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)
您的法定义务是保持您的档案为最新状态 - 换句话说,如果您获悉新信息,则应毫不拖延地更新您的档案。因此,启动合规性检查不应成为更新档案的触发因素。当 ECHA 开始评估档案时,您可以在档案评估状态页面上找到有关档案评估状态的信息。因此,您有机会在发布决定草案之前验证并(如有必要)更新您的档案,尤其是有关用途和吨位的信息。一旦发布决定草案,ECHA 将仅在评估“决策过程”中考虑您在对决定草案的评论中提交的信息。如果您掌握可能从决定草案中删除请求的新信息(例如新的实验研究),则必须通过 REACH-IT 在注册档案更新和对决定草案的评论中提交此类信息。欧洲化学品管理局 (ECHA) 将考虑新信息,并可能相应修改决定。只有在收到决定草案、吨位等级变更和注册类型变更后您可获得的最新实验研究才会在评论截止日期后被纳入考虑。如果您在决定草案评论期后用此类实质性新信息更新您的档案,您必须通过联系表格联系 ECHA。在与 ECHA 沟通时,您必须 (i) 引用相应的决定草案;(ii) 复制您更新中包含的信息;(iii) 解释为什么这些信息未在您对决定草案的评论中提交;以及 (iv) 解释这些信息如何影响评估决定草案中的信息请求。如果您在收到决定草案后停止生产或进口您的物质,请参阅问答 1580。有关更多信息,另请参阅“对注册人的建议”下的“档案评估下的决策”,并查阅实用指南“如何在档案评估中采取行动”。
Answer (EN)
Your legal obligation is to keep your dossier up to date – in other words, to update your dossier without undue delay if you become aware of new information. Therefore, the initiation of a compliance check should not be a trigger for updating your dossier. When ECHA starts the evaluation of a dossier, information on the dossier evaluation status can be found at Dossier evaluation status page. Therefore, you have the opportunity to verify and (if necessary) update your dossier especially regarding use and tonnage information before a draft decision is issued.Once a draft decision is issued, ECHA will only take into account information that is submitted in your comments to the draft decision, in the evaluation “decision making process”. If you are in possession of new information that may remove (a) request(s) from the draft decision (e.g. a new experimental study), you must submit such information both in a registration dossier update via REACH-IT and in your comments to the draft decision. ECHA will consider the new information and may amend the decision accordingly.Only recent experimental studies that became available to you after the receipt of the draft decision, tonnage band changes and registration type changes may be taken into account after the expiry of the commenting deadline. If you update your dossier with such substantial new information after the draft decision commenting period, you must contact ECHA through the contact form. In such communication with ECHA you must (i) refer to the respective draft decision, (ii) reproduce the information contained in your update, (iii) explain why this information was not submitted in your comments to the draft decision, and (iv) explain how this information affects the information requests in the draft evaluation decision. In the specific case where you cease manufacture or import of your substance after receiving the draft decision, please see Q&A 1580.For more information, see also ‘Decision under dossier evaluation’ under the Recommendations to registrants and check the practical guide ‘How to act in dossier evaluation’.