New ECHA Report Published
The final report from the European Chemicals Agency (ECHA)-funded project, 'Nanomaterial Risk Assessment: A Regulatory Way Forward for Sameness and Grouping Approaches', has now been published.
Led by Blue Frog, this two-year collaborative project brought together a consortium of expert organisations, including Purposeful IKE, GreenDecision, Heriot-Watt University, and the UK Centre for Ecology & Hydrology (UKCEH). Together, the consortium addressed one of the key challenges in nanomaterial regulation: developing scientifically robust approaches for assessing variation between nanoforms under the REACH Regulation.
Framework for Identifying Acceptable Variation Between Nanoforms
A key outcome of the project is a proposed framework for identifying acceptable variation between nanoforms. This has the potential to support a more streamlined regulatory process and, ultimately, help reintroduce the principle of 'one substance, one registration' for nanoforms, bringing their regulatory treatment into closer alignment with that of conventional (non-nanoform) substances.
Importantly, while the concept of substance sameness is well established for conventional substances, it does not formally exist for nanoforms under the current regulatory framework. Rather than attempting to define nanoform 'sameness' in the traditional sense, the report focuses on identifying acceptable variation between nanoforms that results in the same overall properties, such as toxicity and environmental fate.
Scientifically Justified Framework with Potential to Reduce Regulatory Burden
The report proposes a scientifically justified framework that uses existing Annex VI substance identity information – including characteristics such as particle size, morphology, crystallinity and surface properties – to determine whether variation between two nanoforms is acceptable. By making greater use of information already generated for substance identification, the approach has the potential to reduce regulatory burden while supporting more consistent and transparent decision-making.
The framework consists of a series of decision trees covering key nanoform characteristics, including composition, size and surface properties. These provide a structured, evidence-based approach for determining whether two nanoforms exhibit acceptable variation and can therefore be considered a single nanoform for regulatory purposes. Each decision point incorporates scientifically derived thresholds based on the current state of knowledge, taking into account factors such as experimental variability and toxicological triggers associated with particle size and morphology.
Development of Substance Identity Profiles for Nanoforms
The identification of acceptable variation between nanoforms could subsequently support the development of Substance Identity Profiles (SIPs) for nanoforms. If adopted through future regulatory implementation, this would represent a significant step towards a more proportionate and efficient registration process, supporting the long-standing principle of one substance, one registration while maintaining a science-based approach to regulatory decision-making.
Foundation for Future Regulatory Implementation of Nanomaterials
The publication of this report marks an important milestone in the continuing development of regulatory science for nanomaterials. The collaborative work of the consortium provides valuable insight into future directions for nanoform registration and assessment and offers a practical framework for supporting consistent regulatory compliance.
The full report is available on the ECHA website:
https://echa.europa.eu/documents/d/guest/nanomaterial_risk_assessment_regulatory_way_forward_for_sameness_and_grouping_approaches_en
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