Journalartikel

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Kluyveromyces lactis strain KLA


AutorenlisteEFSA CEP Panel; Lambré, C; Baviera, JMB; Bolognesi, C; Cocconcelli, PS; Crebelli, R; Gott, DM; Grob, K; Lampi, E; Mengelers, M; Mortensen, A; Rivière, G; Steffensen, IL; Tlustos, C; Van Loveren, H; Vernis, L; Zorn, H; Aguilera, J; Andryszkiewicz, M; Cavanna, D; de Sousa, RF; Liu, Y; Di Piazza, G; Chesson, A

Jahr der Veröffentlichung2022

ZeitschriftEFSA Journal

Bandnummer20

Heftnummer10

eISSN1831-4732

DOI Linkhttps://doi.org/10.2903/j.efsa.2022.7575

VerlagWiley


Abstract
The food enzyme beta-galactosidase (beta-D-galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 11.876 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no concerns arising from its genetic modification or from the manufacturing process have been identified, the Panel considered 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 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 low. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.



Autoren/Herausgeber




Zitierstile

Harvard-ZitierstilEFSA CEP Panel, Lambré, C., Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., et al. (2022) Safety evaluation of the food enzyme β-galactosidase from the genetically modified Kluyveromyces lactis strain KLA, EFSA Journal, 20(10), Article e07575. https://doi.org/10.2903/j.efsa.2022.7575

APA-ZitierstilEFSA CEP Panel, Lambré, C., Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., Gott, D., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Rivière, G., Steffensen, I., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Aguilera, J., Andryszkiewicz, M., ...Chesson, A. (2022). Safety evaluation of the food enzyme β-galactosidase from the genetically modified Kluyveromyces lactis strain KLA. EFSA Journal. 20(10), Article e07575. https://doi.org/10.2903/j.efsa.2022.7575


Zuletzt aktualisiert 2025-21-05 um 16:49