EFSA reaffirms safety of Acesulfame K, raises Acceptable Daily Intake

ITALY – The European Food Safety Authority (EFSA) has recently completed its assessment of acesulfame potassium (K) (E 950), a widely used artificial sweetener, reaffirming its safety for consumption and establishing a new daily intake of 15 mg/kg of body weight (bw).

The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data.

While the sweetener was found to be stable under various conditions, it degrades at pH lower than 3 with increasing temperatures, producing acetylacetamide and acetoacetamide-N-sulfonic acid.

EFSA’s review, therefore, included an evaluation of acesulfame K’s genotoxicity and its degradation products, which concluded that there are no safety concerns.

The new Acceptable Daily Intake (ADI) of 15 mg/kg bw was based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats fed with a diet with 3% acesulfame K for 2 years, corresponding to 1500 mg/kg bw per day.

This update replaces the ADI of 9 mg/kg bw per day established by the Scientific Committee on Food (SCF). 

Despite the increased ADI, however, EFSA does not anticipate changes to the maximum permitted levels of acesulfame K in food products.

Although Acesulfame is authorised for use in the European Union (EU) under Regulation (EC) No 1333/2008, this update follows calls for its ban, with claims linking it to cancer, hormonal disruptions, type 2 diabetes, thyroid issues, and cognitive decline.

Understanding Acesulfame K

Acesulfame K (E 950) is the potassium salt of 6-methyl-1,2,3-oxathiazin- 4(3H)-one-2,2-dioxide, produced through chemical synthesis in different reaction steps using dichloromethane as a solvent. 

The product undergoes several purification processes, including crystallisation, filtration, recrystallisation and centrifugation. 

The Panel noted that acesulfame K is not metabolised, has a half-life of 2 to 4 hours, and is primarily excreted in the urine.

It has also been detected in amniotic fluid, cord blood, and breast milk, indicating transfer across the placenta and into breast milk, though exposure to breast-fed infants is minimal – approximately 1.6% of the maternal dose.

While assessing the evidence of adverse health effects related to the exposure to acesulfame K based on human studies, the panel noted no adverse effects in relation to cancer reported in a 2-year combined chronic toxicity and carcinogenicity study in rats 

For cardiovascular risk factors and disease, the level of evidence for an effect was low, as findings from different studies are inconclusive. One study indicated an association with coronary heart disease, but due to low levels of evidence, no firm conclusions can be drawn in the absence of other studies

Regarding glucose/insulin homeostasis, the level of evidence is moderate, with several small intervention studies showing no effect on short-term glucose homeostasis and a single large cohort study suggesting an association with type 2 diabetes; however, the biological explanation remains unclear. 

The EFSA Scientific Panel on Food Additives and Flavourings (FAF) concluded that it is unlikely for acesulfame K to be associated with cancer, disturbances of the glucose or insulin homeostasis, cardiovascular risk factors and disease, general toxicity, heamatological effects, nephrotoxicity, liver toxicity or toxicity in any organ or tissue. 

This conclusion is consistent with findings from other food regulatory authorities and risk assessment bodies worldwide who have established similar ADI for Acesulfame K.

They include the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA), Health Canada, Food Standards Australia New Zealand (FSANZ), and the U.S. Food and Drug Administration (FDA).

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