No abstract

Hazard identification is an important step in assessing nanomaterial risk and is required under multiple regulatory frameworks in the US, Europe and worldwide. Given the emerging nature of the field and complexity of nanomaterials, multiple studies on even basic material properties often result in varying data pointing in different directions when data interpretation is attempted. Weight of evidence (WOE) evaluation has been recommended for nanomaterial risk assessment, but the majority of WOE frameworks are qualitative in nature and do not satisfy the growing needs for objectivity and transparency that are necessary for regulatory decision making. This paper implements a quantitative WOE framework that utilizes multi-criteria decision analysis methodology for integrating individual studies on nanomaterial hazard resulting from physico-chemical and toxicological properties of nanomaterials. For the first time, a WOE approach explicitly integrates expert evaluation of data quality of available information. Application of the framework is illustrated for titanium dioxide nanoparticles (nano-TiO2), but the approach is designed to compare the relative hazard of several nanomaterials as well as emerging stressors in general.

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.

Nanotechnology is widely used in several industrial and consumer sectors and has the potential to grow further and expand globally. An exploration of stakeholder (SH)’s perceptions is essential to ensuring that robust risk governance processes are in place for nanotechnology and nano-related products. In response, numerous studies have been conducted to investigate SH’s perceptions of nanotechnology and nano-related products over the past 15 years. To build on this work and to capture current perceptions across a wide panel of SHs, we conducted a multi-national and cross-sectoral SH study of awareness, perceptions and opinions regarding the use and potential impact on society and the environment of nanomaterials (NMs) and nano-related products, and SH’s expectations about risk governance. The study was conducted using both quantitative and qualitative inquiries and targeted more than 3000 SHs across different sectors in a total of 15 countries. Results showed a tendency towards more convergence of opinions amongst all the relevant SHs and the public respondents than in past studies. There was consensus on the crucial importance of having unbiased, scientific and trustable information regarding the potential impacts of NMs and nano-related products on the environment, health and safety. SHs were interested in having more internationally harmonised and robust regulation for NMs and nano-related products; improved scientific evidence on nanomaterial hazards, exposures and effects; as well as specific guidance on the safe use of NMs. Overall, this work provides an updated scenario of SHs’ perceptions regarding nanotechnology and nano-related products, underscoring the importance of including SH needs in effective risk governance strategies.

Nanotechnologies have reached maturity and market penetration that require nano‐specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)‐by‐Design (SbD) concepts. This paper provides an overview of the state‐of‐the‐art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re‐thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science‐based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally.