Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Brüschweiler Beat Johannes, Chesson Andrew, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mortensen Alicja, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Castle Laurence, Cravedi Jean-Pierre, Kolf-Clauw Martine, Milana Maria Rosaria, Pfaff Karla, Tavares Poças Maria de Fátima, Svensson Kettil, Wölfle Detlef, Barthélémy Eric, Rivière Gilles
EFSA J. 2019 Jan 14;17(1):e05552. doi: 10.2903/j.efsa.2019.5552. eCollection 2019 Jan.
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.
欧洲食品安全局食品接触材料、酶和加工助剂小组（CEP）评估了用十六烷基三甲基溴化铵（HDTA）改性的蒙脱石粘土，在聚乳酸（PLA）瓶中用作添加剂时的安全性，该PLA瓶用于在环境温度或更低温度下长期储存与水接触的情况，其最大使用量为■■■■■。这种改性粘土，90%（重量/重量）的颗粒尺寸为33.1μm或更小，平均尺寸为9μm，具有层状结构，层厚度低于100nm。当掺入PLA中时，纳米尺寸的层可以分散在基体中，但预计不会迁移。在最高制造温度下预计不会发生热降解。未观察到由于与瓶装水相互作用而导致PLA表面完整性丧失的情况。总体迁移率非常低。在检测限■■■■■未检测到HDTA的迁移。铝的迁移低于或处于检测限■■■■■，保守地说，这大约相当于■■■■■。对含有和不含有改性粘土的瓶装水进行的对比分析未发现与改性剂和/或改性粘土中鉴定出的杂质相对应的额外峰。此外，■■■■■，并且改性剂HDTA已经过评估并获得批准。因此，CEP小组得出结论，如果按照申请人的要求，该物质用作添加剂在PLA塑料瓶和其他用于在环境温度或更低温度下长期储存水的容器中的最大使用量为■■■■■，则用HDTA溴化物改性的蒙脱石粘土物质对消费者不存在安全问题。
