Fabenol® Max, a standardised aqueous extract from Phaseolus vulgaris L., and ‘reduces the absorption of carbohydrates’: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2016;14(2):4401 [8 pp.].
doi
10.2903/j.efsa.2016.4401
Panel members at the time of adoption
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Harry McArdle, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (JJ) Strain, Hendrik Van Loveren and Peter Willatts, for the preparatory work on this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Belgium following an application by Ecopharma BVBA
Question Number
EFSA-Q-2015-00123
Adopted
2 February 2016
Published
23 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (476.39 KB)
Abstract

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 and ‘reduces the absorption of carbohydrates’. The Panel considers that Fabenol® Max, which is an aqueous extract from Phaseolus vulgaris L. standardised by its content of α-amylase inhibitor, 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)’. The Panel notes that the claimed effect was not sufficiently defined and that the applicant did not provide any further information. The Panel concludes that a cause and effect relationship cannot be established between the consumption of Fabenol® Max and a beneficial physiological effect.

Summary

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.

Keywords
Fabenol® Max, kidney bean extract, carbohydrate absorption, health claims
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Number of Pages
8