The OECD has released a new Guidance Document (Series on Testing & Assessment No. 417) establishing a harmonized framework for generating and reporting research data to support regulatory decision-making. The guidance takes a cross-cutting approach to chemicals whileexplicitly addressing nanomaterials and advanced materials, which frequently rely on non-standard academic studies for hazard, exposure, and fate assessment.
The document outlines minimum quality criteria, documentation requirements, reporting templates, and recommendations for transparent data provenance. It also provides guidance on handling methodological uncertainties. This framework aims to facilitate acceptance of nano-related research data when preparing regulatory dossiers under REACH, TSCA, K-REACH, and other frameworks.
