什么是“明显不合理”的改编？

什么是“明显不合理”的改编？

What is a ‘manifestly unreasonable’ adaptation?

根据 REACH 法规附件 VII 至 X 中概述的具体规则或附件 XI 中规定的调整一般规则提交的任何调整都依赖于注册人需要满足并证明支持该调整的独特要素。在通过的决定的截止日期过后，ECHA 将评估在卷宗更新中提交的信息，以回应该决定。如果 ECHA 认为支持任何这些要素的论点“明显不合理”，则构成滥用程序，因此等同于完全未回应第一个通过的 ECHA 决定。在这种情况下，ECHA 可以向相关成员国主管部门和国家当局发送有关此事实的简单信息。“明显不合理”的调整示例包括：任何依赖于已在 ECHA 通过的决定中被拒绝的一个或多个要素的调整。例如，ECHA 决定可能已经指定无法从特定物质进行横向参照；因此，对该横向参照物质的另一项研究将无法满足信息要求。同样，由于缺少文件而被拒绝的调整，并且在后续跟进中仍未提供文件，或者所提供的文件与 ECHA 决定所涉及的档案提交主题中已被拒绝的文件完全相同的调整，也可被视为“明显不合理”。横向参照要求物质之间具有相似性，并解释为什么它们的性质可能相似或遵循相似的模式。如果缺乏这样的解释，则无法满足横向参照的条件。提供了模型预测（QSAR）以满足信息要求；但是，注册物质不属于用于预测的模型的适用范围，或者该模型不适用于特定类型的物质。

Any adaptation submitted according to the specific rules outlined in Annexes VII to X or the general rules of adaptations specified in Annex XI to the REACH Regulation, relies on unique elements that the registrant need to fulfil and demonstrate in support of that adaptation.After the deadline of an adopted decision expires, ECHA assesses the information submitted in a dossier update, in response to that decision. If ECHA considers the arguments in support of any of those elements to be ‘manifestly unreasonable’, then this constitutes an abuse of the process and therefore equals to a complete failure to respond to the first adopted ECHA decision. In such cases, ECHA can send a simple information to the relevant Member State competent authorities and national authorities about this fact.Examples of ‘manifestly unreasonable’ adaptations are:Any adaptation that relies on one or more elements that have already been rejected in the adopted ECHA decision. For instance, an ECHA decision could have specified that the read-across from a specific substance is impossible; therefore, another study on that read-across substance will not be able to fulfil the information requirement. Similarly, an adaptation that was rejected because of missing documentation and for which documentation is still not provided at follow-up, or an adaptation for which the documentation provided is the exact same as the one already rejected in the dossier submission subject addressed by the ECHA decision, can also be considered as ‘manifestly unreasonable’.A read-across requires similarity between substances and an explanation of why their properties are likely to be similar or follow a similar pattern. Where such explanation is lacking, the conditions for read across cannot be fulfilled.A model prediction is provided (QSAR) to fulfil an information requirement; however, the registered substances does not fall within the applicability domain of the model used for the prediction or the model is not suitable for the specific type of substance.