Periodic Reporting for period 1 - MACRAME (Advanced Characterisation Methodologies to assess and predict the Health and Environmental Risks of Advanced Materials)
Reporting period: 2022-12-01 to 2024-05-31
MACRAMÉ’s Central Objective is to:
• detect, characterise and quantify AdMas during handling and processing along the product life-cycle,
• assess potential impacts on (human) health and the environment in intended or unintended exposure situations (i.e. ‘Exposure Points’) in the product value-chain,
• advance the wide-spread applicability of the developed test and characterisation methods, by demonstrating their effectiveness and efficiency in the context of existing, market-relevant industrial AdMas containing products, and
• prepare and initiate standardisation, harmonisation and technological & regulatory validation of test- and characterisation-methods.
Specific Objectives & R&I targets:
Specific Objective 1: Interfacing Communities and Streamlining Methodological Approaches to assess the Risk of AdMa@CMs
Specific Objective 2: Assessment of market-relevant Exposure Points and representative Sampling along the Life-Cycle of five MACRAMÉ Use-Cases
Specific Objective 3: Characterisation - Development & Harmonisation of Methodological Approaches for the Identification, Physical-Chemical Characterisation and Quantification of inhalable AdMa@CMs
Specific Objective 4: Toxicity Tests - Development of new Advanced Methodologies & Harmonisation of existing Methodological Approaches for human and environmental Hazard Characterisation of inhalable AdMa@CMs
Specific Objective 5: Hazard Assessment - Development of the scientific Background to foster regulatory Acceptability of Methods and Methodologies for the Physical-Chemical and Hazard Characterisation of AdMa@CMs
Specific Objective 6: Establish improved Data-Reporting Guidelines and deliver harmonised, FAIR Data for the Characterisation of AdMas at different Life-Cycle Stages
Specific Objective 7: Translation of Detection, Characterisation and Test Methods and combined novel Methodological Approaches into Standards and OECD Test Guidelines & Guidance Documents
• detect, characterise and quantify AdMas during handling and processing along the product life-cycle,
• assess potential impacts on (human) health and the environment in intended or unintended exposure situations (i.e. ‘Exposure Points’) in the product value-chain,
• advance the wide-spread applicability of the developed test and characterisation methods, by demonstrating their effectiveness and efficiency in the context of existing, market-relevant industrial AdMas containing products, and
• prepare and initiate standardisation, harmonisation and technological & regulatory validation of test- and characterisation-methods.
Specific Objectives & R&I targets:
Specific Objective 1: Interfacing Communities and Streamlining Methodological Approaches to assess the Risk of AdMa@CMs
Specific Objective 2: Assessment of market-relevant Exposure Points and representative Sampling along the Life-Cycle of five MACRAMÉ Use-Cases
Specific Objective 3: Characterisation - Development & Harmonisation of Methodological Approaches for the Identification, Physical-Chemical Characterisation and Quantification of inhalable AdMa@CMs
Specific Objective 4: Toxicity Tests - Development of new Advanced Methodologies & Harmonisation of existing Methodological Approaches for human and environmental Hazard Characterisation of inhalable AdMa@CMs
Specific Objective 5: Hazard Assessment - Development of the scientific Background to foster regulatory Acceptability of Methods and Methodologies for the Physical-Chemical and Hazard Characterisation of AdMa@CMs
Specific Objective 6: Establish improved Data-Reporting Guidelines and deliver harmonised, FAIR Data for the Characterisation of AdMas at different Life-Cycle Stages
Specific Objective 7: Translation of Detection, Characterisation and Test Methods and combined novel Methodological Approaches into Standards and OECD Test Guidelines & Guidance Documents
I. The MACRAMÉ Drawing Board - collaborative Strategy Setting & Adoption with all Partners
The MACRAMÉ workflow is highly complex, because it aims to analyse the physical-chemical characteristics and impact on humans and the environment of four different advanced materials during the life-cycle of five products.
II. The MACRAMÉ Foundations - Use-Case Definitions & Sample Provision
WP1 will reconfirm the MACRAMÉ Exposure Points, at which exposure of humans and/or the environment to advanced materials may occur, based on the product-relevant value-chain considerations of five market-relevant MACRAMÉ Use-Cases, chosen to be representative of the three carbon-based MACRAMÉ Material Families (i.e. (a) GRM (incl. GO (graphene oxide) and FLG (few-layer graphene)), (b) carbon fibres (i.e. CNTs), and PLGA).
III. The MACRAMÉ Laboratory - Characterisation & Testing of AdMas in complex Matrices
The ambitious MACRAMÉ objectives will be achieved through the development of (a) a MACRAMÉ Control Material Library (CML) and (b) MACRAMÉ Validated Protocols.
IV. The MACRAMÉ Processor – Centralised Knowledge-Generation
Data from the MACRAMÉ data characterisation techniques will be enriched with information from a multitude of other sources and aggregated for knowledge discovery.
V. The MACRAMÉ Demonstrator – Analyses, Assessments & Validations in industrial Value-Chains
Based on the identified exposure points and the characterisation of AdMas in complex media performed in WP2, WP4 will conduct a detailed Material flow analysis (MFA), in order to obtain an overall assessment of the releases of materials at each stage of their lifecycle for all possible applications and the possible exposure to humans.
