Scientific Opinion on the safety evaluation of the substance, Methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/ or methacrylic acid alkyl (C1-C4) esters, for use in food contact materials
This scientific opinion of EFSA deals with the safety evaluation of the substance methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/ or methacrylic acid alkyl (C1-C4) esters, REF. No 65841 and FCM Substance No 958, for use in PVC coatings for food cans. Migration tests with a representative substance, methacrylic acid, 2,3-epoxypropyl ester, copolymer with methacrylic acid, ethyl ester, showed that migration of the monomers was not detectable (detection limit below 0.02/6 dm2) while the migration of oligomers with a molecular weight below 1000 Da was up to 0.016 mg/6 dm2. No chlorinated species were detected. The oligomeric fraction and the corresponding chlorinated oligomers were tested in three in vitro and two in vivo genotoxicity tests and they were considred as non-genotoxic. Based on the available results of these genotoxicity tests, the Panel considered that there is no concern with respect to genotoxicity in vivo. The oligomeric fraction was also rested in a 90-day oral study in rat and the NOAEL derived was 150 mg/kg b.w. per day. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as additive up to 25 % in PVC coatings for contact with all types of foodstuffs except for beer and beverages, under all conditions of time and temperature including sterilisation followed by long term storage.