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Migration of Polycyclic Aromatic Hydrocarbons (Pahs) from Plastic and Rubber Articles

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Migration of Polycyclic Aromatic Hydrocarbons (Pahs) from Plastic and Rubber Articles Migration of Polycyclic Aromatic Hydrocarbons (PAHs) from plastic and rubber articles Final report on the development of a migration measurement method Study conducted on behalf of DG GROW Barrero-Moreno J, Senaldi C, Bianchi I, Geiss O, Tirendi S, Folgado de Lucena A , Barahona F, Mainardi G, Leva P, Aguar-Fernandez P 2018 EUR 29282 EN This publication is a Technical report by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide evidence-based scientific support to the European policymaking process. The scientific output expressed does not imply a policy position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use that might be made of this publication. Contact information Name: BARRERO Josefa Address: Directorate General Joint Research Centre, Directorate F – Health, Consumers and Reference Materials F.2 – Consumer Products Safety Unit, Via E. Fermi, 2749. TP281, I-21027 Ispra (VA), Italy Email: [email protected] Tel.: +39 033278-9863 JRC Science Hub https://ec.europa.eu/jrc JRC111476 EUR 29282 EN PDF ISBN 978-92-79-89749-8 ISSN 1831-9424 doi: 10.2760/41492 Print ISBN 978-92-79-89748-1 ISSN 1018-5593 doi: 10.2760/637211 Luxembourg: Publications Office of the European Union, 2018 © European Union, 2018 Reuse is authorised provided the source is acknowledged. The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39). For any use or reproduction of photos or other material that is not under the EU copyright, permission must be sought directly from the copyright holders. How to cite this report: Barrero-Moreno, J. et al., Migration of Polycyclic Aromatic Hydrocarbons (PAHs) from plastic and rubber articles, EUR 29282 EN, Publications Office of the European Union, Luxembourg, ISBN 978-92-79-89749-8, doi:10.2760/41492, JRC111476 All images © European Union 2018 Contents Acknowledgements ................................................................................................ 1 Abstract ............................................................................................................... 2 1. Introduction ...................................................................................................... 4 1.1 Scoping study and literature review. Short summary. ....................................... 5 2. Experimental design ........................................................................................ 13 2.1 Selection of reference materials ................................................................... 14 2.1.1 Plastic ad-hoc manufactured ............................................................... 14 2.1.2 Rubber ad-hoc manufactured and raw materials .................................... 15 2.1.3 Recycled rubber granules .................................................................... 17 2.1.4 Commercial products .......................................................................... 19 2.1.5 Extender oils from industries ............................................................... 21 2.2 Development of a method for the total content determination of EU-PAHs in plastic and rubber materials ........................................................................................ 21 2.2.1 Activities undertaken towards the development of an improved methodology for the determination of the 8EU-PAHs in rubber and plastic materials ............... 22 2.2.1.1 Extraction ................................................................................... 22 2.2.1.2 Clean-up/purification .................................................................... 22 2.2.2 Total content analysis of ad-hoc manufactured materials, raw-materials and consumer articles purchased on the retail market ............................................ 23 2.3 Selection of simulants for the Development of a method for the evaluation of the release of EU-PAHs from plastic and rubber materials .......................................... 23 2.3.1 Aqueous biofluid simulants .................................................................. 24 2.3.2 Modified sweat simulant formulation .................................................... 24 2.3.3 Alternative approaches ....................................................................... 25 2.4 Development of a method for the evaluation of the release of EU-PAHs from plastic and rubber materials .............................................................................. 26 2.4.1 Working procedure applied to migration in aqueous biofluid. Preliminary tests with aqueous sweat EN1811 and aqueous saliva DIN 53161-1 ................... 27 2.4.2 20% aqueous Ethanol. Set-up of migration step and in-house validation of protocol ...................................................................................................... 29 2.4.3 Aqueous sweat modification: artificial Skin Surface Film Liquid (SSFL) ...... 33 2.4.4 Migration of EU-PAHs from NR BR onto sebum imbued filter paper strips .. 35 3. Results and discussion ..................................................................................... 37 3.1 Evaluation of the total content of EU-PAHs from plastic and rubber materials .... 37 3.1.1 Extraction ......................................................................................... 37 3.1.1.1 Randall hot extraction compared to ultrasound extraction ................. 37 3.1.1.2 Completeness of extraction ........................................................... 38 3.1.1.3 Estimation of trueness .................................................................. 38 3.1.2 Purification ........................................................................................ 39 i 3.1.2.1 Recovery experiments of SupelMIPTM SPE cartridges ......................... 41 3.2 Total content analysis of ad-hoc manufactured materials, raw-materials and consumer articles purchased on the retail market ................................................ 42 3.2.1 Total EU-PAH content in ad-hoc manufactured test materials and raw materials .................................................................................................... 42 3.2.2 Total EU-PAH content in consumer articles purchased on the retail market 46 3.3 Evaluation of the release of EU-PAHs from plastic and rubber materials ............ 48 3.3.1 20% aqueous Ethanol ........................................................................ 48 3.3.2 Skin Surface Film Liquid ..................................................................... 55 3.3.3 Sebum imbued filter paper strips ......................................................... 60 4. Inter-laboratory study on the migration of EU-PAHs from plastic and rubber materials into 20% aqueous Ethanol .................................................................................... 63 4.1 Test materials and sample preparation ......................................................... 63 4.2 Homogeneity assessment ........................................................................... 63 4.3 Sample distribution .................................................................................... 64 4.4 Results of collaborative trial ........................................................................ 66 5. Conclusions .................................................................................................... 72 References ......................................................................................................... 75 List of abbreviations and definitions ....................................................................... 78 List of Figures ..................................................................................................... 79 List of Tables ...................................................................................................... 80 Annex 1 STANPAHs: Migration of PAHs from plastic and rubber materials intended for the general public - Experimental Design Annex 2 Standard Operating Procedures for the total content determination of EU- PAHs in plastic and rubber materials Annex 3 Standard Operating Procedures for the determination of migration of EU- PAHs from rubber and plastic materials into 20% aqueous Ethanol Annex 4 Migration test protocol using artificial skin surface film liquid (SSFL) as migration medium Annex 5 Migration Test Protocol using Sebum Imbued Strips as Migration Medium Annex 6 Initial Collaborative Trial ii Acknowledgements The authors would like to thank the members of the Project Technical Committee for sharing information and discussions in the meetings. Representatives of European standardisation bodies, European Chemicals Agency, (ECHA), industry stakeholders, experts from Member States, governmental laboratories and academia, were part of it. The authors acknowledge the commitment of the organisations manufacturing and providing the test materials. The authors would also like to thank the laboratories that have participated in the initial collaborative trial conducted in this study, reported in Annex 6. Authors Josefa Barrero-Moreno, Chiara Senaldi, Ivana Bianchi, Otmar Geiss, Salvatore Tirendi, Ana Folgado de Lucena, Francisco Barahona, Giuseppe Mainardi, Paolo Leva and Pilar Aguar-Fernandez 1 Abstract Polycyclic Aromatic Hydrocarbons (PAHs) constitute a large group of chemically related substances many of which are known carcinogens. To minimise human exposure
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