VI. The MACRAMÉ Interpreter – Supporting Science towards Harmonisation & Standardisation
WP5 will elaborate the results of the MACRAMÉ Project in a fashion that is specifically useful and relevant to the standardisation community (i.e. standardisation (TR/TS) project-item proposals), and the policy-making and policy-informing communities (such as the OECD WPMN and WNT).
VII. The MACRAMÉ Facilitator – Streamlined Project Coordination & Impact Maximisation
The MACRAMÉ workflow is highly complex, because it aims to analyse the physical-chemical characteristics and impact on humans and the environment of four different advanced materials during the life-cycle of five products.
II. The MACRAMÉ Foundations - Use-Case Definitions & Sample Provision
WP1 will reconfirm the MACRAMÉ Exposure Points, at which exposure of humans and/or the environment to advanced materials may occur, based on the product-relevant value-chain considerations of five market-relevant MACRAMÉ Use-Cases, chosen to be representative of the three carbon-based MACRAMÉ Material Families (i.e. (a) GRM (incl. GO (graphene oxide) and FLG (few-layer graphene)), (b) carbon fibres (i.e. CNTs), and PLGA).
III. The MACRAMÉ Laboratory - Characterisation & Testing of AdMas in complex Matrices
The ambitious MACRAMÉ objectives will be achieved through the development of (a) a MACRAMÉ Control Material Library (CML) and (b) MACRAMÉ Validated Protocols.
IV. The MACRAMÉ Processor – Centralised Knowledge-Generation
Data from the MACRAMÉ data characterisation techniques will be enriched with information from a multitude of other sources and aggregated for knowledge discovery.
V. The MACRAMÉ Demonstrator – Analyses, Assessments & Validations in industrial Value-Chains
Based on the identified exposure points and the characterisation of AdMas in complex media performed in WP2, WP4 will conduct a detailed Material flow analysis (MFA), in order to obtain an overall assessment of the releases of materials at each stage of their lifecycle for all possible applications and the possible exposure to humans.
VI. The MACRAMÉ Interpreter – Supporting Science towards Harmonisation & Standardisation
WP5 will elaborate the results of the MACRAMÉ Project in a fashion that is specifically useful and relevant to the standardisation community (i.e. standardisation (TR/TS) project-item proposals), and the policy-making and policy-informing communities (such as the OECD WPMN and WNT).
VII. The MACRAMÉ Facilitator – Streamlined Project Coordination & Impact Maximisation
MACRAMÉ TRL-Advancement
MACRAMÉ will push current regulatory boundaries and the availability of standards, TGs and GDs pertaining to them through the integration of different technologies into intelligent, tiered testing approaches that address market-relevant AdMas both at possible Exposure Points and in their relevant complex matrices:
• Novel conceptual and technical approaches to aerosol generation,
• Life-cycle-relevant MACRAMÉ Exposure Points, defined in collaboration with industrial partners providing MACRAMÉ with AdMa@CMs in the five MACRAMÉ Use-Cases.
• MACRAMÉ will stress-test, validate and implement several biological models representative of the human respiratory system,
• MACRAMÉ will extend the existing OECD TG249 Rainbow Trout Fish gill cell toxicity tests by implementing it as an in-vitro barrier model, enabling acute and sub-chronic evaluation of AdMas.
Life-cycle costing (LCC) assessments and the creation of life-cycle-inventories (LCIs) will be conducted on the MACRAMÉ Use-Cases with regard to the economics of incumbent materials and test methods.
MACRAMÉ will develop and implement a novel concept of data-stewardship that will digitally enable state-of-the-art Safe and Sustainable by Design (SSbD) approaches towards the foundations of a newly conceptualised ‘MACRAMÉ Safety & Sustainability Matrix’.
MACRAMÉ will push current regulatory boundaries and the availability of standards, TGs and GDs pertaining to them through the integration of different technologies into intelligent, tiered testing approaches that address market-relevant AdMas both at possible Exposure Points and in their relevant complex matrices:
• Novel conceptual and technical approaches to aerosol generation,
• Life-cycle-relevant MACRAMÉ Exposure Points, defined in collaboration with industrial partners providing MACRAMÉ with AdMa@CMs in the five MACRAMÉ Use-Cases.
• MACRAMÉ will stress-test, validate and implement several biological models representative of the human respiratory system,
• MACRAMÉ will extend the existing OECD TG249 Rainbow Trout Fish gill cell toxicity tests by implementing it as an in-vitro barrier model, enabling acute and sub-chronic evaluation of AdMas.
Life-cycle costing (LCC) assessments and the creation of life-cycle-inventories (LCIs) will be conducted on the MACRAMÉ Use-Cases with regard to the economics of incumbent materials and test methods.
MACRAMÉ will develop and implement a novel concept of data-stewardship that will digitally enable state-of-the-art Safe and Sustainable by Design (SSbD) approaches towards the foundations of a newly conceptualised ‘MACRAMÉ Safety & Sustainability Matrix’.