Scientific Opinion on the safety evaluation of the substance, methacrylic acid, 2-hydroxypropyl ester, CAS No 27813-02-1, for use in food contact materials

Abstract

This scientific opinion of EFSA deals with the safety evaluation of the monomer methacrylic acid, 2-hydroxypropyl ester (synonym: 2-hydroxypropyl methacrylate - HPMA), FCM Substance No 995, to be used as monomer in acrylic resin coatings for food cans at use levels up to 20%. No HPMA monomer was determined in the acetonitrile extract of coated cans at a detection limit corresponding to a maximum migration of 3 µg/6 dm². In the acetonitrile extract the oligomeric fraction with MW < 1000 Da containing the HPMA moiety can be estimated to be up to 1.25 mg/kg food assuming total transfer to the food. The toxicity of HPMA was tested in three in vitro genotoxicity tests with and without metabolic activation and in combined in vivo micronucleus and Comet assays in rats and it was considered as non-genotoxic in vivo. In addition, read-across from a 90-day oral study in rat, with a NOAEL of 150 mg/kg b.w./day, for an oligomer with similar structure was considered feasible. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as monomer in acrylic resin coatings for food cans, cured at a temperature of at least 200 °C.