Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) as a film coating for food supplements.
PVA-PEG graft co-polymer is a branched molecule consisting of about 75 % PVA and 25 % PEG units. The polymer is currently approved in pharmaceuticals in the EU.
The specifications proposed are consistent with those for other already approved film-coating agents for use in the EU, including PVA and PEG, however, the Panel noted that no specifications for the impurities ethylene glycol, diethylene glycol, 1,4-dioxane and ethylene oxide are presently included. The co-polymer is not absorbed from the gastrointestinal tract. In repeated dose oral toxicity studies in animals (rat, rabbit, and dogs) no adverse effects were shown.
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