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我想选择退出分类和标签信息。我需要提供理由吗?
问题(中文)
我想选择退出分类和标签信息。我需要提供理由吗?
Question (EN)
I want to opt-out for classification and labelling information. Do I need to provide a justification?
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)
仅选择退出分类和标签 (C&L) 信息时,选择退出理由要求也适用。必须提供理由,解释为什么可以根据 REACH 法规第 11(3) 条或 19(2) 条单独提交该信息。此理由必须包含在 IUCLID 第 14 节“信息要求”中端点“REACH 注册的选择退出信息”的“理由”字段中。有关如何提供有效理由的更多信息,请参阅问答 1722。在选择退出 C&L 信息之前,您应该记住,即使该信息与联合提交中其他注册人的 C&L 不同,也可以在牵头注册档案中联合提交。在这种情况下,牵头注册档案应在第 2.1 节中有一个单独的 C&L 记录,并链接到第 1.2 节中的相关“物质边界组成”。如果您决定不提供C&L信息,则应在理由书中解释为何未能达成协议将该信息纳入主要注册档案。有关如何报告边界成分的更多信息,请参阅物质身份概况问答。
Answer (EN)
The opt-out justification requirement also applies when opting-out only for classification and labelling (C&L) information. A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided. This justification must be included in the 'Justification' field of the endpoint 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. For further information on how to provide a valid justification see Q&A 1722.
Before opting-out for C&L information, you should bear in mind that this information can be jointly submitted in the lead registration dossier even if it differs from the C&L of the other registrants in the joint submission. In this case, the lead registration dossier should have a separate C&L record in section 2.1 with a link to a relevant ‘boundary composition of the substance’ in section 1.2. If you decide to opt-out for the C&L information, you should therefore explain in your justification why an agreement to include the information in the lead registration dossier could not be reached. For further information on how to report the boundary composition you can consult the Q&As on Substance identity profile.