所有可用的研究是否都应纳入联合提交档案？

所有可用的研究是否都应纳入联合提交档案？

Should all available studies be included to the joint submission dossier?

是的。根据 REACH 法规附件 VI，任何可用且相关的物理化学、毒理学和生态毒理学信息都必须在注册卷宗中提供。实际上，在收集和评估所有现有信息后，注册人必须选择可靠、相关且充分的信息。对于关键研究，必须提供详尽的研究摘要；对于支持性研究，研究摘要即可。《信息要求和化学品安全评估指南》第 R.3 章和 R.4 章也提供了有关信息收集和评估的进一步指导。

Yes. According to Annex VI to the REACH Regulation any physicochemical, toxicological and ecotoxicological information that is available and relevant must be provided in the registration dossier. In practice, after gathering and assessing all existing information, the registrant has to select the information that is reliable, relevant and adequate. For key studies, robust study summaries have to be provided; for supporting studies, study summaries are sufficient. Further guidance on information gathering and evaluation is also provided in chapters R.3 and R.4 of the Guidance on information requirements and chemical safety assessment.