Boosting advanced material's innovation – Are we regulatory prepared?

Abstract

In its policy communications, the European Commission placed advanced materials (AdMa) at the forefront of its strategic agenda, highlighting them as crucial elements to strive for a more sustainable, competitive, and resilient Europe. AdMa are referred to as a broad and heterogeneous group of materials that have been deliberately designed to achieve new, improved or specific functionalities. They are considered to support global challenges such as the energy transition, sustainable mobility concepts or health protection by offering technical solutions. AdMa comprise for instance nanomaterials with an upper size limit of 100 nm that are more complex in structure or composition. However, there are other AdMa that are not or only conditionally considered as nanomaterial. Based on current technical opportunities and innovation funding, it is expected that some of them will be marketed in considerable quantities. At the same time, these developments bring legal challenges related to chemical safety. In this publication we present regulatory challenges and questions that are linked with AdMa in the nanosize range and beyond. This includes considerations on a legal definition of AdMa, and whether AdMa should be regarded as substances, mixtures or articles, methodological challenges and regulatory relevant research to make regulatory risk assessment fit for purpose. Finally, we present a way forward by proposing actions for different stakeholders to encourage Regulatory Preparedness among policy makers and authorities and increase legal clarity for innovators. Timely addressing the regulatory needs in a fit for purpose chemicals legislation and regulatory risk assessment framework will facilitate and enable reaching the European Commission's goals and strategies towards a more sustainable, competitive, and resilient Europe.