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

PET direct IV+, BTB, food contact materials, plastic, poly(ethylene terephthalate) (PET), recycling process, safety assessment
First published in the EFSA Journal
27 April 2018
8 March 2018
Scientific Opinion


The food enzyme is an endo‐1,4‐β‐xylanase (EC produced with a genetically modified strain of ;Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90‐day oral toxicity study in rodents, carried out with this endo‐1,4‐β‐xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo‐1,4‐β‐xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Panel members at the time of adoption

Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean‐Pierre Cravedi, Karl‐Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Vittorio Silano, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at]
EFSA Journal 2018;16(4):5228
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