ID 119 - Biotyna

PL: Biotyna
EN: Biotin
Pdf: biotin

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is biotin, which is a well recognised nutrient and is measurable in foods by established methods. Biotin occurs naturally in foods as free biotin and in protein bound forms; there are eight stereoisomers, but D(+)-biotin is the only naturally occurring isomer that plays a role in human metabolism, and currently the only form authorised for addition to foods (Annex II of the Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to biotin 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, biotin, which is the subject of the health claims, is sufficiently characterised.

2.6. Zmniejszenie zmęczenia (ID 119)

The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The Panel assumes that the target population is the general population.
The Panel considers that reduction of tiredness and fatigue is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

It is well established that biotin is a cofactor for the acetyl-CoA, propionyl-CoA, ß-methylcrotonyl- CoA and pyruvate carboxylase enzymes, which are important in the synthesis of fatty acids, the catabolism of some branched-chain amino acids and for the gluconeogenic pathway.
Pyruvate carboxylase catalyses the carboxylation of pyruvate to form oxaloacetate which, in turn, serves as an intermediate in gluconeogenesis as well as in the citric acid cycle.
Methylcrotonyl-CoA carboxylase is required for the degradation of leucine, a branched-chain amino acid.
Acetyl-CoA carboxylase catalyses the carboxylation of acetyl-CoA to malonyl-CoA which, in turn, serves as a substrate for fatty acid elongation.
Propionyl-CoA carboxylase carboxylates propionyl-CoA to form D-methylmalonyl-CoA which is epimerised to the L-isomer and then transformed to succinyl-CoA, which then enters the citric acid cycle. The metabolic pathway from propionyl-CoA to succinyl-CoA is also part of the oxidation of fatty acids with an odd number of carbon atoms where the final cleavage forms acetyl-CoA and propionyl-CoA. This pathway is also involved in the catabolism of the branched-chain amino acids isoleucine and valine as well as the amino acids methionine and threonine (IoM, 1998; Stryer, 1988).
Biotin may also have a role in the regulation of gene expression arising from its interaction with nuclear histone proteins (EVM, 2003).
Biotin deficiency only appears after weeks to several years of raw egg-white feeding or biotin-free parenteral nutrition. Thinning of hair and progression to loss of all hair, including eyebrows and lashes, has been reported. A scaly (seborrhoeic), red (eczematous) skin rash was present in the majority; in several, the rash was distributed around the eyes, nose, mouth, and perineal orifices. Depression, lethargy, hallucinations, and paraesthesia of the extremities were prominent neurological symptoms in the majority of adults. The most striking neurological findings in infants were hypotonia, lethargy, and developmental delay (Mock, 2005).

3.4. Zmniejszenie zmęczenia (ID 119)

Four references were cited to substantiate the claim. Three were textbooks in which the claimed effect was not mentioned. One was a review on the role of B-vitamins in mitochondrial energy metabolism in which the claimed effect was not mentioned. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
Fatigue is also not among the symptoms of biotin deficiency (Mock, 2005).
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of biotin and the reduction of tiredness and fatigue.

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 biotin 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.

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.