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答案(中文)
REACH 附件 VI 第 2.3.5-2.3.7 点规定了物质定性和定量鉴定的分析数据要求。多种光谱方法可用于确认物质的身份,例如紫外/可见吸收光谱 (UV/Vis)、红外光谱 (IR)、核磁共振 (NMR) 和质谱 (MS)。必须提供定量方法,例如气相色谱 (GC) 或高效液相色谱 (HPLC) 等色谱技术,并结合检测技术来确认成分。对于某些物质,这些信息可能不充分或不合适,在这种情况下,可以提供替代技术的数据。例如,对于无机物质,X 射线衍射 (XRD)、X 射线荧光 (XRF)、原子吸收光谱 (AAS)、电感耦合等离子体发射光谱 (ICP OES)、电感耦合等离子体质谱 (ICP MS) 等可能是更合适的技术。数据应在物质制造或进口时生成。有关报告分析数据的技术说明,请参阅手册中关于如何准备注册和 PPORD 档案的第 8.3.4 节。有关更多信息,请参阅 REACH 和 CLP 下的物质识别和命名指南中的第 3.3 节。对于物质的(组)纳米形式识别,需要有关纳米形式表征的相关分析信息,如 REACH 附件 VI 第 2.4.2-2.4.6 点(粒度分布、形状和形态、表面功能化、表面积)所述,包括必要的分析技术(例如电子显微镜)。欲了解更多信息,请参阅有关物质纳米形式的问答(特别是问答 1680、1686)、“适用于注册和物质识别指南的纳米形式附录”以及如何准备涵盖纳米形式的注册档案的手册。
Answer (EN)
The analytical data requirements for the qualitative and quantitative identification of a substance are specified in points 2.3.5-2.3.7 of Annex VI to REACH. Several spectroscopic methods can be suitable for confirming the identity of the substance, such as Ultraviolet and Visible Absorption (UV/Vis), Infrared (IR), Nuclear Magnetic Resonance (NMR) and Mass spectroscopy (MS). Quantitative methods, such as chromatographic techniques like Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC), coupled with a detection technique, must be provided to confirm the composition. For some substances, this information might not be sufficient or appropriate and, in such cases, data on alternative techniques can be provided. As an example, for inorganic substances, X-ray diffraction (XRD), X-ray fluorescence (XRF), atomic absorption spectroscopy (AAS), inductively coupled plasma optical emission spectroscopy (ICP OES), inductively coupled plasma mass spectrometry (ICP MS) etc. may be more suitable techniques. The data should be generated on the substance as manufactured or imported. For technical instructions on reporting analytical data, see section 8.3.4 in the Manual on how to prepare registration and PPORD dossiers.For further information, see section 3.3 in the Guidance for identification and naming of substances under REACH and CLP.For the identification of (sets of) nanoforms of a substance, relevant analytical information on characterization of nanoforms, as specified in points 2.4.2-2.4.6 of Annex VI to REACH (particle size distribution, shape and morphology, surface functionalization, , surface area), is required, including the necessary analytical techniques (e.g. electron microscopy) . For more information, see Q&As on nanoforms of substances (in particular, Q&As 1680, 1686), ‘Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification’ and Manual on how to prepare registration dossier covering nanoform.