Open AccessSafety evaluation of the food enzyme α‐amylase from a genetically modified Bacillus licheniformis (strain NZYM ‐ AV )
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,
AguileraGómez Margarita,
Kovalkovicová Natália,
Maia Joaquim,
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.2018.5318
Subject(s) - food science , genotoxicity , bacillus licheniformis , amylase , food safety , animal feed , microbiology and biotechnology , food additive , chemistry , strain (injury) , enzyme , toxicity , biology , toxicology , biochemistry , bacteria , bacillus subtilis , genetics , anatomy , organic chemistry
The food enzyme is an α‐amylase (4‐α‐ d ‐glucan glucanohydrolase; EC 3.2.1.1) produced with the genetically modified Bacillus licheniformis strain NZYM ‐ AV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production microorganism or its 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 did not raise a safety concern. The subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel derived a no observed adverse effect level ( NOAEL ) at the highest dose level of 796 mg TOS /kg body weight (bw) per day. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure 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 toxicological and genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.