EFSA opinion · EFSA journal. European Food Safety Authority · 2012Abstract only

Beta-apo-8′-carotenal (E 160e) as a food additive re-evaluated

What it found

In rats, the lowest dose causing kidney changes was 10 mg per kg body weight per day.

The authors used that to set a new acceptable daily intake of 0.05 mg per kg body weight per day.

What they found

Studies in people

How much people take in

Estimates show adults reach the new acceptable daily intake on average and go over it at the 95th percentile. Children reach it on average and go over it at the 95th and 97.5th percentiles.

Animal and lab studies

Kidney changes in rats

In a 13-week rat study, more eosinophilic droplets appeared in the kidneys. The lowest dose causing this was 10 mg of the active ingredient per kg body weight per day.

Reproduction and development

Two studies on reproduction and development found no harmful effects at the highest dose tested, 500 mg per kg body weight per day.

Studies in people and animals

Damage to genetic material

Lab tests and animal studies did not give reason for concern about damage to genetic material.

Other findings

New acceptable daily intake

Using the kidney finding and an uncertainty factor of 200, the authors set an acceptable daily intake of 0.05 mg per kg body weight per day.

What the authors conclude

  • They concluded that the available database provides a basis to revise the acceptable daily intake.
  • They established an acceptable daily intake of 0.05 mg per kg body weight per day based on the lowest dose causing kidney changes in rats and an uncertainty factor of 200.
  • They noted that this new acceptable daily intake is reached or exceeded by some adults and children.

How it was done

The additive had been assessed before, but the earlier acceptable daily intake was withdrawn in 2000. New studies became available after a public call for data.

They looked at lab tests and animal studies, including two 13-week toxicity studies in rats and two studies on reproduction and development. They also estimated how much people might take in from food.

What it can’t tell you

  • We summarised it from the abstract only.
  • The kidney and reproduction findings come from rats, so they cannot show what happens in people.
  • The intake estimates are based on models, not on measured amounts in people.

The paper

Title
Scientific Opinion on the re-evaluation of β-apo-8'-carotenal (E 160e) as a food additive
Type
Scientific opinion of the European Food Safety Authority
Evidence
Studies in people · animals · lab
Summarised from
Abstract only
Cite
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) (2012). Scientific Opinion on the re-evaluation of β-apo-8'-carotenal (E 160e) as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2012.2499Free full textPubMed 42112002DOI

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