Scientific Opinion on the safety assessment of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform 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 the additive (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, FCM substance No 01016, intended to be used at up to 10 % w/w as an impact modifier in rigid non-plasticised polyvinylchloride and up to 15 % w/w in non-plasticised polylactic acid. The final materials are intended to be used for contact with all food types, at room temperature or below, for long-term storage. The monomers constituting the copolymer are listed in Regulation (EU) No 10/2011. The migration of the low-molecular-weight fraction of the additive below 1 000 Da was estimated to be about 0.008 mg/kg food from polyvinylchloride and about 0.007 mg/kg food from polylactic acid. Considering that these low-molecular-weight oligomers are made from authorised monomers, which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concerns. The migration of the additive in nanoparticle form from the polyvinylchloride and polylactic acid was estimated, using conservative migration modelling, to be in the range 1 to 1.3 × 10^–6 mg/kg food. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as an additive at up to 10 % (w/w) in rigid polyvinylchloride and up to 15 % (w/w) in non-plasticised polylactic acid, used in contact with all food types at ambient temperature or below for long-term storage.