Toxicology and genotoxicity
Laboratory studies in the early 2010s examined whether anionic methacrylate copolymer or its breakdown products could damage DNA or cause genetic mutations. The studies found no evidence of genotoxicity. Bioavailability work confirmed very little of the polymer is absorbed into the body after oral ingestion; most passes through and is excreted intact or as small fragments.
Toxicological assessment found no genotoxic activity in standard battery tests and very low systemic bioavailability after oral exposure.
2016LabRegulatory Toxicology and Pharmacology (ScienceDirect), Toxicological assessment of Anionic Methacrylate Copolymer series
EFSA safety review
In 2010 the European Food Safety Authority reviewed the evidence and concluded that use as a coating agent in solid food supplements did not raise a safety concern at the proposed levels. The margin of safety was calculated at least 43-fold for adults and at least 63-fold for children. EFSA noted it could not fully evaluate safety for use in foods for special medical purposes (FSMP) due to insufficient data, and no subsequent EFSA opinion resolved this gap. When the European Commission formally authorised E1207 in 2013, it restricted the permission to solid food supplements only; FSMP was not included.
EFSA concluded that anionic methacrylate copolymer as a glazing and coating agent in solid food supplements does not raise a safety concern at the discussed use levels, with a margin of safety of at least 43 for adults and 63 for children.
2010Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), Scientific Opinion on the safety of anionic methacrylate copolymer for the proposed uses as a food additive
EFSA noted insufficient data to assess safety for use in solid foods for special medical purposes, representing a data gap. The 2013 Commission authorisation (Regulation (EU) No 816/2013) addressed this by restricting E1207 to food category 17.1 (solid food supplements) only, excluding FSMP.
2013Regulatory reviewEFSA ANS Panel, EFSA Journal 2010; Commission Regulation (EU) No 816/2013