About
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
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
| 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
Research citations
- 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.
