Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials

[3-(23-epoxypropoxy)propyl]trimethoxy silane, CAS No 2530-83-8, FCM substanceNo 01068, glass-fibre-reinforced plastics, food contact materials, safety assessment
First published in the EFSA Journal
27 October 2017
Adopted
21 September 2017
Type
Scientific Opinion

Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of [3-(2,3-epoxypropoxy)propyl]trimethoxy silane as a component for sizing glass fibres used for manufacturing glass-fibre-reinforced plastics. The substance is typically applied at up to around 0.2% related to the final plastic. The resulting food contact materials are intended for various scenarios of use, i.e. long-term contact at ambient temperature (e.g. storage tanks) or short-term contact at elevated temperatures (e.g. kitchen utensils). In extracts of treated fibres, neither the substance was detectable at 10 μg/kg fibre nor its hydrolysis product and oligomers at 60 μg/kg fibre. Based on the detection limits, modelling for the plastics and scenarios of intended use resulted in maximum migrations of 0.05 μg/kg food for the substance and 0.15 μg/kg food for the sum of the reaction products. The Panel concludes that the substance has a genotoxic potential. This may also apply to some of its reaction products which contain the epoxy function. However, due to the very low exposure, if any, [3-(2,3-epoxypropoxy)propyl]trimethoxy silane does not raise safety concern if used as a component of sizing agents to treat glass fibres imbedded into low diffusivity plastics (polyethylene terephthalate, polycarbonate, polybutylene terephthalate, thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In addition, the residues in the treated glass fibres must not be detectable at 10 μg/kg for the substance and 60 μg/kg for each of the reaction products (hydrolysed monomers and epoxy-containing cyclic dimer, trimer and tetramer).

Panel members at the time of adoption

Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Vittorio Silano, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2017.5014
EFSA Journal 2017;15(10):5014
Question Number
On request from
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany
Competing interests
In line with EFSA's policy on declarations of interest, Panel member Roland Franz did not participate in the development and adoption of this scientific output.

The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information has been provided under the confidentiality framework and has been redacted awaiting the decision of the Commission: the data provided on the impurities of the products manufactured by three producers of the project consortium of silane and glass fibre producers.