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)
《关于联合提交数据和数据共享的委员会实施条例 (EU) 2016/9》生效后,实施了新的检查,以确保所有提交符合“一种物质,一次注册”(OSOR)原则。根据 OSOR 原则,每种物质每种注册类型(完整或中间)只能进行一次联合注册。此外,如果已经存在有效的联合提交(即主注册人已成功提交主卷宗),则同一注册类型(完整或中间)的个人注册人(即不属于联合提交的一部分)将被阻止更新其卷宗,除非他们成为联合提交的成员。ECHA 建议您采取以下步骤:找到您的共同注册人。确定物质相同性并就数据共享进行协商。对于问答 1171 中描述的情景,您可以部分或全部选择退出共同注册人联合提交的信息。但是,您的提交仍然必须在联合提交的框架内。因此,联合提交可能需要支付一定的行政费用。如果您无法就数据和费用分摊达成一致,您可以向欧洲化学品管理局 (ECHA) 提交数据共享争议。争议机制应作为最后的手段,您需要证明您已尽一切努力达成自愿协议。如果您希望提交部分或全部退出,但无法与牵头注册人就加入联合提交的条件达成自愿协议,您也可以使用上述争议机制。
Answer (EN)
Following the entry into force of the ‘Commission Implementing Regulation (EU) 2016/9 on Joint Submission of Data and Data Sharing', new checks were put in place to ensure that all submissions are in line with the ‘one substance, one registration' (OSOR) principle. According to the OSOR principle there can only be one joint registration per substance per registration type (full or intermediate).
Furthermore, if an active joint submission already exists (i.e. the lead registrant has successfully submitted the lead dossier), individual registrants (i.e. not part of the joint submission) for the same registration type (full or intermediate) are blocked from updating their dossiers, unless they become members of the joint submission.
ECHA advises you to take the following steps:
Find your co-registrants.
Establish substance sameness and negotiate on data sharing.
For the scenarios described in Q&A 1171, you can partially or fully opt-out from information submitted jointly by your co-registrants. However, your submission still has to be in the framework of the joint submission. Therefore, certain administrative fees may be applicable towards the joint submission.
If you cannot agree on the data and cost sharing, you can file a data-sharing dispute with ECHA. The dispute mechanism should be used as a last resort and you will need to demonstrate that you have made every effort to reach a voluntary agreement.
If you wish to submit a partial or full opt-out, but cannot come to a voluntary agreement with the lead registrant on the conditions for joining the joint submission, you can also use the above-mentioned dispute mechanism.