Scientific Opinion on the safety assessment of the substances, kaolin and polyacrylic acid, sodium salt, for use in food contact materials 1

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1 EFSA Journal 2014;12(4):3637 SCIENTIFIC OPINION Scientific Opinion on the safety assessment of the substances, kaolin and polyacrylic acid, sodium salt, 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, Flavorings and Processing Aids (CEF) deals with the safety assessment of kaolin which is used in a combination with polyacrylic acid, sodium salt and is incorporated in a gas barrier layer of ethylene-vinyl alcohol (EVOH) copolymer. The EVOH copolymer is used as an inner layer in multi-layer food contact materials. Morphological studies show stacks of kaolin clay platelets of different sizes dispersed in the EVOH and some of these platelets are below 100 nm in the thickness dimension. Nevertheless, exfoliation into individual platelets does not occur for kaolin as confirmed by WAXS. No migration of the kaolin particles from the EVOH layer was shown. There was no detectable migration of aluminium or magnesium (inorganic constituents of kaolin) from a typical multi-layer plastic material, with detection limits of 0.07 mg/kg and up to 2.2 mg/kg, respectively. These values indicate that migration of these inorganic components is not expected to be significant. Migration of polyacrylic acid sodium salt is not expected to exceed the SML of 6 mg/kg foodstuffs at the conditions of use foreseen. Therefore, the CEF panel concluded that the substance kaolin in the form of particles with a thickness less than 100 nm does not raise a safety concern for the consumer when incorporated up to 12 % in EVOH copolymer. This material is used as an inner layer of a plastic multi-layer structure, in contact with foods and beverages stored at room temperature up to 6 months. The EVOH inner layer containing the particles should be used behind a functional barrier that prevents migration of kaolin particles into the food. European Food Safety Authority, 2014 KEY WORDS kaolin, polyacrylic acid sodium salt, food contact materials, safety evaluation 1 On request from Agencia Española de la Seguridad Alimentaria y Nutrición, Spain, Question No EFSA-Q , adopted on 27 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 (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. Correspondence: cef@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Alessandro Di Domenico, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Martine Kolf-Clauw Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this scientific opinion. Deceased Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), Scientific Opinion on the safety assessment of the substances, kaolin and polyacrylic acid, sodium salt, for use in food contact materials. EFSA Journal 2014;12(4):3637, 8 pp. doi: /j.efsa Available online: European Food Safety Authority, 2014

2 SUMMARY Within the general task of evaluating substances intended for use in materials in contact with food according to the 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 foodstuffs, the CEF Panel received a request from a competent Member State Authority for safety evaluation of a substance following a corresponding application from the industry. In the context of this evaluation procedure, following a request from the Agencia Española de la Seguridad Alimentaria y Nutrición, Spain, the Panel on Food Contact Materials, Enzymes and Processing aids (CEF) was asked to deliver an opinion on kaolin which is used in a combination with and polyacrylic acid, sodium salt, for incorporation in an a gas barrier layer of a multi-layer food contact material, not in direct contact with food. Kaolin (99.5 %) in a combination with polyacrylic acid, sodium salt (0.5 %) intended to be incorporated in EVOH copolymer in order to enhance its gas barrier properties. The mixture is incorporated typically at 4 % in the EVOH copolymer, but depending on the application the concentration can range from 1 % to 12 %. The EVOH copolymer is intended to be used in food contact materials for beverages (alcoholic and non-alcoholic), sauces and dressings, sausages and wet and dry pet food, stored at room temperature up to 6 months. Both substances have been evaluated and authorised for use as additives in plastic materials and articles in contact with foods. Polyacrylic acid, sodium salt is used as an agent to disperse the kaolin in the EVOH. Particle size distribution of kaolin in an aqueous dispersion showed values larger than 0.92 µm (90 %) and larger 2.17 µm (50 %). The specific surface area was 3.2 m 2 /g. Morphological studies show stacks of kaolin clay platelets of different sizes dispersed in the EVOH. These particles have shown strong interfacial adhesion to the polymer. Some of these particles when dispersed in the polymer are below 100 nm in the thickness dimension. Nevertheless, exfoliation into individual platelets does not occur for kaolin as confirmed by WAXS. From a toxicological point of view, migration of aluminium and magnesium ions from kaolin (constituents of the clay) is of interest. Specific migration from a typical multi-layer was not detectable; less than 0.07 mg/kg for aluminium and less than 2.2 mg/kg for magnesium. These values indicate that migration of these inorganic components is not expected to be significant and would result in exposure estimates much lower than the TWI established in 2008 for aluminium and lower than the Tolerable Upper Intake level of 250 mg/day for magnesium. Migration of polyacrylic acid sodium salt, estimated assuming total migration from EVOH layers up to 15 µm, containing 4 % of substance was well below of the SML of 6 mg/kg foodstuffs. This indicates that migration of polyacrylic acid sodium salt at the intended conditions of use does not exceed the SML. Therefore, the CEF panel concluded that the substance kaolin in the form of particles with a thickness less than 100 nm does not raise a safety concern for the consumer when incorporated up to 12 % in EVOH copolymer. This material is used as an inner layer of a plastic multi-layer structure, in contact with foods and beverages stored at room temperature up to 6 months. The EVOH inner layer containing the particles should be used behind a functional barrier that prevents migration of kaolin particles into the food. EFSA Journal 2014;12(4):3637 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the legislation... 4 Terms of reference as provided by the legislation... 4 Assessment Introduction General information Data available in the dossier used for this evaluation Evaluation Non-toxicological data Toxicological data... 6 Conclusions... 7 Documentation provided to EFSA... 7 References... 7 Abbreviations... 8 EFSA Journal 2014;12(4):3637 3

