Scientific Opinion on substantiation of health claims related to thiamine
and energy-yielding metabolism (ID 21, 24, 28), cardiac function (ID 20),
function of the nervous system (ID 22, 27), maintenance of bone (ID 25),
maintenance of teeth (ID 25), maintenance of hair (ID 25), maintenance of
nails (ID 25), maintenance of skin (ID 25) 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:
Thiamine
bone
cardiac function
energy metabolism
hair
health claims
nails
nervous system
skin
teeth
vitamin B1
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is thiamine (also named vitamin B1), which is a well recognised nutrient and is measurable in foods by established methods.
Thiamine occurs naturally in foods and is authorised for addition to foods (Annex I of the Regulation (EC) No 1925/20064 and Annex I of Directive 2002/46/EC5). This evaluation applies to thiamine 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, thiamine, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Metabolizm energetyczny (ID 21, 24, 28)
The claimed effects are related to “energy metabolism” and “macronutrient metabolism”. The Panel assumes that the target population is the general population.
The Panel notes that in the context of the proposed wording, energy metabolism and macronutrient metabolism relates to energy-yielding metabolism of macronutrients.
The Panel considers that normal energy-yielding metabolism is beneficial to human health.
2.2. Czynności serca (ID 20)
The claimed effect is “normal cardiac function”. The Panel assumes that the target population is the general population.
The Panel considers that normal cardiac function is beneficial to human health.
2.3. Funkcjonowanie układu nerwowego (ID 22, 27)
The claimed effect is “neurological function/neurological systems”. 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.
2.4. Utrzymanie prawidłowego stanu kości (ID 25)
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 the maintenance of normal bone is beneficial to human health.
2.5. Utrzymanie prawidłowego stanu zębów (ID 25)
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 the maintenance of normal teeth is beneficial to human health.
2.6. Utrzymanie prawidłowego stanu włosów (ID 25)
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 the maintenance of normal hair is beneficial to human health.
2.7. Utrzymanie prawidłowego stanu paznokci (ID 25)
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 the maintenance of normal nails is beneficial to human health.
2.8. Utrzymanie prawidłowego stanu skóry (ID 25)
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 the maintenance of normal skin is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
Thiamine (as thiamine diphosphate, a co-enzyme for several oxidative decarboxylation reactions and for transketolase) has a central role in energy-yielding metabolism, especially in the metabolism of carbohydrates and of branched-chain amino acids (Bender, 1999; EC, 2003). Thiamine (as thiamine triphosphate), has a function in nerve conduction (Bender, 1999; IoM, 1998). Thiamine deficiency can result in three distinct syndromes: Beriberi, a chronic peripheral neuritis, which may or may not be associated with heart failure and oedema, acute pernicious (fulminating) beriberi, in which heart failure and life-threatening metabolic acidosis predominate, with little or no evidence of peripheral neuritis, and central nervous system disturbances, Wernicke's encephalopathy with Korsakoff's psychosis (SCF, 1993).
3.1. Metabolizm energetyczny (ID 21, 24, 28)
Thiamine is the precursor for thiamine diphosphate, which is a co-enzyme for a number of reactions involved in carbohydrates and of branched-chain amino acids metabolism and central energy-yielding metabolic pathways, e.g. alpha-ketoacid decarboxylation and transketolation reactions.
The Panel concludes that a cause and effect relationship has been established between the dietary intake of thiamine and normal energy-yielding metabolism. However, the evidence provided does not establish that inadequate intake of thiamine leading to impaired energy-yielding metabolism, occurs in the general EU population.
3.2. Czynności serca (ID 20)
Thiamine has a role in energy metabolism in all cells including cells of the cardiac system (Bender, 1999; IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of thiamine and the normal cardiac function. However, the evidence provided does not establish that inadequate intake of thiamine leading to impaired cardiac function occurs in the general EU population.
