REACH下的档案评估和物质评估有什么区别？

REACH下的档案评估和物质评估有什么区别？

What is the difference between dossier evaluation and substance evaluation under REACH?

档案评估包括对测试方案的审查和对注册档案的合规性检查。测试方案由REACH信息要求触发，注册人提交的所有测试方案都必须接受欧洲化学品管理局（ECHA）的审查。审查的目的是确定最合适的测试方案，以满足REACH信息要求。ECHA可以对任何注册档案进行合规性检查，以验证其是否符合REACH信息要求。合规性检查的档案可以随机选择，也可以根据特定关注点进行优先排序。物质评估流程由基于风险的关注点触发，旨在明确某种物质是否对人类健康或环境构成风险。物质评估针对的是物质（包括总吨位、所有用途等）。在物质评估中，任何信息（超出REACH要求）都可以被要求，前提是这些信息对于物质的风险评估而言是必要的。物质评估由成员国进行，而ECHA负责档案评估。这两个过程的决策过程本质上是相同的。

Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern. The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance. Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation. The decision making process is essentially the same for both processes.