1255.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to dietary fibre and maintenance of normal blood cholesterol concentrations (ID 747, 750, 811) 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: Dietary fibre   blood cholesterol   cardiovascular function   health claims  
ID:    811      750      747  
Produkty: Błonnik pokarmowy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is dietary fibre. Dietary fibre is the common name for all carbohydrate components occurring in foods that are non-digestible in the human small intestine. This definition includes non-starch polysaccharides, resistant starch, resistant oligosaccharides with three or more monomeric units, and other non-digestible, but quantitatively minor, components when these components are naturally associated with dietary fibre polysaccharides, especially lignin. The terms „soluble‟ and „insoluble‟ have been used in the literature to classify dietary fibre as viscous, as soluble in water (e.g. pectins) or as water insoluble (e.g. cellulose) in an attempt to link different physico-chemical properties of fibre components to different physiological effects. The above classification is method-dependent, and water solubility does not always predict the physiological effects of dietary fibre (EFSA, 2007).
Total fibre and different types of fibre can be measured in foods by established methods. However, intake of dietary fibre has a number of physiological effects in humans, including reduction of total and/or LDL cholesterol concentrations, which vary depending on the fibre component (EFSA, 2007).
The Panel considers that the food constituent, dietary fibre, which is the subject of the health claim is not sufficiently characterised in relation to the claimed effect.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effects are “normal cardiovascular function”, “cholesterol level” and “blood cholesterol level”. The Panel assumes the target population is the general population.
In the context of the proposed wording, the Panel notes that the claimed effects relate to the maintenance of normal blood cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160mg/dL, may compromise the normal function of the arteries.
The Panel considers that maintaining normal blood cholesterol concentrations is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stężenia cholesterolu we krwi

More than 80 well-controlled clinical trials in healthy and/or hypercholesterolaemic adults investigating the effects of different dietary fibre components on blood lipids have been provided.
Insoluble fibre like wheat bran does not affect serum lipids whereas some types of “water-soluble fibre” in moderate or high amounts have been shown to reduce serum total cholesterol and LDL- cholesterol concentrations (Jenkins et al., 1975, Brown et al., 1999; Jenkins et al., 2000). The cholesterol-lowering effect depends on increased viscosity that reduces the re-absorption of bile acids, increases the synthesis of bile acids from cholesterol, and reduces circulating (LDL) cholesterol concentrations. Viscosity in the small intestine is determined by the concentration, molecular weight and solubility of the fibre. Low molecular weight water-soluble fibre components with lower viscosity have shown little or no effect on LDL-cholesterol concentrations (Chen et al., 2001; Haskell et al., 1992).
In weighing the evidence, the Panel took into account that the food constituent, dietary fibre, that is the subject of the health claims is not sufficiently characterised in relation to the claimed effect, and
that the effects of different fibre components on blood cholesterol concentrations largely depend on their chemical composition.
The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of either total dietary fibre or “water-soluble fibre” and the maintenance of normal blood cholesterol concentrations.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, dietary fibre, which is the subject of the health claims, is not sufficiently characterised in relation to the claimed effect.
The claimed effect effects are “normal cardiovascular function”, “cholesterol level” and “blood cholesterol level”. The target population is assumed to be the general population. Maintenance of normal blood cholesterol concentrations is beneficial to human health.
The evidence provided is insufficient to establish a cause and effect relationship between the consumption of either dietary fibre or “water-soluble fibre” and the maintenance of normal blood cholesterol concentrations.