EFSA opinion · EFSA journal. European Food Safety Authority · 2018

Sodium carboxy methyl cellulose and other celluloses as food additives

What it found

In animal studies, celluloses including sodium carboxy methyl cellulose caused no cancer and showed low toxicity.

Human data show up to 6,000 mg per person per day for 8 months was well tolerated.

What they found

Studies in people

Human tolerance

People who took up to 35 grams of microcrystalline or powdered cellulose had no changes in blood tests. Patients taking up to 6,000 mg per day of some modified celluloses for 8 months tolerated them well.

Animal and lab studies

Not absorbed

Sodium carboxy methyl cellulose and other modified celluloses are not absorbed intact. They pass through the body and come out in the faeces.

Low acute toxicity

Animal studies show that these celluloses have low toxicity when eaten once. No specific harmful effects were seen in short-term studies at levels up to 10% of the diet.

No cancer in animals

Long-term animal studies found no signs that these celluloses cause cancer. The highest dose with no harmful effects was up to 9,000 mg per kg body weight per day.

No DNA damage

Lab tests and animal studies found no evidence that these celluloses damage DNA. This was true for sodium carboxy methyl cellulose and the other celluloses tested.

Reproduction unaffected

Animal studies in mice, rats, hamsters and rabbits found no harmful effects on reproduction or development at doses above 1,000 mg per kg body weight.

Gut bacteria changes

One study in mice reported that carboxy methyl cellulose changed gut bacteria, caused gut inflammation, promoted obesity and worsened blood sugar control. The authors note these effects are not routinely checked in standard toxicity tests.

Other findings

Exposure estimates

The highest daily intake from food additives for the general population was up to 506 mg per kg body weight in toddlers. The authors suggest a total daily intake of around 660 to 900 mg per kg body weight would not need further assessment.

What the authors conclude

  • They conclude that there is no need for a numerical acceptable daily intake and that there would be no safety concern at the reported uses and use levels for these celluloses.
  • They recommend that the European Commission considers lowering the maximum limits for arsenic, lead, mercury and cadmium in the specifications for these celluloses.
  • They state that the available data did not allow for an adequate assessment of the safety of sodium carboxy methyl cellulose in infants and young children consuming foods for special medical purposes.

How it was done

The European Commission asked EFSA to re-check the safety of these celluloses because they had been used as food additives for many years and needed a fresh look at all the evidence.

The authors looked at animal and human studies on ten celluloses, including sodium carboxy methyl cellulose (E 466). They examined short-term, long-term, cancer, reproductive and developmental studies, and estimated how much people eat from food.

What it can’t tell you

  • Animal studies cannot show exactly what happens in people. Human data are limited to short-term use and specific patient groups.
  • The exposure estimates are based on reported use levels. If actual use changes, these estimates may no longer be accurate.
  • The study cannot show whether these celluloses affect gut bacteria or inflammation in people, because those effects were only seen in mice.

The paper

Title
Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives
Type
Scientific opinion of the European Food Safety Authority
Evidence
Studies in people · animals · lab
Summarised from
Full text
Licence
CC BY-ND.
Cite
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Younes M, Aggett P, et al (2018). Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2018.5047Free full textPubMed 32625652DOI

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