Scientific opinion on the substantiation of health claims related to  
Helianthus tuberosus L. and decreasing potentially pathogenic intestinal  
microorganisms (ID 2819), breaking down lactose (ID 2819) and  
maintenance or achievement of a normal body weight (ID 2820) 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:
Helianthus tuberosus L
 
	
	1. Charakterystyka żywności / składnika
	
        
		The food constituent that is the subject of the claim is Jerusalem artichoke with the scientific name  Helianthus tuberosus L.. The characterisation of Helianthus tuberosus L. is performed by comparing  data provided as conditions of use to information extracted from standard reference textbooks (see  Table 2 below and Appendix D for list of standard reference textbooks used for the characterisation).  
Table 2. Information on Helianthus tuberosus L. from standard reference textbooks and the  information provided as conditions of use.   
ID Scientific name  Part used Nature of the preparation Conditions of use  
Text- 
book  
Helianthus tuberosus  
L. =  
H. mollissimus E. E.  
Watson  
Asteraceae  
(Compositae)  
Vernacular name:  
Jerusalem artichoke  
Tuber Fresh; juice; extract;  
tincture.  
Common food  
(topinambur)  
Source of inuline.   
2819 Jerusalem artichoke  
Note: It is assumed to  
be Helianthus  
tuberosus L.  
Tuber  
(Root)  
Dried raw material; extract Dry extract: 135 mg/day.  
Liquid preparation: 0.5-1  
mL/day equivalent to  
297-594 mg of fresh root.  
2820 Jerusalem artichoke  
Note: It is assumed to  
be Helianthus  
tuberosus L.  
Tuber  
(Root)  
Dried raw material; extract Dry extract: 135 mg/day.  
Liquid preparation: 0.5-1  
mL/day equivalent to  
297-594 mg of fresh root.  
The Panel considers that the food constituent, Helianthus tuberosus L., which is the subject of the  health claim is sufficiently characterised with the following conditions of use: Dry extract:  135 mg/day, or liquid preparation: 0.5-1 mL/day equivalent to 297-594 mg of fresh root.   
		
	
	
    
	
	
		
 
	
	2. Znaczenie oświadczenia dla zdrowia człowieka
	
        
		
		
	
	
    
	
	
		
			
2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych (ID 2819)
	
	
			The claimed effect is “gut health”. The Panel assumes that the target population is the general  population.  
“Gut health” is not sufficiently defined. From the proposed wordings, the Panel assumes that the  claimed effect refers to the aspect of: e.g. “supports the gut's population of beneficial bacteria”.  
The numbers/proportions of bacterial groups that would constitute a “healthy intestinal flora” have  not been established. Increasing the number of any groups of bacteria is not in itself considered as  beneficial. The Panel considers that no evidence has been provided that the aspect of the claimed  effect “supports the gut's population of beneficial bacteria” is beneficial to human health.  
The Panel considers that “supports the gut's population of beneficial bacteria” in the context of  decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.  
	
    
			
	
		
			
2.2. Trawienie laktozy (ID 2819)
	
	
			The claimed effect is “gut health”. The Panel assumes that the target population is individuals whose  own lactase enzyme production is insufficient for breaking down lactose.  
“Gut health” is not sufficiently defined. From the proposed wordings, the Panel assumes that the  claimed effect refers to breaking down lactose.   
The Panel considers that breaking down lactose may be beneficial to the health of individuals with  symptomatic lactose maldigestion.  
	
    
			
	
		
			
2.3. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 2820)
	
	
			The claimed effect is “weight control”. The Panel assumes that the target population is the general  population.  
Weight control can be interpreted as the contribution to the maintenance of a normal body weight. In  this context even a moderate weight loss in overweight subjects without achieving a normal body  weight is considered beneficial to health.   
The Panel considers that the maintenance or achievement of a normal body weight is beneficial to  human health.  
	
