Safety evaluation of the food enzyme pullulanase from a genetically modified Bacillus licheniformis (strain DP‐Dzp39)

food enzyme,a-amylase, 1,4-a-D-glucan glucanohydrolase, EC, Bacillus licheniformis,DP-Dzb54, genetically modified microorganism
First published in the EFSA Journal
10 janvier 2019
4 décembre 2018
Scientific Opinion


The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC is produced with the genetically modified Bacillus licheniformis strain DP‐Dzb54 by Danisco. The α‐amylase is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated. The parental strain meets all the requirements for the Qualified Presumption of Safety approach for risk assessment, except the absence of acquired antimicrobial resistance genes. However, this has no practical consequence for the food enzyme as it has been shown not to contain viable cells and DNA from the production strain. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. 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, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur 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.

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
fip [at]
EFSA Journal 2019;17(1):5549
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.