Rationale for regulatory programmes for mycotoxins in human foods and animal feeds

Currently, more than 50 countries have enacted or proposed regulations for mycotoxins in food and feed. There are various factors that may influence the establishment of tolerances for certain mycotoxins, such as the availability of toxicological data, the availability of data on dietary exposure, the distribution of mycotoxins over commodities, legislation of other countries with which trade contacts exist, and the availability of methods of analysis. In practice, only few countries have formally presented the rationale for the need to regulate, or for the selection of a particular maximum tolerated level, as a recent international enquiry demonstrated. Most of the limits for aflatoxins in food were based on rather vague statements of the carcinogenic risk for humans. There was a general consensus that exposure to a potential human carcinogen that could not be totally avoided should be limited to the lowest practical level. Several countries made a claim to a hazard evaluation (Belgium, Canada, India, The Netherlands, Switzerland, South Africa, United Kingdom, United States), although specifics were rather scarce. No rationales for setting limits for other mycotoxins were provided, except for Canada, where risk assessment was done for deoxynivalenol, zearalenone and ochratoxin A. It is apparent that in most countries either the scientific basis for regulation of mycotoxins is non-existent, or the science has not been fully utilized.