Good Emollient NOAEL Data GHS Classified

Candelilla Wax

INCI: CANDELILLA CERA

CAS Number
8002-74-2
Function
wax structurant, thickener, emollient, binder
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-affirmed GRAS under 21 CFR 175.105, 175.320, 176.180, and 184.1976. FEMA GRAS Number: 3479. Listed in CTFA International Cosmetic Ingredient Dictionary. Functions as inactive/excipient in cosmetic formulations. No cosmetic-specific concentration restrictions apply.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Candelilla 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 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 17 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 17 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1815 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1815 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 160 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 157 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 1000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The fume is irritating to the eyes, nose and throat.
Routes of Exposure
The substance can be absorbed into the body by inhalation of fume.

Expert Verdict

Candelilla Wax is a plant-derived wax with a well-established safety profile reviewed by the CIR Expert Panel (1984, reaffirmed 2005, under re-review 2025) and confirmed safe at concentrations up to 25-27%. Unrestricted in the EU under Regulation (EC) No 1223/2009, GRAS-affirmed by the FDA, and listed as food additive E902. Negligible dermal absorption due to high-molecular-weight components; rare cases of allergic contact dermatitis documented in published literature since 2013.

โš ๏ธ
Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion gras-fda natural-origin sensitizer ifra_fragrance fda_food_additive jecfa_concern jecfa_safe

Frequently Asked Questions

Is Candelilla Wax safe in cosmetics?

Candelilla Wax is a plant-derived wax with a well-established safety profile reviewed by the CIR Expert Panel (1984, reaffirmed 2005, under re-review 2025) and confirmed safe at concentrations up to 25-27%. Unrestricted in the EU under Regulation (EC) No 1223/2009, GRAS-affirmed by the FDA, and listed as food additive E902. Negligible dermal absorption due to high-molecular-weight components; rare cases of allergic contact dermatitis documented in published literature since 2013. The EU classifies Candelilla Wax as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Candelilla Wax allowed in the EU?

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

What does Candelilla Wax do in cosmetics?

Candelilla Wax functions as: wax structurant, thickener, emollient, binder. It is classified as a Emollient in our database. CAS number: 8002-74-2.

What is the Margin of Safety for Candelilla Wax?

not established 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 Candelilla Wax?

The NOAEL (No Observed Adverse Effect Level) for Candelilla Wax is 1000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

๐Ÿ“ฑ

Is Candelilla Wax in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Candelilla Wax in your formulation.