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由于不同意附件 VII-X 所提交的数据,我想解释退出的理由。我应该提供哪些信息?
问题(中文)
由于不同意附件 VII-X 所提交的数据,我想解释退出的理由。我应该提供哪些信息?
Question (EN)
I want to justify opting-out due to disagreement on the Annex VII-X data submitted. What information should I provide?
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)
必须在 IUCLID 第 14 节“信息要求”中“REACH 注册的选择退出信息”记录的“理由”字段中提供理由,解释为什么可以根据 REACH 法规第 11(3) 条或 19(2) 条单独提交信息。为了帮助您提供有效的理由,在“理由”字段中提供了模板(单击“插入现有模板”图标)。模板问题也可在手册“如何准备注册和 PPORD 档案”的附件 7 中找到。理由中预期的信息:您需要解释为什么不同意所选的数据。模板“c”的问题 1 包含与此解释相关的元素列表。您需要描述您已采取哪些措施来尝试将您的数据添加到主要档案中,以及为什么无法达成添加这些数据的协议。
Answer (EN)
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 in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click on the ‘Insert existing templates’ icon). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7.
Information expected in the justification:
You need to explain why you disagree on the data selected. Question 1 of template ‘c’ includes a list of elements that can be relevant to this explanation.
You need to describe what actions you had taken to try and add your data to the lead dossier and why it had not been possible to reach an agreement to add this data.