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
 
	
	1. Charakterystyka żywności / składnika
	
        
            
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                Wpływ na białe krwinki (stymulacja makrofagów, zwiększenie ilości leukocytów)
                
            
            
 
            
        
		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
	
        
            
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                Wpływ na białe krwinki (stymulacja makrofagów, zwiększenie ilości leukocytów)
                
            
            
 
            
        
		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)
	
        
            
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                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”.