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What is acesulfame potassium
Acesulfame potassium also called acesulfame K (ace-K) is an artificial sweetener or nonnutritive sweetener, most similar to table sugar in taste and texture. Acesulfame potassium is about 200 sweeter than sucrose (table sugar) and it’s heat-stable, so acesulfame potassium can be used in cooking and baking. Acesulfame potassium is often blended with sucralose and used to decrease the bitter aftertaste of acesulfame. Acesulfame potassium is currently used as a table-top sweetener, in soft drinks, fruit preparations, desserts, breakfast cereals, chewing gum, and other food applications and acesulfame potassium is often used together with other sweeteners, such as saccharin or sucralose, in carbonated low-calorie beverages and other products. Acesulfame potassium is an approved food additive as a sweetener and flavor enhancer in foods in the European Union with the label E 950 1). Acesulfame potassium is stable in foods, beverages and cosmetic preparations under normal storage conditions 2). Under extreme conditions of pH and temperature, detectable decomposition may occur leading to the formation of acetone, CO2, and ammonium hydrogen sulfate, or amido-sulfate, as final decomposition products; under acid (pH 2.5) conditions, minute quantities of acetoacetamide and acetoacetamide N-sulfonic acid are formed as unstable intermediate decomposition products, while under alkaline (pH 3-10.5) conditions, acetoacetic acid and acetoacetamide N-sulfonic acid can be detected 3).
Acesulfame potassium is not broken down when digested, nor is it stored in the body. After being consumed, it’s quickly absorbed by the body and then rapidly excreted, unchanged. Acesulfame potassium has been approved for general use in the European Union (E 950) and the US. Critics say the sweetener has not been studied adequately and may be carcinogenic, affect pregnancy and cause tumors. But these claims have been dismissed by the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA). The EFSA’s predecessor, the Scientific Committee on Food, re-examined the cancer studies in 2000 and concluded there was no “indication of possible carcinogenicity from these studies”.
The reviewing panel also concluded that acesulfame K was not toxic at recommended levels of consumption and could not cause gene mutation.
Acesulfame potassium was approved by the FDA in 1988 4) for use in specific food and beverage categories, and in 1998 acesulfame potassium was approved for use in soft drinks 5) and was later approved as a general purpose sweetener (except in meat and poultry) in 2002. An acceptable daily intake (ADI) of 15 mg/kg body weight per day was established by the Food and Drug Administration (FDA). An acceptable daily intake (ADI) is the maximum amount considered safe to consume each day over the course of your lifetime.
The European Union Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 9 mg/kg body weight per day for acesulfame potassium in 1984 6) based on a 2 year study in the dog, in which the no-observed-adverse-effect-level (NOAEL) of 900 mg/kg body weight was the highest dose tested. In a two-year rat study, a higher NOAEL of 1500 mg/kg body weight was established. In 2000 7), acesulfame potassium was re-evaluated by the European Union (EU) Scientific Committee on Food (SCF) who confirmed an acceptable daily intake (ADI) of 9 mg/kg body weight per day, confirming the appropriateness of the dog study. When acesulfame potassium is used as a table-top sweetener (in liquid, powder or tablet format) it is authorized at quantum satis (“as much as is sufficient”) 8). On the 10th of September 2018, the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) reviewed further toxicological data which confirmed the validity of the earlier long-term study in rats and the no-observed-adverse-effect level (NOAEL) 1500 mg/kg of body weight per day and based on the new toxicological data, the acceptable daily intake (ADI) was increased to 0-15 mg/kg body weight 9).
In addition, acesulfame potassium use in food category classified as “dietary foods for special medical purposes” (defined in Directive 1999/21/EC) is authorized up to the level of 450 mg/kg with the exception of products falling into category “dietary foods for infants and young children for special medical purposes” as defined by Directive 1999/21/EC and special formulae for infants 10). The European Union Regulation No 609/2013 defines “food for special medical purposes” as “food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone” 11).
