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Scientific Opinion on the safety assessment of the active substances iron, iron oxides, sodium chloride and calcium hydroxide for use in food contact materials

EFSA Journal 2013;11(10):3387 [9 pp.]. doi:10.2903/j.efsa.2013.3387
  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Panel Members 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 Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle Acknowledgment The Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Taveres Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this scientific opinion. Contact cef@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Food Standards Agency, UK Question number: EFSA-Q-2012-00739 Adopted: 25 July 2013 Published: 15 October 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of an iron-based oxygen absorber, comprising iron, iron oxides, sodium chloride and calcium hydroxide. This mixture is incorporated into polypropylene, which is then used as an inner layer in multilayer food contact materials; thus, it is not in direct contact with foods. All the substances constituting the oxygen absorber system have been evaluated and authorised for use as additives in plastic food contact materials. Based on the very low migration results provided for a typical multilayer material, 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. Therefore, 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.

© European Food Safety Authority, 2013

Summary

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.

Keywords

iron, iron oxides, sodium chloride, calcium hydroxide, active food contact materials, safety evaluation