Scientific Opinion on the substantiation of a health claim related to Bimuno^®GOS and reducing gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

Following an application from Clasado Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924No /2006 via the Competent Authority of Malta, 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 Bimuno ® GOS and reducing gastro-intestinal discomfort. The food constituent that is the subject of the health claim, Bimuno ® GOS, which is a mixture of β-galacto-oligosaccharides produced through conversion of lactose by enzymes from Bifidobacterium bifidum NCIMB 41171, is sufficiently characterised. The claimed effect is reducing gastro-intestinal discomfort and is considered to be a beneficial physiological effect. The applicant did not provide any studies from which data could be used for the scientific substantiation of the claimed effect of reducing gastro-intestinal discomfort. A cause and effect relationship has not been established between the consumption of Bimuno ® GOS and reducing gastro-intestinal discomfort. 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 constituent that is the subject of the health claim is Bimuno ® GOS, a mixture of β-galactooligosaccharides, which is produced through conversion of lactose by enzymes from Bifidobacterium bifidum NCIMB 41171. The Panel considers that Bimuno ® GOS is sufficiently characterised.The claimed effect proposed by the applicant is "reduce bloating, flatulence and abdominal pain: these effects can be described collectively as abdominal discomfort". The target population proposed by the applicant is the general adult population. Symptoms such as abdominal pain, cramp, bloating, straining, borborygmi (rumbling) and sensation of incomplete evacuation are associated with gastro-intestinal discomfort. Reducing gastro-intestinal discomfort is considered an indicator of improved gastro-intestinal function. Gastro-intestinal discomfort may be measured by using validated subjective global symptom severity questionnaires such as described in consensus opinions. The Panel considers that reducing gastro-intestinal discomfort is a beneficial physiological effect.Following a literature search in PubMed, the applicant identified four human intervention studies and one review publication as being pertinent to the health claim. The applicant also provided two unpublished human intervention studies and three non-human studies for the scientific substantiation of the claim.All the human and non-human studies provided by the applicant for this claim were already submitted in previous applications for the same claim, and which were assessed by the Panel with unfavourable outcomes, except for one unpublished human intervention study.This multicentre, placebo-controlled, randomised, double-blind, parallel study investigated the effect of Bimuno ® GOS on symptoms related to ...

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