Scientific paper ready for submission on the EuroMix toolbox and software

DLO-B, together with ICL, ANSES, DEFRA, URV and others, will optimize and implement models for compound prioritization based on Margin of Exposure (MoE) in a ‘refine and retain’ setting. This will provide a practical implementation of the RISK21 matrix approach in a fully probabilistic setting. The QALIBRA model will be linked into the EuroMix tool, in collaboration between DLO-B and DEFRA. A functional design for the general design and the uncertainty aspects of the EuroMix tool (Milestone 6.4, M24) will be prepared by DLO-B and DEFRA. DLO-B will propose a general software design for an integrated web-based model composed of modules for dietary exposure, non-dietary exposure, in-vitro and in-vivo hazard characterizations using a bioassay and omics toolbox, and models to link the different parts (based on PB-PK, systems biology, benchmark dose modelling and probabilistic margin of exposure). The software will include simpler models in a tiered approach as well. DLO-B will design the front-end for different user categories. DEFRA will propose a comprehensive general approach for addressing uncertainty in aggregate exposure and risk assessments, building on the recommendations of the EFSA working group on uncertainty. Both qualitative and quantitative approaches will be considered. The uncertainty in the exposure will be quantified and uncertainties related to exposure assessment and risk characterisation will be identified. Sensitivity analyses will be also applied to determine key parameters within the EuroMix tool used in the tiered approach to CAG creation and assessment, as part of WP8. The final EuroMix model toolbox will be described in a draft scientific paper (D6.4, M48).