Montmorillonite clay modified with dimethyldialkyl(C16-C18)ammonium chloride

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EFSA Panel on EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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.