Harmonised approach for reporting reliability and relevance of genotoxicity studies
European Food Safety Authority (EFSA), C Andreoli, Gabriele Aquilina, Margherita Bignami, Claudia Bolognesi, Riccardo Crebelli, Mária Dušinská, Rainer Gürtler, Henriqueta Louro, Francesca Marcon, Elsa Nielsen, Josef Schlatter, Christiane Vleminckx, Maria Chiara Astuto, Alexis V. Nathanail, Diane Benford
Abstract
This technical report describes an approach developed by the EFSA cross-cutting Working Group on Genotoxicity for the reporting of reliability and relevance of genotoxicity studies.The scope of this document is to ensure harmonisation and transparency of the approach for evaluation of genotoxicity evidence among EFSA Units dealing with scientific assessments.It is recommended to be used as a template for the drafting of genotoxicity assessments in EFSA Opinions.