Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain UN-01 - Research portal of Justus Liebig University Giessen:

Journal article

Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain UN-01

Authors list: EFSA FEZ Panel; Zorn, Holger; Barat Baviera, Jose Manuel; Bolognesi, Claudia; Catania, Francesco; Gadermaier, Gabriele; Greiner, Ralf; Mayo, Baltasar; Mortensen, Alicja; Roos, Yrjoe Henrik; Solano, Marize L. M.; Sramkova, Monika; Van Loveren, Henk; Vernis, Laurence; Sanmartin, Laura; Aguilera, Jaime; Andryszkiewicz, Magdalena; Apergi, Kyriaki; Peluso, Silvia; di Piazza, Giulio; Liu, Yi

Publication year: 2024

Journal: EFSA Journal

Volume number: 22

Issue number: 11

eISSN: 1831-4732

DOI Link: https://doi.org/10.2903/j.efsa.2024.9081

Publisher: Wiley

Abstract:
The food enzyme alpha-amylase (4-alpha-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain UN-01 by Nagase (Europa) GmbH. The production strain qualified for the qualified presumption of safety approach and no issues of concern arose from the production process of the food enzyme, therefore, the Panel considered that toxicological studies were unnecessary. It is intended to be used in five food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.434 mg TOS/kg body weight per day in European populations. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. Known sources of food allergens were used in the food enzyme manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. 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.

Authors/Editors

- Uni.-Prof. Dr. Holger Zorn

Citation Styles

Harvard Citation style: EFSA FEZ Panel, Zorn, H., Barat Baviera, J., Bolognesi, C., Catania, F., Gadermaier, G., et al. (2024) Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain UN-01, EFSA Journal, 22(11), Article e9081. https://doi.org/10.2903/j.efsa.2024.9081

APA Citation style: EFSA FEZ Panel, Zorn, H., Barat Baviera, J., Bolognesi, C., Catania, F., Gadermaier, G., Greiner, R., Mayo, B., Mortensen, A., Roos, Y., Solano, M., Sramkova, M., Van Loveren, H., Vernis, L., Sanmartin, L., Aguilera, J., Andryszkiewicz, M., Apergi, K., Peluso, S., ...Liu, Y. (2024). Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus amyloliquefaciens strain UN-01. EFSA Journal. 22(11), Article e9081. https://doi.org/10.2903/j.efsa.2024.9081