ID 1606 -
Luteina, Zeaksantyna
PL: Luteina, Zeaksantyna
EN: Lutein, Zeaxanthin
Pdf: various food(s)/food constituent(s)
Oświadczenie (2)
- naturalny pigment plamki (żółtej plamki oka)
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is lutein in combination with zeaxanthin.
Lutein is a carotenoid naturally present in some foods, especially in green leafy vegetables such as spinach and kale. Lutein can be measured by established methods.
Zeaxanthin is a carotenoid naturally present in some foods and can be measured in foods by standard methods.
The Panel considers that the food constituents, lutein and zeaxanthin, which are the subject of the health claim, are sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “natural macular pigment (yellow spot of eye)”. The Panel assumes that the target population is the general population.
From the data provided, it has not been established that a change in macular pigment in the eyes of healthy people is related to eye function. Normal vision, however, is a function of the eye which can be assessed by established methods.
The Panel considers that maintenance of normal vision is a beneficial physiological effect.
A claim on lutein and maintenance of normal vision has already been assessed and the Panel concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of lutein and the maintenance of normal vision (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).
A claim on zeaxanthin and maintenance of normal vision has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).
In this opinion, the Panel assesses whether the consumption of lutein in combination with zeaxanthin has an effect on the maintenance of normal vision.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego wzroku
Five references were provided to substantiate the claimed effect, including one reference concerning the presence of lutein and zeaxanthin in the human macula and retina, and their distribution. The Panel notes that no conclusion can be drawn from this reference for the scientific substantiation of the claimed effect.
Two intervention studies in humans investigated the effect of lutein alone on the density of macular pigment in healthy subjects (Berendschot et al., 2000), and the effect of lutein alone or in combination with other antioxidants, vitamins and minerals on visual function and symptoms in patients with atrophic age-related macular degeneration (ARMD) (Richer et al., 2004). These references have already been considered in the opinion on lutein and maintenance of normal vision, and do not provide any additional scientific data which could be used to substantiate a claim on the combination of lutein and zeaxanthin.
No human intervention studies using lutein in combination with zeaxanthin were provided.
One epidemiological cross-sectional study investigated the relationship between dietary intake and serum concentrations of lutein and zeaxanthin, and macular pigment optical density (MPOD) in 828 healthy Irish subjects (Nolan et al., 2007a). In the same epidemiological study, the authors investigated whether a low MPOD is associated with putative and established risk factors of ARMD (Nolan et al., 2007b). The Panel notes that there is no evidence that high macular density confers a protective effect against ARMD or is related to vision (Broekmans et al., 2002; Davies and Morland, 2004).
The Panel concludes that a cause and effect relationship has not been established between the consumption of lutein in combination with zeaxanthin, and maintenance of normal vision.
Warunki i możliwe ograniczenia stosowania oświadczenia
e.g. 10 mg lutein/day