EFSA opinion · EFSA journal. European Food Safety Authority · 2019

Potassium sorbate and sorbic acid: rat study sets new intake level

What it found

In rats fed sorbic acid, the clearest effect was lower weight gain in the second-generation pups.

From this, the authors set a new group intake level of 11 mg per kg of body weight per day for sorbic acid and potassium sorbate.

What they found

Animal and lab studies

Pup weight gain

Weight gain in the second-generation pups was lower in the mid- and high-dose groups. The authors treated this as the most relevant effect and used it to set the new intake level.

Parent body weight

Parent females in the mid- and high-dose groups gained less weight during pregnancy and nursing. They also ate less food.

Cholesterol levels

Cholesterol in the blood was higher in parent females in the mid- and high-dose groups. It was also higher in first-generation males and females in the high-dose group.

Organ weights

Liver weight went up in parent and first-generation males. Ovary and uterus weights went down in first-generation females in the high-dose group.

Reproductive measures

Fertility, mating, sperm, oestrous cycles and litter size were unaffected. The effect on anogenital distance seen in an earlier study was not confirmed.

Other findings

Stability in food

The industry report gave no new information on breakdown products formed during processing and storage. The authors did not reassess earlier conclusions on this.

What the authors conclude

  • They changed the temporary group intake level of 3 mg sorbic acid per kg of body weight per day to a new group intake level of 11 mg sorbic acid per kg of body weight per day for sorbic acid (E 200) and its potassium salt (E 202).
  • They considered that the most realistic exposure estimates come from reported use levels and analytical data in a non-brand-loyal scenario.
  • They noted that the highest estimates for children aged 3 to 9 were 1.7 mg per kg of body weight per day at the mean and 3.7 mg per kg of body weight per day at the highest levels.

How it was done

The European Commission asked EFSA to look at a new rat study and decide whether the temporary group intake level for sorbic acid and potassium sorbate, set in 2015, should be reconsidered. It also asked EFSA to review an industry report on how these substances hold up during food processing and storage.

They assessed an extended one-generation reproductive toxicity study in CD/Crl:CD rats, with sorbic acid given in the diet at 0, 15,000, 30,000 and 60,000 mg per kg of diet. They also reviewed an industry report summarising published studies on the stability and breakdown products of sorbic acid and potassium sorbate in food.

What it can’t tell you

  • These are animal studies. They cannot show what happens in people.
  • The study did not test effects on the nervous system or the immune system, because those groups were left out.
  • The report on stability in food gave no new data, so questions about breakdown products in real foods remain open.

The paper

Title
Opinion on the follow-up of the re-evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives
Type
Scientific opinion of the European Food Safety Authority
Evidence
Animals and lab studies
Summarised from
Full text
Cite
EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (2019). Opinion on the follow-up of the re-evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2019.5625Free full textPubMed 32626251DOI

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