Scientific Opinion on the safety of neutral methacrylate copolymer for the proposed uses as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of neutral methacrylate copolymer (NMC, a 30% dispersion of the dry copolymer in water) as a glazing agent in solid food supplements and solid foods for special medical purposes (FSMPs). The dispersion contains 0.7% of polyethylene glycol monostearyl ether, which is not a authorised food additive; the opinion does not include a safety evaluation of this substance. From studies on metabolism/toxicokinetics, acute and subchronic oral toxicity, genotoxicity, and developmental toxicity it is concluded that NMC is essentially not absorbed and that any absorbed material is not retained in the tissues. No data on reproductive toxicity, chronic toxicity and carcinogenicity are provided. In the absence of such data, chronic effects on the gastrointestinal tract following oral administration cannot be excluded. Therefore, the Panel considers that an ADI should not be established and that a margin of safety (MOS) approach is appropriate. Data from in vitro Ames and mammalian cell mutation assays and an in vivo micronucleus assay show that NMC does not raise concern with respect to genotoxicity. The calculated anticipated exposure (coating level 200 mg/tablet) to NMC from both its proposed use in food supplements and its approved use in pharmaceuticals is 46.7 mg/kg bw/day for high consumer adults, and 32 mg/kg bw/day for children. Two subchronic toxicity studies in rats and a developmental study in rabbits revealed NOAELs of 2000 mg/kg/bw/day (highest dose level tested) resulting in a MOS of at least 43 for adults and at least 63 for children. The Panel considers these margins of safety sufficient given the lack of absorption and that the exposure estimates are based on worst case assumptions. The Panel concludes that the use of NMC in solid food supplements at the proposed use and use levels is not of safety concern. The Panel could not assess the safety of neutral methacrylate copolymer for uses in solid foods for special medical purposes.