Annatto, Bixin, Norbixin

About

What it is and where it shows up.

Annatto (E160b) is a natural yellow-to-orange food colour extracted from the seeds of the annatto tree (Bixa orellana L.). Its two principal pigments, bixin (oil-soluble) and norbixin (water-soluble), are used to impart yellow to orange-red hues to a wide range of foods including cheese, butter, margarine, snacks, and beverages.

Safety summary

The regulatory and scientific consensus.

EFSA (2016) established an ADI of 6 mg/kg bw/day for bixin and 0.3 mg/kg bw/day for norbixin; bixin exposure is consistently below the ADI across all population groups, while norbixin exposure can exceed the ADI at the 95th percentile in toddlers and children under some high-use scenarios. The 2019 EFSA FAF Panel concluded that annatto E (aqueous-processed bixin) does not raise concern for genotoxicity, and that the overall level of norbixin exposure does not raise a health concern given likely overestimation in exposure modelling. No IARC classification exists; rare hypersensitivity/allergic reactions have been reported in sensitive individuals.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Restricted	Commission Regulation (EU) 2020/771 updated specifications and transition arrangements; E160b(i) and E160b(ii) may not be sold directly to consumers. Foods labelled under old rules could remain on market until exhaustion of stocks after 2 January 2021.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permitted under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Maximum use level of 20 mg/kg (as bixin/norbixin) in table margarine and fat spreads; permitted in various other food categories under GMP or specific limits.source
FDA (Food and Drug Administration) (United States)	Approved	Listed as a permanently approved colour additive exempt from batch certification under 21 CFR 73.30. No numeric ADI established by FDA. Must comply with identity and purity specifications.source

Who should approach with care

Whose guidance would steer them away.

Children — EFSA exposure assessments found norbixin intake can exceed the ADI (0.3 mg/kg bw/day) at the 95th percentile for toddlers and children under high-use scenarios, indicating potential for over-exposure in high consumers.

Infants — High-level norbixin exposure relative to body weight raises concern for the youngest age groups; EFSA noted exceedance of the norbixin ADI at p95 for toddlers in at least one EU country.

Other — Rare hypersensitivity and allergic reactions (urticaria, angioedema) to annatto have been reported in sensitive individuals; those with known annatto sensitivity should avoid products containing E160b.

Research citations

The sources behind this verdict.

1EFSA. Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, 2019. efsa.europa.eu
2PubMed. Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, 2019. pubmed.ncbi.nlm.nih.gov
3EFSA. Exposure assessment of annatto colouring principles bixin and norbixin (E 160b) when used as food additives, 2017. efsa.europa.eu
4EFSA. Scientific opinion on the safety of annatto extracts (E 160b) as a food additive, 2016. efsa.europa.eu
5FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 — Appendix A: List of Food Additives, 2011. fssai.gov.in
6WHO. JECFA evaluation of annatto extracts — 67th meeting (2007): ADI for bixin and norbixin, 2007.

Independently researched6 citations