E1209 — Polyvinyl alcohol-polyethylene glycol graft copolymer

Kollicoat IR, Kollicoat Protect, PVA-PEG graft copolymer, Polyethylene glycol-polyvinyl alcohol grafted copolymer

In the US this graft copolymer is registered in FDA's Inactive Ingredient Database as a pharmaceutical/dietary-supplement excipient (marketed as Kollicoat IR) rather than as a food additive, so no confirmed FDA food-use determination exists for it. The EU authorised it as a coating agent for solid food supplements under Annex II to Regulation (EC) No 1333/2008, with its specifications amended in 2018 after a favourable EFSA opinion raised the permitted ethylene glycol impurity limit to 620 mg/kg.

The EU's Annex II entry for this graft copolymer covers only coating of solid food supplements, and EFSA revisited the entry in 2018 specifically to assess the substance's ethylene glycol impurity — a purity question rather than a re-examination of the polymer's core safety — resulting in an updated impurity ceiling of 620 mg/kg. That EFSA-driven specifications update has no US parallel: the graft copolymer sits in FDA's Inactive Ingredient Database as a pharmaceutical excipient (marketed as Kollicoat IR) rather than under any food-additive purity regime. The EU has thus both authorised the substance for a specific food use and continued actively refining its impurity limits, while the US framework has never engaged with it as a food ingredient at all.