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

Published:
Adopted:
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Wiley Online Library

Meta data

DOI
https://doi.org/10.2903/j.efsa.2020.5874
Keywords
Starch sodium octenyl succinate, E 1450, food additive, infants
On request from
European Commission
Question Number
EFSA‐Q‐2018‐00102
Panel members at the time of adoption
Maged Younes, Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Matthew Wright and Detlef Wölfle.
Note: The full opinion will be published in accordance with Article 8 of Regulation (EU) No 257/2010 once the decision on confidentiality will be received from the European Commission.
* This opinion was first adopted by the FAF Panel on 25 September 2019, as reflected in the minutes of the FAF Plenary Meeting of 24‐26 September 2019: http://www.efsa.europa.eu/sites/default/files/event/190924-m.pdf. However, the adopted version was withdrawn prior to publication (see https://www.efsa.europa.eu/sites/default/files/event/191112-m.pdf) and the current version was adopted by the FAF Panel on 30 June 2020.

Abstract

As a follow‐up to the re‐evaluation of starch sodium octenyl succinate (SSOS; E 1450), the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of SSOS (E 1450) when used in food for infants below 16 weeks of age for food categories 13.1.5.1 and 13.1.1 and to address the data gaps identified during the re‐evaluation of the SSOS (E 1450). The process involved the publication of a call for data. The Panel considered it feasible to amend the specifications based on the analytical evidence submitted. In the call for data, clinical trials were submitted to support the safe use in this age group. In addition, the report of a postnatal piglet study was provided. Due to the low internal validity of the clinical studies, the Panel concluded that a reference point could not be derived from them. The Panel noted that the uncertainty surrounding the results of the piglet study precludes deriving a reference point from this study. On the other hand, both data sources did not clearly indicate an adverse effect due to SSOS (E 1450). 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). When extrapolating this conclusion to the safety assessment of the food additive when used in food categories (FCs) 13.1.5.1 and 13.1.5.2 in food for infants above 16 weeks of age and young children, the Panel considered that there is no indication for safety concern also for these uses within the range reported in the clinical studies.

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