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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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SCIENTIFIC OPINION ADOPTED: 27 September 2017 doi: 10.2903/j.efsa.2018.5047 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 Panel on Food Additives and Nutrient Sources added to Food (ANS), Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Metka Filipic, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambre, 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 and Rudolf Antonius Woutersen 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 on the re-evaluation 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) and enzymatically hydrolysed carboxy methyl cellulose (E 469) 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)), 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), cross-linked carboxy methyl cellulose (E 468), enzymatically hydrolysed carboxy methyl cellulose (E 469) www.efsa.europa.eu/efsajournal EFSA Journal 2018;16(1):5047 Re-evaluation of celluloses (E 460(i), E 460(ii), E 461À466, E 468 and E 469) as food additives Requestor: European Commission Question numbers: EFSA-Q-2011-00545, EFSA-Q-2011-00546, EFSA-Q-2011-00547, EFSA-Q-2011- 00548, EFSA-Q-2011-00551, EFSA-Q-2011-00549, EFSA-Q-2011-00550, EFSA-Q-2011-00552, EFSA-Q- 2011-00553, EFSA-Q-2011-00554 Correspondence: fi[email protected] Panel members: Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipic, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambre, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Acknowledgements: The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies, other organisations that provided data for this scientific output and Alessandra Giarola. Suggested citation: EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Younes M, Aggett P, Aguilar F, Crebelli R, Di Domenico A, Dusemund B, Filipic M, Jose Frutos M, Galtier P, Gott D, Gundert-Remy U, Georg Kuhnle G, Lambre C, Leblanc J-C, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Tobback P, Waalkens-Berendsen I, Wright M, Tard A, Tasiopoulou S and Woutersen RA, 2018. Scientific Opinion on the 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;16(1):5047, 104 pp. https://doi.org/10.2903/j.efsa.2018.5047 ISSN: 1831-4732 © 2018 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 Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(1):5047 Re-evaluation of celluloses (E 460(i), E 460(ii), E 461À466, E 468 and E 469) as food additives Summary 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. These celluloses are authorised as food additives in accordance with Annex II and Annex III of Regulation (EC) No 1333/2008. Cellulose is a linear glucose homopolymer consisting of glucopyranose units linked by b-1,4- glycosidic bonds; its molecular formula is (C6H10O5)m, with the degree of polymerisation (DP) dependent on the origin of the cellulolytic material. Cellulose molecular weight has been calculated to be approximately in the range 50,000–2,500,000. In modified celluloses, the chemical and physical characteristics of the native substances are modified in order to confer different technological properties for particular food applications. Microcrystalline cellulose is purified, partially depolymerised cellulose prepared by treating a- cellulose, obtained as a pulp from strains of fibrous plant material, while powdered cellulose is purified, mechanically disintegrated cellulose prepared by processing a-cellulose. Methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464) and ethyl methyl cellulose (E 465) are celluloses obtained synthetically from fibrous plant material. Each of the celluloses is partially etherified with methyl groups, ethyl groups, hydroxypropyl groups and contains a small degree of hydroxypropyl substitution, and methyl and ethyl groups, respectively. Microcrystalline cellulose (E 460(i)) and powdered cellulose (E 460(ii)) have been previously evaluated by the Scientific Committee on Food (SCF), the most recent evaluation dating in 1999. In 1999, the SCF assessed additional toxicological data and confirmed the ‘ADI not specified’, established in 1978. As a matter of precaution, the Committee repeated the advice given in 1995, according to which, the particle size should not be lower than 5 lm with a tolerance of 10% by the number of particles. The latest evaluation of methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), methyl ethyl cellulose (E 465), carboxy methyl cellulose (E 466) by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) was done in 1989 (JECFA, 1990), where an acceptable daily intake (ADI) ‘not specified’ was established for each modified cellulose. Latest evaluation of enzymatically hydrolysed carboxy methyl cellulose (E 469) was done in 1998 (JECFA, 1999a,b) and an ADI ‘not specified’ was established. The ADI for cross-linked sodium carboxy methyl cellulose previously established by JECFA (2003) is ‘not specified’ based on the substance being poorly absorbed and of low toxicity, with which is in agreement with the known low toxicity of other modified celluloses. Animal and human data clearly demonstrated that microcrystalline cellulose (E 460(i)) and powdered cellulose (E 460(ii)) are not absorbed intact in the gastrointestinal tract and could be fermented during their passage through the large intestine by strains of bacteria found in the human colon. Data for methyl cellulose (E 461), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), cross-linked sodium carboxy methyl cellulose (E 468) and enzymatically hydrolysed carboxy methyl cellulose (E 469) demonstrated that these modified celluloses are not absorbed intact, not fermented and are excreted intact via the faeces.
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