Within the general task of evaluating substances intended for use in materials in contact with food according to 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 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) received a request from the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, for safety assessment of the additive montmorillonite clay modified with dimethyldialkyl(C16-C18)ammonium chloride (with Food Contact Materials (FCM) substance No 1030), on behalf of the applicant PolyOne Europe, Luxembourg, and Nanocor Inc., USA.
The substance, montmorillonite clay modified with dimethyldialkyl(C16-C18)ammonium chloride, is intended to be used 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.
Neither the substance nor the modifier, dimethyldialkyl(C16-C18)ammonium chloride, have been evaluated by the Scientific Committee on Food (SCF) or the European Food Safety Authority (EFSA) in the past. Nevertheless, montmorillonite is the main component of bentonite, which is listed in the Regulation (EU) 10/2011 under FCM Substance No 393 without restriction. Quartz, also used in the manufacture of the modified organoclay, is listed under FCM Substance No 616 without restriction.
Characterisation of the particle size and dispersion of the substance in the matrix showed that partially exfoliated layers of modified clay can occur when incorporated in a polymer with polar character. However, migration of the platelets, which are nano-sized, is not expected.
Migration of aluminium (marker from the natural clay) was undistinguishable from the blank level of 0.14 mg/kg food simulant.
Migration of dimethyldialkyl(C16-C18)ammonium compounds was not detectable with a limit of detection of 6 µg/kg food. Dimethyldioctadecylammonium chloride has been evaluated as the main component of N,N-dimethyl-N,N-di-n-alkyl(C16-18)ammonium chloride in the European Union risk assessment report (EU-RAR) in 2009, and by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) in 2002. It is concluded that there is no evidence for a genotoxic potential of dimethyldioctadecylammonium chloride. It can be expected that both substances have a comparable toxicological profile.
Analyses of a solvent extract of a masterbatch and film samples detected 1-chlorooctadecane, 1‑chlorohexadecane, dimethyloctadecylamine, dimethylhexadecylamine, dimethyltetradecylhexadecylammonium and methyldialkylamines as potential migrants originating from the manufacture and/or degradation of the modifier.
Methyldialkyl(C16-C18)amines, trialkyl(C16-C18)amines and dimethyltetradecylhexadecylammonium were not detected migrating into 95 % ethanol, and thus migration into dry foods is not expected above detection limits. Therefore, no toxicological data were deemed necessary.
The sum of the migration of dimethylhexadecylamine and dimethyloctadecylamine is estimated to be below 50 µg/kg food for the intended applications. Their evaluation is covered by the evaluation of “alkyl, linear with even number of carbon atoms (C12-C20) dimethyl amines” made by the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel) in 2007. They are authorised and listed in Regulation (EU) 10/2011 under FCM Substance No 15 and Reference No 34130 with a specific migration limit of 30 mg/kg food.
Migration of 1-chloroalkanes (sum of 1-chlorohexadecane and 1-chlorooctadecane) was 98 µg/kg into a food simulant. There is no evidence for any genotoxic potential of 1-chlorooctadecane. For 1‑chlorohexadecane, no data were provided but read-across from 1-chlorooctadecane could be 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 to be used at up to 12 % w/w in polyolefins intended for 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.