TY - JOUR

T1 - Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals

AU - Committee, EFSA Scientific

AU - More, Simon John

AU - Hardy, Anthony

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Hougaard Bennekou, Susanne

AU - Bragard, Claude

AU - Boesten, Jos

AU - Halldorsson, Thorhallur Ingi

AU - Hernández-Jerez, Antonio F

AU - Jeger, Michael John

AU - Knutsen, Helle Katrine

AU - Koutsoumanis, Konstantinos Panagiotis

AU - Naegeli, Hanspeter

AU - Noteborn, Hubert

AU - Ockleford, Colin

AU - Ricci, Antonia

AU - Rychen, Guido

AU - Schlatter, Josef R

AU - Silano, Vittorio

AU - Nielsen, Søren Saxmose

AU - Schrenk, Dieter

AU - Solecki, Roland

AU - Turck, Dominique

AU - Younes, Maged

AU - Benfenati, Emilio

AU - Castle, Laurence

AU - Cedergreen, Nina

AU - Laskowski, Ryszard

AU - Leblanc, Jean Charles

AU - Kortenkamp, Andreas

AU - Ragas, Ad

AU - Posthuma, Leo

AU - Svendsen, Claus

AU - Testai, Emanuela

AU - Dujardin, Bruno

AU - Kass, George EN

AU - Manini, Paola

AU - Zare Jeddi, Maryam

AU - Dorne, Jean-Lou CM

AU - Hogstrand, Christer

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

KW - harmonised methodologies

KW - risk assessment

KW - combined exposure to multiple chemicals

KW - mixtures

KW - dose addition

KW - response addition

KW - interactions

U2 - 10.2903/j.efsa.2019.5634

DO - 10.2903/j.efsa.2019.5634

M3 - Journal article

C2 - 32626259

VL - 17

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 3

M1 - e05634

ER -