Journalartikel

Autorenliste: EFSA CEP Panel; 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, Inger-Lise; Tlustos, Christina; Van Loveren, Henk; Vernis, Laurence; Zorn, Holger; Herman, Lieve; Roos, Yrjö; Andryszkiewicz, Magdalena; Cavanna, Daniele; Lunardi, Simone; Marini, Eleonora; Pesce, Francesco; Chesson, Andrew

Jahr der Veröffentlichung: 2024

Zeitschrift: EFSA Journal

Bandnummer: 22

Heftnummer: 2

eISSN: 1831-4732

DOI Link: https://doi.org/10.2903/j.efsa.2024.8615

Verlag: Wiley

Abstract: 
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain NZYM-NB by Novozymes A/S. The production strain meets the requirements for qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in eleven food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was estimated only for the remaining nine food manufacturing processes. Exposure was estimated to be up to 1.327 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arising from the production process of the food enzyme was identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is 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.

Harvard-Zitierstil: EFSA CEP Panel, Lambré, C., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., et al. (2024) Safety evaluation of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain NZYM-NB, EFSA Journal, 22(2), Article e8615. https://doi.org/10.2903/j.efsa.2024.8615

APA-Zitierstil: EFSA CEP Panel, Lambré, C., Barat 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., Herman, L., Roos, Y., ...Chesson, A. (2024). Safety evaluation of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain NZYM-NB. EFSA Journal. 22(2), Article e8615. https://doi.org/10.2903/j.efsa.2024.8615