Scientific Opinion on the safety assessment of the substance, dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, CAS No 287916-86-3, 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(11):3909 [9 pp.].
doi
10.2903/j.efsa.2014.3909
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Material: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Alessandro Di Domenico, Nathalie Gontard, Ragna Bogen Hetland, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima 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
European Commission
Question Number
EFSA-Q-2014-00124
Adopted
7 November 2014
Published in the EFSA Journal
25 November 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, CAS No 287916-86-3, food contact materials substance No 871 for use as a polymeric antistatic additive in hydrophobic plastics (mainly polyethylene and polypropylene) at a maximum used level up to 20 % w/w. The additive is a self-standing polymer and all starting substances used for its manufacture have already been evaluated from the toxicological point of view and they are listed in the Annex I of Regulation (EU) No 10/2011. Migration tests using food simulants 10 % ethanol and poly(2,6-diphenyl-p-phenylene oxide), at test conditions of 10 days at 40 °C, gave no detectable migration of the oligomeric fraction < 1000 Da (limit of detection ca. 18 μg/6 dm2). Considering the absence of genotoxicity of the starting substances used and of the additive itself, the additive does not give rise to safety concerns. The CEF Panel concluded that the substance dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and propene, is not of safety concern if it is used as an additive in polyolefins at levels of up to 20 weight %, in contact with dry foods as represented by simulant E (poly(2,6-diphenyl-p-phenylene oxide) in Regulation (EU) No 10/2011. The contact conditions should be at ambient temperature or below. Migration of the low molecular weight oligomeric fraction less than 1000 Da should in total not exceed 50 µg/kg food.

Keywords
dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, CAS No 287916-86-3, FCM No 871, food contact materials, safety assessment, evaluation
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Number of Pages
9