Open AccessSafety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials
Author(s) -
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 IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Castle Laurence,
Cravedi JeanPierre,
KolfClauw Martine,
Milana Maria Rosaria,
Pfaff Karla,
Tavares Poças Maria de Fátima,
Svensson Kettil,
Wölfle Detlef,
Barthélémy Eric,
Rivière Gilles
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5552
Subject(s) - montmorillonite , polylactic acid , bromide , food contact materials , saponite , materials science , chemical engineering , chemistry , food packaging , composite material , organic chemistry , polymer , food science , engineering
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.