Periodic Reporting for period 3 - Gov4Nano (Implementation of Risk Governance: meeting the needs of nanotechnology)
Reporting period: 2022-03-01 to 2023-02-28
Spanning a period of 50 months, the Gov4Nano (G4N) project has responded with flexibility to a developing process inside the Commission, which has seen the Chemicals Strategy for Sustainability (CSS) become one of the key drivers at the heart of the European Green Deal. The EC-JRC Safe and Sustainable by Design (SSbD) assessment Framework has been developed to target all chemicals and Advanced Materials (AdMa), including nanomaterials (NMs), and is supported by the industry driven AMI2030, highlighting the importance of SSbD in the manufacturing process. G4N from its inception focused on developing responsible governance of the risks posed by NMs, in pristine form or integrated into other products. The direction taken by G4N was also shaped by the collaboration with the two other NMBP13 projects, NANORIGO and RiskGONE, where a strong collaboration led to harmonization of objectives, deliverables and final results. The change in emphasis or refocusing of G4N which happened between 2021 and 2022 is shown in Figure 1. It is noteworthy that this is the first time that such interproject collaboration at this scale has ever been achieved in framework projects.
The project objectives were modified in this period to reflect the refocusing of G4N:
The overarching aim of G4N was to develop a proof of concept of an efficient and effective risk governance process for nanotechnologies, with a tangible legacy, and able to accommodate future technological developments. More specifically,
• To ensure reusable data is made available through the nano-Environment Health Safety infrastructure, which complies with FAIR principles (WP1)
• To develop harmonized guidance for characterization and testing of nanomaterials (WP2)
• To understand and influence how risk perception on nanotechnologies is formed in civil society and (re-)insurance industry (WP3)
• To develop a Nano Risk Governance Portal (NRGP) including Risk Assessment tools, data and guidance (WP4)
• To develop conditions for an organisational form for Nano Risk Governance to coordinate and harmonize transdisciplinary international efforts toward safe and sustainable nano-related products (WP5)
• To engage with stakeholders to provide a solid basis for developing a credible and sustainable mechanism to govern risks related to NMs along the value chain (WP6)
• To develop mechanisms and tools to monitor the progress on implementation of risk governance for nanotechnology across different regulatory sectors (chemicals, biocides, cosmetics, food, medicine) in Europe and beyond (WP7)
G4N evaluated a wide range of scenarios to understand how the scope of integrated nano risk governance could be shaped in terms of what was essential and what was realistically feasible to achieve:
#1 More connectivity and broader engagement with key stakeholders to collect opinions and concerns and critical expertise that may not be captured in technical hazard and risk assessment alone and need to be well understood to ensure effective risk management.
#2 Access to multidisciplinary knowledge and expertise, in particular for more systematically integrating social sciences in assessment and decisions.
#3 Better quality data and easier access to data sets along with appropriate tools for risk assessment.
These key conditions in terms of mission, goals and activities, led to two main options, which were evaluated. Option A, a “Roundtable”, focuses on #1 while option B, a “House” of Nano Risk Governance, addresses #1, #2 and #3. Proof of concept demonstrated broad acceptance and support for a ‘House’ of Risk Governance to address risk governance issues stemming from advanced (nano)materials. This House incorporates other outputs of the NMBP-13 projects such as the Portal and the main aim is to ‘foster safe and sustainable development, use and disposal of (products containing) NMs in Europe’.
The project objectives were modified in this period to reflect the refocusing of G4N:
The overarching aim of G4N was to develop a proof of concept of an efficient and effective risk governance process for nanotechnologies, with a tangible legacy, and able to accommodate future technological developments. More specifically,
• To ensure reusable data is made available through the nano-Environment Health Safety infrastructure, which complies with FAIR principles (WP1)
• To develop harmonized guidance for characterization and testing of nanomaterials (WP2)
• To understand and influence how risk perception on nanotechnologies is formed in civil society and (re-)insurance industry (WP3)
• To develop a Nano Risk Governance Portal (NRGP) including Risk Assessment tools, data and guidance (WP4)
• To develop conditions for an organisational form for Nano Risk Governance to coordinate and harmonize transdisciplinary international efforts toward safe and sustainable nano-related products (WP5)
• To engage with stakeholders to provide a solid basis for developing a credible and sustainable mechanism to govern risks related to NMs along the value chain (WP6)
• To develop mechanisms and tools to monitor the progress on implementation of risk governance for nanotechnology across different regulatory sectors (chemicals, biocides, cosmetics, food, medicine) in Europe and beyond (WP7)
G4N evaluated a wide range of scenarios to understand how the scope of integrated nano risk governance could be shaped in terms of what was essential and what was realistically feasible to achieve:
#1 More connectivity and broader engagement with key stakeholders to collect opinions and concerns and critical expertise that may not be captured in technical hazard and risk assessment alone and need to be well understood to ensure effective risk management.
#2 Access to multidisciplinary knowledge and expertise, in particular for more systematically integrating social sciences in assessment and decisions.
#3 Better quality data and easier access to data sets along with appropriate tools for risk assessment.
