Open AccessSafety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus licheniformis (strain NZYM ‐ AN )
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,
Aguilera Jaime,
Andryszkiewicz Magdalena,
Kovalkovicová Natália,
Rossi Annamaria,
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.2018.5317
Subject(s) - food science , genotoxicity , bacillus licheniformis , food safety , alpha amylase , genetically modified organism , enzyme , microbiology and biotechnology , amylase , generally recognized as safe , food additive , starch , chemistry , strain (injury) , biology , biochemistry , bacteria , bacillus subtilis , gene , toxicity , genetics , organic chemistry , anatomy
The food enzyme is an α‐amylase (4‐α‐ d ‐glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM ‐ AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA ; therefore, there is no safety concern for the environment. The α‐amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids ( TOS ) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.