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Safety assessment of the substance 2,4,4′-trifluorobenzophenone, for use in food contact materials

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Note: 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 limit of detection of food simulant and the highest tested concentration based on the final material have been provided under the confidentiality framework and it is deleted awaiting the decision of the Commission.

Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of 2,4,4′-trifluorobenzophenone (TFB), Chemical Abstracts Service (CAS) No 80512-44-3, Food Contact Materials (FCM) substance No 1061, for use as a co-monomer to manufacture polyether ether ketone (PEEK) plastics. The final articles made of PEEK are intended for repeated use in contact with all types of foods for short-term duration, including at high temperatures. In tests for migration from PEEK under exaggerated test conditions compared to the intended uses, TFB was not detected using a method with a limit of detection of ■■■■■ food simulant. No TFB-related impurities, oligomers or reaction products were detected in the same set of migration tests. No oligomeric fraction below 1,000 Da was found in PEEK samples made without and with TFB used as a co-monomer. The substance was tested in three genotoxicity tests and was considered not to raise a concern for genotoxicity. Therefore, the CEF Panel concluded that TFB is not of safety concern for the consumer if used as co-monomer up to ■■■■■ (the highest tested concentration based on the final material) in the manufacture of PEEK plastics.