Towards harmonised characterisation protocols in NMBP

NMBP-35

The increasing interest in comparing and linking experimental data to achieve reliable end-user products necessitates the development of widely accepted standardised measurement methods as characterisation protocols for materials, processes and final product performance. To improve experimental data quality, reproducibility and traceability there is a need to develop, test, validate and agree on methodologies for measurement and characterisation techniques – such as microscopy, spectroscopy and diffraction techniques, as well as micro- and nano-mechanical tests – that are used in a wide variety of industries and settings through interoperable data exchange mechanisms. It is therefore critical that developers and users of current measurement and characterisation protocols reach a broad-ranging agreement on their standardisation, paving the way for new technologies in response to the emergent needs of Industry Commons.

• Validated and trusted characterisation protocols supporting modelling, life cycle analysis and market harmonisation within the EU;
• Facilitated comparability, enabling quantitative interoperability and traceability of characterisation data leading to increased trust in product quality and performance assessments;
• Increased uptake of emerging characterisation innovations leading to developments of new standards and data exchange mechanisms and supporting the future needs of Industry Commons;
• Accelerated characterisation of materials, and facilitation of simulation leading to a measurable reduction of costs for product design, time-to-market and regulatory compliance.

Collaboration activities:

CHARISMA, EASI-STRESS, NanoMECommons, the three EU-funded Horizon 2020 projects addressed under the call topic “Towards harmonised characterisation protocols in NMBP” (NMBP-35, see EC information) collaborate on the challenges related to characterisation protocols, identifying synergies and points in common between the sister projects. This has been reflected in the organisation of different joint events/workshops since the projects began.

Involvement/contribution in NSC WGs:

• Lead and Contribution to the WG on Education, Training & Communication participating/organising workshops, webinars and events relevant for the nanosafety community. Some examples of this collaboration are:
  • Co-organisation of NanoSafety Training School 2022, with an active participation of CHARISMA
  • Co-organisation of NanoSafety Training School 2023, an oral presentation by Miguel A. Bañares, CHARISMA co-coordinator.

•  Contribution to the WG on Safe and Sustainable by Design (SSbD), Innovation & Regulation
  • CEN Workshop on “Raman devices calibration, verification and twinning protocols” (kick-off meeting on 28 February 2024, online)

• Contribution to the WG on Research Output management, FAIRness & sharing
  • 1st Co-Creation Workshop – “Materials characterization challenges to support the industry transition in the digital era” (13 Dic. 2021, online). This co-creation workshop event was organised by the H2020 project NanoMECommons with the support of the European Materials Modelling Council (EMMC ASBL), the European Materials Characterisation Council (EMCC) as well as 10 other EU funded projects.
  • 2nd Co-Creation Workshop – 1st NMBP-35 joint workshop on “Materials characterization and software tools as key enablers in NMBP-35 projects: towards industrial transition and wider acceptance of new methods and products” (24 Nov. 2023, Athens/hybrid), supported by the European Materials Characterisation Council (EMCC).
  • 2nd NMBP-35 joint workshop on “From Research to industry: How Characterisation & Digitization Changed the Game” (17 Jan. 2024, Madrid/hybrid)

More information on the projects can be found in CORDIS (https://cordis.europa.eu/programme/id/H2020_NMBP-35-2020/en) and on the websites of the different projects (CHARISMA, EASI-STRESS, nanoMECommons).

Safe by design, from science to regulation: multi-component nanomaterials

NMBP-16

DIAGONAL, HARMLESS, SUNSHINE are the three EU-funded Horizon 2020 projects addressing the call topic “Safe by design, from science to regulation: multi-component nanomaterials” (NMBP-16, see EC information) join forces on the challenges related to safe and sustainable multicomponent nanomaterials, and closely collaborate together. The collaboration is focused on different topics. To facilitate good inter-project cooperation, so-called “Ambassadors” were nominated for each key topic. Ambassadors are experts from each project that work on a specific topic, they enable and foster the knowledge exchange aiming to harmonise the projects’ efforts and identify and positively use synergies. The following NMBP-16 Ambassadors task forces were established:

