ID 128 - Witamina K

PL: Witamina K
EN: Vitamin K
Pdf: vitamin K2

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is vitamin K (i.e. phylloquinone and menaquinone) which is a well recognized nutrient and is measurable in foods by established methods.
Vitamin K is a family of structurally similar, fat soluble, 2-methyl-1, 4-naphthoquinones, including phylloquinone (2-methyl-3-phytyl-1,4-naphthoquinone, vitamin K1) and menaquinones (collectively known as vitamin K2). Menaquinones are a large series of compounds containing an unsaturated side chain with differing numbers of isoprenyl units at the 3 position in the methyl-1,4-naphthoquinone nucleus. Depending on the number of isoprenyl units, the individual compounds are designated as menaquinone-n-(MK-n). Phylloquinone (vitamin K1) is found in higher plants and algae, with the highest concentration in green leafy vegetables. Menaquinones (vitamin K2) occur naturally in foods and can also be produced by many bacteria.
Phylloquinone and menaquinones are naturally present in foods and phylloquinone has been authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20064 and Annex I of Directive 2002/46/EC5). This evaluation applies to vitamin K naturally present in foods and to the form authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, vitamin K, which is the subject of the health claim, is sufficiently characterised.

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.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Proteins containing γ-carboxy-glutamic acid (Gla) residues are known to be dependent on vitamin K for their synthesis. These include (but are not limited to) the plasma clotting factors II, VII, IX, X; proteins S, C and Z (which play an anticoagulant rather than a procoagulant role in normal haemostasis); and osteocalcin and matrix Gla protein (MGP), which are abundant in bone and appear to play a role in the control of tissue mineralisation and skeletal turnover.
Vitamin K status is determined through measures of the ratio of carboxylated to non carboxylated vitamin K – dependent proteins.

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.

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”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claims a food should be at least a source of vitamin K as per Annex to Regulation 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population.

Warunki i możliwe ograniczenia stosowania oświadczenia

Minimum 15% RDA per 100g or 100ml or per single servings as per 90/496/EEC