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WTO.欧盟通报欧盟委员会执行条例草案 G/TBT/N/EU/695

来源:CCCME 时间:2020-01-13 00:00:00

WTO.欧盟通报欧盟委员会执行条例草案,关于化学品注册、评估、授权和限制(REACH)的第1907/2006号条例,赋予注册人更新注册的义务
编号:G/TBT/N/EU/695
实施条例草案澄清了注册人根据REACH第22条更新注册档案的义务。REACH审查[1]指出,公司缺乏更新其注册档案的激励措施,仍需努力纠正重要的数据差值或对测试的适当调整。这一结论是基于欧洲药监局10多年的档案评估工作得出的。REACH第22条规定,在第22(1)(a)-(i)条规定的情况下,应“毫不迟延地”进行更新,事实证明,这一措辞很难执行。因此,在第22(1)(a)-(i)条所列的个别情况下,本IR规定了明确的更新时间表。IR不影响REACH中在特定情况下需要更新的其他条款。出于法律明确性和实际可执行性的考虑,信息检索只确定了两个时间范围:3个月内和6个月内完成更新。
[1]从委员会到欧洲议会、理事会和欧洲经济和社会委员会关于REACH的操作和某些要素的结论和行动的审查的一般报告{SWD(2018)58最终版}
英文原文:
The draft Implementing Regulation (IR) provides clarifications regarding the duties of registrants pertaining to updates of their registration dossier in line with Article 22 of REACH. The REACH review[1] identified that incentives are lacking for companies to update their registration dossiers and work is still needed to rectify important data gaps or inappropriate adaptations to testing. This conclusion is based on more than 10 years of dossier evaluation work carried out by ECHA. Article 22 of REACH states that updates should be undertaken 'without undue delay' in the cases provided in Article 22(1)(a)-(i).This wording has proven to be difficult to enforce. Therefore, this IR specifies explicit timeframes for updates in the individual cases listed in Article 22(1)(a)-(i). The IR does not affect other provisions in REACH that require updates in specific situations. For reasons of legal clarity and practical enforceability, the IR identifies only two timeframes: updates to be done within 3 months and within 6 months.
[1] COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions {SWD(2018) 58 final}(技术服务中心)
 

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