ID 1463 - 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 claim is beta-carotene ( -carotene, hereafter beta-carotene), which is a well recognised dietary constituent and it is measurable in foods by established methods. The compound is naturally available from a great variety of fruits and vegetables. Beta-carotene has been authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20064 and Annex II of Directive 2002/46/EC5). This evaluation applies to beta-carotene naturally present in foods and those forms authorised for addition to foods and for use in food supplements (Annex II of the 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 claim is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “immune health in relation to UV-radiation”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that the claimed effect relates to “helps to maintain physiological immune responses of the skin upon UV-radiation (sun exposure)”.
It is known that ultraviolet (UV)-radiation may result in local as well as systemic immunosuppression, resulting in altered resistance to infections and neoplasm.
The Panel considers that maintaining normal physiological immune responses of the skin in relation to UV-radiation (sun exposure) is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowej odpowiedzi immunologicznej skóry na promieniowanie UV (słoneczne)

The references cited to substantiate the claimed effect include three double-blind, randomised, placebo-controlled intervention trials in healthy subjects exposed to sun or UV light receiving either 30 mg beta-carotene per day or placebo (Fuller et al., 1992; Herraiz et al., 1998; Gollnick et al., 1996).
Fuller et al. (1992) performed a parallel designed, double blind, placebo controlled intervention study in 24 males (aged 19-39), in which capsules with 30 mg beta-carotene per day or placebo were given, while on a low-carotenoid diet. After 28 days, all subjects received 12 exposures to a UV-A/B light source over a 16-day period. The total UV-A dose received ranged from 15.9 to 19.3 J/cm2. The total shorter-wave ultraviolet-light (UV-B) dose varied from 1.59 to 1.96 J/cm2. Blood concentrations of carotenoids and delayed-type hypersensitivity (DTH) tests were assessed at baseline, pre-UV, post-UV, and after follow-up. The DTH-test responses were significantly suppressed in the placebo group after UV treatments; the suppression was inversely related to blood beta-carotene concentrations in this group. There was no significant suppression of DTH test responses in the beta- carotene group. The Panel notes that the difference between the beta-carotene and placebo groups was not statistically significant.
Herraiz et al. (1998) performed a placebo-controlled, randomised trial in 14 healthy older men (mean age 65.5 years). They received 30 mg beta-carotene or placebo daily for 47 days while on a low carotenoid diet. After 28 days, half of each group received 12 suberythaemic exposures to UV over a 16-day period. DTH tests and plasma carotenoid concentrations were assessed at baseline, pre-UV and post-UV time points, with DTH testing performed on an area of skin protected from UV exposure. UV exposure resulted in significantly suppressed DTH response in the placebo group but not in the beta-carotene group. Higher blood beta-carotene concentrations were significantly associated with maintenance of DTH response. The Panel notes that the difference between the beta- carotene and placebo groups after UV-exposure was not statistically significant.
Gollnick et al. (1996) conducted a randomised, placebo-controlled, double-blind study in 20 healthy young female students to evaluate the effect of beta-carotene (30 mg/day) after 10 weeks of supplementation and over 13 days of sunlight exposure at sea level (30° latitude, Red Sea, Israel). Development of erythema in selected skin areas exposed to natural sunlight was lower in the group supplemented with beta-carotene. Blood concentrations of beta-carotene did not fall during sun exposure in the beta-carotene group, whereas in the placebo group beta-carotene concentrations decreased significantly to sub-physiological levels. Langerhans cells increased significantly in density per square millimetre/epidermis after pre-supplementation with beta-carotene. After UV-exposure, Langerhans cell density decreased in both groups; however, compared to baseline levels, this was significant in the temporary exposed skin region only for the placebo group. The lymphocyte counts did not change significantly in both groups. In contrast to the study by Fuller et al. (1992), the responses to the different recall antigens did not show any significant changes in both groups compared to baseline.
Some other studies included concerned natural killer cell activity in the elderly and its' restoration by beta-carotene supplementation (Moriguchi et al., 1996; Santos et al., 1996, 1998; Wood et al., 2000); these studies did not involve immunosuppression by UV exposure. A study by Prabhala et al. (1991) evaluated effects of beta-carotene on oral leukoplakia or Barrett's esophagus and on immune cell subpopulations, but did not involve UV exposure. Other studies addressed pathological effects of UV on the skin (Albers et al., 2005), blood concentrations of beta-carotene after repeated ultraviolet radiation exposure (White et al., 1988; Biesalski et al., 1996), protection against photooxidative stress (Biesalski and Obermueller-Jevic, 2001; Stahl and Sies, 2004, 2005), antioxidant activity of beta- carotene (Bendich, 2004; Clydesdale et al., 2001) and effects of cutaneous ultraviolet (UV) exposure (Granstein and Matsui, 2004), or effects of fruit and vegetable extracts on immune function in the elderly (Inserra et al., 1999; Watzl et al., 2003, 2005). The Panel notes that these studies cited provided no scientific data that could be used to substantiate the claimed effect.
UV exposure caused a decrease in blood beta-carotene concentrations and suppressed delayed-type hypersensitivity (DTH) in groups without beta-carotene supplementation. However, the Panel notes that restoration of suppressed DTH and associated parameters by beta-carotene supplementation as compared to placebo was inconsistent (Fuller et al., 1992; Herraiz et al., 1998; Gollnick et al., 1996). The Panel also notes that the intervention studies provided were performed with limited numbers of individuals at doses that were 4-fold higher than indicated in the conditions of use.
The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-carotene and maintaining normal physiological immune responses of the skin in relation to UV-radiation (sun exposure).

Warunki i możliwe ograniczenia stosowania oświadczenia

Up to 10 mg per day (for 4 - 10 weeks)