Safety evaluation of the food enzyme subtilisin from the genetically modified Bacillus subtilis strain DP-Ezx62.

The food enzyme subtilisin (EC 3.4.21.62) is produced with the genetically modified Bacillus subtilis strain DP-Ezx62 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene, and consequently, it does not fulfil the requirements for the qualified presumption of safety (QPS) 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 three food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.060 mg TOS/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the subtilisin to known allergens was made and matches with 2 food, 19 respiratory and 3 contact allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.