| Summary: | <p>This scientific opinion of EFSA deals with the safety evaluation of the active substance iron (II) modified bentonite (FCM Substance No 1003) intended to be incorporated in monolayer or multilayer packages or in sachets for absorbing oxygen from the food environment. All starting substances of the oxygen absorber have been evaluated and approved for use as additives in plastic food contact materials or as food additives. From a toxicological point of view, migration of iron (incorporated) and aluminium (naturally present) ions from bentonite is of interest. 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. The iron (II) modified bentonite is intended and expected to be present in the final article as non-nanoform. However, the formation of nanoparticles due to exfoliation cannot be excluded if the substance is incorporated in unpolar polymers with compatibilisers or without such additives in polar polymers. 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. The CEF Panel concluded that the substance iron (II) modified bentonite does not raise a safety concern for the consumer when used as oxygen absorber incorporated without compatibilisers in polyolefin layers of food packages at levels up to 15% w/w. The substance equally 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.</p>
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