Application of the Margin of Exposure (MOE) approach to substances in food that are genotoxic and carcinogenic.


This paper presents the work of an expert group established by the International Life Sciences Institute - European branch (ILSI Europe) to follow up the recommendations of an international conference on "Risk Assessment of Compounds that are both Genotoxic and Carcinogenic: New Approaches". Twelve genotoxic and carcinogenic chemicals that can be present in food were selected for calculation of a Margin of Exposure (MOE) between a point of departure on the dose-response for oral carcinogenicity in animal studies and estimates of human dietary exposure. The MOE can be used to support prioritisation of risk management action and, if the MOE is very large, on communication of a low level of human health concern. Depending on the approaches taken in determining the point of departure and the estimation of exposure, it is possible to derive very different values for the MOE. It is therefore essential that the selection of the cancer endpoint and mathematical treatment of the data are clearly described and justified if the results of the MOE approach are to be trusted and of value to risk managers. An outline framework for calculating an MOE is proposed in order to help to ensure transparency in the results.

DOI: 10.1016/j.fct.2009.11.003

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@article{Benford2010ApplicationOT, title={Application of the Margin of Exposure (MOE) approach to substances in food that are genotoxic and carcinogenic.}, author={Diane J. Benford and Philip Michael Bolger and Philip Carthew and Myriam Coulet and Michael J Dinovi and Jean-charles Leblanc and Andrew G. Renwick and Woodrow R Setzer and Josef Rudolf Schlatter and Benjamin P. Smith and Wout Slob and Gary M Williams and Tanja Wildemann}, journal={Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association}, year={2010}, volume={48 Suppl 1}, pages={S2-24} }