Scientific Opinion on safety assessment of the active substance, iron (0) modified bentonite as oxygen absorber, for use in active food contact materials

Iron (0) modified bentonite; Boron; Aluminium; Food Contact Materials; Active and intelligent materials; Safety assessment; Evaluation
First published in the EFSA Journal
18 October 2013
27 September 2013
Scientific Opinion

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of iron (0) modified bentonite intended to be incorporated in monolayer or multilayer packages or in sachets for absorbing oxygen from the food environment. All starting substances have been evaluated and approved for use as additives in plastic FCM or as food additives. From a toxicological point of view, migration of iron, boron and aluminium ions from bentonite is of interest. Based on migration results, specific migration limits of iron and boron are not expected to be exceeded under the intended conditions of use. Migration of aluminium is expected to occur at levels corresponding to less than 1 % of the TWI set in 2008. The CEF Panel concluded that the use of iron (0) modified bentonite does not raise a safety concern when used as oxygen absorber incorporated without compatibilisers in polyolefin articles used for long term of storage at room temperature or refrigeration i) at level up to 3 % w/w incorporated in a polyolefin layer in direct contact with all types of food including beverages, or ii) at higher levels, when the food is separated from the active material by a layer of polyolefin that does not contain the oxygen absorber formulation and offering a barrier to diffusion against inorganic species at least equivalent to 10 µm polypropylene. 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. The Panel stressed that the final article should comply with specific migration limits applicable for plastic materials.

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 Tavares Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef [at]
EFSA Journal 2013;11(10):3400 [12 pp.].
Question Number
On request from
Agencia Española de Seguridad Alimentaria y Nutrición, Spain