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REACH绿色合规----一般要求和豁免
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-30 | 427 次浏览 | 分享到:

如果物品中的物质符合以下REACH第7.2条规定的所有条件,欧洲经济区生产商与自欧洲经济区以外进口物品的进口商(或唯一代表)必须向欧洲化学品管理局进行通报: 

• 物质已经纳入到授权候选清单中; 

• 物品中的物质含量高于浓度0.1% w/w;

• 物品中的的浓度高于0.1%w/w的物质,其制造量或进口量高于1吨每年(每个生产商/进口商)。 

Both producers of articles in the EEA and importers  (or OR) of articles from outside the EEA must notify  ECHA if a substance present in articles meets all of the following conditions in line with Art. 7.2 REACH: 

•The substance has been added to the CL for authorisation; 

•The substance present in articles is above a concentration of 0.1% w/w;  

•The substance is present in those articles where the  concentration exceeds 0.1% w/w in quantities totalling over 1 tpa (per producer/importer).


以下任一情况下无需通报: 

•该物质已经由供应链中成员对此用途进行了注册(REACH第7.6条);

•物品的生产商或进口商可以在正常或合理预见的使用条件下(包括处置)排除对人类或环境的暴露。在这种情况下,物品的生产商或进口商必须向物品接收方提供适当的信息(REACH第7.3条)。 

这些一般要求和豁免的详细信息会在后续部分给出。 

Notification is not required in either of the following  conditions: 

•The substance has already been registered for  that use by a member of any supply chain (Art. 7.6 REACH);  

•The article producer or importer can exclude exposure to humans or the environment during normal or  reasonably foreseeable conditions of use, including  disposal. In this case, the article producer or importer  must supply the appropriate information to the recipient of the article (Art. 7.3 REACH). 

The details of these general requirement and exemptions are given in the following sections.


谁必须进行通报? 

假如条件满足,以下任一方必须进行物品中的候选清单物质的通报: 

•将物质添加到物品中的欧洲经济区物品生产商(例如,通过将含有候选清单物质的聚合树脂注塑生产成为聚合物部件);

•从非欧洲经济区生产商处进口物品或者复杂物件的进口商。 

因此,欧洲经济区内物品供应商的所有客户都不需要履行通报,因为通报义务仅属于欧洲经济区物品生产商或者进口商(欧洲法院判决案 例C 106/14判决,2015年9月10日)  

Who must make the notification? 

The notification of a CL substance in an article, assuming  the conditions are met, must be made by either: 

•The EEA producer of the article who combines the  substance into the article (e.g. produces polymer  parts by injection moulding of a polymer resin that  includes a CL substance); 

•The importer of the article, on its own or within a complex object, from a non-EEA producer.

It follows that any customer of an EEA supplier of an  article does not need to notify, as the duty to notify  falls only on EEA producers or importers of articles (ECJ Case C 106/14 Judgment, 10 September 2015).


例如

•欧洲经济区内公司A从非欧洲经济区内制造商处进口物品A(单独物品或在复杂物件之内),物品A所含候选清单物质浓度大于 0.1% w/w 的限值且该物质的年进口量大于1 吨。 

» 公司A需要通报 

Examples 

•Company A, based in the EEA, imports Article A, on  its own or within a complex object, from a non-EEA  producer and that same Article A contains a CL substance above the 0.1% w/w threshold and 1 tpa yearly tonnage. 

» Notification is required by Company A.


•公司A向公司B提供物品A,公司B在欧洲经济区内将物品A组装成复杂物件B,复杂物件B所含候选清单物质浓度大于0.1% w/w 的限值且该物质的年进口量大于1吨。

» 公司B不需要再通报 

•Company A supplies Company B with Article A, and  Company B assembles this same Article A within the  EEA into a Complex Object B and the 0.1% w/w threshold and 1 tpa are still exceeded. 

» No further notification is required by Company B

•公司C从欧洲经济区内的公司A购买单独物 品A;公司C不知道物品A是否在欧洲经济区内制造或从非欧洲经济区制造商处进口。 

» 公司C不需要对物品A进行通报,因为公司C可认为公司A已经履行了对物品A的通报义务。 

•Company C buys Article A on its own from EEA-based  Company A; Company C does not know whether Article A is originally produced in the EEA or imported  from a non-EEA producer. 

» No notification of Article A is required by Company C,  since Company C can assume that Company A has  fulfilled its notification duties for Article A.


•公司C在物品A上用含有候选清单物质的涂料进行涂覆形成涂层物品C。当涂料固化后,候选清单物质含量超过0.1% w/w的限值(基于整个涂层物品C的质量),且(生 产量)大于1吨每年。 

» 公司C仅需对涂层(固化涂料)中的候选清单物质进行通报。 

•Company C coats Article A with a paint which contains  a CL substance to make a coated Article C. When the  paint is cured, the CL substance exceeds the 0.1%  w/w threshold (based on the whole weight of the  coated Article C) and the 1 tpa. 

» Notification is required by Company C only for the CL  substance in the coating (cured paint).


0.1% w/w的限值的计算

根据欧洲法院2015年的一项判决,第7.2条通报和第33条信息传递(参见第5.10节)中浓度限值“0.1% w/w”的计算必须遵循“O5A” 原则;即,计算必须参照候选清单物质在每个单独物品中的重量,或在复杂物件中每个物品中的重量(见第2.1节,“物品”和本指南附 录N) 

Calculation of the 0.1% w/w threshold 

According to a 2015 judgment of the European Court of  Justice, the calculation of the concentration threshold  “0.1% w/w” for both Art. 7.2 notification and Art. 33 communication (see Chapter 5.10) must follow the  “O5A” principle; i.e. the calculation must be done by  reference to the weight of the CL substance in each  article in isolation, or in each article when part of a  complex object (see Chapter 2.1, “Article”, and Annex N  to this Guideline).


O5A原则对含有高于浓度限值的候选清单物质的物品的实际影响总结如下表:

The practical impact of the O5A principle for articles  containing CL substance above the concentration  threshold is summarised in the following table:

例如: 

•候选清单物质S是塑料夹子的一种成分,塑料夹子是由公司D进口的雨刮器总成内的物品: 

•物质S的重量=0.005 g/夹子 • 夹子的重量=0.5 g(每个雨刮器组件有两 个夹子) 

•雨刮器组件的重量=20 g 

•物质在每个夹子中的含量=1.0% 

•物质在每个雨刮器组件中的含量=0.05% 

» 结论:物质限值的计算必须针对物品(夹子)内候选清单物质的重量进行计算,因此在这种情况下,物质限值超过0.1% w/w, 则需要进行通报(如果物质的还超过1吨每年的限值)。

Example 

•A CL Substance S is an ingredient of a plastic clip,  which itself is an article within a wiper assembly,  which is imported by Company D: 

•Weight of substance S = 0.005g per clip 

•Weight of clip = 0.5g (two clips per wiper assembly) 

•Weight of wiper assembly = 20g  

•Percentage substance in each clip = 1.0% 

•Percentage substance in each wiper assembly = 0.05% 

» Conclusion: the substance threshold calculation  must be made with respect to the weight of the CL  substance within the article (clip) alone, and so in  this case the substance threshold of 0.1% w/w is exceeded, and so notification may be required (if the  1 tpa substance threshold is also exceeded).



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