NAMWISE Project to Pioneer Animal-Free Safety Testing in the EU

Due to the high cost, low efficiency, and ethical concerns surrounding in vivo (animal) toxicity testing, there has been a shift toward New Approach Methodologies (NAMs) that do not rely on animal testing. However, regulatory agencies overseeing chemical and pharmaceutical management are just beginning to adopt NAMs or consider their use within authorization frameworks.

 To transform safety testing in the EU, the NAMs within integrated safety and efficacy evaluation of chemicals and pharmaceuticals (NAMWISE) project is working towards optimizing and integrating NAMs into chemical and pharmaceutical regulatory frameworks. The €2 million Horizon Europe-funded project is scheduled to run from December 2024 to May 2027, and involves 18 partners from 8 countries, including academics; regulators; NAMs users; and NAMs developers. The findings from the NAMWISE project will directly inform future European Commission actions and shape EU regulations for chemicals and pharmaceuticals.

 Project objectives and deliverables include:

·         Workshops to gather stakeholder input and foster communication;

·         Analysis of NAMs’ shortcomings and recommendations for overcoming them;

·         Case studies on the successful use of NAMs;

·         Analysis of standardization and validation requirements for NAMs;

·         Trainings for Contract Research Organisations (CROs) applying NAMs for regulatory purposes; and

·         Peer-reviewed publication and white paper on procedures to implement NAMs in regulatory settings. 

As experts in safety assessments of advanced materials, including nanomaterials and food/feed ingredients, we applaud the EU’s investment into NAMs. Having recently published our work on NAMs development for the risk assessment of cellulose nanomaterials, we aim to contribute to the acceptance of NAMs within regulatory frameworks for faster, more sustainable approvals of advanced materials.