ID 104 - Witamina B12

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

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.

2.3. Utrzymanie prawidłowego stanu kości (ID 104)

The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.

2.4. Utrzymanie prawidłowego stanu zębów (ID 104)

The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal teeth is a beneficial physiological effect.

2.5. Utrzymanie prawidłowego stanu włosów (ID 104)

The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal hair is a beneficial physiological effect.

2.6. Utrzymanie prawidłowego stanu skóry (ID 104)

The claimed effect is “bone/teeth/hair/skin and nails health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal skin is a beneficial physiological effect.

2.7. Utrzymanie prawidłowego stanu paznokci (ID 104)

The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal nails 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.

3.3. Utrzymanie prawidłowego stanu kości (ID 104)

A total of nine references were provided, including three textbooks, two opinions from authoritative bodies, one review and three human studies.
One textbook mentioned that cobalamin deficiency had been described in association with reduced bone-derived alkaline phosphatase and osteocalcin in the plasma (Green, 2005). Two studies solely dealt with the putative role of homocysteine as a potential risk factor for the development of osteoporosis (McLean et al., 2004; Van Meurs et al., 2004), without referring to vitamin B12. Dhonukshe-Rutten et al. (2005) reported that high plasma concentrations of homocysteine and low serum concentrations of vitamin B12 and especially the combination of these two parameters were related to high fracture risk, low broadband ultrasound attenuation, and increased bone turnover markers, as studied in 1,267 subjects of the Longitudinal Aging Study Amsterdam. The Panel notes that no conclusions on a causal relationship between the dietary intake of vitamin B12 and the claimed effect can be drawn from this study because residual confounding by other dietary and lifestyle factors inherent in the observational study design cannot be excluded.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin B12 and maintenance of normal bone.

3.4. Utrzymanie prawidłowego stanu zębów (ID 104)

A total of nine references were provided, including three textbooks, two opinions from authoritative bodies, one review and three human studies, which were unrelated to the claimed effect. The Panel considers that no conclusions could be drawn for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin B12 and maintenance of normal teeth.

3.5. Utrzymanie prawidłowego stanu włosów (ID 104)

A total of nine references were provided, including three textbooks, two opinions from authoritative bodies, one review and three human studies, which were unrelated to the claimed effect. The Panel considers that no conclusions could be drawn for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin B12 and maintenance of normal hair.

3.6. Utrzymanie prawidłowego stanu skóry (ID 104)

A total of nine references were provided, including three textbooks, two opinions from authoritative bodies, one review and three human studies, which were unrelated to the claimed effect. The only reference referring to skin mentioned that cobalamin deficiency may also be associated with skin hyper-pigmentation (Green, 2005). The Panel considers that no conclusions can be drawn for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin B12 and maintenance of normal skin.

3.7. Utrzymanie prawidłowego stanu paznokci (ID 104)

A total of nine references were provided, including three textbooks, two opinions from authoritative bodies, one review and three human studies, which were unrelated to the claimed effect. The Panel considers that no conclusions can be drawn for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of vitamin B12 and maintenance of normal nails.

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

Must meet minimum requirements for use of the claim "source of [name of vitamin/s] and/or [name of mineral/s}" as per Annex to Regulation 1924/2006.