Periodic Reporting for period 2 - Gov4Nano (Implementation of Risk Governance: meeting the needs of nanotechnology)
Reporting period: 2020-07-01 to 2022-02-28
Gov4Nano (G4N) builds on more than 10 years of research into health and safety aspects of nanomaterials and nanotechnology. Concepts such as Safe and Sustainable by Design and the Safe Innovation Approach have progressed from theoretical ideas to increasingly practical steps in the design, manufacture and use of nano-enabled products, including disposal and end of life. Current innovation policies are focussed on promoting technology development, but mostly lack a simultaneous, proportional push for appropriate risk governance. Innovators and manufacturers of Advanced Materials such as nano must ensure products are intrinsically Green Materials. Basic knowledge can be translated into products satisfying the criteria of the Green Deal (GD) and Circular Economy when supported by regulation. Therefore, regulatory preparedness must be prominent in all phases of implementing the GD.
Recent changes in the European regulatory landscape, including the formation of DG Environment’s high-level roundtable on the implementation of the Chemicals Strategy for Sustainability (CSS) have necessitated a refocus of earlier G4N activities that were previously related to the establishment of a Council for Risk Governance of Nanotechnology, to allow better alignment with current and emerging societal needs while fostering activities that will generate maximum impact and benefit for all stakeholders including the European Commission (Figure 1). This is enshrined in the 5th G4N amendment.
Concerns about the safety of nanotechnologies may have a negative effect on innovation. G4N ensures best practice for risk evaluation and acceptance of nanotechnologies. Societal relevance is an integral part of this and essential for its credibility. The proposed risk governance approach is based on existing infrastructure and connects key organizations and stakeholders at EU and international level.
The change in emphasis to align with the CSS means changes to the overall objectives:
• To ensure data available through the nano-EHS infrastructure complies with FAIR principles, eventually leading to machine- readable data (WP1)
• To develop harmonized guidance for characterization and testing of nanomaterials (WP2)
• To understand how risk perception on nanotechnologies is formed in civil society and (re-)insurance industry (WP3)
• To develop a Nano Risk Governance Portal including RA 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)
• Engage with stakeholders to provide a solid basis for developing a credible and sustainable mechanism to govern risks related to nanomaterials along the full 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)
Recent changes in the European regulatory landscape, including the formation of DG Environment’s high-level roundtable on the implementation of the Chemicals Strategy for Sustainability (CSS) have necessitated a refocus of earlier G4N activities that were previously related to the establishment of a Council for Risk Governance of Nanotechnology, to allow better alignment with current and emerging societal needs while fostering activities that will generate maximum impact and benefit for all stakeholders including the European Commission (Figure 1). This is enshrined in the 5th G4N amendment.
Concerns about the safety of nanotechnologies may have a negative effect on innovation. G4N ensures best practice for risk evaluation and acceptance of nanotechnologies. Societal relevance is an integral part of this and essential for its credibility. The proposed risk governance approach is based on existing infrastructure and connects key organizations and stakeholders at EU and international level.
The change in emphasis to align with the CSS means changes to the overall objectives:
• To ensure data available through the nano-EHS infrastructure complies with FAIR principles, eventually leading to machine- readable data (WP1)
• To develop harmonized guidance for characterization and testing of nanomaterials (WP2)
• To understand how risk perception on nanotechnologies is formed in civil society and (re-)insurance industry (WP3)
• To develop a Nano Risk Governance Portal including RA 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)
• Engage with stakeholders to provide a solid basis for developing a credible and sustainable mechanism to govern risks related to nanomaterials along the full 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)
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 nanomaterials 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 now, and will continue to evolve to the final phase. This strategy (Figure 2) comprises three main elements, namely Scientific Excellence, Co-creational Excellence and Proving the Outcomes. Scientific excellence is covered mainly by WPs 1, 2 and 4. FAIRness of data (WP1) provides a sound scientific basis to any evaluation or decision making process and recently the GO FAIR Implementation Network ‘AdvancedNano’ has been launched, essential for further development of the FAIRification of nanosafety data (i.e. data on environmental health and safety). Existing OECD Test Guidelines and Guidance Documents generally are not nano-specific and therefore unsuited to use for NMs. WP2 as part of the Malta Initiative is adapting and modifying seven TGs so they can be applied to nano materials. Seven different endpoints are addressed, solubility and dissolution in water and biological media (T2.2) surface chemistry (T2.3) the specific surface area (T2.4) skin sensitisation (T2.5) dustiness (T2.6) environmental transformation (T2.7) and bioaccumulation (T2.8). A Nano Risk Governance Portal (WP4) hosting tools which support the process of Nano-Risk Governance by Risk Assessment and Innovation Risk Management of new NMs is under development, building on the existing NanoReg2 Safe Innovation Approach (SIA) and caLIBRAte Nano-Risk Governance Framework.
