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

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, Vittorio Silano, Claudia Bolognesi, Kevin Chipman, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn & 5 others Martine Kolf-Clauw, Eugenia Lampi, Kettil Svensson, Ellen Van Haver, Laurence Castle

Research output: Contribution to specialist publicationArticle

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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).
Original languageEnglish
Pagese05014
Volume15
No.10
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Oct 2017

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safety assessment
plastics
epoxides
dietary fiber
kitchens
flavorings
polyesters
diffusivity
ambient temperature
manufacturing
detection limit
hydrolysis
glass fibers
extracts
enzymes
temperature

Keywords

  • [3-(23-epoxypropoxy)propyl]trimethoxy silane
  • CAS No 2530-83-8
  • FCM substance No 01068
  • glass-fibre-reinforced plastics
  • food contact materials
  • safety assessment

Cite this

EFSA Panel on Food Contact Materials Enzymes, F. A. P. A. CEF., Silano, V., Bolognesi, C., Chipman, K., Cravedi, J-P., Engel, K-H., ... Castle, L. (2017). Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials. EFSA Journal, 15(10), e05014. https://doi.org/10.2903/j.efsa.2017.5014

Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials. / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia; Chipman, Kevin; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Milana, Maria Rosaria; Pfaff, Karla; Riviere, Gilles; Srinivasan, Jannavi; Tavares Poças, Maria de Fátima; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Kolf-Clauw, Martine; Lampi, Eugenia; Svensson, Kettil; Van Haver, Ellen; Castle, Laurence.

In: EFSA Journal, Vol. 15, No. 10, 10.2017, p. e05014.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, Silano, V, Bolognesi, C, Chipman, K, Cravedi, J-P, Engel, K-H, Fowler, P, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Pfaff, K, Riviere, G, Srinivasan, J, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Kolf-Clauw, M, Lampi, E, Svensson, K, Van Haver, E & Castle, L 2017, 'Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials' EFSA Journal, vol. 15, no. 10, pp. e05014. https://doi.org/10.2903/j.efsa.2017.5014
EFSA Panel on Food Contact Materials Enzymes FAPACEF, Silano V, Bolognesi C, Chipman K, Cravedi J-P, Engel K-H et al. Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials. EFSA Journal. 2017 Oct;15(10):e05014. https://doi.org/10.2903/j.efsa.2017.5014
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia ; Chipman, Kevin ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Mennes, Wim ; Milana, Maria Rosaria ; Pfaff, Karla ; Riviere, Gilles ; Srinivasan, Jannavi ; Tavares Poças, Maria de Fátima ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Kolf-Clauw, Martine ; Lampi, Eugenia ; Svensson, Kettil ; Van Haver, Ellen ; Castle, Laurence. / Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials. In: EFSA Journal. 2017 ; Vol. 15, No. 10. pp. e05014.
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AB - 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).

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