Annatto colouring E 160b and how much people eat
What it found
The amount of bixin eaten stayed below the acceptable daily intake for all groups.
For norbixin, the amount eaten went above the acceptable daily intake at the high level for toddlers and children.
What they found
Bixin stayed below the limit
The estimated exposure to bixin did not go above the acceptable daily intake of 6 mg per kg body weight per day for any population group or any scenario.
Norbixin went above the limit
The estimated exposure to norbixin went above the acceptable daily intake of 0.3 mg per kg body weight per day at the high level for toddlers and children.
Toddlers had the highest amounts
In the maximum scenario, the average exposure to bixin was highest in toddlers at 0.52 mg per kg body weight per day. The high level for bixin in toddlers was 1.05 mg per kg body weight per day.
Main food sources
The main foods contributing to norbixin exposure were unripened cheese, soups and broths, fine bakery wares, flavoured fermented milk products and sauces.
Extra norbixin from bixin extracts
If the natural level of norbixin in bixin-based extracts is raised from 2.5% to 5%, and both are used in the same foods, this would add 0.026 to 0.052 mg per kg body weight per day to norbixin exposure for toddlers at the high level.
What the authors conclude
“EFSA concluded that the estimated exposure to bixin-based annatto extract does not exceed the ADI of 6 mg bixin/kg bw in any of the scenarios carried out.”
Also in their conclusions
- They concluded that the estimated exposure to bixin-based annatto extract does not exceed the acceptable daily intake of 6 mg bixin per kg body weight in any scenario.
- They concluded that the estimated exposure to norbixin-based annatto extract at the proposed uses and maximum use levels would exceed the acceptable daily intake of 0.3 mg norbixin per kg body weight per day at the high level for toddlers and children.
- They considered the non-brand-loyal scenario as the more appropriate and realistic for risk characterisation, and in that scenario the acceptable daily intake for norbixin would be exceeded only at the high level for toddlers in one survey and children in one survey.
How it was done
New uses and use levels for annatto extracts were proposed after the 2016 safety opinion, so the European Commission asked EFSA to work out how much bixin and norbixin people would eat.
EFSA combined food consumption data from 33 dietary surveys in 19 European countries with proposed maximum use levels and reported use levels for bixin and norbixin. They estimated exposure for infants, toddlers, children, adolescents, adults and the elderly.
What it can’t tell you
- This is an exposure assessment, so it estimates how much bixin and norbixin people might eat from food. It does not measure actual amounts in people's bodies or any health effects.
- The estimates rely on food consumption surveys and proposed or reported use levels, so they carry uncertainties. Some food categories could not be matched to consumption data, which may lead to under- or over-estimates.
The paper
- Title
- Exposure assessment of annatto colouring principles bixin and norbixin (E 160b) when used as food additives
- Type
- Scientific opinion of the European Food Safety Authority
- Summarised from
- Full text
- Cite
- European Food Safety Authority (EFSA), Tard A (2017). Exposure assessment of annatto colouring principles bixin and norbixin (E 160b) when used as food additives. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2.17.4966Free full textPubMed 32625627DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error