Journal article

Authors list: EFSA FEZ Panel; Zorn, Holger; Baviera, Jose Manuel Barat; Bolognesi, Claudia; Catania, Francesco; Gadermaier, Gabriele; Greiner, Ralf; Mayo, Baltasar; Mortensen, Alicja; Roos, Yrjo Henrik; Solano, Marize L. M.; Sramkova, Monika; Van Loveren, Henk; Vernis, Laurence; Chesson, Andrew; Herman, Lieve; Andryszkiewicz, Magdalena; Cavanna, Daniele; Gomes, Ana; Kovalkovicova, Natalia; de Nijs, Roos Anna; di Piazza, Giulio; Liu, Yi

Publication year: 2024

Journal: EFSA Journal

Volume number: 22

Issue number: 10

eISSN: 1831-4732

DOI Link: https://doi.org/10.2903/j.efsa.2024.9033

Publisher: Wiley

Abstract: 
The food enzyme endo-1,3(4)-beta-glucanase (3-(1-3;1-4)-beta-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Talaromyces versatilis strain PF8 by Erbsl & ouml;h Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was calculated to be up to 0.110 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2229 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure resulted in a margin of exposure of at least 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that the risk of allergic reactions upon 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 FEZ Panel, Zorn, H., Baviera, J., Bolognesi, C., Catania, F., Gadermaier, G., et al. (2024) Safety evaluation of the food enzyme endo-1,3(4)-β-glucanase from the non-genetically modified Talaromyces versatilis strain PF8, EFSA Journal, 22(10), Article e9033. https://doi.org/10.2903/j.efsa.2024.9033

APA Citation style: EFSA FEZ Panel, Zorn, H., 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., Chesson, A., Herman, L., Andryszkiewicz, M., Cavanna, D., Gomes, A., ...Liu, Y. (2024). Safety evaluation of the food enzyme endo-1,3(4)-β-glucanase from the non-genetically modified Talaromyces versatilis strain PF8. EFSA Journal. 22(10), Article e9033. https://doi.org/10.2903/j.efsa.2024.9033