WPs 3 and 6 engage with numerous stakeholders to the benefit of all G4N WPs gathering different views and opinions which can help form a credible risk governance mechanism for nanomaterials. Combining science-based elements with the organisational and knowledge skills to house the key elements needed to co-create functioning risk governance (WP5) was merged with a skilled process of debate and questioning. This involved value proposition workshops and a force field analysis, leading to a Blueprint for nano risk governance (WP5 D5.2). How the WPs and actions of G4N interact with RiskGONE and NANORIGO is shown in Figure 3. Monitoring the progress of implementation of risk governance for nanotechnology is done via a dashboard of monitoring instruments (WP7) which provides checks and balances on the overall development of G4N. A Monitoring and Evaluation system of criteria and indicators developed is made available through 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 now, and will continue to evolve to the final phase. This strategy (Figure 2) comprises three main elements, namely Scientific Excellence, Co-creational Excellence and Proving the Outcomes. Scientific excellence is covered mainly by WPs 1, 2 and 4. FAIRness of data (WP1) provides a sound scientific basis to any evaluation or decision making process and recently the GO FAIR Implementation Network ‘AdvancedNano’ has been launched, essential for further development of the FAIRification of nanosafety data (i.e. data on environmental health and safety). Existing OECD Test Guidelines and Guidance Documents generally are not nano-specific and therefore unsuited to use for NMs. WP2 as part of the Malta Initiative is adapting and modifying seven TGs so they can be applied to nano materials. Seven different endpoints are addressed, solubility and dissolution in water and biological media (T2.2) surface chemistry (T2.3) the specific surface area (T2.4) skin sensitisation (T2.5) dustiness (T2.6) environmental transformation (T2.7) and bioaccumulation (T2.8). A Nano Risk Governance Portal (WP4) hosting tools which support the process of Nano-Risk Governance by Risk Assessment and Innovation Risk Management of new NMs is under development, building on the existing NanoReg2 Safe Innovation Approach (SIA) and caLIBRAte Nano-Risk Governance Framework.
WPs 3 and 6 engage with numerous stakeholders to the benefit of all G4N WPs gathering different views and opinions which can help form a credible risk governance mechanism for nanomaterials. Combining science-based elements with the organisational and knowledge skills to house the key elements needed to co-create functioning risk governance (WP5) was merged with a skilled process of debate and questioning. This involved value proposition workshops and a force field analysis, leading to a Blueprint for nano risk governance (WP5 D5.2). How the WPs and actions of G4N interact with RiskGONE and NANORIGO is shown in Figure 3. Monitoring the progress of implementation of risk governance for nanotechnology is done via a dashboard of monitoring instruments (WP7) which provides checks and balances on the overall development of G4N. A Monitoring and Evaluation system of criteria and indicators developed is made available through a dedicated toolbox.
The birth of the GD and targeted actions such as the CSS have changed the landscape in which projects such as the NMBP13 operate, necessitating a reorientation of aims and output in order to remain relevant in what is delivered. Now at M40 adjustments are being formalised in a new amendment where the results obtained over the previous months are reassessed and their possible impact in terms of delivering support to the CSS is explained in detail (Figure 4). The interproject cooperation with NANORIGO and RiskGone has been formalised through 6 cross-project core groups, united in a common aim to deliver community relevant results. At the end of G4N conditions for an approved organisational form for Nano Risk Governance will have been defined, linking to new projects (NMBP-15, 16) and partnerships (PARC).
Risk governance tools and guidance for managing potential nanotechnology risks with regards to social, environmental and economic benefits will be made available because of G4N. These operational tools will support validation, verification and qualification of nanomaterials ensuring regulatory compliance can be achieved by industry.
FAIR, high quality data, supported by a standardised curation system, will create the reliable open data platform needed to support a Safe and Sustainable by Design approach by industry, as well as enabling the use as weighted evidence in regulatory procedures.
Consistency of science based risk management approaches developed by G4N will ensure the pivotal role of risk governance, promoting a secure innovation climate for all stakeholders.
Risk governance tools and guidance for managing potential nanotechnology risks with regards to social, environmental and economic benefits will be made available because of G4N. These operational tools will support validation, verification and qualification of nanomaterials ensuring regulatory compliance can be achieved by industry.
FAIR, high quality data, supported by a standardised curation system, will create the reliable open data platform needed to support a Safe and Sustainable by Design approach by industry, as well as enabling the use as weighted evidence in regulatory procedures.
Consistency of science based risk management approaches developed by G4N will ensure the pivotal role of risk governance, promoting a secure innovation climate for all stakeholders.