ID 106 - Witamina B12

PL: Witamina B12
EN: Vitamin B12
Pdf: various food(s)/food constituent(s) that are referring to children’s development

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is vitamin B12, which is a specific group of cobalt-containing corrinoids with biological activity in humans. Recommended biochemical nomenclature restricts the term vitamin B12 for the particular form of cobalamin known as cyanocobalamin and all cobalamins exhibiting qualitatively the biological activity of cyanocobalamin. Cobalamins do not occur in plants but are synthesised by certain bacteria, fungi and algae, which constitute the ultimate source of all cobalamin found in nature (Green, 2005). Vitamin B12 is a well recognised nutrient and is measurable in foods by established methods.
Vitamin B12 occurs naturally in foods and is authorised for addition to foods and for use in food supplements (Annex I of the Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to vitamin B12 naturally present in foods and those forms authorised for addition to foods (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 B12, which is the subject of the health claims, is sufficiently characterised.

2.2. Udział w prawidłowym metabolizmie homocysteiny (ID 96, 103, 106)

The claimed effects are “homocysteine metabolism”, “homocysteine levels”, and “heart health”. The Panel assumes that the target population is the general population.
In the context of the proposed wording for ID 106, the Panel assumes that the claimed effect is related to normal homocysteine metabolism.
The Panel considers that contribution to normal homocysteine metabolism is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

The two forms of vitamin B12 that function as coenzymes for metabolic reactions are methylcobalamin and 5'-deoxyadenosylcobalamin.

3.2. Udział w prawidłowym metabolizmie homocysteiny (ID 96, 103, 106)

Methylcobalamin, a coenzyme form of vitamin B12, is involved in the remethylation of homocysteine to methionine by the methionine synthase which requires both folate and vitamin B12 as cofactors (Stabler, 2006).
Under conditions of maximal metabolic efficiency, plasma concentration of homocysteine ranges from 4 to 10 µmol/L. Metabolic blocks in homocysteine metabolism lead to accumulation of intra- cellular homocysteine with subsequent export into the blood. Depending on the magnitude of the metabolic impairment, plasma homocysteine can rise to varying degrees. Deficiencies of folate, vitamin B6 and vitamin B12 lead to impaired remethylation of homocysteine causing mild, moderate, or severe elevations in plasma homocysteine, depending on the severity of the deficiency, as well as coexistence of genetic or other factors that interfere with homocysteine metabolism (Miller, 2005).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin B12 and contribution to normal homocysteine metabolism.

4.2. Udział w prawidłowym metabolizmie homocysteiny (ID 96, 103, 106)

The Panel considers that the following wording reflects the scientific evidence: “Vitamin B12 contributes to normal homocysteine metabolism”.

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 B12 as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. For vitamin B12 no adverse effects have been reported after high dose supplementation and no Tolerable Upper Intake Levels (ULs) have been set (SCF, 2000).

Warunki i możliwe ograniczenia stosowania oświadczenia

Only for products with at least 100 % RDA