    
			
	
		
 
	
	3. Naukowe uzasadnienia wpływu na zdrowie człowieka
	
        
		
		
	
	
    
	
	
		
			
3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych (ID 2819)
	
	
			Four references were cited to substantiate the claimed effect. One review was related to different  applications of inulin and oligofructose in health and nutrition, however did not specifically address  Helianthus tuberosus L.. Another review was related to digestion and fermentation of “prebiotics” in  general. The Panel notes that these references are not directly related to Helianthus tuberosus L.. A  third review was related to fructans of Helianthus tuberosus L., but did not address the claimed effect  and one trial was performed with a concentrate of Helianthus tuberosus L., but also did not address  the claimed effect. 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 Helianthus tuberosus L. and decreasing potentially pathogenic intestinal  microorganisms.  
	
    
			
	
		
			
3.2. Trawienie laktozy (ID 2819)
	
	
			Four references were cited to substantiate the claimed effect. One review was related to different  applications of inulin and oligofructose in health and nutrition, however did not specifically address  Helianthus tuberosus L.. Another review was related to digestion and fermentation of “prebiotics” in  general. The Panel notes that these references are not directly related to Helianthus tuberosus L.. A  third review was related to fructans of Helianthus tuberosus L., but did not address the claimed effect  and one trial was performed with a concentrate of Helianthus tuberosus L., but also did not address  the claimed effect. 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 Helianthus tuberosus L. and breaking down lactose.  
	
    
			
	
		
			
3.3. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 2820)
	
	
			Four references were cited to substantiate the claimed effect. One review was related to different  applications of inulin and oligofructose in health and nutrition, however did not specifically address  Helianthus tuberosus L.. Another review was related to digestion and fermentation of “prebiotics” in  general. The Panel notes that these references are not directly related to Helianthus tuberosus L.. A  third review was related to fructans of Helianthus tuberosus L., but did not address the claimed effect  and one trial was performed with a concentrate of Helianthus tuberosus L., but also did not address  the claimed effect. 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 Helianthus tuberosus L. and the maintenance or achievement of a normal body  weight.  
	
    
			
	
		
 
Wnioski
	
		On the basis of the data presented, the Panel concludes that:  
Decreasing potentially pathogenic intestinal microorganisms (ID 2819)  
The food constituent Helianthus tuberosus L., which is the subject of the health claim is  sufficiently characterised with the following conditions of use: Dry extract: 135 mg/day, or  liquid preparation: 0.5-1 mL/day, equivalent to 297-594 mg of fresh root.  
The claimed effect is “gut health”. The target population is assumed to be the general  population. Decreasing potentially pathogenic intestinal microorganisms might be beneficial  to human health.  
A cause and effect relationship has not been established between the consumption of  Helianthus tuberosus L. and decreasing potentially pathogenic intestinal microorganisms. 
Breaking down lactose (ID 2819)  
The food constituent Helianthus tuberosus L., which is the subject of the health claim is  sufficiently characterised with the following conditions of use: Dry extract: 135 mg/day, or  liquid preparation: 0.5-1 mL/day equivalent to 297-594 mg of fresh root  
The claimed effect is “gut health”. The target population is assumed to be individuals whose  own lactase enzyme production is insufficient for breaking down lactose. Breaking down  lactose may be beneficial to the health of individuals with symptomatic lactose maldigestion.  
A cause and effect relationship has not been established between the consumption of  Helianthus tuberosus L. and breaking down lactose.  
Maintenance or achievement of a normal body weight (ID 2820)  
The food constituent Helianthus tuberosus L., which is the subject of the health claim is  sufficiently characterised with the following conditions of use: Dry extract: 135 mg/day, or  liquid preparation: 0.5-1 mL/day equivalent to 297-594 mg of fresh root  
The claimed effect is “weight control”. The target population is assumed to be the general  population. The maintenance or achievement of a normal body weight is beneficial to human  health.  
A cause and effect relationship has not been established between the consumption of  Helianthus tuberosus L. and the maintenance or achievement of a normal body weight.