Asuntos regulatorios farmacéuticos: acceso abierto

Risk assessment of tocotrienols from annatto (Bixa orellana L.): regulatory contributions

Abstract

Talita da Silva Ferreira*, Paulo Roberto Nogueira Carvalho and André Limonta Carvalho

Tocotrienols are found naturally in several plant sources, mainly in cereals and oils, such as wheat germ, soybean oil, barley, oats and olive oil. However, these sources have much lower concentrations of tocotrienols. Higher concentrations of tocotrienols are found in Annatto seeds ( Bixa orellana L.). The United States Pharmacopeia Dietary Supplement Compendium (DSC) monograph for Annatto Seed Oil Tocotrienols defines that the tocotrienol fraction must contain at least 70% of the total tocotrienols, calculated on an anhydrous basis from the total tocotrienol content, must contain between 84% and 92% δ-Tocotrienol and between 8% and 16% γ-Tocotrienol. The risk assessment with NaturalMax Annatto Tocotrienol™ Oil 70%, extracted from annatto seeds, showed 100% tocotrienols (gamma and delta-tocotrienol) and less than 1% α-tocopherol on an anhydrous basis. NaturalMax Annatto Tocotrienol™ Oil 70% is an innovative ingredient that has been shown to meet regulatory requirements and can be applied in dietary supplements, cosmetics and pharmaceuticals.