1. Charakterystyka żywności / składnika

• Prawidłowe funkcjonowanie jelit

The food that is the subject of the claim is “prunes”. A prune is any of a variety of plum species. A plum is a stone fruit in the genus Prunus, subgenus Prunus, section Prunus (Old World plums). Most “plums” and “prunes” belong to the species Prunus domestica L. The species is not homogenous and is comprised of many cultivars. More than 1000 cultivars of plums are grown for drying, but only some cultivars of plum are called prunes when fresh or dried, others have always been called “dried plums” when dried. Prunes are characterised by a relatively small size, an oval shape, an easily removed pit (“free-stone plums”) and high sugar content. Thus, all prunes are plums, but not all plums are prunes (fresh or dried). Most industrially produced dried prunes today are produced from Prunus domestica cv. D‟Agen, by dehydration at a temperature of 85-90oC. The content of water, total carbohydrates, protein, fat, and amino acids, as well as a number of different sugars, minerals, vitamins, carotenoids, organic acids, and phenolic compounds in prunes is given in the literature (Stacewicz-Sapuntzakis et al., 2001; Dikeman et al., 2004). In 2000, the US FDA granted the permission to use „dried plums‟ in marketing as an alternative to „prunes‟.
The Panel considers that the food, “prunes” in the meaning of “dried plums of „prune‟ cultivars (Prunus domestica L.)”, which is the subject of the health claims is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

• Prawidłowe funkcjonowanie jelit

The claimed effect is “Normal bowel function/normal gastrointestinal function/normal colonic function”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “maintenance of bowel regularity, and laxative effect”. Changes in bowel function within the normal range e.g. reduced transit time, increased frequency of bowel movements or bulk of stools might be interpreted as improvement of bowel function.
The Panel considers that maintenance of normal bowel function might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Prawidłowe funkcjonowanie jelit

• Prawidłowe funkcjonowanie jelit

Sixteen references were cited to substantiate the claimed effect, of which three references report on human intervention studies (Lucas et al., 2004; Tinker et al., 1991; Piirainen et al., 2007) whereas 13 references provide various background information.
One reference (Lucas et al., 2004) described an intervention study in which 58 post-menopausal women not on hormone replacement therapy and free of any gastrointestinal and eating disorders were randomised to consume either 100 g of dried plum (Prunus domestica L.) or 75 g of dried apples daily for three months. The women were asked to fill out a validated questionnaire regarding their weekly bowel habits. The parameters used to assess bowel habits included stool frequency, estimated faecal bulk, consistency of stool (7-point scale), strain and pain during bowel movement, and feeling of constipation after bowel movement. Thirty-eight women completed the study. The Panel notes that no significant differences were found between the two treatment groups or between different time- points within each group.
A second paper (Tinker et al., 1991) reported on 41 adult men (29-79 years, mean 46.5 years) recruited from the general population but with mild hypercholesterolaemia (fasting plasma cholesterol concentration between 5.2 and 7.5 mmol/L). An 8-week open crossover study was performed (four
weeks with normal diet plus 12 prunes daily (~ 100g; ~6 g dietary fibre by analysis), and four weeks with 360 mL grape juice per day). Biochemical parameters and faecal output were recorded. Faecal wet weight as well as dry weight was higher after the prune period than after the grape juice period and higher than baseline values, with no change in per cent water. The Panel notes that stool consistency, stool frequency and flatulence did not differ between study periods, and that no method for symptom record was provided.
A third paper (Piirainen et al., 2007) described a study with „prune juice‟ (prepared from plum juice concentrate, prune puree, and water, and sweetened with fructose (7%)). The Panel notes that no scientific conclusions can be drawn for the substantiation of the claim from this study that used another food constituent for the intervention rather than dried “prunes”.
Two references provided are general reviews of evaluation and treatment of constipation in children, two are reviews of carbohydrates in human nutrition and of tolerance of low-digestible carbohydrates, three are listings of drugs/remedies or plant-based medications, one is a listing of fruit portion sizes, one is a review of carbohydrate composition of plum and prune preparations (Dikeman et al., 2004), one is an extensive review of chemical composition and potential health effects of prunes and prune juice (Stacewicz-Sapuntzakis et al., 2001), one is a study on spent grain dietary fibre, two are clinical studies on fibre intake in general, faecal excretion and colonic function. The Panel notes that these references do not provide scientific data that could be used to substantiate the claim.
In weighing the evidence, the Panel took into account that one human intervention study did not find any significant difference between the two treatment groups or between different time-points within each group and that the other human intervention study showed some effect on faecal bulk but not on stool frequency or consistency. Another human intervention study cited used another food constituent for the intervention rather than dried “prunes” and the other references provided only background information and did not provide scientific data that could be used to substantiate the claim.
The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of dried plums of „prune‟ cultivars (Prunus domestica L.) and maintenance of normal bowel function.