Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO
Abstract The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan α‐glucohydrolase; EC 3.2.1.3) is produced with the non‐genetically modified Aspergillus niger strain NZYM‐BO by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-03-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.7911 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849724452492804096 |
|---|---|
| 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 Jaime Aguilera Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Elsa Nielsen Karin Nørby Giulio diPiazza Silvia Peluso 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 Lieve Herman Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Elsa Nielsen Karin Nørby Giulio diPiazza Silvia Peluso Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials; Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan α‐glucohydrolase; EC 3.2.1.3) is produced with the non‐genetically modified Aspergillus niger strain NZYM‐BO by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, brewing processes, cereal‐based processes, distilled alcohol production, fruit and vegetable processing for juice production, production of dairy analogues and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by distillation and during starch processing, dietary exposure was not calculated for these two food manufacturing processes. For the remaining five food manufacturing processes, dietary exposure to the food enzyme–TOS was estimated to be up to 2.97 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 1,920 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 646. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), 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-b8ec96892d484aa4b4c185dd9a7a8a8f |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-b8ec96892d484aa4b4c185dd9a7a8a8f2025-08-20T03:10:43ZengWileyEFSA Journal1831-47322023-03-01213n/an/a10.2903/j.efsa.2023.7911Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BOEFSA 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 RoosJaime AguileraMagdalena AndryszkiewiczDaniele CavannaAna CriadoElsa NielsenKarin NørbyGiulio diPiazzaSilvia PelusoYi LiuAndrew ChessonAbstract The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan α‐glucohydrolase; EC 3.2.1.3) is produced with the non‐genetically modified Aspergillus niger strain NZYM‐BO by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, brewing processes, cereal‐based processes, distilled alcohol production, fruit and vegetable processing for juice production, production of dairy analogues and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by distillation and during starch processing, dietary exposure was not calculated for these two food manufacturing processes. For the remaining five food manufacturing processes, dietary exposure to the food enzyme–TOS was estimated to be up to 2.97 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 1,920 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 646. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), 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.2023.7911food enzymeglucan‐1,4‐α‐glucosidase4‐α‐d‐glucan α‐glucohydrolaseEC 3.2.1.3glucoamylaseAspergillus 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 Lieve Herman Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Daniele Cavanna Ana Criado Elsa Nielsen Karin Nørby Giulio diPiazza Silvia Peluso Yi Liu Andrew Chesson Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO EFSA Journal food enzyme glucan‐1,4‐α‐glucosidase 4‐α‐d‐glucan α‐glucohydrolase EC 3.2.1.3 glucoamylase Aspergillus niger |
| title | Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO |
| title_full | Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO |
| title_fullStr | Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO |
| title_full_unstemmed | Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO |
| title_short | Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the non‐genetically modified Aspergillus niger strain NZYM‐BO |
| title_sort | safety evaluation of the food enzyme glucan 1 4 α glucosidase from the non genetically modified aspergillus niger strain nzym bo |
| topic | food enzyme glucan‐1,4‐α‐glucosidase 4‐α‐d‐glucan α‐glucohydrolase EC 3.2.1.3 glucoamylase Aspergillus niger |
| url | https://doi.org/10.2903/j.efsa.2023.7911 |
| work_keys_str_mv | AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT claudelambre safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT josemanuelbaratbaviera safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT claudiabolognesi safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT piersandrococconcelli safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT riccardocrebelli safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT davidmichaelgott safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT konradgrob safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT evgenialampi safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT marcelmengelers safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT alicjamortensen safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT gillesriviere safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT ingerlisesteffensen safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT christinatlustos safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT henkvanloveren safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT laurencevernis safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT holgerzorn safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT lieveherman safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT yrjoroos safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT jaimeaguilera safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT magdalenaandryszkiewicz safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT danielecavanna safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT anacriado safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT elsanielsen safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT karinnørby safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT giuliodipiazza safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT silviapeluso safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT yiliu safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo AT andrewchesson safetyevaluationofthefoodenzymeglucan14aglucosidasefromthenongeneticallymodifiedaspergillusnigerstrainnzymbo |