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我想利用REACH法规附件V(6)中关于水合物注册的具体规定。我应该如何申报注册涵盖的不同成分?

问题(中文)
我想利用REACH法规附件V(6)中关于水合物注册的具体规定。我应该如何申报注册涵盖的不同成分?
Question (EN)
I want to make use of the specific provision in Annex V(6) to the REACH Regulation for the registration of hydrates. How should I report the different compositions that are covered by the registration?
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)
您应该按以下步骤操作:在第 1.1 节中,为无水物质分配参考物质,并选择相应的物质类型(单组分、多组分或 UVCB)。由于技术原因,请在第 1.2 节中将无水物质的成分作为第一成分进行报告,成分类型为“物质的法人实体成分”。如果您生产或进口该无水物质,则应将该物质的成分作为第一成分进行报告。如果您不生产或进口该无水物质,您仍然需要在第 1.2 节中将与该无水物质相对应的成分作为第一成分进行报告。在这种情况下,我们建议您报告理论成分,其中无水物质的参考物质的典型浓度为 100% (w/w)。选择“物质的法人实体成分”作为成分类型。在“描述”字段中,注明报告的成分为理论成分。在“偏差理由”字段中,请注明以下内容:“该成分既非生产也非进口。仅出于技术原因进行报告,因为适用水合物注册豁免”。请报告所有其他相关成分,包括注册涵盖的不同水合物的成分。对于涉及水合物的成分,请在“偏差理由”字段中注明“无水物质注册涵盖的水合物”。所报告水合物成分的“成分类型”应为“物质的法人实体成分”。
Answer (EN)
You should proceed as follows: Assign the reference substance for the anhydrous substance and select the corresponding type of substance (mono-constituent, multi-constituent or UVCB) in Section 1.1. For technical reasons, report the composition of the anhydrous substance as the first composition with the composition type "Legal entity composition of the substance" in Section 1.2. If you manufacture or import the anhydrous substance, you should report the composition of that substance as the first composition. If you do not manufacture or import the anhydrous substance, you will still need to report a composition corresponding to the anhydrous substance as the first composition in Section 1.2. In this case, we recommend you to report a theoretical composition where the reference substance for the anhydrous substance is reported at a typical concentration of 100 % (w/w). Select "Legal entity composition of the substance" as the type of composition. In the "Description" field, indicate that the reported composition is theoretical. In the "Justification for deviation" field, indicate the following: "This composition is neither manufactured nor imported. It is only reported for technical reasons because the derogation for the registration of hydrates is applied". Report all other relevant compositions, including the composition of the different hydrates that are covered by the registration. For the compositions referring to hydrates, indicate "Hydrate covered by the registration of the anhydrous substance" in the "Justification for deviation" field. The ‘Type of composition' of the reported hydrate compositions should be ‘legal entity composition of the substance'.