Scientific Opinion on the substantiation of health claims related to niacin
and energy-yielding metabolism (ID 43, 49, 54), function of the nervous
system (ID 44, 53), maintenance of the skin and mucous membranes (ID 45,
48, 50, 52), maintenance of normal LDL-cholesterol, HDL-cholesterol and
triglyceride concentrations (ID 46), maintenance of bone (ID 50),
maintenance of teeth (ID 50), maintenance of hair (ID 50, 2875) and
maintenance of nails (ID 50, 2875) 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:
HDL- cholesterol
LDL-cholesterol
Niacin
bone
energy-yielding metabolism
hair
health claims
mucous membranes
nails
nervous system
skin
teeth
triglycerides
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is niacin, which is a well recognised nutrient and is measurable in foods by established methods.
Preformed niacin occurs naturally in foods either as nicotinamide or as the derived pyridine nucleotide coenzymes (nicotinamide adenine dinucleotide, NAD and nicotinamide adenine dinucleotide phosphate, NADP) or as nicotinic acid. Niacin can also be synthesised in the body from dietary tryptophan. Niacin is the common term for nicotinamide and nicotinic acid 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 niacin naturally present in foods and those forms authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, niacin, which is the subject of the health claim is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Metabolizm energetyczny (ID 43, 49, 54)
The claimed effects are related to “energy metabolism / nutrient utilisation” “macronutrient metabolism” and “NAD and NADP. These nucleotides are key components of oxidation-reduction reactions, ATP synthetic pathways and ADP-ribose transfer reactions”. 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.
The Panel considers that normal energy-yielding metabolism is beneficial to human health.
2.2. Funkcjonowanie układu nerwowego (ID 44, 53)
The claimed effects are “neurological functions” and “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.
2.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 45, 48, 50, 52)
The claimed effects are “normal structure and function of skin and mucous membranes (such as in the intestines)”, “structure and function of skin”, “bone/teeth/hair/skin and nail health” and “skin and mucous membranes”. 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 stężenia cholesterolu HDL, cholesterolu LDL i trójglicerydów we krwi (ID 46)
The claimed effect is “blood lipids”. The Panel assumes that the target population is the general population.
From the wordings proposed the Panel assumes that the claim refers to the maintenance of normal blood triglycerides, LDL- and HDL-cholesterol concentrations.
The Panel considers that maintenance of normal LDL-cholesterol, normal HDL-cholesterol and triglycerides concentrations are beneficial to human health.
2.5. Utrzymanie prawidłowego stanu kości (ID 50)
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 maintenance of normal bone is beneficial to human health.
2.6. Utrzymanie prawidłowego stanu zębów (ID 50)
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 maintenance of normal teeth is beneficial to human health.
2.7. Utrzymanie prawidłowego stanu włosów (ID 50, 2875)
The claimed effect is “bone/teeth/hair/skin and nail health” and “hairs and nails care”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal hair is beneficial to human health.
2.8. Utrzymanie prawidłowego stanu paznokci (ID 50, 2875)
The claimed effect is “bone/teeth/hair/skin and nail health” and “hairs and nails care”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal nails is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
Niacin (as NAD and NADP) has a central role in the hydrogen/electron transfer redox reactions in cells. The most important functions of NAD are in the major catabolic pathways in relation to the oxidation of energy-producing fuels whereas the principal functions of NADP are in reductive biosyntheses, such as lipid biosynthesis (Jacob, 2006; EVM, 2002; IoM, 2000).
3.1. Metabolizm energetyczny (ID 43, 49, 54)
Niacin supports energy-yielding metabolism as it is the functional factor of two important coenzymes, nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which activate over 200 dehydrogenases essential to electron transport and other cellular respiratory reactions (Jacob, 2006; EVM, 2002; IoM, 2000).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of niacin and normal energy-yielding metabolism. However, the evidence provided does not establish that inadequate intake of niacin leading to impaired energy-yielding metabolism occurs in the general EU population.
