Journal article

Publication year: 2018

Pages: 5008-

Journal: EFSA Journal

Volume number: 16

Issue number: 1

DOI Link: https://doi.org/10.2903/j.efsa.2018.5008

Publisher: Wiley

Abstract: 
The food enzyme considered in this opinion is an endo-1,4-beta-xylanase (EC 3.2.1.8) produced with a genetically modified Bacillussubtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-beta-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panelconsidered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Harvard Citation style: Silano, V., Bolognesi, C., Castle, L., Chipman, K., Cravedi, J., Fowler, P., et al. (2018) Safety evaluation of the food enzyme xylanase from a genetically modified Bacillussubtilis strain TD160(229), EFSA Journal, 16(1), p. 5008. https://doi.org/10.2903/j.efsa.2018.5008

APA Citation style: Silano, V., Bolognesi, C., Castle, L., Chipman, K., Cravedi, J., Fowler, P., Franz, R., Grob, K., Gürtler, R., Husøy, T., Kärenlampi, S., Mennes, W., Milana, M., Pfaff, K., Riviere, G., Srinivasan, J., de Fatima, M., Pocas, T., Tlustos, C., ...Engel, K. (2018). Safety evaluation of the food enzyme xylanase from a genetically modified Bacillussubtilis strain TD160(229). EFSA Journal. 16(1), 5008. https://doi.org/10.2903/j.efsa.2018.5008