Periodic Reporting for period 2 - NanoHarmony (Towards harmonised test methods for nanomaterials)
Reporting period: 2021-10-01 to 2023-09-30
Keeping pace with rapidly evolving innovation is a challenge for regulation, while it is essential in order to build trust and safety. International and European regulations, e.g. REACH, require standardised and harmonised test methods to make legislation enforceable. In the field of manufactured nanomaterials (MNs), test guidelines have to be adapted to be workable. The Malta Initiative (MI) is an activity to strengthen the development of regulatory applicable test methods in Europe and the NMBP-34 CSA call was launched to support this effort.
NanoHarmony, one of the NMBP-34 projects, directly supported eight OECD projects by delivering the scientific background for updating and developing Test Guidelines (TGs) and Guidance Documents (GDs). The focus on OECD TGs was chosen because of their international acceptance via the Mutual Acceptance of Data agreement for the assessment of chemicals towards safety for human health and the environment. NanoHarmony coordinated the efforts that other EU-funded projects made towards OECD TG development.
The first core activity of NanoHarmony was to develop and translate scientific knowledge and data that has regulatory relevance. The second core activity was to establish a sustainable international expert and stakeholder network to facilitate identification of future regulatory development needs and a smooth transfer from science to regulation. The third core activity was to support future TG developers towards a smooth and effective TG development process.
These three core activities were interlocked efficiently in NanoHarmony. The key results will help regulation to keep pace with innovation.
NanoHarmony, one of the NMBP-34 projects, directly supported eight OECD projects by delivering the scientific background for updating and developing Test Guidelines (TGs) and Guidance Documents (GDs). The focus on OECD TGs was chosen because of their international acceptance via the Mutual Acceptance of Data agreement for the assessment of chemicals towards safety for human health and the environment. NanoHarmony coordinated the efforts that other EU-funded projects made towards OECD TG development.
The first core activity of NanoHarmony was to develop and translate scientific knowledge and data that has regulatory relevance. The second core activity was to establish a sustainable international expert and stakeholder network to facilitate identification of future regulatory development needs and a smooth transfer from science to regulation. The third core activity was to support future TG developers towards a smooth and effective TG development process.
These three core activities were interlocked efficiently in NanoHarmony. The key results will help regulation to keep pace with innovation.
Development of the scientific basis for OECD TGs
NanoHarmony developed the scientific basis towards OECD TGs/GDs for eight regulatory endpoints this included literature research on available data, development and validation of SOPs and regular expert consultations. The scientific work was documented in several publicly available deliverables and publications to keep the scientific and regulatory community up-to-date. The outcomes were presented during several expert meetings, workshops and international conferences.
Support for a smooth and effective test method development
The present OECD TG development process was assessed by compiling an awareness strategy plan. This includes a detailed process description for validation and the timelines leading to the formal acceptance by OECD. Stakeholders were consulted via an online survey that gained input from regulators, industry, developers and users of OECD TGs. The results of the anonymous survey together with insights gained during interviews, webinars and workshops provided insights in the obstacles and challenges along the TG development process from different perspectives. A major hurdle identified was lack of knowledge on the TG development process. To address this, NanoHarmony developed freely available Training Material, that provides a low-level entry into the topic. To provide more in-depth guidance, NanoHarmony developed the OECD TG Process Mentor, an interactive web-based guidance tool for TG development. Recommendations to further streamline the processes of OECD TG developments were captured in the NanoHarmony White Paper that is publicly available and was actively advertised.
Cooperation - Expert and stakeholder networks
Cooperation was a central tool of NanoHarmony and was crucial for achieving its goals, namely development of OECD TGs/GDs as well as developing process improvements. Strong cooperation with the NMBP-34 sister project NANOMET, OECD, the MI, the EU NanoSafety Cluster and other EU-funded projects was initiated and established. The established high-profile network includes scientific experts, stakeholders from industries, contract research organisations, regulators, different EU-projects, in Europe and beyond (e.g. through the NanoHarmony Associated Partners). As such, the network ensures a high integration of different knowledge carriers and stakeholders. For each endpoint, expert groups including OECD experts met regularly. Three international online workshops were held in November 2020, 2021 and 2023. These workshops plus the eight webinars were used to reach out to a broad audience of different international stakeholders. Stakeholders were kept up to date by regular newsletters.
To further support future TG development, NanoHarmony cooperated with the MI and AMI2030 in bringing the topic further to the attention of policy makers. Activities included contributions in writing the MI Position Paper and the publication of a White Paper. NanoHarmony organised the Policy Meeting “European Safety and Sustainability Assessment: Fit for the Future” that contributed to informing key stakeholders, especially policy makers, of the importance of OECD TG development. Additionally, this meeting showed the achievements made by NanoHarmony in this area, while suggesting how the legacy of the project should be taken forward into a proposed European Test Methods Strategy.
NanoHarmony developed the scientific basis towards OECD TGs/GDs for eight regulatory endpoints this included literature research on available data, development and validation of SOPs and regular expert consultations. The scientific work was documented in several publicly available deliverables and publications to keep the scientific and regulatory community up-to-date. The outcomes were presented during several expert meetings, workshops and international conferences.
