Excellent Emollient NOAEL Data

Carnauba Wax

INCI: COPERNICIA CERIFERA (CARNAUBA) WAX

CAS Number
8015-86-9
Function
Wax; viscosity modifier; film-former
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA GRAS (Generally Recognized as Safe) for food use per 21 CFR 184.1978 with no limitation other than GMP. Approved as inactive ingredient for pharmaceutical tablets and capsules. No restrictions for cosmetic use. JECFA ADI: 0-7 mg/kg bw. FDA VCRP (2023): 808 formulations reported. FDA RLD (2024): 5,199 formulations reported. Maximum reported concentration in use: up to 30% in mascaras.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

9 study endpoints found for Carnauba Wax. 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 500 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
NOAEL 8800 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 250 mg/kg bw/day oral dog Chronic COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Reproductive COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
dose_tested 8800 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Carnauba Wax is an EU-permitted ingredient with no concentration restrictions, not listed in any Annex as prohibited or restricted. The CIR Expert Panel concluded it is safe in cosmetics with negligible dermal absorption due to high molecular weight C24-C32 ester constituents, extremely high oral NOAEL of approximately 10 g/kg bw/day, and negative genotoxicity testing.

⚠️
Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved gras-fda natural-origin no-sccs-opinion epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Carnauba Wax safe in cosmetics?

Carnauba Wax is an EU-permitted ingredient with no concentration restrictions, not listed in any Annex as prohibited or restricted. The CIR Expert Panel concluded it is safe in cosmetics with negligible dermal absorption due to high molecular weight C24-C32 ester constituents, extremely high oral NOAEL of approximately 10 g/kg bw/day, and negative genotoxicity testing. The EU classifies Carnauba Wax as "permitted". Safety rating: EXCELLENT. 9 toxicological study endpoint(s) are available in our database.

Is Carnauba Wax allowed in the EU?

Carnauba Wax EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Carnauba Wax do in cosmetics?

Carnauba Wax functions as: Wax; viscosity modifier; film-former. It is classified as a Emollient in our database. CAS number: 8015-86-9.

What is the Margin of Safety for Carnauba Wax?

adequate 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 Carnauba Wax?

The NOAEL (No Observed Adverse Effect Level) for Carnauba Wax is 500 mg/kg bw/day based on a Reproductive study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Carnauba Wax compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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