Scientific Opinion on the substantiation of health claims related to dried plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function (ID 1164, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2012;10(6):2712 [17 pp.].
doi
10.2903/j.efsa.2012.2712
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00161
Adopted
25 April 2012
Published
5 June 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13.1 of Regulation (EC) No 1924/2006 in the framework of further assessment related to plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function. The food that is the subject of the claim, prunes (dried plums of ‘prune’ cultivars (Prunus domestica L.)) is sufficiently characterised. The claimed effect, maintenance of normal bowel function, is a beneficial physiological effect. The proposed target population is the general population. In weighing the evidence, the Panel took into account that two human intervention studies showed an effect of dried plums on bowel function, that one study with considerable limitations showed an effect of dried plums on stool consistency, but not on other measures of bowel function, that another study with considerable limitations did not show an effect of dried plums on bowel function when compared to dried apple, and that there is good evidence for plausible mechanisms by which some components of prunes may contribute to the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of dried plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function. In order to obtain the claimed effect, about 100 g of dried plums (prunes) should be consumed daily. The target population is the general population.

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. The Commission has agreed with EU Member States that a certain number of Article 13 health claims would be eligible for further assessment by EFSA in order to be able to take a final decision on whether or not to include these claims in the list of permitted health claims. This opinion addresses the scientific substantiation of a health claim in relation to dried plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims, references that EFSA has received from Member States or directly from stakeholders and the additional information provided by the competent Authority of France for further assessment of this claim.

The food that is the subject of the health claim is prunes. The Panel considers that prunes, (dried plums of ‘prune’ cultivars (Prunus domestica L.)) are sufficiently characterised.

The claimed effect, which is eligible for further assessment, is maintenance of normal bowel function. The proposed target population is the general population. The Panel considers that maintenance of normal bowel function is a beneficial physiological effect.

In its earlier opinion the Panel considered two human intervention studies. In the framework of further assessment, two additional human intervention studies, which addressed the effect of dried plums alone on bowel function, were provided. References which addressed proposed mechanisms by which some components identified in prunes could contribute to exerting the claimed effect were also considered. This evaluation is based on the scientific references provided in the present and the previous submission which addressed the effects of dried plums of ‘prune’ cultivars (Prunus domestica L.) on maintenance of normal bowel function and on the mechanisms by which dried plums could exert the claimed effect in the target population.

In one human intervention study an effect of dried plums on bowel function as indicated by increased faecal weight was observed, in a further study dried plums showed an effect on bowel function similar to psyllium for which there is evidence to support a laxative effect, one study with considerable limitations showed an effect of dried plums on stool consistency but not on other measures of bowel function and one study with considerable limitations did not show an effect of dried plums on bowel function when compared to dried apple.

Prunes contain dietary fibre, both soluble and insoluble, and sorbitol. Insoluble components of the dietary fibre resist breakdown by the microflora and exert a physical effect on faecal bulk by their presence and by retaining water within the cellular structure, whereas the soluble components are extensively degraded by the microflora resulting in a substantial stimulation of microbial growth and thereby an increased faecal bulk. Increased faecal mass will increase the diameter of the lumen of the colon, thereby decreasing intraluminal pressure and allowing increased forward flow of the faeces. Sorbitol is poorly absorbed in the small intestine and acts as an osmotic laxative. The Panel considers that there is good evidence for plausible mechanisms by which some components of prunes (i.e. sorbitol and dietary fibre) may contribute to an improvement in bowel function.

In weighing the evidence, the Panel took into account that two human human intervention studies showed an effect of dried plums on bowel function, that one study with considerable limitations showed an effect of dried plums on stool consistency, but not on other measures of bowel function, that another study with considerable limitations did not show an effect of dried plums on bowel function when compared to dried apple, and that there is good evidence for plausible mechanisms by which some components of prunes may contribute to the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of dried plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function.

The Panel considers that the following wording reflects the scientific evidence: “Dried plums/prunes can contribute to normal bowel function”.

The Panel considers that, in order to obtain the claimed effect, about 100 g of dried plums (prunes) should be consumed daily. The target population is the general population.

Keywords
Prunes, dried plums, Prunus domestica L., bowel function, health claims
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Number of Pages
17