• Open Access

Scientific Opinion on the safety evaluation of the substance, 1,3-bis(isocyanatomethyl)benzene, CAS No. 3634–83-1 for use in food contact materials


  • EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

  • Panel members: Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Fatima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá, Detlef Wölfle
  • Correspondence: cef@efsa.europa.eu
  • Acknowledgement: The European Food Safety Authority wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this scientific opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot, Maria Rosaria Milana, Karla Pfaff, Fatima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this EFSA scientific opinion.
  • Adoption date: 5 July 2012
  • Published date: 24 July 2012
  • Question number: EFSA-Q-2012-00062
  • On request from: Ministry for Health, Welfare and Sport, the Netherlands


This scientific opinion of EFSA deals with the risk assessment of the monomer 1,3-bis(isocyanatomethyl) benzene, CAS No. 3634–83-1, FCM Substance No 988. In water and gastric fluid simulant, immediate and complete hydrolysis of the substance to 1,3-benzenedimethanamine occurs. The toxicity of 1,3-bis(isocyanatomethyl)benzene was tested in three in vitro genotoxicity tests, with and without metabolic activation and in an in vivo micronucleus assay in rats and was considered as non-genotoxic in vivo. In addition, its hydrolysis product, 1,3-benzenedimethanamine, was tested in two in vitro tests, in the presence and absence of a metabolising system, and one in vivo mouse micronucleus assay. The tests were negative. No concern for genotoxicity in vivo is raised by 1,3-bis(isocyanatomethyl)benzene and its hydrolysis product 1,3-benzenedimethanamine. The CEF Panel concluded that that the use of the substance 1,3-bis(isocyanatomethyl)benzene as co-monomer in the manufacture of a middle layer coating in a multilayer film does not raise safety concern if the migration of its hydrolysis product, 1,3-benzenedimethanamine, does not exceed 0.05 mg/kg food.