$^{4}$ The term “new chemistries” relates to chemicals with new structures, that do not have structural or functional  analogues or belong to a family/group of chemicals with available  in vivo  information.  $^{3}$ Farm to Fork strategy – for a fair, healthy and environmentally-friendly food system 2  • NAMs have not yet been incorporated successfully in regulatory assessments, a main reason  is that NAMs offer a different kind of information compared with traditional reference points  used for setting reference values such as Health Based Guidance Values (HBGV). While full  replacement of animal studies for “new chemistries 4 ” is not on the immediate horizon, most  EFSA assessments are focused on chemicals or groups of chemicals for which there is already  information available, but in some of the cases there are data gaps that might need to be  addressed for the risk assessment. The use of NAMs for addressing these gaps can avoid  • The implementation of the use of NAMs in hazard assessment and risk characterisation of  chemicals in food and feed will be supported by case studies, covering all domains requiring  chemical risk assessment either as regulated products (additives, novel foods, pesticides) or  contaminants. The results will be used for developing cross-cutting guidance with an evolved  paradigm using NAMs for increasing the mechanistic understanding in the risk  characterisation process. The focus will be the integration of new tools with existing data  and the use of NAMs to fill data gaps in comprehensive risk assessments. 5) minimise EFSA requests for conducting new animal studies by supporting Panels and  units in the appraisal of NAMs studies. 4) evolving the risk assessment paradigm towards informative mechanistic-based  characterisations, through the integration of hazard and exposure drivers in  mechanistically informed risk assessments triggering the identification of susceptible  population groups;  3) using epidemiological knowledge (e.g. molecular epidemiology and -omics enhanced  epidemiological studies) and human data following occupational or environmental  exposure, including human inter-individual differences in metabolism and biomonitoring; 2) using existing chemical data and modelling internal dosimetry:  in-silico  tools, enhanced  data models, Toxicokinetic and Toxicodynamic (TKTD) modelling and quantitative  in  vitro in vivo  extrapolation (QIVIVE); 1) understanding the molecular and cellular mechanisms of chemical toxicity leading to  adversity: use of  in vitro mechanistic and -omics data, organoids and microfluidic  systems, high throughput screening (HTS), high content screening (HCS), for the  identification of Mode of Action (MoA) and inform about Adverse Outcome Pathways  (AOP); • The theme will cover all newly developed NAMs and, where applicable, their integration in  EFSA comprehensive regulatory risk assessments, with five complementary areas: • The scope is limited to chemical risk assessments, initially aimed to human health, with the  intention to extend it at a later stage to animal health and environmental assessments.  • The main objective is to facilitate the incorporation of NAMs in chemical food and feed risk  assessments, contributing to European (PARC) and international (OECD, APCRA) initiatives  promoting the implementation of the Farm to Fork Strategy 3 , reducing the need for animal  verification studies and, ultimately, phasing out animal testing.  approaches include integrated approaches to testing and assessment (IATAs), defined  approaches for data interpretation, and performance-based evaluation of test methods.  Opportunities: