Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment

While whole animal studies have their place in risk assessment of food and feed components, it is thought that more modern approaches such as human focused new approached methodologies (NAMs) would bring advantages including a greater focus to the human species, a focus on molecular mechanism and kinetics and the possibility of addressing susceptible populations. This report outlines the thinking from the authors and culminates in activity proposals in seven distinct but interacting scientific areas i.e. development of additional AOPs/AOP networks (AOPs), advanced cell culture models including Organ on a chip (OoC), toxicokinetic assessment with a focus on physiological based kinetic modelling (PBK), exposome, human susceptibility, data integration and new concepts in human risk assessment. Furthermore, the development of a Forum is proposed to facilitate the implementation of new approaches and concepts in risk assessment. The report was compiled by the project team, renowned experts in the various areas, and recommendations were discussed with EFSA and further refined following consultation with external experts via a dedicated workshop. The authors are convinced that if the recommendations are taken up, there will be a significant impact in the field, resulting in increasing the uptake and utilisation of these emerging technologies by all stakeholders involved.