Excellent Cosmetic Ingredient NOAEL Data

Copernicia Cerifera Wax

INCI: COPERNICIA CERIFERA CARNAUBA WAX

CAS Number
8015-86-9
Function
Film Forming, Emollient, Viscosity Controlling, Skin Conditioning
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA GRAS direct food additive 21 CFR 184.1978. FDA SCOGS Report No. 47 confirms safety. Also permitted in food contact substances. Exempt from REACH (Annex V, Article 9).

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 Copernicia Cerifera 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

Monitor heavy metal impurities per EU food additive specifications (As ≤3 ppm, Pb ≤2 ppm, Hg ≤1 ppm). Rare allergenicity in atopic individuals — patch test at 50% in petrolatum if sensitization is suspected. 2025 CIR re-review may update conclusions based on new use data in children's products, airbrush products, and oral preparations.

⚠️
Concern Level: Low

Regulatory Flags

potential-allergen epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Copernicia Cerifera Wax safe in cosmetics?

Monitor heavy metal impurities per EU food additive specifications (As ≤3 ppm, Pb ≤2 ppm, Hg ≤1 ppm). Rare allergenicity in atopic individuals — patch test at 50% in petrolatum if sensitization is suspected. 2025 CIR re-review may update conclusions based on new use data in children's products, airbrush products, and oral preparations. The EU classifies Copernicia Cerifera Wax as "permitted". Safety rating: EXCELLENT. 9 toxicological study endpoint(s) are available in our database.

Is Copernicia Cerifera Wax allowed in the EU?

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

What does Copernicia Cerifera Wax do in cosmetics?

Copernicia Cerifera Wax functions as: Film Forming, Emollient, Viscosity Controlling, Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 8015-86-9.

What is the Margin of Safety for Copernicia Cerifera 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 Copernicia Cerifera Wax?

The NOAEL (No Observed Adverse Effect Level) for Copernicia Cerifera 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.

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