2.1. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 1136, 1444, 4299)

The claimed effects are “weight management”, “weight control including weight loss”, and “intense sweeteners help to maintain a healthy body weight; intense sweeteners help to control calorie intake”. The Panel assumes that the target population is the general population.
Weight management can be interpreted as the contribution to maintenance of a normal body weight. In this context, weight loss in overweight individuals without achieving a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.

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.

2.4. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 1134, 1167, 1283)

The claimed effects are “dental health/sweeteners can not be fermented by oral bacteria, they are non- cariogenic”, “foods which under typical conditions of use are neither cariogenic nor erosive, help
maintain healthy teeth and are, therefore, toothfriendly”, and “dental health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, conditions of use, and references provided, 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 caused by 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 achieved. 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 maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by 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.

3.1. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała(ID 1136, 1444, 4299)

The evidence provided by consensus opinions/reports from authoritative bodies and by reviews shows that data from both intervention and observational studies comparing high intakes of sugars (mainly as added sugars) to high intakes of starch with respect to weight gain is inconsistent (IoM, 2005; van Dam and Seidell, 2007), and that epidemiological studies do not show a positive association between total sugar intake and obesity (IoM, 2005).
The references provided for the scientific substantiation of the claim included five narrative reviews on the effects of intense sweeteners as sugar replacers on satiety, food intake, body weight and safety aspects which did not provide original data for the scientific substantiation of the claim (Bellisle and Drewnowski, 2007; Benton, 2005; Gougeon et al., 2004; Renwick, 1994; Vermunt et al., 2003).
One systematic review and meta-analysis of 16 intervention studies on the effects of intense sweeteners (i.e. mainly aspartame) as sugar replacers on satiety, energy intake and body weight (de la Hunty et al., 2006) was provided. These references contained all of the human intervention studies submitted individually in the consolidated list.
The meta-analysis by de la Hunty et al. (2006) included a total of 16 studies, of which only 10 had body weight changes as an outcome (Blackburn et al., 1997; Gatenby et al., 1997; Kanders et al., 1988; 1990; Naismith and Rhodes, 1995; Porikos et al., 1977; 1982; Raben et al., 2002; Reid and Hammersley, 1998; Tordoff and Alleva, 1990). These studies evaluated the effects of replacing sucrose with aspartame or other artificial sweeteners (Gatenby et al., 1997; Raben et al., 2002) in solid foods and/or beverages on body weight changes in the context of hypocaloric diets or of no energy restrictions. The Panel notes that in four of the studies (Naismith and Rhodes, 1995; Porikos et al., 1977; 1982; Reid and Hammersley, 1998) the study duration was between 7 and 12 days, which is too short to assess the effects of the intervention on sustained changes in body weight. In addition, some human intervention studies investigated the effect of replacing sugars with artificial sweeteners in beverages only. The Panel considers that no conclusions can be drawn from these studies, and therefore from the meta-analysis, for the scientific substantiation of the claim.
Three human intervention studies examined the effects of replacing sugars with artificial sweeteners in foods and beverages for 10 weeks or longer on body weight in overweight or obese subjects (Gatenby et al., (1997); Kanders et al., (1988) Blackburn et al., (1997)).
In the study by Gatenby et al. (1997), overweight male and female subjects not using reduced-fat (RF) or reduced-sugar (RS) food products were assigned to consume their usual diet (n=18), a diet where full-fat foods were replaced by reduced-fat foods (RF, n=22), or a diet where conventional sucrose-containing foods were replaced by reduced-sucrose (artificially sweetened) foods (RS, n=25), for 10 weeks after a two-week run-in period. Data analysis was based on the population of completers for which appropriate dietary intake data were available (13, 17 and 19 for control, RF and RS groups, respectively). Post-hoc power calculations led to a power of 90 % to observe a between-group difference in body weight changes of 0.4 kg. Subjects in the RF group significantly reduced fat intake compared to the RS and control groups (p=0.017), whereas subjects in the RS group significantly reduced sucrose intake compared to the RF and control groups (p=0.049). No differences between groups were observed with respect to energy intake or changes in body weight. Whether reduced sucrose items replaced solid foods, beverages, or both, and to what extent, was not reported. The Panel notes that this study does not show a differential effect on body weight of sucrose-sweetened foods and beverages vs. reduced (artificially sweetened) sucrose foods and beverages.
