ID 115 - Biotyna

PL: Biotyna
EN: Biotin
Pdf: biotin

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is biotin, which is a 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 the 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 1925/20064 and Annex II of Directive 2002/46/EC5).
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.

2.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 115)

The claimed effect is “normal structure and function of skin and mucosa”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal skin and mucous membranes is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Biotin is a cofactor for the acetyl CoA, propionyl CoA, β-methylcrotonyl CoA and pyruvate carboxylase enzymes, which are important in the synthesis of fatty acids, the catabolism of some branched-chain amino acids and the gluconeogenic pathway.
Pyruvate carboxylase catalyses the carboxylation of pyruvate to form oxaloacetate which 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 formation of malonyl-CoA which serves as a substrate for fatty acid elongation.
Propionyl CoA carboxylase carboxylates propionyl CoA to form D-methylmalonyl CoA which is racemised to the L-isomer and then transformed to succinyl CoA, which 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 consumption or parenteral nutrition. Thinning of hair and progression to loss of all hair, including eyebrows and lashes, has been reported. A scaly (seborrheic), red (eczematous) skin rash was present in the majority of cases. 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).

3.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 115)

Symptoms of biotin deficiency include a scaly (seborrheic), red (eczematous) skin which is reversible by administration of biotin (Mock, 2005). There is evidence that impaired fatty acid metabolism secondary to reduced activities of the biotin dependent carboxylases (especially acetyl CoA carboxylase) plays an aetiological role in the dermatological manifestation of biotin deficiency (Mock, 1991).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and maintenance of normal skin and mucous membranes. However, the evidence provided does not establish that intake of biotin inadequate for the maintenance of normal skin and mucous membranes occurs in the general EU population.

4.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 115)

The Panel considers that the following wording reflects the scientific evidence: “Biotin contributes to the maintenance of normal skin and mucous membranes.”

5. Warunki i możliwe ograniczenia stosowania oświadczenia

In order to bear the claims a food should be at least 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. No numerical Tolerable Upper Intake Level (UL) has been set for biotin owing to the lack of systematic oral intake dose-response studies of biotin (SCF, 2001).

Warunki i możliwe ograniczenia stosowania oświadczenia

Must at least be a source of vitamin/s as per annex to regulation 1924/2006