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. 2020 Jun 30;18(6):e06153.
doi: 10.2903/j.efsa.2020.6153. eCollection 2020 Jun.

Opinion on the re-evaluation of ascorbyl palmitate (E 304i) 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 Panel on Food Additives and Flavourings (FAF); Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Matthew Wright, Birgit Dusemund, Alicja Mortensen, Dominique Turck, Stefania Barmaz, Camilla Smeraldi, Alexandra Tard, Giorgia Vianello, Ana Maria Rincon, Ursula Gundert-Remy

Opinion on the re-evaluation of ascorbyl palmitate (E 304i) 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 Panel on Food Additives and Flavourings (FAF) et al. EFSA J. .

Abstract

Ascorbyl palmitate (E 304(i)) was re-evaluated in 2015 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of ascorbyl palmitate (E 304(i)) for its uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. 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. On the basis of the data submitted by interested business operators and the considerations from the Panel, a revision of the existing EU specifications for ascorbyl palmitate (E 304 (i)) has been recommended. Based on in vitro data, the FAF Panel assumed that ascorbyl palmitate fully hydrolyses pre-systemically to ascorbic acid and palmitate. The Panel concluded that the intake of both metabolites, at the MPLs for ascorbyl palmitate as a food additive in infant formula belonging to FC 13.1.1 or in food for special medical purposes belonging to FC 13.1.5.1, does not raise health concerns.

Keywords: Ascorbyl palmitate; E 304(i); food additive; infants.

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Figures

Figure 1
Figure 1
‘Risk of bias summary’ (modified from Cochrane Risk of Bias Tool; NTP‐OHAT (2015, 2019); see Appendix B for further details)

  1. Definitely low risk of bias (++), Probably low risk of bias (+), Probably high risk of bias (−), Definitely high risk of bias (−−).

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