Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94
Abstract The food enzyme α‐galactosidase (α‐d‐galactoside galactohydrolase; EC 3.2.1.22) is produced with the genetically modified Saccharomyces cerevisiae strain CBS 615.94 by Kerry Ingredients & Flavours Ltd. The production strain of the food enzyme contains multiple copies of a known antimicr...
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| Format: | Article |
| Language: | English |
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Wiley
2024-03-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.8606 |
| _version_ | 1827302744152604672 |
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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 Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Eleonora Marini 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 Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Eleonora Marini Andrew Chesson |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The food enzyme α‐galactosidase (α‐d‐galactoside galactohydrolase; EC 3.2.1.22) is produced with the genetically modified Saccharomyces cerevisiae strain CBS 615.94 by Kerry Ingredients & Flavours Ltd. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on 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 genetically modified microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used in guar gum processing. The dietary exposure was estimated to be up to 0.828 mg TOS/kg body weight per day in European populations. 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 a 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 | 2024-04-24T16:51:35Z |
| format | Article |
| id | doaj.art-36f4e95481d6422999216140ac6f23c8 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-24T16:51:35Z |
| publishDate | 2024-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-36f4e95481d6422999216140ac6f23c82024-03-29T03:10:39ZengWileyEFSA Journal1831-47322024-03-01223n/an/a10.2903/j.efsa.2024.8606Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94EFSA 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 ZornYrjö RoosJaime AguileraMagdalena AndryszkiewiczNatalia KovalkovicovaYi LiuEleonora MariniAndrew ChessonAbstract The food enzyme α‐galactosidase (α‐d‐galactoside galactohydrolase; EC 3.2.1.22) is produced with the genetically modified Saccharomyces cerevisiae strain CBS 615.94 by Kerry Ingredients & Flavours Ltd. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. However, based on 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 genetically modified microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used in guar gum processing. The dietary exposure was estimated to be up to 0.828 mg TOS/kg body weight per day in European populations. 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 a 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.2024.8606EC 3.2.1.22food enzymegenetically modified microorganismmelibiaseSaccharomyces cerevisiaeα‐d‐galactoside galactohydrolase |
| 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 Yrjö Roos Jaime Aguilera Magdalena Andryszkiewicz Natalia Kovalkovicova Yi Liu Eleonora Marini Andrew Chesson Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 EFSA Journal EC 3.2.1.22 food enzyme genetically modified microorganism melibiase Saccharomyces cerevisiae α‐d‐galactoside galactohydrolase |
| title | Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 |
| title_full | Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 |
| title_fullStr | Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 |
| title_full_unstemmed | Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 |
| title_short | Safety evaluation of the food enzyme α‐galactosidase from the genetically modified Saccharomyces cerevisiae strain CBS 615.94 |
| title_sort | safety evaluation of the food enzyme α galactosidase from the genetically modified saccharomyces cerevisiae strain cbs 615 94 |
| topic | EC 3.2.1.22 food enzyme genetically modified microorganism melibiase Saccharomyces cerevisiae α‐d‐galactoside galactohydrolase |
| url | https://doi.org/10.2903/j.efsa.2024.8606 |
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