毒理学关注阈值方法在食品接触材料风险评估中的应用

Threshold of Toxicological Concern Approach for the Risk Assessment of Substances in Food Contact Materials

食品接触材料中包含诸多有意添加的化学助剂,在生产和使用过程中还会引入大量非有意添加物。食品接触材料中的有意和非有意添加物质种类繁多,难以得出所有物质完整的毒理学数据;而且食品接触材料中存在一些低暴露量的物质,它们对人体造成的风险较小而不必要进行传统的风险评估。毒理学关注阈值(threshold of toxicological concern,TTC)方法作为一种新的风险评估工具,可以对缺乏完整毒理学数据且暴露量较低的化学物质进行风险评估。本文综述TTC方法对食品接触材料中的物质(结构确定和结构未知的物质)进行风险评估的具体应用。对结构已知的物质,可以参照欧洲国际生命科学学会(European International Life Sciences Institute,ILSI)专家组提出的TTC决策树方法;对于未鉴定结构的物质,可以引用一个分步分析的方法,得出未知物质是否需要进行安全关注。本文还指出了TTC方法在食品接触材料风险评估中应用的难点和今后需解决的问题,可为食品接触材料中缺乏毒性数据物质的风险评估提供依据。

Food contact materials contain many chemical agents including intentionally added substances（IAS） and non-intentionally added substances（NIAS）. It is impractical to obtain all toxicological data for IAS and NIAS, and also unnecessary to assess the substances of low exposure level in food contact materials for less risk to human health. The threshold of toxicological concern（TTC） concept, as a novel safety assessment strategy, can be used to assess the substances with insufficient toxicological data and lower exposure level. This paper discusses the application of TTC to assess substances（known and unknown） in food contact materials. Our research is conducted in compliance with TTC decision tree proposed by the European International Life Sciences Institute specialists for the assessment of substances. For unknown substances, a stepwise analytic method is applied to reach a conclusion whether safety concerns are required or not. Difficulties in using TTC and problems to be solved are pointed out. This paper can provide the basis for risk assessment of substances in food contact materials complete toxicological data about which is lacking.