EFSA Journal 2013;11(4):3153 SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active 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 Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the powder mixture of the active substances sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (FCM substance No 1009), bentonite (CAS No 1302-78-9, FCM No 393), sodium chloride (CAS No 7647-14-5, FCM No 985), sodium carbonate (CAS No 497-19-8, FCM No 1008) which are intended to be used as combined oxygen generator and carbon dioxide absorber in packaging containing whole fresh fruits. The powder mixture is placed in a nonwoven polyethylene sachet separated from the food by a pad. In the presence of moisture, sodium carbonate peroxyhydrate first decomposes into sodium carbonate and hydrogen peroxide which decomposes into water and oxygen. Sodium carbonate reacts with carbon dioxide to form sodium bicarbonate. Because the sachet is not placed in direct contact with the food or food exudates, only hydrogen peroxide which decomposes to water and oxygen may be released with no other potential migration of volatile compounds. Based on the conclusion drawn in the EU Risk Assessment Report that hydrogen peroxide is not classified as a mutagen and the results from a subchronic toxicity study with hydrogen peroxide, the Panel concluded that hydrogen peroxide does not raise a safety concern under the intended conditions of use. Therefore the CEF Panel concluded that sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride and sodium carbonate do not raise a safety concern for the consumer when used as combined oxygen generator and carbon dioxide absorber, for packaging of whole fruits. The substances should be used in sachets which prevent the release of the powder mixture into the food. Sachets should not be in direct contact with food or food exudates. European Food Safety Authority, 2013 KEY WORDS Sodium carbonate peroxyhydrate coated, bentonite, sodium chloride, sodium carbonate; CAS numbers 1302-78- 9, 7647-14-5, 497-19-8; FCM substance Nos. 1009, 393, 985, 1008; Food contact materials; Active and intelligent materials; Safety assessment. 1 On request from the Food Standards Agency, UK, Question No EFSA-Q-2011-00236, adopted on 19 March 2013. 2 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, 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: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Hetland Ragna Bogen, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Karla Pfaff, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle 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, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials. EFSA Journal 2013;11(4):3153. [10 pp.] doi:10.2903/j.efsa.2013.3153. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2013
SUMMARY According to the Commission Regulation (EC) No 450/2009 4 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 have 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 1935/2004 5 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 and following a request from the Food Standards Agency, UK, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked to deliver a scientific opinion on sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (FCM substance No 1009), bentonite (CAS number 1302-78-9, FCM substance No 393), sodium chloride (CAS number 7647-14-5, FCM substance No 985), sodium carbonate (CAS number 497-19-8, FCM substance No 1008) for use as a combined oxygen generating and carbon dioxide absorber. The dossier was submitted by the applicant, EMCO Packaging Systems Ltd, UK. The active article is a homogenous powder mixture of water vapour activated compounds: sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (approx. 67.5 %), sodium carbonate (approx. 3.5 %), anhydrous sodium chloride (approx. 13 %) and activated calcium bentonite clay (approx. 16 %). This article is intended to be used as combined oxygen generator and carbon dioxide absorber with whole fresh fruits. The powder mixture is placed in a nonwoven polyethylene sachet separated from the food by a pad. Direct contact of the sachet with food is not intended. In the presence of moisture, coated sodium carbonate peroxyhydrate first decomposes into sodium carbonate and hydrogen peroxide which decomposes into water and oxygen. Sodium carbonate reacts with carbon dioxide to form sodium bicarbonate. The mixture of the substances is intended to be used in sachets which prevent the release of the powder mixture into the food. In addition, the sachets are separated from the food by a pad (e.g. sealed air pad) and direct contact of the sachet with food or food exudates is not intended. Hence no migration of and from the solid ingredients is to be expected and therefore no exposure from the consumption of the packed food is expected. Only hydrogen peroxide may be released which decomposes to water and oxygen with no other potential migration of volatile compounds. Hydrogen peroxide concentration was determined in 3 % acetic acid both by immersion and by placing the sachet between 2 pieces of filter paper saturated with 3 % acetic acid, for 10 days at 40 C, the result was 0.19 mg/kg food (calculated for 6 dm 2 /kg). According to the EU Risk Assessment Report on hydrogen peroxide, hydrogen peroxide is not classified as a mutagen. From a 90-day study in mice with hydrogen peroxide administered in the drinking water a NOAEL of 100 mg/kg drinking water (equivalent to 26 mg/kg b.w. per day for males and 37 mg/kg b.w. per day for females) based on dose-related reductions in food and water consumption and observation of duodenal mucosal hyperplasia could be derived. Based on the default assumption for food contact materials of a consumption of 1 kg food per day by an adult weighing 60 kg, comparison between the NOAEL for male mice and the measured hydrogen peroxide concentration (3.16 µg/kg b.w.) gives a sufficient margin of safety of 8210. 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, 30.5.2009, p. 3 11. 5 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, 13.11.2004, p. 4 17. EFSA Journal 2013;11(4):3153 2
Therefore the CEF Panel concluded that sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride and sodium carbonate do not raise a safety concern for the consumer when used as combined oxygen generator and carbon dioxide absorber, for packaging of whole fruits. The substances should be used in sachets which prevent the release of the powder mixture into the food. Sachets should not be in direct contact with food or food exudates. EFSA Journal 2013;11(4):3153 3
TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 4 Background as provided by the legislation... 5 Terms of reference as provided by the applicant... 5 Assessment... 6 1. Introduction... 6 2. General information... 6 3. Data available in the dossier used for this evaluation... 7 4. Evaluation... 7 4.1. Non-toxicological data... 7 4.2. Toxicological data... 8 Conclusions and recommendations... 8 Documentation provided to EFSA... 9 References... 9 Glossary and abbreviations... 10 EFSA Journal 2013;11(4):3153 4
BACKGROUND AS PROVIDED BY THE LEGISLATION Commission 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 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). In this case, EFSA received an application from the Food Standards Agency, UK, requesting the evaluation of sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate. TERMS OF REFERENCE AS PROVIDED BY THE APPLICANT EFSA is required to carry out an assessment on the risks originating from the migration into food of the substances sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate used as combined oxygen generating and carbon dioxide absorbing system 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 Commission 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):3153 5
ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Food Standards Agency, UK, to evaluate the safety of the compounds sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (FCM substance No 1009), bentonite (CAS number 1302-78-9, FCM substance No 393), sodium chloride (CAS number 7647-14-5, FCM substance No 985) and sodium carbonate (CAS number 497-19-8, FCM substance No 1008), which are used to generate oxygen and absorb carbon dioxide. The request has been registered in the EFSA s register of questions under the number EFSA- Q-2011-00236. The dossier was submitted by the applicant, EMCO Packaging Systems Ltd, UK. 2. General information According to the applicant, the active component is a combined oxygen generating and carbon dioxide absorbing powder mixture of coated sodium carbonate peroxyhydrate (approx. 67.5 %), sodium carbonate (approx. 3.5 %), anhydrous sodium chloride (approx. 13 %) and activated calcium bentonite clay (approx. 16 %). Sodium carbonate peroxyhydrate is coated into a stabilised form. The coating is made from an aqueous solution of sodium carbonate and sodium silicate, and applied by spraying followed by drying. The active substances are all commercially available in a powder form, which are dry-blended and introduced into a nonwoven, gas permeable four-side sealed polyethylene sachet. According to the applicant the sachet is separated from the food by a pad (e.g. sealed air pad); therefore direct contact of the sachet with food is not intended. In a typical application 12 g of powder would be used for 500 g of food. The active mixture has been designed to maintain inside the primary packaging a high oxygen and low carbon dioxide atmosphere which is favourable to the preservation of whole fresh fruits at temperatures from 2 C to 8 C, up to 14 days from the date of packing. The mixture as such has not been evaluated by the SCF or EFSA in the past. However, with the exception of the coated sodium carbonate peroxyhydrate, the substances constituting the active mixture, bentonite, sodium chloride, sodium carbonate, as well as the coating agents, sodium carbonate and sodium silicate, have been evaluated and authorised for plastic materials and articles in contact with food (Commission Regulation (EU) No 10/2011 6 ), as food additives (Commission Regulation (EU) No 1129/2011 7 ) and as food supplements (Commission Regulation (EC) No 1170/2009 8 ) as follows: Bentonite is authorised as an additive for plastic materials and articles in contact with food (Commission Regulation (EU) No 10/2011) with no specific restrictions (FCM Substance No 393). The substance is also approved as food additive (Commission Regulation (EU) No 1129/2011). Sodium chloride is authorised as a food supplement (Commission Regulation (EC) No 1170/2009) with no specific restriction. 6 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance. OJ L 12, 15.1.2011, p. 1 89. 7 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 Text with EEA relevance. OJ L 295, 12.11.2011, p. 1 177. 8 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 (Text with EEA relevance). OJ L 314, 1.12.2009, p. 36 42. EFSA Journal 2013;11(4):3153 6
Sodium carbonate is authorised as an additive or a polymer production aid for plastic materials and articles in contact with food (Commission Regulation (EU) No 10/2011) with no specific restrictions. The substance is also approved as food additive (Commission Regulation (EU) No 1129/2011). Sodium carbonate (E500i) may be added to all foodstuffs following quantum satis principle, except for cocoa and chocolate products (as covered by Directive 2000/36/EC), where the limit of use is 7 % on dry matter without fat, expressed as potassium carbonate and in processed cereal-based foods and baby foods, where sodium carbonate may be used according to quantum satis principle but only as a raising agent. Silicic acid is authorised as an additive for plastic materials and articles in contact with food and sodium salts of authorised acids are also authorised with no specific restrictions (Commission Regulation (EU) No 10/2011). 3. 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: data on identity of the active substances data on physical and chemical properties of the substances data on manufacturing process of the active materials data on intended use of the active materials data on authorisations data on overall migration data on hydrogen peroxide concentration Toxicity data: published references on hydrogen peroxide toxicity 4. Evaluation 4.1. Non-toxicological data The active component contains a powder mixture of coated sodium carbonate peroxyhydrate, sodium carbonate, anhydrous sodium chloride and activated calcium bentonite clay in gas permeable four-side polyethylene sealed sachet separated from food by a pad. In the presence of moisture, coated sodium carbonate peroxyhydrate first decomposes into sodium carbonate and hydrogen peroxide. Then, hydrogen peroxide is transformed into water and oxygen, and sodium carbonate reacts with carbon dioxide to form sodium bicarbonate. Sodium chloride and bentonite clay are moisture access regulators. Overall migration was up to 6.9 mg/dm 2, determined by placing the sachet between 2 pieces of filter paper saturated with 3 % acetic acid for 10 days at 20 C followed by extraction of the filter paper with the simulant (3 % acetic acid). EFSA Journal 2013;11(4):3153 7
