Scientific Opinion on the substantiation of a health claim related to non digestible carbohydrates and a reduction of post prandial glycaemic responses 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 2014;12(1):3513 [13 pp.].
doi
10.2903/j.efsa.2014.3513
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Belgium following an application by Beneo-Orafti SA, Sensus BV and Cosucra-Groupe Warcoing SA
Question Number
EFSA-Q-2013-00615
Adopted
11 December 2013
Published
10 January 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Beneo-Orafti SA, Sensus BV and Cosucra-Groupe Warcoing SA, 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 fructo-oligosaccharides (FOS) from inulin and a reduction of post-prandial glycaemic responses. Non-digestible carbohydrates including FOS are resistant to hydrolysis and absorption in the small intestine and do not contribute to post-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) which should replace sugars in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non-digestible carbohydrates, which is the subject of the health claim, and the food constituent (i.e. sugars) that non-digestible carbohydrates should replace in foods or beverages, are both sufficiently characterised in relation to the claimed effect. The Panel considers that a reduction of post-prandial glycaemic responses might be a beneficial physiological effect. In weighing the evidence, the Panel took into account that consumption of non-digestible carbohydrates results in reduced post-prandial blood glucose (and insulinaemic) responses compared with the consumption of sugars on a weight-by-weight basis owing to the non-digestibility in the small intestine and to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which non-digestible carbohydrates replaced sugars induced lower post-prandial glycaemic and insulinaemic responses than sugar-containing foods/drinks. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates instead of sugar and a reduction of post-prandial glycaemic responses as compared to sugar-containing foods/beverages.

Summary

Following an application from Beneo-Orafti SA, Sensus BV and Cosucra-Groupe Warcoing SA, 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 fructo-oligosaccharides (FOS) from inulin and a reduction of post-prandial glycaemic responses.

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 that is the subject of the health claim is fructo-oligosaccharides (FOS, oligofructose) obtained from chicory (Cichorium intybus L.) inulin, which should replace sugars (i.e. monosaccharides and disaccharides) in foods or beverages in order to obtain the claimed effect (i.e. reduction of post-prandial glycaemic responses). The Panel notes that the characteristic which is most relevant to the claimed effect is not unique to FOS but common to other non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides, resistant starch) because, similar to FOS, non-digestible carbohydrates are resistant to hydrolysis and absorption in the small intestine and do not contribute to post-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) which should replace sugars in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non-digestible carbohydrates, which is the subject of the health claim, and the food constituent (i.e. sugars) that non-digestible carbohydrates should replace in foods or beverages, are both sufficiently characterised in relation to the claimed effect.

The claimed effect proposed by the applicant relates to the reduction of post-prandial blood glucose responses. The target population proposed by the applicant is the general population. The Panel considers that a reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) might be a beneficial physiological effect.

The applicant identified a total of three human intervention studies and three human mechanistic studies as being pertinent to the health claim.

One cross-over trial assessed the effects of test ice creams where the sucrose content was replaced by various sugar replacers on post-prandial blood glucose responses relative to a control ice-cream which contained sucrose. Consumption of the test ice creams elicited significantly lower glucose incremental area under the curve (iAUC) (with the exception of maltitol and maltitol/resistant dextrin containing ice-creams) than the sucrose-containing control ice cream.

A randomised cross-over trial assessed post-prandial glycaemic responses following consumption of a long chain inulin, “native” inulin, and two FOS-containing products. Relative to the glucose containing drink, glycaemic responses were significantly lower after consumption of long-chain inulin, “native” inulin and the two FOS-containing products.

One double-blind, randomised, cross-over study was carried out with a yoghurt with 20 % of the sucrose replaced by FOS derived from chicory inulin. Compared with the reference yoghurt, the glucose iAUC was significantly decreased following consumption of the sugar-reduced yoghurt. There was also a significant reduction in the peak blood glucose values and the insulin iAUC values, whereas no differences were reported for the peak insulin responses.

The three mechanistic studies addressed the non-digestibility of FOS in the human small intestine, which, according to the applicant, constitutes the underlying mechanism for the claimed effect.

It is well established that sugars increase post-prandial glycaemia. Non-digestible carbohydrates including FOS are resistant to hydrolysis and absorption in the small intestine and do not contribute to post-prandial glycaemia. The Panel considers that replacing sugars by any non-digestible carbohydrate (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) would contribute to the claimed effect, i.e. a reduction of post-prandial glycaemic responses.

In weighing the evidence, the Panel took into account that consumption of non-digestible carbohydrates results in reduced post-prandial blood glucose (and insulinaemic) responses compared with the consumption of sugars on a weight-by-weight basis owing to the non-digestibility in the small intestine and to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which non-digestible carbohydrates replaced sugars induced lower post-prandial glycaemic and insulinaemic responses than sugar-containing foods/drinks.

The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates instead of sugars and reduction of post-prandial glycaemic responses as compared to sugar-containing foods/beverages.

The following wording reflects the scientific evidence: “Consumption of foods/drinks containing non-digestible carbohydrates instead of sugars induces a lower blood glucose rise after meals compared to sugar-containing foods/drinks”.

The Panel considers that in order to bear the claim sugars (i.e. monosaccharides and disaccharides) should be replaced in foods or drinks by non-digestible carbohydrates so that foods or drinks contain reduced amounts of sugars as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods. The target population is individuals who wish to reduce their post-prandial blood glucose responses.

Keywords
non-digestible carbohydrates, post-prandial glycaemic responses, health claims
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Number of Pages
13