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Re‐evaluation of silicon dioxide (E 551) as a food additive

Younes, Maged ; Aggett, Peter ; Aguilar, Fernando ; Crebelli, Riccardo ; Dusemund, Birgit ; Filipič, Metka ; Frutos, Maria Jose ; Galtier, Pierre ; Gott, David ; Gundert‐Remy, Ursula ; Kuhnle, Gunter Georg ; Leblanc, Jean‐Charles ; Lillegaard, Inger Therese ; Moldeus, Peter ; Mortensen, Alicja ; Oskarsson, Agneta ; Stankovic, Ivan ; Waalkens‐Berendsen, Ine ; Woutersen, Rudolf Antonius ; Wright, Matthew ; Boon, Polly ; Chrysafidis, Dimitrios ; Gürtler, Rainer ; Mosesso, Pasquale ; Parent‐Massin, Dominique ; Tobback, Paul ; Kovalkovicova, Natalia ; Rincon, Ana Maria ; Tard, Alexandra ; Lambré, Claude

EFSA journal, 2018-01, Vol.16 (1), p.e05088-n/a [Peer Reviewed Journal]

Hoboken: John Wiley & Sons, Inc

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Title:
Re‐evaluation of silicon dioxide (E 551) as a food additive
Author: Younes, Maged ; Aggett, Peter ; Aguilar, Fernando ; Crebelli, Riccardo ; Dusemund, Birgit ; Filipič, Metka ; Frutos, Maria Jose ; Galtier, Pierre ; Gott, David ; Gundert‐Remy, Ursula ; Kuhnle, Gunter Georg ; Leblanc, Jean‐Charles ; Lillegaard, Inger Therese ; Moldeus, Peter ; Mortensen, Alicja ; Oskarsson, Agneta ; Stankovic, Ivan ; Waalkens‐Berendsen, Ine ; Woutersen, Rudolf Antonius ; Wright, Matthew ; Boon, Polly ; Chrysafidis, Dimitrios ; Gürtler, Rainer ; Mosesso, Pasquale ; Parent‐Massin, Dominique ; Tobback, Paul ; Kovalkovicova, Natalia ; Rincon, Ana Maria ; Tard, Alexandra ; Lambré, Claude
Subjects: Brand loyalty ; CAS 112926‐00‐8 ; CAS 112945‐52‐5 ; CAS 7631‐86‐9 ; E 551 ; Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi ; Food additives ; Food sources ; Genotoxicity ; Indication ; Microscopy ; Nanomaterials ; Nanoparticles ; Nutrient sources ; Oral administration ; Particle size ; Particle size distribution ; Physicochemical properties ; Public Health, Global Health, Social Medicine and Epidemiology ; SAS ; Scientific Opinion ; Side effects ; Silica ; Silica fume ; Silica gel ; Silicates ; Silicon ; Silicon dioxide ; Size distribution ; Specifications ; Toxicity ; Toxicity testing
Is Part Of: EFSA journal, 2018-01, Vol.16 (1), p.e05088-n/a
Notes: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
Question number: EFSA‐Q‐2011‐00576
Acknowledgements: The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
Adopted: 23 November 2017
Amended: 1 March 2018
Panel members: Peter Aggett, Fernando Aguilar, Riccardo Crebelli, 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, Ine Waalkens‐Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Requestor: European Commission
Description: The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of silicon dioxide (E 551) when used as a food additive. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. SAS materials used in the available biological and toxicological studies were different in their physicochemical properties; their characteristics were not always described in sufficient detail. Silicon dioxide appears to be poorly absorbed. However, silicon‐containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. E 551 does not raise a concern with respect to genotoxicity. In the absence of a long‐term study with nano silicon dioxide, the Panel could not extrapolate the results from the available chronic study with a material, which does not cover the full‐size range of the nanoparticles that could be present in the food additive E 551, to a material complying with the current specifications for E 551. These specifications do not exclude the presence of nanoparticles. The highest exposure estimates were at least one order of magnitude lower than the no observed adverse effect levels (NOAELs) identified (the highest doses tested). The Panel concluded that the EU specifications are insufficient to adequately characterise the food additive E 551. Clear characterisation of particle size distribution is required. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. Because of the limitations in the available database, the Panel was unable to confirm the current ADI ‘not specified’. The Panel recommended some modifications of the EU specifications for E 551.
Publisher: Hoboken: John Wiley & Sons, Inc
Language: English

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Re‐evaluation of silicon dioxide (E 551) as a food additive

Hoboken: John Wiley & Sons, Inc

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