联合提交的档案中可以包含不同类别的物质吗？

联合提交的档案中可以包含不同类别的物质吗？

Can different classifications of a substance be included in the joint submission dossier?

根据 REACH 法规第 29(2) 条，SIEF 的主要目的之一是在潜在注册人之间对物质的分类和标签存在差异时就分类和标签达成一致。但是，如果所有成员注册人都同意，则牵头注册人可以在注册档案的联合部分中包含该物质的不同分类，例如，不同的杂质概况会导致不同的分类。在这种情况下，成员注册人应将其成员档案中的相关部分留空，以避免被视为选择退出该物质的分类和标签。如果成员注册人无法就在注册档案的联合部分中包含该物质的所有不同分类达成一致，则一个或多个成员注册人可以决定单独提供其物质分类（通过填写其成员档案中的相应部分）。如果是这种情况，则需要根据 REACH 第 11(3) 条进行论证。此外，如果CLP法规附件VI中提供了某种物质的协调C&L，则必须使用该协调C&L。更多信息，请参阅《如何准备注册和PPORD档案》手册。

According to Article 29(2) of the REACH Regulation, one of the main aims of the SIEF is to agree on classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants. Nevertheless if all member registrants agree, the lead registrant may include different classifications of the substance in the joint part of the registration dossier, e.g. if different impurity profiles lead to different classifications. In this case, member registrants should leave the pertinent section of their member dossier empty to avoid being treated as an opt-out for the classification and labelling of the substance. If the member registrants cannot agree on the inclusion of all the different classifications of the substance in the joint part of the registration dossier, one or more of the member registrants may decide to provide their substance classification separately (by filling in the respective section in their member dossier). If this is the case, a justification in accordance with Article 11(3) of REACH is required. In addition, in cases where a harmonised C&L for a substance is provided in Annex VI to the CLP Regulation, then that harmonised C&L must be used. Further information can be found in the manual ‘How to prepare registration and PPORD dossiers’