Regulatory withdrawal from the approved list
E384 was assigned an E-number under earlier European food additive frameworks but was not carried forward into the current harmonised EU list under Regulation 1333/2008. The UK FSA approved-additives list, which reflects the assimilated EU framework post-Brexit, does not include E384. This means its use in food sold in the UK or EU is not authorised regardless of dose.
E384 does not appear in the UK FSA's published list of approved food additives and E numbers, meaning it has no current authorisation for food use in Great Britain.
RegulatoryUK Food Standards Agency, Approved additives and E numbers
EU Regulation 1333/2008 (Annex II) establishes the Union list of food additives authorised for use in food. Isopropyl citrate (E384) is not included in Annex II, so its use in EU food products is not permitted under the current framework.
2008RegulatoryEuropean Parliament and Council Regulation (EC) No 1333/2008 on food additives
Toxicological background
Earlier reviews of isopropyl citrate focused mainly on its metabolic fate. Citrate esters are generally hydrolysed in the gut to citric acid and the corresponding alcohol, and citric acid is a normal metabolite in human physiology. The isopropanol released is metabolised to acetone. Because it was withdrawn from the authorised list before modern systematic re-evaluation processes were completed, a full published EFSA opinion specifically on E384 does not appear to be available. The absence of a current authorisation, rather than a specific identified hazard, appears to be the primary reason it is not permitted.
Citric acid esters in general undergo hydrolysis in the gastrointestinal tract, releasing citric acid (a normal body metabolite) and the esterified alcohol component. The safety concern for isopropyl citrate centres on the isopropanol released on hydrolysis, which is further metabolised to acetone.
Regulatory reviewJECFA (Joint FAO/WHO Expert Committee on Food Additives), evaluation of citric acid and its salts and esters