Fumaric acid and its salts: basic safety profile
Fumaric acid and its authorised salts (sodium, potassium, calcium fumarate) have been evaluated by EFSA and given an acceptable daily intake. Fumaric acid is a normal intermediate in human metabolism via the citric acid (Krebs) cycle, which means the body handles moderate dietary intake through established pathways. Ammonium fumarate would release the same fumarate ion, but it also delivers an ammonium load that the body processes via the urea cycle. At typical food-additive levels, this is not considered a distinct hazard, but the compound has not been formally assessed as a food additive by EFSA or the UK FSA.
EFSA evaluated fumaric acid (E297) and set a group acceptable daily intake of 6 mg/kg body weight per day covering fumaric acid and its calcium, sodium, and potassium salts. Ammonium fumarate was not included in this group evaluation.
2014Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), re-evaluation of fumaric acid (E 297)
Regulatory gap: no authorisation in UK, EU, or comparable jurisdictions
The EU and UK food additive systems operate on a positive list: an additive may only be used if it appears on the approved list with defined conditions of use. E368 (ammonium fumarate) does not appear in Annex II of EU Regulation 1333/2008 or on the UK FSA approved additives list. Checks against the US FDA regulations (21 CFR Parts 172 and 184) find no specific authorisation or GRAS affirmation for ammonium fumarate; the FDA authorises fumaric acid and several of its other salts but not the ammonium salt. Food Standards Australia New Zealand (FSANZ) similarly lists ammonium fumarate (INS 368) as not permitted. The Codex Alimentarius General Standard for Food Additives assigns INS 368 as a functional classification for the compound but carries no positive permitted-use provisions for it. The absence from all these positive lists means ammonium fumarate is not a permitted food additive in any major regulatory jurisdiction reviewed.
The UK FSA approved additives list does not include E368 ammonium fumarate. The EU positive list under Regulation 1333/2008 Annex II authorises sodium fumarate (E365), potassium fumarate (E366), and calcium fumarate (E367), but not the ammonium salt.
RegulatoryUK Food Standards Agency, Approved additives and E numbers; EU Regulation 1333/2008 Annex II
FSANZ lists ammonium fumarate (368) as not permitted under Australian food standards. No authorisation for ammonium fumarate was found in 21 CFR Parts 172 or 184 (US FDA direct food additives and GRAS affirmations); the FDA authorises fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts, but not the ammonium salt.
RegulatoryFood Standards Australia New Zealand, Food additives numerical list; US FDA eCFR Title 21