Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals
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Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. / EFSA Scientific Committee; More, Simon John; Bampidis, Vasileios; Benford, Diane; Bragard, Claude; Hernandez-Jerez, Antonio; Bennekou, Susanne Hougaard; Halldorsson, Thorhallur Ingi; Koutsoumanis, Konstantinos Panagiotis; Lambré, Claude; Machera, Kyriaki; Naegeli, Hanspeter; Nielsen, Søren Saxmose; Schlatter, Josef Rudolf; Schrenk, Dieter; Silano (deceased), Vittorio; Turck, Dominique; Younes, Maged; Benfenati, Emilio; Crépet, Amélie; Te Biesebeek, Jan Dirk; Testai, Emanuela; Dujardin, Bruno; Dorne, Jean Lou CM; Hogstrand, Christer.
In: EFSA Journal, Vol. 19, No. 12, e07033, 2021, p. 1-37.Research output: Contribution to journal › Journal article › Research
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TY - JOUR
T1 - Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals
AU - EFSA Scientific Committee, null
AU - More, Simon John
AU - Bampidis, Vasileios
AU - Benford, Diane
AU - Bragard, Claude
AU - Hernandez-Jerez, Antonio
AU - Bennekou, Susanne Hougaard
AU - Halldorsson, Thorhallur Ingi
AU - Koutsoumanis, Konstantinos Panagiotis
AU - Lambré, Claude
AU - Machera, Kyriaki
AU - Naegeli, Hanspeter
AU - Nielsen, Søren Saxmose
AU - Schlatter, Josef Rudolf
AU - Schrenk, Dieter
AU - Silano (deceased), Vittorio
AU - Turck, Dominique
AU - Younes, Maged
AU - Benfenati, Emilio
AU - Crépet, Amélie
AU - Te Biesebeek, Jan Dirk
AU - Testai, Emanuela
AU - Dujardin, Bruno
AU - Dorne, Jean Lou CM
AU - Hogstrand, Christer
PY - 2021
Y1 - 2021
N2 - Abstract This guidance document provides harmonised and flexible methodologies to apply scientific criteria and prioritisation methods for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. In the context of EFSA’s risk assessments, the problem formulation step defines the chemicals to be assessed in the terms of reference usually through regulatory criteria often set by risk managers based on legislative requirements. Scientific criteria such as hazard-driven criteria can be used to group these chemicals into assessment groups. In this guidance document, a framework is proposed to apply hazard-driven criteria for grouping of chemicals into assessment groups using mechanistic information on toxicity as the gold standard where available (i.e. common mode of action or adverse outcome pathway) through a structured weight of evidence approach. However, when such mechanistic data are not available, grouping may be performed using a common adverse outcome. Toxicokinetic data can also be useful for grouping, particularly when metabolism information is available for a class of compounds and common toxicologically relevant metabolites are shared. In addition, prioritisation methods provide means to identify low-priority chemicals and reduce the number of chemicals in an assessment group. Prioritisation methods include combined risk-based approaches, risk-based approaches for single chemicals and exposure-driven approaches. Case studies have been provided to illustrate the practical application of hazard-driven criteria and the use of prioritisation methods for grouping of chemicals in assessment groups. Recommendations for future work are discussed.
AB - Abstract This guidance document provides harmonised and flexible methodologies to apply scientific criteria and prioritisation methods for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. In the context of EFSA’s risk assessments, the problem formulation step defines the chemicals to be assessed in the terms of reference usually through regulatory criteria often set by risk managers based on legislative requirements. Scientific criteria such as hazard-driven criteria can be used to group these chemicals into assessment groups. In this guidance document, a framework is proposed to apply hazard-driven criteria for grouping of chemicals into assessment groups using mechanistic information on toxicity as the gold standard where available (i.e. common mode of action or adverse outcome pathway) through a structured weight of evidence approach. However, when such mechanistic data are not available, grouping may be performed using a common adverse outcome. Toxicokinetic data can also be useful for grouping, particularly when metabolism information is available for a class of compounds and common toxicologically relevant metabolites are shared. In addition, prioritisation methods provide means to identify low-priority chemicals and reduce the number of chemicals in an assessment group. Prioritisation methods include combined risk-based approaches, risk-based approaches for single chemicals and exposure-driven approaches. Case studies have been provided to illustrate the practical application of hazard-driven criteria and the use of prioritisation methods for grouping of chemicals in assessment groups. Recommendations for future work are discussed.
KW - harmonised methodologies
KW - human risk assessment
KW - combined exposure to multiple chemicals
KW - scientific criteria
KW - grouping
KW - assessment groups
KW - dose addition
U2 - 10.2903/j.efsa.2021.7033
DO - 10.2903/j.efsa.2021.7033
M3 - Journal article
C2 - 34976164
VL - 19
SP - 1
EP - 37
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 12
M1 - e07033
ER -
ID: 287608724