4 BACKGROUND AS PROVIDED BY THE LEGISLATION Before a substance is authorised to be used in food contact materials and is included in a positive list EFSA s opinion on its safety is required. This procedure has been established in Articles 8 and 9 of the 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 4. According to this procedure the industry submits applications to the Member States competent Authorities which in their turn transmit the applications to the EFSA for their evaluation. The application is supported by a technical dossier submitted by the industry following the SCF guidelines for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (EC, 2001). In this case, EFSA received an application from the Agencia Española de la Seguridad Alimentaria y Nutrición, Spain, requesting the evaluation of kaolin, with the CAS number and FCM Substance No 410 which is used in a combination with polyacrylic acid, sodium salt, with the CAS number and FCM Substance No 70. TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION 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. 4 Commission Regulation (EC) No 1935/2004 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 C 117, , p. 1. EFSA Journal 2014;12(4):3637 4

5 ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Agencia Española de la Seguridad Alimentaria y Nutrición, Spain, to evaluate the safety kaolin, with the CAS number and FCM Substance No 410, used in a combination with polyacrylic acid, sodium salt, with the CAS number and FCM Substance No 70. The request has been registered in the EFSA s register of questions under the number EFSA-Q The dossier was submitted by the applicant, NanoBioMatters Industries, S.L., Spain. 2. General information According to the applicant, kaolin (99.5 %) in a combination with polyacrylic acid, sodium salt (0.5 %) intended to be incorporated in EVOH copolymer in order to enhance its gas barrier properties. The EVOH is used as inner layer in a multi-layer, not in direct contact with the food, and contains typically 4 % of the mixture, but depending on the application the concentration can range from 1 % to 12 %. The multi-layers are intended to be used in contact with beverages (alcoholic and non-alcoholic), sauces and dressings, sausages and wet and dry pet food, at room temperature up to 6 months. The substances are listed in Regulation (EU) No 10/ : Kaolin is authorised as additive for plastic materials and articles in contact with foods (FCM Substance No 410), with no specific restriction; Polyacrylic acid, sodium salt, is authorised as additive for plastic materials and articles in contact with foods (FCM Substance No 70), with a specific restriction of 6 mg/kg, expressed as acrylic acid. 3. Data available in the dossier used for this evaluation The studies submitted for evaluation followed the SCF guidelines for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (EC, 2001). Non-toxicity data: Toxicity data: Data on identity Data on physical and chemical properties Data on intended use and authorisation Data on migration of the substance Data on residual content of the substance Data on worst-case migration None 5 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food OJ L , p EFSA Journal 2014;12(4):3637 5