• Stakeholder Engagement
• Grouping and read-across (Hypotheses and IATA editing/development)
• Database Task Force
• Risk Management (incl. Exposure Assessment & Risk Assessment tools)
• MCNMs (Meaning of MCNM, case study comparison and sector-specific transparency)
• Hazard Assessment
• Exploitation

Each task force separately meets on a regular basis. In addition, we have bi-annual meetings where the whole Ambassadors group meets, to discuss and exchange ideas, monitor the overall developments in each of the three projects (as far as confidentiality allows), and define the next steps.

Several relevant output can be highlighted from this inter-project collaboration:

• Grouping: The SUNSHINE, HARMLESS and DIAGONAL projects have extended the GRACIOUS framework to support the grouping of multicomponent nanomaterials, taking into account their enhanced properties and the potential for different components to interact and modify toxicity. This framework has been structured to aid users to prioritise the testing to support decision making related to safety at different technology readiness levels for multicomponent nanomaterials.

• Joint publication in the Environmental Science:Nano journal on the special issue on Advanced Materials, showing how concepts of similarity enable a fast comparative screening of five quantum dots against well known benchmarks materials, with the aim of providing SSbD guidance for these and other challenging multicomponent nanostructured materials. Similarity of multicomponent nanomaterials in a safer-by-design context: the case of core–shell quantum dots. Veronica Di Battista et al. Environ. Sci.: Nano, 2024, Advance Article. DOI: 10.1039/D3EN00338H.

Involvement/contribution in NSC WGs:

• Lead of and Contribution to the WG on Education, Training & Communication organising workshops, webinars and events relevant for the nanosafety community.  Some examples of this collaboration are:

1. 1. Organisation of the NanoSafety Training School 2022 (15-20 May 2022, Venice, Italy)
   2. Contribution to the organisation of the NanoWeek 2022 (20-24 June 2022, Limassol, Cyprus)  and organisation of a speed dating session to present NMBP-15 / -16 platforms/frameworks/tools
   3. Organisation of the NanoSafety Training School 2023 (15-19 May 2023, Venice, Italy)
   4. Contribution to the organisation of the nanoSAFE 2023 (5-9 June 2023, Grenoble, France)
   5. Joint booth at the EuroNanoForum 2023 (11-14 June 2023, Malmö, Sweden)
   6. Co-organisation of ANTHOS 2024 (4-7 March 2024, Vienna, Austria), as panellists of roundtable on 6 March as well as several oral presentations

More information on the projects can be found in CORDIS (https://cordis.europa.eu/programme/id/H2020_NMBP-16-2020/en) and on the websites of the different projects (DIAGONAL, HARMLESS, SUNSHINE). 

Real-time nano-characterisation technologies

NMBP-08

Enterprises using and producing nanomaterials face a constant increase of requirements in regard to fast process and product quality control, regulatory compliance and quicker market introduction of high quality products.

This calls for real-time measurements, necessitating process-adapted nanoscale metrology for the manufacturing industry. Tools and devices for materials characterisation need increased speed and reliability, suitable for industrial demands, while at the same time retaining the same or better measurement accuracy and precision.

• Measurable improvement of speed by at least a factor 2 of nanoscale characterisation procedures, in comparison to already established performance and reliability for the application leading to a significant increase in industrial competitiveness;
• Significant reduction of the time and resources needed for nanomaterial development and upscaling, and for nanomaterials-based product development, which should be quantified with respect to established conditions for specific market sectors, with a return of investment in less than 5 years;
• Quantifiable enhancement of the ability to control the quality and reliability of products, with consequent improvement of product lifetime and associated environmental benefits.

Collaboration activities:

RealNano, PAT4Nano, NanoQI, NanoBat, NanoPAT, and CHALLENGES, the five EU-funded Horizon 2020 projects addressed under the call topic “Real-time nano-characterisation technologies” (NMBP-08, see EC information) collaborate on the challenges related to characterisation technologies, identifying synergies and points in common between the sister projects. This has been reflected in the organisation of different joint events/workshops since the projects began.

