E1205 — Basic methacrylate copolymer
Why it’s used
A synthetic cationic polymer made from butyl methacrylate, methyl methacrylate, and dimethylaminoethyl methacrylate monomers. It is used as a film-coating and glazing agent on tablets and micronutrient particles in solid dietary supplements, forming a protective, quick-dissolving layer that shields sensitive vitamins and minerals from moisture and oxidation during storage.
Other names
Eudragit E, Eudragit E 100, Eudragit E PO, Amino methacrylate copolymer, Basic butylated methacrylate copolymer
Diet flags
Regulatory status
FDA has no affirmed GRAS listing or food-additive regulation covering basic methacrylate copolymer; the only GRAS notice ever filed for it, GRN 710, was closed at the notifier's request in December 2017 before FDA completed its review, so no confirmed FDA food-use determination exists. Source (2026-07-24)
Authorised in the EU only as a glazing/coating agent for solid food supplements and solid foods for special medical purposes under Annex II to Regulation (EC) No 1333/2008, not for general food use. Source (2026-07-24)
Regulatory status by region
The 2017 GRAS notice for basic methacrylate copolymer as a micronutrient coating was withdrawn before FDA finished evaluating it, leaving US use to rely on an unconfirmed, self-determined GRAS conclusion rather than an FDA 'no questions' letter. The EU, by contrast, has a specific but narrow Annex II authorisation limited to glazing/coating solid food supplements and foods for special medical purposes, added by Commission Regulation (EU) No 1129/2011 with specifications set in Regulation (EU) No 231/2012.
In the EU, basic methacrylate copolymer holds a positive but narrow entry on Annex II to Regulation (EC) No 1333/2008, added by Commission Regulation (EU) No 1129/2011 and covering only glazing/coating of solid food supplements and foods for special medical purposes — not general food use, and not the micronutrient-coating use that prompted the US GRAS filing. Purity specifications for the accepted use were fixed separately in Regulation (EU) No 231/2012. Because FDA never completed its own review, this EFSA-supported authorisation stands as the only completed regulatory food-safety assessment on record for the polymer, even though its scope is deliberately narrower than a general food-additive approval would be.
Found in these products
None of the products in our database currently contain E1205.