Hydrogen peroxide concentration was determined in 3 % acetic acid both by immersion testing and by placing the sachet between 2 pieces of filter paper saturated with 3 % acetic acid for 10 days at 40 C. The concentration determined was 0.19 mg/kg food (calculated for 6 dm 2 /kg). The mixture of the substances is intended to be used in sachets which prevent the release of the powder mixture into the food. In addition, the sachets are separated from the food by a pad (e.g. sealed air pad) and direct contact of the sachet with food or food exudates is not intended. Hence no migration of and from the solid ingredients is to be expected and therefore no exposure from the consumption of the packed food is expected. Only hydrogen peroxide may be released which decomposes to water and oxygen with no other potential migration of volatile compounds. 4.2. Toxicological data Hydrogen peroxide is an endogenous by-product of oxidative metabolism in mammalian cells. It is genotoxic in a variety of in vitro test systems. However, when tested in several in vivo tests, genotoxicity was not expressed. According to the EU Risk Assessment Report on hydrogen peroxide, the available studies are not in support of a significant genotoxicity/mutagenicity under in vivo conditions and, according to the principles followed in the EU, hydrogen peroxide is not classified as a mutagen (ECB, 2003). From a 90-day study in mice with hydrogen peroxide administered in the drinking water, a NOAEL of 100 mg/kg drinking water (equivalent to 26 mg/kg b.w. per day for males and 37 mg/kg b.w. per day for females) «based on dose-related reductions in food and water consumption and observation of duodenal mucosal hyperplasia» could be derived (ECB, 2003; FMC, 1997). Based on the default assumption for food contact materials of a consumption of 1 kg food per day by an adult weighing 60 kg (EC, 2001), comparison between the NOAEL for male mice and a daily intake of 3.16 µg/kg b.w. (derived from the measured hydrogen peroxide concentration of 0.19 mg/kg food) gives a sufficient margin of safety of 8210. Based on the conclusion on genotoxicity drawn in the EU Risk Assessment Report and the results from subchronic toxicity studies with hydrogen peroxide, the Panel concluded that no safety concern is expected under the intended conditions of use. The Panel also noted that, with the exception of the coated sodium carbonate peroxyhydrate, all other substances used for the manufacture of the active component have already been evaluated and authorised as substances to be used for plastic materials and articles in contact with food (Commission Regulation (EU) No 10/2011) or as food additives (Commission Regulation (EU) No 1129/2011) or as food supplement (Commission Regulation (EC) No 1170/2009). Taking into consideration the nature of the substances in the mixture and that, due to the intended use of the active component, no migration of the substances into the food is expected, the Panel considered that the use of these substances would not give rise to safety concerns. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The CEF Panel concluded that sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride and sodium carbonate do not raise a safety concern for the consumer when used as combined oxygen generator and carbon dioxide absorber, for packaging of whole fruits. The substances should be used in sachets which prevent the release of the powder mixture into the food. Sachets should not be in direct contact with food or food exudates. EFSA Journal 2013;11(4):3153 8
RECOMMENDATIONS The sachets contain as a powder sodium carbonate peroxyhydrate which is harmful if swallowed and able to cause serious eye damage. Therefore measures should be taken to prevent any contact with the powder mixture. DOCUMENTATION PROVIDED TO EFSA 1. Dossier referenced: EFSA/CEF/FCM/2211. March 2011. Submitted by EMCO Packaging Systems Ltd, UK. 2. Dossier referenced: EFSA/CEF/FCM/2744. May 2012. Submitted by EMCO Packaging Systems Ltd, UK. REFERENCES EC (European Commission), 2001. Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. Available from: http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf. ECB (European Chemicals Bureau), 2003. European Chemicals Bureau, European Union Risk Assessment Report, Hydrogen Peroxide, CAS No 7722-84-1, EINECS No 231-765-0. http://esis.jrc.ec.europa.eu/doc/risk_assessment/report/hydrogenperoxidereport022.pdf EFSA (European Food Safety Authority), 2009. 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, 1-11. Available from http://www.efsa.europa.eu/en/efsajournal/doc/1208.pdf. FMC (FMC Corporation), 1997. FMC Corporation, Hydrogen peroxide 13 week drinking water study with 6-week recovery period in C57BL/6NCrlBR mice. FMC study number: 195-2039. FMC Corporation Toxicology Laboratory, Princetown, NJ. EFSA Journal 2013;11(4):3153 9
GLOSSARY AND ABBREVIATIONS CAS Chemical Abstracts Service CEF Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids EC European Commission EFSA European Food Safety Authority EU European Union FCM Food Contact Materials NOAEL No Observed Adverse Effect Level SCF Scientific Committee on Food UK United Kingdom EFSA Journal 2013;11(4):3153 10