Open AccessSafety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐SB)
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,
Želježić 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.2018.5320
Subject(s) - food science , aspergillus niger , amylase , animal feed , genetically modified organism , food safety , toxicity , enzyme , chemistry , food additive , no observed adverse effect level , biology , microbiology and biotechnology , toxicology , biochemistry , gene , organic chemistry
The food enzyme is an α‐amylase (4‐α‐ d ‐glucan glucanohydrolase; EC 3.2.1.1), produced with the genetically modified Aspergillus niger strain NZYM‐SB by Novozymes A/S. The food enzyme does not contain the production organism or its DNA; therefore, there is no safety concern for the environment. The α‐amylase is intended for use in starch processing, beverage alcohol (distilling) processes and baking processes. 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 for these two uses. Based on the maximum use levels recommended for the baking processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–TOS was estimated to be up to 3.075 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria or micronuclei in human lymphocytes. 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 that, compared with the dietary exposure, resulted in a sufficiently high margin of exposure (MOE). Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the findings in the toxicological and genotoxicity studies, as well as the estimated dietary exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.