The European Food Safety Authority (EFSA) said the substance can be used in food packages up to levels of 15% w/w as it “does not raise a safety concern for the consumer when used as oxygen absorber incorporated without compatibilisers in polyolefin layers of food packages”.
The panel on food contact materials, enzymes and processing aids (CEF) was asked to deliver an opinion after a request from the Agencia Española de Seguridad Alimentaria y Nutrición, Spain.
It focussed its opinion on the safety of iron (II) modified bentonite, made from the starting substances iron(III) chloride anhydrous, bentonite and ascorbic acid for use as oxygen absorber.
No safety concern
The body said that it does not raise a safety concern when it is used in sachets, placed in the headspace of the packaging, that prevent the physical release of their contents into the food and are not in direct contact with liquid foods, exudates, or foods with external aqueous liquid phase.
Aluminium can be estimated to migrate up to 0.3 mg /kg acidic food. This value corresponds to 3.5 % of the TWI set in 2008 by the EFSA AFC Panel. Therefore, under the intended conditions of use, the oxygen absorber formulation was considered toxicologically acceptable, said EFSA.
It added that the substance is intended to be incorporated in monolayer or multilayer packages or in sachets for absorbing oxygen from the food environment.
“Iron can be estimated to migrate up to 4.5 mg/kg acidic food, which is well below the SML value of 48 mg/kg food set in Regulation EU No 10/2011 based on the PMTDI of 0.8 mg/kg bw established by the Joint FAO/WHO Expert Committee on Food Additives in 1983) and the SCF in 1990.
“Aluminium can be estimated to migrate up to 0.3 mg /kg acidic food. Therefore, under the intended conditions of use, the oxygen absorber formulation was considered toxicologically acceptable.”
The active substance, iron (II) modified bentonite, was not evaluated by EFSA in the past. However, non-modified bentonite and iron powder have been evaluated and approved for use as additives in plastic food contact materials.
Migration of these ions from bentonite in sachets that prevent the physical release of their contents into the food and are placed in the headspace of the food packaging not in direct contact with liquid foods, exudates, or foods with external aqueous liquid phase is not expected.