供应链中的授权
下游用户可以使用被授权的物质,前提是他们根据授权给供应链上游行为人的授权条件下使用该物质(REACH第56.2条)。
Authorisation in the supply chain
A DU may use a substance subject to authorisation provided that they use the substance in accordance with the conditions of authorisation granted to an actor up the supply chain for that use (Art. 56.2 REACH).
下游用户使用附录XIV中物质的义务
如果您涉及附录XIV中的物质,则还有其他义务。
• 授权持有者及REACH第56.2条所提及(包括配制品中的物质)的下游用户,除了任何 CLP要求的标签外,须在按照授权用途将物质或含有物质的配制品投放市场前,在标签上标注授权号。按照REACH第64.9条规定公布授权号后,即应立即执行。
• 按照REACH第56(2)条规定使用物质的下游用户须在物质首次供应的三个月内向欧洲化学品管理局通报(REACH第66.1条)。
• 欧洲化学品管理局保留已申请的注册,并允许成员国的主管机构查看。
Downstream user obligations for the use of Annex XIV substances
If you are dealing with a substance included in Annex XIV there are additional obligations.
• Holders of an authorisation, as well as DUs referred to in Art. 56.2 REACH including the substances in a mixture, must include the authorisation number on the label before they place the substance or a mixture containing the substances on the market for an authorised use in addition to any CLP-required labelling. This must be done without delay once the authorisation number has been made publicly available in accordance with Art. 64.9 REACH.
• DUs using a substance in accordance with Art. 56.2 REACH must notify the ECHA within three months of the first supply of the substance (Art. 66.1 REACH).
• ECHA maintains a register of DUs who have made an application and grants access to this register to the competent authorities of the Member States.
授权审查阶
段每个授权单独设定审查期(即4年、7年、12 年) 授权在审查结束后或欧委会撤销用途授权前被视为有效。
发布的第一版附录XIV中没有规定审查期限。 如果需要延长授权用途时,授权持有者应在规定的审查日期的至少18个月前提交延长申请。
Review period of an authorisation
The review period is set for each granted authorisation individually (i.e. 4, 7, 12 years). The authorisation is regarded as valid until the end of the review period or until the European Commission withdraws the granted authorisation of use.
A time-limited review period is not set out in the first publication of Annex XIV. If it is necessary to extend the authorisation of use, the holder of the application has to apply for an extension of the review date at least 18 months before that date (see also Art. 61 REACH).
注
» 如果委员会决定拒绝授权,必须在日落日期前停止使用附录XIV中的物质。
» 这意味着如果委员会日落日期后决定拒绝授权,则必须立即停止对附录XIV中物质的未授权使用。
» 下游用户应做好准备工作,以备授权用途未获通过,并需对附录XIV中的物质采用替代物质。下游用户应制定相应的战略。
» 根据物质清单的结果,建议识别潜在的关键物质。
» 如有必要,应收集支持你的物质用途授权的数据。
NOTE
» If the Commission makes the decision to deny the authorisation, you must stop all uses of the Annex XIV substance after the sunset date.
» That means that if the Commission decision to deny the authorisation is made after the sunset date, you must stop all non-authorised uses of the Annex XIV substance immediately.
» DUs should be prepared in case an authorisation of use is not granted and a substitution of an Annex XIV substance is required. DUs should set out their strategy.
» Following the results of the substance inventory, it is recommended to identify potential critical substances
» If necessary, data to support authorisation for your use should be gathered.
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