Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX
Abstract The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non‐genetically modified microorganism Aspergillus oryzae strain NZYM‐EX by Novozymes A/S. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing pro...
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| Format: | Article |
| Language: | English |
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Wiley
2023-12-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.8507 |
| _version_ | 1797374876846129152 |
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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 Boet Glandorf Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natália Kovalkovičová Yi Liu 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 Boet Glandorf Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natália Kovalkovičová Yi Liu Giulio diPiazza Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non‐genetically modified microorganism Aspergillus oryzae strain NZYM‐EX by Novozymes A/S. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes: processing of dairy products for the production of (1) flavouring preparations, (2) modified milk proteins; processing of plant‐ and fungal‐derived products for the production of (3) protein hydrolysates, (4) soy sauce; processing of meat and fish products for the production of (5) protein hydrolysates; processing of cereals and other grains for the production of (6) baked products, (7) brewed products; (8) processing of yeast and yeast products. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.577 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 440 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 763. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that 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 | 2024-03-08T19:13:02Z |
| format | Article |
| id | doaj.art-ece68b1b939841f3b6edd48207b1a65b |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-08T19:13:02Z |
| publishDate | 2023-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-ece68b1b939841f3b6edd48207b1a65b2023-12-27T10:08:38ZengWileyEFSA Journal1831-47322023-12-012112n/an/a10.2903/j.efsa.2023.8507Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EXEFSA 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 ZornBoet GlandorfLieve HermanYrjö RoosMagdalena AndryszkiewiczDaniele CavannaAna GomesNatália KovalkovičováYi LiuGiulio diPiazzaAndrew ChessonAbstract The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non‐genetically modified microorganism Aspergillus oryzae strain NZYM‐EX by Novozymes A/S. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes: processing of dairy products for the production of (1) flavouring preparations, (2) modified milk proteins; processing of plant‐ and fungal‐derived products for the production of (3) protein hydrolysates, (4) soy sauce; processing of meat and fish products for the production of (5) protein hydrolysates; processing of cereals and other grains for the production of (6) baked products, (7) brewed products; (8) processing of yeast and yeast products. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.577 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 440 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 763. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that 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.2023.8507Aspergillus oryzaeEC 3.4.11.1food enzymeleucyl aminopeptidasenon‐genetically 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 Boet Glandorf Lieve Herman Yrjö Roos Magdalena Andryszkiewicz Daniele Cavanna Ana Gomes Natália Kovalkovičová Yi Liu Giulio diPiazza Andrew Chesson Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX EFSA Journal Aspergillus oryzae EC 3.4.11.1 food enzyme leucyl aminopeptidase non‐genetically modified microorganism |
| title | Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX |
| title_full | Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX |
| title_fullStr | Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX |
| title_full_unstemmed | Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX |
| title_short | Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX |
| title_sort | safety evaluation of the food enzyme leucyl aminopeptidase from non genetically modified aspergillus oryzae strain nzym ex |
| topic | Aspergillus oryzae EC 3.4.11.1 food enzyme leucyl aminopeptidase non‐genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2023.8507 |
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