ID 46 -
Niacyna
PL: Niacyna
EN: Nacin
Pdf: niacin
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.
2.4. 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.
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).
3.4. 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).
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
Adults: Typical starting dose = 10-100 mg three times daily, which can be increased to 1000 mg three times daily, or to tolerance.
There is no evidence that low doses (<50 mg daily) have a significant effect on controlling blood lipid levels.
Sustained-re