Robust Study Summaries (RSS) are detailed study summaries for the following sections: a) Physical and chemical properties, b) Environmental fate and pathways, c) Ecotoxicological information, d) Toxicological information, and e) Analytical methods, that must be included in the IUCLID dossier for both REACH registrants and Biocidal Products Regulation (BPR) applicants. They provide a comprehensive overview of the objectives, methods, results, and conclusions of a full study report, allowing assessors to independently evaluate the study without necessarily consulting the full report.
For REACH registrants, RSS are required for all key studies, particularly those that drive the Derived No-Effect Level (DNEL) for human health endpoints and the No-Observed-Effect Concentration (NOEC) for environmental endpoints. They are also necessary for studies that contribute to the hazard assessment, chemical safety report, and those used in Read-Across and Weight of Evidence approaches.
BPR applicants must provide RSS for information derived for approval and authorisation applications, as well as for all key studies that are used to derive conclusions in the chemical safety assessment and those providing data used in the risk assessment.
When drafting an RSS, it should be independent, self-contained, and avoid bias. If a standard information requirement is waived, a justification must be reported in accordance with ECHA Guidance R.5. The RSS should be formatted according to the IUCLID format, which is a harmonised reporting standard for scientific information.
In cases where supporting studies are submitted, a basic study summary is acceptable, but RSS may still be helpful, especially if there are conflicting results from less valid studies. The RSS should include all relevant information as per the respective OECD Technical Test Guideline, and any deficiencies in the study should be clearly stated.
The IUCLID dossier must be complete and include all necessary administrative data, such as endpoint, type of information, adequacy, and reliability. Statistical methods and results should be clearly reported, and all key data used in the hazard assessment must be robustly summarized.
Overall, the RSS is a critical component of the IUCLID dossier, ensuring that all relevant information is presented in a clear, concise, and accessible manner for regulatory assessment.
Please reach out to us to get support in preparing RSS, environmental risk assessment (ERA) or BPR compliance services.