On February 17, 2015 the European Food Safety Authority (EFSA) published a scientific opinion dealing with the safety assessment of a new additive copolymer in nanoform for use in food contact materials (FCMs). The polymer constitutes of the following monomers listed in the Plastics Regulation (EU) No 10/2011: methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene. The substance was evaluated by the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) for its use as an additive in rigid non-plasticized polyvinylchloride (PVC) at up to 10% and in non-plasticized polylactic acid (PLA) at up to 15%. Migration of the low-molecular-weight (LMW) fraction of the additive (<1000 Da) was estimated to be about 0.008 mg/kg food from PVC and 0.007 mg/kg food from PLA. Since these LMW oligomers are made from already authorized monomers, they do not give rise to safety concerns. Migration of the additive in nanoparticle form was modeled to be in the range 1 to 1.3×10–6 mg/kg food. The opinion stresses that real migration, if any, is expected to be even lower and thus consumer exposure would be negligible. Therefore, the evaluated substance is not of safety concern at the proposed level of use. It can be in contact with any type of foods for long-term storage at room temperature or below.
CEF (February 17, 2015). “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.” EFSA Journal 2015;13(2): 4008.