Updated safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Aspergillus niger strain XYL

Abstract

The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XYL by DSM Food specialties. An evaluation of this food enzyme was made previously, in which EFSA could not conclude on its safety due to data gaps in a genotoxicity test. Subsequently, the applicant provided new data. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.281 mg (total organic solids) 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 4095 mg TOS/kg bw per day for males and of 4457 mg TOS/kg bw per day for females, respectively, the highest doses tested. When compared with the estimated dietary exposure, it results in a margin of exposure of at least 14,573. 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 the likelihood is low. Based on the new data and the data provided previously, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.