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      2154      3780      2156      1867      3507      3505      1321      3520      3786      1315      3241      3790      2151      1850      4007      3767      3524      2193      1367      2673      3290      3541      2188      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      3183      3454      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      3652      3383      1999      1971      3168      3406      3167      3166      1969      3646      3888      1706      2800      3400      1229      2795      3899      2321      2049      3423      3418      1957      2059      2060      1243      3409      1966      3412      2061      1941      3307      3854      3856      2641      3849      1940      3299      1679      3606      3297      2654      2653      2087      3597      1921      3593      2083      1934      3316      3315      2090      3337      2136      3824      2849      3822      2855      2132      3817      2854      2144      3815      3816      2857      3813      1439      3571      3839      3353      2866      3356      3838      3836      2125      3828      3349      3825  
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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.