EFSA Journal (May 2023)

Re‐evaluation of xanthan gum (E 415) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as a food additive for uses in foods for all population groups

  • EFSA Panel on Food Additives and Flavourings (FAF),
  • Maged Younes,
  • Gabriele Aquilina,
  • Laurence Castle,
  • Gisela Degen,
  • Karl‐Heinz Engel,
  • Paul J. Fowler,
  • Maria Jose Frutos Fernandez,
  • Peter Fürst,
  • Rainer Gürtler,
  • Trine Husøy,
  • Melania Manco,
  • Wim Mennes,
  • Peter Moldeus,
  • Sabina Passamonti,
  • Romina Shah,
  • Ine Waalkens‐Berendsen,
  • Matthew Wright,
  • Detlef Wölfle,
  • Birgit Dusemund,
  • Alicja Mortensen,
  • Dominique Turck,
  • Stefania Barmaz,
  • Aguilera Entrena Jaime,
  • Agnieszka Mech,
  • Ana Maria Rincon,
  • Alexandra Tard,
  • Giorgia Vianello,
  • Ursula Gundert‐Remy

DOI
https://doi.org/10.2903/j.efsa.2023.7951
Journal volume & issue
Vol. 21, no. 5
pp. n/a – n/a

Abstract

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Abstract Xanthan gum (E 415) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food. As a follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of xanthan gum (E 415) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category (FC) 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for E 415 laid down in Commission Regulation (EU) No 231/2012. Due to the low validity of the available clinical studies, the Panel concluded that a reference point could not be derived from them but the results of the available studies on neonatal piglets could serve to derive a reference point. The Panel calculated the margin of exposure for infants below 16 weeks of age consuming food for special medical purposes (FC 13.1.5.1) for the highest xanthan gum exposure and concluded that there are no safety concerns for the use of xanthan gum (E 415) as a food additive in FC 13.1.5.1.

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