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MACRAMÉ is a 36 months project, funded by the European Union’s Horizon Europe research and innovation programme, addressing Advanced Characterisation Methodologies to assess and predict the Health and Environmental Risks of Advanced Materials (MACRAMÉ).
The MACRAMÉ Project is fully aligned with the EU ambitions to secure the safety and sustainability of new chemicals, materials, products and processes in order to strive for zero pollution and toxic-free environments, as addressed in the EU’s Chemical Strategy for Sustainability (2020), and in the European Green Deal (2019 & 2021); in doing so, the Project concentrates on methodologies that are applicable to nanomaterials, and widens them to ‘Advanced Materials’ (AdMas) ⎼ a material category that includes but surpasses that of ‘nanomaterials’ (EU, ‘Definition of a Nanomaterial’) – in commercialised products and that are aligned with the future-oriented innovation, safety and sustainability considerations of the OECD (OECD (2020)), the EU (EU (2022)), and several of its Member States (e.g. Germany (2021)). This will be achieved through development and demonstration of novel methodologies, and by advancing their harmonisation & standardisation on three MACRAMÉ Material Families of inhalable carbon-based AdMas of various morphologies and dimensions (Tiwari et al. (2012)), beyond spherical particles: (a) graphene-related material (GRM), (b) carbon nanofibres (CNFs), e.g., carbon nanotubes (CNTs), and (c) Poly Lactic-co-Glycolic Acid (nano)particles (PLGA). The focus on carbon-based AdMas addresses unsolved detection and characterisation issues, especially in complex media. In doing so, MACRAMÉ builds on >15 years of research and innovation (R&I) and knowledge pooling in nanosafety, formed through numerous European and international collaborations. MACRAMÉ will add value to the results of collaborations, such as the Malta-Initiative, and the Graphene Flagship Validation Service and Standardisation Committee, to proactively support EU industries in becoming world-leaders in clean technologies and products and achieving the Green Deal’s ambitious timeline.
The MACRAMÉ R&I Approach (Figure 1) aims to widen the development of harmonised test guidelines (TGs) and guidance documents (GDs) (OECD) and standards (CEN, ISO) to market-relevant AdMas in their complex product matrices. This will be achieved by defining the R&I Strategy through life-cycle assessment for five market-relevant industrial MACRAMÉ Use-Cases. These define the selection of the MACRAMÉ R&I Activities and development of MACRAMÉ Methods, and the benchmarks chosen for monitoring the progress R&I. MACRAMÉ R&I Activities include a range of novel sample preparation techniques and ambitious quantitative detection and imaging methodologies that support reliable and reproducible determination of AdMas in different complex matrices (AdMa@CMs) and using inhalation as their main exposure route. By applying, combining and evaluating both established and novel inhalation toxicity tests a tiered approach to toxicity testing will be developed that will provide data on state-of-the-art characterised control materials for the MACRAMÉ Control Material Library. The library will serve future AdMa toxicological research. The ultimate MACRAMÉ Outcomes are proposals for harmonisation and (pre-)standardisation projects to be provided to and further elaborated with the relevant bodies, (i.e. OECD, VAMAS/CEN/ISO). The proposals will be founded on robust summary datasets, scientific documents and recommendations for hazard- and risk-assessment methodologies for AdMas in complex product matrices (AdMa@CMs). All data and information, obtained from external sources and generated during the Project, will be handled and stored in the MACRAMÉ Information Hub – the Project’s central information processor, whose interoperability is based on a Data Stewardship concept, designed according to IndustryCommons principles.
Figure 1: Illustration of the MACRAMÉ R&I Approach (AdMa@CMs: Advanced Materials in complex matrices; CF: Characterisation Factor; GRM: graphene-related material; IATA: integrated approaches to testing and assessment; LCA: Life-Cycle Assessment; LCC: Life-Cycle-Costing; MFA: Material-Flow Analysis; RA: Risk-Assessment; SSbD: Safe-&-Sustainable-by-Design).
MACRAMÉ’s Central Objective is to:
The MACRAMÉ Mission will be achieved by defining the R&I Strategy through life-cycle assessment for five market-relevant industrial MACRAMÉ Use-Cases. These define the selection of the MACRAMÉ R&I Activities and development of MACRAMÉ Methods, and the benchmarks chosen for monitoring the progress R&I. MACRAMÉ R&I Activities include a range of novel sample preparation techniques and ambitious quantitative detection and imaging methodologies that support reliable and reproducible determination of AdMas in different complex matrices (AdMa@CMs) and using inhalation as their main exposure route. By applying, combining and evaluating both established and novel inhalation toxicity tests a tiered approach to toxicity testing will be developed that will provide data on state-of-the-art characterised control materials for the MACRAMÉ Control Material Library. The library will serve future AdMa toxicological research. The ultimate MACRAMÉ Outcomes are proposals for harmonisation and (pre-)standardisation projects to be provided to and further elaborated with the relevant bodies, (i.e. OECD, VAMAS/CEN/ISO). The proposals will be founded on robust summary datasets, scientific documents and recommendations for hazard- and risk-assessment methodologies for AdMas in complex product matrices (AdMa@CMs). All data and information, obtained from external sources and generated during the Project, will be handled and stored in the MACRAMÉ Information Hub – the Project’s central information processor, whose interoperability is based on a Data Stewardship concept, designed according to IndustryCommons principles.
The resulting efficiency and effectiveness of MACRAMÉ Methods will be demonstrated through their application in Use-Case evaluations, using LCA-, LCC- and ‘Safe & Sustainable by Design’ (SSbD)-based (EWARN (2022)), highlighting benefits like reduced costs of regulatory compliance, by following a MACRAMÉ Safety & Sustainability Matrix. This matrix will be a modular building block for MACRAMÉ’s information-transferring interfaces for different scientific and regulatory communities, and thus provide a stepping-stone for Europe’s route towards a ‘one substance – one assessment’ approach (European Green Deal (2019)) and promote an open strategic autonomy (ETUI (2021)) through key enabling and emerging technologies, including digital ones.
