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.