Interlaboratory Study to Evaluate a Testing Protocol for the Safety of Food Packaging Coatings

Abstract

According to European regulations, migration from food packaging must be safe. However, currently, there is no consensus on how to evaluate its safety, especially for non-intentionally added substances (NIAS). The intensive and laborious approach, involving identification and then quantification of all migrating substances followed by a toxicological evaluation, is not practical or feasible. In alignment with the International Life Sciences Institute (ILSI) and the European Union (EU) guidelines on packaging materials, efforts are focused on combining data from analytics, bioassays and in silico toxicology approaches for the risk assessment of packaging materials. Advancement of non-targeted screening approaches using both analytical methods and in vitro bioassays is key. A protocol was developed for the chemical and biological screening of migrants from coated metal packaging materials. This protocol includes guidance on sample preparation, migrant simulation, chemical analysis using liquid chromatography (LC-MS) and validated bioassays covering endocrine activity, genotoxicity and metabolism-related targets. An inter-laboratory study was set-up to evaluate the consistency in biological activity and analytical results generated between three independent laboratories applying the developed protocol and guidance. Coated packaging metal panels were used in this case study. In general, the inter-laboratory chemical analysis and bioassay results displayed acceptable consistency between laboratories, but technical differences led to different data interpretations (e.g., cytotoxicity, cell passages, chemical analysis). The study observations with the greatest impact on the quality of the data and ultimately resulting in discrepancies in the results are given and suggestions for improvement of the protocol are made (e.g., sample preparation, chemical analysis approaches). Finally, there was agreement on the need for an aligned protocol to be utilized by qualified laboratories for chemical and biological analyses, following best practices and guidance for packaging safety assessment of intentionally added substances (IAS) and NIAS to avoid inconsistency in data and the final interpretation.

Nanoscale Pickering emulsion food preservative films/coatings: Compositions, preparations, influencing factors, and applications

“…To ensure the health and safety of consumers, it is essential to thoroughly verify and evaluate the safety of the edible films while reducing the risk of contamination pathogens. A cytotoxicity test can assess the degree of harmfulness of the samples to humans upon contact with cells (Marin-Kuan et al, 2023). Wu et al (2023) used BEAS-2B human normal lung epithelial cells to verify the toxicity of chayote tuber starch films functionalized by zein-pectin nanoparticle-stabilized CEO PE.…”

“…To ensure the health and safety of consumers, it is essential to thoroughly verify and evaluate the safety of the edible films while reducing the risk of contamination pathogens. A cytotoxicity test can assess the degree of harmfulness of the samples to humans upon contact with cells (Marin‐Kuan et al., 2023). Wu et al.…”

Sustainable biodegradable coatings for food packaging: challenges and opportunities

“…NIAS can either be (1) wholly unidentified compounds, such as contaminants, degradation products, or other reaction products, or (2) anticipated chemicals based on chemical reactions involved in the production of food contact materials. 234…”

“…NIAS can either be (1) wholly unidentified compounds, such as contaminants, degradation products, or other reaction products, or (2) anticipated chemicals based on chemical reactions involved in the production of food contact materials. 234 Marin-Kuan et al 234 reported that it is not viable to use the known time-consuming methods that entail the identification, quantification, and toxicological evaluation of all chemicals that have the potential to migrate to the food. An effort is being made to combine data from analytics, bioassays, and in silico toxicology techniques for the risk evaluation of packaging materials in accordance with the International Life Sciences Institute (ILSI) and the European Union (EU) recommendations on packaging materials.…”

Editorial for the Special Issue “Risk Assessment of Food Contact Materials/Articles”

“…Finally, Marin-Kuan et al combined both identification and testing and present a protocol combining data from analytics and bioassays for the risk assessment of packaging materials. This protocol includes guidance on sample preparation, migrant simulation, chemical analysis using liquid chromatography (LC-MS) and validated bioassays covering endocrine activity, genotoxicity and metabolism-related targets and it was tested through an inter-laboratory study on coating metal packaging materials [ 27 ].…”