SCIENTIFIC OPINION. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3

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1 EFSA Journal 2013;11(10):3387 SCIENTIFIC OPINION Scientific Opinion on the safety assessment of the active substances iron, iron oxides, sodium chloride and calcium hydroxide for use in food contact materials 1 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy 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 KEY WORDS iron, iron oxides, sodium chloride, calcium hydroxide, active food contact materials, safety evaluation 1 On request from the Food Standards Agency, UK, Question No EFSA-Q , adopted on 25 September 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. Correspondence: cef@efsa.europa.eu 3 Acknowledgement: 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. Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzyme, Flavourings and Processing Aids, 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: /j.efsa Available online: European Food Safety Authority, 2013

2 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 , FCM Substance No 983), iron oxides (Fe 2 O 3 with CAS Nos and ; FeO with CAS No ; Fe 3 O 4 with CAS No , FCM Substance No 409), sodium chloride (CAS No and FCM Substance No 985) and calcium hydroxide (CAS No , 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. EFSA Journal 2013;11(10):3387 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the legislation... 4 Terms of reference as provided by the applicant... 4 Assessment Introduction General information Data available in the dossier used for this evaluation Evaluation Non-toxicological data Toxicological data... 7 Documentation provided to EFSA... 7 References... 7 Glossary and abbreviations... 9 EFSA Journal 2013;11(10):3387 3

4 BACKGROUND AS PROVIDED BY THE LEGISLATION Regulation (EC) No 450/ of the Commission of European Communities is a specific measure that lays down specific rules for active and intelligent materials and articles intended for contact with foodstuffs in addition to the general requirements established in Regulation (EC) No 1935/ of the European Parliament and of the Council on materials and articles intended to come into contact with food. The substance(s) responsible for the active and/or intelligent function of the material should be included in a positive list by the Commission following a safety evaluation by EFSA according to the procedure described in the above mentioned regulations. According to this procedure the industry submits applications to the Member States competent Authorities which transmit the applications to EFSA for their evaluation. The application is supported by a technical dossier submitted by the industry following the EFSA guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food (EFSA, 2009). Active materials and articles are intended to extend the shelf-life or to maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food. Intelligent materials and articles monitor the condition of packaged food or the environment surrounding the food. In this case, EFSA received an application from the Food Standards Agency, UK, requesting the evaluation of mixtures comprising iron, iron oxides, sodium chloride and calcium hydroxide, for use as oxygen absorbers. TERMS OF REFERENCE AS PROVIDED BY THE APPLICANT EFSA is required to carry out a risk assessment on the risks originating from the migration into food of the substances, iron, iron oxides, sodium chloride and calcium hydroxide, used as oxygen absorbing components in food contact materials, and deliver a scientific opinion, according to the Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food. The opinion of EFSA will be considered by the Commission for adoption of a Community list of authorised substances where according to the Regulation (EC) No 450/2009 there will be specified: (a) the identity of the substance (b) the function of the substance(s) (c) the reference number (d) if necessary, the conditions of use of the substance(s) or component (e) if necessary, restrictions and/or specifications of use of the substance(s) (f) if necessary, conditions of use of the material or article to which the substance or component is added or into which it is incorporated. 4 Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food. OJ L 135, , pp 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 and repealing Directives 80/590/EEC and 89/109/EEC. OJ L 338, , pp EFSA Journal 2013;11(10):3387 4