6 4. Evaluation 4.1. Non-toxicological data Kaolin (99.5 %) in combination with polyacrylic acid, sodium salt (0.5 %) is intended to be incorporated in EVOH copolymer in order to enhance its gas barrier properties by creating a tortuous path to gases diffusing through the polymer. According to the applicant the incorporation is performed by conventional polymer processing techniques, in a concentration up to 12 %. Polyacrylic acid, sodium salt is used as an agent to disperse the kaolin in the EVOH. Particle size distribution of kaolin in an aqueous dispersion showed values larger than 0.92 µm (90 %) and larger 2.17 µm (50 %). The specific surface area was 3.2 m 2 /g. Morphological studies show stacks of clay platelets of different sizes dispersed in the EVOH. These particles have shown strong interfacial adhesion to the polymer. Some of these particles when dispersed in the polymer are below 100 nm in the thickness dimension. Nevertheless, exfoliation into individual platelets does not occur for kaolin as confirmed by WAXS (Wide-angle X-ray scattering). The EVOH containing the additive is used as intermediate layer in plastic multi-layers and does not make direct contact with the food. Given the nature of the substances, decomposition or degradation is not expected at the production and use conditions. Migration tests for aluminium and magnesium from the kaolin were performed in food simulants water, 10 % ethanol and 3 % acetic acid at 40 ºC for 10 days and in isooctane at 20 ºC for 2 days. A sample with a typical multi-layer structure was used: PE/EVOH + 4 % substance/pe with thickness 40/6/40 µm, with a surface area to volume ratio of 2 dm 2 /kg. There was no detectable migration, as values were similar to the blanks. The migration of magnesium was less than 2.2 mg/kg and migration of aluminium was less than 0.07 mg/kg, for the conventional surface area to mass ratio of 6 dm 2 /kg food or food simulant. Results from TEM (Transmission Electron Microscopy) analysis of a sample of material with structure representative of the intended use, composed of PE/EVOH + 4 % substance/pe with thickness 40/6/40 µm indicate no migration of the kaolin from the EVOH layer into the food contact layer and therefore, no transfer to the food is to be expected. Migration of polyacrylic acid sodium salt, estimated assuming total mass transfer from a 15 µm EVOH sample, containing 4 % of substance, was mg/kg foodstuffs, which is well below the SML of 6 mg/kg. This indicates that migration of polyacrylic acid sodium salt at the intended conditions of use does not exceed the SML Toxicological data The substances in the mixture have already been evaluated from the toxicological point of view and they are authorised in the EU legislation for plastic in contact with food. For the purpose of this evaluation, no further toxicological data are necessary. The Panel took note of the opinion of the AFC Panel (EFSA, 2008) setting a TWI of 1 mg/kg bw /week for aluminium. Based on a conservative scenario of consumption of 1 kg of food per day containing aluminium migrated at the level of detection of the method used of 0.07 mg/kg food, an adult of 60 kg body weight in one week time would be exposed to mg Al/kg bw/ per week, corresponding less than 1 % of the TWI set in Concerning magnesium, the Panel noted that magnesium occurs naturally in foods and is an authorised food supplement (Annex I of Regulation (EC) No 1925/ and Annex I of Directive 2002/46/EC 7 ). 6 Regulation (EC) No 1925/2006 of the European Parliament and the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, OJ L404, , p Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, OJ L 183, , p EFSA Journal 2014;12(4):3637 6

7 In 2001, the SCF established a Tolerable Upper Intake level of 250 mg/day for readily dissociable magnesium salts (SCF, 2001). Therefore, no safety concern is raised at the detected migration level. CONCLUSIONS Having considered the above mentioned data, the CEF Panel concluded that the substance kaolin in the form of particles with a thickness less than 100 nm does not raise a safety concern for the consumer when incorporated up to 12 % in EVOH copolymer. This material is used as an inner layer of a plastic multi-layer structure, in contact with foods and beverages stored at room temperature up to 6 months. The EVOH inner layer containing the particles should be used behind a functional barrier that prevents migration of kaolin particles into the food. DOCUMENTATION PROVIDED TO EFSA 1. O2Block 4x4 C1.33. November Submitted by the applicant NanoBioMAtters Industries, S.L., Spain REFERENCES EC (European Commission), 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 authorization, 6pp. EFSA (European Food Safety Authority), Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) on safety of aluminium from dietary intake. The EFSA Journal 2008, 754, SCF (Scientific Committee for Food), Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Magnesium, 16pp. EFSA Journal 2014;12(4):3637 7

8 ABBREVIATIONS AFC bw CAS EC Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials body weight Chemical Abstracts Service European Commission EFSA European Food Safety Authority EU European Union EVOH Ethylene-vinyl alcohol FCM PE SCF SML TEM TWI Food Contact Materials Polyethylene Scientific committee on food Specific Migration Limit Transmission Electron Microscopy Tolerable Weekly Intake WAXS Wide-angle X-ray scattering EFSA Journal 2014;12(4):3637 8