Re-evaluation of acesulfame K (E 950) as food additive

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Disclaimer

  • This plain language summary (PLS) is a simplified version of EFSA’s Re-evaluation of acesulfame K (E 950) as food additive. The full EFSA report can be found here.
  • The purpose of the PLS is to enhance transparency and inform interested parties on EFSA’s work on the topic using simplified language to present a summary of the main findings.

Overview

  • Acesulfame K (E 950) is a food additive used as a non-nutritive sweetener. It provides sweetness without adding calories or nutritional value.
  • The EU's Scientific Committee on Food (SCF), EFSA’s predecessor, last evaluated E 950 in 2000; the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) conducted its most recent evaluation in 1991.
  • For the current opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) re-evaluated the safety of E 950.
  • EFSA has previously published re-evaluations of other sweeteners: aspartame (E 951) in 2013, thaumatin (E 957) in 2021, neohesperidine DC (E 959) in 2022, erythritol (E 968) in 2023, and saccharins (E 954) in 2024.

What was EFSA asked to do?

  • The European Commission (EC)[1] established a programme to re-evaluate the safety of food additives that were approved in the EU before 20 January 2009. The current FAF Panel assessment of E 950 is part of this programme.

How did EFSA carry out this work?

  • The FAF Panel followed structured protocols based on criteria and methodologies previously established for sweeteners (EFSA, 2020a; EFSA, 2020b; EFSA FAF Panel, 2023; EFSA FAF Panel 2024).
  • These protocols include identifying potential harmful effects (hazard identification), determining the minimum amount in the diet that could harm a healthy person (hazard characterisation) and assessing the level of exposure in the EU population.

What data were used

  • Data gathered from interested parties in response to EFSA calls for information, and studies on E 950 published between January 1999 and November 2024 identified from a literature review;
  • The data comprised evidence from in vitro tests, toxicological studies in experimental animals, and interventional and epidemiological studies in humans; all data were integrated using a weight of evidence approach.

What were the outcomes and their implications?

  • The acceptable daily intake (ADI) considered safe for all population groups was set at 15 mg/kg body weight (bw) per day. This ADI replaces the one set by the SCF in 2000 at 9 mg/kg bw per day.
  • The revised ADI is based on the no observed adverse effect level (NOAEL) in rats of 1500 mg/kg bw per day (3% acesulfame K in the diet), which was the highest dose tested.
  • In the EU, the highest exposure estimate of E 950 was generally below the ADI in all population groups, indicating no safety concern.
  • The limits in EU specifications for the inorganic impurities lead and mercury in E 950 were noted to be above reported limit values in analyses of commercial samples of the food additive.
  • A limit value was reported for acetylacetamide (an organic impurity and degradation product of the food additive) in analyses of commercial samples of E 950; in the EU specifications for this food additive, no specific limit exists for acetylacetamide.

What were the uncertainties?

The following uncertainties were identified and assessed but, overall, not considered to affect the conclusions on safety:

  • Potential overestimation of the dietary exposure to E 950 in the EU population;
  • The potential presence of 5-chloro-acesulfame in E 950 and the lack of experimental data regarding the genotoxicity of this impurity.

What are the key recommendations?

The EC should consider the following amendments to the EU specifications:

  • Inserting a maximum limit of 0.1 mg/kg for 5-chloro-acesulfame in E 950 or, alternatively, requesting appropriate genotoxicity data for 5-chloro-acesulfame;
  • Inserting a maximum limit of 1 mg/kg for acetylacetamide in E 950;
  • Lowering maximum limits for lead and mercury in E 950;
  • Including the Chemical Abstract Service (CAS) number 55589-62-3 for E 950 to facilitate identification.

Glossary

Acceptable daily intake (ADI): An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.

Genotoxicity: The ability of a substance to damage the DNA in cells.

No observed adverse effect level (NOAEL): The greatest concentration or amount of a substance at which no detectable adverse effects occur in an exposed population.

Weight of evidence approach: A process in which all of the evidence relating to a decision is evaluated based on its strength and quality.

[1] Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

References

EFSA (European Food Safety Authority) 2020a. Outcome of the public consultation on a draft protocol for the assessment of hazard identification and characterisation of sweeteners. EFSA Supporting Publications 2020;17(2):EN-1803. https://doi.org/10.2903/sp.efsa.2020.EN-1803

EFSA (European Food Safety Authority), 2020b. Outcome of the public consultation on a draft protocol for assessing exposure to sweeteners as part of their safety assessment under the food additives re-evaluation programme. EFSA Supporting Publications, 17(8), EN-1913. https://doi.org/10.2903/sp.efsa.2020.EN-1913

EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), 2023. Revised protocol on hazard identification and characterisation of sweeteners. Zenodo. https://doi.org/10.5281/zenodo.7788968

EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), 2024. Revised protocol for assessing exposure to sweeteners as part of their safety assessment under the food additives re-evaluation programme. Zenodo. https://doi.org/10.5281/zenodo.13912093

Re-evaluation of acesulfame K (E 950) as food additive

DOI: https://doi.org/10.2903/j.efsa.2025.9317