Fumaric acid and its salts: general safety profile
Fumaric acid occurs naturally in small quantities in many foods. Its calcium salt has not been the subject of extensive dedicated safety evaluation as a food additive, in part because it has not been authorised for use in food. Fumarate is a normal intermediate in human metabolism (part of the citric acid cycle), so dietary fumarate is handled by normal metabolic pathways. No toxicological signals have been identified in available data, but the formal regulatory safety review for use as a food additive has not been completed.
Fumaric acid (E297) has been evaluated by EFSA and assigned an ADI of 'not specified', indicating low concern at typical food-use levels. Its calcium salt has not received a separate EFSA opinion as an authorised additive.
Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
Calcium fumarate is not listed in Annex II of the assimilated EU Regulation 1333/2008 (as at 28 June 2024) and is not on the UK FSA approved-additives list, meaning it has not been granted authorisation for use in food in either jurisdiction. No provisional or temporary authorisation exists for any specific food category.
2024RegulatoryUK FSA approved-additives list; Annex II, Regulation (EC) No 1333/2008 (assimilated into UK law, 28 June 2024 version)