上周刚刚介绍了欧盟对于邻苯二甲酸盐（特别是DEHP）的使用建议以及收益-风险评价指南，结果这周欧盟就更新了这份指南，那正好接着上一期的话题，我们来看一下这份最新的指南都更新了哪些重要内容?

相较于2019年发布的上一版指南，最新的这一版指南主要在以下内容做了更新：

（附录10原文：It should be noted that the sunset date for the continued use of DEHP in medical devices has recently been extended to 1 July 2030 (Commission Regulation (EU) 2023/2482) as described in Annex 5 of these guidelines. After this date authorisation according to REACH (Regulation (EC) 1907/2006) is required, in addition to justification for the use of CMR/ED phthalates according to the MDR (Regulation (EU) 2017/745)）

（原文：in the framework for the evaluation of alternatives in the non-phthalate scenario, the terminology of “potential relevant” candidates for assessment as alternatives for CMR/ED phthalates, has been changed into “most relevant” candidates (starting in Step 5 of the framework). While a number of alternatives might be available, the focus should be limited to the likely most relevant alternatives based on a preliminary evaluation of the suitability of the available alternatives. This is to avoid unnecessary extensive evaluation of many alternatives. For the evaluation of alternatives, a minimum number to be evaluated is suggested to be 3, while evaluation of less than 3 alternatives needs to be justified by additional information.）

主要描述目前使用的邻苯二甲酸盐替代物质的暴露情况，包括它们在医疗器械中的使用情况和潜在的暴露途径。并且讨论替代物质的迁移/泄露特性，以及这些特性如何影响患者和用户的暴露风险。强调在评估替代物质时其化学结构、物理化学亲和性、蒸汽压、分子量等因素都需要重点考虑。

- 提供了关于邻苯二甲酸盐替代物质的毒理学信息，讨论了这些替代物质的致癌性、致突变、生殖毒性的关键终点，并基于这些终点提供了无可见有害作用水平（NOAEL）或最低观察到损害作用的剂量（LOAEL）。

- 提供了可能作为 DEHP 潜在替代物质的清单。