Safety assessment of the substance montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride 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 2015;13(11):4285 [10 pp.].
doi
10.2903/j.efsa.2015.4285
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, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Acknowledgements
The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific output, and EFSA staff member: Eric Barthélémy for the support provided to this scientific output.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany
Question Number
EFSA-Q-2013-00437
Adopted
28 October 2015
Published in the EFSA Journal
18 November 2015
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 Panel) deals with the safety assessment of the additive montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride for use at up to 11.4 % w/w in ethylene-based polymeric materials/blends for sealing layers up to 12.5 µm in direct contact with food. Final articles made with the sealing layers are intended to be used for long-term storage of dry foods at room or refrigerated temperatures. Partially exfoliated layers of the modified clay can occur when incorporated into a polymer with polar character, but migration of the platelets, which are nano-sized, is not expected. Migration of the clay and the modifier was not detected. Impurities from the modifier were identified as dimethyl(C16-C18)amines and 1-chloroalkanes and their migration was estimated to be below 50 and at 98 µg/kg food, respectively. Migration of dimethyl(C16-C18)amines is covered by the evaluation of “alkyl, linear with even number of carbon atoms (C12-C20) dimethyl amines” made by the AFC Panel in 2007, which concluded that the compounds are non-genotoxic. There is no evidence for a genotoxic potential of 1-chlorooctadecane, and read-across from 1-chlorooctadecane to 1-chlorohexadecane was applied. Therefore, the CEF Panel concluded that the substance montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride does not give rise to safety concerns for the consumer if the substance is used at up to 12 % w/w in polyolefins in contact for long-term storage of dry foods (foods, to which simulant E is assigned in Annex III of Regulation (EU) No 10/2011) at room or refrigerated temperatures. Since no data were provided on repeated dose toxicity of 1-chloroalkanes; migration of the sum of 1-chlorohexadecane and 1-chlorooctadecane should not exceed 0.05 mg/kg food.
Keywords
montmorillonite clay modified with dimethyldialkyl(C16-C18)ammonium chloride; CAS numbers 1318-93-0, 1302-78-9, 61789-80-8, 107-64-2; FCM substance No 1030; food contact materials; safety assessment; evaluation
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Number of Pages
10