我是否需要提供制造过程的描述来识别我的 UVCB 物质？

我是否需要提供制造过程的描述来识别我的 UVCB 物质？

Do I need to provide a description of the manufacturing process for the identification of my UVCB substance?

是的。生产工艺描述是UVCB物质的主要标识符。仅凭化学名称不足以描述UVCB物质，因为它未涵盖决定UVCB物质成分及其特性的所有工艺条件。此外，为了避免仅通过成分识别UVCB物质的局限性，生产工艺描述是必不可少的。因此，您需要提供两种类型的信息（成分和生产工艺描述）来识别UVCB物质。UVCB物质的生产工艺信息应包含在IUCLID第1.2节的“描述”字段中。描述通常包含以下内容：起始物料的成分和比例；按发生顺序描述相关生产步骤；用于控制成分的相关操作参数（例如温度、压力、溶剂、催化类型等）；任何提取/分离/纯化步骤的详细信息。如果您认为上述部分信息与您的物质无关，则必须在IUCLID第1.2节的“描述”字段中提供说明。此外，您还可以将反应方案或工艺流程作为附件报告，以补充生产工艺描述，该附件位于 IUCLID 第 1.2 节的“附件描述”标题下。有关在 IUCLID 6 中报告物质身份的技术说明，请参阅《注册和 PPORD 档案准备手册》第 8.3.1-8.3.2 节。

Yes. The manufacturing process description is a main identifier for UVCB substances. The chemical name alone is not sufficient to describe a UVCB substance as it does not include all the process circumstances determining the composition of the UVCB substance and therefore its identity. Moreover, the manufacturing process description is necessary to circumvent the limitations of identifying UVCB substances only by their composition. Therefore, you need to provide both types of information (composition and manufacturing process description) for the identification of UVCB substances. The information on the manufacturing process of a UVCB substance should be included in the "Description" field of IUCLID Section 1.2. The description generally consists of the following: Identity and ratio of starting materials; Description of the relevant manufacturing steps in the order they occur; The relevant operating parameters applied to control the composition (e.g. temperature, pressure, solvent, catalysis type…); Details on any extraction/isolation/purification step. If you consider that part of the abovementioned information is not relevant for your substance, you must provide an explanation in the ‘Description’ field of IUCLID Section 1.2. In addition, you can also report the reaction schemes or process workflows to complement the description of the manufacturing process as an attachment under the "Attached description" heading of IUCLID Section 1.2. For technical instructions on reporting the substance identity in IUCLID 6, see section 8.3.1-8.3.2 in the Manual on how to prepare registration and PPORD dossiers.