ID 4299 - 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.

2.1. 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.

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.

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