Journal article

Authors list: 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; Apergi, Kyriaki; Kovalkovičová, Natália; Liu, Yi; Lunardi, Simone; di Piazza, Giulio; Chesson, Andrew

Publication year: 2024

Journal: EFSA Journal

Volume number: 22

Issue number: 2

eISSN: 1831-4732

DOI Link: https://doi.org/10.2903/j.efsa.2024.8612

Publisher: Wiley

Abstract: 
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain DP-Cyb74 by Genencor International B.V. The production strain met all requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.536 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, 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, 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 Citation style: 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 DP-Cyb74, EFSA Journal, 22(2), Article e8612. https://doi.org/10.2903/j.efsa.2024.8612

APA Citation style: 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 DP-Cyb74. EFSA Journal. 22(2), Article e8612. https://doi.org/10.2903/j.efsa.2024.8612