Melaleuca Alternifolia (Tea Tree) Leaf Oil
Description
essential oil derived from leaves
Function
Properties
Regulatory Status
CAS 68647-73-4 (EC 285-377-1). EU: Not currently listed in Annexes of EC 1223/2009; SCCS/O/303 (Nov 2025) deems safe only at specific concentrations (2% shampoo, 1% shower gel, 1% face wash, 0.1% face cream) for adults only, no spray/aerosol formats. ECHA RAC classified as Repr. Cat 1B (H360) — potential Annex II prohibition pathway pending. US: FDA has not restricted cosmetic use; CIR Panel concludes safe when formulated to be non-sensitizing.
US FDA has not restricted cosmetic use. CIR Expert Panel concluded eight Melaleuca alternifolia-derived ingredients safe in cosmetics when formulated to be non-sensitizing (final report 2021). FDA 2019 final rule excludes TTO from OTC antiseptic rub eligibility. No GRAS status for cosmetic use; FEMA GRAS only for food flavoring.