The EU is funding the three multi-partner research projects PrecisionTox, ONTOX and RISK-HUNT3R under the call „Advancing safety assessment of chemicals without use of animal testing” with a total funding volume of € 60 million over five years.

PrecisionTox, with 15 partners led by the University of Birmingham, started on February 1. The goal of the project is to identify molecular key event (KE) biomarkers that predict chemically induced adverse health effects in humans and to facilitate their uptake into regulatory and industry practice. This goal is supported by three core concepts: PhyloToxicology, which replaces mammalian models with an evolutionarily diverse suite of non-sentient animal species from across the tree of life; Quantitative Susceptibility, which determines safety factors based on genetic variability; and Embedded Translation, which engages key stakeholders in project planning, selection of chemicals for investigation, and case studies for regulatory application.

ONTOX, with 18 partners led by the Vrije Universiteit Brussels, will kick off on May 1. The consortium aims to deliver a generic strategy to predict systemic repeated dose toxicity effects. This will be combined with tailored exposure assessment to enable human risk assessment. The focus will be on 6 new approach methodologies (NAMs) addressing adverse outcomes in the liver (steatosis and cholestasis), kidneys (tubular necrosis and crystallopathy) and developing brain (neural tube closure and cognitive function defects). The NAMs will integrate available data into physiological maps, quantitative adverse outcome pathway networks and ontology frameworks and use artificial intelligence technology to identify data gaps to be filled by targeted in vitro and in silico testing. The NAMs will be evaluated and applied in collaboration with industrial and regulatory stakeholders to maximize end-user acceptance and regulatory confidence.

RISK-HUNT3R, with 37 partners led by the Universiteit Leiden, will start on June 1. The vision of the RISK-HUNT3R consortium is to provide a fully human-centric risk assessment strategy encompassing exposure assessment, information on chemical distribution in the body, hazard characterization, adverse outcome prediction, and determination of actual risk in defined scenarios, also factoring in human (disease) genetics and exposome data. The applicability of all critical test systems integrated into the next generation risk assessment strategy will be assessed. Engagement with all key stakeholders from different industry sectors and international regulatory agencies based on real-world case studies will allow critical evaluation and warrant genuine acceptance of the novel safety testing framework that will be in concordance with the European Commission’s “Green Deal”. The project will seek commercial exploitation of the validated safety assessment approaches to ensure sustainability of the project outcomes and fortify the innovation capacity of the industry sectors involved.