Implementation of the NANoREG Safe-by-Design approach for different nanomaterial applications

Abstract

The Safe-by-Design (SbD) concept is already in use in different industrial sectors as an integral part of the innovation process management. However, the adopted approach is often limited to design solutions aiming at hazard reduction. Safety is not always considered during the innovation process, mainly due to the lack of knowledge (e.g. in small and medium companies, SMEs) and the lack of dialogue between actors along the innovation chain. The net result is that safety is considered only at the end of the innovation process at the market authorization phase, with potential loss of time and money. This is especially valid for manufactured nanomaterials (MNM) for which the regulatory context is not completely developed, and the safety knowledge is not readily available. In order to contribute to a sustainable innovation process in the nanotechnology field by maximising both benefits and safety, the NANoREG project developed a Safe Innovation approach, based on two elements: the Safe-by-Design approach which aims at including risk assessment into all innovation stages; and the Regulatory Preparedness, focused on the dialogue with stakeholders along the innovation chain. In this work we present some examples about the implementation in our Laboratory of this approach for different MNM applications, covering different steps of the innovation chain. The case studies include: the feasibility study of a medical device including substances, for topical application; the testing of two potential nanotech solutions for the consolidation of cultural heritage artifacts; the testing of coatings already on the market for other uses, which was tested as food contact materials (FCM) to evaluate the conformity to food applications. These three examples represent a good opportunity to show the importance of NANoREG SbD and Safe Innovation Approach in general, for developing new nanotechnology-based products, also highlighting the crucial role of EU ProSafe project in promoting this concept to industries and interested stakeholders.