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
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 add...
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| Language: | English |
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Wiley
2020-08-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2020.5874 |
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| author | 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 Ana Maria Rincon Camilla Smeraldi Alexandra Tard Giorgia Vianello Ursula Gundert‐Remy |
| author_facet | 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 Ana Maria Rincon Camilla Smeraldi Alexandra Tard Giorgia Vianello Ursula Gundert‐Remy |
| author_sort | EFSA Panel on Food Additives and Flavourings (FAF) |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T00:35:20Z |
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| id | doaj.art-cd0762da8b3e4752b84f800891d12ded |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T00:35:20Z |
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| spelling | doaj.art-cd0762da8b3e4752b84f800891d12ded2022-12-21T22:10:10ZengWileyEFSA Journal1831-47322020-08-01188n/an/a10.2903/j.efsa.2020.5874Opinion 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 groupsEFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstRainer GürtlerTrine HusøyMelania MancoWim MennesPeter MoldeusSabina PassamontiRomina ShahIne Waalkens‐BerendsenDetlef WölfleMatthew WrightBirgit DusemundAlicja MortensenDominique TurckStefania BarmazAna Maria RinconCamilla SmeraldiAlexandra TardGiorgia VianelloUrsula Gundert‐RemyAbstract 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.https://doi.org/10.2903/j.efsa.2020.5874Starch sodium octenyl succinateE 1450food additiveinfants |
| spellingShingle | 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 Ana Maria Rincon Camilla Smeraldi Alexandra Tard Giorgia Vianello Ursula Gundert‐Remy 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 Starch sodium octenyl succinate E 1450 food additive infants |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Starch sodium octenyl succinate E 1450 food additive infants |
| url | https://doi.org/10.2903/j.efsa.2020.5874 |
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