Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase and β‐glucanase from Disporotrichum dimorphosporum strain DXL
Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.
The food enzyme with xylanases (4‐β‐d‐xylan xylanohydrolase, EC 126.96.36.199) and glucanases active against β‐1,4 linkages is produced with the non‐genetically modified fungus Disporotrichum dimorphosporum strain DXL by DSM Food Specialities B.V. The food enzyme is intended to be used in brewing processes. Based on the maximum use level and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise 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 (NOAEL) at the highest dose of 199 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a high Margin of Exposure of at least 1,100. Similarity of amino acid sequences of the identified xylanases and β‐glucanases to those of known allergens was searched. No matches were found for two endo‐1,4‐β‐glucanases and two endo‐1,4‐β‐xylanases. However, for a third endo‐β‐1,4‐glucanase the search resulted in matches with three mite protein sequences. While incidental cases of allergic reactions to endo‐1,4‐β‐xylanases and β‐glucanases have been reported after inhalation in respiratory sensitised individuals in the workplace, no allergic reactions to xylanases or β‐glucanases have been reported in the literature after oral exposure. The Panel considered that, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.