Annatto
Annatto is a yellow-orange color made from the seeds of the achiote tree. It is used in foods such as cheese, butter and snacks. Its main pigments, bixin and norbixin, suit different types of foods and have distinct safety limits.
Also known as
annatto extract · annatto color · annatto colour · annatto bixin · annatto norbixin · bixin · norbixin · achiote · roucou · E 160b
Why PRūF tracks it
Annatto can cause hives, swelling or a serious allergic reaction in susceptible people, while differing pigment preparations and intake limits require care when judging exposure; the frequency of allergy remains uncertain.
Read the research
Annatto food colors contain bixin or norbixin in preparations that differ in composition and processing. EFSA set separate acceptable daily intakes of 6 milligrams per kilogram of body weight for bixin and 0.3 for norbixin in the assessed preparations; these values cannot be treated as one limit for every annatto extract. A later assessment resolved an earlier DNA-damage uncertainty for aqueous-processed annatto E and found the modeled exposure did not raise a health concern, including a toddler estimate near the norbixin limit. Allergy is the clearest issue for an affected person: hives, swelling and anaphylaxis have been reported, and a controlled oral challenge confirmed a reaction in a selected patient.
The true frequency is uncertain, and those cases do not show a common population risk. FDA permits annatto subject to manufacturing and residue conditions while considering petitions about three older extraction solvents. Those petitions concern manufacturing permissions; they do not establish that a particular food contains those solvents or that annatto pigments are broadly harmful. A 2026 cohort found a diabetes association in lower annatto consumers, but the estimate for higher consumers included no difference, leaving the pattern uncertain and unproven as a causal effect.
Research reviewed on September 5, 2026 · 12 sources
Matches
505–516 of 788 matches
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Research sources
The published research used in the PRūF app.
- 21 CFR 73.30 — Annatto extract
FDA / eCFR · Current through 2026-09-03 · Accessed 2026-09-05
- Regulatory Status of Color Additives — Annatto Extract / Annatto
FDA · 2026-08-14 · Accessed 2026-09-05
- The safety of annatto extracts (E 160b) as a food additive
EFSA · 2016-08-24 · Accessed 2026-09-05
- Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive
EFSA · 2019-03-13 · Accessed 2026-09-05
- A thirteen-week oral toxicity study of annatto extract (norbixin), a natural food color extracted from the seed coat of annatto (Bixa orellana L.), in Sprague-Dawley rats
Hagiwara et al. / Food and Chemical Toxicology · 2003 · Accessed 2026-09-05
- Anaphylaxis to annatto dye: a case report
Nish et al. / Annals of Allergy · 1991-02 · Accessed 2026-09-05
- Reactions after natural and artificial food additives in urticaria: should we pretend they do not exist?
Sadowska et al. / Alergologia Polska · 2022-04/06 · Accessed 2026-09-05
- Annatto extracts evaluation
WHO / JECFA · 2006 evaluation · Accessed 2026-09-05
- Filing of Color Additive Petition From IACM; Request To Remove Three Extraction Solvents
FDA / Federal Register · 2026-04-01 · Accessed 2026-09-05
- Color Additive Petition From Environmental Defense Fund et al.; Reopening of the Comment Period
FDA / Federal Register · 2026-05-28 · Accessed 2026-09-05
- Commission Regulation (EU) 2020/771 as regards Annatto, Bixin, Norbixin (E 160b)
European Commission · 2020-06-12 · Accessed 2026-09-05
- Food Coloring Additives and Incidence of Type 2 Diabetes in the NutriNet-Santé Prospective Cohort
Shah et al. / Diabetes Care · 2026 · Accessed 2026-09-05
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