Cargando…
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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9109230/ https://www.ncbi.nlm.nih.gov/pubmed/35600273 http://dx.doi.org/10.2903/j.efsa.2022.7291 |
_version_ | 1784708861036331008 |
---|---|
author | Younes, Maged Aquilina, Gabriele Engel, Karl‐Heinz Fowler, Paul J Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wright, Matthew Barat Baviera, José Manuel Degen, Gisela Herman, Lieve Leblanc, Jean‐Charles Wölfle, Detlef Aguilera, Jaime Giarola, Alessandra Smeraldi, Camilla Vianello, Giorgia Castle, Laurence |
author_facet | Younes, Maged Aquilina, Gabriele Engel, Karl‐Heinz Fowler, Paul J Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wright, Matthew Barat Baviera, José Manuel Degen, Gisela Herman, Lieve Leblanc, Jean‐Charles Wölfle, Detlef Aguilera, Jaime Giarola, Alessandra Smeraldi, Camilla Vianello, Giorgia Castle, Laurence |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9109230 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-91092302022-05-20 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 Younes, Maged Aquilina, Gabriele Engel, Karl‐Heinz Fowler, Paul J Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wright, Matthew Barat Baviera, José Manuel Degen, Gisela Herman, Lieve Leblanc, Jean‐Charles Wölfle, Detlef Aguilera, Jaime Giarola, Alessandra Smeraldi, Camilla Vianello, Giorgia Castle, Laurence EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2022-05-16 /pmc/articles/PMC9109230/ /pubmed/35600273 http://dx.doi.org/10.2903/j.efsa.2022.7291 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Younes, Maged Aquilina, Gabriele Engel, Karl‐Heinz Fowler, Paul J Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wright, Matthew Barat Baviera, José Manuel Degen, Gisela Herman, Lieve Leblanc, Jean‐Charles Wölfle, Detlef Aguilera, Jaime Giarola, Alessandra Smeraldi, Camilla Vianello, Giorgia Castle, Laurence 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 | 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 | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9109230/ https://www.ncbi.nlm.nih.gov/pubmed/35600273 http://dx.doi.org/10.2903/j.efsa.2022.7291 |
work_keys_str_mv | AT safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT younesmaged safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT aquilinagabriele safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT engelkarlheinz safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT fowlerpaulj safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT frutosfernandezmariajose safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT furstpeter safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT gurtlerrainer safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT gundertremyursula safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT husøytrine safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT mancomelania safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT menneswim safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT moldeuspeter safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT passamontisabina safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT shahromina safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT waalkensberendsenine safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT wrightmatthew safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT baratbavierajosemanuel safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT degengisela safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT hermanlieve safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT leblancjeancharles safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT wolfledetlef safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT aguilerajaime safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT giarolaalessandra safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT smeraldicamilla safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT vianellogiorgia safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract AT castlelaurence safetyoftheproposedamendmentofthespecificationsforenzymaticallyproducedsteviolglycosidese960crebaudiosidedproducedviaenzymaticbioconversionofpurifiedstevialeafextract |