Recent evaluation of the safety of Synthetic Amorphous Silica (SAS) as food additive (E551) by the European Food Safety Authority (EFSA), October 2024

Subject of investigation

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

 

Core statements

  • 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 under 16 weeks of age does not raise a safety concern at the current exposure levels.

 

The substance

E 551 is industrially produced amorphous silicon dioxide, also known as synthetic amorphous silica (SAS). Over the decades, two production methods (wet chemical and pyrogenic) have become established, for which the resulting E 551 products are chemically identical. The food additive is available for downstream processing as a powder.

 

Results in detail

  • The present EFSA opinion provides an updated safety assessment of the food additive E 551 for all age groups, including safety in food for infants under 16 weeks of age. It has taken into account all new relevant data available to EFSA since the completion of the re-evaluation of E 551 in 2018.
  • Dietary exposure to silicon dioxide (E 551) for the general population was estimated at the time of the EFSA re-evaluation in 2018. This suggests a maximum value of 50 mg per kg body weight per day. This is at least one order of magnitude lower than the doses administered in toxicological studies without adverse effects.
     
  • The exposure to E 551 for infants below 16 weeks of age was estimated at the maximum use levels as 3 mg/kg bw per day for the high consumption in both infant formulae and in special infant formulae for medical purposes.
  • EFSA has carried out this safety assessment with an evaluation of all particle sizes. The latest technical data provided by the manufacturers of silicon dioxide was sufficient to clarify open points since the completion of the re-evaluation of the food additive in 2018.
  • Based on the currently available data set, the panel concluded that E 551 does not raise a concern for genotoxicity. The Panel also considered that the conclusion on genotoxicity is applicable to nano aggregates present in E 551.
  • The Panel considered it likely that E 551 has no adverse effects on the human organism.
  • E 551, just like other dietary sources, may contain impurities such as traces of lead, mercury, or aluminum. To limit the exposure of the European Union’s population to toxic elements, EFSA recommended that the existing specifications on E 551 should be amended by lowering the maximum limits for lead, mercury, and arsenic in E 551 and setting a maximum limit for aluminum.

 

Type of study

Meta study: The authors have reassessed the safety of E 551 in accordance with the regulatory requirements of the EU and based on the current scientific literature and the opinions of the industry. Such reassessments are part of the re-evaluation program for food additives authorized in the European Union before 2009, or in case of new scientific findings.

 

About the authors

The Scientific Panel on Food Additives and Flavourings assesses the safety of chemical substances added to foods and the exposure of consumers to these substances. The Panel’s work concerns mainly those substances assessed by the European Food Safety Authority (EFSA) before their use in the EU can be permitted. The members of the Panel are scientists from Europe with specific expertise in the relevant areas.

 

Original publication:

EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes, M., Aquilina, G., Castle, L., Degen, G., Engel, K.-H., Fowler, P., Frutos Fernandez, M.J., Fürst, P., Gürtler, R., Husøy, T., Manco, M., Mennes, W., Moldeus, P., Passamonti, S., Shah, R., Waalkens-Berendsen, I., Wright, M., Andreoli, C., … Gundert-Remy, U. (2024). 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. EFSA Journal, 22(10), e8880. https://doi.org/10.2903/j.efsa.2024.8880