Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of basic methacrylate copolymer (BMC) as a glazing agent in solid food supplements and in solid foods for special medical purposes. The NOAELs derived from the main studies are 1000 mg/kg bw/day (developmental study in rat, the only dose level tested) and 2000 mg/kg bw/day (26-week feeding study in rat, highest dose tested). BMC does not raise concern with respect to genotoxicity. No studies on reproductive toxicity were available and the database on developmental toxicity was limited. Therefore no ADI was derived. The estimated combined exposure for heavy users to BMC from both its use in food supplements and in pharmaceuticals is equal to 23.4 mg/kg bw/day for a 60 kg adult and 16 mg/kg bw/day for children (4-18 years). The calculated worst case exposure to the monomers (MMA, BMA, and DMAEMA) is < 50 µg/kg bw/day for adults and < 32 µg/kg bw/day for children, being significantly below the group TDI of 0.1 mg/kg bw/day (as methacrylic acid) set by the SCF. Using the above NOAELs, given a coating level of 100 mg/tablet and a combined exposure from food supplements and pharmaceuticals, the calculated margin of safety (MOS) for heavy users varies from at least 43 to 85 for adults and from 63 to 125 for children. The MOS from the exposure only from food supplements ranges from 85 to 171 for adults and from 125 to 250 for children. In the light of the high molecular weight of the substance, its lack of absorption and its low toxicity profile, the Panel considers these margins of safety adequate. In conclusion the use of BMC as a glazing agent/coating agent in solid food supplements is not of safety concern at the proposed use levels.