Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials
Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the combined use of cyclooctene homopolymer (PCOE) and cobalt stearate (CoS) intended as a oxygen scavenger in the packaging of all kinds of food stored at room temperature or below for up to...
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| Format: | Article |
| Language: | English |
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Wiley
2022-06-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7364 |
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| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Maria Rosaria Milana Stefan Merkel Eric Barthélémy Gilles Rivière |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Maria Rosaria Milana Stefan Merkel Eric Barthélémy Gilles Rivière |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the combined use of cyclooctene homopolymer (PCOE) and cobalt stearate (CoS) intended as a oxygen scavenger in the packaging of all kinds of food stored at room temperature or below for up to 6 months. The CoS is the oxidation catalyst and the PCOE is intentionally oxidised for the oxygen scavenging function. They are incorporated into a plastic layer that is intended to be either in direct or indirect contact with the food. The potential migration of cobalt and cyclooctene monomer were below their respective specific migration limit (SML). The potential migration of PCOE non‐oxidised oligomeric low molecular weight fraction (LMWF) < 1,000 Da was estimated to be up to ■■■■■ The Panel concluded that this fraction does not raise concern for genotoxicity potential and that the no observed adverse effect level (NOAEL) derived from a subchronic toxicity study would ensure a margin of exposure large enough to not raise a safety concern. However, the Panel considered the analysis of the oxidised PCOE LMWF not sufficiently comprehensive, i.e. that additional oxidation products of different nature may be formed, and that the limit of detection corresponding to ca. ■■■■■ for individual substances is too high. The oxidised PCOE LMWF was not covered by the genotoxicity tests or the 90‐day study on the PCOE oligomers. The assessment of the identified potential oxidised migrants was considered conclusive, but not that of the migrants having remained undetected. Therefore, the CEP Panel was not able to conclude on the safety of the proposed use of cyclooctene homopolymer and cobalt stearate together as active substances in a layer for scavenging oxygen, either in direct contact with the food or separated from the food by a passive layer of polymer. |
| first_indexed | 2024-04-10T05:46:15Z |
| format | Article |
| id | doaj.art-3d8e3ccb930143a0abc6bbd71595cc5d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-10T05:46:15Z |
| publishDate | 2022-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-3d8e3ccb930143a0abc6bbd71595cc5d2023-03-06T00:52:04ZengWileyEFSA Journal1831-47322022-06-01206n/an/a10.2903/j.efsa.2022.7364Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materialsEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiAndrew ChessonPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLaurence CastleEmma Di ConsiglioRoland FranzNicole HellwigMaria Rosaria MilanaStefan MerkelEric BarthélémyGilles RivièreAbstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the combined use of cyclooctene homopolymer (PCOE) and cobalt stearate (CoS) intended as a oxygen scavenger in the packaging of all kinds of food stored at room temperature or below for up to 6 months. The CoS is the oxidation catalyst and the PCOE is intentionally oxidised for the oxygen scavenging function. They are incorporated into a plastic layer that is intended to be either in direct or indirect contact with the food. The potential migration of cobalt and cyclooctene monomer were below their respective specific migration limit (SML). The potential migration of PCOE non‐oxidised oligomeric low molecular weight fraction (LMWF) < 1,000 Da was estimated to be up to ■■■■■ The Panel concluded that this fraction does not raise concern for genotoxicity potential and that the no observed adverse effect level (NOAEL) derived from a subchronic toxicity study would ensure a margin of exposure large enough to not raise a safety concern. However, the Panel considered the analysis of the oxidised PCOE LMWF not sufficiently comprehensive, i.e. that additional oxidation products of different nature may be formed, and that the limit of detection corresponding to ca. ■■■■■ for individual substances is too high. The oxidised PCOE LMWF was not covered by the genotoxicity tests or the 90‐day study on the PCOE oligomers. The assessment of the identified potential oxidised migrants was considered conclusive, but not that of the migrants having remained undetected. Therefore, the CEP Panel was not able to conclude on the safety of the proposed use of cyclooctene homopolymer and cobalt stearate together as active substances in a layer for scavenging oxygen, either in direct contact with the food or separated from the food by a passive layer of polymer.https://doi.org/10.2903/j.efsa.2022.7364cyclooctene homopolymercobalt stearatefood contact materialsplasticactiveoxygen scavenger |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Maria Rosaria Milana Stefan Merkel Eric Barthélémy Gilles Rivière Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials EFSA Journal cyclooctene homopolymer cobalt stearate food contact materials plastic active oxygen scavenger |
| title | Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| title_full | Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| title_fullStr | Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| title_full_unstemmed | Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| title_short | Safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| title_sort | safety assessment of the active substances cyclooctene homopolymer and cobalt stearate in combination for use in active food contact materials |
| topic | cyclooctene homopolymer cobalt stearate food contact materials plastic active oxygen scavenger |
| url | https://doi.org/10.2903/j.efsa.2022.7364 |
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