ID 95 - 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.

2.1. Udział w prawidłowym przebiegu funkcji neurologicznych i psychicznych (psychologicznych) (ID 95, 97, 98, 100, 102, 109)

The claimed effects are “neurological system: structure and function”, “cognitive function in ageing”, “nerve system and cognitive function”, “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The Panel assumes that the target population is the general population.
The Panel notes that the claimed effects relate to neurological and psychological functions.
The Panel considers that contribution to normal neurological and psychological functions, which encompass cognitive and affective domains, 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.

3.1. Udział w prawidłowym przebiegu funkcji neurologicznych i psychicznych (psychologicznych) (ID 95, 97, 98, 100, 102, 109)

Vitamin B12 has a central role in the normal functions of the brain and nervous system. It is well established from clinical studies that vitamin B12 deficiency produces adverse neurological effects owing to demyelination in the spinal cord, brain, and optic and peripheral nerves (Allen et al., 1996; Gibney et al., 2002; Wynn and Wynn, 1998). Serious vitamin B12 deficiency leads to an irreversible polyneuropathy. Clinical signs include e.g. abnormal proprioception, taste, smell and vision, irritability, memory loss, dementia, ataxia (Allen et al., 1996; Gibney et al., 2002; Wynn and Wynn, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin B12 and contribution to normal neurological and psychological functions.

4.1. Udział w prawidłowym przebiegu funkcji neurologicznych i psychicznych (psychologicznych) (ID 95, 97, 98, 100, 102, 109)

The Panel considers that the following wording reflects the scientific evidence: “Vitamin B12 contributes to normal neurological and psychological functions”.

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 at least be a source of vitamin/s as per annex to regulation 1924/2006 Applicable to both children and adults