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(odnośnik otworzy się w nowym oknie). 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/(odnośnik otworzy się w nowym oknie).
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/(odnośnik otworzy się w nowym oknie) 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.
