EU’s next generation risk assessment: hurdles and opportunities for new approach methodologies

Abstract

AbstractThe EU’s decision to ban animal testing for toxicity testing, has positively influenced the pace of developing New Approach Methodologies (NAMs). This development also supports replacing animal methods in other forms of risk assessment (RA), such as for oral-toxicity testing. This study aims to identify the hurdles and opportunities for validation and implementation of NAMs in the current EU’s chemical RA. Through conducting semi-structured interviews with 14 stakeholders, experiences and perspectives about the validation and implementation of NAMs in RA for orally ingested chemicals were analyzed. Stakeholders considered the use of NAMs for RA processes both a cultural and generational issue. Both were perceived as hurdles for reaching the next generation RA approach. The differing views on NAMs originated from experience and stakeholder positions, but communication and collaboration on developing future RA approaches could support overcoming this skepticism. Irrespectively of their background, all interviewees were generally optimistic that NAMs will support the development of more accurate and sustainable RA. This research highlights the need for the EU to adjust legislation and guidance documents to shift in testing requirements from the traditional overexposure approach to more predictive, mechanistic testing in RA, which will take time. This study, however, shows that—when all stakeholders engage in communication and confidence building—NAMs can already play an important role in reducing and refining animal testing.