主题：【转帖】注册人的更多责任

Article 22
Further duties of registrants
1. Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:
(a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;
(b) any change in the composition of the substance as given in section 2 of Annex VI;
(c) changes in the annual or total quantities manufactured or imported by him or in the
quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;
(d) new identified uses and new uses advised against as in section 3.7 of Annex VI for
which the substance is manufactured or imported;
(e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;
(f) any change in the classification and labelling of the substance;
(g) any update or amendment of the chemical safety report or section 5 of Annex VI;
(h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;
(i) any change in the access granted to information in the registration.
The Agency shall communicate this information to the competent authority of the relevant Member State.
2. A registrant shall submit to the Agency an update of the registration containing the
information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the competent authority of the relevant Member State that the information is available on its database.
3. The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration. In cases where the update is in
accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.
4. In cases covered by Articles 11 or 19, each registrant shall submit separately the
information specified in paragraph 1(c) of this Article.
5. An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.
第22条 注册人的更多责任
1.注册后，注册人有责任主动地、无不恰当延迟地更新与其注册相关的信息，并在下列情况下向化学品管理局提交：
（a）自身状况的任何变更，如物品制造商、进口商或生产商身份的变更、或其身份的变如姓名或住址；
（b)附件Ⅵ第2部分规定的物质成分的任何变化；
（c)年产量/年进口量或总产量/总进口量的变化，或生产或进口的物品中物质的总量，只要些变化导致吨位范围的变化，包括停止制造；
（d）制造或进口物质用于新确定的用途和提议的与附件Ⅵ第3.7部分规定相反的新用途；
（e〕有理由认为注册人已得知的物质对人类健康和/或环境风险方面的新知识，这些知
全数据表或化学品安全报告的变化；
（f）质分类和标记的任何变更；
（g）化学品安全报告或附件VI第5部分内容的更新和修正；
（h）注册人确认需要进行附件IX或附件X所规定的试验，在此情况下应提出试验提案
（i）在注册过程中准许获取信息途径的任何变化
化学品管理局应将此类信息通报给各相关成员国的主管部门。
2.注册人应在决定规定的期限内，向化学品管理局提交注册更新信息，其中包括根据第40条、第41条或第46条做出的决定所要求的信息，或根据第60条和第73条的规定正在考虑中的决定所要求的信息。化学品管理局应向各相关成员国的主管部门通报，告之从其数据库中可获得这些信息。
3.对每次更新的注册，化学品管理局应根据第20条第2款第1段和第2段的规定，进行一次完整性审查。对于根据第12条第2款和本条第1款(c)项所做的更新，化学品管理局应对注册人所提供的信息进行完整性审查，必要时第20条第2款可调整适用。
4.对于第11条或第19条所涵盖的情况，每个注册人应分别提交本条1款(。)项所规定的信息。
5.根据第9篇的规定，要求更新信息应交纳相关部分的费用。