Gnosis is delighted to announce that on February 22nd, 2016 the Brazilian National Health Surveillance Agency, ANVISA, has approved the use of vitaMK7®, the Natural Vitamin K2 as MK7, as Novel Food Ingredient to be used in finished products in Brazil.
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 a deeply 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 a fermentation process of Bacillus subtilis spp natto
Today in Japan Bacillus subtilis spp natto is considered as the sole bacterium needed to produce good natto, the traditional Japanese fermented soybean food, which is produced and consumed as a dietary supplement 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 guarantees also a product Allergen-free and Soy-Free.
This regulatory approval follows the inclusion of natural derived Vitamin K2 as menaquinone-7 by the USP in the Official Compendia Monograph of Dietary Supplement, effective from August 2015, where Gnosis had a driving role in proposing the most detailed and accurate specification and in supplying USP with the Vitamin K2 reference standard, and where high quality standards for an optimal Vitamin K2 ingredient have been identified. Also the Australian Health Authority TGA (Therapeutic Goods Administration) has recently recognized the USP Menaquinone-7 monograph for the Australian market.
The ANVISA approval opens the Brazilian market and strengthens Gnosis international position as producer of the naturally occurring forms of Vitamin K2, as menaquinone-7. Gnosis is investing many resources to document the benefits of vitaMK7® as a food ingredient for a healthier lifestyle and prove the superiority of vitaMK7® in directs calcium to the right places in the body. Vitamin K2 as MK7 has been shown to help normalize the efficiency of calcium metabolism, supporting proper calcification of bone tissue while preventing pathological calcification of the vascular and organ systems, especially through the carboxylation of calcium-binding proteins.
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