Safety evaluation of an extension of use 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. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns for adolescents, adults and the elderly in two food manufacturing processes. Subsequently, the applicant requested to extend its use to include four additional processes and revised the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. Dietary exposure was calculated to be up to 0.025 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (2246 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 89,840. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.