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)
是的,他确实需要。通告者(即制造商和进口商)必须始终提供“未分类”的理由。根据提交手册中应用的原则 - 如何准备注册和 PPORD 档案,该手册可在 ECHA 网站 https://echa.europa.eu/manuals 上获取。未分类的原因应根据以下原则选择: - 如果您没有相关数据或其他可与分类标准进行比较的充分可靠信息,则应选择“缺乏数据”; - 如果您有数据或其他信息,但不可靠(例如数据质量差),或者您有几个模棱两可的研究结果或信息,则应选择“不确定”。现有的数据/信息不能被视为分类的坚实基础; - 如果物质经过适当的高质量研究测试或有其他高质量信息可用,则应选择“结论性但不足以进行分类”。还指出,CLP 中存在某些“分类豁免”: - 如果物质被归类为皮肤腐蚀类 1,则无需将其归类为严重眼损伤(反之亦然), - 如果物质被归类为某些物理危险,则无需将其归类为某些其他危险。如果某种物质具有特定的物理状态,例如气体,则无需将其归类为氧化性固体或腐蚀性金属。对于此类分类豁免,您应选择“结论性,但不足以进行分类”作为未分类的原因。请注意,如果未提供特定分类,则必须选择一个原因。选择哪个原因由公司决定。如果您未在 IUCLID 6 中填写任何“未分类”的原因,则档案将无法通过 TCC(技术完整性检查)。
Answer (EN)
Yes, he does. Notifiers, i.e. manufacturers and importers, will always have to provide a justification for "no classification". In line with the principles applied in the Submission Manual - How to prepare registration and PPORD dossiers, available on the ECHA web site at: https://echa.europa.eu/manuals
"The reason for no classification should be selected according to the following principles:
- "data lacking" should be selected if you do not have relevant data or other adequate and reliable information that can be compared with the classification criteria;
- "inconclusive" should be selected if you have data or other information but which is not reliable (e.g. data of poor quality) or if you have several equivocal study results or information. The available data/information cannot be regarded as a firm basis for classification;
- "conclusive although insufficient for classification" should be selected in cases where a substance is tested with the appropriate high quality study or where other high quality information is available.
It is also pointed out that there are certain 'classification waivers' in CLP:
- if a substance is classified for skin corrosion cat.1, it does not need to be classified for serious eye damage (but not vice versa),
- if a substance is classified for certain physical hazards, it does not need to be classified for certain others,
- if a substance has a particular physical state, e.g. it is a gas, it does not need to be classified as an oxidising solid or as corrosive to metals.
In case of such classification waivers you should select "conclusive, but not sufficient for classification" as a reason for no classification.
Note that one reason must be selected where a particular classification is not provided. It is up to the company to decide which reason to select. In case you do not fill in any reason for "no classification" in IUCLID 6, the dossier will fail the TCC (technical completeness check).