Is Beta-Carotene safe in cosmetics?
Beta-Carotene has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Beta-Carotene
Also known as: trans-beta-Carotene, EC No.: 230-636-6, C.I. 40800, Cyclohexene, 1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethyl-, (all-E)-, Diet,beta-carotene supplementation (+14 more)
INCI: BETA-CAROTENE
Beta-Carotene (CAS 7235-40-7) is a cosmetic cosmetic ingredient functioning as Skin conditioning, cosmetic colorant, antioxidant. Reported NOAEL =13 mg/kg bw/day (WHO/JECFA); 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, pharmaceutical, and food safety data.
Function
Skin conditioning, cosmetic colorant, antioxidant
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohexen-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
InChIKey
OENHQHLEOONYIE-JLTXGRSLSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted color additive exempt from certification (21 CFR 73.95); GRAS for food
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Beta-Carotene.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Beta-Carotene. 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 | =13 mg/kg bw/day | oral | - | Toxicology study | WHO/JECFA |
| NOAEL | =13 mg/kg bw/day | oral | - | Toxicology study | WHO/JECFA |
| NOAEL | =14 mg/kg bw/day | dermal | - | Dermal toxicity | WHO/JECFA |
| NOAEL | =14 mg/kg bw/day | dermal | - | Dermal toxicity | WHO/JECFA |
| NOAEL | =30 mg/kg bw/day | - | Rat | Toxicology study | WHO/JECFA |
| NOAEL | =30 mg/kg bw/day | - | Rat | Toxicology study | WHO/JECFA |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | WHO/JECFA |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | WHO/JECFA |
| NOAEL | =64 mg/kg bw/day | - | Rat | Toxicology study | WHO/JECFA |
| NOAEL | =64 mg/kg bw/day | - | Rat | Toxicology study | WHO/JECFA |
EPA ToxValDB — Toxicity Values
3 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | >=20 mg/day | Human | oral | - | EFSA |
| LEL | <=15 mg/day | Human | oral | chronic | EFSA |
| LD50 | >2000 mg/kg | Rat | oral | - | ECHA |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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) |
| BR | permitted_colorant | - | Column 1: All products |
| ASEAN | permitted_colorant | - | All products |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (6)
JECFA Evaluation
beta,beta-CAROTENE | 2019 | WITHDRAWN | The Committee reaffirmed the conclusion from the eighty-fourth meeting that rats are not an appropriate model for deriving an ADI for β-carotene due to the relatively low bioavailability of β-carotene in rats compared with humans. Therefore, the Committee withdrew the two group ADIs of 0–5 mg/kg bw for (1) the sum of the synthetic carotenoids β-carotene,…
Source: WHO/JECFA
JECFA Evaluation
CAROTENES (natural) | 1989 | NO ADI ALLOCATED | TRS 789-JECFA 35/21 | NOT PREPARED
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Dye
Flavouring and nutrient
Fragrance
Pharmaceutical
Processing aids not otherwise specified
Softener and conditioner
Surface modifier
Regulatory List Membership (5)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Beta-Carotene — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
colorant
endocrine_disruptor
eu_children_restricted
ifra_fragrance
fda_food_additive
eu_cosing_listed
jecfa_concern
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Beta-Carotene by CAS number or substance name.
Studies
72
Lowest NOAEL
10
Highest NOAEL
5.000e+4
Units vary across source rows: mg/kg bw/day, mg/kg diet
WHO/JECFA
WHO/JECFA
Known Synonyms
trans-beta-Carotene
EC No.: 230-636-6
C.I. 40800
Cyclohexene, 1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethyl-, (all-E)-
Diet,beta-carotene supplementation
EINECS 230-636-6
Natural Yellow 26
1,1'-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethylcyclohexene), (all E)-
Betacaroteno
Betacarotenum
Karotin
Zlut prirodni 26
UNII-01YAE03M7J
(all-E)-1,1'-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis
(all-E)-1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis[2,6,6-trimethyl-Cyclohexene
1,1'-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaene-1,18-diyl]bis(2,6,6-trimethylcyclohexene)
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethyl-1-cyclohexenyl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohex-1-en-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]cyclohex-1-ene
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohexen-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
Chemical Function
Dye
Softener and conditioner
Flavouring and nutrient
Fragrance
Pharmaceutical
Regulatory Lists
IFRA Transparency
Australia; Food and drug - smoking-related products
Europe; Personal care
Canada; pharmaceutical
Canada; pharmaceutical
general_foods
pharmaceutical
Personal care
Europe; supplements
Europe; food_additive; supplements
Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
BETA CAROTENE
ChEMBL ID
CHEMBL1293
Max Phase
4
Adverse Event Associations
1526
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Beta-carotene
E Number
E160a
ADI
5 mg/kg bw
Food Category
preservative
Frequently Asked Questions
Is Beta-Carotene allowed in the EU?
Beta-Carotene EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Beta-Carotene do in cosmetics?
Beta-Carotene functions as: Skin conditioning, cosmetic colorant, antioxidant. It is classified as a cosmetic ingredient in our database. CAS number: 7235-40-7.
What is the NOAEL for Beta-Carotene?
The NOAEL (No Observed Adverse Effect Level) for Beta-Carotene is =13 mg/kg bw/day based on a Toxicology study study via oral route in rat. A total of 10 study endpoints are available. Source: WHO/JECFA.
Is Beta-Carotene used outside cosmetics?
Beta-Carotene also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Beta-Carotene compliance across multiple jurisdictions:
Ingredient Decoder
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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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