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为没有数字标识符的 UVCB 物质创建联合提交(EC/CAS)

问题(中文)
为没有数字标识符的 UVCB 物质创建联合提交(EC/CAS)
Question (EN)
Creating a joint submission for a UVCB substance without numerical identifiers (EC/CAS)
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)
在进行联合提交时,您需要首先与所有共同注册人就物质的化学名称达成一致。因此,我们建议您首先阅读欧洲化学品管理局 (ECHA) 的《REACH 和 CLP 物质识别和命名指南》第 4.3 章 UVCB 物质。此外,对于某些 UVCB 物质类型(例如油脂化学品、精油、金属等),还请咨询我们针对特定行业的物质识别支持。UVCB 物质的化学名称必须在 IUCLID 档案第 1.1 节中参考物质的“IUPAC 名称”字段中报告。即使 UVCB 物质的命名约定不遵循 IUPAC 命名法,此规定也适用。化学名称的拼写非常重要,您在 REACH-IT 联合提交中的名称和 IUCLID 档案第 1.1 节“标识”中的名称必须完全相同。这对于通过业务规则检查至关重要。名称不应包含拼写错误,单词或字符之间也不得有空格。创建联合提交1. 通过创建新的联合提交来开始您的注册。使用联合提交创建向导清单中的“手动插入物质标识”链接(见图)。2. 下一步,搜索您的物质名称,然后通过其“化学名称”创建联合提交(见图)。3. 根据您物质的命名约定,选择“其他名称”或“IUPAC名称”作为“化学名称类型”,并在字段中插入您的UVCB物质的派生名称,然后点击“继续”(见图)。这将是您的物质在REACH-IT中的名称。4. REACH-IT可能会建议其他已预注册或已注册的具有相似名称的成分;请确保您在页面底部选择“您的成分”,然后点击“继续”(见图)。5. 该名称现已添加到“选定成分”部分(见图)。点击“继续”并确认您的物质身份,然后继续使用联合提交创建向导。准备并提交您的档案,作为您创建的联合提交的一部分。请记住在IUCLID档案1.2节“成分”中报告您的UVCB物质的所有已识别成分。有关UVCB物质成分要求的更多信息,请参阅我们第32页的指南“如何准备注册和PPORD档案”。此外,请填写1.2节中的“描述”,包括起始物料的身份以及用于制造该物质的生产工艺的描述。有关制造工艺描述,请参阅问答1199。提交档案后,您的物质通过业务规则检查后,将获得一个数字标识符。从联合提交页面导出EC编号,并在任何未来更新的参考物质中使用它。在线索通过业务规则检查后提交的成员应从联合提交页面导出已颁发的 EC 编号,并使用 IUCLID 档案第 1.1 节中列出的数字标识符和正确的 IUPAC 名称。有关如何下载和导出 EC 编号的说明,请参阅问答 1258。
Answer (EN)
When forming a joint submission, you are required to first agree on the substance’s chemical name with all of your co-registrants. Therefore, we recommend that you first read ECHA's "Guidance for identification and naming of substance under REACH and CLP" chapter 4.3. UVCB substances. Also consult our Sector-specific support for substance identification, on certain UVCB substance types (e.g. oleochemicals, essential oils, metals, etc.).The chemical name of the UVCB substance must be reported in the ‘IUPAC name’ field of the reference substance in section 1.1. of your IUCLID dossier. This applies even if the naming conventions for UVCB substances do not follow the IUPAC nomenclature.The spelling of the chemical name is important, the name needs to be identical both in your joint submission in REACH-IT and in IUCLID dossier section 1.1 ‘Identification’. This is important in order to pass the business rules check. The name should not contain spelling errors or additional spaces between words or characters.Creating a joint submission1. Start your registration by creating a new joint submission. Use the ‘insert the substance identity manually’ link, found in the checklist of joint submission creation wizard (see picture).2.In the next step, search for your substance name and then create the joint submission by its ‘chemical name’ (see picture).3.Select ‘other name’ or ‘IUPAC name’ depending on the naming convention of your substance as the ‘chemical name type’ and insert the derived name of your UVCB substance into the field and click continue (see picture). This will be the name of your substance in REACH-IT.4.REACH-IT might suggest other already pre-registered or registered constituents with similar names; please ensure that you select ‘your constituent’ at the bottom of the page and click ‘continue’ (see picture).5.The name has now been added to the section ‘selected constituents’ (see picture). Click ‘continue’ and confirm you substance identity and continue with the joint submission creation wizard.Prepare and submit your dossier as part of the joint submission you created.Remember to report all the identified constituents of your UVCB substance in IUCLID dossier section 1.2 ‘composition’. For further information on composition requirements for UVCB substances consult our guidance “How to prepare registration and PPORD dossiers.” on page 32. Also, fill in the ‘Description’ in section 1.2 including the identity of the starting materials and a description of the production process used to manufacture the substance. For Manufacturing process description see Q&A 1199.Once you have submitted your dossierA numerical identifier will be issued to your substance once it has passed the business rules check. Export the EC number from the joint submission page and use it in the reference substance in any future updates. Members submitting after the lead has passed the business rules check should export the issued EC number from the joint submission page and use the numerical identifier and the correct IUPAC name in section 1.1 of the IUCLID dossier. Instructions on how to download and export the EC number can be found in Q&A 1258.