您如何断定是否需要监管风险管理以及需要哪种监管风险管理？

您如何断定是否需要监管风险管理以及需要哪种监管风险管理？

How do you conclude whether and which regulatory risk management may be needed?

ECHA 对监管需求的评估主要基于 REACH 注册档案中提供的信息。根据 REACH、CLP 和其他欧盟法规，监管风险管理的（预见的）需求取决于已识别的潜在危害、用途以及已识别的暴露或释放可能性。监管需求评估是一个迭代过程，可以从信息水平较低、对最佳推进方式存在高度不确定性开始，逐步生成数据，并最终针对物质（组）提出更明确的监管管理方案。需要注意的是，监管需求评估是迭代式的：因此，预见的监管行动可能会根据新信息、进一步评估或政策变化而变化。预计欧盟将对许多已评估物质采取监管风险管理行动。然而，大多数此类物质可能需要进一步生成数据并确认其危害，然后才能确认是否需要采取计划行动或启动相关行动。监管风险管理行动可以由成员国和/或 ECHA（应委员会要求）通过正式程序启动。

ECHA’s assessment of regulatory needs is mainly based on the information provided in the REACH registration dossiers. A (foreseen) need for regulatory risk management under REACH, CLP and other EU legislations depends on the potential hazards identified, the uses and potential for exposure or releases identified. The assessment of regulatory needs is an iterative process that can start from a low level of information and high uncertainty on the best way forward, moving to data generation and to proposing more definitive regulatory management options for the (groups of) substance(s). Note that the assessment of regulatory needs is iterative: the foreseen regulatory actions may therefore change based on new information, further assessment or change in policy.  EU regulatory risk management actions are expected for many assessed substances. However, most of these substances may require further data generation and confirmation of their hazards before the need for planned actions can be confirmed or actions can be initiated. Regulatory risk management actions can be initiated either by Member States and/or ECHA (upon request by the Commission) through the formal processes.