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 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.

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alex Odermatt reports financial support was provided by Federal Food Safety and Veterinary Office FSVO. Alex Odermatt reports administrative support was provided by Swiss Centre for Applied Human Toxicology (SCAHT). This involves handling of reporting to the FSVO and the transfer of funds from the FSVO. Martin Wilks reports a relationship with SCAHT that includes: director. Nicolas Roth reports a relationship with SCHAT that includes: employment. Jane Muncke and Birgit Geueke report a relationship with Food Packaging Forum that includes: employment. Jane Muncke and Birgit Geueke were not restricted in any way by the FPF in planning and conducting this work. Beat J. Brueschweiler reports a relationship with Swiss Federal Food Safety and Veterinary Office (FSVO) that includes: employment. Beat J. Brueschweiler acted in a personal expert capacity and not as a sponsor representative. Benoit Schilter reports a relationship with Nestlé R&D Centre that includes: previous employment. Benoit Schilter was not restricted in any way by Nestlé R&D Centre in planning and conduction this work.