Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229)

Vittorio Silano , Claudia Bolognesi , Laurence Castle , Kevin Chipman , Jean Pierre J. P. Cravedi (1) , Paul Fowler , Roland Franz , Konrad Grob , Rainer Gürtler , Trine Husøy , Sirpa Kärenlampi , Wim Mennes , Maria Rosaria Milana , Karla Pfaff , Gilles Rivière , Jannavi Srinivasan , Maria de Fátima Tavares Poças , Christina Tlustos , Detlef Wölfle , Holger Zorn , Andrew Chesson , Boet Glandorf , Lieve Herman , Klaus‐dieter Jany , Francesca Marcon , Andre Penninks , Andrew Smith , Margarita Aguilera‐gomez , Magdalena Andryszkiewicz , Davide Arcella , Natalia Kovalkovicova , Yi Liu , Joaquim Maia , Karl‐heinz Engel

1 ToxAlim - ToxAlim

The food enzyme considered in this opinion is an endo-1,4-beta-xylanase (EC 3.2.1.8) produced with a genetically modified Bacillussubtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-beta-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panelconsidered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use.

Mots clés: food enzyme; xylanase-endo-1; 4-beta-xylanase; 4-beta-D-xylan xylanohydrolase; genetically modified microorganism

Mots clés: Bacillus subtilis

Domaines: Alimentation et Nutrition; Ingénierie des aliments

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean Pierre J. P. Cravedi, et al.. Safety evaluation of the food enzyme xylanase from a genetically modified Bacillus subtilis strain TD160(229). EFSA Journal, 2018, 16 (1), 20 p. ⟨10.2903/j.efsa.2018.5008⟩. ⟨hal-02622032⟩