Guidance Document on the Generation, Reporting and Use of Research Data for Regulatory Assessments

This Guidance Document aims to enhance utility and regulatory uptake of research data. The document focuses on hazard, exposure and risk assessment data generated outside of regulatory testing frameworks, promoting harmonised approaches for using scientifically robust, reliable and relevant information for decision-making across jurisdictions and policy areas. The document is structured around the lifecycle of research data, from generation and reporting to identification, evaluation and integration into regulatory assessments. The guidance includes practical recommendations for funders, researchers, publishers, repository managers, assessors and risk managers. Additional sections of the document offer tools, references and case studies to support stakeholders in implementing guidance. This guidance is intended to improve regulatory use of information derived from sources other than guidelines studies and to be particularly helpful for chemicals for which regulations require review of all available data or for chemicals which may not have standard data requirements.