Scientific Opinion on the safety of polyvinyl alcohol-polyethylene glycol-<em>graft</em>-co-polymer as a food additive

polyvinyl alcohol-polyethylene glycol-graft-co-polymer; PVA-PEG graft co-polymer; CAS Registry Number 96734-39-3; coating food supplements; instant release film coating; PVA; PEG
First published in the EFSA Journal
12 August 2013
4 July 2013
Scientific Opinion

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 > 106 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.

Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2013;11(8):3303 [30 pp.].
Question Number
On request from
European Commission