Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus subtilis strain Glu3-3.

The food enzyme glutaminase (l-glutamine amidohydrolase; EC 3.5.1.2) is produced with the genetically modified Bacillus subtilis strain Glu3-3 by Angel Yeast Co., Ltd. The production strain of the food enzyme contains multiple copies of acquired antimicrobial resistance genes. The food enzyme was considered free of viable cells of the production strain, but the absence of DNA was not demonstrated. As no other concerns arising from the microbial source 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 seven food manufacturing processes. Dietary exposure was estimated to be up to 29.311 mg total organic solids/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the glutaminase 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. Because the absence of DNA from the production organism in the food enzyme was not demonstrated, the Panel could not conclude on the safety of the food enzyme.