Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map
Background: The presence of polyethylene terephthalate (PET) oligomers in food contact materials (FCMs) is well-documented. Consumers are exposed through their migration into foods and beverages; however, there is no specific guidance for their safety evaluation. Objectives: This systematic evidence...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Environment International |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0160412023002519 |
| _version_ | 1797812102852771840 |
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| author | Verena N. Schreier Emre Çörek Christian Appenzeller-Herzog Beat J. Brüschweiler Birgit Geueke Martin F. Wilks Benoit Schilter Jane Muncke Thomas J. Simat Martin Smieško Nicolas Roth Alex Odermatt |
| author_facet | Verena N. Schreier Emre Çörek Christian Appenzeller-Herzog Beat J. Brüschweiler Birgit Geueke Martin F. Wilks Benoit Schilter Jane Muncke Thomas J. Simat Martin Smieško Nicolas Roth Alex Odermatt |
| author_sort | Verena N. Schreier |
| collection | DOAJ |
| description | Background: The presence of polyethylene terephthalate (PET) oligomers in food contact materials (FCMs) is well-documented. Consumers are exposed through their migration into foods and beverages; however, there is no specific guidance for their safety evaluation. Objectives: This systematic evidence map (SEM) aims to identify and organize existing knowledge and associated gaps in hazard and exposure information on 34 PET oligomers to support regulatory decision-making. Methods: The methodology for this SEM was recently registered. A systematic search in bibliographic and gray literature sources was conducted and studies evaluated for inclusion according to the Populations, Exposures, Comparators, Outcomes, and Study type (PECOS) framework. Inclusion criteria were designed to record hazard and exposure information for all 34 PET oligomers and coded into the following evidence streams: human, animal, organism (non-animal), ex vivo, in vitro, in silico, migration, hydrolysis, and absorption, distribution, metabolism, excretion/toxicokinetics/pharmacokinetics (ADME/TK/PK) studies. Relevant information was extracted from eligible studies and synthesized according to the protocol. Results: Literature searches yielded 7445 unique records, of which 96 were included. Data comprised migration (560 entries), ADME/TK/PK-related (253 entries), health/bioactivity (98 entries) and very few hydrolysis studies (7 entries). Cyclic oligomers were studied more frequently than linear PET oligomers. In vitro results indicated that hydrolysis of cyclic oligomers generated a mixture of linear oligomers, but not monomers, potentially allowing their absorption in the gastrointestinal tract. Cyclic dimers, linear trimers and the respective smaller oligomers exhibit physico-chemical properties making oral absorption more likely. Information on health/bioactivity effects of oligomers was almost non-existent, except for limited data on mutagenicity. Conclusions: This SEM revealed substantial deficiencies in the available evidence on ADME/TK/PK, hydrolysis, and health/bioactivity effects of PET oligomers, currently preventing appropriate risk assessment. It is essential to develop more systematic and tiered approaches to address the identified research needs and assess the risks of PET oligomers. |
| first_indexed | 2024-03-13T07:33:26Z |
| format | Article |
| id | doaj.art-73693be193ec4c62800623585ed38310 |
| institution | Directory Open Access Journal |
| issn | 0160-4120 |
| language | English |
| last_indexed | 2024-03-13T07:33:26Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Environment International |
| spelling | doaj.art-73693be193ec4c62800623585ed383102023-06-04T04:23:06ZengElsevierEnvironment International0160-41202023-06-01176107978Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence mapVerena N. Schreier0Emre Çörek1Christian Appenzeller-Herzog2Beat J. Brüschweiler3Birgit Geueke4Martin F. Wilks5Benoit Schilter6Jane Muncke7Thomas J. Simat8Martin Smieško9Nicolas Roth10Alex Odermatt11Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, SwitzerlandDepartment of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, SwitzerlandUniversity Medical Library, University of Basel, Basel, SwitzerlandFederal Food Safety and Veterinary Office (FSVO), Risk Assessment Division, Bern, SwitzerlandFood Packaging Forum Foundation, Zurich, SwitzerlandDepartment of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, SwitzerlandConsultant of Food Contact Materials Safety, Lausanne, SwitzerlandFood Packaging Forum Foundation, Zurich, SwitzerlandChair of Food Contact Materials, Dresden University of Technology, Dresden, GermanyDepartment of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, SwitzerlandDepartment of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, SwitzerlandDepartment of Pharmaceutical Sciences, University of Basel, Basel, Switzerland; Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Basel, Switzerland; Corresponding author at: Division of Molecular and Systems Toxicology, Department of Pharmaceutical Sciences, Klingelbergstrasse 50, 4056 Basel, Switzerland.Background: The presence of polyethylene terephthalate (PET) oligomers in food contact materials (FCMs) is well-documented. Consumers are exposed through their migration into foods and beverages; however, there is no specific guidance for their safety evaluation. Objectives: This systematic evidence map (SEM) aims to identify and organize existing knowledge and associated gaps in hazard and exposure information on 34 PET oligomers to support regulatory decision-making. Methods: The methodology for this SEM was recently registered. A systematic search in bibliographic and gray literature sources was conducted and studies evaluated for inclusion according to the Populations, Exposures, Comparators, Outcomes, and Study type (PECOS) framework. Inclusion criteria were designed to record hazard and exposure information for all 34 PET oligomers and coded into the following evidence streams: human, animal, organism (non-animal), ex vivo, in vitro, in silico, migration, hydrolysis, and absorption, distribution, metabolism, excretion/toxicokinetics/pharmacokinetics (ADME/TK/PK) studies. Relevant information was extracted from eligible studies and synthesized according to the protocol. Results: Literature searches yielded 7445 unique records, of which 96 were included. Data comprised migration (560 entries), ADME/TK/PK-related (253 entries), health/bioactivity (98 entries) and very few hydrolysis studies (7 entries). Cyclic oligomers were studied more frequently than linear PET oligomers. In vitro results indicated that hydrolysis of cyclic oligomers generated a mixture of linear oligomers, but not monomers, potentially allowing their absorption in the gastrointestinal tract. Cyclic dimers, linear trimers and the respective smaller oligomers exhibit physico-chemical properties making oral absorption more likely. Information on health/bioactivity effects of oligomers was almost non-existent, except for limited data on mutagenicity. Conclusions: This SEM revealed substantial deficiencies in the available evidence on ADME/TK/PK, hydrolysis, and health/bioactivity effects of PET oligomers, currently preventing appropriate risk assessment. It is essential to develop more systematic and tiered approaches to address the identified research needs and assess the risks of PET oligomers.http://www.sciencedirect.com/science/article/pii/S0160412023002519OligomerPolyethylene terephthalateSystematic evidence mapHealth risk assessmentExposureToxicology |
| spellingShingle | Verena N. Schreier Emre Çörek Christian Appenzeller-Herzog Beat J. Brüschweiler Birgit Geueke Martin F. Wilks Benoit Schilter Jane Muncke Thomas J. Simat Martin Smieško Nicolas Roth Alex Odermatt Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map Environment International Oligomer Polyethylene terephthalate Systematic evidence map Health risk assessment Exposure Toxicology |
| title | Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map |
| title_full | Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map |
| title_fullStr | Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map |
| title_full_unstemmed | Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map |
| title_short | Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map |
| title_sort | evaluating the food safety and risk assessment evidence base of polyethylene terephthalate oligomers a systematic evidence map |
| topic | Oligomer Polyethylene terephthalate Systematic evidence map Health risk assessment Exposure Toxicology |
| url | http://www.sciencedirect.com/science/article/pii/S0160412023002519 |
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