来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-30 | 235 次浏览 | 分享到:

法律文本(REACH第3.30条)中的“每年” 的定义已经在本指南定义部分列出,指每个日历年,但就像法律文本其他部分一样没有明确说明它适用于单独物质、配制品中的物质或物品中的物质。 

The definition of “per year” in the legal text (Art. 3.30  REACH) which is copied into the definition section of  this Guideline, means per calendar year, but does not explicitly state that it applies to substances on their  own, in mixtures or in articles as other parts of the legal  text do.

此外,REACH第3.30条规定“.…..除非另有说明,对于已至少连续三年进口或制造的分阶段物质,每年的总量应该按前三个日历年的平均产量或进口量计算。”因此适用于这样进口/ 制造的物质,无需对物品中候选清单物质进行通报。REACH工作组认为这项规定的实施是为了避免需求突然增加导致法人实体无法履行注册义务的情况。 

Furthermore, Art. 3.30 REACH states “… unless stated  otherwise, for phase in substances that have been  imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the average production or import volumes for the three  preceding calendar years.” and therefore applies to substances imported/manufactured as such and has  nothing to do with notification of CL substances in  articles. TF-REACH is of the opinion that this provision  was put in place to avoid situations where a sudden  increase in demand would lead to legal entities being  unable to comply with the registration obligations.

考虑到术语“每年”一词以及是否适用于通报,我们得出的结论是在通报的情况下,“每年”是从物质被列入候选清单进行授权开始。 如果当物质被列入候选清单进行授权,在该日历年的剩余时间内没有达到1吨每年的限值, 则下一年应该从1月1日开始计算。这一决定的原因是在物质列入候选清单前公司没有物品中候选清单物质的汇总信息。 

Having given due consideration to the term “per year”  and whether it should apply to notification, we reached  the conclusion that in the case of notification the “per year” starts from when the substance is included in the CL for authorisation. In case the 1 tpa threshold is not  reached during the remainder of the calendar year when  the substance appeared on the CL for authorisation,  the calculation should start again on 1st January of  the following year. The reason behind this decision is that companies will not have accumulated information  about a CL substance being present in an article before  the substance appears on the CL.


Should a notification not be necessary during the  calendar year following the introduction of the substance  on the CL due to the tonnage not being tripped, the situation should be monitored as the tonnage threshold  may be exceeded in subsequent calendar years when  production/import of articles containing the substance increases.


某种物质在2012年6月1日被列入候选清单。 进口或生产包含该物质物品的公司必须从该时间点开始调查和计算直到该日历年结束,而不是从2012年初开始。2012年6月1日该物质的吨位为0,且在2013年1月1日重新为0。生产/ 进口含有候选清单物质的物品,每个日历年都 需要进行吨位的计算,但前提是第一次吨位计算后(含候选清单物质的物品的)生产/进口数量有所增加。每个法人实体的每个物质只需通报一次。


A substance is added to the CL on 1st June 2012. The company importing or producing articles containing  this substance will have to start investigating and calculating from that point in time until the end of that  calendar year and not from the beginning of 2012. The  tonnage of the substance is considered to be zero on 1st June 2012 and again on the 1st January 2013. The  tonnage calculation needs to be done for each calendar  year that you produce/import articles following the  inclusion of the substance on the CL, but only if there is  an increase in production/import volumes (of articles  containing the substance) after the first tonnage  calculation. A notification is only required once per  substance per legal entity.


根据O5A的计算原则,在复杂物件中物质含量超过0.1% w/w,该物质在复杂物件中多个不同物品中的含量也超过限值。同样,同种组件(即,使用了相同物质)也可以多次出现在同一复杂物件中。然而,每个法人实体只需要对每种物质通报一次,于是年度吨位,和产生的物质通报,应该根据所有未被注册的用途进行汇总。


Aggregation of substance notifications 

According to the O5A principle of calculating which  substances exceed the 0.1% w/w threshold in complex  objects, the same substance could be present above  the threshold in multiple different articles within an  imported complex object. Likewise, it follows that  the same type of component (i.e. the same type of  substance use) can be present multiple times within  that same complex object. However, notification  needs to be made only once per substance per legal  entity, and so it follows that the annual tonnage,  and any resulting substance notifications, should  be aggregated according to all uses that are not  registered uses.


• 在欧洲经济区内的公司A,进口了含有相同候选清单物质的复杂物件,“物质A”存在于多个如下物品中:


• Company A, based in the EEA, imports a complex  object which contains the same CL substance,  “Substance A”, in multiple articles as follows:

未达到案例的目的,假设上述候选清单物质, 有三项用途尚未注册。 

» 公司A必须就物质A进行一次通报,涵盖三种用途:PVC增塑剂、涂层助剂和加工助剂。

For the purposes of this example, it is assumed that  three of the above CL substance uses are not already  registered. 

» Company A must make one notification for Substance  A covering the three uses: plasticiser for PVC; coating  aid; and processing aid.