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Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re‐evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 a...

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Autores principales: Mortensen, Alicja, Aguilar, Fernando, Crebelli, Riccardo, Di Domenico, Alessandro, Dusemund, Birgit, Frutos, Maria Jose, Galtier, Pierre, Gott, David, Gundert‐Remy, Ursula, Lambré , Claude, Leblanc, Jean‐Charles, Lindtner, Oliver, Moldeus, Peter, Mosesso, Pasquale, Parent‐Massin, Dominique, Oskarsson, Agneta, Stankovic, Ivan, Waalkens‐Berendsen, Ine, Wright, Matthew, Younes, Maged, Tobback, Paul, Horvath, Zsuzsanna, Tasiopoulou, Stavroula, Woutersen, Rudolf Antonius
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009865/
https://www.ncbi.nlm.nih.gov/pubmed/32625282
http://dx.doi.org/10.2903/j.efsa.2017.4911
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author Mortensen, Alicja
Aguilar, Fernando
Crebelli, Riccardo
Di Domenico, Alessandro
Dusemund, Birgit
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Lambré , Claude
Leblanc, Jean‐Charles
Lindtner, Oliver
Moldeus, Peter
Mosesso, Pasquale
Parent‐Massin, Dominique
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Wright, Matthew
Younes, Maged
Tobback, Paul
Horvath, Zsuzsanna
Tasiopoulou, Stavroula
Woutersen, Rudolf Antonius
author_facet Mortensen, Alicja
Aguilar, Fernando
Crebelli, Riccardo
Di Domenico, Alessandro
Dusemund, Birgit
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Lambré , Claude
Leblanc, Jean‐Charles
Lindtner, Oliver
Moldeus, Peter
Mosesso, Pasquale
Parent‐Massin, Dominique
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Wright, Matthew
Younes, Maged
Tobback, Paul
Horvath, Zsuzsanna
Tasiopoulou, Stavroula
Woutersen, Rudolf Antonius
collection PubMed
description Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re‐evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) ‘not specified’. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read‐across approach, the Panel considered that adequate data on short‐ and long‐term toxicity and carcinogenicity, and reproductive toxicity are available. Based on in silico analyses, modified starches are considered not to be of genotoxic concern. No treatment‐related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404–E 1451 at the 95th percentile of the refined (brand‐loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day.
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spelling pubmed-70098652020-07-02 Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives Mortensen, Alicja Aguilar, Fernando Crebelli, Riccardo Di Domenico, Alessandro Dusemund, Birgit Frutos, Maria Jose Galtier, Pierre Gott, David Gundert‐Remy, Ursula Lambré , Claude Leblanc, Jean‐Charles Lindtner, Oliver Moldeus, Peter Mosesso, Pasquale Parent‐Massin, Dominique Oskarsson, Agneta Stankovic, Ivan Waalkens‐Berendsen, Ine Wright, Matthew Younes, Maged Tobback, Paul Horvath, Zsuzsanna Tasiopoulou, Stavroula Woutersen, Rudolf Antonius EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re‐evaluation of 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) ‘not specified’. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read‐across approach, the Panel considered that adequate data on short‐ and long‐term toxicity and carcinogenicity, and reproductive toxicity are available. Based on in silico analyses, modified starches are considered not to be of genotoxic concern. No treatment‐related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404–E 1451 at the 95th percentile of the refined (brand‐loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day. John Wiley and Sons Inc. 2017-10-05 /pmc/articles/PMC7009865/ /pubmed/32625282 http://dx.doi.org/10.2903/j.efsa.2017.4911 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Mortensen, Alicja
Aguilar, Fernando
Crebelli, Riccardo
Di Domenico, Alessandro
Dusemund, Birgit
Frutos, Maria Jose
Galtier, Pierre
Gott, David
Gundert‐Remy, Ursula
Lambré , Claude
Leblanc, Jean‐Charles
Lindtner, Oliver
Moldeus, Peter
Mosesso, Pasquale
Parent‐Massin, Dominique
Oskarsson, Agneta
Stankovic, Ivan
Waalkens‐Berendsen, Ine
Wright, Matthew
Younes, Maged
Tobback, Paul
Horvath, Zsuzsanna
Tasiopoulou, Stavroula
Woutersen, Rudolf Antonius
Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title_full Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title_fullStr Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title_full_unstemmed Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title_short Re‐evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) as food additives
title_sort re‐evaluation of oxidised starch (e 1404), monostarch phosphate (e 1410), distarch phosphate (e 1412), phosphated distarch phosphate (e 1413), acetylated distarch phosphate (e 1414), acetylated starch (e 1420), acetylated distarch adipate (e 1422), hydroxypropyl starch (e 1440), hydroxypropyl distarch phosphate (e 1442), starch sodium octenyl succinate (e 1450), acetylated oxidised starch (e 1451) and starch aluminium octenyl succinate (e 1452) as food additives
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009865/
https://www.ncbi.nlm.nih.gov/pubmed/32625282
http://dx.doi.org/10.2903/j.efsa.2017.4911
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