Citric acid esters of mono- and diglycerides of fatty acids in infant formula
What it found
The authors found no safety concern from using E 472c in food for infants below 16 weeks of age, based on comparing its breakdown products with those in breast milk.
They also said the technical data support updating the EU specifications for E 472c.
What they found
Studies in people
Clinical studies
The authors re-assessed clinical studies and considered them to have major methodological flaws. Four new clinical studies were provided, but none was appropriate for comparing a formula containing E 472c with the same formula without it.
Animal and lab studies
Impurities in samples
In commercial samples of E 472c, lead was found in one sample at 0.0065 mg/kg, while mercury, cadmium and arsenic were below the limits of quantification in all samples tested. Acrolein was not detected or was below the limit of quantification in six samples.
Other findings
Use levels in formula
One company reported that E 472c is used in infant formula for infants below 16 weeks of age at levels up to 1849 mg/L as consumed when sold as powder, and up to 8900 mg/L as consumed when sold as liquid. In special formulae for infants of that age under special medical conditions, levels were up to the maximum levels set in the EU.
Exposure estimates
For infants consuming formula sold as liquid, mean exposure was estimated at 1780 mg/kg body weight per day and high-level exposure at 2314 mg/kg body weight per day. For formula sold as powder, mean exposure was 370 mg/kg body weight per day and high-level exposure was 481 mg/kg body weight per day.
Breakdown products vs breast milk
The levels of lauric, myristic, palmitic and stearic acid in infant formula and special medical food containing E 472c were similar to those in breast milk. Total glycerol in infant formula containing E 472c at the maximum level was 3.8 g/L, in the same range as breast milk at around 4 g/L.
Citric acid comparison
The maximum citric acid content in infant formula containing E 472c was calculated as 2.2 g/L, about two times higher than the 1.1 g/L in breast milk. The authors considered this two-fold higher level not to be of safety concern.
What the authors conclude
“the Panel concluded that there is no safety concern from its use at the reported use levels and at the maximum permitted levels in food for infants below 16 weeks of age (FCs 13.1.1 and 13.1.5.1).”
Also in their conclusions
- They concluded that there is no safety concern from the use of E 472c at the reported use levels and at the maximum permitted levels in food for infants below 16 weeks of age.
- They also concluded that the technical data provided by the interested business operators support an amendment of the EU specifications for E 472c.
How it was done
The authors did this work because the earlier assessment of E 472c did not cover its use in food for infants below 12 weeks of age, and they wanted to address data gaps and update the specifications.
They looked at data submitted by companies, including analytical results for impurities in commercial samples of E 472c, reported use levels in infant formula, clinical studies, and post-marketing surveillance reports. They estimated how much E 472c infants below 16 weeks of age might consume from formula sold as powder or liquid, and compared the breakdown products of E 472c in infant formula with those in breast milk.
What it can’t tell you
- The clinical studies had major flaws and could not be used to compare formula with E 472c against formula without it.
- The authors based their conclusion on comparing the breakdown products of E 472c in formula with those in breast milk, rather than on studies in infants.
- The post-marketing surveillance reports had a low number of symptoms and could not show cause and effect.
The paper
- Title
- Re-evaluation of citric acid esters of mono- and diglycerides of fatty acids (E 472c) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation
- Type
- Scientific opinion of the European Food Safety Authority
- Evidence
- Studies in people · animals · lab
- Summarised from
- Full text
- Cite
- EFSA Panel on Food Additives and Flavourings (FAF), Castle L, Andreassen M, et al (2025). Re-evaluation of citric acid esters of mono- and diglycerides of fatty acids (E 472c) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2025.9202Free full textPubMed 39816965DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error