Excellent Emollient

Microcrystalline Wax

INCI: CERA MICROCRISTALLINA

CAS Number
64742-60-5
Function
wax structurant, thickener, oil binder, film-forming agent
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS status confirmed. Listed in FDA Inactive Ingredients Database for topical, oral, and vaginal preparations. Permitted under 21 CFR 172.886 (food contact) and 21 CFR 178.3710. No sunscreen active classification. No specific cosmetic use restrictions; CIR safety assessment (1984, reaffirmed 2005) supports safe use.

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.

Expert Verdict

Microcrystalline Wax (CAS 64742-60-5; EU INCI: Cera Microcristallina) is permitted without concentration limits under EU Cosmetics Regulation 1223/2009 and holds GRAS status in the US (21 CFR 172.886). Dermal absorption is negligible due to high molecular weight, eliminating systemic exposure concerns. CIR (1984/2005), EFSA (2023), German BfR (2018), and JECFA (1995) all confirm safety with no genotoxicity, carcinogenicity, or sensitization concern; pharmaceutical-grade purity and compliance with Cosmetics Europe Recommendation No. 14 for lip products is required.

⚠️
Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion gras-fda

Frequently Asked Questions

Is Microcrystalline Wax safe in cosmetics?

Microcrystalline Wax (CAS 64742-60-5; EU INCI: Cera Microcristallina) is permitted without concentration limits under EU Cosmetics Regulation 1223/2009 and holds GRAS status in the US (21 CFR 172.886). Dermal absorption is negligible due to high molecular weight, eliminating systemic exposure concerns. CIR (1984/2005), EFSA (2023), German BfR (2018), and JECFA (1995) all confirm safety with no genotoxicity, carcinogenicity, or sensitization concern; pharmaceutical-grade purity and compliance with Cosmetics Europe Recommendation No. 14 for lip products is required. The EU classifies Microcrystalline Wax as "permitted". Safety rating: EXCELLENT.

Is Microcrystalline Wax allowed in the EU?

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

What does Microcrystalline Wax do in cosmetics?

Microcrystalline Wax functions as: wax structurant, thickener, oil binder, film-forming agent. It is classified as a Emollient in our database. CAS number: 64742-60-5.

What is the Margin of Safety for Microcrystalline 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.

Compliance Tools

Check Microcrystalline Wax compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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