Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Gundert-Remy Ursula, Husøy Trine, Mennes Wim, Moldeus Peter, Oskarsson Agneta, Rainieri Sandra, Shah Romina, Waalkens-Berendsen Dina Hendrika, Wölfle Detlef, Boon Polly, Parent-Massin Dominique, Tobback Paul, Wright Matthew, Chrysafidis Dimitrios, Rincon Ana Maria, Tard Alexandra, Lambré Claude
EFSA J. 2018 Oct 10;16(10):e05420. doi: 10.2903/j.efsa.2018.5420. eCollection 2018 Oct.
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. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.
欧洲食品安全局食品添加剂和调味剂小组（FAF）提供了一份科学意见，重新评估了热氧化大豆油与脂肪酸单甘油酯和二甘油酯相互作用产物（TOSOM，即E 479b）作为食品添加剂时的安全性。食品科学委员会（SCF）和粮农组织/世卫组织食品添加剂联合专家委员会（JECFA）分别得出的每日允许摄入量（ADI）为25毫克/千克体重和30毫克/千克体重。关于TOSOM的吸收、分布、代谢、排泄（ADME）没有可靠信息。在一项针对猪的有限亚慢性毒性研究中未检测到不良反应。该小组在一项大鼠慢性和致癌性研究中确定未观察到不良反应水平（NOAEL）为5400，这是测试的最高剂量。没有遗传毒性数据。没有关于生殖或发育毒性的可靠研究。从慢性和致癌性研究来看，未描述生殖器官的病变，并且致癌作用的缺乏减轻了对接触部位最初的遗传毒性的担忧。该小组得出结论，现有的毒理学数据不足以支持当前的ADI，特别是由于缺乏ADME数据以及没有发育毒性研究。TOSOM（E 479b）仅在一个食品类别中获得授权，并且仅提交了一个等于最大允许水平的报告使用水平。幼儿的估计高暴露量（P95）达到每天10.1毫克/千克体重的上限值。将幼儿每天估计的最高暴露量10毫克/千克体重与每天5400毫克/千克体重的NOAEL（测试的最高剂量）进行比较时，则安全边际（MoS）为540。因此，该小组认为使用TOSOM（E 479b）不存在安全问题，特别是考虑到这种食品添加剂目前的使用有限。该小组还建议对E 479b的欧盟规格进行一些修改。