The study by Kanders et al. (1988) was designed to assess the effects of adding aspartame-sweetened foods and beverages to a low fat, hypocaloric diet for 12 weeks on compliance and weight loss. A total of 59 obese subjects (10 men) were randomised to consume aspartame-sweetened foods (e.g. puddings) and beverages (milkshakes, diet beverages), or to abstain from them, during 12 weeks in the context of a low-energy diet for weight loss. Changes in body weight did not differ significantly between groups for either males or females (results for the whole study sample combined were not provided). The Panel notes that this study does not show a differential effect on body weight of sucrose-sweetened foods and beverages vs. reduced (artificially sweetened) sucrose foods and beverages. In an abstract published two years later, Kanders et al. (1990) reported on the 46 subjects who participated in a 12-month weight maintenance period after the 12-week intervention. The Panel notes that this weight maintenance phase was not controlled for aspartame intake, that comparisons between intervention and control groups were not reported, that body weight changes were not reported, and that details on the statistical analysis used were not provided. The Panel considers that no conclusions can be drawn from the weight maintenance phase of this study for the scientific substantiation of the claim.
In a study by Blackburn et al. (1997), 163 obese women were randomised to either consume or abstain (control) from aspartame-sweetened foods and beverages during 16 weeks of a 19-week multidisciplinary weight loss program, a one-year maintenance program, and a two-year follow-up period. The no aspartame group was asked to use up to 50 g of sugar or honey as daily sweetener. No differences in body weight loss were observed between the aspartame and control groups during the
active weight loss phase (-9.9 6.1 kg vs. -9.8 6.5, corresponding to about -10 % of initial body weight in both groups). During the weight maintenance phase, the aspartame group regained less weight than the control group (2.6 % vs. 5.4 % of initial body weight). Although a direct statistical comparison between groups is not reported in this paper, the meta-analysis by de la Hunty et al. (2006) reported no statistically significant differences between groups (p=0.143). When all study participants were considered together, a greater percentage of weight loss from baseline was predicted by randomisation to the aspartame group (p=0.05), but percentage weight loss was positively correlated with physical exercise (r=0.32, p=0.005) and self-reported eating control (r=0.37, p=0.0001), rather than with aspartame intake (r=0.19, p=0.07). As reported physical exercise and energy intake was not different between groups, the differences observed in body weight changes are difficult to explain. However, the Panel notes that dietary records in overweight subjects are not reliable to assess energy intake as they tend to closely report prescribed energy intakes. The Panel notes that the later phase (i.e after follow-up) of the study was uncontrolled. During the study, no
differences were found between groups with respect to desire for sweets or hunger. Whether aspartame consumption replaced sugar predominantly in foods or in beverages, and to what extent, is not reported. The Panel notes that this study does not support a differential effect on body weight of sucrose-sweetened foods and beverages vs. reduced (artificially sweetened) sucrose foods and beverages.
The Panel notes that three human intervention studies did not show an effect of replacing sugars by artificial sweeteners in foods and beverages on body weight in overweight and obese subjects, and that no studies which addressed the effects of replacing sugars by artificial sweeteners in foods and beverages on body weight in normal weight subjects were provided.
There is some evidence from epidemiological and intervention studies that high intake of sugars in the form of sugar-sweetened beverages might contribute to body weight gain (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010). However, the Panel notes that the effect on body weight of replacing sugars by intense sweeteners in beverages only is not the subject of the health claim evaluated in this opinion.
In weighing the evidence, the Panel took into account that data from both intervention and observational studies comparing high intakes of sugars (mainly as added sugars) to high intakes of starch with respect to weight gain is inconsistent, that epidemiological studies do not show a positive association between total sugar intake and obesity, and that three human intervention studies did not show an effect on body weight of replacing sugars by intense sweeteners in foods and beverages.
The Panel concludes that a cause and effect relationship has not been established between total sugar intake and body weight gain, and 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 contribution to the maintenance or achievement of a normal body weight.

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.

3.4. Utrzymanie mineralizacji zębów poprzez zmniejszenie demineralizacji (ID 1134, 1167, 1283)

A claim on 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 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.