• Open Access

Scientific Opinion on the safety evaluation of the substance, 2-phenyl-3, 3-bis(4-hydroxyphenyl)phthalimidine, CAS No. 6607–41-6, 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 Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this 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-2009-00834
  • On request from: Food Standards Agency, United Kingdom


This scientific opinion of EFSA deals with the risk assessment of the substance 2-phenyl-3, 3-bis(4-hydroxyphenyl)phthalimidine with the CAS No. 6607–41-6 and the FCM substance No 872, for use as a co-monomer for manufacturing polycarbonate polymers intended to be used for single and repeated contacts with all kinds of foodstuffs without restriction in time and temperature. Based on three in vitro genotoxicity tests and a mouse micronucleus test in vivo on the substance, the Panel considered that there is no concern with respect to genotoxicity of the substance. The CEF Panel concluded that there is no safety concern for the consumer if 2-phenyl-3, 3-bis(4-hydroxyphenyl)phthalimidine is used as a co-monomer in polycarbonate copolymer and its migration does not exceed 0.05 mg/kg food. Potential migration of aniline, an impurity of the substance, should be in compliance with the restriction set in the Commission Regulation (EU) No 10/2011, i.e. not detectable.