The Lab
Specimen No. 0227
CautionDerivedfood dyesfood natural colors

Annatto

CAS 8015-67-6 · E160b · bixin · norbixin

Natural carotenoid colour from the seeds of Bixa orellana (bixin/norbixin). Toxicologically low-concern — EFSA set acceptable daily intakes and found bixin exposure below the ADI — but rated caution because it is a documented, if uncommon, cause of IgE-mediated allergic reactions (hives, angioedema) in sensitive people.

medium confidence
Researched July 7, 2026

Concerns

  • EFSA established ADIs of 6 mg/kg bw/day for bixin and 0.3 mg/kg bw/day for norbixin; bixin exposure was below the ADI for all population groups, though norbixin could exceed its ADI at the 95th percentile under a proposed extension of use (EFSA 2016/2019)
  • Rare IgE-mediated hypersensitivity reactions (e.g., hives) have been documented in sensitive individuals, but such reactions are uncommon (EFSA 2016)

Regulatory flags

  • IARC Class: NL
  • EDC Status: None
  • Regulatory: US: permitted (colour exempt from certification); EU: permitted (E 160b), ADI bixin 6 / norbixin 0.3 mg/kg bw
  • Evidence Grade: B

Commonly found in

Cheddar cheeseButterSnacksCerealsSmoked fish

Research disclaimer: This rating is based on available peer-reviewed research and regulatory assessments at the time of publication. It is not medical advice. Consult a qualified professional for personal health or skin concerns.

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