Re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives

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Disclaimer

  • This Plain Language Summary (PLS) is a simplified communication of EFSA's Re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. The full EFSA opinion 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

  • Saccharin and its sodium, potassium and calcium salts, or saccharins (E 954), are food additives used as non-nutritive sweeteners. They provide sweetness without adding calories or nutritional value.
  • The EU’s Scientific Committee on Food initially evaluated saccharins in 1995.
  • For the current opinion, the EFSA Panel on Food Additives and Flavourings (the FAF Panel) re-evaluated the safety of saccharins.
  • 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, and erythritol (E 968) in 2023.

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 European Union (EU) before 20 January 2009. The current FAF Panel assessment of saccharins 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).
  • 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

The following data were used:

  • data gathered from interested parties in response to an EFSA call for information;
  • a literature review of studies on saccharins published between January 1994 and February 2024.

What were the outcomes and their implications?

  • The acceptable daily intake (ADI) that is safe for all population groups was set at 9 mg/kg body weight per day.
  • This ADI replaces the one set by the Scientific Committee on Food in 1995 at 5 mg/kg body weight per day of sodium saccharin or 3.8 mg/kg body weight per day of free saccharin.
  • The previous ADI was based on the increased incidence of bladder tumours observed in rat studies. However, there is now scientific agreement that these tumours are specific to male rats and not relevant to humans.
  • The highest estimates for chronic exposure to saccharins are lower than the ADI in all population groups, indicating no safety concern.

What were the uncertainties?

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

  • overestimation of exposure in the EU population;
  • lack of long-term studies to address the influence of saccharins on blood glucose regulation;
  • lack of a clear conclusion on the impact of saccharins on weight gain in humans due to the limited available evidence.

What are the key recommendations?

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

  • include a definition that restricts the manufacturing of saccharins to the Remsen-Fahlberg process; 
  • list the Chemical Abstract Service (CAS) numbers for saccharin, sodium saccharin and potassium saccharin;
  • amend the purity of calcium saccharin to not less than 99% on an anhydrous basis; 
  • remove the parameter ’readily carbonisable substances’;
    lower the limit of lead and arsenic impurities.

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.

Remsen-Fahlberg process: A chemical process for manufacturing saccharins.

Readily carbonisable substances: Substances that occur as organic impurities in a manufacturing process and can be easily converted into carbon or a carbon-rich material.

[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.7788969 

Re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives
DOI: https://doi.org/10.2903/j.efsa.2024.9044 

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