Open AccessSafety evaluation of the food enzyme α‐amylase from a genetically modified strain of Bacillus licheniformis ( DP ‐Dzb54)
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,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Herman Lieve,
Aguilera Jaime,
Andryszkiewicz Magdalena,
Diveki Zoltán,
Chesson Andrew
Publication year - 2019
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.2019.5549
Subject(s) - bacillus licheniformis , food science , food safety , amylase , genetically modified organism , enzyme , strain (injury) , microbiology and biotechnology , starch , biology , chemistry , biochemistry , gene , bacteria , genetics , bacillus subtilis , anatomy
The food enzyme α‐amylase (4‐α‐ d ‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP ‐Dzb54 by Danisco. The α‐amylase is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated. The parental strain meets all the requirements for the Qualified Presumption of Safety approach for risk assessment, except the absence of acquired antimicrobial resistance genes. However, this has no practical consequence for the food enzyme as it has been shown not to contain viable cells and DNA from the production strain. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.