Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus niger (strain XEA)

• Published in: EFSA journal 2018-04, Vol.16 (4), p.e05228-n/a
• Main Authors: Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean‐Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, van Loveren, Henk, Želježić, Davor, Aguilera‐Gómez, Margarita, Arcella, Davide, Kovalkovičová, Natália, Maia, Joaquim, Liu, Yi, Engel, Karl‐Heinz
• Format: Article
• Language: English
• Subjects: 4‐β‐xylanase; Additives; Allergenicity; Allergens; Amino acid sequence; Amino acids; Aspergillus niger; Aspergillus niger; Baking; Body weight; Brewing; EC 3.2.1.8; endo‐1; Enzymes; Evaluation; Exposure; Food; Food additives; Food allergies; Food and Nutrition; Food consumption; Food engineering; food enzyme; Food processing; Food safety; Genetic modification; genetically modified microorganism; Genotoxicity; Life Sciences; Manufacturing; Manufacturing industry; Microorganisms; Organic solids; Safety; Scientific Opinion; Toxicity; Toxicity testing; Xylanase
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2018.5228

The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90‐day oral toxicity study in rodents, carried out with this endo‐1,4‐β‐xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo‐1,4‐β‐xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.