Safety assessment of the active substances ... - Wiley Online Library

SCIENTIFIC OPINION ADOPTED: 21 June 2016 doi: 10.2903/j.efsa.2016.4529

Safety assessment of the active substances citric acid and sodium hydrogen carbonate for use in active 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 the active substances citric acid, CAS No 77-92-9 and FCM substance No 139, and sodium hydrogen carbonate, CAS No 144-55-8 and FCM substance No 21, intended to be used as a carbon dioxide (CO2) generator in trays of fresh poultry meat at refrigeration temperature. The two substances are activated by contact with meat exudate, whereupon they react together and release carbon dioxide. The active substances are already authorised for use in plastic materials and articles in contact with food (Regulation (EU) No 10/2011) and as food additives (Regulation (EU) No 1129/2011). In this application, they are not intended to transfer into the food. The substances are physically separated from the poultry meat to prevent direct contact. In addition, according to the test results provided, the pack design prevents any return of meat exudate. Backflow of the exudate has to be prevented, as this could cause an addition of sodium hydrogen carbonate, citric acid or the reaction product sodium citrate to the fresh poultry meat, which is not permitted for this food type according to Regulation (EC) No 853/2004 and Regulation (EU) No 1129/2011. Considering the nature of the substances and their intended reaction product carbon dioxide, along with the absence of the formation and any consequential migration of unwanted by-products, the CEF Panel concluded that the active substances, citric acid and sodium hydrogen carbonate, used to generate CO2 in the atmosphere of packed fresh poultry meat do not raise a safety concern to the consumer. There should be neither direct contact of the active substances with the fresh poultry meat nor any backflow of exudate that could bring the active substances into contact with the food. © 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, citric acid (E330, CAS No 77-92-9, FCM substance No 139), sodium hydrogen carbonate (E500ii, CAS No 144-55-8, FCM substance No 21), CO2 emitter ~ola de Seguridad Requestor: Ministerio de Sanidad Servicios Sociales e Igualdad - Agencia Espan n, Direccio n Ejecutiva, Spain Alimentaria y Nutricio Question number: EFSA-Q-2015-00848 Correspondence: fi[email protected]

www.efsa.europa.eu/efsajournal

EFSA Journal 2016;14(7):4529

Citric acid and sodium hydrogen 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, tima Tavares Pocßas, Kettil Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fa € Svensson and Detlef Wolfle for the preparatory work on this scientific opinion and EFSA staff member Katharina Volk for the support provided to this scientific opinion. 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 substances citric acid and sodium hydrogen carbonate for use in active food contact materials. EFSA Journal 2016; 14(7):4529, 7 pp. doi:10.2903/j.efsa.2016.4529 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.


2

EFSA Journal 2016;14(7):4529


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 ....................................................................................................................... 3.2. Toxicological data .............................................................................................................................. 4. Conclusions....................................................................................................................................... Documentation provided to EFSA ............................................................................................................... References................................................................................................................................................ Abbreviations ............................................................................................................................................


3

1 4 4 4 4 4 5 6 7 7 7 7 7

EFSA Journal 2016;14(7):4529


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, Igualdad - Agencia Espan requesting the evaluation of the active substances citric acid and sodium hydrogen carbonate, with the CAS Nos 77-92-9 and 144-55-8, and the food contact material (FCM) substance Nos 139 and 21. 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 substances 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 citric acid and sodium bicarbonate to be used in a carbon dioxide (CO2) emitter for active FCM 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) Data on performance (CO2 generation and exudate absorption)

Toxicological data

• 2.2.

No toxicological data were submitted.

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

2

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.


4

EFSA Journal 2016;14(7):4529


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 substance(s) 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 existing guidance from the EFSA Scientific Committee.

3.

Assessment

According to the applicant, the active substances, citric acid (C6H8O7) and sodium hydrogen carbonate (NaHCO3), are intended to be used as a carbon dioxide (CO2) generator in trays for fresh poultry meat at refrigeration temperature for a period of up to 2 weeks. In the presence of water coming from the meat exudate, the active substances react together to form sodium citrate (Na3C6H5O7) and release the gas CO2 into the atmosphere of the pack, which is intended to have an effect on microbial growth in the meat. H2 O 3NaHCO3 þ C6 H8 O7 H2 O ! Na3 C6 H5 O7 þ 3CO2 " þ 4H2 O The CO2 emitter coating is applied on the bottom of the tray. It is composed by a resin (polystyrene), a solvent (ethyl acetate) and the active substances. Once the coating is applied, the solvent is evaporated during the drying stage. The active coating is separated from the poultry meat by a rigid polyethylene terephthalate (PET) perforated layer which is sealed on the four sides to the tray, and therefore direct contact between the active substances and the meat is not foreseen. In addition, according to the applicant, there is no return of the exudate under the foreseeable conditions of use. The substances used in the passive parts of the CO2 generator are authorised for use in plastic materials and articles in contact with food under Regulation (EU) No 10/2011. Styrene is authorised as monomer for plastic materials and articles in contact with food under Regulation (EU) No 10/20113 (FCM substance No 193). Ethyl acetate is authorised as additive for polymer production aid for plastic materials and articles in contact with food under Regulation (EU) No 10/2011 (FCM substance No 327). Although authorised without restrictions, the use of ethyl acetate for food applications is self-limiting due to its odour. 3

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.


