Summarized data of genotoxicity tests for designated food additives in Japan.

The Ministry of Health, Labour and Welfare has carried out genotoxicity tests for food additives used in Japan in cooperation with the Japan Food Additives Association since 1979. Hayashi et al. summarized these data and published a list of 337 designated additives (Shitei-tenkabutsu in Japanese) with genotoxicity test data in 2000. Thereafter, 29 items were eliminated, and 146 items were newly added. Currently, 454 designated additives are allowed to be used as food additives in Japan. This report, based on the Hayashi report, covers the addition of newly derived genotoxicity test data. Routinely, the bacterial reverse mutation test (Ames test), mammalian cell chromosomal aberration test, and in vivo rodent bone marrow micronucleus test have been used for the evaluation of genotoxicity of food additives. In addition to the data from these tests being updated in this report, it newly includes results of transgenic rodent somatic and germ cell gene mutation assays (TGR assays), incorporated in the Organisation for Economic Co-operation and Development (OECD) test guidelines after 2000. We re-evaluated the genotoxicity of 13 designated food additives considering their TGR data.