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 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 .  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.  • 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  Scope and objectives: $^{1}$ European Partnership for the Assessment of Risk from Chemicals (PARC/EUChemRisk) $^{2}$ Accelerating the Pace of Chemical Risk Assessment (APCRA) is an international government-to-government  initiative whose aim is to promote collaboration and dialogue on the scientific and regulatory needs for the  application and acceptance of NAMs in regulatory decision making  European Food Safety Authority  Via Carlo Magno 1A – 43126 Parma, Italy  Tel. +39 0521 036 111│ www.efsa.europa.eu  ANNEX 4  Theme (Concept) Paper on New Approach  Methodologies 