Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals

More, Simon John and Hardy, Anthony and Bampidis, Vasileios and Benford, Diane and Hougaard Bennekou, Susanne and Bragard, Claude and Boesten, Jos and Halldorsson, Thorhallur Ingi and Hernández-Jerez, Antonio F. and Jeger, Michael John and Knutsen, Helle Katrine and Koutsoumanis, Konstantinos Panagiotis and Naegeli, Hanspeter and Noteborn, Hubert and Ockleford, Colin and Ricci, Antonia and Rychen, Guido and Schlatter, Josef R. and Silano, Vittorio and Nielsen, Søren Saxmose and Schrenk, Dieter and Solecki, Roland and Turck, Dominique and Younes, Maged and Benfenati, Emilio and Castle, Laurence and Cedergreen, Nina and Laskowski, Ryszard and Leblanc, Jean Charles and Kortenkamp, Andreas and Ragas, Ad and Posthuma, Leo and Svendsen, Claus and Testai, Emanuela and Dujardin, Bruno and Kass, George E.N. and Manini, Paola and Zare Jeddi, Maryam and Dorne, Jean Lou CM and Hogstrand, Christer (2019) Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. EFSA Journal, 17 (3). ISSN 1831-4732

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Abstract

This Guidance document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, animal health and ecological areas. First, a short review of the key terms, scientific basis for combined exposure risk assessment and approaches to assessing (eco)toxicology is given, including existing frameworks for these risk assessments. This background was evaluated, resulting in a harmonised framework for risk assessment of combined exposure to multiple chemicals. The framework is based on the risk assessment steps (problem formulation, exposure assessment, hazard identification and characterisation, and risk characterisation including uncertainty analysis), with tiered and stepwise approaches for both whole mixture approaches and component-based approaches. Specific considerations are given to component-based approaches including the grouping of chemicals into common assessment groups, the use of dose addition as a default assumption, approaches to integrate evidence of interactions and the refinement of assessment groups. Case studies are annexed in this guidance document to explore the feasibility and spectrum of applications of the proposed methods and approaches for human and animal health and ecological risk assessment. The Scientific Committee considers that this Guidance is fit for purpose for risk assessments of combined exposure to multiple chemicals and should be applied in all relevant areas of EFSA's work. Future work and research are recommended.

Item Type:
Journal Article
Journal or Publication Title:
EFSA Journal
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/1100/1110
Subjects:
ID Code:
135656
Deposited By:
Deposited On:
23 Jul 2019 13:35
Refereed?:
Yes
Published?:
Published
Last Modified:
16 Sep 2020 05:42