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每次有新的与分类相关的信息可用时,是否都需要更新 C&L 通知,还是公司可以等到注册该物质后再更新?

问题(中文)
每次有新的与分类相关的信息可用时,是否都需要更新 C&L 通知,还是公司可以等到注册该物质后再更新?
Question (EN)
Is it required to update the C&L notification every time new information relevant for classification becomes available or are companies allowed to wait until they register the substance?
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)
对于此前仅用于研发目的且在严格控制条件下每年使用量低于一吨的物质,潜在注册人在准备进行 REACH 注册时,必须收集可用数据,确定相关现有信息是否符合 REACH 法规附件 XI,并制定测试方案。在此期间,物质的分类很可能会发生变化。CLP 法规第 15(1) 条规定,制造商、进口商和下游用户有义务“毫不拖延地”评估新信息。CLP 法规第 40(2) 条进一步要求 C&L 通知人在“做出更改分类的决定时”更新其 C&L 通知。ECHA 建议潜在注册人根据具体情况,仔细考虑何时更新 C&L 通知。需要考虑的因素包括:提交注册卷宗所需的额外时间、对物质安全使用的潜在影响以及修改安全数据表和标签的实际后果。公司还应保留所有文件并咨询其成员国的相关部门。
Answer (EN)
When preparing for the REACH registration of substances which have previously been only used for R&D purposes in amounts below one tonne per year used under strictly controlled conditions, potential registrants must collect available data, determine if relevant existing information is in line with Annex XI to the REACH Regulation and develop a testing programme. During this period, there is a high likelihood that the classification of the substance will change. Article 15(1) of the CLP Regulation obliges manufacturers, importers and downstream users to assess new information "without undue delay". Article 40(2) of the CLP Regulation further requires C&L notifiers to update their C&L notification "when, ---, a decision to change the classification has been taken". ECHA recommends that the potential registrant carefully considers, on a case-by-case basis, when to update the C&L notification. Factors to be taken into consideration could, for instance, be additional time needed until the registration dossier is submitted, potential impact on the safe uses of the substance and practical consequences of revising the safety data sheet and labels. Companies should also keep all documentation available and consult the relevant authorities of their Member State.