Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Dusemund Birgit, Filipič Metka, Frutos Maria Jose, Galtier Pierre, Gott David, Gundert-Remy Ursula, Kuhnle Gunter Georg, Leblanc Jean-Charles, Lillegaard Inger Therese, Moldeus Peter, Mortensen Alicja, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Boon Polly, Chrysafidis Dimitrios, Gürtler Rainer, Mosesso Pasquale, Parent-Massin Dominique, Tobback Paul, Cascio Claudia, Rincon Ana Maria, Lambré Claude
EFSA J. 2018 Mar 2;16(3):e05180. doi: 10.2903/j.efsa.2018.5180. eCollection 2018 Mar.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) 'not specified' for the fatty acids (myristic-, stearic-, palmitic- and oleic acid) and their salts. The sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations. There were no data on subchronic toxicity, chronic toxicity, reproductive and developmental toxicity of the salts of fatty acids. There was no concern for mutagenicity of calcium caprylate, potassium oleate and magnesium stearate. From a carcinogenicity study with sodium oleate, a no observed adverse effect level (NOAEL) could not be identified but the substance was considered not to present a carcinogenic potential. Palmitic- and stearic acid which are the main fatty acids in E 470a and E 470b were already considered of no safety concern in the re-evaluation of the food additive E 570. The fatty acid moieties of E 470a and E 470b contributed maximally for 5% to the overall intake of saturated fatty acids from all dietary sources. Overall, the Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels.
欧洲食品安全局食品添加剂和添加到食品中的营养源专家委员会（ANS）提供了一项科学意见，重新评估脂肪酸的钠盐、钾盐和钙盐（E 470a）以及脂肪酸的镁盐（E 470b）用作食品添加剂时的安全性。1991年，食品科学委员会（SCF）为脂肪酸（肉豆蔻酸、硬脂酸、棕榈酸和油酸）及其盐类确定了一个“未指定”的群体每日允许摄入量（ADI）。脂肪酸的钠盐、钾盐、钙盐和镁盐预计会在胃肠道中解离为脂肪酸羧酸盐及其相应的阳离子。关于脂肪酸盐的亚慢性毒性、慢性毒性、生殖和发育毒性，没有相关数据。辛酸钙、油酸钾和硬脂酸镁的致突变性无需担忧。从油酸钠的致癌性研究中，无法确定无观察到有害作用水平（NOAEL），但该物质被认为不具有致癌潜力。E 470a和E 470b中的主要脂肪酸棕榈酸和硬脂酸在食品添加剂E 570的重新评估中已被认为不存在安全问题。E 470a和E 470b的脂肪酸部分对所有膳食来源中饱和脂肪酸总摄入量的贡献最大为5%。总体而言，专家委员会得出结论，无需设定数值ADI，并且脂肪酸的钠盐、钾盐、钙盐和镁盐（E 470a和E 470b）在报告的使用和使用水平下不存在安全问题。
