ID 463 - Substancje słodzące - ksylitol, sorbitol, mannitol, laktitol, izomalt, erytryt, D-tagatoza, izomaltuloza, sukraloza, polidekstroza

PL: Substancje słodzące - ksylitol, sorbitol, mannitol, laktitol, izomalt, erytryt, D-tagatoza, izomaltuloza, sukraloza, polidekstroza
EN: Carbohydrates - non-cariogenic e.g. isomaltulose; tagatose, polyols, polydextrose. Absence of, or low , fermentable carbohydrates
Pdf:

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

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, which are the subject of the health claims, 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 effects.
The Panel considers that the food constituents, the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose, which are the subject of the health claims, are sufficiently characterised in relation to the claimed effects.

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.

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.

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”.

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).

Warunki i możliwe ograniczenia stosowania oświadczenia

According to US 21CFR§101.80: the food shall not lower plaque pH below 5,7 by bacterial fermentation during consumption and up to 30 min after consumption, as determined by plaque pH telemetry, and other comparable methods.