Copolymer in nanoform


copolymer in nanoform, FCM substance No 998, FCM substance No 859, FCM substance No 1043, food contact materials, safety assessment, evaluation
First published in the EFSA Journal
16 April 2014
27 March 2014
Scientific Opinion

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the additives (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, (FCM substance Nos 998, 859 and 1043), intended to be used up to 10 % w/w as an impact modifier in rigid (unplasticized) polyvinylchloride (PVC). The final material is intended to be used for contact with all food types, at room temperature or lower, for long time storage. The monomers constituting the copolymer are listed in Regulation (EU) 10/2011). The migration from PVC of the low molecular weight fraction of the additive below 1000 Da was estimated to be about 0.009 mg/kg food. Considering that these low molecular weight oligomers are made from authorised monomers, which by reaction are expected to lack the reactive functional groups, they do not give rise to safety concern. The migration of the additive in nanoparticle form from the PVC was estimated, using conservative migration modelling, to be about 1 x 10-6 mg/kg food and so consumer exposure would be very low, if any. The CEF Panel concluded that there is no safety concern for the consumer if the substances are used as additives individually or in combination at up to a total of 10 % w/w in rigid PVC used in contact with all food types at ambient temperature or below including long-term storage.

Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef [at]
EFSA Journal 2014;12(4):3635 [8 pp.].
Question Number
On request from
Food Standards Agency, United Kingdom
Print on demand
Number of Pages