EFSA Scientific Committee, Anthony Hardy , Diane Benford , Thorhallur Halldorsson , Michael John Jeger , Helle Katrine Knutsen , Simon More , Hanspeter Naegeli , Hubert Noteborn , Colin Ockleford , Antonia Ricci , Guido Rychen , Josef R Schlatter , Vittorio Silano , Roland Solecki , Dominique Turck , Maged Younes , Jean‐Louis Bresson , John Griffin , Susanne Hougaard Benekou , Henk van Loveren , Robert Luttik , Antoine Messean , André Penninks , Giuseppe Ru , Jan Arend Stegeman , Wopke van der Werf , Johannes Westendorf , Rudolf Antonius Woutersen , Fulvio Barizzone , Bernard Bottex , Anna Lanzoni , Nikolaos Georgiadis , Jan Alexander
03 August 2017
EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered.
This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1296/full