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Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive

The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regu...

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Autores principales: Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul, Fürst, Peter, Gürtler, Rainer, Gundert‐Remy, Ursula, Husøy, Trine, Mennes, Wim, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Boon, Polly, Crebelli, Riccardo, Di Domenico, Alessandro, Filipič, Metka, Mortensen, Alicja, Van Loveren, Henk, Woutersen, Ruud, Gergelova, Petra, Giarola, Alessandra, Lodi, Federica, Frutos Fernandez, Maria Jose
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448092/
https://www.ncbi.nlm.nih.gov/pubmed/32874237
http://dx.doi.org/10.2903/j.efsa.2020.6034
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author Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Mennes, Wim
Moldeus, Peter
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Boon, Polly
Crebelli, Riccardo
Di Domenico, Alessandro
Filipič, Metka
Mortensen, Alicja
Van Loveren, Henk
Woutersen, Ruud
Gergelova, Petra
Giarola, Alessandra
Lodi, Federica
Frutos Fernandez, Maria Jose
author_facet Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Mennes, Wim
Moldeus, Peter
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Boon, Polly
Crebelli, Riccardo
Di Domenico, Alessandro
Filipič, Metka
Mortensen, Alicja
Van Loveren, Henk
Woutersen, Ruud
Gergelova, Petra
Giarola, Alessandra
Lodi, Federica
Frutos Fernandez, Maria Jose
collection PubMed
description The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Hydrogenated poly‐1‐decene is of low acute toxicity and does not raise concern for genotoxicity. Toxicity and carcinogenicity, as well as reproductive and developmental toxicological studies, were not available; therefore, the Panel based the derivation of the acceptable daily intake (ADI) on the no observed adverse effect level (NOAEL) identified in the subchronic study in rats and established an ADI of 20 mg/kg bw per day. Dietary exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive was calculated based on regulatory maximum level exposure assessment scenario. Mean exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive ranged from no exposure in infants to 2.35 mg/kg bw per day in toddlers. The high exposure to hydrogenated poly‐1‐decene (E 907) ranged from 0 mg/kg bw per day in infants and adults to 6.69 mg/kg bw per day in toddlers. The exposure estimates in the regulatory maximum level exposure assessment scenario did not exceed the ADI of 20 mg/kg bw per day for all population groups. The Panel concluded that the exposure to hydrogenated poly‐1‐decene (E 907) does not raise a safety concern when used at the maximum permitted levels.
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spelling pubmed-74480922020-08-31 Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Mennes, Wim Moldeus, Peter Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Boon, Polly Crebelli, Riccardo Di Domenico, Alessandro Filipič, Metka Mortensen, Alicja Van Loveren, Henk Woutersen, Ruud Gergelova, Petra Giarola, Alessandra Lodi, Federica Frutos Fernandez, Maria Jose EFSA J Scientific Opinion The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Hydrogenated poly‐1‐decene is of low acute toxicity and does not raise concern for genotoxicity. Toxicity and carcinogenicity, as well as reproductive and developmental toxicological studies, were not available; therefore, the Panel based the derivation of the acceptable daily intake (ADI) on the no observed adverse effect level (NOAEL) identified in the subchronic study in rats and established an ADI of 20 mg/kg bw per day. Dietary exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive was calculated based on regulatory maximum level exposure assessment scenario. Mean exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive ranged from no exposure in infants to 2.35 mg/kg bw per day in toddlers. The high exposure to hydrogenated poly‐1‐decene (E 907) ranged from 0 mg/kg bw per day in infants and adults to 6.69 mg/kg bw per day in toddlers. The exposure estimates in the regulatory maximum level exposure assessment scenario did not exceed the ADI of 20 mg/kg bw per day for all population groups. The Panel concluded that the exposure to hydrogenated poly‐1‐decene (E 907) does not raise a safety concern when used at the maximum permitted levels. John Wiley and Sons Inc. 2020-02-28 /pmc/articles/PMC7448092/ /pubmed/32874237 http://dx.doi.org/10.2903/j.efsa.2020.6034 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
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Mennes, Wim
Moldeus, Peter
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Boon, Polly
Crebelli, Riccardo
Di Domenico, Alessandro
Filipič, Metka
Mortensen, Alicja
Van Loveren, Henk
Woutersen, Ruud
Gergelova, Petra
Giarola, Alessandra
Lodi, Federica
Frutos Fernandez, Maria Jose
Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title_full Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title_fullStr Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title_full_unstemmed Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title_short Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive
title_sort re‐evaluation of name of hydrogenated poly‐1‐decene (e 907) as food additive
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448092/
https://www.ncbi.nlm.nih.gov/pubmed/32874237
http://dx.doi.org/10.2903/j.efsa.2020.6034
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