이산화규소 (실리카)

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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.

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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.