Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA
Abstract The food enzyme asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified microorganism Aspergillus oryzae strain NZYM‐OA by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the...
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| Format: | Article |
| Language: | English |
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Wiley
2023-04-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.7914 |
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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 Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Silvia Peluso Giulio diPiazza Rita Ferreira deSousa 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 Natalia Kovalkovicova Yi Liu Silvia Peluso Giulio diPiazza Rita Ferreira deSousa Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified microorganism Aspergillus oryzae strain NZYM‐OA by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in various food manufacturing processes to prevent acrylamide formation. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.051 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 1,182 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 23,176. 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 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. |
| first_indexed | 2024-03-12T22:08:14Z |
| format | Article |
| id | doaj.art-9b4b4c0d13f84287b689f6ee53b9e4b4 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-12T22:08:14Z |
| publishDate | 2023-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-9b4b4c0d13f84287b689f6ee53b9e4b42023-07-24T08:18:22ZengWileyEFSA Journal1831-47322023-04-01214n/an/a10.2903/j.efsa.2023.7914Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OAEFSA 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 AndryszkiewiczNatalia KovalkovicovaYi LiuSilvia PelusoGiulio diPiazzaRita Ferreira deSousaAndrew ChessonAbstract The food enzyme asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified microorganism Aspergillus oryzae strain NZYM‐OA by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in various food manufacturing processes to prevent acrylamide formation. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.051 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 1,182 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 23,176. 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 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.2023.7914food enzymeasparaginasel‐asparagine amidohydrolaseEC 3.5.1.1Aspergillus oryzaegenetically modified microorganism |
| 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 Natalia Kovalkovicova Yi Liu Silvia Peluso Giulio diPiazza Rita Ferreira deSousa Andrew Chesson Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA EFSA Journal food enzyme asparaginase l‐asparagine amidohydrolase EC 3.5.1.1 Aspergillus oryzae genetically modified microorganism |
| title | Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA |
| title_full | Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA |
| title_fullStr | Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA |
| title_full_unstemmed | Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA |
| title_short | Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM‐OA |
| title_sort | safety evaluation of the food enzyme asparaginase from the genetically modified aspergillus oryzae strain nzym oa |
| topic | food enzyme asparaginase l‐asparagine amidohydrolase EC 3.5.1.1 Aspergillus oryzae genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2023.7914 |
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