved with two work groups in different topics of the project, and was able to contribute to the successful completion of the project in May 2019. In the experimental part of the project, a toolbox of consecutive in vitro tests was developed with cultures of liver cells focused on the toxicological endpoint fatty liver disease (steatosis). In a second step, the toolbox was tested successfully with single substances with known mechanisms of action (Luckert et al., 2018). Then the test battery was used for the characterisation of mixture effects of selected model substances. It was shown that above all dose addition effects predominate. With the developed test system, tailored for the toxicological endpoint “fatty liver (steatosis)”, a non-animal alternative toolbox is available. The toolbox can now be used for the testing of other relevant substance classes in order to investigate interactions of substances in mixtures such as inhibition, dose addition or synergism. The objective is to improve the data basis for the risk assessment of substances in mixtures and to reduce animal testing in the same time. However, further research is required to entirely substitute animal testing in the frame of cumulative risk assessment. Furthermore, BfR analysed the current legal framework as well as available methods and approaches for risk assessment of chemical mixtures, identified gaps and gave specific recommendations for the implementation of the new testing strategy (more information in Rotter et al., 2019). Building on this outcome, “EuroMix” invited international researchers and risk managers to four harmonisation workshops, in order to discuss current challenges and define necessary steps for the implementation of an internationally harmonised approach to the risk assessment of combined exposures to multiple chemicals. In the frame of “EuroMix” project, World Health Organisation (WHO) organised an expert consultation on the development of guidance for the risk assessment of combined exposure to multiple chemicals in May 2019. A pragmatic approach has been published subsequently to the meeting (WHO, 2019). The most relevant results of the entire project will be published at the “EuroMix” website (http://www.euromixproject.eu/) and in a planned publication (special issue of the scientific journal „Food and Chemical Toxicology“) scheduled for winter 2019. In the future, health risk assessment of chemical mixtures shall be continuously improved, also with regard to the regulatory framework, through alternative test methods and the harmonisation of the risk assessment of chemical mixtures within the European Union as well as within the frame of the Codex Alimentarius. Currently first discussions on a follow-up of “EuroMix” take place. Publications: • Luckert C., Braeuning A., de Sousa G., et al.. 2018. Adverse outcome pathway-driven analysis of liver steatosis in vitro: A case study with cyproconazole. Chem. Res. Toxicol. 31, 784-798. • Rotter, S., Beronius, A., Boobis, A.R., Hanberg, A., van Klaveren, J., Luijten, M., Machera, K., Nikolopoulou, D., van der Voet, H., Zilliacus, J., Solecki, R., 2019. Overview on legislation and scientific approaches for risk assessment of combined exposure to multiple chemicals: the potential EuroMix contribution. Crit. Rev. Toxicol. 48, 796-814. • WHO, 2019. FAO/WHO Expert Consultation on Dietary risk assessment of chemical mixtures (Risk assessment of combined exposure to multiple chemicals), WHO, Geneva, 16-18 April 2019.
Section overview
Subjects
- Food Chemistry
- Toxicology
Collaborative Project
EuroMix - A tiered strategy for risk assessment of mixtures of multiple chemicals
Framework programme
Funding programme
Excutive institution
National Institut for Public Health and the Environment (RIVM)
