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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
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...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425341/ https://www.ncbi.nlm.nih.gov/pubmed/32817762 http://dx.doi.org/10.2903/j.efsa.2020.5874 |
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| author | Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Dusemund, Birgit Mortensen, Alicja Turck, Dominique Barmaz, Stefania Rincon, Ana Maria Smeraldi, Camilla Tard, Alexandra Vianello, Giorgia Gundert‐Remy, Ursula |
| author_facet | Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Dusemund, Birgit Mortensen, Alicja Turck, Dominique Barmaz, Stefania Rincon, Ana Maria Smeraldi, Camilla Tard, Alexandra Vianello, Giorgia Gundert‐Remy, Ursula |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-7425341 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2020 |
| publisher | John Wiley and Sons Inc. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-74253412020-08-16 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 Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Dusemund, Birgit Mortensen, Alicja Turck, Dominique Barmaz, Stefania Rincon, Ana Maria Smeraldi, Camilla Tard, Alexandra Vianello, Giorgia Gundert‐Remy, Ursula EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2020-08-13 /pmc/articles/PMC7425341/ /pubmed/32817762 http://dx.doi.org/10.2903/j.efsa.2020.5874 Text en © 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 http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
| spellingShingle | Scientific Opinion Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Husøy, Trine Manco, Melania Mennes, Wim Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Dusemund, Birgit Mortensen, Alicja Turck, Dominique Barmaz, Stefania Rincon, Ana Maria Smeraldi, Camilla Tard, Alexandra Vianello, Giorgia Gundert‐Remy, Ursula 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 | 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 | Scientific Opinion |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425341/ https://www.ncbi.nlm.nih.gov/pubmed/32817762 http://dx.doi.org/10.2903/j.efsa.2020.5874 |
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