1489.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and protection of cells from premature aging, antioxidant activity, antioxidant content and antioxidant properties, and protection of DNA, proteins and lipids from oxidative damage pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
Słowa kluczowe: Antioxidants   DNA   ageing   health claims   lipids   oxidative damage   proteins  
ID:    3494      3256      3800      3797      1878      1880      3780      2154      2156      1867      3507      1321      3505      3520      3786      1315      3241      3790      2151      1850      4007      3767      3524      2193      1367      2673      3290      2188      3541      1833      3269      2668      3549      3277      2181      4163      2475      3729      3200      3437      1805      3169      1260      3444      1257      1808      1258      3174      3448      1264      3176      3175      1797      3177      3456      1256      3454      3183      3701      3460      2511      2263      3712      3705      3469      3232      4150      2734      3212      570      3484      3485      1285      3216      2823      3916      3374      2817      3679      3678      1200      2832      2043      1468      3362      1988      1445      2020      2021      1989      3386      2835      3662      2025      3383      3652      1999      1971      3168      3406      3167      1969      3166      3646      3888      1706      2800      3400      1229      2795      2321      3899      2049      3423      3418      1957      2059      2060      1243      3409      3412      1966      2061      3307      1941      3854      3856      2641      3849      1940      3299      1679      3297      3606      2654      2653      2087      3597      1921      3593      2083      3316      1934      3315      2090      3337      2136      3824      2849      3822      2855      2132      3817      2854      3815      2144      3816      3813      2857      1439      3571      3353      3839      3838      3356      2866      3836      2125      3828      3349      3825  
Produkty: Kapsaicyna   Portulaka pospolita   Betalainy   Polifenole kory francuskiej sosny morskiej   Tamaryszek francuski   Jeżówka blada   Morwa czarna   Dąbrówka żółtokwiatowa   Wyciąg ze skórek białych winogron   Sok z winogron   Wawrzyn szlachetny   Andrographis paniculata   Ostrokrzew paragwajski   Antyoksydanty z granatu   Spirulina   Wyciąg z chmielu   Stokrotka pospolita   Pluskwica gałęziasta   Boczniak ostrygowaty   Hurma wschodnia   Estragon   Czapetka pachnąca   Czosnek pospolity   Róża dzika   Rumianek pospolity   Chlorofil   Wiśnie   Fiołek wonny   Kasztanowiec zwyczajny   Migdałecznik chebułowiec   Acerola   Antyoksydanty   Pierwiosnek lekarski   Czystek   Kolcowój pospolity   Wyciąg z pestek winogron   Imbir cytwarowy   Propolis   Żeń-szeń właściwy   Babka lancetowata   Kurkumina   Wyciąg ze skórek czerwonych winogron   Skwalen   Nawłoć pospolita   Miód   Rozmaryn lekarski   Siemie lniane   Oregano   Flawan-3-ol   Sosna nadmorska   Cebula   Nagietek polny   Drzewo kajeputowe   Ptychopetalum   Wodorosty   Cynamon   Mniszek lekarski   Złocień Maruna   Glutation   Porzeczka czarna   Lespedeza   Niepokalanek pospolity   Sulforafan   Melisa lekarska   Mleczko pszczele   Orzech włoski   Resweratrol   Aloes zwyczajny   Chanca piedra   Lipa   Szałwia lekarska   Drzewko herbaciane   Głowienka pospolita   Mięta nadwodna   Daktylowiec właściwy   Drzewo sandałowca   Bez czarny   Przytulia czepna   Strączyniec   Glukomannan   Winorośl właściwa   Olej z nasion owoców jagodowych (takich jak borówka, żurawina, jeżyna, malina)   Werbena pospolita   Jemioła pospolita   Liściokwiat garbnikowy   Pieprz metystynowy   Gujawa właściwa   Antocyjany z bzu czarnego   Drzewo ipe   Borówki, kora sosnowa   Polifenole w oliwie z oliwek   Mącznica lekarska   Banan   Beta-karoten   Jarząb domowy   Bibhitaka   Senes wąskolistny   Aspalat prosty   Ketmia róża chińska   Miłorząb dwuklapowy   Cytryna zwyczajna   Wyciąg z ostropestu plamistego   Rabarbar dłoniasty   Wyciąg z mchu islandzkiego   Migdałecznik arjuna   Chyawanprash   Flawonole i antocyjanidyny z borówek   Lippia trójlistna   Mastyks chioski   Kiełki pszenicy   Borówka czarna   Rabarbar lekarski   Oczar wirginijski   Ostropest plamisty   Mieszanka ziołowa: Triphala   Macierzanka tymianek   Majeranek   Bioflawonoidy   Sok z czarnej porzeczki   Chmiel zwyczajny   Cząber górski   Suszone śliwki   Karczoch zwyczajny   Picrorhiza Kurroa   Traganek   Szałwia muszkatołowa   Żurawina wielkoowocowa   Olej z rokitnika zwyczajnego i flawonoidy z owoców rokitnika   Wierzbówka kiprzyca   Kasztan jadalny   Wyciąg z chmielu z ksantohumolem   Antocyjany   Szałwia czerwonokorzeniowa   Składniki fenolowe żurawiny i borówki brusznicy (katechiny, flavonoidy, kwasy fenolowe, lignany), witamina C   Wierzbownica drobnokwiatowa   Grejpfrut   Borówka brusznica   Figowiec pospolity   Boldoa aromatyczna   Szanta zwyczajna   Wyciąg z liści oliwki   Kocanka włoska   Jałowiec pospolity   Jiaogulan   Aloes uzbrojony  

