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4-(1,1,3,3-四甲基丁基)苯酚乙氧基化物(条目 42)和 4-壬基苯酚(支链和直链,乙氧基化物)(条目 43)条目分别涵盖多种物质。IUCLID 授权申请档案中的物质识别部分(1.1 和 1.2)应如何填写?

问题(中文)
4-(1,1,3,3-四甲基丁基)苯酚乙氧基化物(条目 42)和 4-壬基苯酚(支链和直链,乙氧基化物)(条目 43)条目分别涵盖多种物质。IUCLID 授权申请档案中的物质识别部分(1.1 和 1.2)应如何填写?
Question (EN)
The entries for 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (entry 42) and 4-Nonylphenol, branched and linear, ethoxylated (entry 43) cover several substances each. 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)
这些附件XIV条目相对较宽泛,涵盖定义明确的物质以及UVCB物质、聚合物和同系物。如果申请涉及其中某个条目范围内的某种特定物质,则应按照《手册:如何准备授权申请》中的通用说明,在1.1和1.2节中对该特定物质进行描述。如果申请涉及适用条目(即授权清单中的条目42或条目43)涵盖的多种物质,则该申请仍将被视为针对该特定条目的“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,出于技术原因,IUCLID 申请档案第 1.1 节应包含以下信息:IUPAC 名称:授权清单中条目的名称(分别为“4-壬基酚,支链和直链”或“4-(1,1,3,3-四甲基丁基)苯酚,乙氧基化”);物质类型 - 成分:“其他”:“附件 XIV 条目下的多种物质”。在这种情况下,可以在第 1.2 节中提供有关申请物质实际成分的可用信息,并使用可重复的块功能将其列为不同的成分。需要提醒的是,在所有情况下,REACH 附件 XIV 物质条目编号(这些条目的编号分别为“42”和“43”)都应在 IUCLID 档案第 1.3 节中提供。手册:如何准备授权申请中提供了有关如何准备 IUCLID 授权申请档案的一般说明。需要注意的是,如果申请同时涉及两个条目(42 和 43),则需要提交一份多物质档案。在这种情况下,ECHA 将根据手册中的说明,对两种物质收取费用,因此 IUCLID 档案应包含两个物质数据集。
Answer (EN)
These Annex XIV entries are relatively broad entries, covering well-defined substances and UVCB substances, polymers and homologues. If the application concerns one particular substance within the scope of one of these entries, 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. If the application concerns more than one substance covered by the applicable entry (i.e., either entry 42 or entry 43 in the authorisation list), the application will still be considered as an application for "one Annex XIV substance" for that specific entry. 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 section 1.1 of the IUCLID application dossier should contain the following information: IUPAC name: the name of the entry as it appears in the Authorisation List (“4-Nonylphenol, branched and linear” or “4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated” accordingly); Type of substance – Composition: “other:” “multiple substances under Annex XIV entry”. In this case, in section 1.2 the available information about the actual compositions of the substances applying for can be provided, listed as different compositions by using the repeatable block-function. It is reminded that in all cases the REACH Annex XIV substance entry number (for these entries the number is "42" and “43” accordingly) shall 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. It is noted that in the case the application concerns both entries (42 and 43) a single multi-substance dossier will need to be submitted. In this case, ECHA will charge a fee for two substances and the IUCLID dossier shall accordingly contain two substance datasets, according to the instructions provided in the manual.