PLS: Re-evaluation of erythritol (E 968) as a food additive

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Disclaimer

  • This Plain Language Summary (PLS) is a simplified communication of EFSA Re-evaluation of erythritol (E 968) as a food additive. 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

  • Erythritol (E 968) is a sugar alcohol (polyol) used as a sweetener. The European Commission (EC) Regulation (EU) No 231/2012 defines erythritol as being “obtained by fermenting carbohydrate sources with safe and suitable food-grade osmophilic yeasts, such as Moniliella pollinis or Moniliella megachiliensis, followed by purification and drying”.
  • The EU's Scientific Committee on Food (SCF) assessed the safety of erythritol in 2003 and the European Food Safety Authority (EFSA) issued other erythritol-related advice in 2010, 2013, and 2015.
  • In the current opinion, EFSA re-evaluated the safety of erythritol. This will be of interest to policymakers, scientists, the media, food processors, retailers and the public.

What was EFSA asked to do?

  • As part of an ongoing safety review, EFSA is reassessing the safety of all food additives that were approved for use before 20 January 2009, which includes erythritol (E 968) among other sweeteners.
  • The EC also asked EFSA to consider exempting erythritol from the laxative warning label requirement for foods with more than 10% added polyols as established by Regulation (EU) No 1169/2011.

How did EFSA carry out this work?

  • EFSA followed structured protocols [1] [2] , for the safety evaluation of erythritol, based on criteria and methodologies set out beforehand. The approach included identifying the potential harmful effects of erythritol (hazard identification), determining the minimum amount of erythritol in the diet that could cause harm to a healthy person (hazard characterization) and assessing the level of exposure to erythritol in the EU population.

What data were used?

The re-evaluation of erythritol used:

  • EFSA and the SCF’s previous opinions and working documents;
  • data on erythritol gathered from interested parties in response to EFSA's calls for data;
  • a literature review of studies on erythritol published between January 2002 and September 2023.

The exemption of erythritol from the laxative warning label used:

  • data submitted by the Cargill Research and Development (R&D) Centre Europe, which made the application for the exemption.

What were the limitations/uncertainties?

The following limitations and uncertainties were identified, but they did not affect the conclusions on the safety of erythritol:

  • The analysed dataset comprised human interventional studies with a small number of participants. The studies did not include participants from all age groups. 
  • The acute and chronic exposure assessments contained various uncertainties, which likely overestimated erythritol exposure.
  • Some epidemiological studies investigated the role of circulating erythritol on cardiovascular disease and related risk factors but there is uncertainty whether the circulating levels of erythritol in these studies reflect dietary exposure from its use as a food additive.

What were the outcomes and their implications?

  • The erythritol manufacturing process with non-genetically modified yeast (Moniliella pollinis strain BC or Moniliella megachiliensis strain KW3-6) is safe. 
  • The only impurity found in erythritol produced using the evaluated manufacturing process was lead. 
  • It is recommended to lower the limit for the maximum presence of lead in erythritol, currently 0.5 mg/kg, to reduce consumer lead consumption from the use of this food additive.
  • Erythritol does not need microbiological criteria in the EU specifications because it is unlikely to be contaminated with microorganisms.
  • Erythritol's chemical properties make it generally stable in food at different temperatures and acidity.
  • Erythritol is not genotoxic.
  • There was limited but consistent evidence, although no long-term studies, that erythritol does not affect blood sugar levels in humans. 
  • Current evidence does not show a connection (i.e. cause and effect) between consuming foods containing erythritol and an increased risk of cardiovascular diseases and related risk factors. Nevertheless, further research might be helpful to clarify the nature of the association found in some observational studies. 

Concerning the laxative warning label:

  • The lowest no observed adverse effect level (NOAEL) of erythritol that did not cause diarrhoea in human studies was 0.5 grams per kilogram of body weight.
  • Based on this NOAEL, an acceptable daily intake (ADI) of 0.5 grams of erythritol per kilogram of body weight per day was set as protection from the immediate laxative effect of erythritol but also from any potential adverse long-term effects, secondary to diarrhoea, such as electrolyte imbalance.
  • In all groups of people, both acute and chronic exposure to erythritol is above the newly set ADI. People with a high intake of erythritol (E 968) may experience adverse effects after either single or repeated exposure.
  • The warning ’excessive consumption may produce laxative effects’ is still valid.

What are the key recommendations?

The EC should consider:

  • Requesting more detailed data on how much erythritol is present in food to improve the exposure assessment. 
  • Amending the EU specifications for erythritol to list the permitted microorganisms that can be used in the manufacturing of erythritol as non-genetically modified Moniliella pollinis strain BC or Moniliella megachiliensis strain KW3-6.
  • Lowering the limit for the maximum level of lead in erythritol to reduce lead intake in consumers from the use of the food additive.

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.

Acute exposure: A one-off or short-term exposure to a substance, usually less than 24 hours.

Chronic exposure: A long-term constant or intermittent exposure to a substance which may have an impact on health over time.

Exposure assessment: One of the key steps in risk assessment, relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved.

Genotoxicity: The degree to which a substance is capable of damaging the DNA in cells.

Hazard: A substance or activity which has the potential to cause adverse effects to living organisms or environments.

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.

Polyol: A compound usually containing several alcoholic hydroxyl groups.