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

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. T...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009953/
https://www.ncbi.nlm.nih.gov/pubmed/32625304
http://dx.doi.org/10.2903/j.efsa.2017.5014
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author 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
author_facet 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
collection PubMed
description 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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spelling pubmed-70099532020-07-02 Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials 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 EFSA J Scientific Opinion 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). John Wiley and Sons Inc. 2017-10-27 /pmc/articles/PMC7009953/ /pubmed/32625304 http://dx.doi.org/10.2903/j.efsa.2017.5014 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
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
title Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
title_full Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
title_fullStr Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
title_full_unstemmed Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
title_short Safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
title_sort safety assessment of the substance [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009953/
https://www.ncbi.nlm.nih.gov/pubmed/32625304
http://dx.doi.org/10.2903/j.efsa.2017.5014
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