Risk Governance of Nanotechnology

Project Information

RiskGONE

Grant agreement ID: 814425

DOI

10.3030/814425

Project closed

EC signature date 19 December 2018

Start date 1 January 2019

End date 31 August 2023

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials

Total cost

€ 4 999 979,94

EU contribution

€ 4 999 979,94

Coordinated by

STIFTELSEN NILU
Norway

Periodic Reporting for period 3 - RiskGONE (Risk Governance of Nanotechnology)

Reporting period: 2022-03-01 to 2023-08-31

Summary of the context and overall objectives of the project

Engineered nanomaterials (ENMs) are used in many fields but we still have relatively limited knowledge about their hazards and risks. In Europe, ENMs are regulated through the legislation for industrial chemicals (REACH). However, due to the peculiar features of nanoscale materials, the suitability to ENMs of the regulatory tests (OECD test guidelines (TGs) and guidance documents (GDs)) and procedures used to rank the safety of conventional chemicals, need to be verified, and if necessary, adapted to be applicable to ENMs.
The aim of the RiskGONE project was to define science-based Risk Governance (RG) processes for ENMs, by updating existing risk assessment (RA) procedures (or processes) and RG frameworks for conventional chemicals through implementing newest knowledge on ENMs.
The RiskGONE was designed to address standardization, validation and adaptation of OECD TG/GDs on characterization, human and environmental hazard and risk-benefit assessment (WPs 3, 4, 5, 6) and their implementation for RG (WP2), with strong focus on communication with all relevant stakeholders (WP7), ethical aspects (WP8) and efficient management (WP1).
With the completion of all planned activities, RiskGONE successfully fulfilled its aims and maximized the impact of its outcomes, by creating new knowledge on RG and RA of ENMs, enabling better prediction of potential human health and environmental impacts of ENMs, guiding decision-making and holistic safety governance of ENMs, supporting regulation and sustainable innovation, and democratizing access to data, computational models and decision tools.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The RiskGONE Consortium successfully implemented all the planned activities: development of a roadmap towards standardization and validation of OECD TG/GDs, new approach methodologies (NAMs), digitization through web solutions, creation of the RiskGONE database, Cloud platform, decision trees for RG framework, and training materials for efficient and fast transfer of knowledge.
A RG framework tailored to ENMs has been outlined, as introduced in Isigonis et al. (2020) and further developed and presented in RiskGONE’s Deliverable 2.3 (publicly available), which describes the incorporation of TGs/GDs/SOPs within the framework, through the design and implementation of decision trees to assist stakeholders in structuring their assessment of ENMs and nano-enabled products.
To allow easy access to, and use by, all interested stakeholders, the RiskGONE RG framework and underpinning decision trees were implemented into the RiskGONE Cloud Platform, available at https://enaloscloud.novamechanics.com/riskgone.html. The Platform hosts all RiskGONE’s scientific outputs, organized into various categories and sections, for easy navigation.
Over 20 TGs/GDs/SOPs and scientific methods for RA of ENMs, for the risk-benefit calculation (WP3), characterisation, fate and dosimetry (WP4), human (WP5), and environmental hazard assessment (WP6) of ENMs were evaluated, adapted and pre-validated through interlaboratory studies. Whenever possible and relevant, this work was translated into the OECD WPMN/WNT programme, including through collaboration with the Malta Initiative and the EU project NanoHarmony. Communication with National delegations at OECD (e.g. UK and Norway) was initiated to get support for new TGs/GDs submissions for methods pre-validated by RiskGONE. Work was also performed with respect to nano-specific adverse outcome pathways (AOPs), with systematic reviews of literature related to human toxicity and ecotoxicity, and the development of an AOP for reproductive toxicity Daphnia magna (WPs 5, 6). NAMs and mechanistically relevant, high throughput and high content analysis methods, such as impedance-based methods, 3D in vitro models, were also tested with ENMs. The harmonization of data curation and extraction was also pursued, with the development and/or update of data entry templates (Jeliazkova et al., 2023, in press in Nature Protocols) and the creation of the RiskGONE database as part of the Nanosafety Data Interface at https://enanomapper.adma.ai/.
RiskGONE collaborated with the other H2020 NMBP-13 projects, NANORIGO and Gov4Nano, discussing the definition of the RG framework, IT solutions, and case studies implementation to test the framework. The NMBP-13 projects developed a Nano-Risk Governance Portal which is now available at https://nanoriskgov.eu/ and aims to become a one-stop-shop to access nano-specific information, guidance, methods, tools, and data to support RG of nanotechnologies.
The NMBP-13 projects also focused on a common approach to stakeholder engagement, with the organization of several joint events and webinars, including co-organization of the final NMBP-13 conference hosted by the OECD in Paris on January the 24th and 25th 2023, a crucial event where the results of the projects were widely disseminated and discussed with the most relevant stakeholders.
Communication and dissemination activities, and links to international bodies (WP7), were pursued through the organization of webinars, workshops, conferences, meetings and interviews, through the RiskGONE project website, LinkedIn profile, Vimeo, and newsletter, and scientific publications. Training materials in the form of hands-on videos, presentations, factsheets, and SOPs were developed, and training courses have been provided to stakeholders.
Scientific quality and progress (WP1) and ethical issues (WP8) have been constantly addressed to ensure the best implementation of the project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

RiskGONE generated many unique results and outputs beyond the state-of-the-art (> 66 publications in high profile journals, 70 deliverables, Cloud Platform), creating new knowledge on RA and RG of ENMs that is directly applicable to safety, sustainability and regulation of emerging areas such as advanced materials, and key European policy ambitions namely the European Chemicals Strategy for Sustainability (CSS) and the Zero Pollution Action Plan. RiskGONE also closely linked with the Partnership for Assessment of the Risks of Chemicals (PARC), and other initiatives, and with regulatory agencies presenting the achievements and outcomes that could be applied, not only for ENM safety but also to RA and RG of advanced materials and chemicals generally.
Collectively, the RiskGONE RG framework and tools enable better prediction of human health and environmental impacts of ENMs, guiding decision-making and holistic governance of ENMs. The IT solutions (RiskGONE Cloud Platform, Nano-Risk Governance Portal, harmonized data collection templates and database) provide transparent and accessible support tools for the RA and decision-making processes, democratizing access to data, computational models and decision tools, and supporting future development of safer advanced materials.
RiskGONE’s production of over 20 nano-specific draft GDs/TGs and corresponding training materials to support RA of ENMs, and contribution to the work towards ongoing and future OECD WPMN/WNT projects is supporting regulation and sustainable innovation. The exploration of NAMs and AOPs in RiskGONE contributes to the implementation of next generation of risk assessment into regulatory framework.
RiskGONE facilitated the communication with stakeholders and civil society regarding the RG of ENMs via dissemination and communication activities, including > 35 training materials, > 20 webinars, workshops and courses.

RiskGONE universal nanotechnologies RG framework