PMID 38125973 Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolytica VRM Agency safety evaluation · EFSA Journal, 2023 The fermentation route can leave different impurities, so separate specifications are required. Absence of kaurenoic acid (LOD 0.3 mg/kg) dispels the genotoxicity concern. The 4 mg/kg limit applies.
Key summary
An EFSA Panel opinion on the safety of a new process producing steviol glycosides by fermenting simple sugars with a genetically modified strain of Yarrowia lipolytica (Y. lipolytica VRM). Because the manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a-d, the panel concluded that separate specifications are required for the additive produced as described in the application. Viable cells and DNA from the production strain are not present in the final product. Demonstrating the absence of kaurenoic acid with a method having a detection limit of 0.3 mg/kg was considered adequate to dispel the potential genotoxicity concern. Since all steviol glycosides follow the same metabolic pathways, the current ones were considered to fall within the same group of substances, so existing data on rebaudioside M and structurally related glycosides were judged sufficient with a similar metabolic fate and toxicity expected. The bacterial reverse mutation assay and the in vitro micronucleus assay were both negative. The existing intake limit of 4 mg/kg expressed as steviol equivalents was considered applicable, and the panel concluded there is no safety concern at the proposed uses and use levels.
Show original 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. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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