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EFSA Scientific Opinion Silicon dioxide

Silicon dioxide, silanated, has been authorised for use as an additive in all types of plastics as part of a re-evaluation according to the European Food Safety Authority (EFSA). A scientific opinion was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nano-form.

 

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 nano-form. 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

 

 

Original-Publication:

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Statement on the safety assessment of the substance silicon dioxide, silanated, FCM Substance No 87 for use in food contact materials. EFSA Journal 2014;12(6):3712,7pp. doi:10.2903/j.efsa.2014.3712

 

 

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Information on the sponsorship programmes of the German Federal Ministry of Education and Research on nanotechnologies for humans and the environment.

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Knowledge Base

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A database with important and generally understandable aspects on health and environment of applied nanomaterials as well as facts on the safety of manufactured nanomaterials.

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The chapters on release, exposure, uptake and behavior of nanomaterials in the human body and in the environment as well as the risk assessment will give you a first overview.

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