Sorbitan tristearate and related sorbitan esters as food additives
What it found
The authors set a group daily intake limit of 10 mg per kg body weight for sorbitan esters including sorbitan tristearate, and estimated that usual and high intakes stay below it.
The work looked at how the body handles these additives and at lab tests for gene damage.
What they found
Animal and lab studies
How the body handles it
After being taken in, sorbitan monostearate can be broken down into its fatty acid part and sorbitol anhydrides, which leave the body in urine or breath, or it can pass out intact in faeces.
Gene damage tests
The authors considered that sorbitan esters did not raise concern for damage to genes in the tests they looked at.
Other findings
New group daily limit
The authors set a group acceptable daily intake of 10 mg per kg body weight per day, expressed as sorbitan, for sorbitan esters E 491 to E 495 taken singly or together. This is equivalent to 26 mg sorbitan monostearate per kg body weight per day.
Intake estimates
Using a non-brand-loyal scenario, estimated intakes at the average and at the 95th percentile level did not go above the new daily limit in any population group.
Older daily limits
Earlier, in 1974, a daily limit of 25 mg per kg body weight was set for E 491, E 492 and E 495 singly or together, and a separate group limit of 5 mg per kg body weight was set for E 493 and E 494 singly or together.
Specification change
The authors concluded that the 'congealing range' specification could eventually be replaced by another identification parameter such as melting point.
What the authors conclude
“The Panel concluded that the exposure at the mean and the 95th percentile level, using non-brand-loyal scenario, did not exceed the ADI in any of the population groups.”
Also in their conclusions
- They derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491-495) singly or in combination.
- They concluded that the exposure at the mean and the 95th percentile level, using non-brand-loyal scenario, did not exceed the ADI in any of the population groups.
- They concluded that the 'congealing range' could be eventually replaced by another identification parameter such as melting point.
How it was done
The authors re-evaluated the safety of these sorbitan esters when used as food additives, updating earlier limits set in 1974.
They reviewed how sorbitan monostearate is processed by the body after being taken in, looked at lab tests for gene damage, and used a no observed adverse effect level of 2,600 mg per kg body weight per day from animal studies to set a new group daily intake limit. They then compared estimated intakes across population groups with this limit.
What it can’t tell you
- We summarised it from the abstract only.
- This is a safety re-evaluation based on existing data, not a new study in people. It cannot show what happens with long-term use in real life.
- The intake estimates rely on assumptions about how much people eat and drink, so they cannot give exact amounts for any one person.
The paper
- Title
- Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives
- 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 Nutrient Sources added to Food (ANS), Mortensen A, Aguilar F, et al (2017). Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2017.4788Free full textPubMed 32625491DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error