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) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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. This opinion addresses the scientific substantiation of health claims in relation to “prunes” 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 and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claim is “prunes”. The Panel considers that “prunes” in the meaning of “dried plums of „prune‟ cultivars (Prunus domestica L.)” is sufficiently characterised. The claimed effect is “normal bowel function/normal gastrointestinal function/normal colonic function”. The target population is assumed to be the general population. In the context of the proposed wordings, 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. 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 intervention 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.