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, Gürtler Rainer, Mosesso Pasquale, Parent-Massin Dominique, Tobback Paul, Chrysafidis Dimitrios, Rincon Ana Maria, Tard Alexandra, Lambré Claude
EFSA J. 2018 Aug 2;16(8):e05375. doi: 10.2903/j.efsa.2018.5375. eCollection 2018 Aug.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) 'not specified' for silicon dioxide and silicates. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) recently provided a scientific opinion re-evaluating the safety of silicon dioxide (E 551) when used as a food additive. The Panel noted that the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; and no confirmed cases of kidney effects have been found in the EudraVigilance database despite the wide and long-term use of high doses of magnesium trisilicate up to 4 g/person per day over decades. However, the Panel considered that accumulation of silicon from calcium silicate in the kidney and liver was reported in rats, and reliable data on subchronic and chronic toxicity, carcinogenicity and reproductive toxicity of silicates and talc were lacking. Therefore, the Panel concluded that the safety of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives cannot be assessed. The Panel considered that there is no mechanistic rationale for a group ADI for silicates and silicon dioxide and the group ADI established by the SCF is obsolete. Based on the food supplement scenario considered as the most representative for risk characterisation, exposure to silicates (E 552-553) for all population groups was below the maximum daily dose of magnesium trisilicate used as an antacid (4 g/person per day). The Panel noted that there were a number of approaches, which could decrease the uncertainties in the current toxicological database. These approaches include - but are not limited to - toxicological studies as recommended for a Tier 1 approach as described in the EFSA Guidance for the submission of food additives and conducted with an adequately characterised material. Some recommendations for the revision of the EU specifications were proposed by the Panel.
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，重新评估硅酸钙（E 552）、硅酸镁（E 553a）和滑石粉（E 553b）用作食品添加剂时的安全性。1991年，食品科学委员会（SCF）为二氧化硅和硅酸盐确定了“未指定”的群体每日允许摄入量（ADI）。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）最近提供了一项科学意见，重新评估二氧化硅（E 551）用作食品添加剂时的安全性。该专家委员会指出，硅酸盐和滑石粉的吸收率非常低；没有迹象表明硅酸钙、硅酸镁和滑石粉具有遗传毒性或发育毒性；尽管在几十年里每天高达4克/人的大剂量三硅酸镁被广泛长期使用，但在欧洲药物警戒数据库中未发现确诊的肾脏影响病例。然而，该专家委员会认为，有报道称大鼠肾脏和肝脏中存在来自硅酸钙的硅蓄积，并且缺乏关于硅酸盐和滑石粉的亚慢性和慢性毒性、致癌性及生殖毒性的可靠数据。因此，该专家委员会得出结论，无法评估硅酸钙（E 552）、硅酸镁（E 553a(i)）、三硅酸镁（E 553a(ii)）和滑石粉（E 553b）用作食品添加剂时的安全性。该专家委员会认为，对于硅酸盐和二氧化硅设定群体ADI没有机理依据，且SCF确定的群体ADI已过时。基于被认为是风险特征描述中最具代表性的食品补充剂情况，所有人群组对硅酸盐（E 552 - 553）的暴露量低于用作抗酸剂的三硅酸镁的最大日剂量（4克/人/天）。该专家委员会指出，有多种方法可减少当前毒理学数据库中的不确定性。这些方法包括但不限于按照欧洲食品安全局食品添加剂提交指南中一级方法所建议的毒理学研究，并使用充分表征的材料进行研究。该专家委员会还针对欧盟规范的修订提出了一些建议。
