Safety assessment of poly(2-ethyl-2-oxazoline) for use in food contact materials.

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of poly(2-ethyl-2-oxazoline) intended to be used as an additive to manufacture repeated use filter membranes based on ■■■■■. The filter membranes are used to process aqueous and alcoholic foods, for up to 24 h per day up to ■■■■■ at temperatures up to 35°C. The substance is a polymer with ≤ ■■■■■% w/w low molecular weight fraction (LMWF, < 1000 Da). Migration tests simulated the actual use conditions by repeatedly flushing ■■■■■-based filter membranes with the food simulant 20% ethanol in consecutive contact steps. The specific migration of the sum of the LMW oligomers was below 50 μg/kg food. The specific migration of the monomer and of some impurities was not detected at the respective limits of detection (≤ 4 μg/kg food). The specific migration of the remaining impurities was not measured but calculated and was generally below 0.15 μg/kg food. Genotoxicity studies on 2-hydroxy-N-(hydroxyethyl)propanamide, which is structurally related to the LMW oligomers, demonstrated that the LMW oligomers do not raise a concern for genotoxicity. The in silico assessment of the impurities did not show the presence of structural alerts for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumers if (i) it is used in repeated use ■■■■■-based filter membranes at temperatures up to 35°C for the processing of foodstuffs for which simulants A, B, C are laid down in Regulation (EU) 10/2011, except human milk, liquid infant formula and water that could be used to reconstitute infant formula; and (ii) its content in the filter membrane does not exceed 40.7% w/w, calculated based on the levels of the substance and ■■■■■ in the initial wet membrane solution and considering a residual level of other components of 2% w/w.