RT Journal Article
T1 Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals.
A1 EFSA Scientific Committee, 
A1 More, Simon John
A1 Bampidis, Vasileios
A1 Benford, Diane
A1 Bragard, Claude
A1 Hernandez-Jerez, Antonio
A1 Bennekou, Susanne Hougaard
A1 Halldorsson, Thorhallur Ingi
A1 Koutsoumanis, Konstantinos Panagiotis
A1 Lambré, Claude
A1 Machera, Kyriaki
A1 Naegeli, Hanspeter
A1 Nielsen, Søren Saxmose
A1 Schlatter, Josef Rudolf
A1 Schrenk, Dieter
A1 Silano, Vittorio
A1 Turck, Dominique
A1 Younes, Maged
A1 Benfenati, Emilio
A1 Crépet, Amélie
A1 Te Biesebeek, Jan Dirk
A1 Testai, Emanuela
A1 Dujardin, Bruno
A1 Dorne, Jean Lou Cm
A1 Hogstrand, Christer
K1 assessment groups
K1 combined exposure to multiple chemicals
K1 dose addition
K1 grouping
K1 harmonised methodologies
K1 human risk assessment
K1 scientific criteria
AB 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.
YR 2021
FD 2021-12-17
LK https://hdl.handle.net/10668/26746
UL https://hdl.handle.net/10668/26746
LA en
DS RISalud
RD Apr 17, 2025