Journal article

Publication year: 2019

Pages: 5549-

Journal: EFSA Journal

Volume number: 17

Issue number: 1

DOI Link: https://doi.org/10.2903/j.efsa.2019.5549

Publisher: Wiley

Abstract: 
The food enzyme -amylase (4--d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP-Dzb54 by Danisco. The -amylase is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated. The parental strain meets all the requirements for the Qualified Presumption of Safety approach for risk assessment, except the absence of acquired antimicrobial resistance genes. However, this has no practical consequence for the food enzyme as it has been shown not to contain viable cells and DNA from the production strain. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panelconsiders that toxicological tests are not needed for the assessment of this food enzyme. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panelconsidered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. Based on the data provided, the Panelconcluded that this food enzyme does not give rise to 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 -amylase from a genetically modified strain of Bacilluslicheniformis (DP-Dzb54), EFSA Journal, 17(1), p. 5549. https://doi.org/10.2903/j.efsa.2019.5549

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., Aguilera, J., Andryszkiewicz, M., ...Chesson, A. (2019). Safety evaluation of the food enzyme -amylase from a genetically modified strain of Bacilluslicheniformis (DP-Dzb54). EFSA Journal. 17(1), 5549. https://doi.org/10.2903/j.efsa.2019.5549