EFSA safety review: no toxicological concern at permitted levels
EFSA evaluated E1209 twice, in 2013 and 2017. The main focus was on trace impurities (ethylene glycol and diethylene glycol) carried over from manufacture, not the polymer itself. At maximum permitted levels in supplements, calculated daily intake of these impurities stays well below the safety reference value set for them. The polymer backbone is not expected to be absorbed from the gut in meaningful amounts.
EFSA's 2013 opinion authorised E1209 for use in solid food supplements and concluded there was no safety concern at the proposed use level.
2013Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal 2013
A 2017 EFSA re-evaluation of amended specification limits found that even at higher permitted impurity levels, estimated daily exposure to ethylene glycol and diethylene glycol remained below the group TDI of 0.5 mg/kg body weight per day.
2017Regulatory reviewEFSA ANS Panel, EFSA Journal 2017 (10.2903/j.efsa.2017.4865)
At the 95th percentile in toddlers (the highest modelled group), estimated daily exposure from supplement use reached 0.221 mg/kg body weight per day, below the impurity safety threshold.
2017RegulatoryEFSA ANS Panel, EFSA Journal 2017 (10.2903/j.efsa.2017.4865)
Polyethylene glycol (PEG) and polyvinyl alcohol (PVA): component considerations
PEG is widely used in pharmaceuticals and has its own extensive safety record. High doses can draw water into the bowel (used therapeutically as a laxative). PVA is also well-characterised and poorly absorbed from the gut. At the tiny quantities present as a tablet coating in a supplement, neither component is expected to exert a pharmacological effect. The graft copolymer is a distinct molecule from its parent polymers, but the safety data package covers the combined structure.
Polyvinyl alcohol is poorly absorbed from the gastrointestinal tract and has been used in pharmaceutical tablet coatings for decades with no identified systemic concern at coating-level quantities.
2013Regulatory reviewEFSA ANS Panel, EFSA Journal 2013 (10.2903/j.efsa.2013.3303)