EFSA has reassessed the safety of erythritol (E 968), a sugar alcohol (polyol) used as a sweetener in a variety of food and beverages, as part of an ongoing safety review of all food additives approved for use before 20 January 2009. Date of publication: 20 December 2023
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.
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.
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.
The re-evaluation of erythritol used:
The exemption of erythritol from the laxative warning label used:
The following limitations and uncertainties were identified, but they did not affect the conclusions on the safety of erythritol:
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.
The EC should consider:
References
[1] Revised protocol on hazard identification and characterisation (https://zenodo.org/records/7788969)
[2]Draft protocol for assessing exposure to sweeteners as part of their safety assessment under the food additives re-evaluation programme (https://doi.org/10.2903/sp.efsa.2020.EN-1913, see Supporting Information)
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.
Find out more on the study here:
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8430