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

doi:10.2903/j.efsa.2020.5874

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

Research output: Contribution to specialist publication › Article

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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.

Original language	English
Pages	e05874
Number of pages	60
Volume	18
No.	8
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2020.5874
Publication status	Published - Aug 2020

Keywords

Starch sodium octenyl succinate
E 1450
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 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, 18(8), e05874. https://doi.org/10.2903/j.efsa.2020.5874

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. / Younes, Maged; Aquilina, Gabriele; Castle, Laurence et al.
In: EFSA Journal, Vol. 18, No. 8, 08.2020, p. e05874.

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, Rincon, AM, Smeraldi, C, Tard, A, Vianello, G, Gundert-Remy, U & EFSA Panel on Food Additives and Flavourings (FAF) 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' EFSA Journal, vol. 18, no. 8, pp. e05874. https://doi.org/10.2903/j.efsa.2020.5874

Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ 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 Aug;18(8):e05874. Epub 2020 Aug 13. doi: 10.2903/j.efsa.2020.5874

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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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author = "Maged Younes and Gabriele Aquilina and Laurence Castle and Karl-Heinz Engel and Paul Fowler and {Frutos Fernandez}, {Maria Jose} and Peter F{\"u}rst and Rainer G{\"u}rtler and Trine Hus{\o}y and Melania Manco and Wim Mennes and Peter Moldeus and Sabina Passamonti and Romina Shah and Ine Waalkens-Berendsen and Detlef W{\"o}lfle and Matthew Wright and Birgit Dusemund and Alicja Mortensen and Dominique Turck and Stefania Barmaz and Rincon, {Ana Maria} and Camilla Smeraldi and Alexandra Tard and Giorgia Vianello and Ursula Gundert-Remy and {EFSA Panel on Food Additives and Flavourings (FAF)}",

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AU - Younes, Maged

AU - Aquilina, Gabriele

AU - Castle, Laurence

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

AU - Fürst, Peter

AU - Gürtler, Rainer

AU - Husøy, Trine

AU - Manco, Melania

AU - Mennes, Wim

AU - Moldeus, Peter

AU - Passamonti, Sabina

AU - Shah, Romina

AU - Waalkens-Berendsen, Ine

AU - Wölfle, Detlef

AU - Wright, Matthew

AU - Dusemund, Birgit

AU - Mortensen, Alicja

AU - Turck, Dominique

AU - Barmaz, Stefania

AU - Rincon, Ana Maria

AU - Smeraldi, Camilla

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