Scientific Opinion on the safety evaluation of the substance, 2H‐perfluoro‐[(5,8,11,14‐tetramethyl)‐tetraethyleneglycol ethyl propyl ether] CAS No 37486‐69‐4 for use in food contact materials

Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the substance 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] (CAS No 37486-69-4, FCM substance No 903), for use as polymer production aid (PPA) for manufacturing sintered and non-sintered (processed) fluoropolymers. Finished articles are intended to be used for single and repeated contact with all kinds of foodstuffs at all temperatures. Residual content of the substance was not detected in sintered or processed (non-sintered) articles at temperatures at or above 360 °C and was detected in fluoropolymers processed (non-sintered) at 300 °C from which total mass transfer was calculated to be 13 µg/kg food. Based on migration modelling under highly conservative assumptions, estimated migration of the substance present at the measured residual level in articles processed (non-sintered) at temperatures of 300 °C, is in the range of 1 µg/kg. For repeated use applications, migration at each following use will be considerably lower. Based on negative results from three adequately performed in vitro genotoxicity tests, the Panel considered that the substance is non-genotoxic. The CEF Panel concluded that there is no safety concern for the consumer if the substance 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] is only used as a polymer production aid in the polymerisation of fluoropolymers intended for a) repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times, b) repeated use materials and articles only when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.