Starch sodium octenyl succinate (E 1450) in infant foods
What it found
The panel found no clear sign of harm from starch sodium octenyl succinate in infants below 16 weeks, based on clinical trials and a piglet study.
The trials were too weak to set a reference point.
What they found
Studies in people
Clinical trials in infants
Six clinical trials in infants below 16 weeks were submitted. Five had a high risk of bias and one had a moderate risk of bias, so the panel could not use them to set a reference point.
Animal and lab studies
Piglet study
A study in postnatal piglets was the most suitable animal data. Because female piglets showed no effects and male piglet body weights did not follow a dose pattern, the panel could not set a reference point from it.
Studies in people and animals
No clear adverse effect
Neither the clinical trials nor the piglet study clearly showed a harmful effect from starch sodium octenyl succinate.
Other findings
Exposure estimates
For infants below 16 weeks eating special medical foods, estimated intake ranged from 1,676 to 5,200 mg/kg body weight per day. For infant formula with carry-over, estimates ranged from 12 to 286 mg/kg body weight per day.
Specifications updated
The panel found it feasible to lower limits for sulfur dioxide and heavy metals, and to add new limits for cadmium and microbiological criteria.
Gut bacteria
The panel noted that changes in gut bacteria are hard to interpret without measuring a specific health outcome.
What the authors conclude
“Given the available data, the Panel concluded that at use levels of SSOS in food for infants below 16 weeks within the range reported in the clinical studies (up to 2,725 mg/kg body weight (bw) per day), there is no indication for safety concern and reiterated the conclusion of the Panel on Food Additives and Nutrient Sources added to Food (ANS) that there was no need for a numerical acceptable daily intake (ADI).”
Also in their conclusions
- They concluded that at use levels of SSOS in food for infants below 16 weeks within the range reported in the clinical studies (up to 2,725 mg/kg body weight per day), there is no indication for safety concern.
- They reiterated that there was no need for a numerical acceptable daily intake.
- They considered that there is no indication for safety concern also for uses in food for infants above 16 weeks and young children within the range reported in the clinical studies.
How it was done
The European Commission asked EFSA to fill data gaps from an earlier review and to check the additive for infants below 16 weeks of age, who may take it in special medical foods or infant formula.
The panel looked at six clinical trials in infants below 16 weeks, a study in postnatal piglets, and older animal and human data. It also estimated how much infants and young children might take in from foods and formula.
What it can’t tell you
- The clinical trials had a high risk of bias, so they cannot show a clear cause-and-effect link.
- The piglet study results were uncertain, so they cannot show what happens in human infants.
- The exposure estimates are based on assumptions and may not match what infants actually eat.
The paper
- Title
- Opinion on the re-evaluation of starch sodium octenyl succinate (E 1450) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups
- Type
- Scientific opinion of the European Food Safety Authority
- Evidence
- Studies in people · animals · lab
- Summarised from
- Full text
- Licence
- CC BY-ND. Words in quotation marks are the authors’; the rest is our summary.
- Cite
- EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (2020). Opinion on the re-evaluation of starch sodium octenyl succinate (E 1450) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2020.5874Free full textPubMed 32817762DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error