SAFE+ Algorithmics GmbH, Untere Läng 8c, 82205 Gilching, Germany.
Systox Limited, Sutton Grange, Parvey Lane, Sutton, Cheshire SK11 0HX, UK.
Molecules. 2021 Dec 26;27(1):121. doi: 10.3390/molecules27010121.
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.
食品接触材料（FCM）在消费前可能会从其制造过程中向食品中转移化学物质。监管框架通过规定用于评估 FCM 的方法来确保消费者安全，这些方法依赖于对实际食品或食品模拟物的迁移测试。一次性 FCM 的标准迁移测试条件是合理保守的，采用公认的最坏情况下的接触时间和温度。对于重复使用的 FCM，使用最坏条件的连续三个测试中的第三个被用作这些物品使用寿命期间经常发生的更短接触期的替代物。食品接触法规允许在 FCM 中的化学物质和在长时间接触过程中 FCM 与食品/模拟物之间发生的分配情况下使用迁移建模，在这种情况下，有利于达到稳定状态。本研究表明，在重复使用条件下很少达到稳定状态，并且分配仅起着次要作用，导致迁移基本上受到扩散控制。已经确定了在分配不起重要作用的使用域内，可以使用基于扩散参数的建模。这些发现有可能为重复使用制品的迁移建模提供便利，从而为监管指导和合规实践带来好处。
