Scientific Opinion on the substantiation of health claims related to biotin
and energy-yielding metabolism (ID 114, 117), macronutrient metabolism
(ID 113, 114, 117), maintenance of skin and mucous membranes (ID 115),
maintenance of hair (ID 118, 2876) and function of the nervous system
(ID 116) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Biotin
energy-yielding metabolism
hair
health claims
macronutrient metabolism
nervous system
skin and mucous membranes
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. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Metabolizm energetyczny (ID 114, 117)
The claimed effects are “fat, carbohydrate, energy metabolism” and “fat metabolism and energy production”. The Panel assumes that the target population is the general population.
The Panel considers that normal energy-yielding metabolism is beneficial to human health.
2.2. Metabolizm makroskładników (ID 113, 114, 117)
The claimed effects are “protein and amino acid metabolism”, “fat, carbohydrate, energy metabolism” and “fat metabolism and energy production”. The Panel assumes that the target population is the general population.
The Panel considers that normal macronutrient metabolism is beneficial to human health.
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.
2.4. Utrzymanie prawidłowego stanu włosów (ID 118, 2876)
The claimed effects are “hair growth & follicle formation” and “hair loss and regrowth”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal hair is beneficial to human health.
2.5. Funkcjonowanie układu nerwowego (ID 116)
The claimed effect is “neurological system function”. The Panel assumes that the target population is the general population.
The Panel considers that normal function of the nervous system 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).
3.1. Metabolizm energetyczny (ID 114, 117)
Biotin is a cofactor for four carboxylase enzymes which are also involved in energy-yielding metabolism (IoM, 1998; Stryer, 1988).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and normal energy-yielding metabolism. However, the evidence provided does not establish that inadequate intake of biotin leading to impaired energy-yielding metabolism occurs in the general EU population.
3.2. Metabolizm makroskładników (ID 113, 114, 117)
Biotin is a cofactor for four carboxylase enzymes which are also involved in macronutrient metabolism (IoM, 1998; Stryer, 1988).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and normal macronutrient metabolism. However, the evidence provided does not establish that inadequate intake of biotin leading to impaired macronutrient metabolism occurs in the general EU population.
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.
3.4. Utrzymanie prawidłowego stanu włosów (ID 118, 2876)
In addition to textbooks, animal studies and case reports, one reference was provided on the effect of high doses of biotin on alopecia and hair quality (Floersheim, 1992). The Panel notes that in this study no objective methods were used to determine the improvement in hair loss and hair quality.
Symptoms of biotin deficiency include thinning of hair and progression to loss of all hair, including eyebrows and lashes. Growth of normal hair generally appears after one or two months of treatment of the deficiency (Mock, 2005).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and maintenance of normal hair. However, the evidence provided does not establish that intake of biotin inadequate for the maintenance of normal hair occurs in the general EU population.
3.5. Funkcjonowanie układu nerwowego (ID 116)
Biotin has a role in the metabolic pathway of all cells including brain and nerve cells.
Biotin deficiency symptoms include central nervous system abnormalities such as hypotonia, lethargy, and developmental delay in infants, and depression, hallucinations, and paraesthesia of the extremities in adults (FAO/WHO, 2004).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and normal function of the nervous system. However, the evidence provided does not
establish that inadequate intake of biotin leading to impaired function of the nervous system occurs in the general EU population.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Metabolizm energetyczny (ID 114, 117)
The Panel considers that the following wording reflects the scientific evidence: “Biotin contributes to normal energy-yielding metabolism.”
4.2. Metabolizm makroskładników (ID 113, 114, 117)
The Panel considers that the following wording reflects the scientific evidence: “Biotin contributes to normal macronutrient metabolism.”
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.”
4.4. Utrzymanie prawidłowego stanu włosów (ID 118, 2876)
The Panel considers that the following wording reflects the scientific evidence: “Biotin contributes to the maintenance of normal hair.”
4.5. Funkcjonowanie układu nerwowego (ID 116)
The Panel considers that the following wording reflects the scientific evidence: “Biotin contributes to the normal function of the nervous system.”
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).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, biotin, which is the subject of the health claims is sufficiently characterised.
Energy-yielding metabolism (ID 114, 117)
The claimed effects are “fat, carbohydrate, energy metabolism” and “fat metabolism and energy production”. The target population is assumed to be the general population. Normal energy-yielding metabolism is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of biotin and normal energy-yielding metabolism.
The evidence provided does not establish that inadequate intake of biotin leading to impaired energy-yielding metabolism occurs in the general EU population.
The following wording reflects the scientific evidence: “Biotin contributes to normal energy- yielding metabolism.”
Macronutrient metabolism (ID 113, 114, 117)
The claimed effects are “protein and amino acid metabolism”, “fat, carbohydrate, energy metabolism” and “fat metabolism and energy production”. The target population is assumed to be the general population. Normal macronutrient metabolism is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of biotin and normal macronutrient metabolism.
The evidence provided does not establish that inadequate intake of biotin leading to impaired macronutrient metabolism occurs in the general EU population.
The following wording reflects the scientific evidence: “Biotin contributes to normal macronutrient metabolism.”
Maintenance of skin and mucous membranes (ID 115)
The claimed effect is “normal structure and function of skin and mucosa”. The target population is assumed to be the general population. Maintenance of normal skin and mucous membranes is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of biotin and the maintenance of normal skin and mucous membranes.
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.
The following wording reflects the scientific evidence: “Biotin contributes to the maintenance of normal skin and mucous membranes.”
Maintenance of hair (ID 118, 2876)
The claimed effects are “hair growth & follicle formation” and “hair loss and regrowth”. The target population is assumed to be the general population. Maintenance of normal hair is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of biotin and maintenance of normal hair.
The evidence provided does not establish that intake of biotin inadequate for the maintenance of normal hair occurs in the general EU population.
The following wording reflects the scientific evidence: “Biotin contributes to the maintenance of normal hair.”
Function of the nervous system (ID 116)
The claimed effect is “neurological system function”. The target population is assumed to be the general population. Normal function of the nervous system is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of biotin and normal neurological function.
The evidence provided does not establish that inadequate intake of biotin leading to impaired function of the nervous system occurs in the general EU population.
The following wording reflects the scientific evidence: “Biotin contributes to the normal function of the nervous system.”
Conditions and possible restrictions of use
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.
