Scientific Opinion on the substantiation of health claims related to a  
combination of lycopene, proanthocyanidins, vitamin C, vitamin E,  
selenium and beta-carotene and contribution to normal collagen formation  
(ID 1669) and protection of the skin from UV-induced damage (ID 1669)  
pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]  
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3  
European Food Safety Authority (EFSA), Parma, Italy  
Słowa kluczowe:
Lycopene
 
UV-induced damage
 
beta-carotene
 
collagen
 
health claims
 
proanthocyanidins
 
selenium
 
skin
 
vitamin C
 
vitamin E
 
	
	1. Charakterystyka żywności / składnika
	
        
		The food constituent that is the subject of the health claims is a combination of lycopene (from tomato  extract), proanthocyanidins (from grape seed extract), vitamin C, vitamin E, selenium, and beta- carotene.  
From the references provided, the Panel assumes that the food constituent which is the subject of the  claim is a supplement which contains per capsule 25 mg standardised tomato extract (with 5 %  lycopene), 25 mg standardised grape seed extract (with 8.5-13 % proanthocyanidins), 60 mg  vitamin C, 10 mg vitamin E, 25 µg selenium, and 2.4 mg beta-carotene. Lycopene, proanthocyanidins,  vitamin C, vitamin E, selenium and beta-carotene are well recognised compounds and can be  measured in foods by established methods.  
The Panel considers that the food constituent, a combination of lycopene, proanthocyanidins, vitamin  C, vitamin E, selenium, and beta-carotene, which is the subject of the health claims, is sufficiently  characterised.  
		
	
	
    
	
	
		
 
	
	2. Znaczenie oświadczenia dla zdrowia człowieka
	
        
		
		
	
	
    
	
	
		
			
2.1. Udział w prawidłowym tworzeniu kolagenu (ID 1669)
	
	
			The claimed effect is “skin health”. The Panel assumes that the target population is the general  population.  
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the  contribution to normal collagen formation.  
The Panel considers that contribution to normal collagen formation is a beneficial physiological  effect.  
	
    
			
	
		
			
2.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1669)
	
	
			The claimed effect is “skin health”. The Panel assumes that the target population is the general  population.  
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the  protection of the skin from UV-induced damage.  
The Panel considers that protection of the skin from UV-induced damage is a beneficial physiological  effect.  
	
    
			
	
		
 
	
	3. Naukowe uzasadnienia wpływu na zdrowie człowieka
	
        
		
		
	
	
    
	
	
		
			
3.1. Udział w prawidłowym tworzeniu kolagenu (ID 1669)
	
	
			Most of the references provided for the substantiation of the claim reported on health outcomes  unrelated to the formation of collagen, or evaluated the effects of single food constituents of the  combination that is the subject of the health claim. The Panel considers that no conclusions can be  drawn from these references for the scientific substantiation of the claim on the fixed combination of  food constituents.  
The Panel concludes that a cause and effect relationship has not been established between the  consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and  beta-carotene and contribution to normal collagen formation.  
A claim on vitamin C and normal collagen formation has already been assessed with a favourable  outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).  
	
    
			
	
		
			
3.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1669)
	
	
			Most of the references provided for the substantiation of the claim reported on the effects of single  food constituents rather than the combination of food constituents, which is the subject of the claim.  The Panel considers that no conclusions can be drawn from these references for the scientific  substantiation of the claim on the fixed combination of food constituents.  
In one randomised, double-blind, placebo-controlled trial (Greul et al., 2002), 48 female subjects  received either the food supplement, which is the subject of the health claim, or a placebo three times  daily for 12 weeks. At weeks 11 and 12 total body skin irradiation with UVB was performed. The  dose of UVB exposure was calculated on the basis of individual minimal erythemal dose (MED) for  skin type II/III. Six millimetres punch biopsies were taken from the gluteal region at baseline, before  (week 10) and after UVB exposure (week 12) to assess levels of metalloproteinases (MMP) 1 and 9  and proliferation rate of keratinocytes. Also MED and erythema grade were assessed visually and by  chromameter. The Panel notes that, whereas changes on these outcome measures (i.e. decrease in  MED/erythema grade, MMP-1 and MMP-9 levels, and proliferation rate of keratinocytes) may  indicate a reduction in UV-induced skin damage, they can also reflect a reduction in the capacity of  the skin to react to molecular and cellular damage. The Panel considers that, in the absence of direct  markers of molecular or cellular damage to the skin, no conclusions can be drawn from this study for  the scientific substantiation of the claim.  
One in vitro study (El Hindi et al., 2004) assessed the effects of a combination of lycopene,  proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene in two different skin models.  The Panel notes that evidence provided in in vitro studies is not sufficient to predict the occurrence of 
an effect of the consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E,  selenium and beta-carotene on the protection of the skin from UV-induced damage in vivo in humans.  
The Panel concludes that a cause and effect relationship has not been established between the  consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and  beta-carotene and protection of the skin from UV-induced damage.  
Claims on beta-carotene and lycopene, respectively, and protection of the skin from UV-induced  (including photo-oxidative) damage have already been assessed with unfavourable outcomes (EFSA  Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a, 2011b).  
	
    
			
	
		
 
Wnioski
	
		On the basis of the data presented, the Panel concludes that:  
The food constituent, a combination of lycopene, proanthocyanidins, vitamin C, vitamin E,  selenium, and beta-carotene, which is the subject of the health claims, is sufficiently  characterised.  
Contribution to normal collagen formation (ID 1669)  
The claimed effect is “skin health”. The target population is assumed to be the general  population. In the context of the proposed wordings, it is assumed that the claimed effect  refers to the contribution to normal collagen formation. Contribution to normal collagen  formation is a beneficial physiological effect.  
A cause and effect relationship has not been established between the consumption of a  combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and  beta-carotene and contribution to normal collagen formation.  
A claim on vitamin C and normal collagen formation has already been assessed with a  favourable outcome.  
Protection of the skin from UV-induced damage (ID 1669)  
The claimed effect is “skin health”. The target population is assumed to be the general  population. In the context of the proposed wordings, it is assumed that the claimed effect  refers to the protection of the skin from UV-induced damage. Protection of the skin from  UV-induced damage is a beneficial physiological effect.  
A cause and effect relationship has not been established between the consumption of a  combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and  beta-carotene and protection of the skin from UV-induced damage.  
Claims on beta-carotene and lycopene, respectively, and protection of the skin from UV- induced (including photo-oxidative) damage have already been assessed with unfavourable  outcomes.