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 Vibigaba (germinated brown rice) and weight loss

Health Claim: Vibigaba and reduction of body weight in the context of an energy-restricted diet

Following an application from Loc Troi group, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 Vibigaba (germinated brown rice) and weight loss.

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 for the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on health claim applications and the guidance on the scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations.

The food proposed by the applicant as the subject of the health claim is Vibigaba (germinated brown rice). The Panel considers that the germinated brown rice Vibigaba, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is ‘in the context of an energy-restricted diet contributes to weight loss’. The proposed target population is ‘adults with metabolic syndrome’. The Panel considers that reduction of body weight in the context of an energy-restricted diet is a beneficial physiological effect.

The Panel notes that the applicant did not perform a comprehensive literature search to identify human intervention studies which could be pertinent to the claim other than the one provided by the applicant. The applicant did not reply to a specific request from the European Food Safety Authority (EFSA) to provide this information.

The applicant identified one human intervention study as being pertinent to the claim. The Panel notes the important methodological limitations of the study (e.g. statistical analysis not appropriate for the study design) and that the information provided on the design and conduct of the study is insufficient for a complete scientific evaluation. Upon a request from EFSA to provide additional information on the study which would allow a full scientific evaluation, the applicant did not reply. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.

The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of the claim.

On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of Vibigaba (germinated brown rice) and reduction of body weight in the context of an energy-restricted diet.

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