Regulatory Status
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Safety Data
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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.
Regulatory Flags
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.
Compliance Tools
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