Alex Zabeo

The Safe and Sustainable by Design (SSbD) framework for chemicals and materials was established under the European Green Deal Chemical Strategy for Sustainability, aiming for a zero-pollution economy and a toxic-free environment. In line with the European Commission’s SSbD recommendation and framework, a pre-market sustainability assessment must take a life cycle perspective covering all pillars of sustainability: environmental, social, and economic. While environmental and economic assessments are well established, Social Life Cycle Assessment (S-LCA) has been less explored, especially when applied to advanced materials. To contribute to Step 5 of the SSbD Framework, this study presents a S-LCA applied during early stages of product development and optimisation. The case study concerns a novel PFAS-free anti-sticking coating, assessed in comparison with a conventional benchmark. The screening-level analysis identified potential social risk hotspots along the supply chain. Results indicate that differences between alternatives are predominantly driven by suppliers’ geographical locations rather than by process-specific characteristics. The results highlight the value of early-stage social assessments in supporting informed decision-making during research and development, increasing awareness of potential supply-chain risks, and guiding innovation toward more sustainable outcomes.

The application of nanomaterials in medicine has led to novel pharmaceuticals and medical devices that have demonstrated a strong potential for increasing the efficacy/performance and safety of therapeutic and diagnostic procedures to address a wide range of diseases. However, the successful translation of these technologies from their inception (proof-of-concept) to clinical practice has been challenged by substantial gaps in the scientific and technical capacity of R&D companies, especially SMEs, to keep up with the ever-evolving regulatory expectations in the emerging area of nanomedicine. To address these challenges, the EU Horizon 2020 project REFINE has developed a Decision Support System (DSS) to support developers of nanotechnology-enabled health products in bringing their products to the clinic. The REFINE DSS has been developed to support experts, innovators, and regulators in the implementation of intelligent testing strategies (ITS) for efficient preclinical assessment of nanotechnology-enabled health products. The DSS applies logical rules provided by REFINE experts which generate prioritized lists of assays to be performed (i.e. ITSs) for physicochemical characterisation and for immunotoxicological endpoints. The DSS has been tested against several case studies and was validated by internal project experts as well as external ones. Graphical abstract

This manuscript describes an innovative approach to socio-economic assessment of (advanced) engineered nanomaterials and nano-enabled products (NEPs) to support safe-and-sustainable-by-design (SSbD) decision making by industries in the early stages of product development. This semi-quantitative methodology is based on a sound conceptual framework grounded in the combination of social life cycle analysis and multi-criteria decision analysis methods and supports decision making based upon socio-economic impacts assessed over the full life cycle of a product. To facilitate its application by industries, the methodology was implemented as an Excel-based self-assessment tool. This easy-to-use, cost- and time-efficient tool can guide users through their SSbD decision making regarding newly developed nanomaterials and NEPs and can also be applied to re-evaluate existing materials and NEPs in order to improve their sustainability from a socio-economic perspective. The relatively low requirements of this tool regarding the level of efforts and expert knowledge needed for its application make it a good starting point for initial assessment to highlight socio-economic issues in the value chain. The results of this initial screening can be further used for more detailed analysis in the later stages of product development by performing a full social life cycle assessment (S-LCA).

The application of nanomaterials in medicine has led to novel pharmaceuticals and medical devices that have demonstrated a strong potential for increasing the efficacy/performance and safety of therapeutic and diagnostic procedures to address a wide range of diseases. However, the successful translation of these technologies from their inception (proof-of-concept) to clinical practice has been challenged by substantial gaps in the scientific and technical capacity of R&D companies, especially SMEs, to keep up with the ever-evolving regulatory expectations in the emerging area of nanomedicine. To address these challenges, the EU Horizon 2020 project REFINE has developed a Decision Support System (DSS) to support developers of nanotechnology-enabled health products in bringing their products to the clinic. The REFINE DSS has been developed to support experts, innovators and regulators in the implementation of Intelligent Testing Strategies (ITS) for efficient preclinical assessment of nanotechnology-enabled health products. The DSS applies logical rules provided by REFINE experts which generate prioritized lists of assays to be performed (i.e. ITSs) for physicochemical characterisation and for immunotoxicological endpoints. The DSS has been tested against several case studies and was validated by internal project experts as well as external ones.

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.

Nanotechnologies have been increasingly used in industrial applications and consumer products across several sectors, including construction, transportation, energy, and healthcare. The widespread application of these technologies has raised concerns regarding their environmental, health, societal, and economic impacts. This has led to the investment of enormous resources in Europe and beyond into the development of tools to facilitate the risk assessment and management of nanomaterials, and to inform more robust risk governance process. In this context, several risk governance frameworks have been developed. In our study, we present and review those, and identify a set of criteria and tools for risk evaluation, mitigation, and communication, the implementation of which can inform better risk management decision-making by various stakeholders from e.g., industry, regulators, and the civil society. Based on our analysis, we recommend specific methods from decision science and information technologies that can improve the existing risk governance tools so that they can communicate, evaluate, and mitigate risks more transparently, taking stakeholder perspectives and expert opinion into account, and considering all relevant criteria in establishing the risk-benefit balance of these emerging technologies to enable more robust decisions about the governance of their risks.