Safety assessment of the substance basic copper - Wiley Online Library

SCIENTIFIC OPINION ADOPTED: 23 June 2016 doi: 10.2903/j.efsa.2016.4537

Safety assessment of the substance basic copper (II) carbonate for use in intelligent food contact materials EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of basic copper (II) carbonate, CAS No 12069-69-1, for use as intelligent substance in the ink of a freshness indicator applied in labels inside trays of fresh poultry meat at temperatures from 2°C to 10°C and for a period of up to 12 days. Being a salt of carbonic acid, basic copper (II) carbonate is authorised and listed under Regulation (EU) No 10/2011 (food contact material (FCM) substance No 21: carbonic acid, salts) as, according to Article 6 of Regulation (EU) No 10/2011, salts of copper are authorised even if they are not included in the Union list. The residual amount of solvents in the printed label was determined and assuming total mass transfer from a 0.02 dm2 label into 400 g food would give a worst-case migration in the order of . No migration of copper is expected taking into account the nature of the application with no direct contact between the substance and the food. However, even complete transfer in case of incidental direct contact would remain several orders of magnitude lower than the migration limit applicable at the date of the assessment (5 mg/kg). The CEF Panel, having considered the above-mentioned data, concluded that the use of the substance basic copper (II) carbonate as a freshness indicator for packed poultry meat does not raise a safety concern to the consumer if the migration limit of copper is met. © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: food contact materials, active and intelligent materials, freshness indicator, basic copper (II) carbonate, CAS No 12069-69-1, FCM substance No 21 ~ola de Seguridad Requestor: Ministerio de Sanidad Servicios Sociales e Igualdad - Agencia Espan Alimentaria y Nutricion, Direccion Ejecutiva, Spain Question number: EFSA-Q-2016-00007 Correspondence: fi[email protected]

www.efsa.europa.eu/efsajournal

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Basic copper (II) carbonate

Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul €renlampi, Wim Mennes, Maria €rtler, Trine Husøy, Sirpa Ka Fowler, Roland Franz, Konrad Grob, Rainer Gu Penninks, Vittorio Silano, Andrew Smith, Maria de Fa tima Tavares Pocßas, Rosaria Milana, Andre €lfle, Holger Zorn and Corina-Aurelia Zugravu Christina Tlustos, Detlef Wo Acknowledgements: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine tima Tavares Pocßas, Kettil Svensson and Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fa €lfle for the preparatory work on this scientific opinion and EFSA staff member Katharina Volk for Detlef Wo the support provided to this scientific opinion. Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The quantitative composition of the ink, the amount of the intelligent substance and the reaction product per label and the residual amount of solvents has been provided under confidentiality and it is deleted awaiting the decision of the Commission Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on the safety assessment of the active substance basic copper (II) carbonate for use in intelligent food contact materials. EFSA Journal 2016;14(7):4537, 7 pp. doi:10.2903/j.efsa.2016.4537 ISSN: 1831-4732 © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.


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Table of contents Abstract.................................................................................................................................................... 1. Introduction...................................................................................................................................... 1.1. Background and Terms of Reference as provided by the requestor........................................................ 2. Data and methodologies .................................................................................................................... 2.1. Data................................................................................................................................................. 2.2. Methodologies................................................................................................................................... 3. Assessment....................................................................................................................................... 3.1. Non-toxicological data ....................................................................................................................... 4. Conclusions....................................................................................................................................... Documentation provided to EFSA ............................................................................................................... References................................................................................................................................................ Abbreviations ............................................................................................................................................


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1.

Introduction

1.1.

Background and Terms of Reference as provided by the requestor

Regulation (EC) No 450/20091 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 1935/20042 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 European Food Safety Authority (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 EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food’ (EFSA, 2009b). In this case, EFSA received an application from the Ministerio de Sanidad Servicios Sociales e ~ola de Seguridad Alimentaria y Nutricio n, Direccio n Ejecutiva, Spain, requesting Igualdad - Agencia Espan the evaluation of the active substance basic copper (II) carbonate, with the CAS No 12069-69-1 and the food contact material (FCM) substance No 21 (carbonic acid, salts). According to Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food, EFSA is asked to carry out an assessment of the risks related to the intended use of the substance and to deliver a scientific opinion.

