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Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 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 re‐evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cel...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009359/ https://www.ncbi.nlm.nih.gov/pubmed/32625652 http://dx.doi.org/10.2903/j.efsa.2018.5047 |
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author | Younes, Maged Aggett, Peter Aguilar, Fernando Crebelli, Riccardo Di Domenico, Alessandro Dusemund, Birgit Filipič, Metka Jose Frutos, Maria Galtier, Pierre Gott, David Gundert‐Remy, Ursula Georg Kuhnle, Gunter Lambré, Claude Leblanc, Jean‐Charles Lillegaard, Inger Therese Moldeus, Peter Mortensen, Alicja Oskarsson, Agneta Stankovic, Ivan Tobback, Paul Waalkens‐Berendsen, Ine Wright, Matthew Tard, Alexandra Tasiopoulou, Stavroula Woutersen, Rudolf Antonius |
author_facet | Younes, Maged Aggett, Peter Aguilar, Fernando Crebelli, Riccardo Di Domenico, Alessandro Dusemund, Birgit Filipič, Metka Jose Frutos, Maria Galtier, Pierre Gott, David Gundert‐Remy, Ursula Georg Kuhnle, Gunter Lambré, Claude Leblanc, Jean‐Charles Lillegaard, Inger Therese Moldeus, Peter Mortensen, Alicja Oskarsson, Agneta Stankovic, Ivan Tobback, Paul Waalkens‐Berendsen, Ine Wright, Matthew Tard, Alexandra 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 re‐evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxy methyl cellulose (E 469) and cross‐linked carboxy methyl cellulose (E 468) as food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) ‘not specified’ for unmodified and modified celluloses. Celluloses are not absorbed and are excreted intact in the faeces; in addition, microcrystalline cellulose, powdered and modified celluloses could be fermented by the intestinal flora in animals and humans. Specific toxicity data were not always available for all the celluloses evaluated in the present opinion and for all endpoints. Given their structural, physicochemical and biological similarities, the Panel considered it possible to read‐across between all the celluloses. The acute toxicity of celluloses was low and there was no genotoxic concern. Short‐term and subchronic dietary toxicity studies performed with E 460(i), E 461, E 462, E 463, E 464, E 466 and E 469 at levels up to 10% did not indicate specific treatment related adverse effects. In chronic toxicity studies performed with E 460(i), E 461, E 463, E 464, E 465 and E 466, the no observed adverse effect level (NOAEL) values reported ranged up to 9,000 mg/kg body weight (bw) per day. No carcinogenic properties were detected for microcrystalline cellulose and modified celluloses. Adverse effects on reproductive performance or developmental effects were not observed with celluloses at doses greater than 1,000 mg/kg bw by gavage (often the highest dose tested). The combined exposure to celluloses (E 460–466, E 468 and E 469) at 95th percentile of the refined (brand‐loyal) exposure assessment for the general population was up to 506 mg/kg bw per day. The Panel concluded that there was no need for a numerical ADI and that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i); E 460(ii); E 461–466; E 468 and E 469). The Panel considered an indicative total exposure of around 660–900 mg/kg bw per day for microcrystalline, powdered and modified celluloses. |
format | Online Article Text |
id | pubmed-7009359 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70093592020-07-02 Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives Younes, Maged Aggett, Peter Aguilar, Fernando Crebelli, Riccardo Di Domenico, Alessandro Dusemund, Birgit Filipič, Metka Jose Frutos, Maria Galtier, Pierre Gott, David Gundert‐Remy, Ursula Georg Kuhnle, Gunter Lambré, Claude Leblanc, Jean‐Charles Lillegaard, Inger Therese Moldeus, Peter Mortensen, Alicja Oskarsson, Agneta Stankovic, Ivan Tobback, Paul Waalkens‐Berendsen, Ine Wright, Matthew Tard, Alexandra 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 re‐evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxy methyl cellulose (E 469) and cross‐linked carboxy methyl cellulose (E 468) as food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) ‘not specified’ for unmodified and modified celluloses. Celluloses are not absorbed and are excreted intact in the faeces; in addition, microcrystalline cellulose, powdered and modified celluloses could be fermented by the intestinal flora in animals and humans. Specific toxicity data were not always available for all the celluloses evaluated in the present opinion and for all endpoints. Given their structural, physicochemical and biological similarities, the Panel considered it possible to read‐across between all the celluloses. The acute toxicity of celluloses was low and there was no genotoxic concern. Short‐term and subchronic dietary toxicity studies performed with E 460(i), E 461, E 462, E 463, E 464, E 466 and E 469 at levels up to 10% did not indicate specific treatment related adverse effects. In chronic toxicity studies performed with E 460(i), E 461, E 463, E 464, E 465 and E 466, the no observed adverse effect level (NOAEL) values reported ranged up to 9,000 mg/kg body weight (bw) per day. No carcinogenic properties were detected for microcrystalline cellulose and modified celluloses. Adverse effects on reproductive performance or developmental effects were not observed with celluloses at doses greater than 1,000 mg/kg bw by gavage (often the highest dose tested). The combined exposure to celluloses (E 460–466, E 468 and E 469) at 95th percentile of the refined (brand‐loyal) exposure assessment for the general population was up to 506 mg/kg bw per day. The Panel concluded that there was no need for a numerical ADI and that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i); E 460(ii); E 461–466; E 468 and E 469). The Panel considered an indicative total exposure of around 660–900 mg/kg bw per day for microcrystalline, powdered and modified celluloses. John Wiley and Sons Inc. 2018-01-16 /pmc/articles/PMC7009359/ /pubmed/32625652 http://dx.doi.org/10.2903/j.efsa.2018.5047 Text en © 2018 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 Younes, Maged Aggett, Peter Aguilar, Fernando Crebelli, Riccardo Di Domenico, Alessandro Dusemund, Birgit Filipič, Metka Jose Frutos, Maria Galtier, Pierre Gott, David Gundert‐Remy, Ursula Georg Kuhnle, Gunter Lambré, Claude Leblanc, Jean‐Charles Lillegaard, Inger Therese Moldeus, Peter Mortensen, Alicja Oskarsson, Agneta Stankovic, Ivan Tobback, Paul Waalkens‐Berendsen, Ine Wright, Matthew Tard, Alexandra Tasiopoulou, Stavroula Woutersen, Rudolf Antonius Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title | Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title_full | Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title_fullStr | Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title_full_unstemmed | Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title_short | Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives |
title_sort | re‐evaluation of celluloses e 460(i), e 460(ii), e 461, e 462, e 463, e 464, e 465, e 466, e 468 and e 469 as food additives |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009359/ https://www.ncbi.nlm.nih.gov/pubmed/32625652 http://dx.doi.org/10.2903/j.efsa.2018.5047 |
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