Foods for special medical purposes (FSMPs) with added acesulfame potassium (E 950) was designed to cover or supplement dietary protein requirement in order to maintain physiological growth and development of the target population (1- to 3-year-old children with special medical conditions). Foods for special medical purposes (FSMPs) are prescribed by healthcare professionals. According to the applicant, the use of acesulfame potassium sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regime is a key factor to their health. Furthermore, the European Food Safety Authority Panel concluded that the use of acesulfame potassium (E 950) in food for special medical purposes (FSMP) at the level up to 9 mg/g protein corresponding up to 450 mg/kg in the final reconstituted product (FSMP) and providing 10 g protein/day to 1- to 3-year-old children would not be of safety concern 12). Finally, the European Food Safety Authority Panel concluded that consumption of food for special medical purposes (FSMP)-containing acesulfame potassium at levels greater than 5.9 mg/g protein (corresponding to a concentration greater than 300 mg/kg of the product as consumed) in any other scenario proposed to provide daily intake of either 20 g protein/child per day or of 3 g protein/kg body weight per day would lead to an acesulfame potassium intake above the acceptable daily intake (ADI) for young children aged 1–3 years. These conclusions were based on the assumption that the food for special medical purposes (FSMP) is the only source of exposure to acesulfame potassium (E 950). The European Food Safety Authority Panel recommended the overall exposure to acesulfame potassium in young children aged 1–3 years consuming food for special medical purposes (FSMP) should be re-assessed taking into consideration other possible sources of intake when acesulfame potassium (E 950) will be re-evaluated as a part of the re-evaluation programme of food additives.
In 2016 the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS) concluded that the proposed extension of use of acesulfame potassium (E 950) for use in the food for special medical purposes (FSMP) at the level of 5.9 mg/g protein corresponding to 300 mg/kg in the final reconstituted product (FSMP) and providing 10 g protein/day to 1- to 3-year-old children would not be of safety concern 13).
Acesulfame potassium pregnancy
No relevant published information was not found regarding the use of acesulfame potassium during pregnancy. However, information is available on non-nutritive sweeteners or artificial sweeteners (e.g., aspartame, sucralose, acesulfame K, saccharin, xylitol and steviol glycosides) as a group. Non-nutritive sweeteners or artificial sweeteners are increasingly being consumed by children and pregnant women around the world, yet their long-term health impact is unclear 14).
Few studies have investigated the effects of prenatal non-nutritive sweeteners exposure on obesity-related outcomes in offspring (Table 1). Two recent studies in Canada 15) and Denmark 16) have reported a positive and apparently sex-specific association between daily artificially-sweetened beverage consumption during pregnancy and higher BMI-z scores in male offspring, while a third study in the US found no association 17). There is an emerging body of evidence from human and animal studies suggesting that early-life exposure to non-nutritive sweeteners may have adverse effects on cardio-metabolic health and development 18). However, current evidence remains inconclusive due to the lack of randomized controlled trials, lack of evidence from low and middle-income countries, limitations of observational studies, and lack of mechanistic studies 19). It is difficult to draw firm conclusions regarding the global impact of non-nutritive sweeteners during pregnancy and childhood due to the lack of data on consumption trends, inconsistencies between observational studies, paucity of evidence from low and middle-income countries, and lack of well-designed randomized controlled trials examining prenatal and early-life exposure to non-nutritive sweeteners. Further research is needed to address the limitations of existing studies and critically evaluate the impact of early-life non-nutritive sweeteners exposure. Limited studies in rodents provide complementary evidence on this topic, but these have rarely examined prenatal exposure separately from postnatal exposure, and most have used extreme doses that may not be relevant to humans 20).
Given the increasing popularity of non-nutritive sweeteners among all segments of the population, including pregnant women and children, further research is urgently needed to address this global knowledge gap. Considering the established detrimental effects of dietary sugars and the current uncertainty regarding non-nutritive sweeteners, limiting both is likely the most appropriate recommendation to pregnant women and children at this time, until higher quality evidence is available 21).
Table 1. Summary of human studies evaluating non-nutritive sweetener (NNS) exposure during pregnancy and obesity-related outcomes in offspring.