2.

Data and methodologies

2.1.

Data

The applicant has submitted a dossier in support of their application for the authorisation of basic copper (II) carbonate to be used in a freshness indicator in packaging for poultry meat. Data submitted and used for the evaluation are: Non-toxicological data and information • Chemical identity • Description of manufacturing process of substance/FCM • Physical and chemical properties • Intended use • Existing authorisation(s) • Migration of the substance • Residual content of the substance • Identification, quantification and migration of reaction products and impurities Toxicological data • No toxicological data were submitted.

2.2.

Methodologies

In the context of the 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, 2009b), the safety evaluation is conducted using the general methodological framework established for monomers and additives used to make plastics and published as the guidelines of the Scientific Committee on Food (SCF) (European Commission, 2001). 1

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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. 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.


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The assessment was conducted in line with the principles laid down in Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. This Regulation underlines that applicants may consult the guidelines of the SCF for the presentation of an application for safety assessment of a substance to be used in FCM prior to its authorisation (European Commission, 2001), including the corresponding data requirements. The dossier that the applicant submitted for evaluation was in line with the SCF guidelines (European Commission, 2001). The methodology is based on the characterisation of the substances that are the subject of the request for safety assessment prior to authorisation, its impurities and reaction and degradation products, the evaluation of the exposure to those substances through migration, and the definition of minimum sets of toxicity data required for safety assessment. For active substances that are intended to be released themselves or to cause the release of other substances into foods, additional considerations apply with respect to their safety and status as direct food additives. These considerations are described in the EFSA guidelines on active or intelligent substances (EFSA, 2009b). To establish the safety from ingestion of migrating substances, the toxicological data indicating the potential hazard and the likely human exposure data need to be combined. Exposure is estimated from studies on migration into food or food simulants and considering that a person may consume daily up to 1 kg of food in contact with the relevant FCM. As a general rule, the greater the exposure through migration, the more toxicological data is required for the safety assessment of a substance. Currently, there are three tiers with different thresholds triggering the need for more toxicological information as follows: 1) In case of high migration (i.e. 5–60 mg/kg food), an extensive data set is needed. 2) In case of migration between 0.05 and 5 mg/kg food, a reduced data set may suffice. 3) In case of low migration (i.e. < 0.05 mg/kg food), only a limited data set is needed. More detailed information on the required data is available in the SCF guidelines (European Commission, 2001). The assessment was conducted in line with the principles described in the EFSA Guidance on transparency in the scientific aspects of risk assessment (EFSA, 2009a) and considering the relevant guidance from the EFSA Scientific Committee.

3.

Assessment

According to the applicant, the intelligent substance basic copper (II) carbonate is intended to be used in the ink of a freshness indicator in trays of fresh poultry meat at temperatures from 2°C to 10°C and for a period of time of up to 12 days. The intelligent substance basic copper (II) carbonate (CuCO3 Cu(OH)2) in the ink of a printed label, reacts with hydrogen sulfide (H2S) gas that is released from poultry meat degradation and permeates through the paper and into the ink layer. This results in the formation of copper sulfide (CuS) and induces a colour change in the label from pale greenish-blue to dark brown-black. CuCO3 Cu(OH)2 þ 2H2 S ! 2CuS þ H2 CO3 þ 2H2 O The intelligent substance is incorporated in the ink which comprises a nitrocellulose resin with solvents (ethanol, ethyl acetate, 2-propanol and dipropylene glycol monomethyl ether (DPM)) and a plasticiser (acetyl tributyl citrate (ATBC)). During the manufacturing process, the solvents are evaporated. According to Article 6 of Regulation (EU) No 10/2011, salts of copper are authorised even if they are not included in the Union list. Being a salt of carbonic acid, copper (II) carbonate basic is authorised and listed under Regulation (EU) No 10/2011 (FCM substance No 21: carbonic acid, salts). The specific migration limit (SML) for copper is 5 mg/kg food. The Panel is aware that this migration limit for copper along with certain other metals may be under revision in the future. The passive components nitrocellulose resin, solvents (ethanol, ethyl acetate, 2-propanol) and plasticiser (ATBC) are authorised for use in plastic materials and articles according to Regulation (EU) No 10/2011. Nitrocellulose is authorised for use as monomer or other starting substance (FCM substance No 562). Ethanol (FCM substance No 113) and 2-propanol (FCM substance No 118) are both authorised for use as additive, polymer production aid and monomer. Ethyl acetate (FCM substance No 327) is authorised for use as additive or polymer production aid. ATBC (FCM substance


