EFSA Journal (Dec 2023)

Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolytica VRM

  • EFSA Panel on Food Additives and Flavourings (FAF),
  • Maged Younes,
  • Gabriele Aquilina,
  • Gisela Degen,
  • Karl‐Heinz Engel,
  • Paul Fowler,
  • Maria Jose Frutos Fernandez,
  • Peter Fürst,
  • Ursula Gundert‐Remy,
  • Rainer Gürtler,
  • Trine Husøy,
  • Melania Manco,
  • Wim Mennes,
  • Sabina Passamonti,
  • Peter Moldeus,
  • Romina Shah,
  • Ine Waalkens‐Berendsen,
  • Matthew Wright,
  • José Manuel Barat Baviera,
  • David Gott,
  • Lieve Herman,
  • Jean‐Charles Leblanc,
  • Detlef Wölfle,
  • Jaime Aguilera Entrena,
  • Civitella Consuelo,
  • Agnieszka Mech,
  • Salvatore Multari,
  • Vasantha Palaniappan,
  • Laura Ruggeri,
  • Camilla Smeraldi,
  • Alexandra Tard,
  • Laurence Castle

DOI
https://doi.org/10.2903/j.efsa.2023.8387
Journal volume & issue
Vol. 21, no. 12
pp. n/a – n/a

Abstract

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Abstract The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a‐d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels.

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