Regulatory

EFSA has recently published a positive opinion on a marketing claim for all K vitamins including MK-7, and bone health, according to Regulation (EC) 1924/2006 article 13.1.

ActivK™ has been subjected to a thorough safety evaluation by EFSA. Based on this evaluation, EFSA has published the following opinion on vitamin K2 (MK-7) from natto, as a dietary supplement and food ingredient:

"The Panel concludes that vitamin K2 (menaquinone) from the K2 containing oil formulation of the present opinion is bioavailable as a source of vitamin K. The Panel also concludes that the use of menaquinone-rich edible oil meeting the specifications provided, in foods for the general population (including food supplements) and in foods for particular nutritional uses, other than baby foods and infant formula, at the proposed use levels is not of safety concern."

Products containing a minimum of 15% of the Recommended Daily Allowance (EURDA) for vitamin K (75μg) are permitted to carry the above claim. This means products must contain minimum 11.25μg MK-7 per 100g or 100ml or per single serve of food & beverage.

Danisco’s recommendation is 22.5μg per serving. Under the Regulation (EC) 1924/2006 article 13.1, this would allow a claim such as "rich in" labelling on the final food product.

Danisco’s Regulatory Team has many years of experience in ingredients approval, claim management and substantiation. Our regulatory experts are located around the globe in the market they serve and can support our customers with their claim communication and product registration issues.