Annatto
The question

Is Annatto safe in cereal?

CautionCereal

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.

What the research flags

  • 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
IARC Class: NL

Other cereal ingredients on file

Sources & references

  1. [1]
    Peer-reviewedPeer-reviewed journal — j.efsa.2016.4544
  2. [2]
    Peer-reviewedPeer-reviewed journal — j.efsa.2019.5626

Research disclaimer: Ratings reflect peer-reviewed research and regulatory assessments available at the time of publication, not the dose or formulation of any specific cereal product. This is not medical advice.