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 - Université de Lille Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 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

Maged Younes
  • Fonction : Auteur
Gabriele Aquilina
  • Fonction : Auteur
Laurence Castle
  • Fonction : Auteur
Karl-Heinz Engel
  • Fonction : Auteur
Paul Fowler
  • Fonction : Auteur
Maria Jose Frutos Fernandez
  • Fonction : Auteur
Peter Furst
  • Fonction : Auteur
Rainer Gurtler
  • Fonction : Auteur
Trine Husoy
  • Fonction : Auteur
Melania Manco
  • Fonction : Auteur
Wim Mennes
  • Fonction : Auteur
Peter Moldeus
  • Fonction : Auteur
Sabina Passamonti
  • Fonction : Auteur
Romina Shah
  • Fonction : Auteur
Ine Waalkens-Berendsen
  • Fonction : Auteur
Detlef Wolfle
  • Fonction : Auteur
Matthew Wright
  • Fonction : Auteur
Birgit Dusemund
  • Fonction : Auteur
Alicja Mortensen
  • Fonction : Auteur
Stefania Barmaz
  • Fonction : Auteur
Ana Maria Rincon
  • Fonction : Auteur
Camilla Smeraldi
  • Fonction : Auteur
Alexandra Tard
  • Fonction : Auteur
Giorgia Vianello
  • Fonction : Auteur
Ursula Gundert-Remy
  • Fonction : Auteur

Résumé

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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hal-04388366 , version 1 (11-01-2024)

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Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, et al.. 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, 2020, EFSA Journal, 18, pp.e05874. ⟨10.2903/j.efsa.2020.5874⟩. ⟨hal-04388366⟩

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