Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CIN by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombina...
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| Format: | Article |
| Language: | English |
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Wiley
2022-08-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7461 |
| _version_ | 1817983133464657920 |
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| author | EFSA Panel on Food Contact Materials, Enzyme 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 Giulio Di Piazza Rita Ferreira de Sousa Natalia Kovalkovikova Yi Liu Andrew Chesson |
| author_facet | EFSA Panel on Food Contact Materials, Enzyme 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 Giulio Di Piazza Rita Ferreira de Sousa Natalia Kovalkovikova Yi Liu Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzyme and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CIN by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.73 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and four matches were found. The Panel considered that under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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 | 2024-04-13T23:29:40Z |
| format | Article |
| id | doaj.art-46ac551084604ebca6c04f766769e97f |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-13T23:29:40Z |
| publishDate | 2022-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-46ac551084604ebca6c04f766769e97f2022-12-22T02:24:57ZengWileyEFSA Journal1831-47322022-08-01208n/an/a10.2903/j.efsa.2022.7461Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CINEFSA Panel on Food Contact Materials, Enzyme 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 AndryszkiewiczGiulio Di PiazzaRita Ferreira de SousaNatalia KovalkovikovaYi LiuAndrew ChessonAbstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CIN by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.73 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and four matches were found. The Panel considered that under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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.2022.7461food enzymechymosinrenninEC 3.4.23.4Kluyveromyces lactisgenetically modified microorganism |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzyme 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 Giulio Di Piazza Rita Ferreira de Sousa Natalia Kovalkovikova Yi Liu Andrew Chesson Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN EFSA Journal food enzyme chymosin rennin EC 3.4.23.4 Kluyveromyces lactis genetically modified microorganism |
| title | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN |
| title_full | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN |
| title_fullStr | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN |
| title_full_unstemmed | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN |
| title_short | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CIN |
| title_sort | safety evaluation of the food enzyme chymosin from the genetically modified kluyveromyces lactis strain cin |
| topic | food enzyme chymosin rennin EC 3.4.23.4 Kluyveromyces lactis genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2022.7461 |
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