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approaches include integrated approaches to testing and assessment (IATAs), defined approaches for data interpretation, and performance-based evaluation of test methods. 

• 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. 

• 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 theme will cover all newly developed NAMs and, where applicable, their integration in EFSA comprehensive regulatory risk assessments, with five complementary areas: 

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); 

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); 

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; 

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; 

5) minimise EFSA requests for conducting new animal studies by supporting Panels and units in the appraisal of NAMs studies. 

• 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. 

## Opportunities: 

• 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 

