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【转帖】注册 Registration

REACH/EUP

  • 要求年产量超过1吨的所有现有化学品和新化学品及应用于各种产品中的化学物质注册其基本信息。只有通过注册的物质才能在欧盟内生产或进口。

    每一个物质的生产商和进口商须向化学管理署提交该物质的注册档案,并缴纳相应的费用。但是要求联合提交同一个物质的注册信息,即遵循“一个物质,一次注册”原则。作为联合注册的成员,可以与其他成员共同分摊注册的费用。

    为了易于管理、接受大量注册档案的提交,提交给化学署的注册档案需电子化处理。化学管理署会给每一个收到的注册档案一个注册编号和注册日期,并立刻把这些信息传递给注册人。

    在提交注册文档后的三周内,化学署会对提交的注册文档作一个完整性确认,以确定该档案符合REACH注册的要求。如果注册档案不完整,化学署将在注册提交之日起的三周内,通知注册人在规定的期限内提交进一步信息,把注册档案补充完整。

    对于分阶段物质,提供了预注册程序。通过预注册的物质,就可以继续在欧盟内生产和销售,只须在规定的最后期限前通过正式注册。

    对于分阶段物质,在期限内有大量的注册需要完成。因此,化学署对于每个提交的注册,需要在在3周内检查注册的资料是否完整;但是对于在截止日期前2个月内提交的每个注册,欧盟将在3个月内来检查注册是否完整。

      注册人需要在设定的期限内向化学署提交更新的档案,要求提交缺少的信息。然后化学署确定这些信息的提交日期,在3个星期内对更新的档案再进一步检查其完整性。

      如果注册人没在期限内能完成注册,注册将被化学署拒绝,制造商或进口商将不能开始或继续物质的制造或进口。

      如果有必要,化学署将会转送注册档案、注册号和日期、完整性检查的结果给成员国当局,制造商和进口商确立能够实施行动。为不完整的档案提交的补充信息,连同第二次完整性检查的结果提交给主管机关。

    All the exisiting, new chemical substances itself and which applied to every manufacture need to registrate basic information when the output in quantities of 1 tonne or more per year.Only registered substances are allowed to be manufactured or imported.
    Each manufacturer or importer of a substance shall submit his registration dossier for the substance to the Agency, accompanied by a fee.But they should submit the information of the same substance jointly,that is”one subject,one registration”.As a consortium member he only has to pay one third of the registration fee.
    The registration dossiers submitted to the Agency will be handled electronically to facilitate the management of the expected amount of registrations that will be submitted. The Agency assigns a registration number and a registration date to each registration dossier received and immediately communicates this information to the registrant.
    Within 3 weeks of the registration date, the Agency performs an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date about which further information is needed and will set a deadline for completion of the dossier.
    For phase-in substances, a considerable number of registrations are expected to arrive just before the deadlines for the registrations. Therefore, the Agency is given 3 months from each registration deadline to check the completeness of those registrations that have been submitted within 2 months of the deadlines. However, the Agency will have to check the completeness of registrations submitted more than 2 months before the deadlines, within 3 weeks of receipt.
    The registrant needs to submit the requested missing information in an updated dossier to the Agency within the set deadline. The Agency then confirms the submission date of this information and makes a further completeness check within 3 weeks of receipt of the updated dossier.
    If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the Agency and the manufacturer or importer is not allowed to start or continue manufacture or import of the substance.
    The Agency will forward the registration dossier, the registration number and date, and the result of the completeness check to the authorities of the Member States in which the manufacturers and importers are established to enable enforcement action, if necessary. Also the further information that is submitted for completion of the dossier will be forwarded to the competent authority together with the result of the second completeness check.
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  • nameylf

    第1楼2007/12/27

    俺要把这些帖子都顶一遍,以引起大家对这个问题的关注!也给楼主打打气!

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  • 仪器超市

    第2楼2007/12/27

    顶起,跟着组织走!

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  • 小鸟飞翔

    第3楼2007/12/27

    1吨是根据各成分来说还是最终产品?
    譬如:生产涂料3吨,组成包括树脂0.9吨,溶剂0.8吨,颜料0.5吨,填料,0.7吨,其他0.1吨,那需不需要注册?

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  • xuxiaohong_7624

    第4楼2008/02/19

    REACH法规中的吨数范围1吨/年,10吨/年等均指某一化学品或配制品(混合物)的年总量,与物品的量无直接关系。

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