Application of the Margin of Exposure Approach to Compounds in Food Which Are Both Genotoxic and Carcinogenic


ILSI Europe Report Series. 2009:1-36

The margin of exposure (MOE) approach for advising risk managers on potential health concerns arising from the presence of genotoxic carcinogens in foods has been discussed by several international expert groups. The ILSI Europe Task Force on Risk Assessment of Genotoxic Carcinogens in Food set up an expert group to work through the elaboration of MOEs for different chemicals detected in foods, covering ranges of carcinogenic potencies and using data on carcinogenicity and exposure that was of variable quantity and quality. The aim was to develop a better understanding of the MOE approach and how MOEs might be interpreted.

A workshop was organised, attended by participants from academia, national and EU regulatory/advisory authorities and from the food industry, to discuss the outcomes of this work. Members of the expert group presented their results and the critical issues identified during the analysis of 12 case studies. Participants discussed various technical issues with specific reference to the choice of cancer data, the mechanism of action, mathematical modelling and the selection of reference points, and exposure considerations.

The value, interpretation and communication of the MOE approach was also discussed.

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