Involvement/contribution in NSC WGs:

• Contribution to the WG on Education, Training & Communication participating/organising workshops, webinars and events relevant for the nanosafety community. Some examples of this collaboration are:

1. 1. 1. Joint participation at the NanoInnovation 2022 (19-23 Sept. 2022, Rome, Italy), concretely at the CHALLENGES Training School on Real time nano characterization related technologies (21-23 Sept. 2023).
      2. Collaboration in the NanoMECommons workshop (13 Dec. 2021, online) on Materials characterization challenges to support the industry transition in the digital era.
      3. Coordinators of the NanoBat project representing the NMBP-08 projects at a booth at the Conference on Industrial Technologies IndTech2022 in Grenoble, France (June 27-29, 2022) – applying nanotechnology tools for a competitive, sustainable and sovereign industry for the future of Europe

More information on the projects can be found in CORDIS (https://cordis.europa.eu/programme/id/H2020_DT-NMBP-08-2019/en) and on the websites of the different projects (RealNano, PAT4Nano, NanoQI, NanoBat, NanoPAT, and CHALLENGES).

Integrated approach for impact assessment of safe and sustainable chemicals and materials

RESILIENCE-01-22

The Commission initiative for Safe and Sustainable by Design sets a framework for assessing the safety and sustainability of chemicals and materials. This framework has highlighted the challenge to integrate  health, environmental, social and economic impacts in an overarching approach that can support safe and sustainable by design (SSbD) decision making for chemicals and advanced materials.  The Horizon Europe projects ANALYST, INSIGHT, INTEGRANO, and SUNRISE were financed under the call topic HORIZON-CL4-2023-RESILIENCE-01-22 to address this challenge. The four projects have adopted complementary approaches to the development and implementation of methodologies for integrated health, environmental, social and economic impact assessment at the EU and global scales. The goal is to support and facilitate SSbD decision making when having to weigh multiple safety and sustainability criteria against each other in order to account for often diverging stakeholder trade-offs. The projects all aim to foster the acceptance and effective uptake of the developed approaches within key industries. This is achieved via a diversity of case studies targeting chemicals and materials of high societal relevance from major industrial sectors. The projects engage all relevant stakeholders along the value chain (e.g., industries, consultants, regulators, policy makers and the civil society) to take into account the existence of conflicting interests and potential impacts affecting each of them differently. The goal is to foster a shared support and agreement on the developed methodologies in order to ensure their transfigurative impact.

Collaboration activities:

ANALYST, INSIGHT, INTEGRANO, and SUNRISE, the four EU-funded Horizon Europe projects addressed under the call topic “Integrated approach for impact assessment of safe and sustainable chemicals and materials” (HORIZON-CL4-2023-RESILIENCE-01-22, see EC information) are planning a meeting at NanoTox 2024 (23-25 Sept. 2024, Venice) to kick-start the collaboration, identify synergies and points in common between them to increase collaboration and avoiding duplication of work.

More information on the projects can be found in CORDIS and on the websites of the different projects.

Innovative methods for safety and sustainability assessments of chemicals and materials

RESILIENCE-01-21

The Commission initiative for Safe and Sustainable by Design sets a framework for assessing the safety and sustainability of chemicals and materials, which should be considered as a reference for project proposals. This topic aims at developing new methods, or improve existing methods, to support the improvement of safety and sustainability assessment.

In the EU, the legislation regulating chemical substances often includes their safety screening and testing according to the EU test methods regulation, which predominantly contains test methods harmonised under the OECD. For safety assessment, e.g. human and eco-toxicity, there is a lack of validated in vitro and in silico tools for a variety of substances and materials. An advance in alternative methods for safety assessment (e.g. New Approach Methodologies, NAMs) is needed, preferably without animal models, but also to support modelling and design of new Safe and Sustainable by Design chemicals and materials. Research should improve and harmonise screening and testing protocols/strategies and hazard/risk assessments by developing robust, reliable and faster test methods or models, including high-throughput and in silico models.

