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The European Food Safety Authority (EFSA) has reevaluated the safety profile of erythritol (E 968), pinpointing concerns over its laxative effects. Accordingly, it has set new guidelines for its acceptable daily intake and has urged cautionary measures for high-consumption individuals.
Erythritol is a sugar alcohol widely used as a sweetener in food products. It is made by fermenting carbohydrate sources with safe and suitable food-grade osmophilic yeasts, followed by purification and drying.
EFSA’s analysis was part of an ongoing safety review of all food additives approved for use in Europe before January 20, 2009. It used data from previous scientific opinions and studies and aimed to reassess erythritol’s safety for consumers and its potential exemption from a currently required laxative warning label.
The evaluation investigated erythritol’s manufacturing process and potential contaminants and sought to address uncertainties about human exposure to the compound.
EFSA’s Findings
It found that the manufacturing process was safe when it used specific yeast strains, namely Moniliella pollinis strain BC or M megachiliensis strain KW3-6.
Erythritol was stable under different food conditions, and the EFSA report dismissed concerns regarding microbiologic contamination.
Of importance, EFSA established an acceptable daily intake of erythritol 0.5 g/kg body weight to safeguard against its laxative effect and to mitigate against long-term effects, such as electrolyte imbalance arising from prolonged exposure to erythritol-induced diarrhea.
“An acceptable daily intake of 0.5 g/kg body weight implies that an average person (70 kg) could safely consume around 35 g per day. This upper limit appears quite conservative, especially when the dose is spread out over the day. The suggested limit is particularly sensible to prevent diarrhea, especially in individuals who are sensitive to higher doses,” Bettina Wölnerhanssen, co-head of metabolic research at St. Claraspital Hospital in Basel, Switzerland, told Medscape Medical News.
“Individual tolerance to sugar alcohols, including erythritol, varies. Some individuals may be more sensitive to its laxative effects than others,” she added. Wölnerhanssen was not involved in the EFSA assessment.
Among the impurities investigated, lead was the only one found in erythritol that is produced using the evaluated manufacturing process. The report recommended lowering the current limit for the maximum presence of lead in erythritol of 0.5 mg/kg to reduce consumer lead consumption.
The evaluation also reported that although current evidence does not establish a direct cause and effect relationship between erythritol and elevated cardiovascular risk, further research is needed to better understand a potential association.
Next Steps
Commenting on gaps existing in the current assessment of erythritol’s safety, Wölnerhanssen noted that “long-term data from different populations who could benefit from the use of this sweetener, for example patients with diabetes, are missing. It would make sense to support research projects that could close this knowledge gap.”
EFSA urged the European Commission to request more detailed data from food manufacturers on erythritol content in food products to improve exposure assessments. It also proposed modifications to EU specifications, emphasizing the need to list permitted microorganisms in erythritol manufacturing processes and advocating for a reduction in its maximum allowable lead content.
EFSA also reported that the available data did not support exempting erythritol from the current requirement of warning labels that say “excessive consumption may produce laxative effects” on products containing more than 10% erythritol.
The report’s outcomes underscore the necessity for heightened caution among consumers and regulatory bodies regarding the consumption and permissible limits of erythritol in food products.
“Individuals highly sensitive to sugar alcohols should avoid consuming large amounts of erythritol at once,” said Wölnerhanssen.
