Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

food enzyme, glucoamylase, glucan 1,4-a-glucosidase, EC 3.2.1.3,Aspergillus niger,genetically modified microorganism
First published in the EFSA Journal
31 October 2018
Adopted
26 September 2018
Type
Scientific Opinion

Abstract

The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW 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. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level at the highest dose of 1,244 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions occurring is considered to be low. Based on the data provided and the removal of TOS during the intended food production processes, 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, Holger Zorn.
Panel on Food Contact Materials, Enzymes and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5446
EFSA Journal 2018;16(10):5446
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 decision on confidentiality will be received from the European Commission.