EFSA opinion · EFSA journal. European Food Safety Authority · 2020

Dimethylpolysiloxane (E 900) as a food additive re-evaluated

What it found

In animal studies, dimethylpolysiloxane caused eye changes only where it touched the eye directly, not through the body.

The authors set a new acceptable daily intake of 17 mg per kg of body weight per day.

What they found

Animal and lab studies

Eye effects in rats

Corneal opacities and other eye changes were seen in rats. These were caused by direct contact with the substance in feed or faeces, not by it reaching the eye through the body.

No body-wide effects

The Panel considered that taking dimethylpolysiloxane by mouth did not cause any harmful effects throughout the body in any species or dose tested.

New acceptable daily intake

From a 26-month rat study, a level of 1,742 mg per kg body weight per day for females and 2,055 mg per kg body weight per day for males was found with no harmful effects. Using the female value and a 100-fold safety factor, the Panel set an acceptable daily intake of 17 mg per kg body weight per day.

Damage to genetic material

The Panel found no concern about dimethylpolysiloxane (E 900) damaging genetic material.

Studies in people and animals

Absorption and excretion

In mice, rats, monkeys and people, only a very small amount of dimethylpolysiloxane was taken in from the gut. More than 99.9% passed out unchanged in the faeces.

Other findings

Exposure estimates

For all population groups and all scenarios, the estimated daily intake from food did not go above the new acceptable daily intake of 17 mg per kg body weight per day.

What the authors conclude

“The Panel concluded that there is not a safety concern at the reported uses and use levels for dimethyl polysiloxane (E 900).”
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al, 2020

Also in their conclusions

  • They concluded that there is not a safety concern at the reported uses and use levels for dimethyl polysiloxane (E 900).
  • They withdrew the previous acceptable daily intake of 1.5 mg/kg body weight per day set by the Scientific Committee on Food in 1990.
  • They recommended that EU specifications be amended, including setting limits for cyclopolysiloxanes and copper, lowering limits for toxic elements, and revising the name to poly(dimethylsiloxane).

How it was done

The European Commission asked the Panel to re-evaluate the safety of dimethylpolysiloxane (E 900) as a food additive, taking into account new scientific information since the last evaluation.

The Panel reviewed existing studies in animals and people, including a 26-month toxicity study in rats, and estimated how much people eat from foods containing E 900.

What it can’t tell you

  • The safety assessment relies mostly on animal studies. They cannot show exactly what happens in people.
  • The exposure estimates are based on food consumption data and reported use levels, not on actual measurements in people's bodies.

The paper

Title
Re-evaluation of dimethyl polysiloxane (E 900) as a food additive
Type
Scientific opinion of the European Food Safety Authority
Evidence
Studies in people · animals · lab
Summarised from
Full text
Cite
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (2020). Re-evaluation of dimethyl polysiloxane (E 900) as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2020.6107Free full textPubMed 37649521DOI

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