Scientific Opinion on the substantiation of a health claim related to “non fermentable” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation 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 2013;11(7):3329 [13 pp.].
doi
10.2903/j.efsa.2013.3329
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 France following an application by Roquette Frères
Question Number
EFSA-Q-2013-00040
Adopted
10 July 2013
Published
26 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Roquette Frères, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 Nutriose® which should replace “fermentable carbohydrates” in foods or beverages in order to obtain the claimed effect, i.e. maintenance of tooth mineralisation by reducing tooth demineralisation. From the information provided, the Panel noted that the main characteristic of carbohydrates which is relevant to the claimed effect is the rate and amount of acid production resulting from their fermentation by saccharolytic bacteria in the oral cavity. This Opinion applies to “non-fermentable” carbohydrates, which should replace “fermentable” carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by the fermentation of carbohydrates is a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing “fermentable” carbohydrates at an exposure frequency of four or more times daily and an increased tooth demineralisation, and that the consumption of foods/beverages containing “non-fermentable” carbohydrates instead of “fermentable” carbohydrates may maintain tooth mineralisation by decreasing tooth demineralisation. In order to bear the claim, “fermentable” carbohydrates should be replaced in foods or beverages by “non-fermentable” carbohydrates, so that consumption of such foods or beverages does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion.

Summary

Following an application from Roquette Frères, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 Nutriose® and maintenance of tooth mineralisation by reducing tooth demineralisation.

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 applicant stated that the food that is the subject of the health claim is Nutriose®, which should replace “fermentable carbohydrates” (i.e. sugars and starches) in foods or beverages in order to obtain the claimed effect (i.e. “maintenance of tooth mineralisation by decreasing tooth demineralisation”).

From the information provided, the Panel notes that the main characteristic of carbohydrates which is relevant to the claimed effect is the rate and amount of acid production resulting from their fermentation by saccharolytic bacteria in the oral cavity, and that this characteristic can be measured in vivo or in situ by plaque pH-telemetry under standard conditions.

In this context, and for the purpose of this Opinion, “fermentable” carbohydrates are defined as carbohydrates or carbohydrate mixtures as consumed in foods or beverages that lower plaque pH, as determined in vivo or in situ by plaque pH telemetry tests, below a conservative value of 5.7 by bacterial fermentation during and up to 30 minutes after consumption.Also, for the purpose of this Opinion, the term “non-fermentable” carbohydrates denotes carbohydrates or carbohydrate mixtures as consumed in foods or beverages that do not lower plaque pH below 5.7 under the same test conditions.

This Opinion applies to “non-fermentable” carbohydrates, which should replace “fermentable” carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel notes that “non-fermentable” carbohydrates which have a neutral taste cannot substitute for the sweet taste of sugar.

The Panel considers that the food constituent, “non-fermentable” carbohydrates, which is the subject of the health claim, and the food constituent (i.e. “fermentable” carbohydrates) that “non-fermentable” carbohydrates should replace in foods or drinks are sufficiently characterised in relation to the claimed effect.

The claimed effect is “maintenance of tooth mineralisation by decreasing tooth demineralisation”. The target population proposed by the applicant is the general population. The Panel considers that maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by the fermentation of carbohydrates is a beneficial physiological effect.

The evidence available from consensus opinions, reports from authoritative bodies and reviews shows that an increased risk of dental caries in children is associated with a high frequency of intake of “cariogenic” sugars, and that frequent consumption of sweets, confectionery products and sugar-containing drinks is associated with a higher risk of caries. Foods rich in starch, especially when the starch molecule is easily available to degradation by amylase, may also contribute to the higher risk of caries.

The evidence available from consensus opinions, reports from authoritative bodies and reviews indicates that the decrease in pH in plaque as a consequence of metabolic acid production by saccharolytic bacteria when exposed to fermentable carbohydrates (i.e. sugars and starches) may promote demineralisation and prevent remineralisation of hydroxyapatite crystals. Tooth hydroxyapatite crystals are very resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops. The Panel considers that foods lowering plaque pH, as determined in vivo or in situ by pH telemetry, below a conservative value of 5.7 by bacterial fermentation during and up to 30 minutes after consumption may promote demineralisation and prevent remineralisation of hydroxyapatite crystals.

A claim on a number of sugar replacers and maintenance of tooth mineralisation by decreasing tooth demineralisation has already been assessed with a favourable outcome. The Panel considers that the scientific substantiation and proposed conditions of use for the above-mentioned claim on sugar replacers also apply to “non-fermentable” carbohydrates, which should replace “fermentable carbohydrates” in foods and beverages in order to obtain the claimed effect.

The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing “fermentable” carbohydrates at an exposure frequency of four or more times daily and an increased tooth demineralisation, and that the consumption of foods/beverages containing “non-fermentable” carbohydrates instead of “fermentable” carbohydrates may maintain tooth mineralisation by decreasing tooth demineralisation, provided that such foods/beverages do not lead to dental erosion.

The Panel considers that in order to bear the claim, “fermentable” carbohydrates should be replaced in foods or beverages by “non-fermentable” carbohydrates, so that consumption of such foods or beverages does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion.

Keywords
Nutriose®, dietary fibre, non-fermentable carbohydrates, tooth mineralisation, tooth demineralisation, enamel, health claims
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Number of Pages
13