Scientific Opinion on the safety of anionic 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 anionic methacrylate copolymer (AMC, a 30% dispersion of the dry copolymer in water) as a coating agent for solid food supplements and solid foods for special medical purposes (FSMPs). The dispersion contains 0.3% sodium lauryl sulphate, which is not an authorised food additive. The opinion does not include a safety evaluation of this substance. From studies on toxicokinetics, acute and subchronic oral toxicity, genotoxicity, and developmental toxicity it is concluded that AMC is essentially not absorbed and that if any very low amounts of material were absorbed such material would not be retained in the tissues. No data on reproductive toxicity, chronic toxicity and carcinogenicity are provided. In the absence of such data, chronic effects in 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 do not raise concern with respect to genotoxicity. A subchronic toxicity study and a developmental toxicity study in the rat provided NOAELs of respectively 1500 mg/kg bw/day (highest dose tested) and 1000 mg/kg bw/day (one dose tested). The anticipated exposure to AMC from both its use in food supplements and in pharmaceuticals is 23.4 mg/kg bw/day for high consumer adults and 16 mg/kg bw/day for children. From the NOAELs, a coating level of 100 mg/tablet AMC and a combined exposure (food supplements and pharmaceuticals), MOS values between 43 to 64 for adults and 63 to 94 for children were calculated. The Panel considers these MOS sufficient given the lack of absorption and that the exposure estimates are based on worst case assumptions. The Panel concludes that the use of AMC in solid food supplements at the proposed use and use levels is not of safety concern. The Panel could not assess the safety of anionic methacrylate copolymer for uses in solid foods for special medical purposes.