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

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; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2020.6153

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

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 TurckStefania Barmaz, Camilla Smeraldi, Alexandra Tard, Giorgia Vianello, Ana Maria Rincon, Ursula Gundert-Remy, EFSA Panel on Food Additives and Flavourings (FAF)

Research output: Contribution to specialist publication › Article

5 Citations (Scopus)

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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.

Original language	English
Pages	e06153
Number of pages	37
Volume	18
No.	6
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2020.6153
Publication status	Published - Jun 2020

Keywords

Ascorbyl palmitate
E 304(i)
food additive
infants

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© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made https://creativecommons.org/licenses/by-nd/4.0/
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Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Husøy, T., Manco, M., Mennes, W., Moldeus, P., Passamonti, S., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Wright, M., Dusemund, B., Mortensen, A., ... EFSA Panel on Food Additives and Flavourings (FAF) (2020). 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 Journal, 18(6), e06153. https://doi.org/10.2903/j.efsa.2020.6153

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. / Younes, Maged; Aquilina, Gabriele; Castle, Laurence et al.
In: EFSA Journal, Vol. 18, No. 6, 06.2020, p. e06153.

Research output: Contribution to specialist publication › Article

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gürtler, R, Husøy, T, Manco, M, Mennes, W, Moldeus, P, Passamonti, S, Shah, R, Waalkens-Berendsen, I, Wölfle, D, Wright, M, Dusemund, B, Mortensen, A, Turck, D, Barmaz, S, Smeraldi, C, Tard, A, Vianello, G, Rincon, AM, Gundert-Remy, U & EFSA Panel on Food Additives and Flavourings (FAF) 2020, '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 Journal, vol. 18, no. 6, pp. e06153. https://doi.org/10.2903/j.efsa.2020.6153

Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ et al. 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 Journal. 2020 Jun;18(6):e06153. Epub 2020 Jun 30. doi: 10.2903/j.efsa.2020.6153

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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.",

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AU - Aquilina, Gabriele

AU - Castle, Laurence

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

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