Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol
Abstract The food enzyme microbial collagenase (EC 3.4.24.3) is produced with the genetically modified Streptomyces violaceoruber strain pCol by Nagase (Europa) GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism a...
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| Format: | Article |
| Language: | English |
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Wiley
2024-02-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8624 |
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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 Daniele Cavanna Cristina Fernàndez‐Fraguas Silvia Peluso Elsa Nielsen Karin Nørby Giulio diPiazza Laura Sanmartín Cabo 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 Cristina Fernàndez‐Fraguas Silvia Peluso Elsa Nielsen Karin Nørby Giulio diPiazza Laura Sanmartín Cabo Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme microbial collagenase (EC 3.4.24.3) is produced with the genetically modified Streptomyces violaceoruber strain pCol by Nagase (Europa) GmbH. 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 two food manufacturing processes: the production of modified meat and fish products and the production of protein hydrolysates from meat and fish proteins. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.098 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 940 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 856. 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 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 | 2024-03-07T19:21:12Z |
| format | Article |
| id | doaj.art-a748399ca63345fabe09de15d7e9193d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2025-03-20T09:07:59Z |
| publishDate | 2024-02-01 |
| publisher | Wiley |
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| spelling | doaj.art-a748399ca63345fabe09de15d7e9193d2024-09-27T06:01:00ZengWileyEFSA Journal1831-47322024-02-01222n/an/a10.2903/j.efsa.2024.8624Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pColEFSA 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 CavannaCristina Fernàndez‐FraguasSilvia PelusoElsa NielsenKarin NørbyGiulio diPiazzaLaura Sanmartín CaboYi LiuAndrew ChessonAbstract The food enzyme microbial collagenase (EC 3.4.24.3) is produced with the genetically modified Streptomyces violaceoruber strain pCol by Nagase (Europa) GmbH. 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 two food manufacturing processes: the production of modified meat and fish products and the production of protein hydrolysates from meat and fish proteins. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.098 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 940 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 856. 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 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.2024.8624collagenaseEC 3.4.24.3food enzymegenetically modified microorganismmicrobial collagenaseStreptomyces violaceoruber |
| 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 Cristina Fernàndez‐Fraguas Silvia Peluso Elsa Nielsen Karin Nørby Giulio diPiazza Laura Sanmartín Cabo Yi Liu Andrew Chesson Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol EFSA Journal collagenase EC 3.4.24.3 food enzyme genetically modified microorganism microbial collagenase Streptomyces violaceoruber |
| title | Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol |
| title_full | Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol |
| title_fullStr | Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol |
| title_full_unstemmed | Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol |
| title_short | Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol |
| title_sort | safety evaluation of the food enzyme microbial collagenase from the genetically modified streptomyces violaceoruber strain pcol |
| topic | collagenase EC 3.4.24.3 food enzyme genetically modified microorganism microbial collagenase Streptomyces violaceoruber |
| url | https://doi.org/10.2903/j.efsa.2024.8624 |
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