EFSA opinion · EFSA journal. European Food Safety Authority · 2024Abstract onlyConflicts declared

Silicon dioxide (E 551) as a food additive for all ages

What it found

The authors say silicon dioxide (E 551) does not raise a safety concern in all population groups at the reported uses and use levels.

This includes its use in food for infants below 16 weeks of age.

What they found

Animal and lab studies

Uncertainty from studies

The authors say there are few toxicological studies with a proper dispersion protocol, apart from the studies on damage to genetic material. This creates uncertainty in the assessment of potential toxicological effects from exposure to E 551 nanosize aggregates.

Other findings

Margin of exposure

The authors say the margin of exposure should be at least 36 for there to be no safety concern. The calculated margins of exposure for all population groups were all above 36.

Safety in all groups

The authors concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels.

Infants below 16 weeks

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.

Specifications amendment

The authors concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012.

What the authors conclude

“The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels.”
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al, 2024

Also in their conclusions

  • They concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels.
  • They concluded that 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.
  • They 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.

How it was done

The paper follows up on earlier conclusions and recommendations about silicon dioxide (E 551) as a food additive, and looks at its use in food for infants below 16 weeks of age.

The authors looked at new information on the characterisation of the silicon dioxide used as E 551 and applied nano-specific considerations alongside the conventional safety assessment. They used a margin of exposure approach instead of setting an acceptable daily intake, because of uncertainties from the limits of the database.

What it can’t tell you

  • We summarised it from the abstract only.
  • The authors note that few toxicological studies used a proper dispersion protocol, apart from the studies on damage to genetic material, which creates uncertainty in the assessment.
  • The paper does not set an acceptable daily intake, so it cannot say what amount of E 551 would be considered acceptable each day.

The paper

Title
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
Type
Scientific opinion of the European Food Safety Authority
Evidence
Animals and lab studies
Summarised from
Abstract only
Cite
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (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. European Food Safety Authority. doi:10.2903/j.efsa.2024.8880Free full textPubMed 39421729DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error