Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified...
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| Format: | Article |
| Language: | English |
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Wiley
2022-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2022.7370 |
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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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Rita Ferreira de Sousa Sandra Rainieri 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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Rita Ferreira de Sousa Sandra Rainieri 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 glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal‐based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme–TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme 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 by dietary exposure cannot be excluded, but the likelihood was 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. |
| first_indexed | 2024-03-13T08:22:00Z |
| format | Article |
| id | doaj.art-c943c8b3b0a140679ee7389b933d0d2f |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-13T08:22:00Z |
| publishDate | 2022-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-c943c8b3b0a140679ee7389b933d0d2f2023-05-31T09:06:32ZengWileyEFSA Journal1831-47322022-07-01207n/an/a10.2903/j.efsa.2022.7370Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BCEFSA 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 ZornBoet GlandorfLieve HermanJaime AguileraMagdalena AndryszkiewiczYi LiuRita Ferreira de SousaSandra RainieriAndrew ChessonAbstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal‐based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme–TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme 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 by dietary exposure cannot be excluded, but the likelihood was 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.https://doi.org/10.2903/j.efsa.2022.7370food enzymeα-amylase4-α-d-glucan glucanhydrolaseEC 3.2.1.1glycogenaseBacillus licheniformis |
| 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 Boet Glandorf Lieve Herman Jaime Aguilera Magdalena Andryszkiewicz Yi Liu Rita Ferreira de Sousa Sandra Rainieri Andrew Chesson Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC EFSA Journal food enzyme α-amylase 4-α-d-glucan glucanhydrolase EC 3.2.1.1 glycogenase Bacillus licheniformis |
| title | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC |
| title_full | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC |
| title_short | Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐BC |
| title_sort | safety evaluation of the food enzyme α amylase from the genetically modified bacillus licheniformis strain nzym bc |
| topic | food enzyme α-amylase 4-α-d-glucan glucanhydrolase EC 3.2.1.1 glycogenase Bacillus licheniformis |
| url | https://doi.org/10.2903/j.efsa.2022.7370 |
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