进口到欧盟用作运输分离中间体的物质，在用作中间体之前经过纯化步骤后，能否保持其中间状态？

进口到欧盟用作运输分离中间体的物质，在用作中间体之前经过纯化步骤后，能否保持其中间状态？

Can a substance that is imported into the EU for use as a transported isolated intermediate; maintain its intermediate status where it undergoes a purification step prior to its use as an intermediate?

如《中间体指南》附录4（第35页）所述，“由于制造工艺的实际性质以及制造场所的财政属性，在物质(A)的制造和其在物质(B)制造中的使用之间可能需要一个或多个步骤，以促进/确保物质B合成过程中的正确化学处理。” 因此，在中间体制造之后、合成之前进行的必要纯化并不妨碍其被视为中间体。REACH法规第3(15)(c)条并不要求运输分离中间体的制造及其合成必须在同一法人实体运营的场所进行。但是，为了享受REACH法规第18条规定的注册卷宗信息减少的优惠，注册人必须确保该物质在其整个生命周期内在严格受控的条件下进行处理——即使经过纯化也是如此。还必须确保该物质始终用于制造、消耗或合成另一种物质。中间体指南可在 ECHA 网站上查阅：http://echa.europa.eu/guidance-documents/guidance-on-reach

As described in Appendix 4 of the Guidance on Intermediates (page 35)" due to the practical nature of manufacturing processes and to the fiscal attributes of manufacturing sites, one or more steps between the manufacturing of the substance (A) and its use in the manufacturing of substance (B) may be necessary to facilitate/ensure proper chemical processing in the synthesis of substance B." Therefore, necessary purification of the intermediate, which takes place after its manufacture and before the synthesis, does not prevent it from being considered an intermediate. Article 3(15)(c) of the REACH Regulation does not require that the manufacture of the transported isolated intermediate and its synthesis is done on sites operated by the same legal entity. However, in order to benefit from the reduced information requirements for registration dossiers submitted under Article 18 of the REACH Regulation, the registrant must ensure that the substance is handled under strictly controlled conditions throughout its lifecycle - also if it undergoes a purification. It must also be ensured that the substance is always manufactured for and consumed in or used in the synthesis of another substance. The Guidance on Intermediates is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach