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, Kovalkovicova Natalia, Rincon Ana Maria, Tard Alexandra, Lambré Claude
EFSA J. 2018 Jan 17;16(1):e05088. doi: 10.2903/j.efsa.2018.5088. eCollection 2018 Jan.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of silicon dioxide (E 551) when used as a food additive. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) 'not specified' for silicon dioxide and silicates. SAS materials used in the available biological and toxicological studies were different in their physicochemical properties; their characteristics were not always described in sufficient detail. Silicon dioxide appears to be poorly absorbed. However, silicon-containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. E 551 does not raise a concern with respect to genotoxicity. In the absence of a long-term study with nano silicon dioxide, the Panel could not extrapolate the results from the available chronic study with a material, which does not cover the full-size range of the nanoparticles that could be present in the food additive E 551, to a material complying with the current specifications for E 551. These specifications do not exclude the presence of nanoparticles. The highest exposure estimates were at least one order of magnitude lower than the no observed adverse effect levels (NOAELs) identified (the highest doses tested). The Panel concluded that the EU specifications are insufficient to adequately characterise the food additive E 551. Clear characterisation of particle size distribution is required. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. Because of the limitations in the available database, the Panel was unable to confirm the current ADI 'not specified'. The Panel recommended some modifications of the EU specifications for E 551.
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）发布了一项科学意见，重新评估二氧化硅（E 551）用作食品添加剂时的安全性。用作E 551的合成无定形二氧化硅（SAS）形式包括气相二氧化硅和水合二氧化硅（沉淀二氧化硅、硅胶和含水二氧化硅）。食品科学委员会（SCF）确定二氧化硅和硅酸盐的每日允许摄入量（ADI）为“未规定”。现有生物学和毒理学研究中使用的SAS材料在物理化学性质上有所不同；其特性描述往往不够详细。二氧化硅似乎吸收很差。然而，在一些组织中发现了含硅物质（在某些情况下推测为二氧化硅）。尽管亚慢性、生殖和发育毒理学研究存在局限性，包括纳米二氧化硅研究，但未发现不良反应迹象。E 551在遗传毒性方面不存在问题。由于缺乏纳米二氧化硅的长期研究，专家委员会无法将现有慢性研究的结果外推至符合E 551当前规格的材料，该慢性研究中的材料未涵盖食品添加剂E 551中可能存在的纳米颗粒的整个尺寸范围。这些规格并不排除纳米颗粒的存在。最高暴露估计值比确定的未观察到不良反应水平（NOAELs，测试的最高剂量）至少低一个数量级。专家委员会得出结论，欧盟规格不足以充分表征食品添加剂E 551。需要明确表征粒度分布。基于现有数据库，在报告的使用和使用水平下，没有迹象表明E 551具有毒性。由于现有数据库存在局限性，专家委员会无法确认当前的ADI“未规定”。专家委员会建议对E 551的欧盟规格进行一些修改。
