Relationship to PGPR (E476) and the gap in safety evaluation
E498 is chemically similar to E476 (PGPR) but involves only partial esterification of the polyglycerol backbone. EFSA has conducted two full re-evaluations of E476 (in 2017 and a follow-up in 2022), concluding it raises no safety concern at the levels used in food. E498 has not been separately evaluated by EFSA or the UK FSA, and it does not appear in the EU's authorised additives list (Annex II of Regulation 1333/2008). The absence of authorisation means there is no agreed safety assessment, ADI, or specification for this specific compound in the UK or EU.
EFSA re-evaluated PGPR (E476), the fully esterified relative of E498, and raised its ADI from 7.5 to 25mg/kg body weight per day, concluding the data supported no safety concern at authorised levels.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources, EFSA Journal
A 2022 EFSA follow-up on E476 found no new data that would alter the 2017 conclusions, and addressed specification updates and proposed use extensions in edible ices and emulsified sauces.
2022Regulatory reviewEFSA Panel on Food Additives and Flavourings, EFSA Journal
E498 does not appear in the UK FSA's approved additives and E numbers list, meaning it has no legal basis for use in food placed on the UK market.
RegulatoryUK Food Standards Agency, Approved Additives and E Numbers (food.gov.uk)
Castor oil fatty acids: ricinoleic acid background
The fatty acid backbone of E498, like E476, is dominated by ricinoleic acid from castor oil. Ricinoleic acid is a hydroxy-fatty acid with a long history of use in food and pharmaceutical emulsifiers. Animal studies on PGPR showed low acute oral toxicity and no genotoxicity or carcinogenicity signals at high doses, but those findings apply to the fully esterified E476 and cannot be assumed to transfer directly to the partially esterified E498 without equivalent studies.
Rat metabolism studies showed that ingested PGPR (E476) is largely hydrolysed in the gastrointestinal tract to glycerol, ricinoleic acid, and polyglycerol, with most absorbed as normal fatty-acid metabolites. These findings relate to E476, not E498 specifically.
1998AnimalFedtke N et al., Food and Chemical Toxicology