Safety assessment of the substance 2,3,3,4,4,5,5-heptafluoro-1-pentene, for use in food contact materials
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of 2,3,3,4,4,5,5-heptafluoro-1-pentene (Chemical Abstracts Service (CAS) No 1547-26-8, Food Contact Materials (FCM) substance No 1063) for use as a comonomer in different combination with the comonomers, ethylene and tetrafluoroethylene, to manufacture fluoropolymers. The fluoropolymer is intended to be used as a polymeric processing agent in a wide range of plastics. Finished articles made with those plastics are intended for contact with all kind of foodstuffs at room temperature or below with no time limit or at high temperatures. Worst-case migration of the substance, of the sum of its impurities and of fluoropolymer low molecular weight oligomers below 1,500 Da from finished articles were estimated to be 0.02 μg/kg food, below 0.02 μg/kg food and 1.5 μg/kg food, respectively. Based on negative results in a bacterial mutation assay and in an in vivo combined micronucleus/comet assay, the Panel considers that the substance does not give rise to concern for genotoxicity. In view of the worst-case migration calculations for the impurities and the oligomers, the lack of genotoxicity of the substance and the mechanism of polymerisation, no additional data are requested on impurities or oligomers. The CEF Panel concluded that 2,3,3,4,4,5,5-heptafluoro-1-pentene does not raise a safety concern for the consumer if used as comonomer together with tetrafluoroethylene and/or ethylene comonomers to manufacture fluorocopolymers for application as a polymer processing aid at up to 0.2% w/w of the FCM. For this application, the low molecular weight fraction below 1,500 Da in the fluorocopolymer should be no greater than 30 mg/kg.
The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information has been provided under the confidentiality framework and has been redacted awaiting the decision of the Commission: the level of impurities in heptafluoropentene; the maximum amount of heptafluoropentene intended to be used to manufacture fluorocopolymers; the residual amount of heptafluoropentene in fluorocopolymers; methods of analysis of extractable amount of oligomers in fluorocopolymers; the level of the oligomeric faction below 1,500 Da in fluorocopolymers; the maximum amount of the fluorocopolymer intended to be used as processing aid to manufacture plastics; and the migration potential of impurities from plastics