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Approaching safety and sustainability questions on Advanced Materials

GRAPHENE-RELATED MATERIALS SYNOPSIS

Approaching safety and sustainability questions on Advanced Materials The OECD Working Party on Manufactured Nanomaterials (WPMN) is a subsidiary body of the OECD Chemicals and Biotechnology Committee. Its work focuses on the human health, environmental safety and sustainability implications of manufactured nanomaterials and advanced materials and supports the application of a Safer and Sustainable Innovation Approach (SSIA). The WPMN seeks to ensure, in a timely manner, that hazard, exposure and risk assessment approaches for these materials are high-quality, science-based and internationally harmonised, while integrating safety and sustainability considerations at early stages of material design and development. Through international co-operation, including the development, validation and use of methods for safety testing, exposure assessment and risk assessment, the WPMN plays an important role in supporting the responsible development and deployment of innovative materials. Its work promotes regulatory preparedness, safety by design, lifecycle thinking and innovation enabling frameworks, ensuring that technological progress is accompanied by a sound understanding of potential risks, benefits and contributions to human health and environmental sustainability.

What are Graphene Related Materials (GRM)? In the context of the OECD WPMN case study, the term graphene related materials (GRM) is used to describe the broad and heterogeneous group of two-dimensional, carbon-based materials. The term is intentionally inclusive, recognising that multiple names and categorisations exist in scientific literature, and that developing a formal definition was outside the scope of the case study. GRM include diverse materials with a wide range of physicochemical characteristics, such as graphene, few layer graphene, graphene oxide, reduced graphene oxide and functionalised derivatives, which may differ substantially in physicochemical properties, behaviour and applications. These materials are often considered nanomaterials, as at least one external dimension is in the nanoscale.

Why is a closer look at GRM important? GRM exhibit unique physical, mechanical, and electronical properties such as high electrical and thermal conductivity and tensile strength. Therefore, they are finding an increasing number of applications across multiple sectors, including composites, batteries, coatings, electronics, construction materials, water treatment and consumer products. Although often used in small quantities, GRM are frequently incorporated into products with long lifetimes and potentially large production volumes. This underscores the importance of addressing safety assessment, sustainability considerations, and regulatory preparedness at an early stage, to support responsible innovation.

APPROACHING SAFETY AND SUSTAINABILITY QUESTIONS ON ADVANCED MATERIALS . 3

Framing of the issue A case study on GRM was conducted to explore potential safety and sustainability issues and support safe and sustainable innovation. Building on expert discussions held during a workshop in November 2024, the case study identified key issues and highlighted the need for early action to strengthen regulatory preparedness. 1. Significant information gaps together with limited quality of available studies due to, e.g., lack of dispersion protocols and analytical limitations preventing conclusive assessment of their safety and sustainability. Important data gaps remain regarding toxicokinetics, long term and repeated exposure effects, dustiness, and realistic exposure scenarios. For environmental safety, information on long-term ecotoxicity, fate and behaviour across environmental compartments is still limited. While GRM may offer performance related sustainability benefits (such as enhanced energy efficiency of batteries), current assessments are constrained by limited industrial scale data on production processes, energy and resource use, and end of life options, including recyclability and potential environmental release. 2. The case study highlights the significant diversity within the GRM family, including variations in layer number, lateral dimensions, surface chemistry, functionalisation, impurities, and production methods. This heterogeneity presents challenges for consistent identification, physicochemical characterisation, grouping and read across, all of which are fundamental to safety testing and risk assessment. While several OECD Test Guidelines and Guidance Documents are applicable in principle, their suitability for two dimensional materials has not been systematically evaluated and may be limited in practice. 3. From a regulatory perspective, it is agreed that GRM fall under existing general chemical and sector specific chemical legislation, often as nanomaterials. Nevertheless, current information requirements and assessment approaches may not fully capture the specific characteristics of two dimensional materials. The case study highlights the need for clearer guidance such as on minimum characterisation requirements, on approaches for grouping and read across, review guidance for sample preparation and dosimetry as well as models and strategies to assess exposure, and the need to develop reference materials to support consistent and reliable safety assessment.

4 . APPROACHING SAFETY AND SUSTAINABILITY QUESTIONS ON ADVANCED MATERIALS

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Regulators and policymakers should consider: i. Evaluating the suitability of existing OECD Test Guidelines and Guidance Documents for the various GRM, and identifying where adaptations, new guidance or further validation may be needed. ii. Establishing a minimum data set for describing the identity of GRM, such as number of layers, lateral dimensions, composition, impurities, and functionalisation.

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Industry should consider: i. Contributing to closing data gaps relevant for the safety assessment of GRM, including information on realistic material forms, potential releases, and transformation during the life cycle. ii. Improving the availability of data related to sustainability, including energy and resource use in production, scalability of manufacturing processes, and end‑of‑life aspects such as recyclability and waste management, while exploring safer and more resource‑efficient production routes.

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Academia should consider: i. Conducting targeted studies to address identified knowledge gaps on human health, environmental safety and sustainability of GRM. ii. Providing the scientific basis for the development, refinement and validation of test methods and guidance, including comprehensive physicochemical characterisation information, and information on dispersion protocols applied during the studies.

Recommendations on the next steps Regarding the signals and open questions identified for GRM, it was recommended that the WPMN: •

Keeps track of ongoing research activities and literature reviews that can fill data gaps and/or substantiate the identified signals.

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Prioritises which application areas, questions and signals are of interest from a regulatory perspective.

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Promotes addressing key follow-up actions for example by closing information gaps, method development and harmonisation, and establishment of assessment guidance.

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Further explores safety and sustainability of GRM and their applications to provide guidance to support responsible innovation.

SYNOPSIS

What is needed by whom?

Approaching safety and sustainability questions on Advanced Materials Synopsis on Graphene-Related Materials

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Advanced materials case study on graphene related materials (GRM) OECD WORK ON NANOMATERIALS AND ADVANCED MATERIALS

Nanomaterials and advanced materials CONTACTS Bob Diderich: bob.diderich@oecd.org Mar Gonzalez: mar.gonzalez@oecd.org