Impact of Partitioning in Short-Term Food Contact Applications Focused on Polymers in Support of Migration Modelling and Exposure Risk Assessment.

Rainer Brandsch,Dieter Schuster,Mark Pemberton,Frank Welle

doi:10.3390/molecules27010121

Rainer Brandsch, Dieter Schuster + Show 2 more

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https://doi.org/10.3390/molecules27010121

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Abstract

Food contact materials (FCMs) can transfer chemicals arising from their manufacture to food before consumption. Regulatory frameworks ensure consumer safety by prescribing methods for the assessment of FCMs that rely on migration testing either into real-life foods or food simulants. Standard migration testing conditions for single-use FCMs are justifiably conservative, employing recognized worst-case contact times and temperatures. For repeated-use FCMs, the third of three consecutive tests using worst-case conditions is taken as a surrogate of the much shorter contact period that often occurs over the service life of these items. Food contact regulations allow for the use of migration modelling for the chemicals in the FCM and for the partitioning that occurs between the FCM and food/simulant during prolonged contact, under which steady-state conditions are favored. This study demonstrates that the steady-state is rarely reached under repeated-use conditions and that partitioning plays a minor role that results in migration essentially being diffusion controlled. Domains of use have been identified within which partitioning does not play a significant role, allowing modelling based upon diffusion parameters to be used. These findings have the potential to advance the modelling of migration from repeated-use articles for the benefit of regulatory guidance and compliance practices.

Highlights

In the last two decades, significant advances have been made in migration modelling through the consideration of the underlying physical-chemical processes that occur under single and repeated-use conditions and offers opportunities for more realistic migration and exposure assessments when compared to conventional testing protocols [1,2,3,4,5,6,7,8]
The role of the partition coefficient in diffusion modelling was systematically evaluated for food contact articles that are in short-term contact with food
Minor role means that the impact of a wide range of partition coefficients on the migration modelling results is less than 10%

Summary

Introduction

In the last two decades, significant advances have been made in migration modelling through the consideration of the underlying physical-chemical processes that occur under single and repeated-use conditions and offers opportunities for more realistic migration and exposure assessments when compared to conventional testing protocols [1,2,3,4,5,6,7,8] These advances include the prediction of diffusion coefficients DP in the polymers that are used for food contact materials and articles [2,9,10]. The adaptation of existing regulations to recognize these developments will lead to a better understanding of the true health risks that could be associated with these materials and to the creation of opportunities that focus compliance and enforcement activities

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