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哪些信息可以单独提交?
Question (EN)
What information can be submitted separately?
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)
根据 REACH 法规第 10(a) 条第 (iv)、(vi)、(vii) 或 (ix) 款规定,成员注册人可单独提交以下信息:分类和标签;应用附件 VII 至 XI 所获得信息的研究摘要;如附件 I 要求,应用附件 VII 至 XI 所获得信息的稳健研究摘要;以及附件 IX 至 X 所列内容的测试提案。REACH 法规第 11(3) 条允许在特定条件下“选择退出”。此类“选择退出”只能涵盖牵头注册人代表所有成员注册人提交的部分或全部终端信息。但是,无论信息是否共享,成员注册人仍需参与联合提交。
Answer (EN)
Member registrants can submit the following information separately, as specified in Article 10(a) (iv), (vi), (vii) or (ix) of REACH:
The classification and labelling;
Study summaries of the information derived from the application of Annexes VII to XI;
Robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; and
Proposal for testing where listed in Annexes IX to X.
Article 11(3) of REACH allows an "opt-out" under specific conditions. Such an "opt out" can only cover some or all of the endpoints submitted by the lead registrant on behalf of all member registrants. However, the member registrants have to remain part of the joint submission regardless of whether information is shared.