来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-26 | 144 次浏览 | 分享到:


If a DU identifies a new hazard of a substance or a substance in a mixture, the supplier has to be informed  in order to enable the appropriate risk assessment to be performed. The purpose is to cover the hazards in an update of his registration dossier and to communicate  down the supply chain the appropriate Risk Management  Measures (RMMs)


下游用户有义务了解REACH信息传递的工具 (如:安全数据表/扩展安全数据表、使用说明、暴露状况等)。因此,强烈建议下游用户掌握阅读包括用途描述在内的安全数据 表/扩展安全数据表信息的方法。 为了与供应商暴露状况进行比较,下游用户应利用欧洲化学品管理局指南规定的用途描述,编制自身特定使用条件下的暴露状况。 


DUs are obliged to understand the REACH  communication tools (e.g. SDS/Ext-SDS, use  descriptors, exposure scenarios etc.). Thus, it is  highly recommended that DUs learn how to read the  information in the SDS/Ext-SDS including the use descriptors.  In order to be able to compare the suppliers’ exposure  scenarios, DUs should prepare their own ESs for their use conditions, using the Use Descriptors as  described in the ECHA Guidelines.

下游用户可为注册准备工作提供帮助。下游用户有权以书面形式(纸张或电子形式)向供应商告知其物质用途,以使其成为确认用途。下游用户也可提供一般用途描述系统,此系统是向供应商确认的最简化方式。下游用户在确认其物质用途时,如有必要,应提供足够的信息,以使供应商能够在化学安全评估中,确定暴露状况/用途和暴露类别(REACH第37(2)条) 。 

DUs may assist in the preparation of a registration. They  have the right to make known in writing (on paper or electronically) their use(s) to the supplier so that they become identified uses. A DU can also provide a system  of brief general descriptions of uses that can be used as a minimum to identify such uses to the supplier. In making the use(s) known, DUs must provide sufficient  information to allow the supplier to prepare an exposure  scenario/use and exposure category that can be included in the chemical safety assessment (Art. 37.2  REACH) if necessary.


The deadline for this feedback communication was 1 year before the relevant registration deadline.


For any new registration after May 2018 it is strongly  advised that DUs start communicating as early as  possible with their suppliers.

如果下游用户以书面形式正式向供应商要求将其物质用途包含在确定用途,供应商应按照 REACH第14条,对用途进行评估,如果(出于保护人体健康或环境的原因)不能将此用途定为确认用途,则供应商必须立即以书面形式向欧洲化学品管理局和下游用户提供作此决定的原因(REACH第37.3条)。 

If a DU makes a formal request in writing to a supplier to have the use(s) of a substance included and the supplier, after having assessed the use in accordance  with Art. 14 REACH, is unable to include it as an identified  use (for reasons of protection of human health or the environment), the supplier must without delay provide ECHA and the downstream user with the reason(s) for that decision in writing (Art. 37.3 REACH).


For suppliers or distributors with only a small number of customers, it is possible to communicate by letter.  However, most suppliers (and distributors) within the automotive industry have significantly more complex  supply chains with a large number of customers of different sizes. For these companies, there is a great deal of concern that using letters could result in an unmanageable administrative burden. The use of  electronic exchange of information is recommended  (see also Chapter 5.6.3 of this Guideline).


汽车制造商及一级供应商一般不会填写公司具体的暴露状况调查表,但需要其预填写的电子表格(最好采用下游用户协调组织(DUCC)用户模板及/或欧洲化学工业委员会(CEFIC)模板),这类表格只需检查其完整性,即包括了你的确认用途。 物质或配制品的物质供应商应联系相应的与物质相关的组织,以确保其用途被定为一般暴露状况中的确认用途。(请参见附录L3“ 汽车行业对暴露状况的建议”) 


Vehicle manufacturers and tier one suppliers in  general will not respond to company specific  questionnaires in regard to exposure scenarios, but  require a pre-populated spreadsheet (preferably  the DUCC User template and/or CEFIC template) that  needs only to be checked for completeness i.e. that  identified uses are covered. Suppliers of substances or substances in mixtures are urged to contact the appropriate association for the substance in question, to make sure that  their use becomes an identified use in the generic  exposure scenario (see Annex L3 “Automotive  Industry Recommendation on Exposure Scenarios”).


To protect intellectual property rights it is recommended that the DU explains the use in general terms.  Nevertheless in special cases it may be useful to communicate in detail with the supplier to make sure  that all conditions of use and/or risk management measures are covered by the exposure scenario.


• 第一步,确认工业生产过程中所用的单独物质及配制品中的物质(参见第5.3节)。 

• 第二步,如果供应商计划实施注册程序,应询问供应商是否制定了覆盖其用途在内的用途和暴露状况。 

• 下游用户也可查看提供给他们的安全数据表/扩展安全数据表,确认其物质用途及所有的使用条件/风险管理措施是否都已包括在内(后见第5.6.1节和5.6.2节)。如果供应商未制定详细的使用条件和暴露状况,下游用户可主动向其供应商提供与制定暴露状况/用途相关的信息,以确保将其用途包括在内。 

DU should therefore:  

• As a first step, identify the substances and substances in mixtures used in their industrial processes (see  Chapter 5.3).  

• As a second step, if the supplier intends to carry out  registration procedures, ask whether the supplier has already established use and exposure scenarios covering their use(s). 

• DU may also check SDSs/Ext-SDSs provided to them to see whether their uses and all conditions of use/ RMMs are already covered (see next Chapters 5.6.1 and 5.6.2). If the supplier has not elaborated a use  and exposure scenario, a DU may take a proactive  role and provide their supplier with information to  develop an exposure scenario/use in order to ensure  that their uses will be covered.


汽车行业下游用户对单独物质或配制品中物质的使用应包括在供应商的注册卷宗中,以确保此用途成为确认用途。 下游用户应尽早确认其供应商是否有效地支持他们对物质的使用,以确保物质/配制品物质的持续供应。 可通过查看扩展安全数据表,对产量超过10吨每年的有害物质进行确认。 


The use of a substance on its own or in a mixture by DUs within the automotive industry should be covered in the supplier’s registration dossier so that  the use becomes an identified use. DUs must check as soon as possible whether or not  their supplier will effectively support their use(s), in  order to ensure continuous supply of the substance/ substance in mixture.  This check can be done for hazardous substances  manufactured above 10 tpa by reading the Ext-SDS.


It is in the DUs interest to make sure that the substances they use will be registered in time to avoid  possible disruption. The consequence of being put in contact with a would-be registrant could influence a  company’s business case and therefore the purchasing  department must be involved. Even if a substance is  pre-registered a DU cannot rely on a registration being  made for that substance.