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E160B — Annatto, bixin, norbixin
Why it’s used
A yellow-to-red natural color extracted from the seeds of the annatto (achiote) tree, used to give products like cheese, butter, margarine, and snack foods a yellow-orange color.
Other names
Annatto extract, Achiote, Bixin, Norbixin
Diet flags
Vegan, passesVegetarian, passes
Regulatory status
USA — Allowed
Listed as a single color additive exempt from certification, permitted for coloring foods generally at GMP levels with no specific numerical concentration cap. Source (2026-07-23)
EU — Restricted
Since 2020, split into two separate EU food additives, Annatto bixin (E160b(i)) and Annatto norbixin (E160b(ii)), each with its own ADI and category-specific maximum use levels. Source (2026-07-23)
Regulatory status by region
The FDA regulates annatto extract as one color additive under 21 CFR 73.30, allowed generally at GMP levels with no numerical concentration cap. The EU takes a more granular approach: after EFSA's 2016 re-evaluation found bixin and norbixin warranted separate risk assessments, the European Commission split the additive into two listings, each with its own ADI and category-specific maximum levels. Source: eCFR 21 CFR 73.30 and EUR-Lex CELEX 32020R0771, verified 2026-07-23.
Following EFSA's 2016 safety re-evaluation, which concluded bixin and norbixin have different toxicological profiles and needed separate ADIs (6 mg bixin/kg bw/day and 0.3 mg norbixin/kg bw/day), Commission Regulation (EU) 2020/771 split the single E160b listing into Annatto bixin and Annatto norbixin, each with its own category-specific maximum use levels. The FDA has not made an equivalent split and continues to regulate annatto extract as one substance without numerical limits. Source: EUR-Lex CELEX 32020R0771, verified 2026-07-23.
Found in these products
1 product in our database contains E160B.