2.1. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 463, 464, 563, 618, 647, 1182, 1591, 2907, 2921, 4300)

The claimed effects are “dental health”, “mouth, teeth”, “remineralisation of teeth”, “not cariogenic”, and “do not promote tooth decay”. The Panel assumes that the target population is 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.
Demineralisation of tooth tissues can occur following acid production through the fermentation of carbohydrates by acid-producing bacteria in dental biofilms. The effect may be balanced by remineralisation when pH is neutralised and a state of calcium and phosphate supersaturation is met.
If demineralisation is not balanced by remineralisation then net demineralisation of tooth tissues results, which, if sustained, can lead to dental caries. Demineralisation of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages, and frequent consumption can lead to dental erosion. Dental caries and dental erosion are diseases with a high prevalence in the EU.
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 the erosive properties of a food.

2.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 617, 619, 669, 1590, 1762, 2903, 2908, 2920)

The claimed effects are “low glycaemic properties”, “reduced speed of digestion and absorption results in lower glycaemic response”, and “post-prandial blood glucose”. The Panel assumes that the target population is 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.
Postprandial glycaemia is interpreted as the elevation of blood glucose concentrations after consumption of a food and/or meal. This function is a normal physiological response which varies in magnitude and duration, and which may be influenced by the chemical and physical nature of the food or meal consumed, as well as by individual factors (Venn and Green, 2007). Reducing post-prandial glycaemic responses may be beneficial to subjects with, for example, impaired glucose tolerance, as long as post-prandial insulinaemic responses are not disproportionally increased. Impaired glucose tolerance is common in the general population of adults.
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.

3.1. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 463, 464, 563, 618, 647, 1182, 1591, 2907, 2921, 4300)

The evidence provided by consensus opinions, reports from authoritative bodies and reviews shows that an increased risk of dental caries in children is associated with a high frequency (more than about four times daily) of intake of “cariogenic” sugars (mainly sucrose, glucose and fructose), rather than with the total amount of dietary sugars, and that frequent consumption of sweets, confectionery products and sugar-containing drinks is associated with a higher risk of caries (Anderson et al., 2009; DoH, 1991; EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010; IoM, 2005; Moynihan and Petersen, 2004). Foods rich in starch may also contribute, especially when the starch molecule is easily available to degradation by amylase (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010; FDA, 1996).
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. Tooth hydroxyapatite crystals are very resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops. Typically, the critical pH for dental enamel is around 5.5. The Panel notes that
demineralisation of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages, and that frequent consumption can lead to dental erosion.
Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose are slowly metabolised by bacteria in the mouth. The rate and amount of acid production from these food constituents is significantly less than that from sucrose. Although frequent or long-term use of some sugar alcohols (e.g. sorbitol, mannitol and xylitol), especially as part of a daily diet containing other carbohydrates which are preferentially metabolised by oral bacteria, may result in some adaptation by the bacteria to these substances, the effect would not be such that consumption of sugar alcohols would cause the loss of minerals from tooth enamel (Edgar, 1998; FDA, 1996, 2010; Imfeld, 1999; Touger-Decker and van Loveren, 2003).
The evidence provided in relation to this 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. The Panel considers that foods lowering plaque pH below a conservative value of 5.7 by bacterial fermentation during and up to 30 minutes after consumption, as determined in vivo or in situ by pH telemetry, may promote demineralisation and prevent remineralisation of the hydroxyapatite crystals (FDA, 1996).
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 by decreasing tooth demineralisation compared with sugar-containing foods, provided that such foods/drinks do not lead to dental erosion.

3.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 617, 619, 669, 1590, 1762, 2903, 2908, 2920)

Postprandial glycaemic and insulinaemic responses following consumption of the sugar alcohols considered in this opinion are significantly lower compared to glucose or sucrose on a weight basis in healthy and diabetic subjects when consumed in liquid form at doses between 10 and 50 g. The addition of the sugar alcohols to simple and complex meals compared to the addition of glucose or sucrose leads to similar results. The reduced post-prandial blood glucose response of sugar alcohols compared to glucose or sucrose is explained by the interference of the alcohol group that replaces the carbonyl group with digestion and absorption, and the occurrence of saccharide linkages other than the alpha-1-4 and alpha-1-6 glycosidic bonds present in available carbohydrates (Livesey, 2003).
Postprandial glycaemic and insulinaemic responses following consumption of isomaltulose have been shown to be significantly lower in healthy subjects compared to sucrose on a weight basis when consumed in water (Achten et al., 2007; Kawai et al., 1985; MacDonald and Daniel, 1983), and compared to dextrin when consumed in a liquid diet for enteral nutrition (14 % protein, 31 % fat and 55 % carbohydrate), with or without a standard breakfast in which isomaltulose replaced about 55 % of dextrin (Arai et al., 2007). The reduced rate of digestion and absorption, and subsequent reduced post-prandial blood glucose response of isomaltulose compared with sucrose or dextrin, is explained by the slower hydrolysis of the disaccharide alpha-1,6-glycosidic bonds by isomaltase compared with other disaccharides (Achten et al., 2007; Arai et al., 2007).
The effects of D-tagatose (the C-4 epimer of D-fructose) on post-prandial blood glucose and insulin responses have been shown to be about 3 % of those of glucose on a weight by weight basis when administered in liquid solution (SUGiRS, 2004). Polydextrose, a glucose polymer with sorbitol end
groups and randomly branched chains (average degree of polymerisation of 12), which is indigestible in the small intestine, and sucralose, an intense sweetener with no energy value, are also likely to induce lower post-prandial glycaemic and insulinaemic responses than glucose or disaccharides on a weight basis.
No evidence has been provided that adding the sugar replacers considered in this opinion to available carbohydrate-containing foods affects the post-prandial glycaemic or insulinaemic responses to those foods.
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 resulted in reduced 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.
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.

4.1. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 463, 464, 563, 618, 647, 1182, 1591, 2907, 2921, 4300)

The Panel considers that the following wording reflects the scientific evidence: “Frequent consumption of sugars contributes to tooth demineralisation. Consumption of foods/drinks containing instead of sugar may help maintain tooth mineralisation by decreasing tooth demineralisation”.

4.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 617, 619, 669, 1590, 1762, 2903, 2908, 2920)

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

5.1. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 463, 464, 563, 618, 647, 1182, 1591, 2907, 2921, 4300)

The Panel considers that in order 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/EC6).

5.2. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 617, 619, 669, 1590, 1762, 2903, 2908, 2920)

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 foods7 (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).