Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials

Abstract

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

Evaluation of the Suitability of Mammalian In Vitro Assays to Assess the Genotoxic Potential of Food Contact Materials

“…These are present at low quantities and can be found in great numbers. NIAS are heterogeneous substances difficult to identify and, consequently, toxicological information is lacking [2,3]. Both IAS and NIAS might migrate into the packaged good and could potentially lead to an adverse health effect.…”

“…The rationale of the TTC concept is based on the previous observation that for any chemical, there is a threshold of exposure below which no health concern is expected and there is no appreciable risk [7]. However, the application of this concept requires the exclusion of the following cohorts of concern: (1) the substances with genotoxic potential, with a threshold set at 0.15 µg person −1 per day; (2) The organophosphates or N-methyl carbamates responsible for neurotoxic effects, with a threshold set at 18 µg person −1 per day. Finally, (3) for substances with reactive functional groups, which structure suggests toxicity, Cramer Class III with a threshold set at 90 µg person −1 per day is applied [7][8][9].…”

“…In the guideline by ILSI [1], the use of in vitro bioassays is recommended as a tool to estimate the risk of unknown substances migrating from an FCM. In vitro assays are recognized methods and have proven to successfully complement analytical methods in the characterization of unknown substances, as reported for potential endocrine effects [2,[12][13][14].…”

Potential endocrine disrupting properties of toys for babies and infants

“…systems can be used [11,12]. Berger et al [6] have detected significant endocrine activity in two out of eleven tested plastic teethers using Yeast Estrogen and Yeast Androgen screen assays.…”

Evaluation of the presence of potential hazardous substances from plastic and textile fibre recycling

“…On the way to that fraction collector, the flow was directed to an inverted Y-piece where vaporized trap solvent is infused. The latter flow is directed outside the GC oven allowing subsequent condensation and stepwise collection of liquid fractions with trapped analytes on a 384-well plate for further application to assays Veyrand et al (2017). performed a migration study on a plastic cup suspected to release the endocrine active substance 4-nonylphenol (4NP).…”