Open AccessSafety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM ‐ BF )
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Brüschweiler Beat Johannes,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mortensen Alicja,
Riviere Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Jany KlausDieter,
Kärenlampi Sirpa,
Penninks André,
Želježic Davor,
AguileraGómez Margarita,
Andryszkiewicz Magdalena,
Arcella Davide,
Gomes Ana,
Kovalkovičová Natália,
Liu Yi,
Rossi Annamaria,
Engel KarlHeinz,
Chesson Andrew
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.2018.5450
Subject(s) - food science , aspergillus niger , brewing , genotoxicity , enzyme , animal feed , no observed adverse effect level , ingredient , toxicity , genetically modified organism , strain (injury) , starch , chemistry , food additive , microbiology and biotechnology , biology , biochemistry , fermentation , gene , anatomy , organic chemistry
The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA . This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic solids ( TOS ) are removed by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme– TOS was estimated to be below 3.627 mg TOS /kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no‐observed‐adverse‐effect level ( NOAEL ) at the highest dose of 1,360 mg TOS /kg bw per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. 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 of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.