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

EFSA Scientific Committee

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Article numbere05634
Number of pages77
JournalEfsa journal
Volume17
Issue number3
DOIs
Publication statusPublished - 25 Mar 2019

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risk assessment process
environmental assessment
animal health
risk assessment
human health
Health
hazard identification
risk characterization
hazard characterization
uncertainty analysis
exposure assessment
ecotoxicology
animal and human health
application methods
committees
methodology
case studies
dosage
Toxicology
Uncertainty

Cite this

@article{538e9f5a5fcc4f57a30457493af7b09e,
title = "Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals",
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.",
author = "{EFSA Scientific Committee} and More, {Simon John} and Vasileios Bampidis and Diane Benford and Bennekou, {Susanne Hougaard} and Claude Bragard and Halldorsson, {Thorhallur Ingi} and Hernandez-Jerez, {Antonio F.} and Koutsoumanis, {Konstantinos Panagiotis} and Hanspeter Naegeli and Schlatter, {Josef R.} and Vittorio Silano and Nielsen, {Soren Saxmose} and Dieter Schrenk and Dominique Turck and Maged Younes and Emilio Benfenati and Laurence Castle and Nina Cedergreen and Anthony Hardy and Ryszard Laskowski and Leblanc, {Jean Charles} and Andreas Kortenkamp and Ad Ragas and Leo Posthuma and Claus Svendsen and Roland Solecki and Emanuela Testai and Bruno Dujardin and Kass, {George E. N.} and Paola Manini and Jeddi, {Maryam Zare} and Dorne, {Jean-Lou C. M.} and Christer Hogstrand",
year = "2019",
month = "3",
day = "25",
doi = "10.2903/j.efsa.2019.5634",
language = "English",
volume = "17",
journal = "Efsa journal",
issn = "1831-4732",
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Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. / EFSA Scientific Committee.

In: Efsa journal, Vol. 17, No. 3, e05634, 25.03.2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

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

AU - EFSA Scientific Committee

AU - More, Simon John

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bennekou, Susanne Hougaard

AU - Bragard, Claude

AU - Halldorsson, Thorhallur Ingi

AU - Hernandez-Jerez, Antonio F.

AU - Koutsoumanis, Konstantinos Panagiotis

AU - Naegeli, Hanspeter

AU - Schlatter, Josef R.

AU - Silano, Vittorio

AU - Nielsen, Soren Saxmose

AU - Schrenk, Dieter

AU - Turck, Dominique

AU - Younes, Maged

AU - Benfenati, Emilio

AU - Castle, Laurence

AU - Cedergreen, Nina

AU - Hardy, Anthony

AU - Laskowski, Ryszard

AU - Leblanc, Jean Charles

AU - Kortenkamp, Andreas

AU - Ragas, Ad

AU - Posthuma, Leo

AU - Svendsen, Claus

AU - Solecki, Roland

AU - Testai, Emanuela

AU - Dujardin, Bruno

AU - Kass, George E. N.

AU - Manini, Paola

AU - Jeddi, Maryam Zare

AU - Dorne, Jean-Lou C. M.

AU - Hogstrand, Christer

PY - 2019/3/25

Y1 - 2019/3/25

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.

U2 - 10.2903/j.efsa.2019.5634

DO - 10.2903/j.efsa.2019.5634

M3 - Article

VL - 17

JO - Efsa journal

JF - Efsa journal

SN - 1831-4732

IS - 3

M1 - e05634

ER -