Scientific Opinion on the substantiation of health claims related to niacin and reduction of tiredness and fatigue (ID 47), contribution to normal
energy-yielding metabolism (ID 51), contribution to normal psychological functions (ID 55), maintenance of normal blood flow (ID 211), and
maintenance of normal skin and mucous membranes (ID 4700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Niacin
blood flow
energy-yielding metabolism
fatigue
health claims
mucous membranes
psychological functions
skin
tiredness
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, as 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 1925/20066 and Annex I of Directive 2002/46/EC7). 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 claims is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zmniejszenie zmęczenia (ID 47)
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.
2.2. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 51)
The claimed effect is “energy and vitality”. The Panel assumes that the target population is the general population. In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect is related to energy-yielding metabolism.
A claim on niacin and normal energy-yielding metabolism has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.3. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 55)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
2.4. Utrzymanie prawidłowego przepływu krwi (ID 211)
The claimed effect is “niacin enhances the blood flow because of its vascular dilatation effect”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal blood flow is a beneficial physiological effect.
2.5. Utrzymanie prawidłowego stanu skóry i błon śluzowych (ID 4700)
The claimed effect is “normal structure and function of skin and mucous membranes (such as the intestine)”. The Panel assumes that the target population is the general population.
A claim on niacin and maintenance of normal skin and mucous membranes has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Zmniejszenie zmęczenia (ID 47)
A combined deficiency of niacin and tryptophan causes the classical symptoms of pellagra. The clinical features of pellagra are dermatitis, diarrhoea and dementia. Symptoms also 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 reduction of tiredness and fatigue. However, the evidence provided does not establish that inadequate intake of niacin leading to tiredness and fatigue occurs in the general EU population.
3.2. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 55)
A combined deficiency of niacin and tryptophan causes the classical symptoms of pellagra. The clinical features of pellagra are dermatitis, diarrhoea and dementia. Symptoms also 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 contribution to normal psychological functions. However, the evidence provided does not establish that inadequate intake of niacin leading to impaired psychological functions occurs in the general EU population.
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3.3. Utrzymanie prawidłowego przepływu krwi (ID 211)
Five references were cited to substantiate the claim, two of which were textbooks where the claimed effect was not mentioned, and one of which was related to dietary reference values for vitamins and minerals from an authoritative body. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
In the remaining two textbooks the effect of nicotinic acid at daily doses of at least 30 mg on vasodilatation was mentioned. The Panel notes that this dose of nicotinic acid is above the Tolerable Upper Intake level (UL) (10 mg; SCF, 2002).
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.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Zmniejszenie zmęczenia (ID 47)
The Panel considers that the following wording reflects the scientific evidence: “Niacin can contribute to the reduction of tiredness and fatigue”.
4.2. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 55)
The Panel considers that the following wording reflects the scientific evidence: “Niacin contributes to normal psychological functions”.
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 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 (ULs) have been established for free nicotinic acid and nicotinamide (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 characterised.
Reduction of tiredness and fatigue (ID 47)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. Reduction of tiredness and fatigue is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of niacin and the reduction of tiredness and fatigue.
The evidence provided does not establish that inadequate intake of niacin leading to tiredness and fatigue occurs in the general EU population.
The following wording reflects the scientific evidence: “Niacin can contribute to the reduction of tiredness and fatigue”.
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Contribution to normal energy-yielding metabolism (ID 47)
The claimed effect is “energy and vitality”. The target population is assumed to be the general population. In the context of the clarifications provided by Member States, it is assumed that the claimed effect is related to energy-yielding metabolism.
A claim on niacin and normal energy-yielding metabolism has already been assessed with a favourable outcome.
Contribution to normal psychological functions (ID 55)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The target population is assumed to be the general population. Contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of niacin and contribution to normal psychological functions.
The evidence provided does not establish that inadequate intake of niacin leading to impaired psychological functions occurs in the general EU population.
The following wording reflects the scientific evidence: “Niacin contributes to normal psychological functions”.
Maintenance of normal blood flow (ID 211)
The claimed effect is “niacin enhances the blood flow because of its vascular dilatation effect”. The target population is assumed to be the general population. Maintenance of normal blood flow is a beneficial physiological effect.
The claim for niacin and maintenance of normal blood flow encourages excess consumption of niacin and therefore does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Maintenance of normal skin and mucous membranes (ID 4700)
The claimed effect is “normal structure and function of skin and mucous membranes (such as the intestine)”. The target population is assumed to be the general population.
A claim on niacin and maintenance of normal skin and mucous membranes has already been assessed with a favourable outcome.
Conditions and possible restrictions of use
In order to bear the claims 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.
