TY - GEN
T1 - Safety assessment of the substance [3-(2,3-epoxypropoxy)propyl]trimethoxy silane, for use in food contact materials
AU - EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF)
AU - Silano, Vittorio
AU - Bolognesi, Claudia
AU - Chipman, Kevin
AU - Cravedi, Jean-Pierre
AU - Engel, Karl-Heinz
AU - Fowler, Paul
AU - Grob, Konrad
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Kärenlampi, Sirpa
AU - Mennes, Wim
AU - Milana, Maria Rosaria
AU - Pfaff, Karla
AU - Riviere, Gilles
AU - Srinivasan, Jannavi
AU - Tavares Poças, Maria de Fátima
AU - Tlustos, Christina
AU - Wölfle, Detlef
AU - Zorn, Holger
AU - Kolf-Clauw, Martine
AU - Lampi, Eugenia
AU - Svensson, Kettil
AU - Van Haver, Ellen
AU - Castle, Laurence
PY - 2017/10
Y1 - 2017/10
N2 - 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).
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).
KW - [3-(23-epoxypropoxy)propyl]trimethoxy silane
KW - CAS No 2530-83-8
KW - FCM substance No 01068
KW - glass-fibre-reinforced plastics
KW - food contact materials
KW - safety assessment
U2 - 10.2903/j.efsa.2017.5014
DO - 10.2903/j.efsa.2017.5014
M3 - Article
SN - 1831-4732
VL - 15
SP - e05014
JO - EFSA Journal
JF - EFSA Journal
PB - European Food Safety Authority (EFSA)
ER -