Regulatory challenges and risk assessment of graphene-enabled products: insights for safe commercialisation in Europe

The development of graphene-enabled products in a variety of industrial sectors like medical devices, textiles, aerospace, or food contact materials has raised significant regulatory challenges with regards to risk assessment. The work performed under the Graphene Flagship Work Package SH11 termed SafeGraph, aimed to identify challenges while implementing regulation as well as to develop a regulatory roadmap addressing these issues. This study explores and discusses the regulatory gaps and safety assessment challenges associated with graphene-enabled products and based on regulatory requirements with a particular focus on risk assessment, exposure concerns, and potential environmental impacts. Through case studies involving skin sensors, drinking water filters, wearable electronics, and de-icing systems for aircrafts, we identified critical safety and compliance issues across various sectors. The work used four Graphene Flagship case studies as showcases to address the above markets (CHEMsens, GRAPHIL, WEARgraph and GICE). These case studies underscore the need for updated regulatory guidelines tailored to graphene’s unique properties. This study provides insights into current challenges of assessing risks and proposes steps to ensure safe and sustainable commercialisation of graphene-based products, advocating for harmonised regulatory frameworks.