Scientific Opinion on the substantiation of health claims related to lutein
and protection of DNA, proteins and lipids from oxidative damage
(ID 3427), protection of the skin from UV-induced (including
photo-oxidative) damage (ID 1605, 1779) and maintenance of normal vision
(ID 1779, 2080) 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:
Lutein
UV-induced damage
health claims
oxidative damage
vision
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is lutein.
Lutein is a carotenoid naturally present in foods and especially in green leafy vegetables such as spinach and kale. Lutein can be measured in foods by established methods. Lutein preparations from natural sources (e.g. plant petals) often contain minor amounts of zeaxanthin.
The Panel considers that the food constituent, lutein, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 3427)
The claimed effect is “natural antioxidant”. 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 body cells and molecules from oxidative damage caused by free radicals.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation and pollutants). These reactive intermediates damage biologically relevant molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers such as antioxidant nutrients.
The Panel considers that protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.
2.2. Ochrona skóry przed uszkodzeniem promieniami ultrafioletowymi (UV) (ID 1605, 1779)
The claimed effects are “skin health” and “antioxidant activity”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to UV-dependent premature aging of the skin related to photo-oxidative damage of skin structure and texture, and to direct UV-induced skin damage (sunburn).
The Panel considers that protection of the skin from UV-induced (including photo-oxidative) damage is a beneficial physiological effect.
2.3. Utrzymanie prawidłowego wzroku (ID 1779, 2080)
The claimed effects are “antioxidant properties” and “antioxidant activity”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal vision.
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), 2010). The references cited for this claim did not provide any additional scientific data which could be used to substantiate the claim.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
3.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 3427)
None of the three references provided for the scientific substantiation of this claim addressed the effects of lutein consumption on markers of oxidative damage in humans. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of lutein and protection of DNA, proteins and lipids from oxidative damage.
3.2. Ochrona skóry przed uszkodzeniem promieniami ultrafioletowymi (UV) (ID 1605, 1779)
Some of the references provided addressed the effects of lutein consumption in combination with zeaxanthin or other antioxidant molecules (e.g. tocopherol, ascorbate) on different skin outcomes. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
In a placebo-controlled, double-blind, randomised, multicentre study, 20 women (25-50 years) were randomly allocated to receive 10 mg of lutein naturally containing 0.6 mg zeaxanthin in capsules daily (n=10) or placebo (n=10) over a period of 12 weeks (Palombo et al., 2007). The effects of lutein on skin surface lipids, lipid peroxidation, photoprotective activity, skin elasticity, and skin hydration were evaluated. Skin surface lipids, skin hydration and elasticity were unrelated to the claimed effect. Lipid peroxidation was assessed using malondialdehyde (MDA) measured by a colorimetric assay. The Panel notes that this method is not a reliable method to assess lipid peroxidation. Photoprotective
activity was measured as changes in minimal erythemal dose (MED). The Panel notes that UV-induced erythema (sunburn or skin reddening) is a primary reaction of the skin following overexposure to UV (sun) light and that it represents an inflammatory response of cutaneous tissue as a consequence of light-dependent molecular and cellular damage. However, the Panel also notes that, whereas a reduction in skin erythema after UV light or sun exposure may indicate a reduction in UV-induced skin damage, it can also reflect a reduction in the capacity of the skin to react to molecular and cellular damage, and that the data provided in this study did not allow such effects to be distinguished. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of lutein and protection of the skin from UV-induced (including photo-oxidative) damage.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, lutein, which is the subject of the health claims, is sufficiently characterised.
Protection of DNA, proteins and lipids from oxidative damage (ID 3427)
The claimed effect is “natural antioxidant”. The target population is assumed to be the general population. Protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of lutein and protection of DNA, proteins and lipids from oxidative damage.
Protection of the skin from UV-induced (including photo-oxidative) damage (ID 1605, 1779)
The claimed effects are “skin health” and “antioxidant activity”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effects refer to UV dependent premature aging of the skin related to photo- oxidative damage of skin structure and texture, and to direct UV-induced skin damage (sunburn). Protection of the skin from UV-induced (including photo-oxidative) damage is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of lutein and the protection of the skin from UV-induced (including photo-oxidative) damage.
Maintenance of normal vision (ID 1779, 2080)
The claimed effects are “antioxidant properties” and “antioxidant activity”. In the context of the proposed wordings, it is assumed that the claimed effects refer to the maintenance of normal vision. The target population is assumed to be the general population.
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. The references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.
