Safety evaluation of an extension of use of the food enzyme β-galactosidase from the genetically modified Aspergillus niger strain TOL

Abstract

The food enzyme β-galactosidase (β-d-galactoside galactohydrolase, EC 3.2.1.23) is produced with the genetically modified Aspergillus niger strain TOL by DSM Food Specialties B.V. 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 when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include two additional processes. In the present assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. The dietary exposure was calculated to be up to 3.144 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 330. Based on 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.