2. Znaczenie oświadczenia dla zdrowia człowieka


1.1. Ochrona komórek przed przedwczesnym starzeniem (ID 1468, 2832)

The claimed effects are “antioxidant activity” and “antioxidant properties”. The Panel assumes that the target population is the general population. The proposed wordings include “protect cells from premature aging”, “antioxidant containing foods support of healthy aging”. No definition has been provided of “premature aging” or of “healthy aging” in relation to the antioxidant properties of foods. The Panel considers that this claimed effect is general and non-specific and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

1.2. Aktywność antyoksydacyjna, zawartość antyoksydantów, właściwości antyoksydacyjne (ID 570, 1285, 1315, 1468, 1797, 1805, 1808, 1833, 1850, 1969, 1971, 1988, 1989, 2020, 2021, 2049, 2060, 2132, 2475, 2673, 2800, 2817, 2823, 2832, 2855, 2866)

The claimed effects are “antioxidant activity/content” and/or “antioxidant properties”. The Panel assumes that the target population is the general population. The Panel assumes that these claimed effects refer to the capacity of food/food constituents to scavenge free radicals and/or to their reducing capacity. The Panel considers that claims made on the antioxidant capacity/content or properties of food/food constituents based on their capability of scavenging 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. The Panel considers that no evidence has been provided to establish that having antioxidant activity/content and/or antioxidant properties is a beneficial physiological effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and a beneficial physiological effect related to antioxidant activity, antioxidant content, or antioxidant properties.
Food(s)/food constituent(s) with antioxidant properties
EFSA Journal 2010; 8(2):1489 6

1.3. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 1200, 1229, 1243, 1256, 1257, 1258, 1260, 1264, 1321, 1367, 1439, 1445, 1679, 1706, 1867, 1878, 1880, 1921, 1934, 1940, 1941, 1957, 1966, 1999, 2025, 2043, 2059, 2061, 2083, 2087, 2090, 2125, 2136, 2144, 2151, 2154, 2156, 2181, 2188, 2193, 2263, 2321, 2511, 2641, 2653, 2654, 2668, 2734, 2795, 2835, 2849, 2854, 2857, 3166, 3167, 3168, 3169, 3174, 3175, 3176, 3177, 3183, 3200, 3212, 3216, 3232, 3241, 3256, 3269, 3277, 3290, 3297, 3299, 3307, 3315, 3316, 3337, 3349, 3353, 3356, 3362, 3374, 3383, 3386, 3400, 3406, 3409, 3412, 3418, 3423, 3437, 3444, 3448, 3454, 3456, 3460, 3469, 3484, 3485, 3494, 3505, 3507, 3520, 3524, 3541, 3549, 3571, 3593, 3597, 3606, 3646, 3652, 3662, 3678, 3679, 3701, 3705, 3712, 3729, 3767, 3780, 3786, 3790, 3797, 3800, 3813, 3815, 3816, 3817, 3822, 3824, 3825, 3828, 3836, 3838, 3839, 3849, 3854, 3856, 3888, 3899, 3916, 4007, 4150, 4163)

The claimed effects refer to the protection of body cells and molecules (such as DNA, proteins and lipids) from oxidative damage, including UV-induced oxidative damage. The Panel assumes that the target population is the general population. 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, pollutants). These reactive intermediates can damage molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers like antioxidant nutrients. The Panel considers that the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka


2.1. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 1200, 1229, 1243, 1256, 1257, 1258, 1260, 1264, 1321, 1367, 1439, 1445, 1679, 1706, 1867, 1878, 1880, 1921, 1934, 1940, 1941, 1957, 1966, 1999, 2025, 2043, 2059, 2061, 2083, 2087, 2090, 2125, 2136, 2144, 2151, 2154, 2156, 2181, 2188, 2193, 2263, 2321, 2511, 2641, 2653, 2654, 2668, 2734, 2795, 2835, 2849, 2854, 2857, 3166, 3167, 3168, 3169, 3174, 3175, 3176, 3177, 3183, 3200, 3212, 3216, 3232, 3241, 3256, 3269, 3277, 3290, 3297, 3299, 3307, 3315, 3316, 3337, 3349, 3353, 3356, 3362, 3374, 3383, 3386, 3400, 3406, 3409, 3412, 3418, 3423, 3437, 3444, 3448, 3454, 3456, 3460, 3469, 3484, 3485, 3494, 3505, 3507, 3520, 3524, 3541, 3549, 3571, 3593, 3597, 3606, 3646, 3652, 3662, 3678, 3679, 3701, 3705, 3712, 3729, 3767, 3780, 3786, 3790, 3797, 3800, 3813, 3815, 3816, 3817, 3822, 3824, 3825, 3828, 3836, 3838, 3839, 3849, 3854, 3856, 3888, 3899, 3916, 4007, 4150, 4163)

