Journalartikel

Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain NZYM-BC


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; Glandorf, B; Herman, L; Aguilera, J; Andryszkiewicz, M; Liu, Y; de Sousa, RF; Rainieri, S; Chesson, A

Jahr der Veröffentlichung2022

ZeitschriftEFSA Journal

Bandnummer20

Heftnummer7

eISSN1831-4732

DOI Linkhttps://doi.org/10.2903/j.efsa.2022.7370

VerlagWiley


Abstract
The food enzyme alpha-amylase (4-alpha-D-glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal-based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme-TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and one 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 was 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. (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 α-amylase from the genetically modified Bacillus licheniformis strain NZYM-BC, EFSA Journal, 20(7), Article e07370. https://doi.org/10.2903/j.efsa.2022.7370

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., Glandorf, B., Herman, L., ...Chesson, A. (2022). Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain NZYM-BC. EFSA Journal. 20(7), Article e07370. https://doi.org/10.2903/j.efsa.2022.7370


Zuletzt aktualisiert 2025-21-05 um 16:47