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六溴环十二烷 (HBCDD) 条目有 2 个 EC 条目和 5 个 CAS 条目。IUCLID 授权申请卷宗中的物质识别部分(1.1 和 1.2)应该如何填写?
问题(中文)
六溴环十二烷 (HBCDD) 条目有 2 个 EC 条目和 5 个 CAS 条目。IUCLID 授权申请卷宗中的物质识别部分(1.1 和 1.2)应该如何填写?
Question (EN)
The entry for Hexabromocyclododecane (HBCDD) indicates 2 EC entries and 5 CAS entries. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?
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)
附件 XIV 中的 HBCDD 条目是一个相对宽泛的条目,可以考虑用于描述 UVCB 物质(溴位置未定义)、多组分物质(包含一种以上已定义的非对映异构体,浓度在 ≥10% 至 <80% 之间)和单组分物质(一种非对映异构体 ≥80%)。如果申请涉及一种特定的 HBCDD 物质(UVCB、多组分或单组分),则应在 1.1 和 1.2 节中描述该特定物质,并遵循《手册:如何准备授权申请》(链接至:https://echa.europa.eu/manuals)中提供的一般说明。如果申请涉及 HBCDD 条目涵盖的多种物质(例如,由于同一制造商采用不同的生产工艺,或者申请人联合申请生产/进口的 HBCDD 物质差异很大),则该申请仍可被视为“一种附件 XIV 物质”的申请。因此,ECHA 将针对“一种物质”收取费用,因此 IUCLID 档案应包含一个物质数据集。在后一种情况下,由于技术原因,应在 IUCLID 申请档案第 1.1 节中填写以下信息:IUPAC 名称:六溴环十二烷;物质类型 - 成分:其他:附件 XIV 条目下的多种物质。申请物质的实际成分可以使用可重复的块功能在第 1.2 节中单独列出为不同的成分。在每个列出的成分的“简要描述”字段中,请注明备注,例如“物质由制造地点 A 制造”或“物质由申请人 B 制造/进口”。提醒您,REACH 附件 XIV 物质条目编号(对于 HBCDD,此编号为“3”)应始终在 IUCLID 档案第 1.3 节中提供。如何准备 IUCLID 授权申请档案的一般说明请参阅手册:如何准备授权申请(链接:https://echa.europa.eu/manuals)
Answer (EN)
The Annex XIV entry for HBCDD is a relatively broad entry, which might be considered to describe UVCB substances (with undefined Br positions), as well as multi-constituent substances (containing more than one defined diastereoisomers at concentrations between ≥10% and <80%), and mono-constituent substances (one diastereoisomer ≥80%).
If the application concerns one particular HBCDD substance (either UVCB, or multi- or mono-constituent), then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals).
Should the application concern more than one substances covered by the HBCDD entry (for instance due to different manufacture processes by one manufacturer, or in case of a joint application with applicants manufacturing/importing significantly different HBCDD substances), the application can still be considered as an application for "one Annex XIV substance". Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.
In this latter case, for technical reasons in section 1.1 of the IUCLID application dossier the following information should be filled in: IUPAC name: Hexabromocyclododecane; Type of substance – Composition: other: multiple substances under Annex XIV entry. The actual compositions of the substances applying for can be listed individually as different compositions in section 1.2 by using the repeatable block-function. In the "Brief description" field of each listed composition, please indicate also a remark, e.g. "substance manufactured from manufacturing site A" or "substance manufactured/imported by applicant B".
It is reminded that the REACH Annex XIV substance entry number (for HBCDD this number is "3") shall always be given in section 1.3 of the IUCLID dossier.
General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals)