Journal article

Publication year: 2019

Pages: 5554-

Journal: EFSA Journal

Volume number: 17

Issue number: 1

DOI Link: https://doi.org/10.2903/j.efsa.2019.5554

Publisher: Wiley

Abstract: 
The food enzyme pullulanase (pullulan 6--glucanohydrolase; EC 3.2.1.41) is produced with a genetically modified Bacilluslicheniformis (strain DP-Dzp39) by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. This pullulanase is intended to be used in brewing processes, starch processing for glucose syrups production and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated for these food processes. For brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 0.053mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not raise concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panelidentified a no-observed-adverse-effect level at the highest dose of 500mg TOS/kg bw per day that, compared to the estimated dietary exposure, results in sufficiently high margin of exposure (atleast 9,400). The amino acid sequence of the food enzyme did not match those of known allergens. The Panelconsidered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panelconcluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Harvard Citation style: Silano, V., Baviera, J., Bolognesi, C., Brüschweiler, B., Cocconcelli, P., Crebelli, R., et al. (2019) Safety evaluation of the food enzyme pullulanase from a genetically modified Bacilluslicheniformis (strain DP-Dzp39), EFSA Journal, 17(1), p. 5554. https://doi.org/10.2903/j.efsa.2019.5554

APA Citation style: Silano, V., Baviera, J., Bolognesi, C., Brüschweiler, B., Cocconcelli, P., Crebelli, R., Gott, D., Grob, K., Lampi, E., Mortensen, A., Riviere, G., Steffensen, I., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Herman, L., Kärenlampi, S., Marcon, F., ...Chesson, A. (2019). Safety evaluation of the food enzyme pullulanase from a genetically modified Bacilluslicheniformis (strain DP-Dzp39). EFSA Journal. 17(1), 5554. https://doi.org/10.2903/j.efsa.2019.5554