Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)

Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)

Abstract The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme‐catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in...

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Main Authors: EFSA Panel on Food Additives and Flavourings (FAF), Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl‐Kraupp, Ursula Gundert‐Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti, José Manuel Barat Baviera, Gisela Degen, David Gott, Lieve Herman, Jean‐Charles Leblanc, Peter Moldeus, Ine Waalkens‐Berendsen, Detlef Wölfle, Civitella Consuelo, Borana Dino, Simone Lunardi, Agnieszka Mech, Salvatore Multari, Camilla Smeraldi, Alexandra Tard, Laura Ruggeri
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:EFSA Journal
Subjects:
enzyme‐catalysed bioconversion
Komagaetella phaffi
Rebaudioside M
stevia
Steviol glycosides
Online Access:https://doi.org/10.2903/j.efsa.2025.9396
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Summary:Abstract The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme‐catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain K. phaffii CGMCC 7539. The final product is composed mostly of rebaudioside M (> 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from K. phaffii CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain K. phaffii CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme‐catalysed bioconversion.
ISSN:1831-4732

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