Sustainability aspects cover the entire life cycle including the design phase, raw material extraction, production, use and end-of-life. Sustainability assessment across the life cycle is in growing demand and there is the need to further develop methods for a robust assessment. The development of absolute sustainability methods [The term absolute sustainability refers to the possibility of a chemical to comply with safety and to carry limited environmental impacts within the planetary boundaries] that consider ecosystems carrying capacities are also needed. The integration of life cycle assessment with risk assessment is likewise a challenge. New and improved approaches are needed to increase the quality, the efficiency and the effectiveness of existing methods to drive innovation and to bridge gaps in the data for sustainability and life cycle assessment.

Projects will consider following activities:

• Address a set of at least three chemicals/groups of chemicals/(advanced) materials for which the project consortium will develop new methods and models for safety and sustainability assessment along their life cycle in accordance with the Safe and Sustainable by Design Framework (See documents defining the SSbD framework on:). Selected materials can be composed of/contain the selected chemicals. The justification for their selection should include socio-economic aspects and a gap analysis with regards to existing methods and models and their relevance to improve the current safety and sustainability assessments;
• Methods and models developed can be either for the already existing chemicals and materials or to be used during the design phase of future chemicals and materials;
• For each method or model developed an ‘in project interlaboratory’ validation should be done, and the method or model shall be shared via the most appropriate open platform, e.g. the Horizon Europe Partnership on the Assessment of Risks from Chemicals (PARC)[[https://www.anses.fr/en/content/european-partnership-assessment-risks-chemicals-parc]] to encourage use and feedback from stakeholders. In addition, an initial standardisation or validation dossier should be prepared and submitted to an appropriate body/initiative, e.g. the OECD, EU Reference Laboratory for alternatives to animal testing (EURL ECVAM);
• Data produced during the development process and in particular for inclusion in the validation/standardisation dossier must be FAIR (Findable, Accessible, Interoperable, Reusable) and shared through available platforms (e.g. the Information Platform for Chemical Monitoring – IPCHEM). Data for the validation/standardisation dossier shall be produced according to existing guidelines and stored in standardised data formats.
• collaboration with the European Partnership on Assessments of Risks from Chemicals (PARC) is encouraged with regards to their task on delivering the SSbD toolbox. Proposals should allocate the necessary resources for collaboration with the relevant projects mentioned above. Proposals should also build on the extensive experience from European, national or regional clusters/platforms and initiatives such as the Malta Initiative engaged in validation/standardisation of methods.
• Cooperation with the European Commission’s Joint Research Centre (JRC) may be envisaged in areas of mutual interest with regards to new methods development and their wider uptake.

International collaboration on uptake of new methods and/or models shall be enhanced involving relevant players from academia, public authorities and the private sector.

Collaboration activities:

CheMatSustain, CHIASMA, SSbD4CheM, and TOXBOX the four EU-funded Horizon Europe projects addressed under the call topic “Innovative methods for safety and sustainability assessments of chemicals and materials” (HORIZON-CL4-2023-RESILIENCE-01-21, see EC information) collaborate on the challenges related to development of alternative methods for safety assessment (e.g., in vitro models, computational simulations, and high-throughput screening techniques) without animal models and development of absolute sustainability methods identifying synergies and points in common between the sister projects to increase collaboration and avoiding duplication of work.

In January 2023 the respective project coordinators were invited to the Kick-off meetings of the other sister projects to shortly pitch their own projects and start thinking about potential collaboration.

Involvement/contribution in NSC WGs:

• Contribution to the WG on Education, Training & Communication participating/organising
  • Participation in ANTHOS’24 (4-7 March 2024, Vienna, Austria) – Project pitch of SSbD4CheM and CHIASMA.

More information on the projects can be found in CORDIS (https://cordis.europa.eu/programme/id/HORIZON_HORIZON-CL4-2023-RESILIENCE-01-21/en) and on the websites of the different projects.

Advanced characterisation methodologies to assess and predict the health and environmental risks of nanomaterials

DigEm-01-35