ID 1610 - Likopen

PL: Likopen
EN: Lycopene
Pdf: lycopene

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is lycopene (psi, psi-carotene).
Lycopene is a well recognised dietary constituent and is measurable in foods, blood and tissues by established methods. Major dietary sources of lycopene are tomatoes and tomato products. Lycopene is also the natural red colorant of water melons, pink grapefruit and rose hips. Dietary sources of lycopene, or lycopene preparations from natural sources, usually contain other food constituents (e.g. other carotenoids and/or polyphenols) which may contribute to the claimed effects. Synthetic lycopene has recently been authorised in the EU as a novel food ingredient6. The present opinion applies to lycopene from all sources with appropriate bioavailability in the specified amounts.
The Panel considers that the food constituent, lycopene, which is the subject of the health claims, is sufficiently characterised.

2.3. Udział w prawidłowym funkcjonowaniu serca (ID 1610, 2372)

The claimed effects are “heart health” and “cardio-vascular 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 cardiac function.
The Panel considers that contribution to normal cardiac function is a beneficial physiological effect.

3.3. Udział w prawidłowym funkcjonowaniu serca (ID 1610, 2372)

A number of the references provided were narrative reviews or consensus opinions on the health effects of lycopene which did not allow evaluation of original data, or reports on intervention studies which assessed the effects of other carotenoids or antioxidant vitamins, either alone or in combination with lycopene, on health outcomes unrelated to the claimed effect, e.g. on lipid peroxidation and on the susceptibility of lipoproteins to oxidative stress. The three animal studies provided reported on health outcomes unrelated to the claimed effect, i.e. on the effect of probucol on atherosclerosis in rabbits, on the role of lycopene on adriamycin-induced heart and kidney toxicity in rats, and on the effect of lycopene in a rat model of myocardial ischemia-reperfusion injury. The three in vitro studies provided related to the involvement of reactive oxygen species in the generation of mitochondrial DNA lesions in human fibroblasts, to the effect of carotenoids on macrophage cholesterol metabolism, and to the ageing of cultured retinal pigment epithelial cells. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Among the references provided, three human observational studies addressed the association between blood concentrations of lycopene and combined risk for coronary heart disease and stroke (Rissanen et al., 2001; Sesso et al., 2004), intima-media thickness (Rissanen et al., 2001), or blood concentrations of C-reactive protein and E-selectin (Rowley et al., 2003). None of these studies reported on dietary intakes of lycopene. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Three human observational studies addressed the association between blood concentrations of lycopene and risk of coronary heart disease (Ito et al., 2006; Kristenson et al., 1997; Sesso et al., 2003). The Panel notes that in one prospective cohort study (Ito et al., 2006) and in one cross- sectional study (Kristenson et al., 1997) lycopene dietary intakes were not reported, and that the nature of the relationship between dietary lycopene and blood concentrations of lycopene has not been established in these studies. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Only one of the three human observational studies reported on lycopene dietary intakes (Sesso et al., 2003).
Sesso et al. (2003) reported on a prospective cohort study of 39,876 middle-aged and older women initially free of cardiovascular disease and cancer. Dietary lycopene intakes were divided into quintiles, and primary lycopene food sources (total tomato-based products, including tomatoes, tomato juice, tomato sauce and pizza) were categorised. During 7.2 years of follow-up, 719 cardiovascular disease cases (including myocardial infarction, stroke, revascularisation and cardiovascular disease death) occurred. Compared with women in the 1st quintile of lycopene intake, multivariate relative risks (95 % CI) for increasing quintiles of lycopene intake in relation to myocardial infarction were 1.10 (0.72-1.69), 1.01 (0.65-1.57), 0.90 (0.57-1.44) and 0.69 (0.41-1.15) (p for trend=0.09). For the consumption of tomato-based products, women consuming 1.5 to <4, 4 to
<7, 7 to <10 and 10 servings/week had relative risks (95 % CI) for myocardial infarction of 0.94 (0.65-1.37), 0.67 (0.43-1.06), 0.70 (0.38-1.29) and 0.39 (0.12-1.30) (p for trend=0.033) compared with women consuming <1.5 servings/week. The Panel notes that lycopene intake was not associated with a decreased risk of myocardial infarction in this study.
In weighing the evidence, the Panel took into account that one observational study did not show an association between lycopene dietary intakes and risk of myocardial infarction (Sesso et al., 2003),
and that the nature of the relationship between dietary lycopene and blood concentrations of lycopene was not established in the two observational studies provided, which did not report on lycopene intakes (Ito et al., 2006; Kristenson et al., 1997).
The Panel concludes that a cause and effect relationship has not been established between the consumption of lycopene and contribution to normal cardiac function.

Warunki i możliwe ograniczenia stosowania oświadczenia

40-60 mg per day