2.1. Utrzymanie prawidłowego stanu kości (ID 123, 127, 128, 2879)

The claimed effects are “bone structure”, “bone integrity”, “bone calcification” and “bone health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that the claimed effects relate to the maintenance of normal bone.
The Panel considers that the maintenance of normal bone is beneficial to human health.

2.2. Krzepnięcie krwi (ID 124, 126)

The claimed effects are “heart health” and “blood coagulation”. The Panel assumes that the target population is the general population.
The Panel considers that normal blood coagulation is beneficial to human health.

2.3. Funkcjonowanie serca i naczyń krwionośnych (ID 124, 125 2880)

The claimed effects are “cardiovascular health”, “vascular health”, and “heart health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that the claimed effects relate to the normal function of the heart and blood vessels.
The Panel considers that the normal function of the heart and blood vessels is beneficial to human health.

3.1. Utrzymanie prawidłowego stanu kości (ID 123, 127, 128, 2879)

Vitamin K functions as a cofactor in the post-translational carboxylation of several bone proteins, of which the most abundant one is osteocalcin. Osteocalcin (OC) is a small Gla-protein uniquely synthesized in bone and circulating under- carboxylated osteocalcin (ucOC) provides a measure of the vitamin K status of bone (IoM, 2001).
There is evidence that OC plays a role in the control of tissue mineralisation and skeletal turnover (Adams and Pepping, 2005; Berkner, 2005). In addition, some epidemiological studies suggest that low vitamin K intake or status is associated with osteoporosis, osteopenia and increased risk of fracture (Booth et al., 2000; Hodges et al., 1991; Hodges et al., 1993; Ikeda et al., 2006; Kanai et al., 1997; Katsuyama et al., 2002; Katsuyama et al., 2004; Tamatani et al., 1998), and intervention trials provide some evidence of an effect of vitamin K1 and vitamin K2 supplementation in reducing bone loss and of vitamin K2 supplementation in reducing the risk of fracture, the latter primarily in Japanese populations (Cockayne et al., 2006, Bolton-Smith, 2001; Bolton-Smith et al., 2007; Braam et al., 2003; Bunyaratavej et al., 2001; Feskanich et al., 1999; Ishida and Kawai, 2004; Knapen et al., 2007; Ozuru et al., 2002; Orimo et al., 1998; Ushiroyama et al., 2002). In a population based cohort study in 2,016 peri-menopausal and early postmenopausal women, vitamin K1 intake was not associated with any effects on bone mineral density (BMD) or fracture risk (Rejnmark et al., 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin K and the maintenance of normal bone.

3.2. Krzepnięcie krwi (ID 124, 126)

Vitamin K is needed for the normal function of many of the enzymes involved in the coagulation cascade through carboxylation of glutamic acid in the side chain, and hence allowing calcium fixation (IoM, 2001).
Restriction of vitamin K intakes to levels almost impossible to achieve in any nutritionally adequate, self-selected diet (10 µg/day for several weeks) do not impair normal haemostatic control in healthy subjects. Although there is some interference in the hepatic synthesis of the vitamin K-dependent clotting factors that can be measured by sensitive assays, standard clinical measures of pro-coagulant potential are not changed, except in some breast-fed infants.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin K and normal blood coagulation.

3.3. Funkcjonowanie serca i naczyń krwionośnych (ID 124, 125, 2880)

Vitamin-K dependent proteins have been identified in vascular tissue, including a matrix Gla-protein (MGP). In a MGP knockout mouse model, spontaneous calcification of soft tissues (mostly arteries) occurs (Luo et al., 1997). In the Keutel syndrome, due to a mutation of the gene encoding the human MGP, patients display several of the same features as the knockout mice, including abnormal calcification of cartilage of ears, nose, and respiratory tract. However, they do not appear to have increased incidence of coronary arterial disease or rupture of abdominal aortic aneurysm (Munroe et al., 1999).
The health claims (ID 124, 125 and 2880) are made on vitamin K2. From the literature available, four papers refer to the role of vitamin K from all sources and/or vitamin K2 in relation to the heart and/or blood vessels (Jie et al., 1995; Maas et al., 2007; Geleijnse et al., 2004; Beulens et al., 2009). The Panel considers that studies investigating the relationship between vitamin K intake (from all sources and/or as vitamin K2) and arterial calcification or the elastic properties of the arteries (which may interfere with normal vascular structure and function) are pertinent to the claimed effect.
Three cross-sectional studies investigated the relationship between vitamin K intake and arterial calcification in women. Whereas one study found lower vitamin K (mainly vitamin K1) intakes in women with aortic atherosclerosis (Jie et al., 1995) as compared to controls, another study reported that vitamin K2 (but not vitamin K1) intake was inversely related to the presence of coronary calcification (Beulens et al., 2008), and the third showed no association between either vitamin K1 or vitamin K2 intake and breast arterial calcification after adjustment for confounders (Maas et al., 2007).
An observational prospective study in 4,807 older men and women found that high intakes of vitamin K2 (but not of K1) were associated with a significantly lower degree of aortic calcification and lower incidence of coronary heart disease after adjustment for confounders (Geleijnse et al., 2004). The Panel notes that no definite conclusion can be drawn from this single prospective study on a causal link between the intake of vitamin K2 and the normal function of the heart and blood vessels.
In weighing the evidence, the Panel took into account the inconsistency of the results reported in three cross-sectional studies, and that no definite conclusion can be drawn from a single prospective study on a causal link between the intake of vitamin K2 and the normal function of the heart and blood vessels.
The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the dietary intake of vitamin K2 and the normal function of the heart and blood vessels.

4.1. Utrzymanie prawidłowego stanu kości (ID 123, 127, 128, 2879)

The Panel considers that the following wording reflects the scientific evidence: “Vitamin K contributes to maintenance of normal bone”.

4.2. Krzepnięcie krwi (ID 124, 126)

The Panel considers that the following wording reflects the scientific evidence: “Vitamin K contributes to normal blood coagulation”.