Following an application from Ecopharma BVBA, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 Fabenol® Max, a standardised aqueous extract from Phaseolus vulgaris L., and ‘reduces the absorption of carbohydrates’.
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 general guidance for stakeholders on the evaluation of Article 13.5 and 14 health claims. The scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations are outlined in another EFSA guidance.
The food that is the subject of the health claim is an aqueous extract from P. vulgaris L. standardised by its content of α-amylase inhibitor and marketed under the brand name of Fabenol® Max. The Panel considers that the food is sufficiently characterised.
According to the applicant, consumption of the food ‘offers potential benefits in the maintenance of healthy blood sugar levels’. The meaning of ‘healthy blood sugar levels’ was not specified. The target population proposed by the applicant is ‘the general population that wants to manage their carbohydrate intake (for the maintenance of healthy blood sugar levels or optimal body composition)’.
From the information provided in the application, including the four human studies submitted for substantiation, the Panel could not establish whether the claim refers to (i) a reduction in post-prandial blood glucose responses; (ii) a (long-term) maintenance of normal blood glucose concentrations; or (iii) body weight, e.g. a reduction in body fat/body weight. Therefore, the applicant was requested to specify the claimed effect, i.e. the beneficial physiological effect, which is the subject of the application. The applicant did not reply to this request.
The Panel notes that the claimed effect is not sufficiently defined and that the applicant did not provide any further information as requested by EFSA.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of Fabenol® Max and a beneficial physiological effect.