Robust study summaries effectively support hazard assessment

ECHA/NR/23/13

The final report of the OECD’s project, led by ECHA, on the role of robust study summaries for the hazard assessment of chemicals finds they are fit for purpose. It has also identified a number of areas for improvement to further increase their trustworthiness and usefulness.  

Helsinki, 2 May 2023 – ECHA, in cooperation with the OECD, has conducted a project to evaluate the role of the robust study summaries concept. The aim was to verify their adequacy for hazard assessment as well as to identify potential areas for improvement. 

The final report of this project finds that robust study summaries provide reliable information for hazard assessment. Assessment becomes more efficient as full study reports do not need to be consulted. The OECD harmonised templates provide a standard format for robust study summaries and help increase their consistency. 

To further improve their quality, usefulness and accuracy, the study suggests to: 

•    implement a robust study summary review process;
•    provide trainings and manuals for writing robust study summaries; and
•    continue developing validation rules.

The outcome of the study will serve as a basis for prioritising improvement actions in the future.

Background

A robust study summary is a detailed summary of the objectives, methods, results, and conclusions of a full study report. Its goal is to minimise the need to consult the full study report to make the assessment more efficient. 

The OECD has developed harmonised templates to report the relevant information for the risk assessment of chemicals. These templates are implemented in IUCLID, a software application to record, store, maintain and exchange data on intrinsic and hazard properties of chemical substances.

The project was divided into three work packages. The first report, published in April 2022, captured the comments and suggestions of the users, collected from a survey and a series of interviews. The second phase analysed the quality and the accuracy of a series of robust study summaries. The findings were published in March 2023.

The reports of this project were commissioned by ECHA, provided by the Yordas Group and reviewed by an OECD Steering Committee.