MOEshort forMargin of Exposure - Margin of Exposure

The ratio of a suitable reference value from the dose-response relationship relative to the estimated exposure to the substance in humans. The benchmark dose lower confidence limit 10 % (BMDL10) or the tumour dose 25 % (TD25short forTumor Dose) is usually used as the reference value, i. e. a dose of a substance that is associated e.g. with a certain increase in tumour rates. An MOEshort forMargin of Exposure value is not a health-based guidance value: rather, it serves to prioritise the urgency of risk management measures for substances for which, based on current scientific knowledge, no safe intake value can be derived (in particular, for example, for genotoxic carcinogens). Risk management autho- rities consider an MOEshort forMargin of Exposure of 10,000 or higher, if derived from a BMDL10 from an animal carcinogenicity study, to be of low concern in terms of public health. Consequently, these substances are assigned a low priority for risk management measures. From a toxicological  point of view and considering the total intake amount, an MOEshort forMargin of Exposure of 10,000 or higher is is to be assessed as ‘of low concern’ with regard to possible tumour diseases, but should not be equated with ‘harmless’.