ID 1158 -
	
		
			Orzech włoski
		
		
		
	 
PL: Orzech włoski
EN: JUGLANS REGlA  L.
Pdf: 
 
	Oświadczenie (2)
	
		
			-  zdrowie serca (układu krążenia)
 
		
			-  metabolizmu lipidów / zdrowia serca
 
		
	
 
        
        
                
1. Charakterystyka żywności / składnika
                
                
                    The food that is the subject of the health claims is walnuts.
Walnuts are seeds from the walnut tree (genus Juglans) of which about 20 different species are  known in different parts of the world. Walnuts are drupes, rather than nuts. One of the most popular  varieties of walnut is the Persian or English walnut, which has a large seed and a thinner shell,  yielding more edible walnut meat by weight than other species. Black walnuts are another commonly  sold walnut species, as are white walnuts, also called butternuts. The nut kernels contain about  57-65 % fat, of which about 3-6 % are saturated fatty acids (SFAs), 9-15 % are monounsaturated fatty  acids (MUFAs), and 35-47 % are polyunsaturated fatty acids (PUFAs) (33-38 % linoleic acid (LA),  and 2-9 % alpha-linolenic acid (ALA)). The nut kernels also contain about 5-7 % fibre, of which  about 25 % is soluble fibre, 15-29 % protein, and small amounts of plant sterols and other  phytochemicals. The Panel notes the variation in terms of macronutrient composition between  different types of walnuts.
The Panel considers that the food, walnuts, which is the subject of the health claims, is sufficiently  characterised in relation to the claimed effects.
                 
                 
	        
        
        
        
        
                
2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1156, 1158)
                
                
                    The claimed effects are “heart health (cardiovascular health)” and “lipid metabolism/heart health”.  The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel  assumes that the claimed effects refer to the maintenance of normal blood LDL-cholesterol  concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the  arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.1 mmol/L), may compromise the  normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial  physiological effect.
                 
                 
	        
        
        
        
        
                
3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1156, 1158)
                
                
                    Among the references provided for the scientific substantiation of the claim were consensus opinions  or textbook chapters on the effects of different dietary fatty acids, as well as narrative reviews and  human studies on the effect of diets with different fatty acid composition on cardiovascular risk  factors. Some human studies addressed outcomes unrelated to the claimed effect, such as postprandial  endothelial function or cardiovascular risk. The Panel considers that no conclusions can be drawn  from these references for the scientific substantiation of the claimed effect.
All of the human intervention studies provided in the consolidated list on the effects of the  consumption of walnuts on blood lipids were considered in the systematic review by Mukuddem- Petersen et al. (2005), which addressed the effects of nuts in general, including walnuts, on blood  lipid profile. Nine of the studies selected used walnuts as the intervention (Abbey et al., 1994;  Almario et al., 2001; Chisholm et al., 1998; Iwamoto et al., 2002; Morgan et al., 2002; Munoz et al.,  2001; Ros et al., 2004; Sabate et al., 1993; Zambon et al., 2000). In two of these studies the  intervention and control periods were in the same order for all subjects, with no wash-out period in  between (Abbey et al., 1994; Almario et al., 2001); the Panel notes that these studies were not  controlled for a temporal effect, and considers that no conclusions can be drawn from these studies  for the scientific substantiation of the claimed effect.
Among the seven studies with randomised, controlled cross-over designs, three used a Mediterranean  diet as control (Munoz et al., 2001; Ros et al., 2004; Zambon et al., 2000), two used a National  Cholesterol Education Program (NCEP) step I diet (Morgan et al., 2002; Sabate et al., 1993), one used  a low fat diet (Chisholm et al., 1998), and one used a Japanese diet (Iwamoto et al., 2002). The  duration of the intervention was 4-6 weeks. Four of the studies, which included a total of 127 normo-  and hypercholesterolaemic subjects with a daily walnut intake of 40-84 g, observed a significant  decrease in total (from -4.3 to -12.4 %) and LDL-cholesterol (from -6.7 to -16.3 %) concentrations  during the walnut diet compared to the “control” diet (Iwamoto et al., 2002; Ros et al., 2004; Sabate et  al., 1993; Zambon et al., 2000), whereas in the remaining three studies differences between  intervention and control groups were not significant (n=73; walnut intake = 41-78 g/day). No  significant differences between groups were observed in any of the studies with respect to HDL- cholesterol and triglyceride concentrations, with the exception of a significant decrease in HDL-
cholesterol (-4.9 %) in the study by Sabate et al. (1993), where walnuts primarily replaced MUFAs.  The Panel notes that the data from these studies could not be pooled in a meta-analysis because of the  heterogeneity of the designs, particularly with respect to the control diet and type of subjects included  (normocholesterolaemic vs. hypercholesterolaemic). The Panel also notes that in these studies walnuts  replaced various types of dietary fats in different amounts (SFAs, MUFAs), which had variable  effects on the lipid profile (Mensink et al., 2003). None of these studies controlled for the fatty acid  composition of the intervention diet, and therefore it could not be assessed whether the consumption  of walnuts had an effect on blood lipids beyond what could be expected from their fatty acid profile  (e.g. LA and ALA content). In the systematic review by Mukuddem-Petersen et al. (2005), the  predictive equation by Mensink and Katan (1992) was used to compare the actual observed changes in  total and LDL-cholesterol with the predicted changes in total and LDL-cholesterol concentrations,  based on differences in the dietary fatty acid composition in the individual nut and control diets.  However, all studies on nuts included in the review were pooled for this calculation, and no particular  figure for walnuts only was provided.
One observational human study addressed the association between blood cholesterol and walnuts (oil  and kernel) consumption. Lavedrine at al. (1999) carried out a cross-sectional survey on 793 subjects  (426 males and 367 females) aged 18-65 years, from Dauphine, France, where walnuts and walnut oil  are part of the usual diet. To assess the level of walnut consumption, a food frequency questionnaire  (1-year recall) was used. Blood samples were taken to measure LDL and total cholesterol. No  significant differences in blood LDL or total cholesterol concentrations were observed between non- consumers, intermediate consumers and frequent consumers of walnuts and walnut oil. The Panel  notes that this cross-sectional study does not show an association between walnut or walnut oil  consumption and blood LDL-cholesterol concentrations.
In weighing the evidence, the Panel took into account that the evidence provided did not establish that  consumption of walnuts had an effect on blood LDL-concentrations beyond what could be expected  from their fatty acid composition and that the LDL-cholesterol-lowering effect of walnuts could be  attributed to their content of MUFAs and PUFAs.
The Panel concludes that a cause and effect relationship has not been established between the  consumption of walnuts and maintenance of normal blood LDL-cholesterol concentrations beyond  what could be expected from the fatty acid composition of walnuts.
A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets  and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a  favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011).
A claim on linoleic acid and maintenance of blood cholesterol concentrations (EFSA Panel on  Dietetic Products Nutrition and Allergies (NDA), 2009a) and a claim on alpha-linolenic acid and  maintenance of blood cholesterol concentrations (EFSA Panel on Dietetic Products Nutrition and  Allergies (NDA), 2009b) have also already been assessed with favourable outcomes.
                 
                 
	        
        
        
Warunki i możliwe ograniczenia stosowania oświadczenia
30 g/day daily