Good Cosmetic Ingredient SCCS/CIR Reviewed

Hexamidine

INCI: HEXAMIDINE

CAS Number
3811-75-4
Function
Preservative / antimicrobial (biocide)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.1%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” no specific CFR restriction; CIR assessed as safe as used

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

Safety Data

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

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: unknown
NOAEL: 50 mg/kg/day (dermal)
cir
Verdict: unknown
NOAEL: 0.4 % (dermal)

Expert Verdict

Must not exceed 0.1% (Annex V/47); antimicrobial efficacy testing required for preservative claims; structurally an amidine with potential for ocular irritation at higher concentrations; compatible salt forms (diisethionate, diparaben) may be preferred for formulation stability

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Concern Level: Moderate

Regulatory Flags

preservative

Frequently Asked Questions

Is Hexamidine safe in cosmetics?

Must not exceed 0.1% (Annex V/47); antimicrobial efficacy testing required for preservative claims; structurally an amidine with potential for ocular irritation at higher concentrations; compatible salt forms (diisethionate, diparaben) may be preferred for formulation stability The EU classifies Hexamidine as "restricted". Safety rating: GOOD. This ingredient has been reviewed by cir.

Is Hexamidine allowed in the EU?

Hexamidine EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.

What does Hexamidine do in cosmetics?

Hexamidine functions as: Preservative / antimicrobial (biocide). It is classified as a cosmetic ingredient in our database. CAS number: 3811-75-4.

What is the Margin of Safety for Hexamidine?

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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