Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Annatto (Bixin/Norbixin). NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 5000 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | swine | Subchronic | COSMOS_DB |
| NOAEL | 1012 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 2000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 204 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 56 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.8 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
Expert Verdict
Bixin (CAS 6983-79-5) and Norbixin (CAS 542-40-5) from Annatto extract (CAS 1393-63-1). EU: Permitted colorant in Annex IV (EC 1223/2009), CI 75120, for all cosmetics including eye area. US: FDA permanently listed color additive exempt from certification under 21 CFR 73.2030. Note: Cis-bixin is a confirmed contact sensitizer; norbixin tested negative.
Regulatory Flags
Frequently Asked Questions
Is Annatto (Bixin/Norbixin) safe in cosmetics?
Bixin (CAS 6983-79-5) and Norbixin (CAS 542-40-5) from Annatto extract (CAS 1393-63-1). EU: Permitted colorant in Annex IV (EC 1223/2009), CI 75120, for all cosmetics including eye area. US: FDA permanently listed color additive exempt from certification under 21 CFR 73.2030. Note: Cis-bixin is a confirmed contact sensitizer; norbixin tested negative. The EU classifies Annatto (Bixin/Norbixin) as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Annatto (Bixin/Norbixin) allowed in the EU?
Annatto (Bixin/Norbixin) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Annatto (Bixin/Norbixin) do in cosmetics?
Annatto (Bixin/Norbixin) functions as: Colorant (orange). It is classified as a Colorant in our database. CAS number: 1393-63-1.
What is the Margin of Safety for Annatto (Bixin/Norbixin)?
not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Annatto (Bixin/Norbixin)?
The NOAEL (No Observed Adverse Effect Level) for Annatto (Bixin/Norbixin) is 5000 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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