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我是否必须注册经过化学表面处理的物质?

问题(中文)
我是否必须注册经过化学表面处理的物质?
Question (EN)
Do I have to register chemically surface-treated substances?
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)
在表面处理工艺中,以下物质与表面处理工艺相关:“基础物质”:以颗粒形式存在的物质,用于表面处理。“表面处理剂”:与基础物质表面发生反应的物质,即在表面处理工艺中用作起始材料的物质。“表面处理物质”:使用表面处理剂处理基础物质后得到的物质。根据 REACH 法规,如果物质经过表面处理,则所得的表面处理物质不得注册。然而,这会对基础物质和表面处理剂的注册要求产生影响。这些影响取决于经过表面处理的基础物质的形式。基础物质为纳米形态。如果基础物质为纳米形态,则根据 REACH 附件 VI,表面处理是纳米形态的表征参数。任何基础物质的表面处理以及反应条件或表面处理剂摩尔比的任何变化都会产生不同的纳米形态,必须在注册档案中具体报告。基础物质的每种纳米形态都必须根据 REACH 附件 VI 第 2.4.2 至 2.4.5 节进行表征,并在注册档案中具体报告。注册档案中涵盖的每种表面处理纳米形态都必须根据 REACH 附件 VI 第 2.4.3 节进行表征。此表征必须包括“表面功能化或处理的描述以及每种试剂的标识,包括 IUPAC 名称和 CAS 或 EC 编号”。注册档案还必须包含关于表面处理纳米形态的一组特定的危险数据(即附件 VII 至 X 的信息要求)。这组危险数据必须与根据附件 VI 表征的相应表面处理纳米形态明确关联。有关在注册中报告纳米形态的指南,请参阅物质纳米形态的问答和“适用于注册和物质识别指南的纳米形态附录”。基础物质不是纳米形态如果基础物质的形态不是纳米形态,则对物质进行任何表面处理都会导致颗粒的“二维”改性,即仅在颗粒表面与表面处理剂发生化学反应。因此,根据 REACH 物质识别和命名指南的标准,表面处理物质不能被视为混合物,也不能定义为不同的物质。关于基础物质:进行表面处理的基础物质制造商或进口商以及表面处理物质的进口商必须在基础物质的注册卷宗中包含以下信息:在注册卷宗的第 1.2 部分中:基础物质的标识;以及表面处理剂的标识和表面处理过程的描述(在“描述”字段中)。有关表面处理物质特有的任何危害或风险的信息。这些危害或风险必须在档案中通过分类和标签、化学品安全评估以及由此产生的暴露情景进行适当涵盖。关于表面处理剂:如果表面处理物质的制造商或进口商在欧盟/欧洲经济区单独生产或进口表面处理剂,则必须由其注册该表面处理剂。当表面处理剂必须注册时,注册档案必须在其第3.5节中包含“表面处理”用途的描述。
Answer (EN)
In a surface-treatment process, the following substances are relevant:“Basis substance”: Substance in the form of particles on which the surface treatment is applied.“Surface-treating agent”: Substance reacting with the surface of the basis substance, i.e. the substance used as the starting material in the surface-treatment process.“Surface-treated substance”: Substance resulting from treatment of the basis substance with the surface-treating agent.When a substance is surface-treated, the resulting surface-treated substance must not be registered as such under REACH. There are, nevertheless, consequences on the registration requirements for the basis substance and the surface-treating agent. These consequences depend on the form of the basis substance which is surface treated.The basis substance is a nanoformIn case the form of the basis substance is a nanoform, the surface treatment is a characterisation parameter of the nanoform according to Annex VI to REACH. Any surface treatment of the basis substance and any change in the reaction conditions or in the molar ratio of the surface-treating agent generates a different nanoform that must be specifically reported in the registration dossier. Each nanoform of the basis substance must be characterised and specifically reported in the registration dossier according to sections 2.4.2 to 2.4.5 of Annex VI to REACH.Each surface-treated nanoform covered in a registration dossier must be characterised according to Section 2.4.3 of Annex VI to REACH. This characterisation must include a “Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number”. The registration dossier must also contain a specific set of hazard data (i.e. information requirements of Annexes VII to X) on the surface-treated nanoform. This set of hazard data must be clearly linked to the corresponding surface-treated nanoform characterised in accordance with Annex VI.For guidelines on reporting nanoforms in a registration, see Q&As on nanoforms of substances and ‘Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification’.The basis substance is not a nanoformIn case the form of the basis substance is not a nanoform, any surface treatment of the substance would result in a “two dimensional” modification of particles, i.e. a chemical reaction only at the surface of the particles with the surface-treating agent. Therefore, a surface-treated substance cannot be regarded as a mixture nor be defined as a different substance based on the criteria of the Guidance for identification and naming of substances under REACH.Concerning the basis substance:A manufacturer or importer of the basis substance who applies the surface treatment, and an importer of the surface-treated substance must include the following information in the registration dossier of the basis substance:In Section 1.2 of the registration dossier:the identification of the basis substance; andthe identification of the surface-treating agent and a description of the surface-treatment process (in the ‘Description’ field).Information on any hazards or risks specific to the surface-treated substance. These hazards or risks must be appropriately covered in the dossier by the classification and labelling and by the chemical safety assessment and resulting exposure scenarios.Concerning the surface-treating agent:The surface-treating agent must be registered by the manufacturer or importer of the surface-treated substance if they manufacture or import the surface-treating agent on its own in the EU/EEA. When the surface-treating agent must be registered, the registration dossier must include a description of the use “surface treatment” in Section 3.5 of the registration dossier.