5 ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the UK Food Standards Agency to evaluate the safety of an iron-based oxygen absorber system for food packaging. The absorber is composed of iron (CAS No , FCM Substance No 983), iron oxides (Fe 2 O 3 with CAS Nos and ; FeO with CAS No ; Fe 3 O 4 with CAS No , FCM Substance No 409), sodium chloride (CAS No and FCM Substance No 507) and calcium hydroxide (CAS No , FCM Substance No 394). The request has been registered in the EFSA s register of questions under EFSA-Q The dossier was submitted on behalf of the applicant, Toyo Seikan, Japan. 2. General information According to the applicant, the oxygen absorber system is prepared by mixing together iron, iron oxides (Fe 2 O 3, FeO and Fe 3 O 4 ), sodium chloride and calcium hydroxide. The oxygen-absorbing principle is based on iron oxidation in the presence of water. The other chemicals are used to provide a medium to facilitate the iron oxidation. The active mixture is blended with polypropylene, which is used as an inner layer in multilayer materials. This layer containing the oxygen absorber is therefore separated from the food by a polypropylene layer not containing the active mixture and separated from the outside (i.e. the non-food contact side) by a barrier layer against oxygen permeation. These oxygen absorber multilayer materials are intended to be used as packaging for oxygen-sensitive foods that contain water, such as milk, coffee, soup, tuna, corn, fruit syrup and cooked rice. The foods may be in-pack treated at temperatures up to 125 C for periods of time up to 60 minutes, before or after long-term storage at room temperature. The active mixture as such has not been evaluated by the Scientific Committee for Food (SCF) or EFSA in the past. However, all the substances constituting the oxygen absorber system are authorised as additives in plastic materials and articles intended for contact with foods (Regulation (EU) No 10/ ): iron and sodium chloride have also been evaluated as active substances (Regulation (EC) No 450/2009) as follows: Iron powder is authorised as an additive for plastic materials and articles in contact with foods with a specific restriction of 48 mg iron/kg food based on a provisional maximum tolerable daily intake TDI (PMTDI) of 0.8 mg/kg bw set by JECFA/WHO (1983) and agreed by the SCF (SCF, 1990) (FCM Substance No 983). Iron(II) has also been evaluated for use in oxygen scavenger mixtures incorporated in polyolefin layers (EFSA CEF Panel, 2012a, 2013). The CEF Panel concluded that the active substances do not raise a safety concern (a) when incorporated without compatibilisers in polyolefin layers of food packaging materials at levels up to 15 % w/w (EFSA CEF Panel, 2012a) and (b) when incorporated in polyethylene and in polypropylene articles used for longterm storage and/or hot fill up to 95 C for several minutes in (i) direct contact with dry and fatty foods and (ii) indirect contact with aqueous or acidic foods, separated from the active material by a layer of at least 10 μm polyethylene or polypropylene that does not contain the oxygen absorber formulation (EFSA CEF Panel, 2013). Iron oxide (stoichiometry unspecified) is authorised as an additive for plastic materials and articles in contact with foods without a specific migration limit (FCM Substance No 409). The specific migration limit for iron applies. 6 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food OJ L , pp EFSA Journal 2013;11(10):3387 5

6 Sodium chloride is covered by the sodium salt of hydrochloric acid authorised as an additive for plastic materials and articles in contact with foods, with no specific restriction (FCM Substance No 507). In addition, sodium chloride (common salt) may be used as an ingredient in the preparation of food (Regulation (EC) No 1925/2006). Sodium chloride has also been evaluated for use in oxygen scavenger mixtures incorporated in polyolefin layers (EFSA CEF Panel, 2012a, 2013) with the same conclusion as quoted above for iron. Calcium hydroxide is authorised as an additive for plastic materials and articles in contact with foods with no specific migration restriction (FCM Substance No 394). It is also listed in Regulation (EU) No 1129/2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of Food Additives (specific maximum level: quantum satis) (E 526) Data available in the dossier used for this evaluation The studies submitted for evaluation followed the EFSA guidelines on submission of a dossier for safety evaluation by EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food (EFSA, 2009). Non-toxicity data Toxicity data Data on identity Data on physical and chemical properties Data on manufacturing process Data on function, intended use and authorisation Data on specific migration of iron None 4. Evaluation 4.1. Non-toxicological data The oxygen-scavenging principle is based on iron oxidation. The oxidation of iron is an electrochemical process occurring in the presence of water and other chemicals used to provide a medium to facilitate the oxidation reaction. Specific migration of iron into 3 % acetic acid solution, with contact conditions of four hours at 100 C, was 0.02 mg/kg, for a typical multilayer material, i.e. where the layer containing the oxygen absorber formulation is separated from the food by a polypropylene layer not containing the formulation. Migration of iron into water and 10 % ethanol, under the same test conditions, was not detected at the limit of detection of 0.01 mg/kg and 0.02 mg/kg respectively. This very low migration confirmed the effectiveness of a propylene barrier layer in limiting the migration of inorganic species and that the specific migration limit for iron of 48 mg/kg food is not expected to be exceeded. Considering the inorganic nature of the active components, no migration tests were conducted using a simulant for fatty foods, and this is acceptable. Considering the nature of the active ingredients, their mode of action and their placement in an inner layer in a multilayer material, the formation and release of potential by-products linked to the use of the oxygen-scavenging system is not expected. 7 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ L354, pp EFSA Journal 2013;11(10):3387 6

