Safety evaluation of the food enzyme α‐amylase from the genetically modified Pseudomonas fluorescens strain BD15754

food enzyme, α‐amylase, 1,4‐a‐d‐glucan glucanohydrolase, EC, Pseudomonas fluorescens, genetically modified microorganism
First published in the EFSA Journal
5 mars 2020
4 février 2020
Scientific Opinion

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 α‐amylase (4‐a‐d‐glucan glucanohydrolase; EC is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α‐amylase 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, 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 rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 887 mg TOS/kg body weight (bw) per day. 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 of such reactions to occur is considered to be low. However, the food enzyme contains residual amounts of a highly important antimicrobial for human medicine, with the consequent risk of promoting the development of resistance. Therefore, the Panel concludes that the food enzyme α‐amylase, produced with the genetically modified P. fluorescens strain BD15754 cannot be considered safe.

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 and Holger Zorn.
Panel on Food Contact Materials, Enzymes and Processing Aids
fip [at]
EFSA Journal 2020;18(3):6043
Question Number
On request from
European Commission