Guidance on the assessment of the biological relevance of data in scientific assessments

Hardy, Anthony and Benford, Diane and Halldorsson, Thorhallur and Jeger, Michael John and Knutsen, Helle Katrine and More, Simon and Naegeli, Hanspeter and Noteborn, Hubert and Ockleford, Colin and Ricci, Antonia and Rychen, Guido and Schlatter, Josef R and Silano, Vittorio and Solecki, Roland and Turck, Dominique and Younes, Maged and Bresson, Jean-Louis and Griffin, John and Hougaard Benekou, Susanne and van Loveren, Henk and Luttik, Robert and Messean, Antoine and Penninks, André and Ru, Giuseppe and Stegeman, Jan Arend and van der Werf, Wopke and Westendorf, Johannes and Woutersen, Rudolf Antonius and Barizzone, Fulvio and Bottex, Bernard and Lanzoni, Anna and Georgiadis, Nikolaos and Alexander, Jan (2017) Guidance on the assessment of the biological relevance of data in scientific assessments. EFSA Journal, 15 (8): 04970. ISSN 1831-4732

Abstract

Abstract 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.