![]() Silicon dioxide (E 551) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria are defined in the Commission Regulation (EU) No 231/2012. The Panel recommended some modifications of the EU specifications for E 551. Because of the limitations in the available database, the Panel was unable to confirm the current ADI ‘not specified’. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. Clear characterisation of particle size distribution is required. The Panel concluded that the EU specifications are insufficient to adequately characterise the food additive E 551. 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). These specifications do not exclude the presence of nanoparticles. 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. E 551 does not raise a concern with respect to genotoxicity. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. However, silicon-containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Silicon dioxide appears to be poorly absorbed. 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. The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. 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 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.
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