Open AccessScientific 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
Author(s) -
Flavourings
Publication year - 2012
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2012.2825
Subject(s) - food contact materials , genotoxicity , polycarbonate , monomer , micronucleus test , food additive , food packaging , food safety , chemistry , food science , polymer , toxicology , organic chemistry , toxicity , biology
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.