Safety evaluation of the food enzyme α‐amylase from Bacillus licheniformis (strain DP‐Dzb44)

food enzyme,a-amylase, 1, 4-a-D-glucan glucanohydrolase, EC 3.2.1.1, glycogenase,Bacillus licheniformis, genetically modified microorganism
First published in the EFSA Journal
14 June 2019
Adopted
22 May 2019
Type
Scientific Opinion

Abstract

The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzb44 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The α‐amylase is intended to be used in distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, toxicological studies were not considered necessary and no dietary exposure was calculated. 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 conditions of use, the risk of allergic sensitisation and elicitation reactions can be excluded. 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.

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 Rivière, 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.2019.5738
EFSA Journal 2019;17(6):5738
Question Number
On request from
European Commission
Disclaimer
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.