On March 8, 2017 a kick-off meeting for the new project MigraTox (FPF reported) was held in Vienna, Austria. MigraTox is co-led by the Austrian Research Institute for Chemistry and Technology (OFI) and FH Campus Wien University of Applied Sciences, Vienna, Austria, and coordinated by Christian Kirchnawy from OFI. This project aims to further develop an approach utilizing in vitro bioassays to support safety assessment of non-intentionally added substances (NIAS) in food contact materials (FCMs).
In line with the NIAS risk assessment strategy proposed by the International Life Sciences Institute (ILSI) in 2015 (FPF reported), the project team wants to establish a workflow where in vitro bioassays will be used to exclude the presence of substances with high toxicological potential in FCM migrates. This will allow simplifying the risk assessment of unknown NIAS, because in this case “by referring to the threshold of toxicological concern (TTC) a substance can be assumed as safe even without identification and toxicological testing up to a daily intake of 90 µg/person.” MigraTox will first focus on genotoxicity assays and address sample preparation, as well as assay sensitivity, validation, and standardization. Other endpoints (e.g. tests for endocrine activity) may be included depending on time and resources. The MigraTox team calls on industry to collaborate by participating in discussions and providing FCM samples.
One of the industry partners of MigraTox is Nestlé. Nestlé’s work on developing and utilizing in vitro bioassays for FCMs testing was presented at the MigraTox meeting by Julie Mollergues and Karma Fussel, both from Chemical Food Safety, Nestlé Research Centre, Lausanne, Switzerland. They have used the assays for cytotoxicity, genotoxicity and endocrine disruption potential (interactions with estrogen receptor, androgen receptor and aryl hydrocarbon receptor) to test the migrates from plastic FCMs (e.g. polystyrene) or various coatings. The Nestlé team also invests in the optimization of in vitro testing systems, such as improving the metabolic capacity of mammalian cell-based assays (described in an article by Mollergues and colleagues published in ALTEX in December 2016) or increasing the sensitivity of genotoxicity assays (e.g. a recently optimized protocol allowed for increasing sensitivity by an order of magnitude). Karma Fussel views in vitro bioassays as valuable tools for assessing packaging in lieu of detailed toxicological data, and also advocates for using in vitro testing as a decision-making tool to be applied in guiding product design and selecting products with the best safety profiles.
Peter Oldring, regulatory affairs manager at Valspar Corporation, UK, informed that the ILSI Packaging Task Force has initiated a new working group to review how and which bioassays can be used to demonstrate the absence of genotoxicity. This group does not aim to optimize the available tests or develop new ones, but rather will use the existing data to highlight the advantages and limitations of the existing assays. Other endpoints may be looked at if time allows. Evaluation of NIAS test methods (particularly for polyethylene terephthalate (PET) bottles) also forms a focus of a new industry group led by the European PET industry association Petcore Europe (FPF reported).
OFI (2017). “Project ‘MIGRATOX’” (pdf)
Mollergues, J., et al. (2017). “Incorporation of a metabolizing system in biodetection assays for endocrine active substances.” ALTEX (published December 22, 2016).