Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract
Abstract The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a proposed amendment of the specifications of enzymatically produced steviol glycosides (E 960c) with respect to the inclusion of rebaudioside D produced via enzyme‐catalysed bioconve...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-05-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7291 |
| _version_ | 1818470377798500352 |
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| author | EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Matthew Wright José Manuel Barat Baviera Gisela Degen Lieve Herman Jean‐Charles Leblanc Detlef Wölfle Jaime Aguilera Alessandra Giarola Camilla Smeraldi Giorgia Vianello Laurence Castle |
| author_facet | EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Matthew Wright José Manuel Barat Baviera Gisela Degen Lieve Herman Jean‐Charles Leblanc Detlef Wölfle Jaime Aguilera Alessandra Giarola Camilla Smeraldi Giorgia Vianello Laurence Castle |
| author_sort | EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings) |
| collection | DOAJ |
| description | Abstract The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a proposed amendment of the specifications of enzymatically produced steviol glycosides (E 960c) with respect to the inclusion of rebaudioside D produced via enzyme‐catalysed bioconversion of purified stevia leaf extract. Rebaudioside D (95% on dry basis) is produced via enzymatic bioconversion of purified stevia leaf extract using uridine diphosphate (UDP)‐glucosyltransferase (UGT) and sucrose synthase enzymes produced by the genetically modified yeast K. phaffii UGT‐A, that facilitates the transfer of glucose to purified stevia leaf extract via glycosidic bonds. The same enzymes from K. phaffii UGT‐A may be used in the manufacturing process of the food additive, rebaudioside M produced via enzyme modification of steviol glycosides from stevia (E 960c(i)). The Panel considered that separate specifications would be needed for this food additive produced via the manufacturing process described in the current application, aligned with those already established for E 960c(i). The Panel concluded that there is no toxicological concern for Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract using UDP‐glucosyltransferase and sucrose synthase produced by a genetically modified strain of the yeast K. phaffii. However, based on the available data, the Panel could not exclude the possibility that some residual amount of DNA coding for the kanamycin resistance gene could remain in the final product. Should this gene propagate in microbiota due to the presence of recombinant DNA in the final product, this would be of concern. Therefore, the Panel concluded that the safety of Rebaudioside D produced via this enzymatic bioconversion was not sufficiently demonstrated with the available data given that the absence of recombinant DNA was not shown. |
| first_indexed | 2024-04-13T21:36:27Z |
| format | Article |
| id | doaj.art-c6c1609664f74d91936eb91550792c6b |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-13T21:36:27Z |
| publishDate | 2022-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-c6c1609664f74d91936eb91550792c6b2022-12-22T02:28:57ZengWileyEFSA Journal1831-47322022-05-01205n/an/a10.2903/j.efsa.2022.7291Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extractEFSA FAF Panel (EFSA Panel on Food Additives and Flavourings)Maged YounesGabriele AquilinaKarl‐Heinz EngelPaul J FowlerMaria Jose Frutos FernandezPeter FürstRainer GürtlerUrsula Gundert‐RemyTrine HusøyMelania MancoWim MennesPeter MoldeusSabina PassamontiRomina ShahIne Waalkens‐BerendsenMatthew WrightJosé Manuel Barat BavieraGisela DegenLieve HermanJean‐Charles LeblancDetlef WölfleJaime AguileraAlessandra GiarolaCamilla SmeraldiGiorgia VianelloLaurence CastleAbstract The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a proposed amendment of the specifications of enzymatically produced steviol glycosides (E 960c) with respect to the inclusion of rebaudioside D produced via enzyme‐catalysed bioconversion of purified stevia leaf extract. Rebaudioside D (95% on dry basis) is produced via enzymatic bioconversion of purified stevia leaf extract using uridine diphosphate (UDP)‐glucosyltransferase (UGT) and sucrose synthase enzymes produced by the genetically modified yeast K. phaffii UGT‐A, that facilitates the transfer of glucose to purified stevia leaf extract via glycosidic bonds. The same enzymes from K. phaffii UGT‐A may be used in the manufacturing process of the food additive, rebaudioside M produced via enzyme modification of steviol glycosides from stevia (E 960c(i)). The Panel considered that separate specifications would be needed for this food additive produced via the manufacturing process described in the current application, aligned with those already established for E 960c(i). The Panel concluded that there is no toxicological concern for Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract using UDP‐glucosyltransferase and sucrose synthase produced by a genetically modified strain of the yeast K. phaffii. However, based on the available data, the Panel could not exclude the possibility that some residual amount of DNA coding for the kanamycin resistance gene could remain in the final product. Should this gene propagate in microbiota due to the presence of recombinant DNA in the final product, this would be of concern. Therefore, the Panel concluded that the safety of Rebaudioside D produced via this enzymatic bioconversion was not sufficiently demonstrated with the available data given that the absence of recombinant DNA was not shown.https://doi.org/10.2903/j.efsa.2022.7291steviol glycoside preparationsrebaudioside Denzymatic bioconversionyeast K. phaffii |
| spellingShingle | EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings) Maged Younes Gabriele Aquilina Karl‐Heinz Engel Paul J Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Peter Moldeus Sabina Passamonti Romina Shah Ine Waalkens‐Berendsen Matthew Wright José Manuel Barat Baviera Gisela Degen Lieve Herman Jean‐Charles Leblanc Detlef Wölfle Jaime Aguilera Alessandra Giarola Camilla Smeraldi Giorgia Vianello Laurence Castle Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract EFSA Journal steviol glycoside preparations rebaudioside D enzymatic bioconversion yeast K. phaffii |
| title | Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract |
| title_full | Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract |
| title_fullStr | Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract |
| title_full_unstemmed | Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract |
| title_short | Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract |
| title_sort | safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides e 960c rebaudioside d produced via enzymatic bioconversion of purified stevia leaf extract |
| topic | steviol glycoside preparations rebaudioside D enzymatic bioconversion yeast K. phaffii |
| url | https://doi.org/10.2903/j.efsa.2022.7291 |
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