• Open Access

Lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Authors

  • EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)


  • Panel members: Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
  • Correspondence: nda@efsa.europa.eu
  • Acknowledgement: 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 output.
  • Adoption date: 23 September 2015
  • Published date: 13 October 2015
  • Question number: EFSA-Q-2015-00375
  • On request from: Competent Authority of the United Kingdom

Abstract

Following an application from DuPont Nutrition BioSciences ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to lactitol and the maintenance of normal defecation. The food constituent that is the subject of the claim is lactitol. The Panel considers that the food constituent lactitol, which is the subject of the claim, is sufficiently characterised. The Panel considers that the maintenance of normal defecation is a beneficial physiological effect. A total of 15 human intervention studies were identified as pertinent to the health claim. Twelve studies with various methodological limitations consistently showed that consumption of at least 10 g/day lactitol increases stool frequency; five out of six studies found that lactitol softens stool consistency; and two studies showed that lactitol increases stool bulk. The Panel also acknowledges the plausible mechanisms of action by which lactitol could exert the claimed effect. The dose of 10 g/day lactitol does not induce diarrhoea. The Panel concludes that a cause and effect relationship has been established between the consumption of lactitol and the maintenance of normal defecation. The following wording reflects the scientific evidence: “lactitol can contribute to normal defecation”. To obtain the claimed effect, 10 g of lactitol should be consumed daily. The target population is the general adult population.

Ancillary