Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA)
Abstract The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Bacillus subtilis strain NBA by DSM Food Specialities B.V. This α‐amylase is intended to be used in baking processes. The genetic modifications do not give rise to saf...
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doaj-07f1f62f5cea4186b93e742ef339a71e2021-05-03T02:29:20ZengWileyEFSA Journal1831-47322019-05-01175n/an/a10.2903/j.efsa.2019.5681Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA)EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiBeat Johannes BrüschweilerPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLieve HermanAndré PenninksDavor ŽelježicMagdalena AndryszkiewiczDavide ArcellaYi LiuKarl‐Heinz EngelAndrew ChessonAbstract The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Bacillus subtilis strain NBA by DSM Food Specialities B.V. This α‐amylase is intended to be used in baking processes. The genetic modifications do not give rise to safety concerns and the food enzyme is free from viable cells of the production organism and recombinant DNA. 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. Since the production strain is not cytotoxic and since the introduced genetic modifications do not raise safety concerns, the presumption of safety made for the parental strain is extended to the production strain. 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. However, the Panel considers no toxicological studies other than assessment of allergenicity necessary. This is based on the QPS status of the production strain and the absence of any hazards from the product and downstream processing. Based on the maximum use level recommended for the baking processes and individual data from the European Food Safety Authority (EFSA) Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.093 mg TOS/kg body weight per day in European populations. 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 data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.https://doi.org/10.2903/j.efsa.2019.5681food enzymealpha‐amylase4‐α‐d‐glucan glucanohydrolaseEC 3.2.1.11,4‐α‐d‐glucan glucanohydrolaseBacillus subtilis |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman André Penninks Davor Želježic Magdalena Andryszkiewicz Davide Arcella Yi Liu Karl‐Heinz Engel Andrew Chesson |
spellingShingle |
EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman André Penninks Davor Želježic Magdalena Andryszkiewicz Davide Arcella Yi Liu Karl‐Heinz Engel Andrew Chesson Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) EFSA Journal food enzyme alpha‐amylase 4‐α‐d‐glucan glucanohydrolase EC 3.2.1.1 1,4‐α‐d‐glucan glucanohydrolase Bacillus subtilis |
author_facet |
EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Beat Johannes Brüschweiler Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Lieve Herman André Penninks Davor Želježic Magdalena Andryszkiewicz Davide Arcella Yi Liu Karl‐Heinz Engel Andrew Chesson |
author_sort |
EFSA Panel on Food Contact Materials, Enzymes, Processing Aids (CEP) |
title |
Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) |
title_short |
Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) |
title_full |
Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) |
title_fullStr |
Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) |
title_full_unstemmed |
Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus subtilis (strain NBA) |
title_sort |
safety evaluation of the food enzyme alpha‐amylase from a genetically modified bacillus subtilis (strain nba) |
publisher |
Wiley |
series |
EFSA Journal |
issn |
1831-4732 |
publishDate |
2019-05-01 |
description |
Abstract The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Bacillus subtilis strain NBA by DSM Food Specialities B.V. This α‐amylase is intended to be used in baking processes. The genetic modifications do not give rise to safety concerns and the food enzyme is free from viable cells of the production organism and recombinant DNA. 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. Since the production strain is not cytotoxic and since the introduced genetic modifications do not raise safety concerns, the presumption of safety made for the parental strain is extended to the production strain. 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. However, the Panel considers no toxicological studies other than assessment of allergenicity necessary. This is based on the QPS status of the production strain and the absence of any hazards from the product and downstream processing. Based on the maximum use level recommended for the baking processes and individual data from the European Food Safety Authority (EFSA) Comprehensive European Food Consumption Database, dietary exposure was estimated to be up to 0.093 mg TOS/kg body weight per day in European populations. 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 data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use. |
topic |
food enzyme alpha‐amylase 4‐α‐d‐glucan glucanohydrolase EC 3.2.1.1 1,4‐α‐d‐glucan glucanohydrolase Bacillus subtilis |
url |
https://doi.org/10.2903/j.efsa.2019.5681 |
work_keys_str_mv |
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