中文内容由 Google Cloud Translation 自动生成，仅供参考；请以英文原文为准。问答资料来自欧盟化学品管理局（ECHA）官方网站。
答案（中文）
如果评估成员国认为需要更多信息来阐明该物质的潜在风险，则可起草一份决议，具体说明补充数据请求。CoRAP 中最初确定的关注点并不限制成员国的评估，因此潜在请求可以针对该物质的任何特性或暴露场景。该物质的注册人将有机会就决议草案提出意见。该决议草案将由其他成员国和欧洲化学品管理局 (ECHA) 审查并同意，如有修订提案，成员国委员会也将予以同意。完成此程序后，ECHA 将根据成员国委员会的协议作出最终决定。如果成员国委员会未能达成一致意见，则由欧盟委员会作出决定。该决定将包含注册人必须提交所需信息的截止日期。也可能不需要提交任何信息请求，因为现有信息可以阐明风险。在这种情况下，物质评估将被视为完成。一旦注册人提交了所要求的信息，负责的成员国还有 12 个月的时间来评估这些信息，并决定是否有必要进一步索取信息或者是否可以结束评估。在后一种情况下，负责的成员国应考虑是否以及如何将获得的信息用于社区层面的风险管理措施。成员国可能会得出结论：需要采取欧盟范围内的风险管理措施（例如，欧盟范围内的限制、欧盟范围内的授权、欧盟统一的分类和标签、职业暴露限值、《水框架指令》下的环境保护措施）或应在国家层面采取行动。结论也可以是，通过已经采取的措施，风险已得到充分控制。ECHA 会将结论告知欧盟委员会、注册人和其他成员国。关于数据请求和评估报告的决定将在最终确定后公开。值得注意的是，由于生成所要求的信息在某些情况下可能需要几年时间（例如，在长期研究和年度环境监测的情况下），因此从采用 CoRAP 到完成最终评估报告也可能需要几年时间。
Answer (EN)
If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available. In such cases, the substance evaluation is considered to be completed.
Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:
EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
Actions at national level should be taken.
The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.
The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.