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Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Journal 2013;11(10):3412 [12 pp.]. doi:10.2903/j.efsa.2013.3412
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members 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 Acknowledgment 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 nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Competent Authority of France following an application by Vivatech Question number: EFSA-Q-2013-00650 Adopted: 09 October 2013 Published: 30 October 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Vivatech, submitted for authorisation of a health claim pursuant to Article 13(5) 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 hydroxyanthracene derivatives and improvement of bowel function. 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 notes that the effect of hydroxyanthracene derivatives from the root and rhizome of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, from the leaves or fruits of Cassia senna L. and/or Cassia angustifolia Vahl, from the bark of Rhamnus frangula L., from the bark of Rhamnus purshianus D.C. and from Aloe barbadensis Miller and/or various aloe species, mainly Aloe ferox Miller and its hybrids on the short-term alleviation of occasional constipation is well established. The Panel concludes that a cause and effect relationship has been established between consumption of hydroxyanthracene derivatives and improvement of bowel function.

© European Food Safety Authority, 2013

Summary

Following an application from Vivatech, submitted for authorisation of a health claim pursuant to Article 13(5) 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 hydroxyanthracene derivatives and improvement of bowel function.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.

The food that is the subject of the health claim is Transitech®, a food supplement which contains per tablet on average 226.8 mg powdered dried underground parts of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids standardised for hydroxyanthracene derivatives (2.2 to 2.76 %, 5 mg/tablet), 38 mg of powdered dried root of Althaea officinalis L., 38 mg of powdered dried petals of Rosa centifolia L., 18 mg of powdered dried expressed juice from leaves of Cynara scolymus L. standardised for cynarine (2.5 %), 18 mg of powdered dried leaves of Ocimum basilicum L., 18 mg of powdered dried seeds of Coriandrum sativum L., 1.7x108 CFU Saccharomyces cerevisiae UVAFERM SC (LYCC 6062), 4x106 CFU Bifidobacterium longum R0175 and 4x106 CFU Lactobacillus helveticus R0052.

The Panel considers that the food, Transitech®, which is the subject of the claim, is sufficiently characterised.

The claimed effect as proposed by the applicant is “improves bowel function”. The target population proposed by the applicant is the “general population experiencing disturbed defecation”.

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 applicant provided two unpublished randomised controlled trials as pertinent to the claim.

One study had considerable methodological limitations, and no conclusions could be drawn from this study for the scientific substantiation of the claim.

The second study was a randomised, placebo-controlled, double-blind study of parallel design which evaluated the effects of a daily consumption of Transitech® vs. placebo over 10 days on stool frequency as the primary endpoint. Secondary outcomes included colonic transit time, stool size, stool consistency and bloating. The average number of daily stools was significantly higher in the intervention group compared to the control group, averaged over the 10 day intervention, and colonic transit time was significantly shorter in the intervention group than in the placebo group.

iarrhoea occurred in two subjects in the intervention group and one in the control group.

The Panel notes the established effect of hydroxyanthracene derivatives from the root and rhizome of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, but also from the leaves or fruits of Cassia senna L. and/or Cassia angustifolia Vahl, from the bark of Rhamnus frangula L., from the bark of Rhamnus purshianus D.C. and from Aloe barbadensis Miller and/or various aloe species, mainly Aloe ferox Miller and its hybrids, on the short-term alleviation of occasional constipation, at the proposed conditions of use (i.e. 10 mg per day), and the established mechanism by which hydroxyanthracene derivatives exert an effect on bowel function (i.e. stimulation of colonic motility, inhibition of absorption of water and electrolytes, and stimulation of secretion of water and electrolytes into the lumen of the colon resulting in enhanced concentrations of fluid and electrolytes in the lumen of the colon).

The Panel also notes that the available evidence does not establish that any of the other food constituents in Transitech® exert an effect on bowel function. The Panel also notes that in the absence of a group consuming hydroxyanthracene derivatives alone in the studies submitted by the applicant, no conclusions can be drawn on whether Transitech® exerts an effect on bowel function over and above an effect of hydroxyanthracene derivatives. The available evidence also does not establish that the combination of food constituents in Transitech® would lead to a lower incidence of abdominal pain and passage of liquid stools which may be caused by the consumption of hydroxyanthracene derivatives, as claimed by the applicant.

In weighing the evidence, the Panel took into account the established effect of hydroxyanthracene derivatives on bowel function, and that the mechanism by which hydroxyanthracene derivatives exert the effect is known. The Panel also took into account that the evidence provided by the applicant did not establish that any of the other food constituents in Transitech® exert an effect on bowel function over and above the effect of hydroxyanthracene derivatives, or lead to a lower incidence of untoward effects of hydroxyanthracene derivatives.

The Panel concludes that a cause and effect relationship has been established between consumption of hydroxyanthracene derivatives and improvement of bowel function.

The Panel considers that the following wording reflects the scientific evidence: “Hydroxyanthracene derivatives improve bowel function”.

The Panel considers that in order to bear the claim, a product should provide 10 mg hydroxyanthracene derivatives per day either from the root and rhizome of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, and/or from the leaves or fruits of Cassia senna L. and/or Cassia angustifolia Vahl, and/or from the bark of Rhamnus frangula L and/or from the bark of Rhamnus purshianus D.C. and/or from Aloe barbadensis Miller and/or various aloe species, mainly Aloe ferox Miller and its hybrids. The target population is adults.

In relation to the restrictions of use, the Panel notes that stimulant laxatives should not be consumed continually for periods longer than one to two weeks. The use of stimulant laxatives for more than two weeks requires medical supervision. Long-term use of stimulant laxatives should be avoided owing to the danger of electrolyte imbalance, impaired function of the intestine, and dependence on laxatives. Stimulant laxatives should only be used if an effect on bowel function cannot be achieved by a change of diet or the administration of bulk forming agents.

Keywords

Transitech®, hydroxyanthracene derivatives, bowel function, health claims