ID 48 - Niacyna

PL: Niacyna
EN: Nacin
Pdf: niacin

Oświadczenie (4)

Oświadczenie (2)

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.

2.3. 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.

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).

3.3. 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.

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).

Warunki i możliwe ograniczenia stosowania oświadczenia

The product must contain at least 15% of RDA per daily dosage as per 90/496/EC Agency guidance for supplements is that products containing >20 mg of Nicotinic acid should carry the label advisory statement "[This amount of Nicotinic acid]* may cause skin flushes in sensitive individuals". Applicable to both children and adults