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.

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.

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 use of nano-scale copper oxide (CuO) and basic copper carbonate (Cu₂(OH)₂CO₃) in both ionic and micronized wood preservatives has raised concerns about the potential of these substances to cause adverse humans health effects. To address these concerns, we performed quantitative (probabilistic) human health risk assessment (HHRA) along the lifecycles of these formulations used in antibacterial and antifungal wood coatings and impregnations by means of the EU FP7 SUN project’s Decision Support System (SUNDS, www.sunds.gd). The results from the risk analysis revealed inhalation risks from CuO in exposure scenarios involving workers handling dry powders and performing sanding operations as well as potential ingestion risks for children exposed to nano Cu₂(OH)₂CO₃ in a scenario involving hand-to-mouth transfer of the substance released from impregnated wood. There are, however, substantial uncertainties in these results, so some of the identified risks may stem from the safety margin of extrapolation to fill data gaps and might be resolved by additional testing. Our stochastic approach successfully communicated the contribution of different sources of uncertainty in the risk assessment. The main source of uncertainty was the extrapolation from short to long-term exposure, which was necessary due to the lack of (sub)chronic in vivo studies with CuO and Cu₂(OH)₂CO₃. Considerable uncertainties also stemmed from the use of default inter- and intra-species extrapolation factors.

This study aimed to investigate the awareness of Corporate Social Responsibility (CSR) among wineries located in the Italian regions of Veneto and Friuli Venezia Giulia (FVG) (1), (2) the obstacles (3) and market drivers of its implementation (4), the practices and range of actions that are concretely implemented in the field of CSR (5), the implications that this management approach can have on company performance (6), and the communication tools used. The methodology adopted is based on a qualitative approach integrated with quantitative measures. In total, 28 wineries participated in the study. The results show that all of the wineries were aware of the importance of implementing CSR, although they mainly refer to environmental issues. Sponsorship in fair trade activities is considered the most relevant market driver, while Italian consumers are generally perceived as not particularly interested in sustainable wine production. The practices implemented are mainly focused on reducing environmental impact. Interesting insights have emerged from this study, such as an unusual disparity between theoretical knowledge and practical implementation of socially responsible activities, a tendency to adapt the entrepreneurial style towards CSR, as well as a fundamental willingness to implement good practices that go beyond the legal requirements currently in force.