Following an application from DuPont Nutrition BioSciences ApS, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 lactitol and the maintenance of normal defecation.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The general approach of the NDA Panel to the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on the evaluation of Article 13(5) and 14 health claims (EFSA NDA Panel, 2011a) and the guidance on the scientific requirements for health claims related to gut and immune function are outlined in a specific EFSA guidance document (EFSA, 2011c).
The food constituent that is the subject of the health claim is lactitol. The Panel considers that lactitol is sufficiently characterised. The claimed effect proposed by the applicant is “normal bowel function by increasing stool frequency, increasing stool bulk and moisture, softening stool consistency and reducing transit time”. The target population proposed by the applicant is the general population.
The Panel notes that the proposed claimed effect refers to the maintenance of normal defecation. The Panel considers that the maintenance of normal defecation is a beneficial physiological effect. A total of 15 human intervention studies were identified by the applicant as being pertinent to the health claim. The Panel considers that the outcomes measured in one study are not relevant to assess the claimed effect on the maintenance of normal defecation. Out of 14 studies, stool frequency was measured in 12 studies, stool consistency in 12 studies, stool bulk in two studies and transit time in three studies. In some studies, the effect of lactitol was compared with either the baseline value or a control placebo group, and in other studies lactitol was compared with lactulose, assuming that lactulose has an effect on defecation. The Panel notes that these studies were not designed as equivalence studies. Hence, no conclusions can be drawn from them for the scientific substantiation of the claim. The Panel also notes that transit time is not necessarily related to normal defecation. The Panel considers that no conclusions can be drawn from studies assessing transit time for the scientific substantiation of the claim.
In weighing the evidence, the Panel took into account that 12 studies with various methodological limitations consistently showed that consumption of at least 10 g/day lactitol increases stool frequency; that five out of six studies found that lactitol softens stool consistency; and that 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.
On the basis of the data presented, 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”. The claimed effect can be obtained by consuming 10 g of lactitol daily. The target population is the general adult population.
Read here the full EFSA scientific opinion.
(Source: EFSA website)