,The Cosmetic Ingredient Review (CIR) Expert Panel issued a Draft Amended Safety Assessment on alkyl gallates, including Propyl Gallate, Caprylyl (Octyl) Gallate, Dodecyl (Lauryl) Gallate, and Ethylhexyl Gallate. These ingredients are esters of gallic acid that function primarily as antioxidants in cosmetic formulations, preventing rancidity and oxidative degradation in products such as creams, lotions, lipsticks, and hair preparations. The review was reopened due to newly available toxicological data and updated information on frequency and concentration of use reported in the FDA’s Voluntary Cosmetic Registration Program. The assessment evaluates toxicokinetics, dermal absorption, acute and repeated-dose toxicity, reproductive and developmental toxicity, genotoxicity, carcinogenic potential, and irritation and sensitization profiles. Historically, Propyl Gallate was considered safe in cosmetics at concentrations up to 0.1%, though concerns regarding contact sensitization and potential endocrine activity have been discussed in scientific literature. The updated review carefully examines these issues alongside exposure data to determine current safety margins. The Panel will finalize its conclusion following further expert deliberation, ensuring that present-day cosmetic uses remain safe under current conditions and concentrations of use.
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