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
Meta data
Competing interests: One member of the Panel did not participate in the discussion because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests
Abstract
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.