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This report evaluates the training courses delivered under the contract OC/EFSA/SCER/2017/01 ‐ Lot 1. Within the period of January 2018 to February 2022 a total of 21 training courses were provided, eight on‐site training courses in Parma at EFSA, six virtual training courses during the Covid‐19 pandemic and seven eLearning courses comprising various numbers of modules. The courses covered different aspects of chemical and biological risk assessment and related tools, namely i) harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals (mixture assessment), ii) risk assessment of the application of nanoscience and nanotechnologies in agro/food/feed (nanotoxicity); iii) science‐based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides (endocrine disruption); iv) principles on genotoxicity on scientific assessment (genotoxicity) and v) computational toxicology approaches and tools (in silico). All tutors were experts in their field and had previously performed training courses on these topics. The target participants of the training courses were members of EFSA’s Scientific Committee/Panels and their working groups as well as employees from national and international regulatory agencies associated with risk assessment of feed and food compounds. Members of the EFSA Networks as well as EFSA scientific staff also participated in the training courses. Courses were evaluated based on the feedback of participants and continuously improved also by integrating updated or new EFSA guidance documents.

Additional file 1: Table S1. PECO statements defined for the present study. Table S2. Eligibility criteria stablished for research articles inclusion or exclusion. Table S3: Search terms, data search and number of items retrieved in the BPAF single target search for each database. Table S4: Number of references and date of BPAF search in the three databases and applicants dossier.

The EuroMix handbook for mixture risk assessment describes the methodology and tools forassessing risks of combined exposures to multiple substances developed by the EuroMix project. The handbook is consistent with and expands upon the recent documents on mixture risk assessment published by OECD and EFSA. The aim is to provide a practical handbook for harmonised application of the EuroMix outcome under consideration of EFSA and OECD guidance and not to repeat the basic principles and information provided in the documents from OECD and EFSA. The handbook contains concise descriptions of the methodology and tools developed in the EuroMix project. Annexes in the handbook provide detailed information, useful templates and illustrative examples. The mixture risk assessment can be performed using the web‐based EuroMix toolbox. The handbook refers to the toolbox but the aim of the handbook is not to provide a step‐by‐step manual for the toolbox. The EuroMix methodology focuses on component‐based mixture risk assessment where substances are grouped based on toxicological considerations. Toxicity and exposure information for each substance in the assessment group is used for estimation of the combined risk using the dose addition hypothesis and relative potency factors (RPFs). The exposure assessment of mixtures is based on probabilistic methodology considering the individual consumption and concentration data allowing estimation of different percentiles of exposure to the mixture. The focus is on dietary exposure but other exposure routes are also described. The EuroMix methodology is very flexible, enabling assessment of both data‐rich and data‐poor substances. The handbook and EuroMix toolbox can also be applied for substances grouped based on other than toxicological considerations, e.g. structure or exposure considerations. The handbook starts by introducing the EuroMix toolbox. Thereafter, the handbook describes the EuroMix methodology and tools for the key elements in the framework for mixture risk assessment: problem formulation, hazard assessment, exposure assessment and risk characterisation. Finally, general issues of tiering approaches and uncertainty analysis are described. &nbsp

To maximise implementation of the new risk assessment strategies developed in EuroMix, training has been given for the stakeholders who will use the new tools and models. The aim of the training sessions is that the stakeholders will gain understanding of the scientific basis behind the new risk assessment strategies, be able to use the developed tools and to interpret and assess the output as well as implement the strategies in their own context.&nbsp

A toolbox has been built to assess risks from combined exposure to multiple chemicals using probabilistic methods. The toolbox has more than 40 modules to address all areas of risk assessment, and includes a data repository with data collected in the EuroMix project. This paper gives an introduction to the toolbox and illustrates its use with examples from the EuroMix project. The toolbox can be used for hazard identification, hazard characterisation, exposure assessment and risk assessment, with special emphasis on the use of in vitro results. Examples shown for hazard identification are the selection of substances relevant for a specific adverse outcome based on adverse outcome pathways and QSAR models. Examples for hazard characterisation are the calculation of benchmark doses and relative potency factors with uncertainty estimates from dose response data, and the use of kinetic models to perform in vitro in vivo extrapolation. Examples for exposure assessment are assessing cumulative exposure at either the external or the internal level, where the latter option is needed in case dietary and non-dietary routes have to be aggregated. Finally, risk assessment is illustrated by graphical displays of the margin of exposure for single substances and cumulated, including uncertainties for the exposure and hazard characterisation estimates., The final version of this document has been published as: van der Voet, H., Kruisselbrink, J. W., de Boer, W. J., van Lenthe, M. S., van den Heuvel, J. J. B., Crépet, A., Kennedy, M. C., Zilliacus, J., Beronius, A., Tebby, C., Brochot, C., Luckert, C., Lampen, A., Rorije, E., Sprong, C. and van Klaveren, J. D. (2020). The MCRA toolbox of models and data to support chemical mixture risk assessment. Food and Chemical Toxicology 138, 111185. https://doi.org/10.1016/j.fct.2020.111185

An important aim of the EuroMix project was to develop and implement a web-based platform (the EuroMix toolbox) including data and models accessible to all key-actors in risk assessment and risk management. The platform includes or links to relevant models to provide estimates of hazard, exposure and risk.This document provides a short description ofthe final EuroMix toolbox, MCRA 9.0, which is available at https://mcra.rivm.nl.An overview of the modules in the toolbox is given.

A toolbox has been built to assess risks from combined exposure to multiple chemicals using probabilistic methods. The toolbox has more than 40 modules to address all areas of risk assessment, and includes a data repository with data collected in the EuroMix project. This paper gives an introduction to the toolbox and illustrates its use with examples from the EuroMix project. The toolbox can be used for hazard identification, hazard characterisation, exposure assessment and risk assessment, with special emphasis on the use of in vitro results. Examples shown for hazard identification are the selection of substances relevant for a specific adverse outcome based on adverse outcome pathways and QSAR models. Examples for hazard characterisation are the calculation of benchmark doses and relative potency factors with uncertainty estimates from dose response data, and the use of kinetic models to perform in vitro in vivo extrapolation. Examples for exposure assessment are assessing cumulative exposure at either the external or the internal level, where the latter option is needed in case dietary and non-dietary routes have to be aggregated. Finally, risk assessment is illustrated by graphical displays of the margin of exposure for single substances and cumulated, including uncertainties for the exposure and hazard characterisation estimates.