Excellent Humectant SCCS/CIR Reviewed

Propanediol

INCI: PROPANEDIOL

CAS Number
504-63-2
Function
Humectant; solvent; antimicrobial contributor; water activity reduction agent; self-preservation contributor
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA GRAS status confirmed via GRN No. 302 (September 7, 2009) for food use; no cosmetic-specific restrictions under FD&C Act. Not an OTC monograph ingredient. Fully permitted for cosmetic use without limitation.

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.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: safe
NOAEL: 200 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 400 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 1000 mg/kg/ day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 1000 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 15 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

Expert Verdict

Propanediol (CAS 504-63-2) is permitted without restriction under EU Cosmetics Regulation 1223/2009 and holds FDA GRAS status (GRN No. 302, 2009), with a wide margin of safety for cosmetic use up to 39.9%, minimal dermal absorption (0.12% at 48h), and a clean sensitization profile.

⚠️
Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved gras-fda non-sensitizing epa_safer_alternative ifra_fragrance

Frequently Asked Questions

Is Propanediol safe in cosmetics?

Propanediol (CAS 504-63-2) is permitted without restriction under EU Cosmetics Regulation 1223/2009 and holds FDA GRAS status (GRN No. 302, 2009), with a wide margin of safety for cosmetic use up to 39.9%, minimal dermal absorption (0.12% at 48h), and a clean sensitization profile. The EU classifies Propanediol as "permitted". Safety rating: EXCELLENT. This ingredient has been reviewed by cir.

Is Propanediol allowed in the EU?

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

What does Propanediol do in cosmetics?

Propanediol functions as: Humectant; solvent; antimicrobial contributor; water activity reduction agent; self-preservation contributor. It is classified as a Humectant in our database. CAS number: 504-63-2.

What is the Margin of Safety for Propanediol?

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.

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