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

Abstract 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. T...

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Main Authors: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Vittorio Silano, Claudia Bolognesi, Jean‐Pierre Cravedi, Karl‐Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn, Corina‐Aurelia Zugravu, Martine Kolf‐Clauw, Eugenia Lampi, Kettil Svensson, Eric Barthélémy, Laurence Castle
Format: Article
Language:English
Published: Wiley 2017-05-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2017.4840
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author EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Vittorio Silano
Claudia Bolognesi
Jean‐Pierre Cravedi
Karl‐Heinz Engel
Paul Fowler
Roland Franz
Konrad Grob
Rainer Gürtler
Trine Husøy
Sirpa Kärenlampi
Wim Mennes
Maria Rosaria Milana
André Penninks
Andrew Smith
Maria de Fátima Tavares Poças
Christina Tlustos
Detlef Wölfle
Holger Zorn
Corina‐Aurelia Zugravu
Martine Kolf‐Clauw
Eugenia Lampi
Kettil Svensson
Eric Barthélémy
Laurence Castle
author_facet EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Vittorio Silano
Claudia Bolognesi
Jean‐Pierre Cravedi
Karl‐Heinz Engel
Paul Fowler
Roland Franz
Konrad Grob
Rainer Gürtler
Trine Husøy
Sirpa Kärenlampi
Wim Mennes
Maria Rosaria Milana
André Penninks
Andrew Smith
Maria de Fátima Tavares Poças
Christina Tlustos
Detlef Wölfle
Holger Zorn
Corina‐Aurelia Zugravu
Martine Kolf‐Clauw
Eugenia Lampi
Kettil Svensson
Eric Barthélémy
Laurence Castle
author_sort EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
collection DOAJ
description Abstract 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 doaj.art-96f1164e7c87439ba5a23262552382362023-11-07T12:40:55ZengWileyEFSA Journal1831-47322017-05-01155n/an/a10.2903/j.efsa.2017.4840Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materialsEFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Vittorio SilanoClaudia BolognesiJean‐Pierre CravediKarl‐Heinz EngelPaul FowlerRoland FranzKonrad GrobRainer GürtlerTrine HusøySirpa KärenlampiWim MennesMaria Rosaria MilanaAndré PenninksAndrew SmithMaria de Fátima Tavares PoçasChristina TlustosDetlef WölfleHolger ZornCorina‐Aurelia ZugravuMartine Kolf‐ClauwEugenia LampiKettil SvenssonEric BarthélémyLaurence CastleAbstract 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.https://doi.org/10.2903/j.efsa.2017.48401,2,3,4‐tetrahydronaphthalene‐26‐dicarboxylic aciddimethyl ester (TDCM)CAS No 23985‐75‐3FCM substance No 1066monomer
spellingShingle EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
Vittorio Silano
Claudia Bolognesi
Jean‐Pierre Cravedi
Karl‐Heinz Engel
Paul Fowler
Roland Franz
Konrad Grob
Rainer Gürtler
Trine Husøy
Sirpa Kärenlampi
Wim Mennes
Maria Rosaria Milana
André Penninks
Andrew Smith
Maria de Fátima Tavares Poças
Christina Tlustos
Detlef Wölfle
Holger Zorn
Corina‐Aurelia Zugravu
Martine Kolf‐Clauw
Eugenia Lampi
Kettil Svensson
Eric Barthélémy
Laurence Castle
Safety assessment of the substance 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester for use in food contact materials
EFSA Journal
1,2,3,4‐tetrahydronaphthalene‐2
6‐dicarboxylic acid
dimethyl ester (TDCM)
CAS No 23985‐75‐3
FCM substance No 1066
monomer
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 1,2,3,4‐tetrahydronaphthalene‐2
6‐dicarboxylic acid
dimethyl ester (TDCM)
CAS No 23985‐75‐3
FCM substance No 1066
monomer
url https://doi.org/10.2903/j.efsa.2017.4840
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