Is Annatto (Bixin/Norbixin) safe in cosmetics?
Annatto (Bixin/Norbixin) has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
GOOD
Colorant
Annatto (Bixin/Norbixin)
Also known as: C.I. Natural Orange 4, San Annatto 2380, C.I. 75120, Annatto coloring dye, Annatto extract (Bixa orellana L.) (+7 more)
INCI: CI 75120
Annatto (Bixin/Norbixin) (CAS 1393-63-1) is a cosmetic colorant functioning as Colorant (orange). EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.
Function
Colorant (orange)
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permanently listed under 21 CFR 73.2030 as annatto, exempt from certification. Permitted in all cosmetics including eye area at GMP-consistent levels.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Annatto (Bixin/Norbixin).
Calculate MoS for your specific formulation with the MoS Calculator.
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 (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| ASEAN | permitted_colorant | - | All products |
| ASEAN | permitted_colorant | - | All products |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Dye
Flavouring and nutrient
Fragrance
No specific technical function
Processing aids not otherwise specified
Softener and conditioner
Surface modifier
Regulatory List Membership (6)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Annatto (Bixin/Norbixin) — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
contact-sensitizer-cis-bixin
eye-area-permitted
natural-colorant
annex-iv-eu
fda-exempt-certification
eu_children_restricted
ifra_fragrance
fda_food_additive
eu_cosing_listed
Known Synonyms
C.I. Natural Orange 4
San Annatto 2380
C.I. 75120
Annatto coloring dye
Annatto extract (Bixa orellana L.)
Annatto seed (Bixa orellana L.)
Annotta extract
Bixa orellana extract
EINECS 215-735-4
FEMA No. 2103
FEMA No. 2104
UNII-6PQP1V1B6O
Chemical Function
Dye
Fragrance
Deodorizer
Softener and conditioner
No specific technical function
Flavouring and nutrient
Regulatory Lists
Personal care
Europe; Personal care
consumer_product
general_foods
pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
IFRA Transparency
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care - dental care - toothpaste
children; Europe; Personal care
children; Europe; Personal care
IFRA Transparency
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
Achiote
Food Category
preservative
Frequently Asked Questions
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.
Is Annatto (Bixin/Norbixin) used outside cosmetics?
Annatto (Bixin/Norbixin) also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Annatto (Bixin/Norbixin) 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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