Health risk assessment of the use of sweeteners in soft drinks

In consideration of the occurrence data on various sweeteners in market-relevant soft drinks submitted as part of the extension of the "food additive" module of the BfRshort forGerman Federal Institute for Risk Assessment MEAL Study, the BfRshort forGerman Federal Institute for Risk Assessment has examined the extent to which an update of the BfRshort forGerman Federal Institute for Risk Assessment's opinions is necessary. When reviewing the BfRshort forGerman Federal Institute for Risk Assessment's opinions "External Link:Sweeteners: Majority of studies confirm no adverse health effects – however, the study situation is insufficient" (from 23 September 2019) and External Link:"Do mixtures of several sweeteners pose risks for human health?" (from 30 October 2021), particular attention should be paid to assessing the exposure of young children and primary school pupils. The concentration data and more recent food consumption data (KiESEL and EsKiMo-II) should be taken into account.

Analytical data on the concentrations of sweeteners in market-relevant soft drinks were collected as part of the expansion of the food additive module of the BfRshort forGerman Federal Institute for Risk Assessment MEAL Study. The data show that the sweeteners

• acesulfame K,
• aspartame,
• cyclamate,
• saccharin,
• sucralose and
• steviol glycosides

are used separately or in combination. In individual cases, concentrations within the maximum permitted levels for cyclamate and acesulfame K were found in cola/ cola-mixed drinks with no added sugar. In the current exposure assessment, in addition to the BfRshort forGerman Federal Institute for Risk Assessment's opinions "External Link:Sweeteners: Majority of studies confirm no adverse health effects – however, the study situation is insufficient" (from 23 September 2019) and External Link:"Do mixtures of several sweeteners pose risks for human health?" (from 30 October 2021),  the exposure of young children and primary school pupils as well as older children and adolescents up to the age of 17 was estimated, taking into account the occurrence data determined and current food consumption data (KiESEL and EsKiMo-II). The results of these estimates can be summarised as follows:

• The exposure assessments do not indicate an increased health risk for children and adolescents from the consumption of soft drinks containing sweeteners, notwithstanding other sources of sweeteners.

Based on occurrence data from the BfRshort forGerman Federal Institute for Risk Assessment MEAL Study or on the assumed concentrations at the maximum permitted levels and taking into account current food consumption data from KiESEL and EsKiMo II, none of the scenarios considered resulted in an exposure estimate that exceeded the acceptable daily intake for the sweeteners examined in soft drinks in the age groups considered.

The exposure assessments based on the data used therefore provide no evidence of an increased health risk for children and adolescents aged 0.5 to 17 years from the consumption of soft drinks containing sweeteners.

• Increased consumption of soft drinks containing sweeteners (especially cyclamate and acesulfame K) or intake from additional sources of exposure could lead to an exceedance of the acceptable daily intake for certain sweeteners.

Assuming that the maximum permitted levels for sweeteners are used instead of the analytical data from the BfRshort forGerman Federal Institute for Risk Assessment MEAL Study, it appears that the acceptable daily intake (ADIshort forAcceptable Daily Intake) for the sweeteners examined would not be exceeded for infants, children and adolescents even if consumed by high consumers. However, for younger children under 6 years of age, children aged 6–11 years and children and adolescents aged 12 years and older, exposure to cyclamate and acesulfame K was estimated to exceed the respective ADIshort forAcceptable Daily Intake by 73 % to 88 % in the case of high consumption. Increased consumption of soft drinks containing sweeteners (especially cyclamate and acesulfame K) or intake from additional sources of exposure (e.g. other food categories such as confectionery or dairy products) could lead to the respective acceptable daily intake (ADIshort forAcceptable Daily Intake) being exceeded in these age groups at concentrations within the maximum permitted levels.

• An update of the BfRshort forGerman Federal Institute for Risk Assessment's opinions "External Link:Sweeteners: Majority of studies confirm no adverse health effects – however, the study situation is insufficient" (from 23 September 2019) and External Link:"Do mixtures of several sweeteners pose risks for human health?" (from 30 October 2021),  is not necessary.In the BfRshort forGerman Federal Institute for Risk Assessment opinion "External Link:Sweeteners: Majority of studies confirm no adverse health effects – however, the study situation is insufficient" (from 23 September 2019), a hypothetical worst-case scenario was assumed in which a person’s entire daily fluid intake was provided by a beverage sweetened with a single sweetener containing the maximum permitted level of that sweetener. Under this assumption, it would be theoretically possible for toddlers and primary school children with a body weight below the median (P50) to exceed the ADIshort forAcceptable Daily Intake for acesulfame K and cyclamate. This has since been refuted by the calculations made in this report based on consumption data and analytical data.

In the BfRshort forGerman Federal Institute for Risk Assessment opinion External Link:"Do mixtures of several sweeteners pose risks for human health?" (from 30 October 2021) on the combined use of selected sweeteners in soft drinks, the BfRshort forGerman Federal Institute for Risk Assessment investigated whether the available data, specifically from animal studies, provided any evidence of health risks from the combined use of relevant sweeteners. The considerations were based on the example of the combined use of sweeteners in non-alcoholic soft drinks. The examples show that combined effects can occur in principle. The analytical data from the BfRshort forGerman Federal Institute for Risk Assessment MEAL Study show that in particular the sweeteners acesulfame K, aspartame, cyclamate, saccharin, sucralose and steviol glycosides are used separately or in combination in market-relevant soft drinks. In individual cases, concentrations approaching the specified maximum permitted levels for cyclamate and acesulfame K were found in cola/ cola-mixed drinks. This finding supports the statements made in the BfRshort forGerman Federal Institute for Risk Assessment's opinion "External Link:Do mixtures of several sweeteners pose risks for human health?" (from 30 October 2021) on the combined use of selected sweeteners in soft drinks and underlines the importance of experimental data on the potential effects of the combined use of sweeteners.