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REACH绿色合规----豁免:不包括物质暴露 (REACH第7.3条)
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-31 | 391 次浏览 | 分享到:

因可避免人体或环境暴露的候选清单物质而制定的通报豁免文件无需提交给欧洲化学品管理局,但应存档,以便根据要求提交给执法机构。豁免通报的理由可以是以下一项或多项: 

• 即使在废弃过程中,物品也不会产生排放物; 

• 如果物质通过技术手段加入到物品中,且具有物品不可能开裂或破损从而导致物质泄漏的解释说明; 

• 如果物质嵌入物品的基体中,并且描述了在物品的不同使用周期阶段,物品基体及物质与基体间的结合的稳定性; 

• 物质可在物品内保持完全不变及不可能移出物品或摆脱其约束(如:由于物质固有的物理化学性质或物品的特殊涂层); 

• 物品释放的物质通过技术手段得到控制或直接消除(如:废弃物热处理过程中)。 

Documentation for a notification exemption due to exclusion of human or environmental exposure to a CL substance does not need to be submitted to ECHA, but should be retained so that it can be presented to the  enforcement authorities on request. A justification of an exemption to notify could include evidence that one or more of the following applies:  

• There are no emissions from the article, even during  disposal; 

• The substance is contained in the article by technical means, and there is an explanation of why the article is unlikely to be opened, broken, or lead to release of  the substance; 

• The substance is embedded in the matrix of the article, and there is a description of the stability of the article matrix and the bonds between the substance  and the matrix during the different life cycle stages  of the article; 

• The substance remains fully immobile inside the article and does not migrate out or escape its confines  (e.g. due to the inherent physicochemical properties  of the substance, or a special coating of the article); 

• The amount of substance released from the article is  contained by technical means or directly destroyed  (e.g. during thermal treatment of waste).


注:

关于通报的提示 

» 汽车行业建议避免使用REACH第7.3条的豁免,因为证明“无暴露”比通报根据困难且成本更高。 

» 欧洲化学品管理局可能会要求通报者根据REACH第7.5条对通报的物质进行注册,即使你已经符合一般注册标准。 

» 对于在物质被列入授权候选清单前生产或进口的物品中的物质,不需要通报。 

» 包含在物品或复杂物件中的配制品不适用第7.2条。

» 每个法人实体对每种物质只需要通报一次。但是,如果条件发生了变化,如: 吨位变化,则需要对原申报进行更新。 

» 有关基于暴露豁免通报的更多信息, 请参阅欧洲化学品管理局“物品中物质 要求指南” https://echa.europa.eu/ documents/10162/23036412/articles_ en.pdf.

» 根据欧洲化学品管理局13,在某些情况下,复杂物件的生产商可能不知道物品中候选清单物质的技术功能,在这种情况下,通报者必须做出假设。 

» 候选清单可在ECHA网站上获得,它包括物质数据集,其中IUCLID文件的某些部分已填写(物质标识,组成和分类信息)。

NOTE:

Tips on notification 

» AI recommendation is to avoid using the Art. 7.3  REACH exemption, since it will likely be more difficult and costly to demonstrate “no exposure”than to make a notification. 

» ECHA may require a notifier to perform a registration of the notified substance under Art. 7.5 REACH, even if the general registration criteria are  met in your case. 

» A notification is not required for a substance in articles that were produced or imported before  the substance was included on the CL for authorisation. 

» Mixtures contained or integrated in an article or  complex object are not covered by Art. 7.2. 

» A notification needs only to be done once per substance per legal entity. However, if your circumstances change, e.g. in regard to a tonnage band  change, an update of the original notification will  be necessary.

» For more information on exposure-based exemption from notification please refer to ECHA’s“Guidance on requirements for substances in articles” https://echa.europa.eu/documents/10162/ 23036412/articles_en.pdf. 

» According to ECHA13, in some cases the producer of complex objects may not be aware of the technical function of the CL substance incorporated  into an article, in which case an assumption has  to be made by the notifier. 

» The Candidate List, which is available on the ECHA website, includes substance datasets with some  sections of the IUCLID file already filled in (substance identity, composition and classification  information).



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