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

Author:

Cattaneo Irene,Kalian Alexander D.ORCID,Di Nicola Matteo R.ORCID,Dujardin Bruno,Levorato Sara,Mohimont Luc,Nathanail Alexis V.ORCID,Carnessechi Edoardo,Astuto Maria ChiaraORCID,Tarazona Jose V.,Kass George E. N.,Liem Antoine K. Djien,Robinson Tobin,Manini Paola,Hogstrand ChristerORCID,Price Paul S.,Dorne Jean Lou C. M.

Abstract

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.

Funder

European Food Safety Authority

Publisher

MDPI AG

Subject

Health, Toxicology and Mutagenesis,Toxicology

Reference115 articles.

1. EFSA Scientific Committee, Dorne, J.-L.C., Hogstrand, C., Dujardin, B., Kass, G.E., Liem, A.D., Tarazona, J., Machera, K., Robinson, T., and Manini, P. (2022). EFSA International Workshop on RA of Combined Exposure to Multiple Chemicals. EFSA Support. Publ., 19, 7422E.

2. EFSA Scientific Committee, More, S.J., Bampidis, V., Benford, D., Bennekou, S.H., Bragard, C., Halldorsson, T.I., Hernández-Jerez, A.F., Koutsoumanis, K., and Naegeli, H. (2019). Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. EFSA J., 17, e05634.

3. EFSA Scientific Committee, More, S.J., Bampidis, V., Benford, D., Bragard, C., Hernandez-Jerez, A., Bennekou, S.H., Halldorsson, T.I., Koutsoumanis, K.P., and Lambré, C. (2021). Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. EFSA J., 19, e07033.

4. EC (European Commission) Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Establishing a European Chemicals Agency, Amending Directive 1999/45/EC and Repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, EC (European Commission). Article 3 of the REACH.

5. EC (European Commission) Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16December 2008 on Classification, Labelling and Packaging of Substances and Mixtures, Amending and Repealing Directives 67/548/EEC and 1999/45/EC, and Amending Regulation (EC) No. 1907/2006, EC (European Commission). Article 2 of the CLP.

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