Scientific Opinion on the safety assessment of the substances, kaolin and polyacrylic acid, sodium salt, for use in food contact materials

kaolin, polyacrylic acid sodium salt, food contact materials, safety evaluation
First published in the EFSA Journal
16 April 2014
27 March 2014
Scientific Opinion


This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) deals with the safety assessment of kaolin which is used in a combination with polyacrylic acid, sodium salt and is incorporated in a gas barrier layer of ethylene-vinyl alcohol (EVOH) copolymer. The EVOH copolymer is used as an inner layer in multi-layer food contact materials. Morphological studies show stacks of kaolin clay platelets of different sizes dispersed in the EVOH and some of these platelets are below 100 nm in the thickness dimension. Nevertheless, exfoliation into individual platelets does not occur for kaolin as confirmed by WAXS. No migration of the kaolin particles from the EVOH layer was shown. There was no detectable migration of aluminium or magnesium (inorganic constituents of kaolin) from a typical multi-layer plastic material, with detection limits of 0.07 mg/kg and up to 2.2 mg/kg, respectively. These values indicate that migration of these inorganic components is not expected to be significant. Migration of polyacrylic acid sodium salt is not expected to exceed the SML of 6 mg/kg foodstuffs at the conditions of use foreseen. Therefore, the CEF panel concluded that the substance kaolin in the form of particles with a thickness less than 100 nm does not raise a safety concern for the consumer when incorporated up to 12 % in EVOH copolymer. This material is used as an inner layer of a plastic multi-layer structure, in contact with foods and beverages stored at room temperature up to 6 months. The EVOH inner layer containing the particles should be used behind a functional barrier that prevents migration of kaolin particles into the food.

Panel members at the time of adoption

Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef [at]
EFSA Journal 2014;12(4):3637
Question Number
On request from
Agencia Española de la Seguridad Alimentaria y Nutrición, Spain