PMID 39421729 Re-evaluation of silicon dioxide (E 551) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as a food additive for uses in foods for all population groups Agency follow-up opinion · EFSA Journal, 2024 Applied a margin of exposure approach. All population groups clear the threshold of 36, so no safety concern. Uncertainty from the lack of dispersion protocols remains.
Key summary
A follow-up to the conclusions and recommendations of the 2018 re-evaluation of silicon dioxide (E 551), together with a risk assessment for its use in food for infants below 16 weeks of age. Using newly available characterisation data for the synthetic amorphous silica used as E 551 and following the principles of the 2021 EFSA guidance on particles, the conventional safety assessment was complemented with nano-specific considerations. Given the uncertainties from database limitations and the absence of a genotoxicity concern, the panel applied a margin of exposure approach rather than deriving an intake limit, and concluded the margin should be at least 36. Margins calculated from the refined non-brand-loyal exposure estimates of the 2018 re-evaluation exceeded 36 for all population groups. The conclusion is no safety concern for any population group at reported uses, and none for infants below 16 weeks in food categories 13.1.1 and 13.1.5.1 at current exposure levels. The panel noted, however, that apart from the genotoxicity studies the paucity of studies with a proper dispersion protocol creates uncertainty about the effects of exposure to nanosize aggregates.
Show original abstract
The present opinion is the follow-up of the conclusions and recommendations of the Scientific Opinion on the re-evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle-TR, the conventional safety assessment has been complemented with nano-specific considerations. Given the uncertainties resulting from the limitations of the database and in the absence of genotoxicity concern, the Panel considered that it is not appropriate to derive an acceptable daily intake (ADI) but applied the margin of exposure (MOE) approach for the risk assessment. The Panel concluded that the MOE should be at least 36 for not raising a safety concern. The calculated MOEs considering the dietary exposure estimates for all population groups using the refined non-brand loyal scenario, estimated at the time of the 2018 re-evaluation, were all above 36. The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels. The use of E 551 in food for infants below 16 weeks of age in FC 13.1.1 and FC 13.1.5.1 does not raise a safety concern at the current exposure levels. The Panel also concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012. The paucity of toxicological studies with proper dispersion protocol (with the exception of the genotoxicity studies) creates uncertainty in the present assessment of the potential toxicological effects related to the exposure to E 551 nanosize aggregates. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 32625658 Re-evaluation of silicon dioxide (E 551) as a food additive Agency re-evaluation opinion · EFSA Journal, 2018 Could not confirm the existing intake limit because the specifications do not characterise particle size distribution. No indication of toxicity at reported uses, however.
Key summary
An EFSA Panel opinion re-evaluating silicon dioxide (E 551). The forms of synthetic amorphous silica used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel, and hydrous silica). The Scientific Committee on Food had established a group intake limit of 'not specified' for silicon dioxide and silicates. The materials used in the available biological and toxicological studies differed in their physicochemical properties and were not always described in sufficient detail. Silicon dioxide appears to be poorly absorbed, though silicon-containing material was found in some tissues. Despite limitations in the subchronic, reproductive, and developmental studies, including those with nano silicon dioxide, there was no indication of adverse effects, and no genotoxicity concern. In the absence of a long-term study with nano silicon dioxide the panel could not extrapolate the available chronic study to a material complying with the current specifications, which do not exclude the presence of nanoparticles. The highest exposure estimates were at least an order of magnitude below the identified no observed adverse effect levels. The panel concluded that the EU specifications are insufficient to adequately characterise the additive, that clear characterisation of particle size distribution is required, that there was no indication of toxicity at the reported uses, and that because of database limitations it could not confirm the current intake limit.
Show original abstract
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. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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