EFSA re-evaluation and intake concerns in toddlers
In 2017 EFSA's food additives panel re-evaluated all five sorbitan esters and set a new group acceptable daily intake of 10mg/kg body weight per day, expressed as sorbitan. This was reduced from the 1974 level of 25mg/kg bw/day. At the 95th percentile of consumption, toddlers reached estimated intakes around 10.6mg/kg bw/day in the most conservative modelling scenario, putting the heaviest young consumers close to the group limit. EFSA concluded there was no safety concern at typical use levels but noted that toddler intakes warrant monitoring if use levels increase.
EFSA set a group ADI of 10mg/kg body weight per day for sorbitan esters (E491-E495), reduced from 25mg/kg bw/day set in 1974, based on a NOAEL of 2,600mg/kg bw/day from a long-term mouse study with a 100-fold uncertainty factor.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Under a refined non-brand-loyal exposure scenario, toddlers showed the highest estimated intakes, reaching approximately 10.6mg/kg bw/day at the mean in the most conservative scenario, approaching the group ADI.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Genotoxicity and carcinogenicity
The 2017 EFSA review concluded that sorbitan esters do not raise concern for genotoxicity, though the data were limited for some individual esters. Long-term rodent studies showed no carcinogenic effect. Reproductive and developmental toxicity studies found no adverse effects, though the panel noted limitations in some of the underlying study data.
EFSA concluded that sorbitan esters did not raise concern with respect to genotoxicity, and long-term rodent studies showed no indication of carcinogenicity.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
2025 EFSA opinion on use in enzyme preparations
In 2025, EFSA's Panel on Food Additives and Flavourings assessed a proposed extension of E491 use into enzyme preparations used in food processing. This is a specialised industrial application rather than a direct consumer intake route. EFSA's review focused on whether the existing group ADI remains adequate for the extended use.
EFSA's FAF Panel issued a scientific opinion in 2025 on the safety of amending E491's conditions of use in enzyme preparations, part of ongoing regulatory maintenance of the permitted additives list.
2025Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal