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(4):3155 SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the active substances iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite for use in food contact materials 1 ABSTRACT EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2, 3 European Food Safety Authority (EFSA), Parma, Italy This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of iron based oxygen absorber systems comprising iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, incorporated in sachets, patches and cards. Iron, the main active ingredient reacts with oxygen to form iron hydroxide and iron oxide, thereby removing oxygen from the primary packaging. Only activated carbon has not been evaluated as such, but it meets the specifications for activated charcoal which is authorised as additive for plastic materials and articles in contact with foods. All other ingredients of the oxygen absorber formulations have been evaluated and approved for use as additives in plastic food contact materials and/or as food additives and/or food supplements or feed additives. The active system being based on solid ingredients and not intended for direct contact with liquid food or food with an external liquid surface, migration through the gas phase was screened for 9 representative active systems. No volatiles derived from the active mixtures were detected. Therefore the CEF Panel concluded that the substances do not raise a safety concern when used in oxygen absorbers in sachets, patches or cards, placed in the headspace of the packaging or when used in direct contact with food, excluding liquid food or foods that have an external aqueous liquid phase on the surface such as sliced fruits and fresh meat. European Food Safety Authority, On request from the Food Standards Agency, UK, Question No EFSA-Q , adopted on 19 March 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, 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: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Alessandro Di Domenico, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Trine Husøy, Martine Kolf-Clauw, Eugenia Lampi, Catherine Leclerq, Maria Rosaria Milana, Karla Pfaff, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfe for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on the safety evaluation of the active substances iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite for use in food contact materials. EFSA Journal 2013;11(4):3155. [12 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2013

2 KEY WORDS Iron based oxygen absorbers Food contact materials; active and intelligent materials; oxygen absorbers; iron; safety assessment; evaluation. EFSA Journal 2013;11(4):3155 2

3 SUMMARY Iron based oxygen absorbers According to the Commission Regulation (EC) No 450/ 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 EFSA before their inclusion into a positive Community list. The procedure of the evaluation and the tasks of EFSA are described in the Regulation (EC) No 1935/ 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 Food Standards Agency, UK, the Panel on Food Contact Materials, Enzymes and Processing Aids (CEF) was asked to deliver an opinion on the safety of mixtures comprising active iron (CAS No , FCM Substance No 983), sodium chloride (CAS No , FCM Substance No 983); water (CAS No , FCM Substance No 515), silica gel (CAS No , FCM Substance No 504), activated carbon (CAS No / , FCM Substance No 984), monosodium glutamate (CAS No , FCM Substance No 1023), potassium acid tartrate (CAS No , FCM Substance No 1018), powdered cellulose (CAS No , FCM Substance No 553), malic acid (CAS No , FCM Substance No 499), chabazite (CAS No , FCM Substance No 1019), hydroxypropyl cellulose (CAS No , FCM Substance No 559), potassium carbonate (CAS No , FCM Substance No 21), sodium thiosulfate (CAS No , FCM Substance No 519), propylene glycol (CAS No , FCM Substance No 109), glycerin (CAS No , FCM Substance No 103), polyethyleneglycol sorbitan monooleate (CAS No , FCM Substance No 569), sodium propionate (CAS No , FCM Substance No 1020) and clinoptilolite (CAS No , FCM Substance No 1021), for use as iron based oxygen absorbers in sachets, patches or cards. The dossier was submitted on behalf of Multisorb Technologies, USA. Iron, the main active ingredient reacts with oxygen to form iron hydroxide and iron oxide, thereby removing oxygen from the primary packaging. Only activated carbon was not evaluated as such, but it meets the specifications for activated charcoal which is authorised as additive for plastic materials and articles in contact with foods. All other ingredients of the oxygen absorber formulations have been evaluated and approved for use as additives in plastic food contact materials and/or as food additives and/or as food supplements or feed additives. As the active system is based on solid ingredients, only migration through the gas phase is expected. Therefore, the applicant screened by headspace gas chromatography coupled to mass spectrometry the volatiles produced by 9 representatives active systems. No volatiles derived from the active mixtures were detected. The CEF Panel concluded that the substances: iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, do not raise a safety concern when used in oxygen absorbers in sachets, patches or cards, placed in the headspace of the packaging or when used in direct contact with food, excluding liquid food or foods that have an external aqueous liquid phase on the surface such as sliced fruits and fresh meat. Activated carbon should in addition comply with the same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC with exception of ash content which can be up to 10 % (w/w). 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 , p 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 , p EFSA Journal 2013;11(4):3155 3

4 Iron based oxygen absorbers TABLE OF CONTENTS Abstract... 1 Summary... 3 Table of contents... 4 Background as provided by the legislation... 5 Terms of reference as provided by the applicant... 5 Assessment Introduction General information Data available in the dossier used for this evaluation Evaluation Non-toxicological data Toxicological data Conclusions Documentation provided to EFSA References Glossary and abbreviations EFSA Journal 2013;11(4):3155 4

5 BACKGROUND AS PROVIDED BY THE LEGISLATION Iron based oxygen absorbers Regulation (EC) No 450/2009 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 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food. 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. 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 the EFSA according to the procedure described in the abovementioned regulations. According to this procedure the industry submits applications to the Member States competent Authorities which transmit the applications to EFSA for 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). In this context, EFSA received an application from the Food Standards Agency, UK, requesting the evaluation of mixtures comprising iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, in sachets, patches and cards, for use as oxygen absorber. TERMS OF REFERENCE AS PROVIDED BY THE APPLICANT The EFSA is required to carry out an assessment on the risks originating from the migration into food of the iron, sodium chloride, water, silica gel, activated carbon, monsodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, used in oxygen absorbing systems 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(s); (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. EFSA Journal 2013;11(4):3155 5

6 Iron based oxygen absorbers ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Food Standards Agency, UK, to evaluate the safety of various iron based oxygen absorber systems for food packaging. These absorbers are composed of iron (CAS No , FCM Substance No 983 ), sodium chloride (CAS No , FCM Substance No 983); water (CAS No , FCM Substance No 515), silica gel (CAS No , FCM Substance No 504), activated carbon (CAS No / , FCM Substance No 984), monosodium glutamate (CAS No , FCM Substance No 1023), potassium acid tartrate (CAS No , FCM Substance No ), powdered cellulose (CAS No , FCM Substance No 553), malic acid (CAS No , FCM Substance No 499), chabazite (CAS No , FCM Substance No ), hydroxypropyl cellulose (CAS No , FCM Substance No 559), potassium carbonate (CAS No , FCM Substance No 21), sodium thiosulfate (CAS No , FCM Substance No 519), propylene glycol (CAS No , FCM Substance No 109), glycerin (CAS No , FCM Substance No 103), polyethyleneglycol sorbitan monooleate (CAS No , FCM Substance No 569), sodium propionate (CAS No , FCM Substance No ) and clinoptilolite (CAS No , FCM Substance No 1021). The request has been registered in the EFSA s register of questions under the number EFSA-Q The dossier was submitted on behalf of Multisorb Technologies, USA. 2. General information According to the applicant, the oxygen absorbers are prepared by mixing together iron, sodium chloride, water and depending on the intended use some of the following substances: silica gel, activated carbon, monsodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite. These substances are used in different mixtures formulated according to the target oxygen absorption capacity and the food contact applications. The mixtures are placed into sachets, patches or cards. Sachets, patches and cards are intended to be used for dry foods applications (such as tea/coffee, bakery products, dried fruits, vegetables, spices, flour, pasta) and fat containing foods (such as processed, cured and smoked meats, cheese, nuts and bakery products containing fat, such as cakes and cookies). They are not intended for direct contact with liquid food or food with an external liquid surface. The range of contact conditions is from chilled up to ambient temperature for long time storage. Sachets, patches, cards are constituted by multilayer materials including plastic films and/or paper and adhesive in their structures. Layers are either perforated plastic or non woven substrates in order to allow gas exchanges with the atmosphere surrounding the product. After filling, sachets, patches are heat sealed. For cards both layers between which the active powder is deposited, are stuck together with an adhesive. All applied technologies are used to prevent the physical release to food of the active mixtures under foreseeable condition of uses. Mixtures based on the above listed chemicals have not been evaluated by the SCF or EFSA in the past. However, the substances constituting the oxygen absorber systems (iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polysorbate 80, sodium propionate are authorised either for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) or as food additives (Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the EFSA Journal 2013;11(4):3155 6

7 Iron based oxygen absorbers European Parliament and of the Council by establishing a Union list of food additives6) or food supplements (sodium chloride) (Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements7), as follows: Iron powder is authorised as additive for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with a specific restriction of 48 mg iron/kg food based on a Provisional Maximum TDI (PMTDI) of 0.8 mg/kg bw set by JECFA/WHO (1983) and agreed by the SCF (1990) (FCM Substance No 983). Sodium chloride is an authorised food supplement (Regulation EC No 1170/2009) with no specific restriction. Water is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restrictions. The water specifications must be in compliance with Directive 98/83/EC 8 (FCM Substance No 515). Silica gel (silicon dioxide) is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with the restriction For synthetic amorphous silicon dioxide: primary particles of nm which are aggregated to a size of μm which may form agglomerates within the size distribution of 0.3 μm to the mm size (FCM Substance No 504). It is also listed in Regulation (EU) No 1129/2011 amending 9 Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of Food Additives, with a specific maximum level of 10g/kg or higher, depending on the foodstuffs (E 551). Activated carbon should meet the requirements for activated charcoal, which is authorised as additive for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with the following restriction: Only for use in PET at maximum 10 mg/kg of polymer (evaluated by EFSA in ). Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC 11 with exception of ash content which can be up to 10 % (w/w) (FCM Substance No 984). Monosodium glutamate is listed in the 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 (E 621), with a specific maximum level of 10g/kg, individually or in combination, expressed as glutamic acid. 6 Commission Regulation (EU) No 1129/2011 of 11 November 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, OJ L295, p Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements, OJ L 314, , p Council directive 98/83/ECof 3 November 1998 on the quality of water intended for human consumption, OJ L 330, , p Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ L354, p EFSA (European Food Safety Authority), 2004, 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, Commission directive 95/45/EC, of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs, OJ L 226, , p. 1. EFSA Journal 2013;11(4):3155 7

8 Iron based oxygen absorbers Potassium acid tartrate is listed in the 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, (E 336), with no specific restriction. Cellulose (powdered) is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restrictions (FCM Substance No 553). Malic acid (E 296) is a food ingredient and an authorised food additive, listed in the 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, with a specific maxim level of 3 g/kg or higher, depending on the foodstuffs. It is also authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with the restriction in case of use as a monomer only to be used as a comonomer in aliphatic polyesters up to maximum level of 1 % on a molar basis (FCM Substance No 499). Chabazite (calcium aluminium silicate) (E 556) is listed in the 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, with no specific restriction. Hydroxypropyl cellulose is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restriction (FCM Substance No 559). Potassium carbonate is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restriction (FCM Substance No 21 carbonic acid, salts). Sodium thiosulfate is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with a restriction of 7 mg/kg expressed as SO2 (FCM Substance No 519). Propylene glycol is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restriction (FCM Substance No 109). Glycerin is authorised as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restriction (FCM Substance No 103). Polyethyleneglycol sorbitan monooleate (polysorbate 80) is authorized as additive or monomer for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) with no specific restriction (FCM Substance No 569). Sodium propionate is listed in the 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, with no specific restriction. Clinoptilolite is a natural zeolite comprising a microporous arrangement of silica and alumina tetrahedra. It has the complex formula: (Na,K,Ca)2-3Al3(Al, 2Si13O36 12(H 2 O). According to an Opinion of the FEEDAP Panel (EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2013), clinoptilolite is considered safe as a feed additive up to mg clinoptilolite/kg complete feed for all animal species. EFSA Journal 2013;11(4):3155 8

9 3. Data available in the dossier used for this evaluation Iron based oxygen absorbers The studies submitted for evaluation followed 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). Non-toxicity data: - Data on identity - Data on physical and chemical properties - Data on manufacturing process - Data on function, intended use and authorisation - Data on overall migration studies - Data on identification and migration studies of volatiles Toxicity data: - None 4. Evaluation 4.1. Non-toxicological data The main active ingredient of each commercial oxygen absorber is iron which reacts with oxygen to form iron hydroxide and iron oxide, thereby removing oxygen from the primary packaging. Depending on the intended uses, the oxygen absorber mixture may contain in addition to iron powder, water and sodium chloride, some of the following substances added to provide a suitable reaction medium depending on their own properties: silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite. Activated carbon, powdered cellulose, chabazite, silica gel and clinoptilolite are used as water activity modifiers. Hydroxypropyl cellulose, glycerine, propylene glycol are used as binders. Monosodium glutamate, potassium acid tartrate, potassium carbonate, sodium thiosulfate and malic acid act as buffers to keep the ph at the optimum range to promote the iron oxidation. Sodium chloride and water play the role of electrolyte to facilitate the reaction. Polyethyleneglycol sorbitan monooleate is used to decrease the surface tensions and to permit a good dispersion of chemical ingredients. Sodium propionate acts as antimicrobial agent. Overall migration was measured by direct contact (total immersion or one side contact) with food simulants. However, these experiments were not considered relevant due to the design of sachets, cards or patches which are constituted by perforated and/or non-woven materials and because direct contact with liquid food or food with an external liquid surface is not intended by the applicant. Therefore those data were not taken into account. As the active system is based on solid ingredients, only migration through the gas phase is expected. Therefore, the applicant screened by headspace gas chromatography coupled to mass spectrometry (HS-GCMS) the volatiles produced by 9 representatives active systems, placed for 30 minutes at 100 C in sealed glass vessels. No volatiles derived from the active mixtures were detected. EFSA Journal 2013;11(4):3155 9

10 4.2. Toxicological data Iron based oxygen absorbers All ingredients of the oxygen absorber formulations have been evaluated and approved for use as additives in plastic food contact materials, as food additives or food supplements. Activated carbon was not evaluated as such, but it meets the specifications for activated charcoal, which is authorised as additive for plastic materials and articles in contact with foods (Regulation (EU) No 10/2011) i.e. same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC with the exception of ash content which may be up to 10 % (w7w). All these ingredients are expected to be stable in normal storage and handling conditions. Thus no toxicity studies are required. As regards clinoptilolite, the Panel noted that due to the insolubility of the substance no appropriate genotoxicity in vitro testing is feasible and only inconclusive information on the occurrence of chromosomal aberrations in vivo in mouse are available. However, read across from studies on other zeolites (notably zeolite A or silver zeolite A; EFSA, 2005) does not give rise to concern for genotoxicity. Moreover, the Panel noted that according to an Opinion of the FEEDAP Panel (EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2013) clinoptilolite is not absorbed in target animals and is considered safe as a feed additive up to mg clinoptilolite/kg complete feed for all animal species. Based on the above information and considering that no migration into food is expected in the intended conditions of use, the Panel concluded that the composition of the oxygen absorbers would not give rise to safety concerns. CONCLUSIONS The CEF Panel concluded that the substances: iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, do not raise a safety concern when used in oxygen absorbers in sachets, patches or cards, placed in the headspace of the packaging or when used in direct contact with food, excluding liquid food or foods that have an external aqueous liquid phase on the surface such as sliced fruits and fresh meat. Activated carbon should in addition comply with the same purity requirements as for Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC with exception of ash content which can be up to 10 % (w/w). DOCUMENTATION PROVIDED TO EFSA 1. Dossier referenced: 10A11J124I. November Submitted on behalf of the applicant, Multisorb Technologies, USA. 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, Available from: EFSA (European Food Safety Authority), Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request related to a 7 th list of substances for food contact materials. The EFSA Journal 2005, 201, Available from: 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, Available from EFSA Journal 2013;11(4):

11 Iron based oxygen absorbers EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Scientific Opinion on the safety and efficacy of clinoptilolite of sedimentary origin for all animal species. EFSA Journal 2013;11(1):3039 [13 pp.] doi: /j.efsa Available online: JECFA (Joint FAO/WHO Expert Committee on Food Additives), Evaluation of certain additives and contaminants. 27th report. WHO Techn. Report Series, No 696; EFSA Journal 2013;11(4):

12 Iron based oxygen absorbers GLOSSARY AND ABBREVIATIONS EC FCM FEEDAP JECFA/WHO LMWF LOAEL Mn Mw NDA PET PMTDI REF No SCF SML w/w European Commission Food Contact Materials Additives and Products or Substances used in Animal Feed The Joint FAO/WHO Committee on Food Additives Low molecular weight fraction Low observed adverse effect level Number average molecular weight Weight average molecular weight Dietetic Products, Nutrition and Allergies Poly(ethylene terephthalate) Provisional Maximum Tolerable Daily Intake Reference Number Scientific committee on food Specific Migration Limit Weight by weight Overall migration: Specific 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 stimulant The amount of a specific substance released from a food contact material or article into food or food stimulant EFSA Journal 2013;11(4):

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