On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled "A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs)" by Andrea Haase, Ph.D., German Federal Institute for Risk Assessment (BfR), Shirin M. Usmani, Ph.D., BfR, Irene Cattaneo, European Food Safety Authority (EFSA), Maria Chiara Astuto, EFSA, and Francesco Cubadda, Ph.D., National Institute of Health (ISS). The authors explain how the NAMs4NANO project, funded by EFSA, enhances the regulatory application of NAMs for assessing nanomaterial risks in the food and feed sector. The authors propose to establish three qualification programs, covering NAMs for nanomaterial physicochemical characterization; characterization of nanomaterials in relevant biological fluids; and toxicity screening. According to the authors, the proposed system has been tested initially for one selected model as an example that can be applied to investigate nanomaterial uptake and transport across intestinal barrier, and to evaluate the nanomaterial effects on barrier integrity. The authors note that more case studies are currently ongoing to qualify selected NAMs in the forthcoming implementation plan of the qualification system. The authors invite key stakeholders to collaborate on relevant case studies that can be used to test the qualification system.
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