Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

food enzyme, xylanase, endo‐1,4‐β‐xylanase, 1,4‐β‐d‐xylan xylanohydrolase, EC, Bacillus pumilus, non‐genetically modified microorganism
First published in the EFSA Journal
20 novembre 2019
24 ottobre 2019
Scientific Opinion

Note: 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.


The food enzyme 1,4‐β‐d‐xylan xylanohydrolase (EC is produced with the non‐genetically modified strain Bacillus pumilus (strain BLXSC) by Advanced Enzyme Technologies Ltd. The food enzyme is intended to be used in baking processes, grain treatment for the production of starch and gluten fractions, and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for baking processes. Based on the maximum recommended use levels for baking processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight (bw) per day. As the production strain of B. pumilus meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. 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 (other than distilled alcohol production), the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but is considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Alicja Mortensen, Gilles Rivière, 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 2019;17(11):5901
Question Number
On request from
European Commission