Journal article

Publication year: 2021

Pages: e06432-

Journal: EFSA Journal

Volume number: 19

Issue number: 4

DOI Link: https://doi.org/10.2903/j.efsa.2021.6432

Publisher: Wiley

Abstract: 

The food enzyme isomaltulose synthase (sucrose glucosylmutase; EC 5.4.99.11) is produced with Serratia plymuthica strain Z12A by BENEO-Palatinit GmbH. The food enzyme is used only in the formof an immobilised preparation of non-viable cells for the production of isomaltulose. Residual amountsof total organic solids (TOS) are removed by the purification steps applied during the production ofisomaltulose consequently, dietary exposure was not calculated. Genotoxicity tests did not indicatesafety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicitystudy in rats. The Panel identified a no observed adverse effect level of 1,011 mg TOS/kg body weight(bw) per day, the highest dose tested. Similarity of the amino acid sequence of the enzyme to those of known allergens was searched and no match was found. The Panel considered that, under theintended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposurecannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the use of an immobilised food enzyme and the removal of TOS during the production of isomaltulose the Panel concluded that this food enzyme preparation does not give rise to safety concerns under the intended conditions of use.

Harvard Citation style: Silano, V., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., Gott, D., et al. (2021) Safety evaluation of the food enzyme preparation isomaltulose synthase from Serratia plymuthicastrain Z12A, EFSA Journal, 19(4), p. e06432. https://doi.org/10.2903/j.efsa.2021.6432

APA Citation style: Silano, V., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., Gott, D., Grob, K., Manbré, C., Lampi, E., Mengelers, M., Mortensen, A., Rivière, G., Steffensen, I., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Herman, L., Aguilera, J., ...Chesson, A. (2021). Safety evaluation of the food enzyme preparation isomaltulose synthase from Serratia plymuthicastrain Z12A. EFSA Journal. 19(4), e06432. https://doi.org/10.2903/j.efsa.2021.6432