2018年10月10日,欧盟食品安全局(EFSA)发布与脂肪酸一甘油酯氧化的大豆油和与脂肪酸二甘油酯氧化的大豆油(E479b)作为食品添加剂安全性的评估结果。
欧盟食品添加剂和调味剂小组( FAF )经过评估后,认为现有的毒理学数据不足以支持目前需要进行ADME和发育毒理学研究的每日容许摄入量(ADI)。
部分原文报道如下:
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted.