Acetyl Hexapeptide-19

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.

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.