Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus licheniformis strain AE‐TA by Amano Enzyme Inc. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of...
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Wiley
2024-05-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8780 |
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| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Kyriaki Apergi Daniele Cavanna Cristina Fernàndez‐Fraguas Natalia Kovalkovicova Silvia Peluso Giulio diPiazza Yi Liu Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Kyriaki Apergi Daniele Cavanna Cristina Fernàndez‐Fraguas Natalia Kovalkovicova Silvia Peluso Giulio diPiazza Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus licheniformis strain AE‐TA by Amano Enzyme Inc. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining six processes. It was estimated to be up to 0.056 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety approach to safety assessment. Consequently, in the absence of other concerns, the Panel considered that toxicological studies were not needed for the safety assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for the production of distilled alcohol), but the likelihood is 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. |
| format | Article |
| id | doaj-art-a2bda18b407748449fc4dcfeda389022 |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-a2bda18b407748449fc4dcfeda3890222025-08-20T02:16:49ZengWileyEFSA Journal1831-47322024-05-01225n/an/a10.2903/j.efsa.2024.8780Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TAEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornYrjö RoosJaime AguileraMagdalena AndryszkiewiczKyriaki Apergi Daniele CavannaCristina Fernàndez‐FraguasNatalia KovalkovicovaSilvia PelusoGiulio diPiazzaYi LiuAndrew ChessonAbstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus licheniformis strain AE‐TA by Amano Enzyme Inc. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining six processes. It was estimated to be up to 0.056 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety approach to safety assessment. Consequently, in the absence of other concerns, the Panel considered that toxicological studies were not needed for the safety assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for the production of distilled alcohol), but the likelihood is 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.https://doi.org/10.2903/j.efsa.2024.87804‐α‐d‐glucan glucanohydrolaseamylaseBacillus licheniformisEC 3.2.1.1food enzymeglycogenase |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Gilles Rivière Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Kyriaki Apergi Daniele Cavanna Cristina Fernàndez‐Fraguas Natalia Kovalkovicova Silvia Peluso Giulio diPiazza Yi Liu Andrew Chesson Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA EFSA Journal 4‐α‐d‐glucan glucanohydrolase amylase Bacillus licheniformis EC 3.2.1.1 food enzyme glycogenase |
| title | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA |
| title_full | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA |
| title_short | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Bacillus licheniformis strain AE‐TA |
| title_sort | safety evaluation of the food enzyme α amylase from the non genetically modified bacillus licheniformis strain ae ta |
| topic | 4‐α‐d‐glucan glucanohydrolase amylase Bacillus licheniformis EC 3.2.1.1 food enzyme glycogenase |
| url | https://doi.org/10.2903/j.efsa.2024.8780 |
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