Vitamin K2 has been added to the Official Diary of the Union (Diário Oficial da União Brazil’s, DOU, equivalent to the U.S. Federal Register) and allows the commercialization of both vitaMK7 powder and oil grades.
Brazil is the only country in Latin America to have a well-defined legislation for functional and health claims for either nutrient or non-nutrient components.
ANVISA has positively approved vitaMK7, after an evaluation of safety in accordance to current ANVISA regulations.
VitaMK7 is the active isomer of natural vitamin K2 with the highest bioavailability and longest half-life in the blood, exclusively manufactured by Gnosis through the fermentation process of Bacillus subtilis spp natto [U.S. Patent No. 7,718,407].
Today in Japan Bacillus subtilis spp natto is considered as the sole bacterium needed to produce natto, the traditional Japanese fermented soybean food, which is produced and consumed as a source of vitamin K2.
The Novel Food Approval of ANVISA recognizes the value of vitaMK7 and of its natural-derived production process that does not use any chemical or solvent and is free from additives and preservatives. VitaMK7 contains > 99% of all-trans menaquinone-7 and is > 99% Pure (by HPLC). The manufacturing process also guarantees an allergen and soy free product.
This regulatory approval follows the inclusion of naturally derived vitamin K2 as menaquinone-7 by the USP in the Official Compendia Monograph of Dietary Supplement. Also the Australian Health Authority TGA (Therapeutic Goods Administration) recently recognized the USP Menaquinone-7 monograph for the Australian market.