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