Contact persons for Italy:
Chiara Laura Battistelli, Cecilia Bossa and Olga Tcheremenskaia, Istituto Superiore di Sanità, Environment and Health Department
ISS has co-coordinated with the European Chemical Agency (ECHA) the “QSAR Assessment Framework" project (2021-2023), promoted by the OECD Working Party on Hazard Assessment (WPHA). The expert group led by ISS and ECHA has included about 40 representatives from different OECD member countries and international regulatory agencies. In this project, the main objective was to develop a systematic and harmonized framework for evaluating of (Quantitative) Structure Activity Relationship models - (Q)SAR and their predictions. The final project documentation, which includes the guidance document and the checklists in Excel, has been recently published on the OECD website (1).
The framework, in principle, is applicable regardless of the modelling technique used to build the model (or battery of models) and regardless of the endpoint and regulatory application, while the confidence level and the acceptable uncertainty are context-dependent and should be determined by the evaluator on a case-by-case basis.
The new guidance provides regulators with a harmonized and transparent methodology for assessing the use of models and predictions in regulatory frameworks, increasing confidence in accepting methods alternative to animal testing to assess the hazards of chemicals.
- OECD (2023), (Q)SAR Assessment Framework: Guidance for the regulatory assessment of (Quantitative) Structure - Activity Relationship models, predictions, and results based on multiple predictions, OECD Series on Testing and Assessment, No. 386, Environment, Health and Safety, Environment Directorate, OECD
