Journal article

Publication year: 2021

Pages: e06562-

Journal: EFSA Journal

Volume number: 19

Issue number: 4

DOI Link: https://doi.org/10.2903/j.efsa.2021.6562

Publisher: Wiley

Abstract: 

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus subtilis strain DP‐Ezd31 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a safety concern. The production strain was not shown to meet the criteria for Qualified Presumption of Safety (QPS) approach to safety assessment. The substitute studies provided were not considered suitable for the toxicological assessment of this food enzyme. A search for similarity of the amino acid sequence to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. In the absence of suitable toxicological studies, the Panel cannot conclude on the safety of the food enzyme.

Harvard Citation style: Lambré, C., Barat Baviera, J., Bolognesi, C., Cocconcelli, P., Crebelli, R., Gott, D., et al. (2021) Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain DP‐Ezd31 , EFSA Journal, 19(4), p. e06562. https://doi.org/10.2903/j.efsa.2021.6562

APA Citation style: 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., Andryszkiewicz, M., Bernascoi, G., Gomes, A., ...Chesson, A. (2021). Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Bacillus subtilis strain DP‐Ezd31 . EFSA Journal. 19(4), e06562. https://doi.org/10.2903/j.efsa.2021.6562