ID 1319 - Granatowiec właściwy

PL: Granatowiec właściwy
EN: Pomegranate
Pdf: pomegranate/pomegranate juice

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food that is the subject of the health claims is pomegranate/pomegranate juice and polyphenols in pomegranate/pomegranate juice.
The information provided (e.g. food, conditions of use) for the majority of the health claims on pomegranate and pomegranate juice refers to the type and/or amount of polyphenols in pomegranate/pomegranate juice that should be consumed daily in order to achieve the claimed effect. The Panel assumes that such phenolic compounds are also mentioned (and occasionally quantified) to allow standardisation of pomegranate juice, for which information on composition and on the manufacturing process has not been provided. In the remaining health claims, reference is made to dried fruit or herb powders for which the information on composition and on the manufacturing process has not been provided.
Polyphenols comprise a very wide group (several thousands of compounds) of plant secondary metabolites including flavonoids, isoflavonoids, phenolic acids, proanthocyanidins and other tannins, and lignans with different biological activities. Polyphenol content in foods is usually expressed as gallic acid equivalents (GAE), but also other phenolic compounds such as catechin/epicatechin or caffeic acid which are used for standardisation. This standardisation refers to traditional spectrophotometrical measurement of total polyphenols using the Folin-Ciocalteau method (Singleton and Rossi, 1965), which is based on reducing capacity. The method is not specific for polyphenols because other reducing compounds such as ascorbic acid, sugars and proteins will also be included in the quantification, thus leading to an overestimation of the actual polyphenol content. The total polyphenol content assessed with this method is not suitable for characterisation of polyphenols in foods.
Regarding the nature of specific polyphenols in pomegranate (Prunus granatum), punicalagin and ellagic acid have been specified in the conditions of use. Punicalagins are tannins that are known to be hydrolysed in vivo into smaller polyphenols such as ellagic acid. Punicalagin and ellagic acid can be measured in foods by established methods. Pomegranate polyphenols are bioavailable (Mertens- Talcott et al., 2006; Seeram et al., 2006).
The Panel considers that, whereas pomegranate/pomegranate juice and polyphenols in pomegranate/pomegranate juice are not sufficiently characterised, the food constituents, punicalagin and ellagic acid in pomegranate/pomegranate juice, which the Panel assumes to be the subject of the health claims, are sufficiently characterised.

2.3. Ochrona lipidów przed uszkodzeniem oksydacyjnym (ID 1201, 1319, 2123)

The claimed effects are “antioxidative function”, “antioxidant properties”, and “antioxidants and immunity”. The Panel assumes that the target population is the general population.
The Panel considers that “immunity” is not sufficiently defined for a scientific evaluation and the proposed wordings or scientific references submitted for this claim (ID 2123) do not provide further information. The Panel also considers that no evidence has been provided to establish that having antioxidant properties is a beneficial physiological effect.
In the context of the proposed wordings and conditions of use, the Panel assumes that the claimed effects relate to the protection of lipids 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, 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 lipids from oxidative damage may be a beneficial physiological effect.

3.3. Ochrona lipidów przed uszkodzeniem oksydacyjnym (ID 1201, 1319, 2123)

Most of the references provided in the list addressed topics other than polyphenols in pomegranate/pomegranate juice and the claimed effect. These references included narrative reviews on polyphenols, food composition tables, in vitro testing of antioxidant properties and human studies investigating the effects of polyphenols on anti-angiogenic potential or in relation to cancer prevention. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
A single arm, uncontrolled intervention study in 13 healthy male volunteers which assessed the effects of pomegranate juice consumption (50 mL per day containing 1.5 mmol total polyphenols) for two weeks on changes in the ex vivo activity of serum paraoxonase (an HDL-associated esterase), in plasma lipid peroxides (AAPH induced spectrophotometric method), and in the oxidation lag time of low-density lipoproteins (LDL) ex vivo was provided (Aviram et al., 2000). A second single arm (Rosenblat et al., 2006), uncontrolled intervention study in 10 healthy subjects and 10 non-insulin dependent diabetes mellitus (NIDDM) patients under pharmacological treatment was provided with the consolidated list. All subjects consumed 50 mL per day of pomegranate juice containing 1979 mg/L of tannins (1561 mg/L of punicalagin and 417 mg/L of hydrolysable tannins), 384 mg/L of
anthocyanins (delphinidin 3,5-diglucoside, cyanidin 3,5-diglucoside, delphinidin-3-glucoside, cyanidin 3-glucoside and pelargonidine 3-glucoside) and 121 mg/L of ellagic acid derivatives for three months. Serum concentrations of lipid peroxides, thiobarbituric acid reactive substances (TBARS), serum SH groups, serum paraoxonase 1 (PON1) activity, cellular peroxides and glutathione content in monocytes-derived macrophages (HMDM), and oxidised LDL uptake by HMDM were measured at the beginning and end of the intervention. The Panel considers that no conclusions can be drawn from these small and uncontrolled studies for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of punicalagin/ellagic acid in pomegranate/pomegranate juice and the protection of lipids from oxidative damage.

Warunki i możliwe ograniczenia stosowania oświadczenia

300 ml daily - There are no documented limits for the effective ingredients. Due to inadequate data, pregnant women, nursing women, patients over antidepressant medicines (Mirtazapine), antipsychotic medicines (Risperidone, Ketiapine), statines medicines (Simvastatine, atorvastatine), antihypertensive medicines should take doctor’s advice (relative contra-indication). There are no documented upper limits in the consumption of pomegranate juice. Time that a result is seen cannot be clarified yet. Interaction only with medicines referred (after doctor’s advice) Process method cannot affect the effective ingredients.