Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX
Abstract The food enzyme peroxidase (phenolic donor: hydrogen‐peroxide oxidoreductase, EC 1.11.1.7) is produced with the genetically modified Aspergillus niger strain MOX by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free fr...
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Wiley
2023-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.8095 |
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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 Natalia Kovalkovicova 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 Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme peroxidase (phenolic donor: hydrogen‐peroxide oxidoreductase, EC 1.11.1.7) is produced with the genetically modified Aspergillus niger strain MOX by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in whey processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.635 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 2,162 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 3,405. 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. |
| format | Article |
| id | doaj-art-176ffa49daf14fa6b7b74f29c5a400a0 |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-176ffa49daf14fa6b7b74f29c5a400a02025-08-20T03:18:46ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8095Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOXEFSA 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 AndryszkiewiczNatalia KovalkovicovaYi LiuAndrew ChessonAbstract The food enzyme peroxidase (phenolic donor: hydrogen‐peroxide oxidoreductase, EC 1.11.1.7) is produced with the genetically modified Aspergillus niger strain MOX by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in whey processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.635 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 2,162 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 3,405. 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.2023.8095food enzymeperoxidasephenolic donor: hydrogen‐peroxide oxidoreductaseEC 1.11.1.7lactoperoxidaseAspergillus 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 Natalia Kovalkovicova Yi Liu Andrew Chesson Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX EFSA Journal food enzyme peroxidase phenolic donor: hydrogen‐peroxide oxidoreductase EC 1.11.1.7 lactoperoxidase Aspergillus niger |
| title | Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX |
| title_full | Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX |
| title_fullStr | Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX |
| title_full_unstemmed | Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX |
| title_short | Safety evaluation of the food enzyme peroxidase from the genetically modified Aspergillus niger strain MOX |
| title_sort | safety evaluation of the food enzyme peroxidase from the genetically modified aspergillus niger strain mox |
| topic | food enzyme peroxidase phenolic donor: hydrogen‐peroxide oxidoreductase EC 1.11.1.7 lactoperoxidase Aspergillus niger |
| url | https://doi.org/10.2903/j.efsa.2023.8095 |
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