• Open Access

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


  • EFSA Panel on Food additives and Nutrient Sources added to Food (ANS)

  • Panel members: 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
  • Correspondence: ans@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group ‘B’ on Food Additives and Nutrient Sources added to Food: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, David Gott, Torben Hallas-Møller, Jürgen König, Oliver Lindtner, Daniel Marzin, Inge Meyland, Alicja Mortensen, Iona Pratt, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen for the preparatory work on this scientific opinion.
  • Adoption date: 4 July 2013
  • Published date: 12 August 2013
  • Question number: EFSA-Q-2012-00911
  • On request from: European Commission


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.