ID 1460 - Beta-karoten

PL: Beta-karoten
EN: Beta carotene
Pdf: vitamin A

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is beta-carotene ( -carotene). Beta- carotene is a well recognised dietary constituent and is measurable in foods, blood and tissues by established methods. The compound is naturally available from a great variety of fruits and vegetables. Beta-carotene is a precursor of vitamin A (pro-vitamin A) and is authorised for addition to foods and for use in food supplements (Annex II of Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to beta-carotene naturally present in foods and added to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, beta-carotene, which is the subject of the health claims, is sufficiently characterised.

2.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 19, 197, 1262, 1460)

The claimed effects are “antioxidants and aging”, “protection of tissues and skin against oxidant agents (sun rays exposure)”, “antioxidant activity” and “protection of DNA”. The Panel assumes that the target population is the general population.
No definition has been provided of “aging” or “premature aging” in relation to the antioxidant properties of foods. The Panel considers that the claimed effect is general and non-specific, and does not comply with the criteria laid down in Regulation (EC) No 1924/2006. The Panel also considers that claims made on the antioxidant capacity/content or properties of food/food constituents based on their capability to scavenge free radicals in vitro refer to a property of the food/food constituent measured in model systems, and that the information provided does not establish that this capability exerts a beneficial physiological effect in humans as required by Regulation (EC) No 1924/2006.
In the context of the proposed wordings, the Panel assumes that the claimed effects relate 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.

3.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 19, 197, 1262, 1460)

A number of the references provided were narrative reviews or consensus opinions on the health effects of beta-carotene which did not allow an evaluation of original data, or reported on intervention studies that assessed the effects of beta-carotene in combination with other carotenoids or antioxidant vitamins on health outcomes unrelated to the claimed effect, including UV-induced erythema or UV- induced immunomodulation, which are not reliable markers of photo-oxidative damage. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The human intervention studies provided, which investigated the effects of beta-carotene on oxidative damage to molecules in blood, were not controlled (i.e. did not include a control arm with no treatment). In addition, these studies assessed changes in DNA strand breaks (Zhao et al., 2006), changes in ex vivo DNA damage after challenge with hydrogen peroxide (Torbergsen and Collins, 2000; Zhao et al., 2006) or changes in susceptibility of LDL to oxidation determined in the presence of copper ions and analysed by measuring thiobarbituric acid-reactive substances (TBARS) (Levy et
al., 2000), which are not reliable markers of oxidative damage to DNA and lipids, respectively. 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 dietary intake of beta-carotene and protection of DNA, proteins and lipids from oxidative damage.

Warunki i możliwe ograniczenia stosowania oświadczenia

Min 15% RDA of beta-carotene (as vitamin A, conversion factor 6)