The Nanotechnology Industries Association (NIA) has actively engaged in the development process of the European Commission and Joint Research Centre’s Framework for safe- and-sustainable-by-design (SSbD) chemicals and materials.

Following the workshop where the three case studies testing the Framework were presented, NIA would like to raise the following concerns on its implementation:

• It is evident that applying the Framework requires considerable time and resources to collect and analyse all the necessary data. The case studies demonstrated that even large companies have either encountered difficulties in finding all the expert profiles needed in-house or preferred to outsource the work, raising the question of how SMEs can realistically hope to use the Framework in its current form;
• It is also clear that the Framework approach does not fully capture the nature of entire categories of substances, which would not progress beyond the initial safety assessment. This would make the whole sustainability assessment redundant and potentially exclude chemicals with promising potential in green applications from ever being considered sustainable-by-design;
• It is not clear how use of the Framework will be encouraged in third countries; if uptake outside the EU remains low, European companies could be left at a competitive disadvantage, but also encounter difficulties in running the exercise if their non-EU suppliers are not cooperative in providing the information needed.

“The Framework has the potential to be a great driver of the transition toward safer and more sustainable chemicals”, said Dr Blanca Suárez Merino, NIA’s Director of Regulatory Affairs: “For this reason, it must be usable by as many companies as possible. The current document is still highly theoretical, and we welcome the considerable effort already ongoing via Horizon Europe-funded projects to develop practical tools with industry involvement. A critical component of the shift to SSbD chemicals will also be the increased acceptance of novel test approaches, such as New Approach Methodologies (NAMs), for regulatory purposes”.

NIA welcomes the leading role taken by the European Commission in promoting the safety and sustainability of chemicals: but if we are to deliver the SME Strategy for a sustainable and digital Europe alongside the Green Deal and Chemicals Strategy for Sustainability, the SSbD approach must be made more accessible and beneficial to SMEs, which play a vital role in introducing new advanced materials to keep Europe globally competitive.