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在收到有关 i) 待决申请或 ii) 授权决定的法律实体变更通知后,ECHA 和欧盟委员会将采取什么行动?何时采取行动?

问题(中文)
在收到有关 i) 待决申请或 ii) 授权决定的法律实体变更通知后,ECHA 和欧盟委员会将采取什么行动?何时采取行动?
Question (EN)
What will ECHA and the European Commission do and by when, following a notification of a change of legal entity regarding i) a pending application or ii) authorisation decision?
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)
如果变更涉及待决的授权申请,ECHA 将告知所通知的变更是否符合问答 1241 中所述的要求,并且是否有适当的记录。此外,它将就变更是微小变更(即纯粹的行政变更以及不会对申请内容或 RAC 和 SEAC 意见条款产生重大影响的变更)还是重大变更(即所有其他情况)给出意见。ECHA 尽力在两周内处理通知。如果变更得到确认,ECHA 将向原始法人实体提供令牌。原始法人实体需要将令牌传达给继任法人实体,继任法人实体需要在 REACH-IT 中接受法人实体变更。变更自通知之日起生效。在这种情况下,ECHA 将修改其关于法人实体变更的数据库。如果变更是重大变更,RAC 和 SEAC 可能需要更多时间在意见制定过程中评估变更的影响。如果欧洲化学品管理局 (ECHA) 已采纳意见,其将向欧盟委员会提交评估报告,以便其在做出授权决定时予以考虑。在涉及已获授权的案件中,ECHA 将向欧盟委员会提交其对变更性质的评估报告,包括是否应根据 REACH 第 61(2) 条启动授权审查的评估。评估对 RAC 和 SEAC 意见或授权决定(可能触发授权审查)的影响的时间表取决于申报流程的阶段。ECHA 或欧盟委员会可能会要求您就申报提供澄清或补充信息。
Answer (EN)
If the change concerns a pending application for authorisation, ECHA will communicate whether the notified change corresponds to the requirements described in Q&A 1241 and is properly documented. Furthermore, it will give its view on whether the change is minor (i.e. purely administrative changes and changes that would not have material implications on the content of the application or the terms of the RAC and SEAC opinions) or major (i.e. all other cases). ECHA endeavours to process notifications in two weeks. If the change is confirmed, ECHA will provide to the original legal entity a token. The original legal entity will need to communicate the token to the successor legal entity, who will need to accept the legal entity change in REACH-IT. The change is considered valid as of the date of the notification. In this case ECHA will amend its database concerning the change of the legal entity. If the change is major, the RAC and the SEAC might need additional time to assess the implications of the change during the opinion-making process. If ECHA has already adopted an opinion, it will send its assessment to the European Commission so that it can take this into account when deciding on the authorisation. In cases concerning granted authorisations, ECHA will send its assessment on the nature of the change to the European Commission, including its assessment on whether a review of the authorisation should be triggered on the basis of Article 61(2) of REACH. The timelines for the assessment about any implications for the RAC and SEAC opinions or for the authorisation decision (potential trigger of a review of the authorisation) depend on the stage in the process at which the notification was made. ECHA or the Commission may request for clarifications or additional information concerning your notification.