Integrating Selection and Risk Assessment of Chemical Mixtures: A Novel Approach Applied to a Breast Milk Survey

Crépet, Amélie; Vasseur, Paule; Jean, Julien; Badot, Pierre‐Marie; Nesslany, Fabrice; Vernoux, Jean-Paul; Feidt, Cyril; Mhaouty-Kodja, Sakina

doi:10.1289/ehp8262

Cited by 8 publications

(7 citation statements)

References 110 publications

(127 reference statements)

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“…The assessment includes 32 chemicals with positive concentrations in 180 breast milk samples from six French lactariums (ANSES, in press; Crépet et al, in press). Using a lower bound scenario, censored data were replaced by zero values when not detected and by the limit of detection when not quantified (EFSA, 2010).…”

Section: Appendix E – Exposure‐driven Approach As a Prioritisation Me...mentioning

confidence: 99%

“…The example presented here illustrates the use of an exposure‐driven approach to identify low‐priority contaminants for grouping within human breast milk as described elsewhere (Crépet et al, in press).…”

Section: Appendix E – Exposure‐driven Approach As a Prioritisation Me...mentioning

confidence: 99%

“…This method has been so far mostly applied by national agencies (e.g. ANSES) using probability of co‐exposure patterns to identify low‐priority chemicals present in (a) breast milk (Crépet et al, in press) and total diet (Béchaux et al, 2013; Crépet et al, 2013a,b; Traoré et al, 2016); (b) biomonitoring data in body fluids (blood and urinary) providing correlations of internal exposure between multiple chemicals from Horizon 2020 research projects Helix and HBM4EU (Tamayo‐Uria et al, 2019; Ottenbros et al, 2021)…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals

More¹,

Bampidis²,

Benford³

et al. 2021

EFS2

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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.

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Section: Appendix E – Exposure‐driven Approach As a Prioritisation Me...mentioning

confidence: 99%

Section: Appendix E – Exposure‐driven Approach As a Prioritisation Me...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals

More¹,

Bampidis²,

Benford³

et al. 2021

EFS2

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“…The RPI is estimated by adjusting the exposure levels to each of the mixture components using their RPF values and Equation (1) is amended accordingly (Equation (7)) [ 113 ].

…”

Section: Points Of Priority and Challenges In Risk Assessment Methodo...mentioning

confidence: 99%

Priorities and Challenges in Methodology for Human Health Risk Assessment from Combined Exposure to Multiple Chemicals

Nikolopoulou

Ntzani

Kyriakopoulou

et al. 2023

Toxics

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This paper reviews key elements in the assessment of human health effects from combined exposure to multiple chemicals taking into consideration current knowledge and challenges to identify areas where scientific advancement is mostly needed and proposes a decision-making scheme on the basis of existing methods and tools. The assumption of dose addition and estimation of the hazard index (HI) is considered as a starting point in component-based risk assessments. When, based on the generic HI approach, an unacceptable risk is identified, more specific risk assessment options may be implemented sequentially or in parallel depending on problem formulation, characteristics of the chemical group under assessment, exposure levels, data availability and resources. For prospective risk assessments, the reference point index/margin of exposure (RPI/MOET) (Option 1) or modified RPI/normalized MOET (mRPI/nMOET) (Option 2) approaches may be implemented focusing on the specific mixture effect. Relative potency factors (RPFs) may also be used in the RPI approach since a common uncertainty factor for each mixture component is introduced in the assessment. Increased specificity in the risk assessment may also be achieved when exposure of selected population groups is considered (Option 3/exposure). For retrospective risk assessments, human biomonitoring data available for vulnerable population groups (Option 3/susceptibility) may present more focused scenarios for consideration in human health risk management decisions. In data-poor situations, the option of using the mixture assessment factor (MAF) is proposed (Option 4), where an additional uncertainty factor is applied on each mixture component prior to estimating the HI. The magnitude of the MAF may be determined by the number of mixture components, their individual potencies and their proportions in the mixture, as previously reported. It is acknowledged that implementation of currently available methods and tools for human health risk assessment from combined exposure to multiple chemicals by risk assessors will be enhanced by ongoing scientific developments on new approach methodologies (NAMs), integrated approaches to testing and assessment (IATA), uncertainty analysis tools, data sharing platforms, risk assessment software as well as guideline development to meet legislative requirements.

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“…It is applicable for substances without hazard metrics or when a large number of chemicals have to be evaluated. Recently, the application of a novel exposure-driven prioritisation approach has been published and illustrates its applicability for biomonitoring data focusing on multiple contaminants in human breast milk [ 60 ].…”

Section: Scientific Criteria For Grouping Chemicals Into Assessment G...mentioning

confidence: 99%

Risk Assessment of Combined Exposure to Multiple Chemicals at the European Food Safety Authority: Principles, Guidance Documents, Applications and Future Challenges

Cattaneo

Kalian

Nicola

et al. 2023

Toxins

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Human health and animal health risk assessment of combined exposure to multiple chemicals use the same steps as single-substance risk assessment, namely problem formulation, exposure assessment, hazard assessment and risk characterisation. The main unique feature of combined RA is the assessment of combined exposure, toxicity and risk. Recently, the Scientific Committee of the European Food Safety Authority (EFSA) published two relevant guidance documents. The first one “Harmonised methodologies for the human health, animal health and ecological risk assessment of combined exposure to multiple chemicals” provides principles and explores methodologies for all steps of risk assessment together with a reporting table. This guidance supports also the default assumption that dose addition is applied for combined toxicity of the chemicals unless evidence for response addition or interactions (antagonism or synergism) is available. The second guidance document provides an account of the scientific criteria to group chemicals in assessment groups using hazard-driven criteria and prioritisation methods, i.e., exposure-driven and risk-based approaches. This manuscript describes such principles, provides a brief description of EFSA’s guidance documents, examples of applications in the human health and animal health area and concludes with a discussion on future challenges in this field.

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Integrating Selection and Risk Assessment of Chemical Mixtures: A Novel Approach Applied to a Breast Milk Survey

Cited by 8 publications

References 110 publications

Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals

Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals

Priorities and Challenges in Methodology for Human Health Risk Assessment from Combined Exposure to Multiple Chemicals

Risk Assessment of Combined Exposure to Multiple Chemicals at the European Food Safety Authority: Principles, Guidance Documents, Applications and Future Challenges

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