Younes Maged, Aquilina Gabriele, Engel Karl-Heinz, J Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Gundert-Remy Ursula, Husøy Trine, Manco Melania, Mennes Wim, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Barat Jose Manuel, Degen Gisela, Herman Lieve, Leblanc Jean-Charles, Aguilera Jaime, Giarola Alessandra, Rincon Ana Maria, Smeraldi Camilla, Vianello Giorgia, Castle Laurence
EFSA J. 2022 Feb 9;20(2):e07066. doi: 10.2903/j.efsa.2022.7066. eCollection 2022 Feb.
The EFSA Panel on Food Additive and Flavourings (FAF) assessed the safety of glucosylated steviol glycosides proposed for use as a new food additive in different food categories. Glucosylated steviol glycosides consist of a mixture of glucosylated steviol glycosides, containing 1-20 additional glucose units bound to the parent steviol glycosides. Glucosylated steviol glycosides consist of not less than 95% (on dry, dextrin-free, basis) of total steviol glycosides, comprised of glucosylated and parent steviol glycosides. Glucosylated steviol glycosides are produced via enzymatic bioconversion using cyclomaltodextrin glucanotransferase (CGTase) (EC 2.4.1.19), derived from a non-genetically modified strain of that catalyses the transfer of glucose from starch to steviol glycosides mixtures isolated from the dried leaves of . The Panel considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus, the toxicological data previously assessed by the ANS Panel for steviol glycosides (E 960) were considered to support their safety as food additive. The existing acceptable daily intake (ADI) for steviol glycosides (E 960) of 4 mg/kg body weight (bw) per day expressed as steviol can also be applied to glucosylated steviol glycosides. The Panel concluded that there is no safety concern for the use of glucosylated steviol glycosides as a new food additive at the proposed use and use levels. The Panel recommended some modifications to the specifications proposed by the applicant for glucosylated steviol glycosides with respect to the assay, the definition of the proposed new food additive and the proposed maximum limits for arsenic.
欧洲食品安全局食品添加剂和调味剂小组(FAF)评估了拟用作不同食品类别中新食品添加剂的葡萄糖基化甜菊糖苷的安全性。葡萄糖基化甜菊糖苷由葡萄糖基化甜菊糖苷混合物组成,其中含有1至20个额外的葡萄糖单元连接到母体甜菊糖苷上。葡萄糖基化甜菊糖苷按干基、无糊精计,总甜菊糖苷含量不少于95%,包括葡萄糖基化甜菊糖苷和母体甜菊糖苷。葡萄糖基化甜菊糖苷是通过使用环糊精葡糖基转移酶(CGTase)(EC 2.4.1.19)进行酶促生物转化生产的,该酶来源于一种非转基因菌株,可催化葡萄糖从淀粉转移至从[植物名称]干叶中分离出的甜菊糖苷混合物。该小组认为,葡萄糖基化甜菊糖苷的代谢与已获批准的甜菊糖苷充分相似,因此,ANS小组先前评估的甜菊糖苷(E 960)毒理学数据被认为可支持其作为食品添加剂的安全性。以甜菊醇计的甜菊糖苷(E 960)现有的每日允许摄入量(ADI)为每天4毫克/千克体重,也可应用于葡萄糖基化甜菊糖苷。该小组得出结论,在所提议的使用范围和使用水平下,将葡萄糖基化甜菊糖苷用作新食品添加剂不存在安全问题。该小组建议对申请人提出的葡萄糖基化甜菊糖苷规范进行一些修改,涉及含量测定、拟议新食品添加剂的定义以及砷的拟议最大限量。