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Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester (TDCM) for use as a co‐monomer to manufacture polyester layers. The polyes...

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Autores principales: Silano, Vittorio, Bolognesi, Claudia, Cravedi, Jean‐Pierre, Engel, Karl‐Heinz, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Penninks, André, Smith, Andrew, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Zugravu, Corina‐Aurelia, Kolf‐Clauw, Martine, Lampi, Eugenia, Svensson, Kettil, Barthélémy, Eric, Castle, Laurence
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009812/
https://www.ncbi.nlm.nih.gov/pubmed/32625499
http://dx.doi.org/10.2903/j.efsa.2017.4840
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author Silano, Vittorio
Bolognesi, Claudia
Cravedi, Jean‐Pierre
Engel, Karl‐Heinz
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Kolf‐Clauw, Martine
Lampi, Eugenia
Svensson, Kettil
Barthélémy, Eric
Castle, Laurence
author_facet Silano, Vittorio
Bolognesi, Claudia
Cravedi, Jean‐Pierre
Engel, Karl‐Heinz
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Kolf‐Clauw, Martine
Lampi, Eugenia
Svensson, Kettil
Barthélémy, Eric
Castle, Laurence
collection PubMed
description This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester (TDCM) for use as a co‐monomer to manufacture polyester layers. The polyester layer is not intended to be in direct contact with food. The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs. Contact conditions include sterilisation followed by long‐term storage at room temperature. No thermal degradation of TDCM is expected during the manufacture of the middle polyester layer and of the multilayer articles. Total mass transfer of the substance from a polyester monolayer was calculated to be up to 0.032 mg/kg food. Based on three in vitro genotoxicity tests, the CEF Panel considered that the substance does not raise concern for genotoxicity. When tested behind a polypropylene layer, migrating TDCM‐related oligomers, their oxidation products and other related reaction products were identified. The major components were TDCM dimers. When tested behind a cyclo‐olefin polymer layer, none of the TDCM‐related substances were found to migrate. Based on the lack of genotoxicity of the co‐monomer, the ester nature of the oligomers and on (quantitative) structure–activity relationship ((Q)SAR) analysis, the CEF Panel considered that there is no indication of genotoxicity for the oligomers, their oxidation products and other TDCM‐related reaction products. The CEF Panel concluded that the substance is not of safety concern for the consumer if used as a co‐monomer for the manufacture of a polyester layer intended to be used as an inner (non‐food contact) layer of a multilayer material for contact with foods simulated by simulants A, B, C, D1 (as set in Regulation (EU) 10/2011). The migration of the sum of the substance and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food.
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spelling pubmed-70098122020-07-02 Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials Silano, Vittorio Bolognesi, Claudia Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Mennes, Wim Milana, Maria Rosaria Penninks, André Smith, Andrew Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Zugravu, Corina‐Aurelia Kolf‐Clauw, Martine Lampi, Eugenia Svensson, Kettil Barthélémy, Eric Castle, Laurence EFSA J Scientific Opinion This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester (TDCM) for use as a co‐monomer to manufacture polyester layers. The polyester layer is not intended to be in direct contact with food. The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs. Contact conditions include sterilisation followed by long‐term storage at room temperature. No thermal degradation of TDCM is expected during the manufacture of the middle polyester layer and of the multilayer articles. Total mass transfer of the substance from a polyester monolayer was calculated to be up to 0.032 mg/kg food. Based on three in vitro genotoxicity tests, the CEF Panel considered that the substance does not raise concern for genotoxicity. When tested behind a polypropylene layer, migrating TDCM‐related oligomers, their oxidation products and other related reaction products were identified. The major components were TDCM dimers. When tested behind a cyclo‐olefin polymer layer, none of the TDCM‐related substances were found to migrate. Based on the lack of genotoxicity of the co‐monomer, the ester nature of the oligomers and on (quantitative) structure–activity relationship ((Q)SAR) analysis, the CEF Panel considered that there is no indication of genotoxicity for the oligomers, their oxidation products and other TDCM‐related reaction products. The CEF Panel concluded that the substance is not of safety concern for the consumer if used as a co‐monomer for the manufacture of a polyester layer intended to be used as an inner (non‐food contact) layer of a multilayer material for contact with foods simulated by simulants A, B, C, D1 (as set in Regulation (EU) 10/2011). The migration of the sum of the substance and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food. John Wiley and Sons Inc. 2017-05-24 /pmc/articles/PMC7009812/ /pubmed/32625499 http://dx.doi.org/10.2903/j.efsa.2017.4840 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Silano, Vittorio
Bolognesi, Claudia
Cravedi, Jean‐Pierre
Engel, Karl‐Heinz
Fowler, Paul
Franz, Roland
Grob, Konrad
Gürtler, Rainer
Husøy, Trine
Kärenlampi, Sirpa
Mennes, Wim
Milana, Maria Rosaria
Penninks, André
Smith, Andrew
Tavares Poças, Maria de Fátima
Tlustos, Christina
Wölfle, Detlef
Zorn, Holger
Zugravu, Corina‐Aurelia
Kolf‐Clauw, Martine
Lampi, Eugenia
Svensson, Kettil
Barthélémy, Eric
Castle, Laurence
Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title_full Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title_fullStr Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title_full_unstemmed Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title_short Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
title_sort safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009812/
https://www.ncbi.nlm.nih.gov/pubmed/32625499
http://dx.doi.org/10.2903/j.efsa.2017.4840
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