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

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

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.

EFSA Journal
EFSA Journal 2013;11(8):3303 [30 pp.].
doi
10.2903/j.efsa.2013.3303
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
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00911
Adopted
4 July 2013
Published
12 August 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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 > 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.

Keywords
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
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Number of Pages
30