Support for a smooth and effective test method development
The present OECD TG development process was assessed by compiling an awareness strategy plan. This includes a detailed process description for validation and the timelines leading to the formal acceptance by OECD. Stakeholders were consulted via an online survey that gained input from regulators, industry, developers and users of OECD TGs. The results of the anonymous survey together with insights gained during interviews, webinars and workshops provided insights in the obstacles and challenges along the TG development process from different perspectives. A major hurdle identified was lack of knowledge on the TG development process. To address this, NanoHarmony developed freely available Training Material, that provides a low-level entry into the topic. To provide more in-depth guidance, NanoHarmony developed the OECD TG Process Mentor, an interactive web-based guidance tool for TG development. Recommendations to further streamline the processes of OECD TG developments were captured in the NanoHarmony White Paper that is publicly available and was actively advertised.
Cooperation - Expert and stakeholder networks
Cooperation was a central tool of NanoHarmony and was crucial for achieving its goals, namely development of OECD TGs/GDs as well as developing process improvements. Strong cooperation with the NMBP-34 sister project NANOMET, OECD, the MI, the EU NanoSafety Cluster and other EU-funded projects was initiated and established. The established high-profile network includes scientific experts, stakeholders from industries, contract research organisations, regulators, different EU-projects, in Europe and beyond (e.g. through the NanoHarmony Associated Partners). As such, the network ensures a high integration of different knowledge carriers and stakeholders. For each endpoint, expert groups including OECD experts met regularly. Three international online workshops were held in November 2020, 2021 and 2023. These workshops plus the eight webinars were used to reach out to a broad audience of different international stakeholders. Stakeholders were kept up to date by regular newsletters.
To further support future TG development, NanoHarmony cooperated with the MI and AMI2030 in bringing the topic further to the attention of policy makers. Activities included contributions in writing the MI Position Paper and the publication of a White Paper. NanoHarmony organised the Policy Meeting “European Safety and Sustainability Assessment: Fit for the Future” that contributed to informing key stakeholders, especially policy makers, of the importance of OECD TG development. Additionally, this meeting showed the achievements made by NanoHarmony in this area, while suggesting how the legacy of the project should be taken forward into a proposed European Test Methods Strategy.
Development of OECD TGs/GDs
The development of OECD TGs/GDs for all eight endpoints will be continued beyond the project duration, in accordance with the OECD schedule. The foreseen experiments and interlaboratory comparison studies were performed. The results were assessed and made publicly available in deliverables and publications. NanoHarmony thereby contributed to the submission of more than eight TGs/GDs applicable to MNs to the OECD. This will contribute to a safe and sustainable world.
Support for a smooth and effective test method development
Obstacles in the OECD TG/GD development process were assessed by analysing the outcomes of the NanoHarmony survey and interviews. Stakeholder consultations during the international NanoHarmony Workshops, as well as additional expert and stakeholder meetings were organised. This led to the establishment of tools that support OECD TG developers and to a seamless cooperation between all stakeholders. This will ultimately contribute to timely developments of test methods ready for regulation.
Cooperation - Expert and stakeholder networks
The high-profile network built in NanoHarmony contributes to the enhancement of efficiency, and to a faster development of test methods ready for regulation, along with high acceptance of the obtained results. The international workshops strengthened the stakeholder network. A strong focus was placed on the exchange with regulators and industry to learn from their perspectives and implement their needs. By continuing the yearly online workshops in the projects MACRAMÉ, nanoPASS and iCare, a continuation of stakeholder exchange is achieved.
Impact
The impact of NanoHarmony is visible beyond the project duration. The developed OECD TGs/GDs are a central output and exploitation of results obtained in NanoHarmony. The strong stakeholder network together with the future-proof exchange between science and regulation form a long-term impact. This serves as a strong basis for further developments of TGs fitting to the regulatory needs and matching the fast-evolving innovation. A lasting legacy of the project will be the recommendations made in the White Paper to support the timely development of TGs. The Process Mentor (testguideline-development.org) and the Training Material complement the White Paper by supporting TG developers.
The development of OECD TGs/GDs for all eight endpoints will be continued beyond the project duration, in accordance with the OECD schedule. The foreseen experiments and interlaboratory comparison studies were performed. The results were assessed and made publicly available in deliverables and publications. NanoHarmony thereby contributed to the submission of more than eight TGs/GDs applicable to MNs to the OECD. This will contribute to a safe and sustainable world.
Support for a smooth and effective test method development
Obstacles in the OECD TG/GD development process were assessed by analysing the outcomes of the NanoHarmony survey and interviews. Stakeholder consultations during the international NanoHarmony Workshops, as well as additional expert and stakeholder meetings were organised. This led to the establishment of tools that support OECD TG developers and to a seamless cooperation between all stakeholders. This will ultimately contribute to timely developments of test methods ready for regulation.
Cooperation - Expert and stakeholder networks
The high-profile network built in NanoHarmony contributes to the enhancement of efficiency, and to a faster development of test methods ready for regulation, along with high acceptance of the obtained results. The international workshops strengthened the stakeholder network. A strong focus was placed on the exchange with regulators and industry to learn from their perspectives and implement their needs. By continuing the yearly online workshops in the projects MACRAMÉ, nanoPASS and iCare, a continuation of stakeholder exchange is achieved.
Impact
The impact of NanoHarmony is visible beyond the project duration. The developed OECD TGs/GDs are a central output and exploitation of results obtained in NanoHarmony. The strong stakeholder network together with the future-proof exchange between science and regulation form a long-term impact. This serves as a strong basis for further developments of TGs fitting to the regulatory needs and matching the fast-evolving innovation. A lasting legacy of the project will be the recommendations made in the White Paper to support the timely development of TGs. The Process Mentor (testguideline-development.org) and the Training Material complement the White Paper by supporting TG developers.