7 4.2. Toxicological data Iron mixture All substances present in the oxygen absorber formulation, iron, iron oxides, sodium chloride and calcium hydroxide, have been evaluated and authorised for use as additives in plastic food contact materials. Iron and sodium chloride have also been evaluated for use in oxygen scavenger mixtures incorporated in polyolefin layers. Therefore, no toxicity data are required. All these ingredients are expected to be stable under normal storage and handling conditions. Based on the above 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 behind a layer not containing the formulation of active substances. The Panel noted that the specific migration limit 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 (JECFA, 1983) and agreed by the SCF (SCF, 1990). It is noted, however, that in 2004 the EFSA NDA Panel concluded that the data available are insufficient to establish a tolerable upper intake level for iron (EFSA, 2004). CONCLUSIONS Having considered the above-mentioned data, 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. DOCUMENTATION PROVIDED TO EFSA 1. Dossier referenced: TO July Submitted on behalf of the applicant, Toyo Seikan, Japan. REFERENCES EFSA (European Food Safety Authority), Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake Level of Iron. The EFSA Journal 2004, 125, EFSA (European Food Safety Authority), Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food. The EFSA Journal 2009, 1208, EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2012a. Scientific Opinion on the safety evaluation of the active substances, activated carbon, water, iron powder, kaolin calcined, sulphur and sodium chloride for use as active component in food contact materials. EFSA Journal 2012;10(3): pp. doi: /j.efsa EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2012b. Scientific Opinion on the safety evaluation of the active substance iron (II) modified bentonite as oxygen absorber for use in active food contact materials. EFSA Journal 2012;10(10): pp. doi: /j.efsa EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids ), Scientific Opinion on the safety evaluation of the active substances, iron, polyethyleneglycol, disodium pyrophosphate, monosodium phosphate and sodium chloride for use in food contact materials. EFSA Journal 2013;11(6):3245, 11 pp. doi: /j.efsa EFSA Journal 2013;11(10):3387 7

8 JECFA (Joint FAO/WHO Expert Committee on Food Additives), Evaluation of certain additives and contaminants. 27th report. WHO Technical Report Series, No pp. SCF (Scientific Committee of Food), 1990, First series of food additives of various technological functions, Report 25th Series EFSA Journal 2013;11(10):3387 8

9 GLOSSARY AND ABBREVIATIONS Overall migration: The sum of the amounts of volatile and non-volatile substances, except water, released from a food contact material or article into food or food simulant Specific migration: bw CAS EC FCM JECFA NDA PMTDI SCF The amount of a specific substance released from a food contact material or article into food or food stimulant body weight Chemical Abstracts Service European Commission Food Contact Materials Joint FAO/WHO Committee on Food Additives Dietetic Products, Nutrition and Allergies provisional maximum tolerable daily intake Scientific Committee for Food w/w weight by weight EFSA Journal 2013;11(10):3387 9