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)
不可以,ECHA 不能改变该决定的截止日期,因为这是成员国代表一致同意的。ECHA 承认,物质测试中的技术困难可能会导致延误或无法在决定规定的截止日期前提供所需信息。无论如何,我们建议您在决定规定的截止日期前提交您的档案更新,包括与可能的延误和预计提交日期相关的任何相关解释和证据。一旦缺失信息可用,您就应该再次更新您的档案。请参阅以下技术说明,以便成功提交:如果您收到了 ECHA 的决定,要求您对某个端点进行测试,但该信息尚不可用,则您应该使用数据豁免记录来解决该端点问题。在数据豁免理由字段中,选择其他:并在下面的自由文本字段中输入以下句子,也称为其他:“此信息将根据 ECHA 决定编号 TPE/CCH/SEV-x-xxxxxxxxxx-xx-xx 稍后提交”,其中将“x”字符替换为 ECHA 向您签发的合规性检查决定编号。如果您无法在评估决定规定的截止日期前提供所要求的研究(例如,由于实验室能力、测试困难),请在同一数据豁免记录中的附加理由字段中添加来自测试机构 (CRO) 的文件,提供:延迟的解释,以及研究完成和研究报告完成的时间表。国家执法机构可能会采取在决定可能的执法行动时,应考虑这些信息。但是,如果您认为技术困难导致您无法进行测试,您可以自行负责调整标准信息要求(参见问答 1064)。截止日期过后,ECHA 将检查是否提交了档案更新,以及所提供的信息是否符合信息要求。如果在后续评估中,ECHA 发现部分或全部所需信息缺失,将通知国家执法机构。
Answer (EN)
No, ECHA cannot alter the deadline of the decision, because it is unanimously agreed by the representatives of the Member States.ECHA acknowledges that technical difficulties in testing a substance may lead to delays or to the inability to provide the requested information by the deadline set in the decision.In any case, we advise you to submit an update of your dossier by the deadline set in the decision, including any relevant explanations and evidence concerning the possible delay and the expected submission date. You should then update your dossier again as soon as the missing information is available.Please find below technical instructions to be followed for a successful submission:If you have received an ECHA decision requesting you to carry out a test for an endpoint, but the information is not yet available, you should address the endpoint with a data waiving record.In the field Justification for data waiving, select other: and type the following sentence in the below free text field also named other: “This information will be submitted later based on ECHA decision number TPE/CCH/SEV-x-xxxxxxxxxx-xx-xx”, where you replace the “x”-characters with the compliance check decision number issued to you by ECHA.If you cannot provide the requested study by the deadline set in the evaluation decision (e.g., due to lab capacity, difficulties in testing), in the same data waiving record, add a document from the testing facility (CRO) in the field Attached justification providing:an explanation for the delay, andtimelines for the study finalisation and study report finalisation.The National Enforcement Authority may take this information into account when deciding on possible enforcement actions.However, if you believe that the technical difficulties prevent you from testing altogether, you can, on your own responsibility, adapt the standard information requirements (see Q&A 1064).After the deadline, ECHA will check whether a dossier update is submitted and whether the information provided fulfils the information requirements. If during the follow-up evaluation ECHA finds that some or all of the requested information is missing, the national enforcement authorities will be informed.