Rationales for the establishment of limits and regulations for mycotoxins

Abstract

Although 50 countries have enacted or proposed regulations for control of aflatoxins in food or feed, and 15 of these countries also have regulations for permitted levels of contamination by other mycotoxins, very few countries have formally presented the rationale for the need to regulate, or for the selection of a particular maximum tolerated level. After several successive inquiries, information concerning the rationale for regulation was obtained from 21 countries. Most of the responses concerned limits for aflatoxin in food, and most of these were based on a vague, unsupported statement 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; the definition of practicality depended on whether the country was an importer or producer of the potentially contaminated commodity. A claim to a hazard evaluation was made by six countries (Canada, Belgium, India, United Kingdom, United States, Switzerland) without providing specifics; and one country, South Africa, referred to a risk determination. The most comprehensive rationale for any mycotoxin regulation was provided by the United States in support of limits for aflatoxin in specific animal feedstuffs. The responses provided no rationale for setting limits for other mycotoxins; but scholarly risk assessments for zearalenone and ochratoxin A have been published by Canadian government scientists, and a symposium presentation provides the information that in Norway patulin is regulated for quality control purposes only. It is apparent that, in most countries, either the scientific basis for regulation of mycotoxins is nonexistent, or the science has not been fully utilized. For a common approach to the control of mycotoxin hazards, access to the best available scientific data, and agreement on its interpretation, now appear to be the most important initial steps.