Scientific Opinion on the substantiation of a health claim related to prunes and contribution to normal bowel function pursuant to Article 14 of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2014;12(11):3892 [8 pp.].
doi
10.2903/j.efsa.2014.3892
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Member State - France
Question Number
EFSA-Q-2008-193
Adopted
30 October 2014
Published
19 November 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to prunes and contribution to normal bowel function. The food constituent, prunes, which is the subject of the health claim, is sufficiently characterised. Contribution to normal bowel function is a beneficial physiological effect without the occurrence of diarrhoea for infants and young children from six months to three years of age. No evidence was provided by the applicant to substantiate the effect of prunes on bowel function without the occurrence of diarrhoea for infants and young children. The Panel concludes that a cause and effect relationship has not been established between the consumption of prunes and contribution to normal bowel function without the occurrence of diarrhoea for infants and young children from six months to three years of age.

Summary

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to prunes and contribution to normal bowel function.

The scope of the application was proposed to fall under a health claim referring to children’s development and health.

The food constituent 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 proposed by the applicant is “contribute to normal bowel function”. The target populations proposed by the applicant are infants and young children from birth to three years of age. The Panel considers that an improvement of bowel function, such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools, is a beneficial physiological effect, provided that it does not result in diarrhoea. The Panel considers that the target populations with respect to this claim are infants and children from 6 months to 36 months.

The Panel notes that no studies investigating the effect of prunes on bowel function in infants and young children were provided by the applicant.

The Panel considers that no evidence was provided by the applicant to substantiate the effect of prunes on bowel function without the occurrence of diarrhoea for infants and young children.

The Panel concludes that a cause and effect relationship has not been established between the consumption of prunes and contribution to normal bowel function without the occurrence of diarrhoea for infants and young children from six months to three years of age.

Keywords
prunes, dried plums, Prunus domestica L., infants, children, bowel function, health claims
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Number of Pages
8