Safety Assessment of Melaleuca alternifolia (Tea Tree)-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 8 Melaleuca alternifolia (tea tree)-derived ingredients as used in cosmetic formulations; 5 of these ingredients are reported to function in cosmetics as skin-conditioning agents. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to minimize impurities that could be present in botanical ingredients. The Panel noted that oxidized tea tree oil could be a sensitizer, and stated that industry should employ methods to minimize oxidation of the oil in the final cosmetic product. The Panel considered all the data and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing.