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E160bColorantLow concern

Annatto

In plain words

The short version

A natural orange-red colorant from achiote seeds — generally safe but a documented allergen.

Why it's green

It's widely considered safe at the amounts used in food, so we mark it green. The Safety section below has the details.

Safety

Safety profile

EFSA set an ADI of 6 mg/kg body weight per day for bixin and 0.3 mg/kg body weight per day for norbixin (2016; applied again in its 2019 opinion). JECFA's ADIs are 0–12 mg/kg body weight for bixin and 0–0.6 mg/kg body weight for norbixin. A documented if uncommon allergen — can cause urticaria, angioedema, and rare anaphylaxis. Annatto is not on the EU list of allergens that require specific labelling (Annex II of Regulation (EU) No 1169/2011).

The detail

Sources

  1. EFSA — Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) (2019) — EFSA (EFSA Journal 2019;17(3):5626, PMC copy), 2019. EFSA ADIs: bixin 6 mg/kg bw/day, norbixin 0.3 mg/kg bw/day (set 2016, applied 2019)
  2. WHO JECFA database — Annatto extracts (INS 160b) — WHO / JECFA, 2006. JECFA ADIs: bixin 0–12, norbixin 0–0.6 mg/kg bw
  3. EUR-Lex — Regulation (EC) No 1333/2008, consolidated text 18.08.2026 (Annex II; E 160b split by Reg. (EU) 2020/771) — EUR-Lex (European Union), 2026. EU numerical maximum levels for E 160b(i) and E 160b(ii)
  4. 21 CFR 73.30 — Annatto extract (color additive exempt from certification) — US eCFR (Office of the Federal Register), 2026. US: used for coloring foods generally under GMP; exempt from certification

Checked against these sources on .

Educational information only. Not medical, dietary or veterinary advice. Spotted an error? Tell us.