5

EFSA Journal 2016;14(7):4529


The active substances are already authorised for use in plastic materials and articles in contact with food and as food additives and are not intended to migrate into the food. Citric acid is authorised under Regulation (EU) No 10/2011 as additive and monomer for plastic materials and articles in contact with food with no specific restriction (FCM substance No 139). The substance is also authorised as food additive under Regulation (EU) No 1129/20114 (E330). As a salt of carbonic acid, sodium hydrogen carbonate is authorised under Regulation (EU) No 10/2011 as additive for plastic materials and articles in contact with food with no specific restriction (FCM substance No 21). It is also authorised as food additive under Regulation (EU) No 1129/2011 (E500ii). According to Regulation (EU) No 1129/2011, the use of citric acid and sodium hydrogen carbonate as food additives for unprocessed meat other than meat preparations as defined by Regulation (EC) No 853/2004 is prohibited. The use of these active substances as CO2 generators has already been evaluated in a combination with a liquid absorber pad made of polyacrylic acid, sodium salt, cross-linked, and cellulose (EFSA CEF Panel, 2013). Under Regulation (EU) No 1129/2011, carbon dioxide (E290) is authorised as food additive for all categories of foods following the quantum satis principle.

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 active substances citric acid (C6H8O7, Figure 1) and sodium hydrogen carbonate (NaHCO3, Figure 2) are intended to be used as a CO2 generator in trays of fresh poultry meat.

Figure 1: Chemical structure of citric acid (C6H8O7)

Figure 2: Chemical structure of sodium hydrogen carbonate (NaHCO3) The active coating is separated from the meat by a rigid PET perforated layer which is sealed on the four sides to the tray. Therefore, direct contact between the active substances in the coating and the food is ruled out. The exudate drains from the meat by gravity, falling into the bottom of the tray where the active coating is. According to the applicant, no exudate returns into contact with the meat after having drained down into the bottom of the tray, even if the tray is inverted upside down, because three features prevent this: (i) the perforated layer is sealed to the tray; (ii) the specific shape and dimensions of the holes in the perforated layer; (iii) the dimensions of the coated cells in the bottom of the tray. This claim was supported by tests using simulated exudate. Backflow of the exudate has to be prevented as this could cause an addition of sodium hydrogen carbonate, citric acid or the reaction product sodium citrate to the poultry meat, whereas the use of these substances as food additives for unprocessed meat other than meat preparations as defined by Regulation (EC) No 853/2004 is not allowed according to Regulation (EU) No 1129/2011. Provided that both direct contact per se and the backflow of exudate are prevented, then the transfer of non-volatile substances to the food is not possible. Therefore, only the possibility of the transfer of volatile substances to the food needs to be considered. The solvent ethyl acetate is 4

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.


6

EFSA Journal 2016;14(7):4529


expected to be completely evaporated under the described manufacturing conditions. The active ingredients are physically embedded on the surface of the polystyrene coating. Under the manufacturing conditions applied and under the intended conditions of use, no chemical interactions with the polystyrene leading to the formation of volatile substances that could migrate are expected.

3.2.

Toxicological data

The Panel noted that citric acid and sodium hydrogen carbonate have already been evaluated and authorised as substances to be used for plastic materials and articles in contact with food under Regulation (EU) No 10/2011 and as food additives under Regulation (EU) No 1129/2011. In addition, considering the nature of the substances and their intended reaction product, carbon dioxide, along with the absence of the formation and any subsequent migration of unwanted by-products, the Panel considered that this use of these substances would not give rise to safety concerns.

4.

Conclusions

The CEF Panel, having considered the above-mentioned data, concluded that the active substances, citric acid and sodium hydrogen carbonate, used to generate carbon dioxide in the atmosphere of packed fresh poultry meat do not raise a safety concern to the consumer. There should be neither direct contact of the active substances with the fresh poultry meat nor any backflow of exudate that could bring the active substances into contact with the fresh poultry meat.

Documentation provided to EFSA Dossier CO2 emitter for poultry meat. December 2015. 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 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 EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on the safety evaluation of the active substances citric acid (E330) and sodium hydrogen carbonate (E500ii), used as carbon dioxide generators, together with liquid absorbers cellulose and polyacrylic acid sodium salt crosslinked, in active food contact materials. EFSA Journal 2013;11(4):3152, 10 pp. doi:10.2903/j.efsa.2013.3152 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 CAS CEF Panel FCM PET SCF

Chemical Abstracts Service EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids food contact materials polyethylene terephthalate Scientific Committee on Food


7

EFSA Journal 2016;14(7):4529