Safety evaluation of the food enzyme endo-1,4-β-xylanase from the non-genetically modified strain LYX.

The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the non-genetically modified microorganism strain LYX by DSM Food Specialties B.V. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in baking processes and cereal-based processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.106 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 227 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2,142. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but 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.