Integrated safety assessment of food contact articles – PackSafe

Forty-one samples were bought in French supermarkets and on French sales websites.The sample database includes the six most frequently used materials (paperboard, HDPE, LDPE, PP, PET and PS). Polyolefins (HDPE, LDPE and PP) are well knowns for the high level of formulation (antioxidants, UV-stabilizers, antistatic agents, slipping agents, monomers, etc.). PET and paperboard are the source of NIAS from recycling processes. PS has been added for comparison due to the presence of substances of concern (e.g. styrene). All samples can be classified into seven categories: rigid bottles, boxes, pots and trays; flexible bags and packaging/films; utensils and containers. Thirty-four % of the collected samples are recycled, 41% are printed and 61 % are in contact with food prior our study.

The protocol of extraction with the concentration step and solvent change to a biocompatible one was optimised.

Chemical fingerprints were collected by GC-MS and all the extracts were analysed with biotests to detect genotoxicity and endocrine disrupting mode of action.

Genotoxicity was assessed with the mini mutagenicity Ames, test, the micronucleus assay and the DNA Damage Response (DDR) test.

For the endocrine disruption, the transactivation assays on the estrogen and androgen receptors were carried out. The TScreen (proliferation assay) detects effect on the thyroid and an indirect mechanism of action was studied with the steroidogenesis assay to look at the effect of the extracts on the synthesis of estradiol and testosterone.

Once the extraction protocol defined, 41 extracts were analysed by analytical chemistry and bioassays.

First anaylysis of the chromatograms obtained by GC-MS do not permit to establish characteristic fingerprint corresponding to different materials. The cardboard seems to have quite the same signature, also for the PS extracts, but for the other polymers, there are huge différences between the composition of the extract inside the same polymer familiy.

Concerning the toxic effect of the mixture of substances present in the extracts,, 6 extracts give a positive repsonse in the genotoxicity biotests and 31 extracts were detected for an endocrine disrupting mode of action.

Chemical analysis and fractionation are on the way to try to identify active substances. Extraction being the worst case, migration analysis will also be performed to assess a more representative consumer exposure.

Spiking experiments with positive genotoxic references will been carried out to check the matrix effect of different FCA extracts on the MMT biotest.

The innovative nature of this project is to use in parallel, chemical signatures of MCDA extracts and robust biotests in order to generate a database allowing decision-making and packaging security at different stages of their cycle of production life. In addition, it will generate data on the toxicity of new SNIs as well as potential «mixing« effects of the extract.
Resulting from a multidisciplinary scientific approach, this project will help packaging manufacturers and their customers (processors, food industries) (1) to better guarantee the safety and conformity of their materials and (2) to encourage their innovation and / or their competitiveness, by offering them relevant and reliable scientific tools.

Séverin et al. (2023) Cahier de la nutrition, 58(2), 134-141
Doi : 10.1016/j.cnd.2022.12.005

The environmental impact of packaging has become a major concern for the food industries, packaging, safety agencies but also consumers. This circular economy will force manufacturers to lighten packaging, recycle and/or reuse it, which implies having the same requirements in terms of health safety as for virgin materials. Indeed, materials in contact with foodstuffs (FCM) can transfer constituents to food by migration. In addition to substances of known origin, FCMs can also contain Non-Intentional Substances (NIS) (impurities, decomposition or reaction products, contaminants resulting from recycling, etc.), often of unknown and unpredictable origin. Most SNIs are neither identified nor quantified, and their toxicity has not been studied. This migration can pose a risk to human health, it must be measured and controlled. European Regulation 10/2011 on plastic materials also requires a risk assessment of SNIs, but to date there is no specific guideline or scientific consensus, making it difficult to assess and manage their risks. In addition, SNIs can be present in all packaging; recycled paper-cardboard, coatings, these can release more substances than their virgin equivalent.
The evaluation of MCDA is currently only based on a study of the genotoxicity and the systemic effects of the starting substances, not taking into account endocrine disruption, nor the "cocktail effects" at low dose. Regarding SNI, it is recognized that the traditional approach based on the identification and quantification of all substances followed by their full toxicological characterization is not feasible (in terms of costs, time, quantity available, etc.). A relevant approach consists in using biotests in addition to analytical and physicochemical techniques on all of the substances which migrate. Biotests are already used with mixtures. However, they need to be better characterized in terms of sensitivity / specificity and robustness with complex extracts of MCDA. The first stage of this project will consist in selecting the most sensitive and specific biotests to identify a hazard (genotoxicity or endocrine disruptor) in packaging extracts by applying the “spiking” methodology, which consists of adding reference substances ( positive and negative) in order to verify the expected response. The extract will be split if the answer is a false negative or a false positive, in order to identify the responsible fraction containing the substances causing the unexpected effect. The second step will consist of testing the selected biotests using extracts from finished packaging that have been subjected to particularly SNI-generating processes (including recycled materials) to assess the risk. The innovative nature of this project is to use in parallel, chemical signatures of MCDA extracts and robust biotests in order to generate a database allowing decision-making and packaging security at different stages of their cycle of production life. In addition, it will generate data on the toxicity of new SNIs as well as potential "mixing" effects of the extract.
Resulting from a multidisciplinary scientific approach, this project will help packaging manufacturers and their customers (processors, food industries) (1) to better guarantee the safety and conformity of their materials and (2) to encourage their innovation and / or their competitiveness, by offering them relevant and reliable scientific tools.