Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials
Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride (BTDA), FCM substance No 1083, as co‐monomer for the production of polyimides used in repeated use materials and articles that are in contact...
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| Format: | Article |
| Language: | English |
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Wiley
2020-07-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2020.6183 |
| _version_ | 1818572445063315456 |
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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 Claude Lambré 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 Karla Pfaff Katharina Volk 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 Claude Lambré 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 Karla Pfaff Katharina Volk 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 benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride (BTDA), FCM substance No 1083, as co‐monomer for the production of polyimides used in repeated use materials and articles that are in contact with acidic and fatty foods at temperatures up to 250°C. Migration of BTDA from a polyimide containing 43% BTDA, ■■■■■ into olive oil was below the limit of quantification of about 3 μg/kg food, and in 3% acetic acid it decreased from 30.3 μg/kg in the first test to 22.1 μg/kg in the third test (2 h/100°C). In a semi‐quantitative screening using acetonitrile and acetonitrile/water to extract the polymer powder, linear and cyclic oligomers were detected at levels below 1 mg/kg material. In thermal desorption of the polymer powder at 250°C, phenol, tentatively identified ■■■■■ were found, but the modelled migrations of these were far below a level of potential concern. ■■■■■. The substance did not induce gene mutations in bacterial and mammalian cells. In an in vitro chromosomal aberration test, the substance was found to be directly clastogenic in the absence of metabolic activation. In an in vivo follow‐up, the substance did not induce the formation of micronuclei in experimental conditions associated with evidence of systemic exposure and therefore the Panel considered that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the use of the substance BTDA is not of safety concern for the consumer if it is applied at up to 43% as a co‐monomer in the production of polyimides for repeated use contact with acidic or fatty foods at temperatures up to 250°C. In addition, the migration of BTDA should not exceed 50 μg/kg. |
| first_indexed | 2024-12-14T18:57:17Z |
| format | Article |
| id | doaj.art-26d577ee4db94dec99650a032ebfd969 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-14T18:57:17Z |
| publishDate | 2020-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-26d577ee4db94dec99650a032ebfd9692022-12-21T22:51:03ZengWileyEFSA Journal1831-47322020-07-01187n/an/a10.2903/j.efsa.2020.6183Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, 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 GrobClaude LambréEvgenia LampiMarcel MengelersAlicja MortensenInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLaurence CastleEmma Di ConsiglioRoland FranzNicole HellwigMaria Rosaria MilanaKarla PfaffKatharina VolkGilles RivièreAbstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride (BTDA), FCM substance No 1083, as co‐monomer for the production of polyimides used in repeated use materials and articles that are in contact with acidic and fatty foods at temperatures up to 250°C. Migration of BTDA from a polyimide containing 43% BTDA, ■■■■■ into olive oil was below the limit of quantification of about 3 μg/kg food, and in 3% acetic acid it decreased from 30.3 μg/kg in the first test to 22.1 μg/kg in the third test (2 h/100°C). In a semi‐quantitative screening using acetonitrile and acetonitrile/water to extract the polymer powder, linear and cyclic oligomers were detected at levels below 1 mg/kg material. In thermal desorption of the polymer powder at 250°C, phenol, tentatively identified ■■■■■ were found, but the modelled migrations of these were far below a level of potential concern. ■■■■■. The substance did not induce gene mutations in bacterial and mammalian cells. In an in vitro chromosomal aberration test, the substance was found to be directly clastogenic in the absence of metabolic activation. In an in vivo follow‐up, the substance did not induce the formation of micronuclei in experimental conditions associated with evidence of systemic exposure and therefore the Panel considered that the substance does not raise concern for genotoxicity. The CEP Panel concluded that the use of the substance BTDA is not of safety concern for the consumer if it is applied at up to 43% as a co‐monomer in the production of polyimides for repeated use contact with acidic or fatty foods at temperatures up to 250°C. In addition, the migration of BTDA should not exceed 50 μg/kg.https://doi.org/10.2903/j.efsa.2020.6183benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydrideBTDACAS No 2421‐28‐5co‐monomerfood contact materialssafety assessment |
| 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 Claude Lambré 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 Karla Pfaff Katharina Volk Gilles Rivière Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials EFSA Journal benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride BTDA CAS No 2421‐28‐5 co‐monomer food contact materials safety assessment |
| title | Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials |
| title_full | Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials |
| title_fullStr | Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials |
| title_full_unstemmed | Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials |
| title_short | Safety assessment of the substance benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride, for use in food contact materials |
| title_sort | safety assessment of the substance benzophenone 3 3 4 4 tetracarboxylic dianhydride for use in food contact materials |
| topic | benzophenone‐3,3′,4,4′‐tetracarboxylic dianhydride BTDA CAS No 2421‐28‐5 co‐monomer food contact materials safety assessment |
| url | https://doi.org/10.2903/j.efsa.2020.6183 |
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