Not assessed by EFSA or the UK FSA as a permitted additive
E478 does not appear in the UK Food Standards Agency approved additives list, which runs from E477 directly to E479b, skipping E478 entirely. The EU Regulation 1333/2008 Annex II union list similarly does not include E478 as an authorised food additive. Without authorisation it has not been subject to a full EFSA safety review as a current-use additive in the EU or UK.
E478 is absent from the UK FSA approved additives and E numbers list. The list moves directly from E477 to E479b.
RegulatoryUK Food Standards Agency, Approved Additives and E Numbers list
E478 is not included in Annex II of EU Regulation 1333/2008, the union list of authorised food additives in the European Union.
2008RegulatoryEuropean Commission, EU Rules on Food Additives
US approval and related compound safety data
The US FDA permits E478 in specific applications such as shortenings, cake mixes and whipped toppings under 21 CFR 172.850. Closely related compounds, including propylene glycol esters of fatty acids (E477) and mono- and diglycerides of fatty acids (E471), have been evaluated by EFSA. The EFSA review of E477 in 2018 found no safety concern at permitted use levels, but E478 is a distinct compound combining both glycerol and propylene glycol esterification with lactic acid and has not received a parallel EU/UK authorisation.
The US FDA lists lactylated fatty acid esters of glycerol and propylene glycol as a permitted food additive in shortening, margarine, cake mixes, icings, fillings and whipped toppings at levels not exceeding good manufacturing practice.
RegulatoryUS Code of Federal Regulations, 21 CFR 172.850
EFSA re-evaluation of propylene glycol esters of fatty acids (E477, the closest authorised EU analogue) found no safety concern at current permitted use levels.
2018Regulatory reviewEFSA Panel on Food Additives and Flavourings, re-evaluation of E477
Propylene glycol component: background signal
Propylene glycol is itself an authorised carrier solvent in the EU (E1520) and is considered low-risk at typical dietary exposures. However, because E478 is not authorised in UK or EU food, there is no EU-approved exposure estimate for the combined compound. The lactic acid and fatty acid portions of the molecule are metabolised normally as common dietary components.
Propylene glycol (E1520) is authorised as a carrier in the EU and has an established acceptable daily intake of 25mg per kg body weight per day set by JECFA.
RegulatoryJECFA, propylene glycol monograph