Short-chain fructooligosaccharides from sucrose and maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2016;14(1):4366 [14 pp.].
doi
10.2903/j.efsa.2016.4366
Panel members at the time of adoption
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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Harry McArdle, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (JJ) Strain, Hendrik Van Loveren and Peter Willatts for the preparatory work on this scientific output. 

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of France following an application by Beghin-Meiji and Tereos Syral.
Question Number
EFSA-Q-2015-00377
Adopted
11 December 2015
Published
8 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Beghin-Meiji and Tereos Syral, 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 Panel) was asked to deliver an opinion on the scientific substantiation of a health claim related to short-chain fructooligosaccharides (scFOS) from sucrose and maintenance of normal defecation. The food constituent that is the subject of the health claim is scFOS from sucrose. The Panel considers that scFOS from sucrose is sufficiently characterised. The claimed effect proposed by the applicant is ‘maintaining normal intestinal transit regularity by increasing stool frequency’. The target population proposed by the applicant is the general population. Upon a request from EFSA, the applicant confirmed that the proposed claimed effect refers to maintenance of normal defecation. The Panel considers that maintenance of normal defecation is a beneficial physiological effect. The Panel considers that one human intervention study did not show an effect of scFOS from sucrose at a dose of 5.7 g/day for 4 weeks on defecation frequency, consistency of stools or dry faecal mass and that in two other human intervention studies 10 g/day of scFOS increased faecal bulk, whereas higher amounts (12.5 g/day) consumed for shorter period did not. Although a number of studies provided some evidence that scFOS are fermented in the colon and increase bacterial mass and faecal bulk, the information provided does not demonstrate that the changes in short-chain fatty acids (SCFA) or bile acids induced by scFOS lead to significant changes in the frequency of stools. The Panel concludes that a cause and effect relationship has not been established between the consumption of scFOS from sucrose and maintenance of normal defecation under proposed conditions of use.

Summary

Following an application from Beghin-Meiji and Tereos Syral 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 European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to deliver an opinion on the scientific substantiation of a health claim related to short-chain fructooligosaccharides (scFOS) from sucrose and maintenance of normal defecation.

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 general approach of the NDA Panel for the evaluation of health claim applications is outlined in the EFSA general guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims.

The food constituent that is the subject of the health claim is short-chain fructooligosaccharides from sucrose. The Panel considers that the food constituent, scFOS from sucrose, is sufficiently characterised.

The claimed effect proposed by the applicant is ‘maintaining normal intestinal transit regularity by increasing stool frequency’. The target population proposed by the applicant is ‘general population’. Upon a request from EFSA, the applicant confirmed that the proposed claimed effect refers to maintenance of normal defecation.

The Panel considers that maintenance of normal defecation is a beneficial physiological effect.

A total of 17 human studies, 11 animal studies and 6 in vitro studies have been identified by the applicant as being pertinent to the health claim.

In weighing the evidence, the Panel took into account that one human intervention study from which conclusions could be drawn did not show an effect of scFOS from sucrose consumed at a dose of 5.7 g/day for 4 weeks on defecation frequency, consistency of stools or dry faecal mass, and that in two other human intervention studies 10 g/day of scFOS consumed for 5 weeks increased faecal bulk, whereas higher amounts (12.5 g/day) consumed for shorter period of time (12 days) did not. The Panel also took into account that, although a number of animal efficacy studies and mechanistic studies provided some evidence that scFOS are fermented in the colon by the gut microbiota and increase bacterial mass and faecal bulk, the information provided by those studies does not demonstrate that the changes in short-chain fatty acids (SCFA) or bile acids which may be induced by scFOS lead to significant changes in the frequency of stools.

On the basis of data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of scFOS from sucrose and maintenance of normal defecation under proposed conditions of use.

Keywords
short-chain fructooligosaccharides from sucrose, defecation, bowel function, constipation, health claim
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Number of Pages
14