3.3. Funkcjonowanie układu nerwowego (ID 22, 27)
Thiamine has a role in energy metabolism in all cells including cells of the nervous system. (Bender, 1999; IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of thiamine and the normal function of the nervous system. However, the evidence provided does not establish that inadequate intake of thiamine leading to impaired neurological function occurs in the general EU population.
3.4. Utrzymanie prawidłowego stanu kości (ID 25)
A total of 6 textbooks or opinions of scientific bodies were provided in which the claimed effect was not stated. The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal bone.
3.5. Utrzymanie prawidłowego stanu zębów (ID 25)
A total of 6 textbooks or opinions of scientific bodies were provided in which the claimed effect was not stated. The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal teeth.
3.6. Utrzymanie prawidłowego stanu włosów (ID 25)
A total of 6 textbooks or opinions of scientific bodies were provided in which the claimed effect was not stated. The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal hair.
3.7. Utrzymanie prawidłowego stanu paznokci (ID 25)
A total of 6 textbooks or opinions of scientific bodies were provided in which the claimed effect was not stated. The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal nails.
3.8. Utrzymanie prawidłowego stanu skóry (ID 25)
A total of 6 textbooks or opinions of scientific bodies were provided in which the claimed effect was not stated. The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal skin.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Metabolizm energetyczny (ID 21, 24, 28)
The Panel considers that the following wording reflects the scientific evidence:
“Thiamine contributes to normal energy-yielding metabolism”.
4.2. Czynności serca (ID 20)
The Panel considers that the following wording reflects the scientific evidence:
“Thiamine contributes to the normal function of the heart”.
4.3. Funkcjonowanie układu nerwowego (ID 22, 27)
The Panel considers that the following wording reflects the scientific evidence:
“Thiamine contributes to the normal function of the nervous system”.
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 thiamine as per Annex to Regulation 1924/2006. Tolerable Upper Intake Levels (UL) have not been established for thiamine in children, adolescents and adults. The target population is the general population.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, thiamine (vitamin B1), which is the subject of the health claims, is sufficiently characterised.
Energy-yielding metabolism (ID 21, 24, 28)
The claimed effect is “energy metabolism, macronutrient metabolism”. 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 thiamine and normal energy-yielding metabolism.
The evidence provided does not establish that inadequate intake of thiamine leading to impaired energy-yielding occurs in the general EU population.
The following wording reflects the scientific evidence: “Thiamine contributes to normal energy metabolism”.
Cardiac function (ID 20)
The claimed effect is “cardiac function”. The target population is assumed to be the general population. Normal cardiac function is beneficial to human health.
A cause and effect relationship has been established between the dietary intake of thiamine and cardiac function.
The evidence provided does not establish that inadequate intake of thiamine leading to impaired cardiac function occurs in the general EU population.
The following wording reflects the scientific evidence: “Thiamine contributes to the normal function of the heart”.
Function of the nervous system (ID 22, 27)
The claimed effect is “neurological 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 dietary intake of thiamine and normal function of the nervous system.
The evidence provided does not establish that inadequate intake of thiamine leading to impaired neurological function occurs in the general EU population.
The following wording reflects the scientific evidence: “Thiamine contributes to the normal function of the nervous system”.
Maintenance of bone (ID 25)
The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population. Maintenance of normal bone is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal bone.
Maintenance of teeth (ID 25)
The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population. Maintenance of normal teeth is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal teeth.
Maintenance of hair (ID 25)
The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population. Maintenance of normal hair is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal hair.
Maintenance of nails (ID 25)
The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population. Maintenance of normal function of nails is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal nails.
Maintenance of skin (ID 25)
The claimed effect is “bone/teeth/hair/skin and nail health”. The Panel assumes that the target population is the general population. Maintenance of normal skin is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of thiamine and the maintenance of normal skin.
Conditions and possible restrictions of use
In order to bear the claims a food should be at least a source of thiamine as per Annex to Regulation 1924/2006.
