Safety evaluation of the food enzyme AMP deaminase from the genetically modified Bacillus subtilis strain CCTCC M 2023264

Abstract The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the genetically modified Bacillus subtilis strain CCTCC M 2023264 by Angel Yeast Co., Ltd. The production strain of the food enzyme contains multiple copies of three acquired antimicrobial resistance genes, therefore it does not fulfil the requirements of the qualified presumption of safety approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. The food enzyme is intended to be used in the processing of yeast and yeast products. Dietary exposure was estimated to be up to 0.006 mg total organic solids/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the AMP deaminase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that 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.