Open AccessSafety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM ‐ SM )
Author(s) -
Silano Vittorio,
Bolognesi Claudia,
Castle Laurence,
Chipman Kevin,
Cravedi JeanPierre,
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 KlausDieter,
Marcon Francesca,
Penninks André,
Smith Andrew,
van Loveren Henk,
Želježic Davor,
AguileraGómez Margarita,
Andryszkiewicz Magdalena,
Arcella Davide,
Kovalkovičová Natália,
Liu Yi,
Engel KarlHeinz
Publication year - 2018
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2018.5171
Subject(s) - food science , bacillus subtilis , amylase , biology , enzyme , animal feed , no observed adverse effect level , genetically modified organism , strain (injury) , toxicity , generally recognized as safe , food additive , enzyme assay , chemistry , bacteria , biochemistry , gene , genetics , organic chemistry , anatomy
The food enzyme considered is a maltogenic amylase (glucan 1,4‐α‐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 TOS /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.