Methods and tools for the safety assessment of nanomaterials

Nanomaterials challenge conventional safety assessment due to their dynamic physico-chemical properties and nano-specific behaviours that are not adequately captured by standard chemical testing strategies and assessments.

To address these challenges, a broad set of methodologies, tools, databases, and tool repositories supporting the safety assessment of nanomaterials were compiled and analysed, with a focus on environmental and human health dimensions. Hazard assessment methodologies were classified into in silico, in vitro, and in vivo methods and further distinguished between human and environmental endpoints, including freshwater, seawater, and soil systems. Particular attention was given to nano-specific challenges affecting hazard testing, such as particle agglomeration and sedimentation leading to reduced effective exposure concentrations.

In parallel, digital tools were classified according to their support for hazard, exposure, fate, or risk assessment and organised into Tiers 1 to 3, ranging from simpler screening approaches to more complex assessments. Tool accessibility was also evaluated in terms of readiness level, associated cost, and maintenance status, providing practical insights into their operational usability. On top of that, relevant nanomaterials databases providing physicochemical characterisation and hazard data were systematically mapped and existing tool repositories were identified to facilitate user navigation and access to established decision-support resources.

This consolidated information strengthens the operationalisation of the Safe and Sustainable by Design (SSbD) framework developed by the European Commission Joint Research Centre, which integrates safety and sustainability considerations from the earliest stages of material development. By improving access to relevant methods, tools, and data, and by clarifying their scope, tier applicability, and known limitations, the approach supports more informed and transparent evaluations at early stages of material development, where data availability is limited and design decisions are most impactful. The analysis also identifies key methodological gaps and provides recommendations to improve and expand the current assessment landscape.