Open AccessSafety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐AY
Author(s) -
Lambré Claude,
Barat Baviera José Manuel,
Bolognesi Claudia,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mengelers Marcel,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Glandorf Boet,
Aguilera Jaime,
Liu Yi,
Chesson Andrew
Publication year - 2022
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.2022.7467
Subject(s) - food science , food safety , amylase , microbiology and biotechnology , enzyme , bacillus licheniformis , starch , genetically modified organism , generally recognized as safe , food additive , chemistry , biochemistry , biology , gene , bacteria , genetics , bacillus subtilis
The food enzyme α‐amylase (4‐α‐ d ‐glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AY by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in starch processing for the production of glucose syrup and other starch hydrolysates, and distilled alcohol production. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure estimation was considered unnecessary. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. As no other concerns arising from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns under the intended conditions of use.