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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

EFSA journal, 2018-01, Vol.16 (1), p.n/a [Peer Reviewed Journal]

2018 European Food Safety Authority. published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. ;2018. This work is published under http://creativecommons.org/licenses/by-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;ISSN: 1831-4732 ;EISSN: 1831-4732 ;DOI: 10.2903/j.efsa.2018.5047 ;PMID: 32625652

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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
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
Subjects: Acute toxicity ; Body weight ; Bone marrow ; Carboxymethyl cellulose ; Carcinogens ; Cellulose ; Chronic toxicity ; Committees ; cross‐linked carboxy methyl cellulose (E 468) ; Crystalline cellulose ; Diet ; enzymatically hydrolysed carboxy methyl cellulose (E 469) ; Ethyl cellulose ; ethyl cellulose (E 462) ; ethyl methyl cellulose (E 465) ; Exposure ; Flora ; Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi ; Food additives ; Food sources ; Genotoxicity ; Hydroxypropyl cellulose ; hydroxypropyl cellulose (E 463) ; hydroxypropyl methyl cellulose (E 464) ; Hyperplasia ; Intestinal microflora ; Metabolism ; methyl cellulose (E 461) ; Methylcellulose ; Microcrystalline cellulose (E 460(i)) ; Mutation ; Nutrient sources ; powdered cellulose (E 460(ii)) ; Public Health, Global Health, Social Medicine and Epidemiology ; Reproduction ; Safety ; Scientific Opinion ; Side effects ; Sodium ; sodium carboxy methyl cellulose (E 466) ; Toxicity
Is Part Of: EFSA journal, 2018-01, Vol.16 (1), p.n/a
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.
Publisher: Hoboken: John Wiley & Sons, Inc
Language: English
Identifier: ISSN: 1831-4732
EISSN: 1831-4732
DOI: 10.2903/j.efsa.2018.5047
PMID: 32625652
Source: PubMed Central
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DOAJ Directory of Open Access Journals

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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

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