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No 138) is authorised as additive or polymer production aid with a group SML of 60 mg/kg food. The solvent DPM is listed in Swiss Ordinance 817.023.21 with a SML of 50 lg/kg.

3.1.

Non-toxicological data

According to the general principles of the safety assessment of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food (EFSA, 2009b), this safety assessment focuses on the risks related to any dietary exposure to chemicals arising from the intended application. The assessment neither considers the efficacy nor the microbiological aspects of the proposed application of these active materials. The substance is an intelligent ink pigment intended as a freshness indicator in trays for poultry meat. The label with the intelligent ink is used in modified atmosphere packaging (MAP) packages, with no oxygen in the head-space, for refrigerated poultry meat. The foreseen conditions of use are: temperature in the range of 2–10°C, up to 12 days of storage, and varying ink to food surface to volume ratios, but typically 0.02 dm2/400 g. The intelligent substance basic copper (II) carbonate is incorporated in a nitrocellulose resin with solvents (ethanol, ethyl acetate, 2-propanol, DPM) and a plasticiser (ATBC). This forms an ink that is printed on a self-adhesive paper label. The ink is cured and solvents evaporated. The label is then stuck to the inner face of the package lid. The ink is applied on the adhesive face of the label so that it can be seen by the consumer through the transparent plastic of the lid. The intelligent substance basic copper (II) carbonate in the printed label reacts with hydrogen sulfide gas released from the poultry degradation. The hydrogen sulfide permeates through the paper and reacts, which results in a change in the colour of the label. The composition of the dry ink layer was provided to EFSA as confidential. It comprises copper salt, plasticiser ATBC and nitrocellulose resin. The amount of the basic copper (II) carbonate in the dry ink is low . The printed surface area of each label is 0.02 dm2. Assuming total reaction, the amount of reaction product copper sulfide is also low . The printed label is stable at 200°C and decomposition of the reaction product starts at 250°C only, therefore the system is stable at the intended temperatures of manufacture and use. The residual amount of solvents in the printed label was determined and found to be low and assuming total mass transfer from a 0.02 dm2 label into 400 g food would give a worstcase migration that is very low and does not give rise to any safety concern . No migration of copper is expected taking into account the nature of the application, where there is no direct contact between the ink layer and the food. Incidental contact of the paper layer of the printed label with the food cannot be ruled out, for example if the pack was turned upside-down. Considering this eventuality, the maximum theoretical migration of copper was calculated by assuming total mass transfer (which is very unlikely) and the result is several orders of magnitude lower than the migration limit for copper applicable at the date of the assessment (5 mg/kg).

4.

Conclusions

The CEF Panel, having considered the above-mentioned data, concluded that the use of the substance basic copper (II) carbonate in a freshness indicator for packed poultry meat does not raise a safety concern to the consumer if the migration limit of copper is met.

Documentation provided to EFSA Dossier Freshness indicator for poultry meat. January 2016. Submitted by Packaging, Transport and Logistic Center (ITENE).

References EFSA (European Food Safety Authority), 2009a. Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessments carried out by EFSA. Part 2: general principles. EFSA Journal 2009; 7(5):1051, 22 pp. doi:10.2903/j.efsa.2009.1051


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EFSA (European Food Safety Authority), 2009b. 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 Journal 2009;7(8):1208, 11 pp. doi:10.2903/j.efsa.2009.1208 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 its authorisation. Available online: http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf

Abbreviations ATBC CAS CEF Panel DPM FCM MAP SCF SML

acetyl tributyl citrate Chemical Abstracts Service EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids dipropylene glycol monomethyl ether food contact materials modified atmosphere packaging Scientific Committee on Food specific migration limit


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