Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY
Abstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CHY by DSM Food Specialties B.V. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Dietary exposure was estimated to b...
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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.2022.7462 |
| _version_ | 1797999767665508352 |
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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 Natalia Kovalkovicova Yi Liu Rita Ferreira deSousa 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 Natalia Kovalkovicova Yi Liu Rita Ferreira deSousa 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 CHY by DSM Food Specialties B.V. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Dietary exposure was estimated to be up to 0.69 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. The production strain contains multiple copies of known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched 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 | 2024-04-11T11:09:59Z |
| format | Article |
| id | doaj.art-c0d0ed057e7543c0bbfaa9f36dad763d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-11T11:09:59Z |
| publishDate | 2022-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-c0d0ed057e7543c0bbfaa9f36dad763d2022-12-22T04:27:58ZengWileyEFSA Journal1831-47322022-08-01208n/an/a10.2903/j.efsa.2022.7462Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHYEFSA 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 PiazzaNatalia KovalkovicovaYi LiuRita Ferreira deSousaAndrew ChessonAbstract The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CHY by DSM Food Specialties B.V. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Dietary exposure was estimated to be up to 0.69 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. The production strain contains multiple copies of known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched 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.2022.7462food enzymechymosinaspartic endopeptidasesrenninEC 3.4.23.4Kluyveromyces lactis |
| 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 Natalia Kovalkovicova Yi Liu Rita Ferreira deSousa Andrew Chesson Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY EFSA Journal food enzyme chymosin aspartic endopeptidases rennin EC 3.4.23.4 Kluyveromyces lactis |
| title | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY |
| title_full | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY |
| title_fullStr | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY |
| title_full_unstemmed | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY |
| title_short | Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY |
| title_sort | safety evaluation of the food enzyme chymosin from the genetically modified kluyveromyces lactis strain chy |
| topic | food enzyme chymosin aspartic endopeptidases rennin EC 3.4.23.4 Kluyveromyces lactis |
| url | https://doi.org/10.2903/j.efsa.2022.7462 |
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