E1206 — Neutral methacrylate copolymer
Why it’s used
A synthetic, non-ionic polymer made from ethyl acrylate and methyl methacrylate monomers in roughly equal parts. It is used as a flexible, pH-independent film-coating agent on tablets in solid dietary supplements, giving a moisture-barrier or sustained-release coat around compressed nutrients.
Other names
Eudragit NE, Eudragit NE 30 D, Eudragit NM, Ethyl acrylate-methyl methacrylate copolymer
Diet flags
Regulatory status
No FDA GRAS notice or food-additive regulation was found covering neutral methacrylate copolymer for food use; in the US it appears mainly as a pharmaceutical/dietary-supplement coating excipient outside FDA's food-additive framework. 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, added to Annex II of Regulation (EC) No 1333/2008 by Commission Regulation (EU) No 816/2013. Source (2026-07-24)
Regulatory status by region
Unlike the EU, the US has no dedicated food-additive or notified-GRAS pathway result for neutral methacrylate copolymer, so any US dietary-supplement use rests on unconfirmed self-GRAS or drug-excipient status rather than an FDA-reviewed food determination. The EU authorised it specifically and narrowly for solid food supplements and foods for special medical purposes via Commission Regulation (EU) No 816/2013, which amended Annex II to Regulation (EC) No 1333/2008.
EFSA's role here supported a targeted 2013 expansion of Annex II to Regulation (EC) No 1333/2008: Commission Regulation (EU) No 816/2013 added neutral methacrylate copolymer strictly as a glazing/coating agent for solid food supplements and foods for special medical purposes, not as a general-purpose food additive. That narrow scope means the authorisation says nothing about broader food uses — outside supplement and FSMP coatings, the substance remains unauthorised in the EU too. Unlike the US, where the polymer sits outside the food-additive framework entirely as a drug-excipient material, the EU treats it as a formally regulated, if tightly scoped, food additive with its own Annex II entry.
Found in these products
None of the products in our database currently contain E1206.