Scientific Opinion on the safety assessment of the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate, in nanoform, for use in food contact materials

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(4):3635 [8 pp.].
doi
10.2903/j.efsa.2014.3635
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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Food Standards Agency, United Kingdom
Question Number
EFSA-Q-2012-00706
Adopted
27 March 2014
Published
16 April 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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.

Summary

Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No.1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Food Standards Agency, United Kingdom, for safety evaluation of the substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer in nanoform either not crosslinked or crosslinked with divinylbenzene or 1,3-butanediol dimethacrylate following a corresponding application submitted on behalf of Arkema (UK).

The safety assessment of (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), was requested for use as an additive (impact modifier) in rigid (unplasticized) polyvinylchloride (PVC), at up to 10 % (w/w). The final material is intended to be used for contact with all types of foodstuffs, at room temperature or lower, for long time storage.

The substance as presented in this opinion has not been evaluated by EFSA in the past. However, the monomers constituting the copolymer are listed in Regulation (EU) 10/2011.

Using conservative migration modelling for rigid PVC containing the additive at the maximum requested level of 10 % w/w and modelling food contact for one year at 25 °C, the migration from PVC of the low molecular weight fraction of the additive below 1 000 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.

Using the same modelling approach, and with an additional conservative assumption that all particles had a size less than 10 nm, the estimated migration of the copolymer in nanoparticle form was 1 x10-6 mg/kg food. Real migration, if any, is expected to be even lower and so consumer exposure would be very low, if any.

The CEF Panel concluded that the three substances (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer, (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene and (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform do not raise a safety concern for the consumer if used as additives individually or in combination at up to a total of 10 % w/w in non-plasticised PVC used in contact with all food types at ambient temperature or below including long-term storage.

Keywords
copolymer in nanoform, FCM substance No 998, FCM substance No 859, FCM substance No 1043, food contact materials, safety assessment, evaluation
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Number of Pages
8