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Disclaimer: This document does not present future project calls as part of the EFSA work programme, or any future position of EFSA. It aims to support the development of a roadmap for action and its content can be subject to change . 

# ANNEX 4 

# Theme (Concept) Paper on New Approach Methodologies 

Revised theme paper in light of the comments received from the EFSA, European Commission, ENVI Agencies, EU Member States and EFSA’s Scientific Committee members in the phases 1 & 2 of EFSA’s consultation process 

## Vision: 

By 2027, 

• The use of new approach methodologies (NAMs) has become the main approach for addressing data gaps, avoiding animal-based verification studies. The large majority of EFSA requests for additional testing are based on NAMs. 

• In agreement with risk managers, mechanistic-based informative risk assessments have been integrated as standard part of EFSA’s regulatory assessments for chemicals in food and feed. 

• EFSA efforts to minimise animal testing is acknowledged and EFSA is recognised as part of a European (and international) coordination platform, as an important partner for the evolution of the risk assessment paradigm and the use of NAMs in regulatory risk assessments. 

• An EFSA Scientific Committee cross-cutting guidance document provides the basis for the use of NAMs in food and feed risk assessment, is implemented across EFSA’ s domains, and guides EFSA contributions for harmonisation at European (i.e., PARC 1 ) and international (i.e., OECD and APCRA$^{2}$) levels. 

## Scope and objectives: 

• The term “NAMs” is used to make reference to any non-animal-based approach that can be used to provide toxicological information in the context of hazard assessments. These new 

