Scientific Opinion on the safety of polyvinyl alcohol‐polyethylene glycol‐ graft ‐co‐polymer as a food additive

Abstract 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. No chronic toxicity/carcinogenicity studies were provided, but no adverse effects following long‐term consumption of PVA‐PEG graft co‐polymer are expected given the absence of any substance‐related adverse effects in the shorter‐term toxicity studies and the fact that the co‐polymer is virtually not absorbed following oral administration. Based on in vitro and in vivo assays the co‐polymer is found to be not genotoxic. From a subchronic feeding study in the dog a NOAEL of approximately 800 mg/kg bw/day (highest dose tested) was identified. Conservative intake estimates from food supplements amounted to 4.3 mg/kg bw/day for children and 5 mg/kg bw/day for adults leading to a sufficient Margin of Safety compared to the NOAEL. From the maximum residual level of vinyl acetate Margins of Exposure of > 10 6 were calculated. The Panel concluded that the use of PVA‐PEG graft co‐polymer food supplements as a film coating is of no safety concern at the proposed uses.