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我有一个包含信息要求的档案,我选择退出,并且收到了(草案)决定。我有哪些义务使我的档案符合规定?
问题(中文)
我有一个包含信息要求的档案,我选择退出,并且收到了(草案)决定。我有哪些义务使我的档案符合规定?
Question (EN)
I have a dossier containing information requirements which I have opted out from and I have received a (draft) decision. What are my obligations to bring my dossier into compliance?
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 将其决定(草案)发送给所有不合规的联合提交注册人。如果您已选择退出一项或多项信息要求(REACH 第 11(3) 条),并且您的信息被发现不合规,您将收到一份决定(草案),其中处理您作为选择退出注册人提供的信息。如果是部分退出,您还可能收到一份决定(草案),其中处理为满足您未选择退出的信息要求而提供的信息的不合规情况。在上述两种情况下的决定通过后,您和另一方决定的收件人将至少需要协调以下事项:如果所请求的信息已经存在,则需要就现有数据的成本和共享达成一致。如果需要生成所请求的信息,则需要:就将要进行的测试达成一致,包括将用作所有注册人代表的测试材料;在 90 天内通知 ECHA 谁将执行测试;并分担成本和获得的新数据
Answer (EN)
ECHA sends its (draft) decision to all non-compliant registrants of the joint submission. If you have opted out for one or more information requirements (Article 11(3) of REACH) and your information is found to be non-compliant, you receive a (draft) decision addressing the information that you have provided as opt-out registrant. In case of a partial opt-out you may also receive a (draft) decision addressing non-compliances of information provided to fulfil information requirement for which you have not opted out.After the adoption of the decisions in both of the above mentioned scenarios, you and the addressees of the other decision will need to coordinate, at least, the following:If the requested information already exists, you will need to agree on the costs and sharing of the existing data.If the requested information needs to be generated, you will need to:agree on the test(s) to be performed, including on the testing material to be used as representative for all registrants;inform ECHA of who will perform the test within 90 days; andshare the costs and new data obtained