Scientific Opinion on the substantiation of health claims related to the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose and maintenance of tooth mineralisation by decreasing tooth demineralisation (ID 463, 464, 563, 618, 647, 1182, 1591, 2907, 2921, 4300), and reduction of post-prandial glycaemic responses (ID 617, 619, 669, 1590, 1762, 2903, 2908, 2920) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2011;9(4):2076 [25 pp.].
doi
10.2903/j.efsa.2011.2076
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.
Acknowledgements

The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Bone/Teeth/Connective Tissue: Rikke Andersen, Olivier Bruyère, Albert Flynn, Ingegerd Johansson, Jukka Meurman and Hildegard Przyrembel. The members of the Claims Sub-Working Group on Weight Management/Satiety/Glucose and Insulin Control/Physical Performance: Kees de Graaf, Joanne Harrold, Mette Hansen, Mette Kristensen, Anders Sjödin and Inge Tetens.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-1404
EFSA-Q-2008-1406
EFSA-Q-2008-1456
EFSA-Q-2008-2327
EFSA-Q-2008-2495
EFSA-Q-2008-3636
EFSA-Q-2008-3641
EFSA-Q-2008-3653
EFSA-Q-2008-1250
EFSA-Q-2008-1251
EFSA-Q-2008-1350
EFSA-Q-2008-1405
EFSA-Q-2008-1434
EFSA-Q-2008-1921
EFSA-Q-2008-2328
EFSA-Q-2008-3640
EFSA-Q-2008-3654
EFSA-Q-2010-00253
Adopted
28 January 2011
Published
8 April 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

No abstract available

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose and maintenance of tooth mineralisation by decreasing tooth demineralisation, and reduction of post-prandial glycaemic responses. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.

The food constituents that are the subject of the health claims are “carbohydrates - non-cariogenic e.g. isomaltulose; tagatose, polyols, polydextrose, absence of, or low, fermentable carbohydrates”, “polydextrose”, “xylitol in candy and bakery industry products and in dairy products”, “polyols”, “isomaltulose”, “isomalt”, “D-tagatose” and “sucralose”. In the context of the proposed wordings and conditions of use, the Panel assumes that the food constituents that are the subject of the health claim are xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose, which should replace sugars in foods in order to obtain the claimed effect. The Panel considers that the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose are sufficiently characterised in relation to the claimed effects.

Maintenance of tooth mineralisation by decreasing tooth demineralisation

The claimed effects are “dental health”, “mouth, teeth”, “remineralisation of teeth”, “not cariogenic”, and “do not promote tooth decay”. The target population is assumed to be the general population. In the context of the proposed wordings, conditions of use and references provided in the consolidated list, the Panel assumes that the claimed effects refer to the maintenance of tooth mineralisation by decreasing tooth demineralisation. The Panel considers that the maintenance of tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque through the fermentation of carbohydrates is a beneficial physiological effect, provided that it is not accompanied by tooth demineralisation resulting from erosive properties of a food.

The evidence provided by consensus opinions, reports from authoritative bodies and reviews also 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 the hydroxyapatite crystals.

The evidence provided in relation to the claim also establishes that in the absence of other fermentable carbohydrate-containing foods, foods containing the sugar replacers considered in this opinion do not promote dental caries because they do not lower plaque pH to the level associated with enamel demineralisation.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of sugar-containing foods/drinks at an exposure frequency of four times daily or more and an increased tooth demineralisation, and that the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, instead of sugar in sugar-containing foods/drinks, may maintain tooth mineralisation compared with sugar-containing foods, provided that such foods/drinks do not lead to dental erosion.

The Panel considers that in order to bear the claim, sugars should be replaced in foods or drinks (which reduce plaque pH below 5.7) by xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, so that consumption of such foods or drinks does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion.

If excessive amounts of bulk sweeteners (polyols) are consumed, laxative effects may occur. In order to ensure that consumers receive adequate information, the labelling of foods containing more than 10 % added polyols must include the advisory statement “excessive consumption may produce laxative effects” (Commission Directive 94/54/EC).

Reduction of post-prandial glycaemic responses

The claimed effects are “low glycaemic properties”, “reduced speed of digestion and absorption results in lower glycaemic response”, and “post-prandial blood glucose”. The target population is assumed to be individuals wishing to reduce their post-prandial glycaemic responses. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the reduction of post-prandial glycaemic responses. The Panel considers that the reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.

In weighing the evidence, the Panel took into account that the food constituents xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose decrease post-prandial blood glucose (or insulinaemic) responses compared with sugars on a weight by weight basis owing to their reduced/delayed digestion/absorption and/or to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose replaced sugars induced lower post-prandial glycaemic and insulinaemic responses than sugar-containing foods/drinks.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose instead of sugar and reduction in post-prandial blood glucose responses (without disproportionally increasing post-prandial insulinaemic responses) as compared to sugar-containing foods/drinks.

The Panel considers that in order to bear the claim, sugars should be replaced in foods or drinks by xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, 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 (section 2.2.3).

If excessive amounts of bulk sweeteners (polyols) are consumed, laxative effects may occur. In order to ensure that consumers receive adequate information, the labelling of foods containing more than 10% added polyols must include the advisory statement “excessive consumption may produce laxative effects” (Commission Directive 94/54/EC).

Keywords
Polyols, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose, polydextrose, tooth mineralisation, tooth demineralisation, post-prandial glycaemic response, health claims
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Number of Pages
25