Safety assessment of the active substance, polyacrylic acid, sodium salt crosslinked, for use in active food contact materials
According to Commission Regulation (EC) No 450/2009 of the Commission of European Communities of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food, substances responsible for the active or intelligent function need first to be evaluated by EFSA before their inclusion into a positive Community list. The procedure of the evaluation and the tasks of EFSA are described in the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food.
In the context of this evaluation procedure following a request from the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), Germany, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF) was asked to deliver an opinion on polyacrylic acid, sodium salt, crosslinked, as a liquid absorber in absorbent pads used in the packaging of fresh or frozen food such as meat, poultry, and seafood as well as fresh fruits and vegetables. The application was submitted by Evonik Industries AG, Germany.
The non-crosslinked polymer is authorised as an additive for plastic materials and articles in contact with food (Regulation (EU) No 10/2011) with a group SML of 6 mg/kg food, expressed as acrylic acid (polyacrylic acid, salts, FCM Substance No 70). Crosslinker 1, used as a crosslinker in polyacrylic acid, sodium salt, crosslinked polymer, has already been evaluated by EFSA (EFSA CEF Panel, 2013). Crosslinkers 2 and 3 have not been evaluated previously. Crosslinker 4 is authorized as a monomer for plastic materials and articles in contact with food (Regulation (EU) No 10/2011).
Specific migration tests were not performed on the absorbent pads due to the high absorption of liquids by the substance. Since the substance is incorporated into the inner layer of the pads, there is no direct contact possible between the substance and the food. Provided that there is no direct contact between the food and the substance and that the absorption capacity of the absorbent pads is not exceeded, the Panel concluded that no migration of the substance itself into the food is expected, therefore no exposure from the consumption of the packed food is expected. Considering the conditions of the manufacturing process, the Panel concluded that volatile substances are not present in the final active material, no migration and therefore no exposure is expected. Based on the residual content of monomeric acrylic acid, sodium salt, the worst case migration calculated for total mass transfer is well below the SML. Based on an estimation of the residual content of the unreacted crosslinkers, the worst case migration calculated for total mass transfer is far below the SML for the crosslinker 4 and in range of 0.002 up to 0.006 mg/kg food for crosslinkers 1, 2 and 3.
The crosslinkers 1, 2 and 3 were each tested in two in vitro gene mutation tests and in one in vivo mouse micronucleus test in bone marrow cells. Based on the negative results in the bacterial reverse mutation test and in the in vivo mouse erythrocyte micronucleus test and taking into account that the substances are structurally related to other authorised substances used in the manufacture of FCM, the Panel concluded that the three crosslinkers do not raise concern for genotoxicity.
The CEF Panel, having considered the above mentioned information, concluded that the use of the substance polyacrylic acid, sodium salt, crosslinked, does not raise a safety concern when used in absorbent pads in the packaging of fresh or frozen meat, as well as fresh fruits and vegetables. The absorbent pads must be used only under conditions in which the liquid absorption capacity is not exceeded and direct contact between the substance and the food is excluded.