Scientific Opinion on the safety assessment of the substances tetraethyl orthosilicate, CAS No. 78-10-4, and hexamethyldisilazane, CAS No. 999 97 3, for use in food contact materials

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Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion and EFSA staff: Joaquim Maia, for the support provided to this scientific opinion.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4337 [7 pp.].
doi
10.2903/j.efsa.2016.4337
Possible conflict of interest
Two members of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Ministry of Health, Welfare and Sport, the Netherlands
Question Number
EFSA-Q-2012-01011
EFSA-Q-2013-00029
Adopted
2 December 2015
Published
12 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of tetraethyl orthosilicate (TEOS), Chemical Abstract Service (CAS) No 78-10-4, Food Contact Material (FCM) substance No 01013, and hexamethyldisilazane (HMDS), CAS No 999-97-3, Ref. No 18455 and FCM substance No 01014. According to the applicant, the two substances are used together as a chain extender for polyethylene terephthalate (PET) to increase the molecular weight of the polymer after recycling. Final articles are intended for contact with all types of foodstuffs for long-term storage at room temperature, with- or without prior pasteurisation at up to 70°C. Specific migration tests for TEOS and HMDS were not performed. Instead, the residual content of the substances in a recycled PET polymer manufactured with the modifier mixture was determined. The substances were not detected at detection levels up to 4 µg/6 dm2, supporting that the substances react completely with the PET chains. In a migration study, a recycled PET modified using the mixture was compared with virgin PET. All detected migrating substances corresponded to oligomers identical to those from the virgin PET, at a detection level estimated to be 3 μg/kg. Based on the toxicological data provided, the CEF Panel concluded that there is no indication of a genotoxic potential for TEOS. HMDS was evaluated in 2007 by the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC). As HMDS is rapidly converted into hexamethyldisiloxane (HMDSO) in humid air or aqueous media, the genotoxic potential of HMDS is covered by the genotoxicity data for HMDSO. The AFC Panel concluded that HMDSO was non-genotoxic. The CEF Panel concluded therefore that the mixture composed of TEOS and HMDS in a ratio of 97:3 does not raise a safety concern for the consumer if it is used at up to 0.12% (w/w) for the production of recycled PET. 

Keywords
tetraethyl orthosilicate; CAS No 78-10-4; FCM substance No 01013; hexamethyldisilazane; CAS No 999-97-3; FCM substance No 01014
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Number of Pages
7