ABSTRACT
Human afflictions that may be caused directly or indirectly by mutagenic substances are carcinogenesis as well as teratogenesis, impaired reproduction, and heritable genetic toxicity. For food additives or food-related substances, the regulatory control should be more strict than for medical drugs or industrial chemicals. In Japan, a guideline for food additives was prepared in 1975 by experts in genetic toxicology. The prevailing idea on the carcinogenicity or genetic toxicity of a chemical was that there would be no threshold for the effect and that even a small intake of these chemicals would cause adverse effects in man. The strategy to combine two test systems with different genetic endpoints, gene mutation, and chromosomal damage is also recommended in the OECD guideline for genetic toxicology. The OECD Expert Committee has prepared guidelines for 15 different assays based on genetic toxicity and has classified the assays according to their utility and application.