| Study, Year | Setting, Year of Study Enrollment/Baseline Intake, Study Name | n | Timing of Prenatal NNS Exposure | Duration of Follow Up | NNS Type, Measure, Method of Assessment | Confounders/Covariates Considered, and Comparators for RCTs | Outcomes in Offspring | Main Finding |
|---|---|---|---|---|---|---|---|---|
| Randomized Controlled Trials | ||||||||
| Nakai et al., 2008 22) | Japan, unspecified | 107 pregnant women | 6th month of pregnancy to 9 months postpartum | 13 months | Xylitol gum, 1 pellet at least 4x/day | Maternal age, oral examination (DMFT); child birthweight, sex. Comparator: no gum | Birth weight (examined as a covariate) | No association of infant birth weight and daily maternal xylitol gum |
| Maslova et al., 2013 23) | Denmark, 1996, DNBC | 60,466 pregnant women | Prenatal; 25th week pregnancy | 7 years | ASB, servings, validated FFQ | Maternal BMI, total energy intake, parity, smoking, exercise, gestational weight gain, education and occupation, breastfeeding duration; child gestational age, sex | Birth weight (examined as a covariate) | No association of infant birth weight with maternal ASB intake |
| Prospective Cohort Studies | ||||||||
| Azad et al., 2016 24) | Canada, 2009, CHILD | 2686 pregnant women | Prenatal exposure | 1 year | ASB, servings, validated FFQ | Maternal BMI, total energy intake, diet quality, age, education, smoking, diabetes; infant gestational age, sex, birth weight; breastfeeding duration, timing of solid food introduction | BMI z-score, overweight | Higher infant BMI and risk of overweight with daily maternal ASB consumption (males only) |
| Gillman et al., 2017 25) | USA, 1999, Project Viva | 1078 pregnant women without gestational diabetes | Prenatal exposure | 6.6–10.9 years | ASB, servings, validated FFQ | Maternal BMI, age, race, education, smoking, parity; household income; child age, sex | Adiposity (BMI z-score, fat mass index, skinfolds), central adiposity (skinfold ratio, WC) | No association of child adiposity with maternal ASB intake |
| Zhu et al., 2017 26) | Denmark, 1996, DNBC | 918 pregnant women with gestational diabetes | Prenatal exposure | 7 years | ASB, servings, validated FFQ | Maternal BMI, energy intake and diet quality, age, employment level, smoking, physical activity; infant sex, breastfeeding duration; child ASB/SSB consumption, physical activity | ||
Footnote: Studies sorted by year of publication. Bold text indicates main direction of association between non-nutritive sweeteners exposure and obesity-related outcome.
Abbreviations: ASB = artificially-sweetened beverage; BMI = body mass index; CHILD = Canadian Healthy Infant Longitudinal Development; DMFT = decayed, missing, and filled teeth; DNBC = Danish National Birth Cohort; FFQ = food frequency questionnaire; GA = gestational age; NNS = non-nutritive sweetener; SES = socioeconomic status; SSB = sugar-sweetened beverage.
[Source 27) ]Acesulfame potassium use during breastfeeding
No well-controlled data are available on the extent of passage of acesulfame potassium into breastmilk 28). However, acesulfame potassium has been found in variable concentrations in the breast milk of nursing mothers who report consuming artificially sweetened beverages and sweetener packets in the past 24 hours. Even some mothers who reported not consuming artificial sweeteners have small amounts of acesulfame potassium in their breastmilk. Some authors suggest that women may wish to limit the consumption of non-nutritive sweeteners while breastfeeding because their effect on the nursing infants are unknown 29), 30).
Drug Levels
Maternal Levels
Twenty lactating women completed background questionnaires about breastfeeding and the intake of nonnutritive sweeteners in the prior 24 hours. Each then donated a milk sample that was analyzed for the presence of nonnutritive sweeteners. Sweetener intake was primarily from diet sodas and sweetener packets. Of the 14 women who reported intake of a nonnutritive sweetener, 9 had acesulfame potassium detectable in their breastmilk in concentrations ranging from 0.01 to 2.22 mg/L. In addition, 4 of the 6 women reporting no nonnutritive sweetener intake also had milk acesulfame potassium levels ranging from 0.02 to 0.09 mg/L, probably from hidden sources in food 31).
Thirty-four women, 14 with normal weight and 20 with obesity, ingested 12 fluidounces of a caffeine-free diet cola containing 68 mg of sucralose and 41 mg acesulfame potassium after an overnight fast prior to breakfast. Breastmilk samples were taken from the same breast every hour for 6 hours. The sweeteners were detectable in breastmilk at baseline before the soda in 21% of women. Peak acesulfame potassium concentrations in breastmilk ranged from 299 to 4764 mcg/L, with one woman having the very high concentration; the median peak concentrations was 945 mcg/L. Acesulfame first appeared in breastmilk 2 hours after ingestion and the peak acesulfame potassium concentration in breastmilk occurred at about 4 hours for all but the outlier, who had a peak concentration at 1 hour after ingestion 32).
Infant Levels
Relevant published information was not found as of the revision date 33).
Effects in Breastfed Infants
Relevant published information was not found as of the revision date 34).
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date 35).
Sucralose use during breastfeeding
No well-controlled data are available on the extent of passage of sucralose into breastmilk 36). However, sucralose has been found in the breastmilk of some nursing mothers who report consuming artificially sweetened beverages and sweetener packets in the past 24 hours. However, because sucralose is poorly absorbed after oral ingestion, it is not likely to reach the bloodstream of the infant or cause adverse effects in breastfed infants 37). However, some authors note that the levels of sucralose in milk can exceed the sweetness threshold in milk and affect intestinal enzymes and microbiome. They suggest that women may wish to limit the consumption of nonnutritive sweeteners while breastfeeding because their effect on the nursing infants are unknown 38), 39).