3.2. Funkcjonowanie układu nerwowego (ID 44, 53)
A combined deficiency of niacin and tryptophan causes the classical symptoms of pellagra. The clinical features of pellagra are dermatitis, diarrhoea and dementia. Neurological symptoms include depression, apathy, headache, fatigue and loss of memory (Jacob, 2006; EVM, 2002; IoM, 2000).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of niacin and normal function of the nervous system. However, the evidence provided does not establish that inadequate intake of niacin leading to impaired function of the nervous system occurs in the general EU population.
3.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 45, 48, 50, 52)
A combined deficiency of niacin and tryptophan causes the classical symptoms of pellagra. The clinical features of pellagra are dermatitis, diarrhoea and dementia. The changes in the skin are among the most characteristic in humans. A pigmented rash develops symmetrically in areas of the skin exposed to sunlight. Changes in the digestive tract are associated with vomiting, constipation or diarrhoea, and a bright red tongue (Jacob, 2006; EVM, 2002; IoM, 2000; Bourgeois et al., 1999; SCF, 2002; SCF, 1993).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of niacin and maintenance of normal skin and mucous membranes. However, the evidence provided does not establish that intake of niacin inadequate for the maintenance of normal skin and mucous membranes occur in the general EU population.
3.4. Utrzymanie prawidłowego stężenia cholesterolu HDL, cholesterolu LDL i trójglicerydów we krwi (ID 46)
Nicotinic acid in high doses (1-6 g/d) has been used for decades in the drug therapy of hyperlipidaemias.
A total of 17 references were cited for the substantiation of the claimed effect, including four review papers, one meta-analysis and twelve human studies. The effects of nicotinic acid at daily doses ranging from 100 mg to 6 g on the lipid profile were assessed in these studies.
The Panel notes that the evidence provided for the substantiation of the claim relates to studies with niacin at intakes above the Tolerable Upper Intake Level (UL) (10 mg; SCF, 2002) and that the proposed conditions of use refer to intakes up to 300 times the UL. The Panel considers that this claim (the proposed wording of this claim) encourages excess consumption of niacin and therefore does not comply with the criteria laid down in Regulation (EC) No 1924/2006 (Article 3c).
3.5. Utrzymanie prawidłowego stanu kości (ID 50)
A total of 14 references were cited for the substantiation of the claimed effect, including 10 textbooks and 3 opinions from authoritative bodies in which the claimed effect was not stated. One human study dealt with hair loss, which is unrelated to the claimed effect. The Panel notes that the references 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 niacin and maintenance of normal bone.
3.6. Utrzymanie prawidłowego stanu zębów (ID 50)
A total of 14 references were cited for the substantiation of the claimed effect, including 10 textbooks and 3 opinions from authoritative bodies in which the claimed effect was not stated. One human study dealt with hair loss, an outcome unrelated to the claimed effect. The Panel notes that the references 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 niacin and maintenance of normal teeth.
3.7. Utrzymanie prawidłowego stanu włosów (ID 50, 2875)
A total of 21 references were cited for the substantiation of the claimed effect, including 10 textbooks and 4 opinions from authoritative bodies in which the claimed effect was not stated and a private- public medicinal database. Four references dealt with outcomes unrelated to the claimed effect such as regulation of vascular tone and the development of an experimental model for niacin deficiency. The Panel notes that these references did not provide any scientific data that could be used to substantiate the claimed effect. One reference cited was not accessible to the Panel after having made every reasonable effort to retrieve it (El-Fekih et al., 2005).
In a non-controlled human study with 41 volunteers presenting with hair loss, the effect of niacin in combination with other compounds on hair loss was examined using subjective evaluation (Raoudi and Robreau, 2006). The Panel notes the small size of the study, the lack of information on the overall nutritional status of the subjects and that no objective methods were used to determine the improvement in hair loss in this study.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of niacin and maintenance of normal hair.
3.8. Utrzymanie prawidłowego stanu paznokci (ID 50, 2875)
A total of 21 references were cited for the substantiation of the claimed effect, including 10 textbooks and 4 opinions from authoritative bodies in which the claimed effect was not stated and a private-
public medicinal database. Five references dealt with outcomes unrelated to the claimed effect such as hair loss, regulation of vascular tone and the development of an experimental model for niacin deficiency. The Panel notes that these references did not provide any scientific data that could be used to substantiate the claimed effect. One reference cited was not accessible to the Panel after having made every reasonable effort to retrieve it (El-Fekih et al., 2005).
