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

Annatto E colouring and how much people take in

What it found

The authors say the food colour annatto E does not raise concern for damage to genes.

They also checked how much bixin and norbixin people take in from food.

What they found

Animal and lab studies

Damage to genes

The panel concluded that the food colour annatto E does not raise concern for damage to genes. Because of this, the daily limits set in 2016 for bixin and norbixin can also be used for annatto E.

Other findings

Bixin intake

For bixin, none of the intake estimates went above the daily limit of 6 mg per kg of body weight per day. This held for all groups of people and all the ways the scientists worked out the numbers, including the proposed new uses.

Norbixin intake

For norbixin, the daily limit was reached at the high level for toddlers in one country, in the refined intake estimates. The panel said the real intake is very likely lower than these estimates.

Overall view

Taking into account the uncertainties and the very likely overestimation of intake, the panel concluded that the level of intake does not raise a health concern.

What the authors conclude

“the Panel concluded that the level of exposure does not raise a health concern”
EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel), Younes M, Castle L, et al, 2019

Also in their conclusions

  • They concluded that food colour annatto E does not raise concern for genotoxicity.
  • They say the acceptable daily intakes established in 2016 for bixin and norbixin can also be applied to annatto E.
  • They concluded that the level of exposure does not raise a health concern.

How it was done

The panel looked again at annatto E because of new proposed uses and higher use levels. They wanted to see whether people's intake of the colouring principles bixin and norbixin stays within the daily limits set in 2016.

They estimated how much annatto, bixin and norbixin people take in from food, using the maximum levels set in the rules, levels given by the food industry, and new proposed levels from a company wanting to use more. They looked at different groups of people and at high intake levels.

What it can’t tell you

  • We summarised it from the abstract only.
  • The intake estimates are based on assumptions about how much of the colouring is in foods and how much people eat. The real amounts could be lower.
  • The panel could not conclude on the safety of annatto E in 2016, but this opinion addresses that gap.

The paper

Title
Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive
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 Flavourings (EFSA FAF Panel), Younes M, Castle L, et al (2019). Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2019.5626Free full textPubMed 32626252DOI

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