Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-KCGT

Abstract

The food enzyme cyclomaltodextrin glucanotransferase ((1–4)-α-d-glucan 4-α-d-[(1–4)- α-d-glucano]-transferase; EC 2.4.1.19) is produced with the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-KCGT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in two food manufacturing processes. The dietary exposure was estimated to be up to 20.27 mg total organic solids (TOS)/kg bw per day in European populations. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2246 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure (MoE) of at least 141 for infants, 111 for toddlers, 154 for children, 362 for adolescents, 508 for adults and 713 for the elderly. A search for the homology of the amino acid sequence of the cyclomaltodextrin glucanotransferase to known allergens was made and matches with three respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use for adolescents, adults and the elderly. The MoE is insufficient to exclude safety concerns for infants, toddlers and children.