Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SM)

. Efsa Panel On Food Contact Materials, Enzymes, Flavourings And Processing Aids (cef) (1) , Vittorio Silano , Claudia Bolognesi , Laurence Castle , Kevin Chipman , Jean Pierre J. P. Cravedi (2) , 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 , Henk van Loveren , Margarita Aguilera‐gomez , Magdalena Andryszkiewicz , Davide Arcella , Natalia Kovalkovicova , Yi Liu , Karl‐heinz Engel

1 EFSA - European Food Safety Authority
2 ToxAlim - ToxAlim

The food enzyme considered is a maltogenic amylase (glucan 1,4-beta-maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the 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 0.168 mg T'OS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), 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. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM-SM does not give rise to safety concerns under the intended conditions of use.

Mots clés: food enzyme; glucan 1; 4-alpha-maltohydroiase; maltogenic amylase; genetically modified microorganism

Mots clés: Bacillus subtilis

Domaines: Alimentation et Nutrition; Ingénierie des aliments

. Efsa Panel On Food Contact Materials, Enzymes, Flavourings And Processing Aids (cef), Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, et al.. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SM). EFSA Journal, 2018, 16 (5), 21 p. ⟨10.2903/j.efsa.2018.5171⟩. ⟨hal-02624532⟩