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

biological relevance, adverse effect, beneficial effect, size of the effect, nature of the effect, scientific assessment
First published in the EFSA Journal
3 August 2017
12 July 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.

Panel members at the time of adoption
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 and Maged Younes.
Scientific Committee
sc.secretariat [at]
EFSA Journal 2017;15(8):4970 [73 pp.].
Question Number
On request from
EFSA Scientific Committee