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 the EFSA before their inclusion into a positive Community list. The procedure of the evaluation and the tasks of EFSA are described in 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 UK Food Standards Agency, the Panel on Food Contact Materials, Enzymes and Processing Aids (CEF) was asked to deliver an opinion on a mixture comprising iron (CAS No 7439-89-6, FCM Substance No 983), iron oxides (Fe2O3 with CAS Nos 1309-37-1 and 1317-60-8; FeO with CAS No 1345-25-1; Fe3O4 with CAS No 1317-61-9, FCM Substance No 409), sodium chloride (CAS No 7647-14-5 and FCM Substance No 985) and calcium hydroxide (CAS No 1305-62-0, FCM Substance No 394) for use as oxygen absorbers. The dossier was submitted on behalf of the applicant, Toyo Seikan, Japan.
The main active ingredient of the oxygen absorber system is iron, which reacts with oxygen in the presence of water. The other chemicals are used to provide a medium to facilitate the iron oxidation.
The oxygen absorber formulation is blended with polypropylene, which is used as an inner layer in multilayer materials. The oxygen absorber multilayer materials are intended to be used in packaging materials coming into contact with various types of oxygen-sensitive foods, for long-term storage, at room temperature, with or without in-pack heating of the foods, at up to 125 °C for up to 60 minutes.
All the substances constituting the oxygen absorber system have been evaluated and authorised for use as additives in plastic food contact materials. Iron has a specific migration limit of 48 mg/kg food, and this limit value for iron applies to iron oxides too. There is no specific migration limit for sodium chloride or calcium hydroxide.
Migration of iron from a typical multilayer material was 0.02 mg/kg into 3 % acetic acid solution when tested for four hours at 100 °C. Migration of iron into other tested food simulants was not detected.
Based on the migration results, the specific migration limits of 48 mg/kg food for iron and of 60 mg/kg food (the overall migration limit) for sodium chloride and for calcium hydroxide are not expected to be exceeded when the oxygen absorber system is used under the intended conditions of use, notably when incorporated into a layer not in direct contact with foodstuffs.
The CEF Panel concluded that the substances iron, iron oxides, sodium chloride and calcium hydroxide do not raise a safety concern when used as oxygen absorbers incorporated in polypropylene and used as requested for the long-term storage of foods at room temperature with or without in-pack heating of the food at up to 125 °C for up to 60 minutes, provided that the food is separated from the active material by a layer of polyolefin that does not contain the oxygen absorber mixture and offers a barrier to the diffusion of inorganic species equivalent to at least 10 µm polypropylene.