Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials

Abstract

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.

Analyzing the surface of functional nanomaterials—how to quantify the total and derivatizable number of functional groups and ligands

“…Although these needs have been meanwhile recognized by metrological institutes, standardization organizations, and regulatory agencies worldwide, the constantly increasing number of new and more advanced NM developed make it difficult to keep track. A categorization or classification of NM could present an appropriate tool that has been addressed by different EU consortia, and stronger requirements on the quality of the analytical data to be provided for scientific publications involving NM could be beneficial to improve the overall confidence in “nano” data [ 31 , 32 , 41 , 247 , 259 ].…”

“…Knowledge of NM surface chemistry presents not only a key issue to understand the nano-bio interface largely cont r o l l i n g N M f u n c t i o n a l i t y a n d p e r f o r m a n c e i n (bio)applications, but is also relevant to assess the fate, exposure, dissolution, transformation, and accumulation of NM, and thus, NM toxicity and potential risks for human health and the environment [31][32][33][34][35][36]. This also includes the evaluation of risks associated with the application of engineered NM in consumer, food, and biomedical products [37][38][39][40][41]. Here, also unintentional changes and modifications in NM surface by time-and environment-dependent aging effects and transformations during the material's life-cycle must be considered, that can affect NM safety aspects [42].…”

“…This is also essential for quality assurance and production control of engineered NM in support of the SbD concept [ 9 , 18 , 23 , 50 , 51 ]. In this context, the development of harmonized and standardized characterization methods not only simplifies to rank, prioritize, and choose safer alternatives during the innovation process of engineering NM, but is similarly beneficial for regulatory frameworks and the confidence in NM [ 41 , 46 , 52 , 53 ]. Nevertheless, there is still a lack of normative measurement and characterization regulations, validated and standardized measurement protocols, reference materials of known surface chemistry for FG quantification, and reference data on application-relevant NM.…”

Carbon Nanotubes: Probabilistic Approach for Occupational Risk Assessment

“…Reliable procedures for risk assessment (RA) need to be constantly implemented to evaluate the possible health impacts of engineered nanomaterials (NMs). Although in theory the RA methodology is well established for other types of chemicals, the RA process for the NMs is challenging on a practical level [1,2]. Among the major limitations concerns the availability of reliable information on NM to properly set the hazard assessment (i.e., hazard identification and dose-response relationship evaluation) and the exposure assessment phases of the RA [1,3].…”

Can an InChI for Nano Address the Need for a Simplified Representation of Complex Nanomaterials across Experimental and Nanoinformatics Studies?

“…Development of high-throughput screening to greatly increase the amount of data available for regulators and for training hazard prediction tools was advocated during Horizon 2020 [ 6 , 7 ]. When combined with development of physicochemical characterization methods, exposure models, and life cycle assessment, this evolution provides a solid foundation for SbD strategies and nanomaterials (NM) risk management that supports sustainable innovation [ 8 , 9 ]. However, a commonly cited roadblock is lack of curated, organized and harmonized datasets for NMs toxicity [ 10 ], like those available for small molecules on UniChem, ChEMBL and other platforms.…”