Drug Levels
Maternal Levels
Twenty lactating women completed background questionnaires about breastfeeding and the intake of nonnutritive sweeteners in the prior 24 hours. Each then donated a milk sample that was analyzed for the presence of nonnutritive sweeteners. Sweetener intake was primarily from diet sodas and sweetener packets. Of the 14 women who reported intake of a nonnutritive sweetener, 3 had sucralose detectable in their breastmilk in concentrations ranging from 0.01 to 0.04 mg/L 40).
Thirty-four women, 14 with normal weight and 20 with obesity, ingested 12 fluidounces of a caffeine-free diet cola containing 68 mg of sucralose and 41 mg acesulfame potassium after an overnight fast prior to breakfast. Breastmilk samples were taken from the same breast every hour for 6 hours. The sweeteners were detectable in breastmilk at baseline before the soda in 21% of women. The highest measured sucralose concentrations in breastmilk ranged from 4 to 7388 mcg/L, with one woman having the very high concentration; the median peak was 8.1 mcg/L. Sucralose first appeared in breastmilk 2 hours after ingestion and the peak concentration milk in outlier occurred at 1 hour after ingestion. For the other women, sucralose concentrations were still rising at 6 hours after ingestion, so the true peak might be higher 41).
Infant Levels
Relevant published information was not found as of the revision date 42).
Effects in Breastfed Infants
Relevant published information was not found as of the revision date 43).
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date 44).
Is acesulfame potassium safe?
On the 10th of September 2018, the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) reviewed further toxicological data which confirmed the validity of the earlier long-term study in rats and the no-observed-adverse-effect level (NOAEL) when an acceptable daily intake (ADI) of 0-9 mg/kg body weight per day was allocated based on a 2 year study in the dog in which the no-observed-adverse-effect level (NOAEL) of 900 mg/kg body weight was the highest dose tested. In a two-year rat study, a higher no-observed-adverse-effect level (NOAEL) of 1500 mg/kg body weight was established 45). In view of the most recent data, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) changed the acceptable daily intake (ADI) to 0-15 mg/kg body weight based on the long-term study in the rat.
Pharmacokinetic studies in humans showed that oral doses of acesulfame potassium were completely absorbed and rapidly excreted unchanged in the urine. The half-life in the plasma was 1.5 hours, which indicated that the period of exposure to the substance was brief and no accumulation occurred 46). Three human volunteers, body weight 70-80 kg, were given a single oral dose of 30 mg 14C-acesulfame potassium in peppermint tea. Absorption was rapid and virtually complete, maximum blood concentrations of 0.28 mg/ml occurring after 1 to 1-1/2 hour. Elimination occurred rapidly with a plasma half-life of 2-1/2 hour. Over 99% of the dose was excreted in urine and less than 1% in feces; 98% of the activity was eliminated in the first 24 hours. From the pharmocokinetic data it was calculated that repeated doses of 30 mg at 3 hour intervals would increase the maximum serum levels 1.7-fold and at 2 hour intervals maximum serum levels would increase 2.4-fold relative to a single dose 47). The metabolism of acesulfame potassium was studied in serum and urine from human volunteers
following a single dose of 30 mg per individual. Only the original substance was detected in all samples 48).
Since acesulfame potassium was not metabolized in any species tested, including humans, and further studies in rats in which repeated doses were given did not reveal any induction of metabolism or change in pharmacokinetic behavior, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that
the rat appeared to be an appropriate model for humans. Consequently, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) decided that, since the 2-year study in rats represented a greater proportion of the lifespan of the species than did the 2-year study in dogs and included exposure to the substance in utero, the acceptable daily intake (ADI) should be based on the no-observed-adverse-effect level (NOAEL) in the rat, i.e., 1500 mg/kg of body weight per day. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also noted new data which indicated that acesulfame potassium had no adverse effects in diabetic rats and was not allergenic in an active systemic anaphylaxis test in guinea pigs 49).
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also reviewed extensive toxicological studies on the breakdown products, acetoacetamide and acetoacetamide- N-sulfonic acid, which indicated that these compounds have a low toxicity and are not mutagenic 50).
In view of these data and of available estimates of exposure to acesulfame potassium, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that acetoacetamide-N-sulfonic acid and acetoacetamide did not represent a health hazard under present or foreseeable conditions of use of acesulfame potassium 51).
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