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REACH绿色合规---- 安全数据表和下游用户义务 (REACH符合性检查)
来源:上海沐睿 | 作者:沐睿环境-莉哥 | 发布时间: 2021-08-26 | 164 次浏览 | 分享到:

安全数据表是一种被广泛认可且有效的向下游用户提供关于欧洲经济区内化学物质和配制品的信息的方法。安全数据表是REACH系统不可分割的一部分。 

SDSs have been a well-accepted and effective method  for the provision of information to DUs in regard to  chemical substances and mixtures in the EEA. They  have been made an integral part of the system of  REACH.


安全数据表提供了一种传递符合以下任一标准的物质和配制品的相关安全信息的途径: 

The SDS provides a mechanism for transmitting  appropriate safety information on substances and  mixtures which meet any of the following criteria:


• 根据CLP分类为危险品; 

• 符合REACH附录VIII规定的持久性、生物累积性和毒性标准;

• 符合REACH附录VIII规定的高持久性和高生物累积性标准; 

• 因其他原因包含在授权候选清单中; 

• 特定条件下不符合有害等级标准的配制品 (REACH第31.3条) 

• classification as hazardous according to CLP; 

• persistent, bioaccumulative and toxic (PBT) according to REACH Annex VIII; 

• very persistent and very bioaccumulative (vPvB)  according to REACH Annex VIII;  

• included in the CL for authorisation for any other  reason; 

• under certain conditions some mixtures which do  not meet the criteria for classification as hazardous  (Art. 31.3 REACH).


注:

按照REACH第31条规定,物品无需编制安全数据表。但按照烟火指令2007/23/EC, 目前车辆所用的点火装置需编制安全数据表,并应将其提供给专业用户。 

NOTE:

According to Art. 31 REACH, an SDS is not required for articles. However according to Art. 13 of the Pyrotechnic Directive 2007/23/EC, an SDS is  currently required for pyrotechnic articles as used in  vehicles and supplied to professional users.


安全数据表/扩展安全数据表包括相关化学品安全报告(CSR)中的任意一个信息任意如果存在。安全数据表/扩展安全数据表中的信息必须与化学品安全报告和注册卷宗中的信息一 致。通常,安全数据表/扩展安全数据表采用预定义用语编制。 

The SDS/Ext-SDS includes information from the  relevant Chemical Safety Report (CSR) if one exists.  The information provided in the SDS/Ext-SDS must be  consistent with the information in the CSR as well as  with the registration dossier. Usually an SDS/Ext-SDS is created by using pre-defined phrases.


注:

汽车行业建议使用欧洲用语名录 (EUPhraC)提供的标准用语,该名录的德语版和英语版可免费获取。本名录所含用语结构合理,经证明,对安全数据表的编制非常有用。 本名录将不断更新,请查看地址:  www.euphrac.eu 

NOTE:

The automotive industry recommends using the  standard phrases provided by European Phrase Catalogue (EuPhraC), which is available free of  charge in German and English. This catalogue  contains phrases in a well-structured form which  have been shown to be useful in SDSs. The catalogue  is being updated continuously and is available at:  www.euphrac.eu


另外,根据REACH第31.7条规定,需编制化学品安全报告的注册者和用户必须将相关的暴露状况加入到安全数据表附录中,形成扩展安全数据表。下游用户在编制扩展安全数据表时,必须考虑供应商提供的相关暴露信息。 5.6 安全数据表和下游用户义务  (REACH符合性检查) 

In addition, according to Art. 31.7 REACH, registrants and users that had to prepare a CSR must place the relevant exposure scenario(s) into an annex of the SDS which then becomes an Ext-SDS. A DU has to take into consideration relevant exposure information received  from suppliers when compiling his Ext-SDS.


安全数据表适用于专业的下游用户,用以提供安全使用物质或配制品的必要信息。安全数据表是提供与人体健康和环境保护密切相关的数据的重要文件。 

The SDS is intended for professional DUs in order  to provide the information necessary to use the  substance or mixture safely. It is an essential document  for providing data with particular relevance to the  protection of human health and the environment.


供应商向其在12个月内供应过物质或配制品的所有接收方提供授权、限制或风险管理措施的更新信息。这种信息应免费提供,采用纸张形式,最好是电子形式。所有注册后的更新都必须包括注册号。但注册号的存在并不会导致安全数据表的更新。 

Any updated information on authorisation, restriction or risk management measures must be made available  by the supplier to all former recipients to whom they  have supplied the substance or mixture within the 12 preceding months. It should be made available free of charge, on paper or preferably electronically.  Any updates following registration must include the  registration number. However, the existence of a  registration number does not trigger an update of the  SDS.


另外还必须承担对非有害物质的信息传递责任 (REACH第32条)。在这种情况下,供应商必须提供以下信息: 

• 物质是否需要授权及本供应链中获得授权或拒绝授权的详细信息(如:授权号、特殊规定)。 

• 所有限制的详细信息 

• 确认并采用相应有效安全风险管理措施所需的所有其他可用的以及相关的物质信息。如果因上述原因之一提供信息,则必须提供注册号(如果有)。

Also for non-hazardous substances communication  duties have to be fulfilled (Art. 32 REACH). Here the  supplier has to provide information on:  

• Whether the substance is subject to authorisation  and details (e.g. authorisation number, special provisions) of any authorisation granted or denied in this  supply chain.  

• Details of any restriction.  

• Any other available and relevant information about  the substance that is necessary to enable appropriate risk management measures to be identified and  applied. In case information has to be given for one of  the above reasons, the registration number has to be  provided if available.


 一般来说,注册者(即制造商或进口商)向欧洲化学品管理局提供的信息与向供应链(有或没有安全数据表)中的下游用户信息传递的信息存在区别。 

In general there is a difference between the information  the registrant (i.e. manufacturer or importer) has  to provide to ECHA and the information he has to  communicate along the supply chain (with or without  SDS) to the DU.


下图所示为供应链中物质的注册与信息传递要求一览表。更详细的一览表,请参见附录P:

The following picture provides an overview of the  registration and communication requirements for a  substance along the supply chain. A more detailed  overview is provided in Annex P:




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