Is Xanthophylls safe in cosmetics?
Xanthophylls has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Cosmetic Ingredient
Xanthophylls
Also known as: beta,epsilon-Carotene-3,3'-diol, (3R,3'R,6'R)-, .beta.,.epsilon.-Carotene-3,3'-diol, (3R,3'R,6'R)-, EINECS 204-840-0, Lutein, all-trans-, NSC 59193 (+8 more)
INCI: XANTHOPHYLL
Xanthophylls (CAS 127-40-2) is a cosmetic cosmetic ingredient functioning as Skin conditioning, Colorant (CI 75135 — yellow). 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 pharmaceutical data.
View industrial chemical safety profile for CAS 127-40-2 →
Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning, Colorant (CI 75135 — yellow)
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
(1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol
InChIKey
KBPHJBAIARWVSC-RGZFRNHPSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted for cosmetic use; not on FDA prohibited/restricted lists
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Xanthophylls.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
4 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOAEL | =200 mg/kg-day | Rat | oral | subchronic | EFSA |
| NOAEL | =200 mg/kg-day | Rat | oral | subchronic | EFSA |
| LEL | =260 mg/kg-day | Rat | oral | subchronic | EFSA |
| ADI | <=2 mg/kg | Human | oral | - | WHO JECFA ADI |
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 |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (4)
JECFA Evaluation
BO-XAN | 2018 | NOT SPECIFIED (group ADI for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic)) | Based on the absence of toxicity in a wide range of studies, the Committee at it's 86th meeting established a group ADI "not specified" for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic). | ">TRS 1014-JECFA 86/39 | FAS 77
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
XANTHOPHYLLS | 1977 | NO ADI ALLOCATED | JECFA noted that no toxicity data were available, thus no evaluation could be made nor could an ADI be established. | TRS 617-JECFA 21/22 | NOT PREPARED
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
LUTEIN from TAGETES ERECTA | 2018 | NOT SPECIFIED (group ADI for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic)) | Based on the absence of toxicity in a wide range of studies, the Committee at it's 86th meeting established a group ADI "not specified" for lutein from Tagetes erecta, lutein esters from Tagetes erecta and zeaxanthin (synthetic). | ">TRS 1014-
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Humectant
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Xanthophylls.
Regulatory Flags
colorant
natural-origin
fda_food_additive
jecfa_concern
Known Synonyms
beta,epsilon-Carotene-3,3'-diol, (3R,3'R,6'R)-
.beta.,.epsilon.-Carotene-3,3'-diol, (3R,3'R,6'R)-
EINECS 204-840-0
Lutein, all-trans-
NSC 59193
Xanthophyll, all-trans-(+)-
UNII-X72A60C9MT
(4R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4R)-4-hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]-3,5,5-trimethylcyclohex-2-en-1-ol
3,3'-Dihydroxy-alpha-carotene
Bo-Xan
E 161b
Lutein ester
beta,epsilon-Carotene-3,3'-diol
Chemical Function
Softener and conditioner
Humectant
Regulatory Lists
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Canada; Personal care; Substances in PCP - Canada (4/2014)
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
LUTEIN
ChEMBL ID
CHEMBL173929
Max Phase
3
Adverse Event Associations
1157
Frequently Asked Questions
Is Xanthophylls allowed in the EU?
Xanthophylls EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Xanthophylls do in cosmetics?
Xanthophylls functions as: Skin conditioning, Colorant (CI 75135 — yellow). It is classified as a cosmetic ingredient in our database. CAS number: 127-40-2.
Is Xanthophylls used outside cosmetics?
Xanthophylls also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Xanthophylls compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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Chemical family
Fragrance (perfuming)
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Chemical family
Fragrance (Perfuming)
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Good
Chemical family
Fragrance ingredient
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