ID 1669 - Likopen, proantocyjanidyny, witamina C, witamina E, selen, beta-karoten (Seresis Pharmaton)

PL: Likopen, proantocyjanidyny, witamina C, witamina E, selen, beta-karoten (Seresis Pharmaton)
EN: Tomato extract, grape seeds extract, vitamin C and E, Selenium(Seresis Pharmaton)
Pdf: various food(s)/food constituent(s) not supported by pertinent human data

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is a combination of lycopene (from tomato extract), proanthocyanidins (from grape seed extract), vitamin C, vitamin E, selenium, and beta- carotene.
From the references provided, the Panel assumes that the food constituent which is the subject of the claim is a supplement which contains per capsule 25 mg standardised tomato extract (with 5 % lycopene), 25 mg standardised grape seed extract (with 8.5-13 % proanthocyanidins), 60 mg vitamin C, 10 mg vitamin E, 25 µg selenium, and 2.4 mg beta-carotene. Lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and beta-carotene are well recognised compounds and can be measured in foods by established methods.
The Panel considers that the food constituent, a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene, which is the subject of the health claims, is sufficiently characterised.

2.1. Udział w prawidłowym tworzeniu kolagenu (ID 1669)

The claimed effect is “skin health”. 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 contribution to normal collagen formation.
The Panel considers that contribution to normal collagen formation is a beneficial physiological effect.

2.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1669)

The claimed effect is “skin health”. 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 the skin from UV-induced damage.
The Panel considers that protection of the skin from UV-induced damage is a beneficial physiological effect.

3.1. Udział w prawidłowym tworzeniu kolagenu (ID 1669)

Most of the references provided for the substantiation of the claim reported on health outcomes unrelated to the formation of collagen, or evaluated the effects of single food constituents of the combination that is the subject of the health claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim on the fixed combination of food constituents.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene and contribution to normal collagen formation.
A claim on vitamin C and normal collagen formation has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).

3.2. Ochrona skóry przed uszkodzeniami wywołanymi promieniami ultrafioletowymi (UV) (ID 1669)

Most of the references provided for the substantiation of the claim reported on the effects of single food constituents rather than the combination of food constituents, which is the subject of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim on the fixed combination of food constituents.
In one randomised, double-blind, placebo-controlled trial (Greul et al., 2002), 48 female subjects received either the food supplement, which is the subject of the health claim, or a placebo three times daily for 12 weeks. At weeks 11 and 12 total body skin irradiation with UVB was performed. The dose of UVB exposure was calculated on the basis of individual minimal erythemal dose (MED) for skin type II/III. Six millimetres punch biopsies were taken from the gluteal region at baseline, before (week 10) and after UVB exposure (week 12) to assess levels of metalloproteinases (MMP) 1 and 9 and proliferation rate of keratinocytes. Also MED and erythema grade were assessed visually and by chromameter. The Panel notes that, whereas changes on these outcome measures (i.e. decrease in MED/erythema grade, MMP-1 and MMP-9 levels, and proliferation rate of keratinocytes) may indicate a reduction in UV-induced skin damage, they can also reflect a reduction in the capacity of the skin to react to molecular and cellular damage. The Panel considers that, in the absence of direct markers of molecular or cellular damage to the skin, no conclusions can be drawn from this study for the scientific substantiation of the claim.
One in vitro study (El Hindi et al., 2004) assessed the effects of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium, and beta-carotene in two different skin models. The Panel notes that evidence provided in in vitro studies is not sufficient to predict the occurrence of
an effect of the consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and beta-carotene on the protection of the skin from UV-induced damage in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lycopene, proanthocyanidins, vitamin C, vitamin E, selenium and beta-carotene and protection of the skin from UV-induced damage.
Claims on beta-carotene and lycopene, respectively, and protection of the skin from UV-induced (including photo-oxidative) damage have already been assessed with unfavourable outcomes (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a, 2011b).

Warunki i możliwe ograniczenia stosowania oświadczenia

Target groups: Adults Applicable to products which contain following daily dosage ranges: Vitamin C: 60-120 mg Selenium: 25-50 mcg Vitamin E: 6.7-13.4 mg Beta-carotene: 2.4-4.8 mg Tomato extract standardized to 5% lycopene (25-50 mg / day) Grape seed extract standardized 5 - 20% proanthocyanidins (25-50 mg / day)