Fumarate as a metabolic compound
Fumarate is a naturally occurring intermediate in the Krebs cycle, the energy-producing pathway found in all human cells. The body generates and processes fumarate continuously as part of normal metabolism. This metabolic familiarity is the basis for the low concern profile of fumaric acid and its salts at typical food-exposure levels.
Fumaric acid (E297) was evaluated by EFSA's Panel on Food Additives and Nutrient Sources (ANS), which noted fumarate is an endogenous metabolite and found no safety concern at the reported uses.
2014Regulatory reviewEFSA ANS Panel opinion on fumaric acid (E 297)
Regulatory non-authorisation in the UK and EU
Unlike fumaric acid (E297), sodium fumarate (E365) does not appear in Annex II of assimilated EU Regulation 1333/2008, the list that defines which additives may legally be used in UK and EU food. The E-number range in the legislation skips from E363 (succinic acid) to E380 (triammonium citrate) with no fumarate salt entries in between. An E-number designation does not itself confer authorisation; inclusion in Annex II is required for lawful use.
E365 sodium fumarate does not appear in Annex II of UK assimilated Regulation (EC) No 1333/2008 (version in force as of June 2024). Only fumaric acid (E297) is listed among permitted fumarate-related additives.
2024RegulatoryUK assimilated Regulation (EC) No 1333/2008 Annex II, legislation.gov.uk
Authorisation in other jurisdictions
Sodium fumarate is permitted as a food additive in the United States under 21 CFR 172.350, which explicitly names fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts as safe for direct addition to food. The Codex Alimentarius General Standard for Food Additives also lists sodium fumarates at INS number 366 as an acidity regulator. This demonstrates that the UK/EU non-authorisation reflects a regulatory gap rather than a global ban or identified safety concern.
21 CFR 172.350 states that fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food for human consumption.
2025RegulatoryUS Code of Federal Regulations, 21 CFR 172.350 (Fumaric acid and salts of fumaric acid)
Sodium fumarates are listed in the Codex Alimentarius General Standard for Food Additives (GSFA, Codex STAN 192-1995) under INS number 366 as an acidity regulator.
2024RegulatoryCodex Alimentarius GSFA Online, INS 366