Most of the references provided addressed potential health effects of dietary antioxidants in general, or of food/food constituents other than those for which the specific claims are proposed, and/or claimed effects other than the protection of body cells and molecules from oxidative damage. The latter includes references on the development or progression of acute or chronic diseases presumed to be associated with increased levels of oxidative stress (e.g. immune dysfunction/susceptibility to infections, cardiovascular diseases, cancer, and degenerative diseases, among others) where oxidative damage to cells or molecules has not been considered as an outcome. The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claimed effect. No human studies which investigated the effects of the food(s)/food constituent(s) on reliable markers of oxidative damage to body cells or to molecules such as DNA, proteins and lipids have been provided in relation to any of the health claims evaluated in this opinion.
Some intervention studies in humans which investigated the effects of the food(s)/food constituent(s) on the overall antioxidant capacity of plasma assessed by different methods have been provided.
Food(s)/food constituent(s) with antioxidant properties
EFSA Journal 2010; 8(2):1489 7
These methods include total reactive antioxidant potential (TRAP), trolox-equivalent antioxidant capacity (TEAC), ferric reducing ability of plasma (FRAP), oxygen radical absorbance capacity (ORAC), and ferrous oxidation-xylenol orange (FOX). The Panel considers that the evidence provided in these studies does not predict the occurrence of an effect of the food(s)/food constituent(s) on the protection of body cells and molecules from oxidative damage (Griffiths et al., 2002; Mayne, 2003; Dolle-Donne, et al., 2006; Knasmuller et al., 2008). Some intervention studies in humans having investigated the effects of the food(s)/ food constituent(s) on markers of lipid peroxidation have been provided in relation to ID 1243, 1468, 1850, 2060, 2511, 2835, 3505 and 3678. Such markers are thiobarbituric acid-reactive substances (TBARS), malondialdehyde (MDA) and/or oxidation lag time of low-density lipoproteins (LDL) ex vivo. The Panel considers that both TBARS and MDA, when used alone, are not reliable markers of lipid peroxidation (Griffiths et al., 2002; Lykkesfeldt, 2007; Knasmuller et al., 2008). The Panel also considers that no evidence has been provided to establish that the oxidation lag time of LDL particles ex vivo predicts the resistance of LDL particles to oxidation in vivo (Griffiths et al., 2002; Lapointe et al., 2006; Verhoye and Langlois, 2009). Thus, for claims supported by references to human studies on the overall antioxidant capacity of plasma only, or on MDA/TBARS/oxidation lag time of LDL particles ex vivo as the only markers of lipid peroxidation, either alone on in combination with animal and/or in vitro studies, the Panel considers that a cause and effect relationship has not been established between the intake of the food/food component and the claimed effect. A number of in vitro studies were provided which addressed the antioxidant properties of different food(s)/food constituent(s), either by testing their capacity to scavenge free radicals under controlled conditions or by testing their capacity to prevent or delay protein, lipid or DNA oxidation in different in vitro models. Also, studies were provided on the relationship between the intake of the food(s)/food constituent(s) and the claimed effect by measuring markers of protein, lipid and/or DNA oxidation in animals, either in vivo or ex vivo. The Panel considers that the evidence provided in the animal and in vitro studies submitted is not sufficient to predict the occurrence of an effect of the food(s)/food constituent(s) on the protection of body cells and molecules from oxidative damage in vivo in humans. The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for substantiation of a claim. Thus, for claims supported by references to animal studies and/or in vitro studies only, the Panel considers that a cause and effect relationship has not been established between the consumption of the food/food component and the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage.

Wnioski

On the basis of the data presented, the Panel concludes that: Protection of cells from premature aging The claimed effects are “antioxidant activity” and “antioxidant properties”. The target population is assumed to be the general population. The proposed wordings include “protect cells from premature aging”, “antioxidant containing foods support of healthy aging”. The claimed effect “protect cells from premature aging” does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Antioxidant activity, antioxidant content, and antioxidant properties The claimed effects are “antioxidant activity/content” and/or “antioxidant properties”. The target population is assumed to be the general population. It is assumed that these claimed
Food(s)/food constituent(s) with antioxidant properties
EFSA Journal 2010; 8(2):1489 8
effects refer to the capacity of food/food constituents to scavenge free radicals and/or to their reducing capacity. No evidence has been provided to establish that having antioxidant activity/content and/or antioxidant properties is a beneficial physiological effect. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and a beneficial physiological effect related to antioxidant activity, antioxidant content, or antioxidant properties.
Protection of DNA, proteins and lipids from oxidative damage The claimed effects refer to the protection of body cells and molecules (such as DNA, proteins and lipids) from oxidative damage, including UV-induced oxidative damage. The target population is assumed to be the general population. The protection of molecules such as 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 the food(s)/food constituent(s) evaluated in this opinion and the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage.