strain NZYM-FX by Novozymes A/S. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in two food manufacturing processes. Since residual amounts of food enzyme-total organic solids are removed in both processes, dietary exposure was not calculated. Given the QPS status of the production strain, in the absence of concerns resulting from the food enzyme manufacturing process and taking into account the negligible dietary exposure under the intended uses, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme 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.
(FEZ) et al. (Fri,) studied this question.
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