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由于对分类和标签信息存在异议,我想解释选择退出的理由。我应该提供哪些信息?
问题(中文)
由于对分类和标签信息存在异议,我想解释选择退出的理由。我应该提供哪些信息?
Question (EN)
I want to justify opting-out due to a disagreement on the classification and labelling information. What information should I provide?
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答案(中文)
选择退出分类和标签数据时,必须在 IUCLID 第 14 节“信息要求”中“退出 REACH 注册信息”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) 条或第 19(2) 条单独提交信息。为了帮助您提供有效的理由,在“理由”字段中提供了一个模板 (d)“对分类和标签信息存在分歧”(点击图标 A)。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:与主注册人对分类和标签信息存在分歧的原因。请参阅以下一些论证依据示例: 用于得出分类的数据的质量(可靠性、充分性) 对分类数据解释的差异 影响分类的成分/杂质/添加剂浓度的差异 影响分类的物质的(纳米)形式的差异 解释您希望单独提交的分类和标签信息与联合提交的信息之间的差异。 对于每个不同的分类,提供对分类所依据的数据的参考。 该参考可以是您自己档案中作为(稳健)研究摘要提交的信息,也可以是公开文献的参考。 解释您为将分类和标签纳入铅档案而采取的措施,以及您关于为什么无法纳入该信息的理由。
Answer (EN)
When opting-out classification and labelling data, 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 a template (d) ‘Disagreement on the classification and labelling information’ is available in the 'Justification' field (click the icon A). The template questions are also available in the manual ‘How to prepare registration and PPORD dossiers’, Annex 7.
Information expected in the justification:
The reason for the disagreement with the lead registrant on the classification and labelling information. See below some examples for the basis of your argumentation:
Quality (reliability, adequacy) of data used in deriving the classification
Difference in interpretation of data for classification
Difference in concentrations of constituents / impurities / additives influencing classification
Difference in (nano)forms of the substance influencing classification
An explanation of the differences in the classification and labelling information that you wish to submit separately compared to the jointly submitted information. For each different classification, provide a reference to the data underlying the classification. This reference may be to information submitted in your own dossier as a (robust) study summary, or alternatively, references to publicly available literature may be provided.
An explanation of the actions you have taken to include your classification and labelling in the Lead dossier and your reasoning as to why it was not possible to include this information.