Safety assessment of the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate, for use in food contact materials
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety evaluation of the substance diethyl[[3,5-bis(1,1dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate. The substance with the CAS no 976-56-7 and the food contact materials (FCM) substance no 1007 is intended to be used in the polymerisation reaction to make poly(ethyleneterephthalate) (PET) plastic. The substance is intended to become a component of the backbone of the polymer and function as an antioxidant, providing thermal stability to the polyester during heat processing. The applications intended are contact with all types of food under any condition of time and temperature. A PET sample made with 0.2% w/w of the substance (i.e. twice the maximum intended) was subjected to a comprehensive set of migration tests. Migration of the substance was not detectable, with detection limits in the range of 3–6 lg/kg for the different simulants used. Using the results provided from a range of extraction and migration tests conducted on the PET sample, the Panel concluded that the potential migration into food of any impurities and possible reaction products coming from the substance was well below 2 lg/kg. Based on negative results from four in vitro genotoxicity tests, the Panel concluded that there is no evidence of genotoxicity of the substance. The substance is an organophosphorus compound but due to its low migration, there is no concern for neurotoxicity. Considering the structures and the low migration of the impurities and reaction products, the Panel concluded that they do not give rise to safety concern. The CEF Panel concluded therefore that the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4hydroxyphenyl]methyl]phosphonate does not raise a safety concern for the consumer if used up to 0.2% w/w (based on the weight of the polymer) in the polymerisation to make PET intended for contact with all types of foods under any contact conditions.