Starch sodium octenyl succinate in infant food
What it found
In clinical studies in infants and a piglet study, no clear harmful effect from starch sodium octenyl succinate was found.
The authors say there is no indication for safety concern at the levels studied.
What they found
Studies in people
Clinical trials in infants
Clinical trials were sent in to support use in infants below 16 weeks. The authors found these studies had low internal validity, so a reference point could not be set from them.
Use levels in infants
At use levels in food for infants below 16 weeks up to 2,725 mg/kg body weight per day, as reported in the clinical studies, the authors found no indication for safety concern.
Animal and lab studies
Piglet study
A study in postnatal piglets was also provided. The authors said uncertainty around the results meant a reference point could not be set from it either.
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
Older infants and children
The authors extended this view to food categories 13.1.5.1 and 13.1.5.2 for infants above 16 weeks and young children, within the range reported in the clinical studies.
Specifications amended
The authors said it was feasible to amend the specifications for starch sodium octenyl succinate based on the analytical evidence sent in.
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 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).
- They considered that there is no indication for safety concern also for uses in food categories 13.1.5.1 and 13.1.5.2 for infants above 16 weeks of age and young children, within the range reported in the clinical studies.
How it was done
The authors were asked to look again at starch sodium octenyl succinate (E 1450) for use in food for infants below 16 weeks of age and to fill gaps left from an earlier review.
They asked for data to be sent in. Clinical trials in infants and a study in postnatal piglets were provided. The authors looked at whether a reference point could be set from these studies.
What it can’t tell you
- We summarised it from the abstract only.
- The clinical studies had low internal validity, so the authors could not set a reference point from them.
- The piglet study had uncertainty around its results, so the authors could not set a reference point from it either.
- The authors could not derive a numerical acceptable daily intake (ADI) from the available data.
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
- Abstract only
- 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