Open AccessSafety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)
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,
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.2018.5170
Subject(s) - genotoxicity , bacillus subtilis , food science , food safety , no observed adverse effect level , food additive , enzyme , strain (injury) , toxicology , biology , exposure assessment , microbiology and biotechnology , chemistry , toxicity , biochemistry , medicine , environmental health , genetics , bacteria , organic chemistry , anatomy
The food enzyme considered in this opinion is aqualysin 1 (EC 3.4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aqualysin 1 is intended to be used in baking processes. Based on the maximum use level recommended 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 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (NOAEL) determined from the repeated dose 90‐day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.