1248.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to silicon and stimulating macrophages and increasing circulating lymphocytes (ID 358) 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: Silicon   health claims   immune   lymphocytes   macrophages  
ID:    358  
Produkty: Krzem  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is “silicon”.
Silicon occurs naturally in foods as silicon dioxide (silica) and silicates, and may also be added as an anti-caking and anti-foaming agent in the form of silica, silicates and dimethylpolysiloxane. Silicate- containing antacids have been widely used for a number of decades. Orthosilicic acid [Si(OH)4] or mono-silicic acid is a water soluble form of silicon. A saturated solution contains 0.1 % silicic acid. Silicic acid can also exist as oligomers and as polysilicic acid (EFSA, 2004). Oligomeric silica is formed as a metastable intermediate in the progressive polymerisation of silicic acid in saturated solutions. This evaluation applies to silicon from all sources with appropriate bioavailability in the specified conditions of use.
The Panel considers that the food constituent, silicon, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “immune health”. The Panel assumes that the target population is the general population.
Immune health is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “stimulating macrophages” and “increasing circulating lymphocytes”.
The Panel considers that no evidence has been provided that “stimulating macrophages” and „increasing circulating lymphocytes”, are beneficial to the health of subjects with normal immune function.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Wpływ na białe krwinki (stymulacja makrofagów, zwiększenie ilości leukocytów)

Two references were cited to substantiate the claimed effect.
The first reference (Schiano et al., 1979) is a human study which addressed the effect of soluble silicium salt on the evolution of trabecular bone volume. The primary outcome measured related to trabecular bone volume and did not deal with outcomes related to the claimed effect. The other parameters measured indicated an increase in circulating lymphocytes and immunoglobulins (especially IgG). However, no evidence has been provided that an increase in circulating lymphocytes are beneficial to the health of subjects with normal immune function.
The second article (Reffitt et al., 2003) presented in vitro results of orthosilicic acid obtained on collagen type 1 synthesis and on osteoblast differentiation. The Panel notes that the reference 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 consumption of silicon and “stimulating macrophages” and “increasing circulating lymphocytes”.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent, silicon, which is the subject of the health claim is sufficiently characterised.
The claimed effect is “immune health”. The target population is assumed to be the general population. No evidence has been provided that “stimulating macrophages” and “increasing circulating lymphocytes” are beneficial to the health of subjects with normal immune function.
A cause and effect relationship has not been established between the consumption of silicon and “stimulating macrophages” and “increasing circulating lymphocytes”.