Current European (EU) policies, such as the Green Deal, envisage safe and sustainable by design (SSbD) practices for the management of chemicals, which cogently entail nanomaterials (NMs) and advanced materials (AdMa). These practices, applied at the earliest stages of innovation and throughout the life-cycle of chemicals, materials and products, could prevent and/or minimise their environmental, health and safety (EHS) and sustainability impacts. This requires a shift from the established risk control paradigms towards prevention-based approaches at the design stage that accelerate the development of safer and more sustainable chemicals, materials, products and processes, while promoting a transition towards a circular economy and a more sustainable future. The EU commission has funded several Horizon 2020 projects applying the concepts of SSbD to nanotechnologies, biotechnologies and advanced materials. This article is inspired from the answers and opinions shared during a stakeholders meeting arranged throughout the workshop entitled ‘Safe and Sustainable by Design Paradigms applied to NMs and AdMa’, held in Venice, Italy, in September 2022. The goal of the workshop was to identify differences and overlaps between the SSbD approaches and to provide common messages on the progress towards the implementation of concrete SSbD concepts, and to reveal challenges faced in their realistic and straightforward execution. In this article, we provide insights into the intersecting industrial domains, the technical and organisational challenges to the practical implementation of the SSbD, and future financial directions in supporting and maintaining the digital products currently under development within the H2020 projects, in order to ultimately enable their uptake by industry and regulators.

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Minimum Quantity Lubrication (MQL) has received much attention from the research community as a potential lubricating system to reduce environmental hazards and health issues that can be commonly found in flood cooling/lubricating systems based on metalworking fluids. The addition of nanoparticles in MQL systems (NMQL) has led to improved machining performance, increasing the cooling capability and reducing friction and tool wear, and some researchers have proved the applicability of this type of system for difficult-to-cut materials. However, the mist generated by MQL systems due to both the MQL system itself and the machining operation may pose an additional hazard to operators which is being overlooked by the research community. These hazards become more severe when using nanoparticles, but unfortunately very few works have paid attention to nanoparticle toxicity as applied in MQL systems, and this issue should be clearly understood before encouraging its implementation in industry. Furthermore, current legislation does not help since regulation of permissible exposure limits when dealing with nanoparticles is still ongoing in most cases. In this work, the toxicity of nanoparticles applied in MQL systems is analyzed, and recent research on studies of nanoparticle toxicity both in vitro and in vivo is presented. A relative comparison of toxicity is provided for those nanoparticles that have been reported in the literature as potential additives for MQL. The review is focused on analyzing the main factors of toxicity of nanoparticles which are identified as size, shape, surface properties, agglomeration and solubility. This review presents guidelines for safer nanolubricant formulations, guiding practitioners towards proper NMQL implementations in industry. Furthermore, current occupational exposure limits and recommendations are provided for all the nanoparticles potentially used in MQL systems, which is of interest in terms of work safety.