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我收到了决议草案。我该怎么办?
Question (EN)
I have received a draft decision. What should I do?
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)
ECHA 将其(草案)决定发送给所有依赖不合规信息要求的注册人。同样,ECHA 将其关于测试提案的(草案)决定发送给所有打算依赖拟议测试来满足其信息要求的注册人。通过明确规定信息要求如何适用于每个吨位等级,ECHA 的决定使注册人能够更明确地了解其各自的法律义务。如果您收到了决定草案,则意味着您的档案或联合提交的注册档案中存在不合规的信息要求(或属性)。所有接收方必须遵守各自的信息要求,并需要共享现有/新数据,同时履行其避免不必要的(脊椎动物)测试的法律义务。如果您收到了决定草案,请在决定中查询联合提交的哪些成员已收到决定草案,并及时与他们联系。您有 30 天的时间就决定内容提出意见。ECHA 强烈建议您将意见汇总到一个合并的文件中。 ECHA 仅接受通过网络表单提交的评论。网络表单的链接已在决议草案随附的通知函中提供。更多信息,请参阅注册人建议下的“卷宗评估中的决议”以及实用指南“如何在卷宗评估中采取行动”。
Answer (EN)
ECHA addresses its (draft) decisions to all registrants relying on non-compliant information requirements. Similarly, ECHA addresses its (draft) decisions on testing proposals to all those registrants intending to rely on the proposed tests to fulfil their information requirement.By setting out clearly how the information requirements apply at each tonnage band, ECHA’s decision gives the registrants greater certainty and clarity on their individual legal obligations.If you have received a draft decision, it means that there are non-compliant information requirements (or properties) in your dossier or in the jointly submitted registration dossier.All recipients must comply with their respective information requirements and will need to share existing/new data while respecting their legal obligation to avoid unnecessary (vertebrate animal) testing.If you have received a draft decision, check in the decision which members of your joint submission have received the draft decision, and get promptly in touch with them.You have 30 days to provide your comments on the content of the decision. ECHA strongly recommends that you provide your comments collectively, in one consolidated set. ECHA only accepts comments submitted using the webform. A link to the webform is provided in the notification letter accompanying the draft decision.For more information, check also the ‘Decision under dossier evaluation’ under recommendations to registrants and the practical guide ‘How to act in dossier evaluation’