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Safety evaluation of a food enzyme with glucan 1,4‐α‐glucosidase and α‐amylase activities from the genetically modified Aspergillus niger strain NZYM‐BX

on the Wiley Online Library


Panel members at the time of adoption

Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.

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 with glucan 1,4‐α‐glucosidase (EC and α‐amylase (EC activities is produced with the genetically modified strain of Aspergillus niger NZYM‐BX 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 its DNA. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The repeated dose 90‐day oral toxicity study in rats made with a substitute enzyme was not considered suitable. However, since no exposure was expected from the intended uses, this study was not considered necessary. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and two matches were 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 is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.