The European Commission (EC) is preparing an Advanced Materials Act to strengthen EU competitiveness and accelerate the safe, sustainable development and uptake of advanced materials. Feedback from a public Call for Evidence indicates that stakeholders broadly support the initiative, highlighting the need for stakeholder collaboration, regulatory alignment, harmonised test methods, and the early integration of safety and sustainability into innovation. RIVM stresses that current regulations and test methods may not adequately assess advanced materials, calling for a robust risk governance system embedded in the EU innovation ecosystem.

A recent review highlights the complexities of nanoparticle behaviour in the body and emphasises the need for physiologically based pharmacokinetic (PBPK) models to better predict their transport and elimination. Insufficient data on kinetic properties of nanoparticles hinder the effective use of PBPK models, particularly regarding the interaction of nanoparticles with the mononuclear phagocyte system (MPS) and the lymphatic circulation. Improving the associated model parameters requires more relevant data, for example, through in vitro testing, and exploring machine learning techniques to establish quantitative relationships between nanoparticle properties and key kinetic parameters.

The Technology Council for Advanced Materials identified the health sector as a fifth focus area for advanced materials, recognising opportunities for these materials to contribute to safe-and-sustainable-by-design devices and cost-effective, enhanced patient outcomes. The forthcoming Advanced Materials Act, expected in late 2026, will create an EU framework that impacts all sectors—including medical devices—making it crucial for stakeholders to stay engaged as regulatory proposals evolve.

The Advanced materials are becoming an increasing focus within European research, innovation, and competitiveness policies. At the same time, expectations are growing for these materials to meet Safe and Sustainable by Design (SSbD) principles, as reflected in recent European Commission policy initiatives and framework updates. RIVM emphasises the urgent need for stronger coordination between material innovation and policy development. This entails better knowledge sharing, clearer guidance for innovators, and structured dialogues, such as regulatory sandboxes, to support both material innovation and regulatory preparedness.

The SUNSHINE project introduces a functionality-safety approach to enhance the safety of advanced materials by linking their designed properties to potential safety risks during early development. This approach seeks to facilitate safer innovation by identifying potential safety issues associated with material functionalities, ultimately guiding targeted testing and redesign. The approach adds value to existing Safe-and-Sustainable-by-Design approaches as it starts from the perspective of functionality and could be applied from a very early innovation stage. It can therefore be beneficial to incorporate functionality-safety relationships in the European Commission’s Material Commons infrastructure.

A recent study applied machine learning to investigate which physicochemical and experimental factors were most involved in genotoxicity of titanium dioxide (TiO2). The findings confirmed that exposure concentration, cell medium composition, and lysis temperature in the comet assay correlate with DNA damage. The identified correlations could provide valuable insights for standardizing this test. However, the study methods and findings are too limited to identify new parameters involved in genotoxicity. Also, the scope was not aimed at providing evidence on the genotoxicity of TiO2, and therefore the study has no direct relevance for the discussion on the carcinogenicity classification of TiO2 nanomaterials.

A recent review discusses the suitability of in vitro models for studying the intestinal uptake of nanomaterials. While Caco-2 cell models are widely recognised for studying chemical uptake, their suitability for nanomaterials is limited due to the complex physiological processes involved, prompting the need for more advanced co-culture models. Significant knowledge gaps remain, especially in standardising and assessing how well these models mimic human biology and relevant exposure scenarios. Currently, the first steps towards harmonization of new approach methodologies as a tool to predict intestinal uptake of nanomaterials are being taken.

Advancements in nanoscience over the past 25 years have significantly influenced fields like nanoelectronics, bionanotechnology, and nanophotonics, driving innovations in computing, healthcare, and energy. Two key publications celebrate these achievements while underscoring the necessity for robust safety governance frameworks to address health, environmental, and ethical concerns associated with nanomaterials. As the integration of nanotechnology into everyday life accelerates, understanding the risks and benefits of these materials becomes crucial, prompting a call for proactive, adaptive regulatory approaches and international collaboration.