Overall assessment from the EFSA 2019 re-evaluation
The European Food Safety Authority re-evaluated the group of sulphate salts including E517 in 2019. The panel concluded that exposure from food use does not raise a concern at the levels actually used in food. No numerical acceptable daily intake was considered necessary because the compounds are normal constituents of the diet and are metabolised by ordinary physiological pathways.
EFSA's Panel on Food Additives and Flavourings concluded that exposure to ammonium sulphate at reported food use levels does not raise a safety concern, and set no numerical ADI.
2019Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2019;17(6):5868
High-dose laxative effect
At very high doses, sulphate salts can cause a laxative effect in humans. EFSA noted this threshold in its re-evaluation. Estimated dietary exposure from food additive use sits far below the level at which this effect has been observed, so it is not relevant to normal food consumption.
A dose of 300mg sulphate per kg body weight per day produced a laxative effect in human studies; mean and high-percentile dietary exposure from E517 use in food was estimated to fall well below this threshold.
2019Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2019;17(6):5868
Ammonia as a metabolite
When ammonium sulphate is metabolised, it releases ammonium ions which the body converts to ammonia and then to urea, which is excreted. This is a normal metabolic route for all dietary protein. At the small quantities supplied by food additives, this pathway presents no issue for people with normal kidney and liver function. People with urea cycle disorders, who cannot process ammonia normally, are a specific exception.
Ammonium ions are a normal product of protein metabolism and are processed via the urea cycle; additive-level exposure contributes negligibly to the total ammonium load from a typical diet.
2019Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal 2019;17(6):5868