Statement on the safety assessment of the substance silicon dioxide, silanated, FCM Substance No 87 for use in food contact materials

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(6):3712 [7 pp.].
doi
10.2903/j.efsa.2014.3712
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq (until july 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Contact
Type
Statement of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00562
Adopted
21 May 2014
Published
12 June 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The substance silicon dioxide, silanated, with FCM substance No 87, is authorised for use as an additive in all types of plastics, without restriction. The re-evaluation of the substance was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nanoform. Information on the basic (untreated) silicon dioxide, the surface treated silicon dioxide, silanated, and a study investigating the migration potential of the silanated silicon dioxide were provided. Having examined the information provided, the CEF Panel concluded that the information provided demonstrates adequately the absence of isolated primary nanoparticles in the basic silicon dioxide and in the silanated silicon dioxide since only aggregates larger than 100 nm along with larger agglomerates were observed using two independent measurement techniques, one of which was transmission electron microscopy (TEM). The particle size range was not affected when the silanated product was incorporated into a low density polyethylene film at 3 % w/w. Furthermore, there was no detectable migration of silicon dioxide, of any particle size, from this film into appropriate food simulants. Therefore at the particle sizes reported, the substance silicon dioxide, silanated, does not raise a safety concern for the consumer in the currently authorised conditions of use.

Summary

The EU Plastics Regulation 10/2011 which came into force on 1 May 2011 required that all materials in nanoform to be used for food contact materials must be specifically approved and specified under Annex 1 of the regulation. Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Commission, for safety re-evaluation of silicon dioxide, silanated, following information received from EVONIK Industries AG.

The substance silicon dioxide, silanated, with FCM substance No 87 is authorised for use as an additive in all types of plastics, without restriction. The re-evaluation of the substance was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nanoform.

Information on the basic (untreated) silicon dioxide, the surface treated silicon dioxide, silanated, and a study investigating the migration potential of the silanated substance were provided. Having examined the information provided, the CEF Panel concluded that the information provided demonstrates adequately the absence of isolated primary nanoparticles in the basic silicon dioxide and in the silanated silicon dioxide since only aggregates larger than 100nm along with larger agglomerates were observed using two independent measurement techniques, one of which was transmission electron microscopy (TEM). The particle size range was not affected when the silanated product was incorporated into a low density polyethylene film at 3 % w/w. Furthermore, there was no detectable migration of silicon dioxide of any particle size from this film into appropriate food simulants. Therefore at the particle sizes reported, the substance silicon dioxide, silanated, does not raise a safety concern for the consumer in the currently authorised conditions of use.

Keywords
silicon dioxide, silanated, FCM substance No 87, safety assessment, evaluation, nanoparticles
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Number of Pages
7