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答案(中文)
根据 REACH 法规第 11 条,注册时必须和可以联合提交哪些信息,请参阅数据共享指南第 6.2 节“可联合提交注册的技术档案部分概述”:http://echa.europa.eu/guidance-documents/guidance-on-reach。部分注册信息必须联合提交,而其他信息则需要单独提交。此外,注册人还可以根据 REACH 法规第 11(3) 条定义的标准,自行决定是否联合提交或单独提交某些信息。必须联合提交以下信息:物质分类和标签信息、(稳健)研究摘要,以及关于已提交的分类和标签信息、研究摘要和稳健研究摘要中哪些已经过评估员审查的说明。在特定条件下(应在档案中说明),允许单独提交这些数据(另见问答 109)。此外,每个注册人必须单独提交以下信息:制造商或进口商的身份、物质的身份、制造和使用信息、1至10吨物质的暴露信息,并注明哪些制造和使用信息已经过评估员审核。注册人可以决定合并或单独提交以下信息:物质安全使用指南、化学品安全报告 (CSR)(如有需要),并注明哪些CSR信息已经过评估员审核。
Answer (EN)
An overview of what must and what may be jointly submitted for registration based on Article 11 of the REACH Regulation is provided in Section 6.2- 'Overview of the part of the technical dossier that may be jointly submitted for Registration' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Some information of the registration has to be submitted jointly whereas other information needs to be submitted separately. Additionally, there is information the registrant(s) may decide themselves whether to submit jointly or separately, according to the criteria defined in Article 11(3) of REACH.
The following information must be submitted jointly: information on the classification and labelling of the substance, (robust) study summaries and an indication as to which of the submitted information on classification and labelling, study summaries and robust study summaries has been reviewed by an assessor. Under specific conditions, which should be explained in the dossier, a separate submission of these data is allowed (see also Q&A 109).
Additionally, each registrant must submit individually: the identity of the manufacturer or importer, the identity of the substance, information on the manufacture and use(s), exposure information for substances in quantities of 1 to 10 tonnes and an indication of which of the submitted information on manufacture and use has been reviewed by an assessor. The registrants may decide to submit the following information jointly or separately: guidance on safe use of the substance, a Chemical Safety Report (CSR) when required and an indication which of the information submitted for the CSR has been reviewed by an assessor.