ID 1163 - 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.

2.2. Utrzymanie prawidłowej erekcji (ID 1163)

The claimed effect is “sexual health in men”. The Panel assumes that the target population is the general male population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal erectile function.
The Panel considers that maintenance of normal erectile function is a beneficial physiological effect.

3.2. Utrzymanie prawidłowej erekcji (ID 1163)

Four references were provided in relation to this claim, which included a human intervention study on the effects of pomegranate juice on prostate-specific antigen (PSA) progression. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
A randomised, double-blind, placebo-controlled, crossover intervention study (described as a pilot study) which investigated the ability of pomegranate juice to improve erections in 53 male subjects with mild to moderate erectile dysfunction (ED) was provided (Forest et al., 2007). Subjects consumed daily eight ounces of pomegranate juice (total dose of 1.5 mmol polyphenols per day) and eight ounces placebo juice for 28 days each with a two-week washout period in between. Efficacy was assessed using the International Index of Erectile Function (IIEF) and the Global Assessment Questionnaires (GAQ). The Panel notes that pomegranate juice has not been characterised with respect to polyphenols (i.e. punicalagin and/or ellagic acid) and that there was no significant effect of pomegranate juice on erectile function measured using either the Global Assessment Questionnaires (GAQ) score or the International Index of Erectile Function (IIEF).
The two remaining references (one full article and one letter to the editor) refer to a study on the effects of different fruit juices, including pomegranate juice, in a rabbit model of arteriogenic erectile dysfunction. The Panel considers that the evidence from this animal study is not sufficient to predict an occurrence of an effect of polyphenols (i.e. punicalagin and/or ellagic acid) in pomegranate/pomegranate juice on the maintenance of normal erectile function in humans.
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 maintenance of normal erectile function.

Warunki i możliwe ograniczenia stosowania oświadczenia

The product must contain at least the equivalent of 240 mL pomegranate juice or 330 mg of punicalagin or 33 mg of ellagic acid