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

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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.

Originalsprog	Engelsk
Artikelnummer	e05634
Tidsskrift	EFSA Journal
Vol/bind	17
Udgave nummer	3
Antal sider	77
ISSN	1831-4732
DOI	https://doi.org/10.2903/j.efsa.2019.5634
Status	Udgivet - 1 mar. 2019

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

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicalsForlagets udgivne version, 8,82 MBLicens: CC BY-ND

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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), Artikel 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, bind 17, nr. 3, e05634. https://doi.org/10.2903/j.efsa.2019.5634

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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.",

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AU - Hougaard Bennekou, Susanne

AU - Bragard, Claude

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AU - Halldorsson, Thorhallur Ingi

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AU - Rychen, Guido

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AU - Silano, Vittorio

AU - Nielsen, Søren Saxmose

AU - Schrenk, Dieter

AU - Solecki, Roland

AU - Turck, Dominique

AU - Younes, Maged

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AU - Cedergreen, Nina

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AU - Leblanc, Jean Charles

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AU - Posthuma, Leo

AU - Svendsen, Claus

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

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