Koster Sander, Rennen Monique, Leeman Winfried, Houben Geert, Muilwijk Bas, van Acker Frederique, Krul Lisette
a TNO , Zeist , the Netherlands.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2014;31(3):422-43. doi: 10.1080/19440049.2013.866718. Epub 2014 Jan 27.
One of the main challenges in food contact materials research is to prove that the presence of non-intentionally added substances (NIAS) is not a safety issue. Migration extracts may contain many unknown substances present at low concentrations. It is difficult and time-consuming to identify all these potential NIAS and concurrently to assess their health risk upon exposure, whereas the health relevance at low exposure levels might not even be an issue. This paper describes a scientifically based, but pragmatic safety assessment approach for unknown substances present at low exposure levels in food contact matrices. This complex mixture safety assessment strategy (CoMSAS) enables one to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure, and allows one to focus on the substances of potential health concern. In particular, substances for which exposure will be below certain thresholds may be considered not of health relevance in case specific classes of substances are excluded. This can reduce the amount of work needed for identification, characterisation and evaluation of unknown substances at low concentration. The CoMSAS approach is presented in this paper using a safety assessment of unknown NIAS that may migrate from three carton samples.
食品接触材料研究中的主要挑战之一是证明非故意添加物质（NIAS）的存在并非安全问题。迁移提取物可能含有许多低浓度存在的未知物质。识别所有这些潜在的NIAS并同时评估其暴露后的健康风险既困难又耗时，而低暴露水平下的健康相关性甚至可能不是问题。本文描述了一种基于科学但务实的食品接触基质中低暴露水平未知物质的安全评估方法。这种复杂混合物安全评估策略（CoMSAS）能够根据未知物质各自的暴露水平，将毒理学相关物质与毒理学相关性较低的物质区分开来，并使人们能够专注于潜在健康问题的物质。特别是，如果排除特定类别的物质，暴露量低于某些阈值的物质可能被认为与健康无关。这可以减少识别、表征和评估低浓度未知物质所需的工作量。本文通过对可能从三个纸箱样品中迁移出的未知NIAS进行安全评估，介绍了CoMSAS方法。