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of niacin and maintenance of normal nails.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Metabolizm energetyczny (ID 43, 49, 54)
The Panel considers that the following wording reflects the scientific evidence: “Niacin contributes to normal energy-yielding metabolism”.
4.2. Funkcjonowanie układu nerwowego (ID 44, 53)
The Panel considers that the following wording reflects the scientific evidence: “Niacin contributes to the normal function of the nervous system”.
4.3. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 45, 48, 50, 52)
The Panel considers that the following wording reflects the scientific evidence: “Niacin contributes to the maintenance of normal skin and mucous membranes”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
The Panel considers that in order to bear the claim a food should be at least a source of niacin 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. Tolerable Upper Intake Levels (UL) have been established for free nicotinic acid as 10 mg/day for adults and for children and adolescents as 2 mg/day for 1-3 years, 3 mg/day for 4-6 years, 4 mg/day for 7-10 years, 6 mg/day for 11-14 years and 8 mg/day for 15-17 years. Tolerable Upper Intake Levels (UL) have been also established for nicotinamide as 900 mg/day for adults and for children and adolescents as 150 mg/day for 1-3 years, 220 mg/day for 4-6 years, 350 mg/day for 7-10 years, 500 mg/day for 11-14 years and 700 mg/day for 15-17 years (SCF, 2002).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, niacin, which is the subject of the health claims, is sufficiently characterized.
Energy-yielding metabolism (ID 43, 49, 54)
The claimed effects are “energy metabolism / nutrient utilization” “macronutrient metabolism” and “NAD and NADP. These nucleotides are key components of oxidation- reduction reactions, ATP synthetic pathways and ADP-ribose transfer reactions”. 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 niacin and normal energy-yielding metabolism.
The evidence provided does not establish that inadequate intake of niacin leading to impaired energy-yielding metabolism occurs in the general EU population.
The following wording reflects the scientific evidence: “Niacin contributes to normal energy- yielding metabolism”.
Function of the nervous system (ID 44, 53)
The claimed effects are “neurological functions” and “neurological systems”. The target population is assumed to be the general healthy 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 niacin and normal function of the nervous system.
The evidence provided does not establish that inadequate intake of niacin leading to impaired function of the nervous system occurs in the general EU population.
The following wording reflects the scientific evidence: “Niacin contributes to the normal function of the nervous system”.
Maintenance of skin and mucous membranes (ID 45, 48, 50, 52)
The claimed effects are “normal structure and function of skin and mucous membranes (such as in the intestines)”, “structure and function of skin” and “skin and mucous membranes”. The Panel assumes that the target population is 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 niacin and maintenance of normal skin and mucous membranes.
The evidence provided does not establish that intake of niacin inadequate for the maintenance of normal skin and mucous membranes occur in the general EU population.
The following wording reflects the scientific evidence: “Niacin contributes to the maintenance of normal skin and mucous membranes”.
Maintenance of normal LDL-cholesterol, HDL-cholesterol and triglyceride concentrations
(ID 46)
The claimed effect is “blood lipids”. The target population is assumed to be the general population. Maintenance of normal LDL-cholesterol, normal HDL cholesterol and triglycerides concentration are beneficial to human health.
The claim should not be evaluated in the context of health claims made on foods.
Maintenance of bone (ID 50)
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 niacin and maintenance of normal bone.
Maintenance of teeth (ID 50)
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 niacin and maintenance of normal teeth.
Maintenance of hair (ID 50, 2875)
The claimed effects are “bone/teeth/hair/skin and nail health” and “hairs and nails care”. 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 niacin and maintenance of normal hair.
Maintenance of nails (ID 50, 2875)
The claimed effects are “bone/teeth/hair/skin and nail health” and “hairs and nails care”. The Panel assumes that the target population is the general population. Maintenance of normal nails is beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of niacin and maintenance of normal nails.
Conditions and possible restrictions of use
In order to bear the claim a food should be at least a source of niacin 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.
