EU Food Safety Authority Finds Safety Risks in Baby Food Using Silica, Exposure Margins Only Reach 36!

On October 17, 2024, the latest news from the European Union Food Safety Authority (EFSA) revealed that the EU Group on Food Additives and Flavorings (FAF) has completed the reassessment of silicon dioxide (E 551) as a food additive. In particular, an in-depth review of the safety of food additives for infants under 16 weeks was conducted, and a comprehensive follow-up evaluation of their use as food additives in all populations was conducted.

According to the latest assessment report, this position paper further complements and updates the previous scientific opinion on silicon dioxide (E 551) as a food additive and covers the safety assessment for all age groups. In addition, the report focuses specifically on the risk assessment of silica (E 551) use in food for infants under 16 years of age, especially for infants under 16 weeks of age. In this assessment, the experts supplemented the traditional safety assessment with nanospecific information based on the latest available information on the SAS characteristics of the E 551 and followed the guidelines for particulate matter issued by the European Food Safety Authority in 2021.

Given the uncertainties created by the limitations of existing databases, and in the absence of genotoxicity concerns, the Panel did not consider it appropriate to arrive at an acceptable daily intake (ADI). Therefore, they used the exposure margin (MOE) method to conduct risk assessment. The Committee concluded that the MOE should be at least 36 to ensure that it does not raise safety concerns. In the 2018 reassessment, experts have considered dietary exposure estimates for all populations using improved non-brand loyalty scenarios, calculating MOEs above 36. Based on these data, the panel concluded that the E 551 does not raise safety concerns for all populations at the levels of use and use mentioned in the report.

In a specific evaluation of the use of E551 in foods for infants under 16 weeks of age, the panel confirmed that the use of E551 does not raise safety concerns at current exposure levels. In addition, the Group concluded that the technical data support the revision of the E 551 specification set out in Commission Regulation (EU) No 231/2012. However, due to the lack of toxicological studies (with the exception of genotoxicity studies) of appropriate dispersion regimens, there is some uncertainty in the current assessment of potential toxicological effects associated with exposure to E 551 nm aggregates.