Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus niger strain AS 29‐286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used...
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Wiley
2023-06-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.8090 |
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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 Jaime Aguilera Magdalena Andryszkiewicz Ana Criado Cristina Fernandez‐Fraguas Yi Liu Elsa Nielsen Karin Nørby Giulio diPiazza 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 Jaime Aguilera Magdalena Andryszkiewicz Ana Criado Cristina Fernandez‐Fraguas Yi Liu Elsa Nielsen Karin Nørby Giulio diPiazza 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 Aspergillus niger strain AS 29‐286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, starch processing for the production of maltodextrins, brewing processes and non‐wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and starch processing for the production of maltodextrins, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 2.158 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 1,774 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 822. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, 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-ab0a0827119142bba670003da30b539b |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-ab0a0827119142bba670003da30b539b2025-08-20T02:09:47ZengWileyEFSA Journal1831-47322023-06-01216n/an/a10.2903/j.efsa.2023.8090Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286EFSA 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 ZornJaime AguileraMagdalena AndryszkiewiczAna CriadoCristina Fernandez‐FraguasYi LiuElsa NielsenKarin NørbyGiulio diPiazzaAndrew ChessonAbstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus niger strain AS 29‐286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, starch processing for the production of maltodextrins, brewing processes and non‐wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and starch processing for the production of maltodextrins, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 2.158 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 1,774 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 822. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, 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.2023.8090food enzymeα‐amylase4‐α‐d‐glucan glucanohydrolaseEC 3.2.1.1glycogenaseAspergillus niger |
| 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 Jaime Aguilera Magdalena Andryszkiewicz Ana Criado Cristina Fernandez‐Fraguas Yi Liu Elsa Nielsen Karin Nørby Giulio diPiazza Andrew Chesson Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 EFSA Journal food enzyme α‐amylase 4‐α‐d‐glucan glucanohydrolase EC 3.2.1.1 glycogenase Aspergillus niger |
| title | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 |
| title_full | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 |
| title_fullStr | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 |
| title_short | Safety evaluation of the food enzyme α‐amylase from the non‐genetically modified Aspergillus niger strain AS 29‐286 |
| title_sort | safety evaluation of the food enzyme α amylase from the non genetically modified aspergillus niger strain as 29 286 |
| topic | food enzyme α‐amylase 4‐α‐d‐glucan glucanohydrolase EC 3.2.1.1 glycogenase Aspergillus niger |
| url | https://doi.org/10.2903/j.efsa.2023.8090 |
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