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

As a follow-up to the re-evaluation of starch sodium octenyl succinate (SSOS; E 1450), the Panel onFood Additives and Flavourings (FAF) w as requested to assess the safety of SSOS (E 1450) when usedin food for infants below 16 weeks of age for food categories 13.1.5.1 and 13.1.1 and to address thedata gaps identied during the re-evaluation of the SSOS (E 1450). The process involved thepublication of a call for data. The Panel considered it feasible to amend the specications based onthe analytical evidence submitted. In the call for data, clinical trials were submitted to sup port the safeuse in this age group. In addition, the report of a postnatal piglet study was provided. Due to the lowinternal validity of the clinical studies, the Panel concluded that a reference point could not be derivedfrom them. The Panel noted that the uncert ainty surrounding the results of the piglet study precludesderiving a reference point from this study. On the other hand, both data sources did not clearlyindicate an adverse effect due to SSOS (E 1450). Given the available data, the Panel concluded that atuse 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 reiteratedthe conclusion of the Panel on Food Additives and Nutrient Sources added to Food (ANS) that therewas no need for a numerical acceptable daily intake (ADI). When extrapolating this conclusion to thesafety assessment of the food additive when used in food categories (FCs) 13.1.5.1 and 13.1.5.2 infood for infants above 16 weeks of age and young children, the Panel considered that there is noindication for safety concern also for these uses within the range reported in the clinical studies.