Following an application from NattoPharma ASA submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to MenaQ7® and maintenance of the elastic properties of the arteries. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is MenaQ7®, which contains 97% menaquinone‐7 by weight. The Panel considers that MenaQ7® is sufficiently characterised. The claimed effect proposed by the applicant is ‘improves arterial stiffness’. Upon a request from EFSA, the applicant agreed that the claimed effect is maintenance of elastic properties of the arteries (by measuring the arterial stiffness). The Panel considers that maintenance of the elastic properties of the arteries is a beneficial physiological effect. No conclusions could be drawn from the three human intervention studies submitted for scientific substantiation of the claim. In the absence of evidence for an effect of MenaQ7® on maintenance of the elastic properties of the arteries in vivo in humans, the studies on the proposed mechanisms by which the food/constituent could exert the claimed effect cannot be used as a source of evidence for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of MenaQ7® and maintenance of the elastic properties of the arteries.
Bibliographical noteFunding Information:
EFSA wishes to acknowledge the contribution of WG on Claims: Jean-Louis Bresson, Stefaan de Henauw, Alfonso Siani and Frank Thies to this opinion.
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- arterial elasticity
- arterial stiffness
- health claim