Is Bixin safe in cosmetics?
Bixin has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
Bixin
Also known as: cis-Bixin, 6,6'-Diapo-psi,psi-carotenedioic acid, 6-methyl ester, 9-cis-, 2,4,6,8,10,12,14,16,18-Eicosanonaenedioic acid,4,8,13,17-tetramethyl-,monomethyl ester, (2E,4Z,6E,8E,10E,12E,14E,16E,18E)-, EINECS 230-248-7, UNII-9L7T4VB66G (+3 more)
INCI: CI 75120
Bixin (CAS 6983-79-5) is a cosmetic cosmetic ingredient functioning as colorant, antioxidant. Reported NOAEL =191 mg/kg bw/day in Rat (EFSA); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.
View industrial chemical safety profile for CAS 6983-79-5 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Bixin is classified GHS Danger (H302, H311, H315, H319, H331, H335) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
colorant, antioxidant
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
(2E,4E,6E,8E,10E,12E,14E,16Z,18E)-20-methoxy-4,8,13,17-tetramethyl-20-oxoicosa-2,4,6,8,10,12,14,16,18-nonaenoic acid
InChIKey
RAFGELQLHMBRHD-SLEZCNMESA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Listed as a color additive (annatto); approved for external use by FDA
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Bixin.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for Bixin. 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 | =191 mg/kg bw/day | oral: feed | Rat | subchronic | EFSA |
| NOAEL | =191 mg/kg bw/day | oral: feed | Rat | subchronic | EFSA |
| NOAEL | =1206 mg/kg bw/day | oral: feed | Rat | subchronic | EFSA |
| NOAEL | =1206 mg/kg bw/day | oral: feed | Rat | subchronic | EFSA |
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | permitted_colorant | - | All products |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "Annatto", "Chemical_Name": "Bixin, Norbixin", "CAS_Number": "1393-63-1", "Colorant_Type": "Natural Colorant", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved", "Notes": "Orange-yellow from seeds"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (1)
JECFA Evaluation
BIXIN | 1959 | NMRS VOL. II-IV/48
Source: WHO/JECFA
Expert Verdict
Expert safety assessment and concern-level summary for Bixin.
Regulatory Flags
natural-colorant
annex-iv-approved
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Bixin by CAS number or substance name.
Studies
4
Lowest NOAEL
191 mg/kg bw/day
Highest NOAEL
1206 mg/kg bw/day
EFSA
Known Synonyms
cis-Bixin
6,6'-Diapo-psi,psi-carotenedioic acid, 6-methyl ester, 9-cis-
2,4,6,8,10,12,14,16,18-Eicosanonaenedioic acid,4,8,13,17-tetramethyl-,monomethyl ester, (2E,4Z,6E,8E,10E,12E,14E,16E,18E)-
EINECS 230-248-7
UNII-9L7T4VB66G
6'-methyl hydrogen 9'-Z-6,6'-diapocarotene-6,6'-dioate
6'-methyl hydrogen 9'-cis-6,6'-diapocarotene-6,6'-dioate
Methyl (9-cis)-hydrogen-6,6'-diapo-psi,psi-carotenedioate
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in food safety data.
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Bixin
Food Category
preservative
Frequently Asked Questions
Is Bixin allowed in the EU?
Bixin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bixin do in cosmetics?
Bixin functions as: colorant, antioxidant. It is classified as a cosmetic ingredient in our database. CAS number: 6983-79-5.
What is the NOAEL for Bixin?
The NOAEL (No Observed Adverse Effect Level) for Bixin is =191 mg/kg bw/day based on a subchronic study via oral: feed route in Rat. A total of 4 study endpoints are available. Source: EFSA.
Is Bixin used outside cosmetics?
Bixin also appears in industrial chemical safety and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Bixin have different safety status in cosmetics vs industrial chemicals?
Bixin is classified GHS Danger (H302, H311, H315, H319, H331, H335) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Bixin compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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