经过评估,专家小组得出结论,在建议的用途和使用水平下,由解脂耶氏酵母发酵生产的甜菊糖苷作为食品添加剂不存在安全问题。部分原文报道如下:
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 co
ncluded 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 co
nsidered that the demo
nstration 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 co
ncerns for potential genotoxicity. Given that all steviol glycosides follow the same me
tabolic pathways, the Panel co
nsidered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel co
nsidered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar me
tabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micro
nucleus 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 co
nsidered to be applicable to the proposed food additive. The Panel co
ncluded that there is no safety co
ncern 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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