Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials
Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2‐ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and ar...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-10-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5864 |
| _version_ | 1818596274986811392 |
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| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Beat Johannes Brüschweiler Laurence Castle Jean‐Pierre Cravedi Emma Di Consiglio Roland Franz Nicole Hellwig Martine Kolf‐Clauw Maria Rosaria Milana Karla Pfaff Maria de Fátima Tavares Poças Kettil Svensson Detlef Wölfle Eric Barthélémy Gilles Rivière |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Beat Johannes Brüschweiler Laurence Castle Jean‐Pierre Cravedi Emma Di Consiglio Roland Franz Nicole Hellwig Martine Kolf‐Clauw Maria Rosaria Milana Karla Pfaff Maria de Fátima Tavares Poças Kettil Svensson Detlef Wölfle Eric Barthélémy Gilles Rivière |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2‐ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 μg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90‐day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2‐ethylhexyl) ester (DEHP). Assuming that impurities migrate pro‐rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered. |
| first_indexed | 2024-12-16T11:29:19Z |
| format | Article |
| id | doaj.art-a4f7f32bd6db4bf085ef66d7567fa82a |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-16T11:29:19Z |
| publishDate | 2019-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-a4f7f32bd6db4bf085ef66d7567fa82a2022-12-21T22:33:16ZengWileyEFSA Journal1831-47322019-10-011710n/an/a10.2903/j.efsa.2019.5864Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materialsEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Vittorio SilanoJosé Manuel Barat BavieraClaudia BolognesiAndrew ChessonPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiAlicja MortensenInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornBeat Johannes BrüschweilerLaurence CastleJean‐Pierre CravediEmma Di ConsiglioRoland FranzNicole HellwigMartine Kolf‐ClauwMaria Rosaria MilanaKarla PfaffMaria de Fátima Tavares PoçasKettil SvenssonDetlef WölfleEric BarthélémyGilles RivièreAbstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2‐ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 μg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90‐day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2‐ethylhexyl) ester (DEHP). Assuming that impurities migrate pro‐rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.https://doi.org/10.2903/j.efsa.2019.5864trimellitic acid, tris(2‐ethylhexyl) esterplasticiserCAS No 3319‐31‐1FCM substance No 1078PVCfood contact materials |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Vittorio Silano José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Beat Johannes Brüschweiler Laurence Castle Jean‐Pierre Cravedi Emma Di Consiglio Roland Franz Nicole Hellwig Martine Kolf‐Clauw Maria Rosaria Milana Karla Pfaff Maria de Fátima Tavares Poças Kettil Svensson Detlef Wölfle Eric Barthélémy Gilles Rivière Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials EFSA Journal trimellitic acid, tris(2‐ethylhexyl) ester plasticiser CAS No 3319‐31‐1 FCM substance No 1078 PVC food contact materials |
| title | Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials |
| title_full | Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials |
| title_fullStr | Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials |
| title_full_unstemmed | Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials |
| title_short | Safety assessment of the substance trimellitic acid, tris (2‐ethylhexyl) ester, for use in food contact materials |
| title_sort | safety assessment of the substance trimellitic acid tris 2 ethylhexyl ester for use in food contact materials |
| topic | trimellitic acid, tris(2‐ethylhexyl) ester plasticiser CAS No 3319‐31‐1 FCM substance No 1078 PVC food contact materials |
| url | https://doi.org/10.2903/j.efsa.2019.5864 |
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