These key conditions in terms of mission, goals and activities, led to two main options, which were evaluated. Option A, a “Roundtable”, focuses on #1 while option B, a “House” of Nano Risk Governance, addresses #1, #2 and #3. Proof of concept demonstrated broad acceptance and support for a ‘House’ of Risk Governance to address risk governance issues stemming from advanced (nano)materials. This House incorporates other outputs of the NMBP-13 projects such as the Portal and the main aim is to ‘foster safe and sustainable development, use and disposal of (products containing) NMs in Europe’.
From its inception, the G4N project has explored different pathways, options and scenarios in order to ascertain which key elements were needed to ensure that a comprehensive and sustainable risk governance mechanism for NMs could be established and maintained for the long term.
The initial strategic concept created to guide G4N has grown and adapted to the changing priorities of the Commission from the start of the project up to the final phase. This strategy (Figure 2) comprises three main elements, namely Scientific Excellence, Co-creational Excellence and Proving the Outcomes. Scientific excellence was covered mainly by WPs 1, 2 and 4. FAIRness of data (WP1) provides a sound scientific basis to any evaluation or decision-making process. The GO FAIR Implementation Network ‘AdvancedNano’ has been launched and is considered a remarkable success with 28 members from the EU, South Korea, and Argentina. Data reuse by new projects has been initiated. WP2 was focused on the development of scientific knowledge for the adaption and modification of seven OECD Test Guidelines for NMs that have been prioritised with the help of the Malta Initiative and the OECD WPMN priority recommendations. Different endpoints have been addressed, solubility and dissolution in water and biological media, surface chemistry, the volume specific surface area, skin sensitisation, dustiness, environmental transformation, and bioaccumulation. A NRGP (WP4) hosting tools, providing access to data and information, which supports the process of Nano-Risk Governance has been launched in collaboration with NANORIGO and RiskGONE. G4N has built on the NanoReg2 Safe Innovation Approach and caLIBRAte Nano-Risk Governance Framework. WPs 3 and 6 engaged with numerous stakeholders to the benefit of all G4N WPs gathering different views and opinions, which helped form ideas. WP5 developed the model for an organizational form, given the working title House of Nano Risk Governance, based on a wide range of input from all G4N WPs, and in conjunction with NANORIGO and RiskGONE. Four main elements of data, tools, portal and framework are joined in the organizational form which is ready for uptake by successor projects. Monitoring the progress of implementation of risk governance for nanotechnology was done via a dashboard of instruments (WP7); the dashboard is now available for new projects as a dedicated toolbox.
The initial strategic concept created to guide G4N has grown and adapted to the changing priorities of the Commission from the start of the project up to the final phase. This strategy (Figure 2) comprises three main elements, namely Scientific Excellence, Co-creational Excellence and Proving the Outcomes. Scientific excellence was covered mainly by WPs 1, 2 and 4. FAIRness of data (WP1) provides a sound scientific basis to any evaluation or decision-making process. The GO FAIR Implementation Network ‘AdvancedNano’ has been launched and is considered a remarkable success with 28 members from the EU, South Korea, and Argentina. Data reuse by new projects has been initiated. WP2 was focused on the development of scientific knowledge for the adaption and modification of seven OECD Test Guidelines for NMs that have been prioritised with the help of the Malta Initiative and the OECD WPMN priority recommendations. Different endpoints have been addressed, solubility and dissolution in water and biological media, surface chemistry, the volume specific surface area, skin sensitisation, dustiness, environmental transformation, and bioaccumulation. A NRGP (WP4) hosting tools, providing access to data and information, which supports the process of Nano-Risk Governance has been launched in collaboration with NANORIGO and RiskGONE. G4N has built on the NanoReg2 Safe Innovation Approach and caLIBRAte Nano-Risk Governance Framework. WPs 3 and 6 engaged with numerous stakeholders to the benefit of all G4N WPs gathering different views and opinions, which helped form ideas. WP5 developed the model for an organizational form, given the working title House of Nano Risk Governance, based on a wide range of input from all G4N WPs, and in conjunction with NANORIGO and RiskGONE. Four main elements of data, tools, portal and framework are joined in the organizational form which is ready for uptake by successor projects. Monitoring the progress of implementation of risk governance for nanotechnology was done via a dashboard of instruments (WP7); the dashboard is now available for new projects as a dedicated toolbox.
The impact of G4N is wide ranging. Numerous ongoing initiatives depend directly or indirectly on G4N output in order to achieve their own aims (Figure 3). G4N has gone far beyond the State of the Art in elucidating which elements are needed for the development of a successful organizational form for governance of the risks from NMs and nano products. In doing so the foundations have been laid for any subsequent initiative which will create an organisational form which can support the Commission in its drive for effective risk governance of chemicals and AdMa, since what has been developed in G4N for NMs also has applicability for AdMa and chemicals in general. The impact of G4N on CSS is shown in Figure 4, which shows where G4N products can be of added value for the actions and aims addressed by the CSS to foster and at the same time incentivize sustainable innovation. Coordination actions and synergies are urgently needed to maintain the momentum established in G4N. Utilizing the legacy of G4N, the goals and ambitions as laid down in the European CSS or the Zero Pollution Action Plan can become an integral part of all crucial innovation programmes dealing with AdMa.