Safety evaluation of the food enzyme α‐amylase from Bacillus amyloliquefaciens strain BANSC

food enzyme, α‐amylase, 4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1, 1,4‐α‐d‐glucan glucanohydrolase, Bacillus amyloliquefaciens, genetically modified microorganism
First published in the EFSA Journal
20 January 2020
Adopted
12 December 2019
Type
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.

Abstract

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified B. amyloliquefaciens strain BANSC by Advanced Enzyme Technologies Ltd. The α‐amylase is intended to be used in brewing and baking processes and in starch processing for glucose syrups production and other starch hydrolysates. Since residual amounts of the food enzyme are removed during the starch processing for glucose syrups production, it is excluded from the dietary exposure estimation. Based on the maximum recommended use levels for brewing and baking processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.468 mg TOS/kg body weight (bw) per day. The parental strain meets the required qualifications to be considered as a Qualified Presumption of Safety (QPS) organism and is therefore presumed to be safe. The conclusions on safety of the food enzyme are made following the QPS approach in relation to the production strain, with additional consideration of the conditions of manufacture. Consequently, the Panel considers no toxicological studies other than assessment of allergenicity necessary. 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 upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the QPS status of the production strain and 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, 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
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.5976
EFSA Journal 2020;18(1):5976
Question Number
On request from
European Commission