The Status of OECD guidelines regarding regulatory compliance of 2D materials: a case study of graphene
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Abstract
The regulatory testing of graphene and other two-dimensional (2D) materials presents significant challenges due to the unique physicochemical properties of these materials. Because graphene is both the most widely used 2D nanomaterial and one of the most structurally variable, it provides a critical case study for evaluating the applicability of OECD Test Guidelines. Strengthening this connection is particularly important because OECD-accepted methods underpin regulatory compliance in frameworks such as the EU’s REACH regulation and the US Toxic Substances Control Act, meaning that gaps in guideline suitability directly affect market authorization and risk management. Existing OECD Test Guidelines (TGs) and Guidance Documents (GDs) were primarily developed for conventional chemicals and often fall short in addressing the specificities of 2D materials. These arise from their atomically thin, layered structures and quantum confinement in one dimension. This article provides a critical overview of the current status of OECD guideline applicability for graphene and proposes future directions for harmonizing regulatory testing approaches to ensure safety and compliance.
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Mundo Nano. Revista Interdisciplinaria en Nanociencias y Nanotecnología por Universidad Nacional Autónoma de México se distribuye bajo una Licencia Creative Commons Atribución-NoComercial 4.0 Internacional.
Basada en una obra en http://www.mundonano.unam.mx.
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