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, Younes M, Aggett P, et al. 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 J. 2018;16(1):e05047doi: 10.2903/j.efsa.2018.5047.
, Younes, M., Aggett, P., Aguilar, F., Crebelli, R., Di Domenico, A., Dusemund, B., Filipič, M., Jose Frutos, M., Galtier, P., Gott, D., Gundert-Remy, U., Georg Kuhnle, G., Lambré, C., Leblanc, J. C., Lillegaard, I. T., Moldeus, P., Mortensen, A., Oskarsson, A., Stankovic, I., Tobback, P., Waalkens-Berendsen, I., Wright, M., Tard, A., Tasiopoulou, S., & Woutersen, R. A. (2018). 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. European Food Safety Authority, 16(1), e05047. https://doi.org/10.2903/j.efsa.2018.5047
, et al. "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. European Food Safety Authority vol. 16,1 (2018): e05047. doi: https://doi.org/10.2903/j.efsa.2018.5047
, Younes M, Aggett P, Aguilar F, Crebelli R, Di Domenico A, Dusemund B, Filipič M, Jose Frutos M, Galtier P, Gott D, Gundert-Remy U, Georg Kuhnle G, Lambré C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Tobback P, Waalkens-Berendsen I, Wright M, Tard A, Tasiopoulou S, Woutersen RA. 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 J. 2018 Jan 16;16(1):e05047. doi: 10.2903/j.efsa.2018.5047. eCollection 2018 Jan. PMID: 32625652; PMCID: PMC7009359.
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EFSA J. 2018 Jan 16;16(1):e05047. doi: 10.2903/j.efsa.2018.5047. eCollection 2018 Jan.

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. European Food Safety Authority

Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Metka Filipič, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambré, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Matthew Wright, Alexandra Tard, Stavroula Tasiopoulou, Rudolf Antonius Woutersen

PMID: 32625652 PMCID: PMC7009359 DOI: 10.2903/j.efsa.2018.5047

Abstract

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.

© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: Microcrystalline cellulose (E 460(i)); cross‐linked carboxy methyl cellulose (E 468); enzymatically hydrolysed carboxy methyl cellulose (E 469); ethyl cellulose (E 462); ethyl methyl cellulose (E 465); hydroxypropyl cellulose (E 463); hydroxypropyl methyl cellulose (E 464); methyl cellulose (E 461); powdered cellulose (E 460(ii)); sodium carboxy methyl cellulose (E 466)

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