Open AccessSafety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Kluyveromyces lactis strain AE‐KL
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,
Herman Lieve,
Kovalkovičová Natália,
Liu Yi,
Piazza Giulio,
Ferreira de Sousa Rita,
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.2022.7571
Subject(s) - kluyveromyces lactis , food science , lactose , food safety , enzyme , strain (injury) , enzyme assay , biology , microbiology and biotechnology , chemistry , biochemistry , gene , saccharomyces cerevisiae , anatomy
The food enzyme β‐galactosidase (β‐ d ‐galactoside galatohydrolase, EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain AE‐KL by Amano Enzyme Inc. As the production strain meets the requirements for a Qualified Presumption of Safety (QPS) approach to safety assessment and as no other issues of concern were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used for lactose hydrolysis in milk processing (including infant formulae), production of fermented milk products and manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 7.933 mg TOS/kg body weight (bw) per day in European populations. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.