Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

food enzyme, xylanase, endo-1, 4-b-xylanase, EC, 1,4-b-D-xylan xylanohydrolase,Aspergillus oryzae, genetically modified microorganism
First published in the EFSA Journal
16 November 2018
23 October 2018
Scientific Opinion


The food enzyme is an endo‐1,4‐β‐xylanase (EC produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.027 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Beat Johannes Brüschweiler, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Riviere, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk van Loveren, Laurence Vernis and Holger Zorn
Panel on Food Contact Materials, Enzymes and Processing Aids
fip [at]
EFSA Journal 2018;16(11):5480
Question Number
On request from
European Commission
The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.