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
C2 - 32626259
VL - 17
SP - e05634
JO - Efsa journal
JF - Efsa journal
SN - 1831-4732
IS - 3
M1 - e05634
ER -