Guidance on the assessment of the biological relevance of data in scientific assessments. (3rd August 2017)

• Record Type: Journal Article
• Authors: Hardy, Anthony; Benford, Diane; Halldorsson, Thorhallur; Jeger, Michael John; Knutsen, Helle Katrine; More, Simon; Naegeli, Hanspeter; Noteborn, Hubert; Ockleford, Colin; Ricci, Antonia; Rychen, Guido; Schlatter, Josef R; Silano, Vittorio; Solecki, Roland; Turck, Dominique; Younes, Maged; Bresson, Jean‐Louis; Griffin, John; Hougaard Benekou, Susanne; van Loveren, Henk; Luttik, Robert; Messean, Antoine; Penninks, André; Ru, Giuseppe; Stegeman, Jan Arend; van der Werf, Wopke; Westendorf, Johannes; Woutersen, Rudolf Antonius; Barizzone, Fulvio; Bottex, Bernard; Lanzoni, Anna; Georgiadis, Nikolaos; Alexander, Jan;
• Is Part Of: EFSA journal. Volume 15:Number 8(2017)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2017-08-03
• Subjects: biological relevance -- adverse effect -- beneficial effect -- size of the effect -- nature of the effect -- scientific assessment; Food -- Europe -- Safety measures -- Periodicals; Food Safety; Food -- Safety measures; Europe; Periodicals; Periodicals; Fulltext; Government Publications, International; Internet Resources; Periodicals; Periodicals; 363.19209405
• DOI: 10.2903/j.efsa.2017.4970
• Languages: English
• ISSNs: 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. Abstract : This publication is linked to the following EFSA Supporting Publications article:http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1296/full