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FDA regulatory approach to steviol glycosides
Food and Chemical Toxicology ( IF 4.3 ) Pub Date : 2018-09-27 , DOI: 10.1016/j.fct.2018.09.062
Judith D. Perrier , Jeremy J. Mihalov , Susan J. Carlson

Stevia rebaudiana (Bertoni) Bertoni, commonly known as stevia, is a plant native to South America that has been cultivated for hundreds of years. In 1995, FDA revised its import alert on stevia leaves and extracts to allow for their use as dietary ingredients in dietary supplements. In 2007, the Joint FAO/WHO Expert Committee on Food Additives established a safe level of intake and specifications for steviol glycosides that included a minimum purity of 95% of seven named steviol glycosides. In 2008, FDA responded without questions to a Generally Recognized as Safe (GRAS) notice for the use of highly purified steviol glycosides obtained from stevia leaves as a general purpose sweetener in food. Due to the existing import alert, FDA filed, evaluated, and has not objected to more than 50 GRAS notices for the use of various high-purity steviol glycosides as sweeteners in food. In this paper, we highlight FDA's practices for filing and evaluating GRAS notices for steviol glycosides. We also provide a summary of the data and information presented in GRAS notices for steviol glycosides in the GRAS Notification program. FDA has received a new wave of GRAS notices that include alternative biotechnological methods for production of steviol glycosides.



中文翻译:

FDA对甜菊醇糖苷的监管方法

甜叶菊(Bertoni)Bertoni,俗称甜叶菊,是南美洲本土的一种植物,已经栽培了数百年。在1995年,FDA修改了其甜叶菊叶和提取物的进口警报,以允许将其用作膳食补充剂中的膳食成分。2007年,粮农组织/世卫组织食品添加剂联合专家委员会确定了甜菊糖苷的安全摄入量和规格,其中最低纯度为7种命名的甜菊糖苷的95%。在2008年,FDA对使用从甜叶菊叶获得的高度纯化的甜菊醇糖苷作为食品中的通用甜味剂使用的“公认安全”(GRAS)通知毫无疑问地做出了回应。由于存在现有的进口警报,因此FDA进行了归档,评估,并且没有反对超过50份关于使用各种高纯度甜菊醇糖苷作为食品甜味剂的GRAS通告。在本文中,我们重点介绍了FDA提交和评估GRAS声明中关于甜菊糖苷的做法。我们还提供了GRAS通知程序中有关甜菊糖苷的GRAS通知中提供的数据和信息的摘要。FDA已收到新的GRAS通知,其中包括生产甜菊醇糖苷的替代生物技术方法。

更新日期:2018-09-27
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