Safety assessment of the substance montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride for use in food contact materials
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
First published in the EFSA Journal:
18 November 2015
28 October 2015
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.
© European Food Safety Authority, 2015
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.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at] efsa.europa.eu
EFSA Journal 2015;13(11):4285
On request from:
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany