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当某种物质被纳入 CoRAP 时,注册人是否有机制可以对其纳入提出质疑或在评估过程中提供意见?

问题(中文)
当某种物质被纳入 CoRAP 时,注册人是否有机制可以对其纳入提出质疑或在评估过程中提供意见?
Question (EN)
When a substance is included in the CoRAP, are there any mechanisms by which a registrant can challenge the inclusion or provide input into the evaluation process?
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)
注册人不得质疑物质被纳入 CoRAP(社区滚动行动计划)的可行性。但是,注册人可以参与评估流程。鼓励 CoRAP 中物质的注册人(尤其是当前年度 CoRAP 中的物质)在评估流程早期联系评估成员国主管部门 (eMSCA)。eMSCA 的联系方式已在 CoRAP 中公布。如果对话尚未开始,eMSCA 通常会在评估开始时联系牵头注册人,并提供会面机会,讨论与物质评估相关的技术问题。注册人应考虑提名一名代表与 eMSCA 进行沟通。在评估的这一阶段,注册人与 eMSCA 之间的互动是非正式的。如果物质评估的结果是需要提出信息请求以澄清疑似问题(即,评估 MSCA 准备物质评估决策草案),则注册人将有机会在 30 个日历日内对任何决策草案正式发表评论,作为决策过程的一部分(REACH 法规第 50-52 条)。评估 MSCA 应考虑注册人的意见,并根据注册人提供的意见/补充信息决定是否需要修改决策草案(REACH 第 50(1) 条)。ECHA 会将通知其他 MSCA 和 ECHA 的决策草案以及收到的修改建议传达给注册人。在此阶段,注册人将有机会对修改建议发表评论(REACH 第 51(5) 条)。提醒注册人有义务始终保持其注册档案为最新,参见第 22(1) 条。
Answer (EN)
Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan). However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal. When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH). ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).