ID 4298 -
Słodziki
PL: Słodziki
EN: Intense sweeteners
Pdf:
1. Charakterystyka żywności / składnika
The food constituents that are the subject of the health claims are “table top sweeteners and foods beverages containing intense sweeteners”, “foods in general, in particular confectionery, soft beverages, water-ice, chocolate-type products, table-top sweeteners and certain foods for a particular nutritional use”, “foods in general, particularly sugar-free chewing gum, candies, chocolate-type products and other confectionery; soft beverages and sports beverages, flavored water and table top sweeteners”, “aspartame sucrose substitute”, and “low calorie sweetener / table-top sweetener (granular & tablets - sucralose based)”.
In the context of the proposed wordings and conditions of use, the Panel assumes that the food constituent that is the subject of the health claims is intense sweeteners, which should replace sugars in foods and beverages in order to obtain the claimed effects.
Intense sweeteners are substances with an intense sweet taste and with no energy value that are used to replace sugars in foods. Intense sweeteners (e.g. acesulfame K; aspartame; cyclamic acid and its sodium and calcium salts; saccharin and its sodium, potassium and calcium salts; sucralose; neohesperidine DC and thaumatin) vary in their chemical composition. This evaluation applies to the intense sweeteners authorised for addition to foods (Annex of Directive 94/35/EC6), according to Regulation (EC) No 1333/20087. Intense sweeteners can be measured in foods by established methods.
The Panel considers that the food constituents, intense sweeteners, which are the subject of the health claims, are sufficiently characterised in relation to the claimed effects.
2.2. Ograniczenie wzrostu stężenia glukozy (glikemii) po posiłku (ID 4298)
The claimed effect is “intense sweeteners have no effect on carbohydrate metabolism or short or long term blood glucose”. The Panel assumes that the target population is individuals who wish to reduce their post-prandial glycaemic responses.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the reduction of post-prandial glycaemic responses.
Post-prandial glycaemia is interpreted as the elevation of blood glucose concentrations after consumption of a food and/or meal. This elevation is a normal physiological response that 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 adult population.
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.
2.3. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 1221, 4298)
The claimed effects are “blood glucose control” and “intense sweeteners have no effect on carbohydrate metabolism or short or long term blood glucose”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal blood glucose concentrations.
The Panel considers that maintenance of normal blood glucose concentrations is a beneficial physiological effect.
3.2. Zmniejszenie stężenia glukozy we krwi (glikemii) po posiłku (ID 4298)
A claim on the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose and reduction of post-prandial blood glucose responses has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011).
The Panel considers that the scientific substantiation and proposed conditions of use also apply to intense sweeteners.
3.3. Utrzymanie prawidłowego stężenia glukozy we krwi (ID 1221, 4298)
Some of the references provided for the scientific substantiation of the claim reported on human intervention studies which were unrelated to the claimed effect, (i.e. assessed the effects of sucralose on post-prandial blood glucose responses). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One human study investigated the effect of a modified diet containing both a fat replacer (beta-glucan derived from oats) and the intense sweetener sucralose compared to a diet containing fructose on blood glucose concentrations (Reyna et al., 2003). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of a claim on intense sweeteners alone.
In the study by Cooper et al. (1988), the effects of a usual diet for blood glucose control supplemented with either 28 g sucrose (sucrose diet) or with 30 g starch and saccharin (saccharin diet) for six weeks each on fasting blood glucose and insulin concentrations were assessed in 17 non-insulin dependent
diabetic patients following a randomised, cross-over design. The Panel notes that fasting blood glucose and insulin concentrations are not appropriate outcome measures of long-term blood glucose control. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In the study by Grotz et al. (2003), 128 subjects with type 2 diabetes were randomly assigned to receive either placebo (cellulose) capsules (n=69) or 667 mg encapsulated sucralose (n=67) daily for 13 weeks. Glycated haemoglobin (HbA1c), fasting plasma glucose and fasting serum C-peptide were measured approximately every two weeks to evaluate blood glucose homeostasis. The Panel notes that in this study sucralose was compared to cellulose, and that such comparison does not allow drawing conclusions on the effect of replacing sugar (sucrose) with sucralose on the maintenance of normal blood glucose concentrations.
The evidence provided by consensus opinions/reports from authoritative bodies and by reviews shows that consumption of intense sweeteners in the diet in replacement of sucrose at the amounts likely to be consumed in a meal or day is unlikely to have an impact on blood glucose control in diabetic subjects (American Diabetes Association, 2002; Gougeon et al., 2004).
No human intervention studies on the effects on long-term blood glucose control of replacing sucrose with intense sweeteners in a food, meal or diet have been provided in the consolidated list.
The Panel concludes that a cause and effect relationship has not been established between the consumption of foods and beverages in which sugars have been replaced by intense sweeteners and maintenance of normal blood glucose concentrations.
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