Excellent Emollient

Beeswax

INCI: CERA ALBA

CAS Number
8012-89-3
Function
Wax; viscosity modifier; film-former
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS status under 21 CFR 184.1973 (direct food additive). Permitted as OTC drug ingredient under 21 CFR 310.545 (skin protectants, ophthalmic products); permitted up to 5% in ophthalmic preparations with emollients per 21 CFR 349.13. For cosmetics, permitted without restrictions under FD&C Act and maintains compliance under MoCRA (Modernization of Cosmetics Regulation Act, 2022). Not classified as an active sunscreen ingredient. Registered in >8,800 cosmetic formulations per 2024 FDA Voluntary Cosmetic Reporting Program (VCRP) data.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Beeswax (Cera Alba, CAS 8012-89-3) is a natural animal-derived wax produced by honeybees with over four decades of documented cosmetic safety history. The CIR Expert Panel concluded it is safe as used in cosmetics in 1984, reaffirmed in 2005, with routine re-review completed in 2025. EU status is fully unrestricted under Regulation (EC) 1223/2009 with no SCCS opinion required. While broadly safe, sensitization potential of approximately 18% has been documented in patients with pre-existing cheilitis or facial dermatitis, primarily driven by propolis cross-reactivity; formulators should consider propolis-free beeswax specifications for susceptible populations.

⚠️
Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion gras-fda natural-origin animal-derived allergen eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Beeswax safe in cosmetics?

Beeswax (Cera Alba, CAS 8012-89-3) is a natural animal-derived wax produced by honeybees with over four decades of documented cosmetic safety history. The CIR Expert Panel concluded it is safe as used in cosmetics in 1984, reaffirmed in 2005, with routine re-review completed in 2025. EU status is fully unrestricted under Regulation (EC) 1223/2009 with no SCCS opinion required. While broadly safe, sensitization potential of approximately 18% has been documented in patients with pre-existing cheilitis or facial dermatitis, primarily driven by propolis cross-reactivity; formulators should consider propolis-free beeswax specifications for susceptible populations. The EU classifies Beeswax as "permitted". Safety rating: EXCELLENT.

Is Beeswax allowed in the EU?

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

What does Beeswax do in cosmetics?

Beeswax functions as: Wax; viscosity modifier; film-former. It is classified as a Emollient in our database. CAS number: 8012-89-3.

What is the Margin of Safety for Beeswax?

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.

Compliance Tools

Check Beeswax compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
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82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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