Acetyl Hexapeptide-1

INCI: ACETYL HEXAPEPTIDE-1

CAS Number
448944-47-6
Function
Skin conditioning agent, melanin stimulator, photo-protection enhancer
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status restricted
US Notes Not classified as a sunscreen active by the FDA; no GRAS classification applies. No specific MoCRA restrictions or monograph entries. Not reviewed by the CIR Expert Panel as of February 2026. Claims related to stimulating melanocyte activity or photo-protection via MC1-R activation may trigger FDA drug classification if marketed as structure/function claims in the US.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

EU: Permitted ingredient (CosIng REF 54133); not listed in Annex II (prohibited), Annex III (restricted), or Annexes IV-VI. No SCCS opinion issued. Mechanistically acts as MC1-R agonist mimicking alpha-MSH, stimulating melanogenesis—a theoretical melanoma biology concern that any Safety Assessor must address. Significant data gaps exist: no peer-reviewed dermal absorption, no sensitization data, no margin of safety calculation, no repeated dose or reproductive toxicity data. Burden of safety demonstration falls on the Responsible Person under EU Regulation (EC) No 1223/2009 Article 10. US: No FDA monograph entry, no GRAS classification; melanogenesis and photo-protection claims carry drug classification risk. Use with full toxicological data package; not suitable for safety assessment without additional studies.

⚠️
Concern Level: Moderate

Regulatory Flags

no-sccs-opinion no-cir-review data-gap melanogenesis-stimulator mc1r-agonist drug-claim-risk high-molecular-weight no-mos-calculated no-sensitization-data no-dermal-absorption-data

Frequently Asked Questions

Is Acetyl Hexapeptide-1 safe in cosmetics?

EU: Permitted ingredient (CosIng REF 54133); not listed in Annex II (prohibited), Annex III (restricted), or Annexes IV-VI. No SCCS opinion issued. Mechanistically acts as MC1-R agonist mimicking alpha-MSH, stimulating melanogenesis—a theoretical melanoma biology concern that any Safety Assessor must address. Significant data gaps exist: no peer-reviewed dermal absorption, no sensitization data, no margin of safety calculation, no repeated dose or reproductive toxicity data. Burden of safety demonstration falls on the Responsible Person under EU Regulation (EC) No 1223/2009 Article 10. US: No FDA monograph entry, no GRAS classification; melanogenesis and photo-protection claims carry drug classification risk. Use with full toxicological data package; not suitable for safety assessment without additional studies. The EU classifies Acetyl Hexapeptide-1 as "permitted". Safety rating: MODERATE.

Is Acetyl Hexapeptide-1 allowed in the EU?

Acetyl Hexapeptide-1 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Acetyl Hexapeptide-1 do in cosmetics?

Acetyl Hexapeptide-1 functions as: Skin conditioning agent, melanin stimulator, photo-protection enhancer. It is classified as a cosmetic ingredient in our database. CAS number: 448944-47-6.

What is the Margin of Safety for Acetyl Hexapeptide-1?

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.

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