Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long-term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure with layers of a thickness below 100 nm. When incorporated in PLA, nanosized layers can be dispersed in the matrix, but are not expected to migrate. Thermal degradation is not expected at the maximum manufacturing temperature. No loss of integrity of the PLA surface due to interaction with bottled water was observed. The overall migration was very low. No migration of HDTA was detected at the limit of detection ■■■■■. Migration of aluminium was below or at the limit of detection ■■■■■, which would conservatively correspond to approximately ■■■■■. Comparative analysis of bottled water with and without the modified clay did not reveal additional peaks corresponding to impurities identified in the modifier and/or in the modified clay. Moreover, ■■■■■, and the modifier HDTA have been evaluated and authorised. Therefore, the CEP Panel concluded that the substance montmorillonite clay modified with HDTA bromide is not of safety concern for the consumer if the substance is used as an additive at up to ■■■■■ in PLA plastic bottles and other containers intended for long-term storage of water at ambient temperature or below, as requested by the applicant.

Keywords: FCM substance No 1075; evaluation; food contact materials; montmorillonite clay modified with hexadecyltrimethylammonium bromide; nano; safety assessment.