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

EFSA Scientific Committee; Simon John More; Anthony Hardy; Vasileios Bampidis; Diane Benford; Susanne Hougaard Bennekou; Claude Bragard; Jos Boesten; Thorhallur Ingi Halldorsson; Antonio F Hernández-Jerez; Michael John Jeger; Helle Katrine Knutsen; Konstantinos Panagiotis Koutsoumanis; Hanspeter Naegeli; Hubert Noteborn; Colin Ockleford; Antonia Ricci; Guido Rychen; Josef R Schlatter; Vittorio Silano; Søren Saxmose Nielsen; Dieter Schrenk; Roland Solecki; Dominique Turck; Maged Younes; Emilio Benfenati; Laurence Castle; Nina Cedergreen; Ryszard Laskowski; Jean Charles Leblanc; Andreas Kortenkamp; Ad Ragas; Leo Posthuma; Claus Svendsen; Emanuela Testai; Bruno Dujardin; George EN Kass; Paola Manini; Maryam Zare Jeddi; Jean-Lou CM Dorne; Christer Hogstrand

doi:10.2903/j.efsa.2019.5634

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

EFSA Scientific Committee, Simon John More, Anthony Hardy, Vasileios Bampidis, Diane Benford, Susanne Hougaard Bennekou, Claude Bragard, Jos Boesten, Thorhallur Ingi Halldorsson, Antonio F Hernández-Jerez, Michael John Jeger, Helle Katrine Knutsen, Konstantinos Panagiotis Koutsoumanis, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R Schlatter, Vittorio SilanoSøren Saxmose Nielsen, Dieter Schrenk, Roland Solecki, Dominique Turck, Maged Younes, Emilio Benfenati, Laurence Castle, Nina Cedergreen, Ryszard Laskowski, Jean Charles Leblanc, Andreas Kortenkamp, Ad Ragas, Leo Posthuma, Claus Svendsen, Emanuela Testai, Bruno Dujardin, George EN Kass, Paola Manini, Maryam Zare Jeddi, Jean-Lou CM Dorne, Christer Hogstrand

107 Citations (Scopus)

29 Downloads (Pure)

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 language	English
Article number	e05634
Journal	EFSA Journal
Volume	17
Issue number	3
Number of pages	77
ISSN	1831-4732
DOIs	https://doi.org/10.2903/j.efsa.2019.5634
Publication status	Published - 1 Mar 2019

Keywords

harmonised methodologies
risk assessment
combined exposure to multiple chemicals
mixtures
dose addition
response addition
interactions

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2903/j.efsa.2019.5634Licence: CC BY-ND

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicalsFinal published version, 8.82 MBLicence: CC BY-ND

Cite this

Committee, EFSA. S., More, S. J., Hardy, A., Bampidis, V., Benford, D., Hougaard Bennekou, S., Bragard, C., Boesten, J., Halldorsson, T. I., Hernández-Jerez, A. F., Jeger, M. J., Knutsen, H. K., Koutsoumanis, K. P., Naegeli, H., Noteborn, H., Ockleford, C., Ricci, A., Rychen, G., Schlatter, J. R., ... Hogstrand, C. (2019). Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. EFSA Journal, 17(3), [e05634]. https://doi.org/10.2903/j.efsa.2019.5634

Committee, EFSAS, More, SJ, Hardy, A, Bampidis, V, Benford, D, Hougaard Bennekou, S, Bragard, C, Boesten, J, Halldorsson, TI, Hernández-Jerez, AF, Jeger, MJ, Knutsen, HK, Koutsoumanis, KP, Naegeli, H, Noteborn, H, Ockleford, C, Ricci, A, Rychen, G, Schlatter, JR, Silano, V, Nielsen, SS, Schrenk, D, Solecki, R, Turck, D, Younes, M, Benfenati, E, Castle, L, Cedergreen, N, Laskowski, R, Leblanc, JC, Kortenkamp, A, Ragas, A, Posthuma, L, Svendsen, C, Testai, E, Dujardin, B, Kass, GEN, Manini, P, Zare Jeddi, M, Dorne, J-LCM & Hogstrand, C 2019, 'Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals', EFSA Journal, vol. 17, no. 3, e05634. https://doi.org/10.2903/j.efsa.2019.5634

@article{4ff8f1607d2c45eb8a6020e83799886f,

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.",

keywords = "harmonised methodologies, risk assessment, combined exposure to multiple chemicals, mixtures, dose addition, response addition, interactions",

author = "Committee, {EFSA Scientific} and More, {Simon John} and Anthony Hardy and Vasileios Bampidis and Diane Benford and {Hougaard Bennekou}, Susanne and Claude Bragard and Jos Boesten and Halldorsson, {Thorhallur Ingi} and Hern{\'a}ndez-Jerez, {Antonio F} and Jeger, {Michael John} and Knutsen, {Helle Katrine} and Koutsoumanis, {Konstantinos Panagiotis} and Hanspeter Naegeli and Hubert Noteborn and Colin Ockleford and Antonia Ricci and Guido Rychen and Schlatter, {Josef R} and Vittorio Silano and Nielsen, {S{\o}ren Saxmose} and Dieter Schrenk and Roland Solecki and Dominique Turck and Maged Younes and Emilio Benfenati and Laurence Castle and Nina Cedergreen and Ryszard Laskowski and Leblanc, {Jean Charles} and Andreas Kortenkamp and Ad Ragas and Leo Posthuma and Claus Svendsen and Emanuela Testai and Bruno Dujardin and Kass, {George EN} and Paola Manini and {Zare Jeddi}, Maryam and Dorne, {Jean-Lou CM} and Christer Hogstrand",

year = "2019",

month = mar,

day = "1",

doi = "10.2903/j.efsa.2019.5634",

language = "English",

volume = "17",

journal = "E F S A Journal",

issn = "1831-4732",

publisher = "European Food Safety Authority (E F S A)",

number = "3",

}

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 - 2019/3/1

Y1 - 2019/3/1

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

SN - 1831-4732

VL - 17

JO - E F S A Journal

JF - E F S A Journal

IS - 3

M1 - e05634

ER -

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

Abstract

Keywords

UN SDGs

Access to Document

Fingerprint

Cite this