Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN
Abstract The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3;1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN by Amano Enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belo...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-02-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.7828 |
| _version_ | 1797848826884653056 |
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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 Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Yi Liu Simone Lunardi Elsa Nielsen Karin Nørby 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 Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Yi Liu Simone Lunardi Elsa Nielsen Karin Nørby Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3;1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN by Amano Enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belongs to a species that has been implicated in opportunistic infections in humans. The food enzyme is intended to be used in baking processes and yeast processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.75 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,788 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 1,022. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. However, due to the presence of viable cells of the production strain in the food enzyme, the Panel concluded that the food enzyme cannot be considered safe. |
| first_indexed | 2024-04-09T18:33:49Z |
| format | Article |
| id | doaj.art-25b4d8fe2f76438d98ad56d3785a7907 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-09T18:33:49Z |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-25b4d8fe2f76438d98ad56d3785a79072023-04-11T12:01:09ZengWileyEFSA Journal1831-47322023-02-01212n/an/a10.2903/j.efsa.2023.7828Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TNEFSA 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 ZornLieve HermanYrjö RoosMagdalena AndryszkiewiczYi LiuSimone LunardiElsa NielsenKarin NørbyAndrew ChessonAbstract The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3;1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN by Amano Enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belongs to a species that has been implicated in opportunistic infections in humans. The food enzyme is intended to be used in baking processes and yeast processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.75 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,788 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 1,022. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. However, due to the presence of viable cells of the production strain in the food enzyme, the Panel concluded that the food enzyme cannot be considered safe.https://doi.org/10.2903/j.efsa.2023.7828food enzymeendo‐1,3(4)‐β‐glucanase3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolaseEC 3.2.1.6β‐1,3‐glucanaseCellulosimicrobium funkei |
| 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 Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Yi Liu Simone Lunardi Elsa Nielsen Karin Nørby Andrew Chesson Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN EFSA Journal food enzyme endo‐1,3(4)‐β‐glucanase 3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolase EC 3.2.1.6 β‐1,3‐glucanase Cellulosimicrobium funkei |
| title | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN |
| title_full | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN |
| title_fullStr | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN |
| title_full_unstemmed | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN |
| title_short | Safety evaluation of the food enzyme endo‐1,3(4)‐β‐glucanase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐TN |
| title_sort | safety evaluation of the food enzyme endo 1 3 4 β glucanase from the non genetically modified cellulosimicrobium funkei strain ae tn |
| topic | food enzyme endo‐1,3(4)‐β‐glucanase 3‐(1→3;1→4)‐β‐d‐glucan 3(4)‐glucanohydrolase EC 3.2.1.6 β‐1,3‐glucanase Cellulosimicrobium funkei |
| url | https://doi.org/10.2903/j.efsa.2023.7828 |
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